Patients with diabetes mellitus not otherwise included

total cholesterol greater than 5.5 mmol per L

Aboriginal or Torres Strait Islander patients;

Patients with hypertension

total cholesterol greater than 6.5 mmol per L;

or

total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L

Patients with high density lipoprotein cholesterol less than 1 mmol per L

total cholesterol greater than 6.5 mmol per L

Patients with familial hypercholesterolaemia identified by:

 (1) DNA mutation; or

 (2) tendon xanthomas in the patient or their first or second degree relative

Patients with:

 (1) family history of coronary heart disease which has become symptomatic before the age of 60 years in one or more first degree relatives; or

 (2) family history of coronary heart disease which has become symptomatic before the age of 50 years in one or more second degree relatives

If aged 18 years or less at treatment initiation:

low density lipoprotein cholesterol greater than 4 mmol per L

If aged more than 18 years at treatment initiation:

low density lipoprotein cholesterol greater than 5 mmol per L;

or

total cholesterol greater than 6.5 mmol per L;

or

total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L

Patients not eligible under the above:

 (1) men over 34 but less than 76 years of age; or

 (2) post-menopausal women less than 76 years of age

total cholesterol greater than 7.5 mmol per L;

or

triglyceride greater than 4 mmol per L

Patients not otherwise included

total cholesterol greater than 9 mmol per L;

or

triglyceride greater than 8 mmol per L

Abciximab

In compliance with authority procedures set out in subparagraph 14 (d):

Patients undergoing percutaneous coronary balloon angioplasty

Patients undergoing percutaneous coronary atherectomy

Patients undergoing percutaneous coronary stent placement

Acamprosate Calcium

In compliance with authority procedures set out in subparagraph 14 (d):

For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence

Acarbose

—

Acetazolamide

—

Acetylcysteine Sodium

Bronchiectasis

Cystic fibrosis

Aciclovir

In respect of the tablet 200 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

Moderate to severe initial genital herpes

Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

In respect of the tablet 800 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of patients with herpes zoster within 72 hours of the onset of the rash

Herpes zoster ophthalmicus

Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L)

In respect of the eye ointment 30 mg per g, 4.5 g:

Herpes simplex keratitis

Acitretin

In compliance with authority procedures set out in subparagraph 14 (d):

Severe intractable psoriasis

Severe forms of disorders of keratinisation

Adalimumab

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:

(a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or

(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and

(b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless:

(i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or

(ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and

(c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;

the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;

a course of treatment is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;

patients are eligible to commence therapy with adalimumab within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of adalimumab therapy specified below, if applicable;

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if:

(i) they have demonstrated an adequate response to their most recent course of PBS-subsidised adalimumab treatment; and

(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

(iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and

(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of adalimumab therapy;

a course of treatment is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 November 2004, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to an inability to receive concomitant methotrexate, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;

the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight

Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;

the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight

Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:

(a) who have demonstrated an adequate response to treatment with adalimumab; and

(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with adalimumab; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;

an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

if the most recent course of adalimumab therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

a course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and

(2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and

(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and

(4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and

(5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and

(2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and

(3) have not failed treatment with adalimumab during the current Treatment Cycle; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:

(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and

(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and

(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;

a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and

(2) were receiving treatment with adalimumab prior to 16 March 2006; and

(3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and

(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form;

the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;

patients are eligible for PBS-subsidised treatment under the above criteria once only

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:

(1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and

(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and

(3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:

(a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and

(b) who has at least 2 of the following:

(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or

(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or

(iii) limitation of chest expansion relative to normal values for age and gender; and

(c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and

(d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response is demonstrated by:

(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and

(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;

both ESR and CRP measurements are included in the authority application and are no more than 1 month old;

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;

the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;

if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;

if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;

if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;

an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;

if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;

the application for authorisation includes:

(a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:

(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and

(ii) a completed BASDAI Assessment Form; and

(iii) a signed patient acknowledgment form; and

(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;

a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with adalimumab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;

the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:

(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and

(b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

(ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;

if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and

(a) who is receiving treatment with adalimumab at the time of application; and

(b) who has not received prior PBS-subsidised treatment with infliximab or etanercept; and

(c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0-10 scale or improved by at least 2 from baseline; and

(d) who has:

(i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or

(ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or

(iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and

(e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

the BASDAI assessment and the ESR and CRP measurements provided are no more than 1 month old at the time of application;

the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:

(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and

(ii) a completed BASDAI Assessment Form; and

(iii) a signed patient acknowledgment form;

the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;

patients are eligible for PBS-subsidised treatment under the above criteria once only

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:

(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or

(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or

(c) an ESR or CRP measurement reduced by at least 20% from baseline;

if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS-subsidised treatment and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:

(a) an ESR measurement no greater than 25 mm per hour; or

(b) a CRP measurement no greater than 10 mg per L;

all measurements provided are no more than 1 month old at the time of application;

the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;

patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

(b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment;

the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;

a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

Adrenaline

In compliance with authority procedures set out in subparagraph 14 (d):

Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where the name of the specialist consulted is included in the authority application

Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis

Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis, where the patient has previously been issued with an authority prescription for this drug

Adrenaline Acid Tartrate

—

Albendazole

In respect of the tablet 200 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of whipworm infestation in an Aboriginal or a Torres Strait Islander person

Treatment of tapeworm infestation

In respect of the tablet 400 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

For the treatment of hydatid disease in conjunction with surgery or when a surgical cure cannot be achieved or where surgery cannot be used

Alendronate Sodium

In respect of the tablet equivalent to 70 mg alendronic acid:

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older with a bone mineral density T-score of negative 3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are stated in the authority application

Continuing treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older with a bone mineral density T-score of negative 3.0 or less, where the patient has previously been issued with an authority prescription for this drug

Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug

In respect of the tablet equivalent to 40 mg alendronic acid:

In compliance with authority procedures set out in subparagraph 14 (d):

Symptomatic Paget's disease of bone

Alendronate Sodium with Colecalciferol

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older with a bone mineral density T-score of negative 3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are stated in the authority application

Continuing treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older with a bone mineral density T-score of negative 3.0 or less, where the patient has previously been issued with an authority prescription for this drug

Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug

"Alfaré"

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 3 months, for intolerance (not infant colic) to cows' milk protein in a child aged less than 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet, and where the date of birth of the patient is included in the authority application

Continuing treatment for intolerance (not infant colic) to cows' milk protein in a child aged less than 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application

Continuing treatment for intolerance (not infant colic) to cows' milk protein in a child aged 2 years or over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

Biliary atresia

Chronic liver failure with fat malabsorption

Chylous ascites

Chylothorax

Cystic fibrosis

Enterokinase deficiency

Proven fat malabsorption

Severe diarrhoea of greater than 2 weeks' duration in an infant aged less than 4 months, where the date of birth of the patient is included in the authority application

Severe intestinal malabsorption including short bowel syndrome

Allopurinol

—

Alprazolam

In compliance with authority procedures set out in subparagraph 14 (d):

Panic disorder where other treatments have failed or are inappropriate

Aluminium Hydroxide - Dried with Magnesium Hydroxide

—

Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide

—

Amantadine Hydrochloride

Parkinson's disease which is not drug induced

Amiloride Hydrochloride

—

Aminoglutethimide

—

Amiodarone Hydrochloride

Severe cardiac arrhythmias

Amisulpride

In compliance with authority procedures set out in subparagraph 14 (d):

Schizophrenia

Amitriptyline Hydrochloride

—

Amlodipine Besylate

—

Amlodipine Besylate with Atorvastatin Calcium

For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and who are currently receiving treatment with a dihydropyridine calcium channel blocker

For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and whose blood pressure and/or angina is inadequately controlled with other classes of antihypertensive and/or anti-anginal agent, and in whom adjunctive therapy with a dihydropyridine calcium channel blocker would be appropriate

For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and who are intolerant of the side effects of other classes of antihypertensive and/or anti-anginal agent, and in whom replacement therapy with a dihydropyridine calcium channel blocker would be appropriate

Amoxycillin Trihydrate

In respect of the tablet, chewable, equivalent to 250 mg amoxycillin, capsule equivalent to 250 mg amoxycillin, capsule equivalent to 500 mg amoxycillin and sachet containing oral powder equivalent to 3 g amoxycillin:

—

In respect of the tablet equivalent to 1 g amoxycillin:

Acute exacerbations of chronic bronchitis

Amoxycillin Trihydrate with Potassium Clavulanate

Infections where resistance to amoxycillin trihydrate is suspected

Infections where resistance to amoxycillin trihydrate is proven

Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP

Infections where resistance to amoxycillin trihydrate is suspected

Infections where resistance to amoxycillin trihydrate is proven

Amoxycillin Trihydrate with Water - Purified BP

—

Amphotericin

—

Ampicillin Sodium

—

Ampicillin Trihydrate

—

Anakinra

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:

(a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or

(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and

(b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless:

(i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or

(ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and

(c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;

the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;

a course of treatment is limited to a maximum of 16 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;

patients are eligible to commence therapy with anakinra within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of anakinra therapy specified below, if applicable; unless this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, in which case the patient is eligible to commence therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs;

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with anakinra within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if:

(i) they have demonstrated an adequate response to their most recent course of PBS-subsidised anakinra treatment; and

(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

(iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and

(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of anakinra therapy;

a course of treatment is limited to a maximum of 16 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 July 2004 and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;

the course of treatment is limited to a maximum of 24 weeks of treatment

Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 December 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;

the course of treatment is limited to a maximum of 24 weeks of treatment

Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:

(a) who have demonstrated an adequate response to treatment with anakinra; and

(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with anakinra; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;

if this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, the patient is eligible to continue PBS-subsidised therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs;

an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

if the most recent course of anakinra therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

a course of treatment is limited to a maximum of 24 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

Anastrozole

Treatment of hormone-dependent breast cancer in post-menopausal women

Anecortave Acetate

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment by an ophthalmologist, as the sole subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS-subsidised treatment with anecortave acetate in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic

In compliance with authority procedures set out in subsubparagraph 14 (d) (ii):

Initial treatment by an ophthalmologist, as the sole subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS-subsidised treatment with anecortave acetate in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic, is submitted to the Medicare Australia CEO by facsimile prior to contact by telephone and is resubmitted to the Medicare Australia CEO by post after the application has been authorised

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment by an ophthalmologist, as the sole subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation due to age-related macular degeneration, where the patient has previously been granted at least 1, but not more than 9, authority prescriptions for anecortave acetate for treatment of the same eye

Apraclonidine Hydrochloride

Short-term reduction of intra-ocular pressure in patients already on maximally tolerated anti-glaucoma therapy

Aprepitant

In compliance with authority procedures set out in subparagraph 14 (d):

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, when aprepitant is used in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where the cytotoxic chemotherapy to be administered to the patient includes any of the following agents:

 altretamine;

 carmustine;

 cisplatin, when a single dose constitutes a cycle of chemotherapy;

 cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;

 dacarbazine;

 procarbazine, when a single dose constitutes a cycle of chemotherapy;

 streptozocin

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer where cyclophosphamide and an anthracycline are to be co-administered, when aprepitant is used in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy

Aripiprazole

In compliance with authority procedures set out in subparagraph 14 (d):

Schizophrenia

Aspirin

—

Atenolol

—

Atorvastatin Calcium

For use in accordance with paragraph 16

Atovaquone

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of mild to moderate Pneumocystis carinii pneumonia in adult patients who are intolerant of trimethoprim with sulfamethoxazole therapy

Atropine Sulfate

—

Auranofin

—

Azathioprine

—

Azithromycin Dihydrate

Uncomplicated urethritis due to Chlamydia trachomatis

Uncomplicated cervicitis due to Chlamydia trachomatis

Trachoma

Azithromycin Dihydrate with Water - Purified BP

Trachoma

Baclofen

—

Balsalazide Sodium

In compliance with authority procedures set out in subparagraph 14 (d):

Ulcerative colitis where hypersensitivity to sulfonamides exists

Ulcerative colitis where intolerance to sulfasalazine exists

"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)

Treatment of carcinoma in situ of the urinary bladder

"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)

Primary and relapsing superficial urothelial carcinoma of the bladder

Beclomethasone Dipropionate

In respect of the pressurised inhalation 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation 100 micrograms per dose, 200 doses (CFC-free formulation):

—

In respect of the pressurised inhalation in breath actuated device 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation in breath actuated device 100 micrograms per dose, 200 doses (CFC-free formulation):

Patients unable to achieve co-ordinated use of other metered dose inhalers containing this drug

Benzathine Penicillin

—

Benzhexol Hydrochloride

—

Benztropine Mesylate

—

Benzydamine Hydrochloride

Radiation induced mucositis

Benzylpenicillin Sodium

—

Betamethasone Acetate with Betamethasone Sodium Phosphate

Alopecia areata

For local intra-articular or peri-articular infiltration

Granulomata, dermal

Keloid

Lichen planus hypertrophic

Lichen simplex chronicus

Lupus erythematosus, chronic discoid

Necrobiosis lipoidica

Uveitis

Betamethasone Dipropionate

Treatment of corticosteroid-responsive dermatoses

Betamethasone Valerate

Treatment of corticosteroid-responsive dermatoses

Betaxolol Hydrochloride

—

Bethanechol Chloride

—

Bicalutamide

In compliance with authority procedures set out in subparagraph 14 (d):

Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy

Bifonazole

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person

Bimatoprost

—

Biperiden Hydrochloride

—

Bisacodyl

Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function

Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities

For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult

Patients receiving palliative care

Terminal malignant neoplasia

Anorectal congenital abnormalities

Megacolon

Bisoprolol Fumarate

In compliance with authority procedures set out in subparagraph 14 (d):

Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated

Bivalirudin Trifluoroacetate

In compliance with authority procedures set out in subparagraph 14 (d):

Patients undergoing non-emergency percutaneous coronary intervention

Bleomycin Sulfate

Germ cell neoplasms

Lymphoma

Brimonidine Tartrate

—

Brimonidine Tartrate with Timolol Maleate

Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL

Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL

Brinzolamide

—

Bromocriptine Mesylate

In respect of the tablet equivalent to 2.5 mg bromocriptine:

Prevention of the onset of lactation in the puerperium for medical reasons

Acromegaly

Parkinson's disease

Pathological hyperprolactinaemia where surgery is not indicated

Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution

Pathological hyperprolactinaemia where radiotherapy is not indicated

Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution

In respect of the capsule equivalent to 5 mg bromocriptine and capsule equivalent to 10 mg bromocriptine:

Acromegaly

Parkinson's disease

Pathological hyperprolactinaemia where surgery is not indicated

Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution

Pathological hyperprolactinaemia where radiotherapy is not indicated

Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution

Budesonide

In respect of the nebuliser suspension 500 micrograms in 2 mL single dose units, 30 and nebuliser suspension 1 mg in 2 mL single dose units, 30:

In compliance with authority procedures set out in subparagraph 14 (d):

Severe chronic asthma in patients who require long-term steroid therapy and who are unable to use other forms of inhaled steroid therapy

In respect of the powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses, powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses and powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses:

—

Budesonide with Eformoterol Fumarate Dihydrate

Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide

Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide

Buprenorphine

Chronic severe disabling pain not responding to non-narcotic analgesics

Bupropion Hydrochloride

In compliance with authority procedures set out in subparagraph 14 (d):

Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where details of the program are specified in the authority application

Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who are entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application

Completion of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where the patient has previously been issued with an authority prescription for commencement of treatment with this drug

Busulfan

—

Cabergoline

In respect of the tablet 500 micrograms:

Prevention of the onset of lactation in the puerperium for medical reasons

In compliance with authority procedures set out in subparagraph 14 (d):

Pathological hyperprolactinaemia where surgery is not indicated

Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution

Pathological hyperprolactinaemia where radiotherapy is not indicated

Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution

In respect of the tablet 1 mg, tablet 2 mg and tablet 4 mg:

Parkinson's disease

Calcipotriol

Chronic stable plaque type psoriasis vulgaris

Calcitriol

In compliance with authority procedures set out in subparagraph 14 (d):

Hypocalcaemia due to renal disease

Hypoparathyroidism

Hypophosphataemic rickets

Vitamin D-resistant rickets

Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug

Calcium Carbonate

In compliance with authority procedures set out in subparagraph 14 (d):

Hyperphosphataemia associated with chronic renal failure

Calcium Citrate

In compliance with authority procedures set out in subparagraph 14 (d):

Hyperphosphataemia associated with chronic renal failure

Calcium Folinate

In respect of the tablet equivalent to 15 mg folinic acid:

Antidote to folic acid antagonists

In respect of the injection equivalent to 50 mg folinic acid in 5 mL, injection equivalent to 100 mg folinic acid in 10 mL and injection equivalent to 300 mg folinic acid in 30 mL:

—

Candesartan Cilexetil

—

Candesartan Cilexetil with Hydrochlorothiazide

Hypertension in patients who are not adequately controlled with 16 mg candesartan cilexetil

Capecitabine

In compliance with authority procedures set out in subparagraph 14 (d):

Advanced breast cancer after failure of prior therapy which includes a taxane and an anthracycline

Advanced breast cancer where therapy with a taxane or an anthracycline is contraindicated

Advanced breast cancer in combination with docetaxel after failure of prior anthracycline-containing chemotherapy

Treatment of advanced or metastatic colorectal cancer

Adjuvant treatment of stage III (Dukes C) colon cancer, following complete resection of the primary tumour

"Caprilon"

Chylous ascites

Chylothorax

Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders

Captopril

In respect of the tablet 12.5 mg, tablet 25 mg and tablet 50 mg:

—

In respect of the oral solution 5 mg per mL, 95 mL:

For patients unable to take a solid dose form of an angiotensin-converting enzyme inhibitor

Carbamazepine

—

Carbimazole

—

"Carbohydrate Free Mixture"

Patients with intractable seizures requiring treatment with a ketogenic diet

Glucose transport protein defects

Pyruvate dehydrogenase deficiency

Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance

Carbomer 974

In compliance with authority procedures set out in subparagraph 14 (d):

Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops

Carbomer 980

In respect of the ocular lubricating gel 2 mg per g, 10 g:

Severe dry eye syndrome, including Sjogren's syndrome

In respect of the eye drops 2 mg per g, single dose units 0.6 mL, 30:

In compliance with authority procedures set out in subparagraph 14 (d):

Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops

Carboplatin

—

Carmellose Sodium

In respect of the eye drops 5 mg per mL, 15 mL and eye drops 10 mg per mL, 15 mL:

Severe dry eye syndrome, including Sjogren's syndrome

In respect of the eye drops 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops 5 mg per mL, single dose units 0.4 mL, 30, eye drops 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel 10 mg per mL, single dose units 0.6 mL, 28:

In compliance with authority procedures set out in subparagraph 14 (d):

Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops

Carmustine

Glioblastoma multiforme, suspected or confirmed, at the time of initial surgery

Carvedilol

In compliance with authority procedures set out in subparagraph 14 (d):

Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated

Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002

Cefaclor Monohydrate

—

Cefaclor Monohydrate with Water - Purified BP

—

Cefepime Hydrochloride

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of febrile neutropenia

Cefotaxime Sodium

Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

Septicaemia, suspected

Septicaemia, proven

Ceftriaxone Sodium

In respect of the powder for injection equivalent to 500 mg ceftriaxone:

Gonorrhoea

Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

Septicaemia, suspected

Septicaemia, proven

In respect of the powder for injection equivalent to 1 g ceftriaxone and powder for injection equivalent to 2 g ceftriaxone:

Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

Septicaemia, suspected

Septicaemia, proven

Cefuroxime Axetil

—

Celecoxib

Symptomatic treatment of osteoarthritis

Symptomatic treatment of rheumatoid arthritis

Cephalexin

—

Cephalexin with Water - Purified BP

—

Cephalothin Sodium

—

Cephazolin Sodium

Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

Septicaemia, suspected

Septicaemia, proven

Chlorambucil

—

Chloramphenicol

—

Chlorpromazine Hydrochloride

—

Chlorthalidone

—

Cholestyramine

—

Chorionic Gonadotrophin

In respect of the injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL:

Anovulatory infertility

For the treatment of infertility in males due to hypogonadotrophic hypogonadism

For the treatment of infertility in males associated with isolated luteinising hormone deficiency

For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation

For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty

Cryptorchism not due to organic obstruction in boys over 12 months of age

In respect of the injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL:

Anovulatory infertility

For the treatment of infertility in males due to hypogonadotrophic hypogonadism

For the treatment of infertility in males associated with isolated luteinising hormone deficiency

For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation

For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty

Ciclesonide

—

Cimetidine

—

Ciprofloxacin Hydrochloride

In respect of the tablet equivalent to 500 mg ciprofloxacin and tablet equivalent to 750 mg ciprofloxacin:

In compliance with authority procedures set out in subparagraph 14 (d):

Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients

Bacterial gastroenteritis in severely immunocompromised patients

Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials

Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials

In respect of the tablet equivalent to 250 mg ciprofloxacin:

Gonorrhoea

In compliance with authority procedures set out in subparagraph 14 (d):

Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients

Bacterial gastroenteritis in severely immunocompromised patients

Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials

Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials

In respect of the ear drops equivalent to 3 mg ciprofloxacin per mL, 5 mL:

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of chronic suppurative otitis media in an Aboriginal or a Torres Strait Islander person aged 1 year and older

In respect of the eye drops equivalent to 3 mg ciprofloxacin per mL, 5 mL:

In compliance with authority procedures set out in subparagraph 14 (d):

Bacterial keratitis

Cisplatin

—

Citalopram Hydrobromide

Major depressive disorders

Cladribine

In compliance with authority procedures set out in subparagraph 14 (d):

Hairy cell leukaemia

Clarithromycin

—

Clindamycin Hydrochloride

Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin

Clomiphene Citrate

Anovulatory infertility

Patients undergoing in-vitro fertilisation

Clomipramine Hydrochloride

Cataplexy associated with narcolepsy

Obsessive-compulsive disorder

Phobic disorders in adults

Clonazepam

In respect of the tablet 500 micrograms, tablet 2 mg and oral liquid 2.5 mg per mL, 10 mL:

In compliance with authority procedures set out in subparagraph 14 (d):

Neurologically proven epilepsy

In respect of the injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent):

Epilepsy

Clonidine Hydrochloride

—

Clopidogrel Hydrogen Sulfate

In compliance with authority procedures set out in subparagraph 14 (d):

Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events:

in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin

in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding

in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs

Prevention of recurrence of myocardial infarction or unstable angina:

in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin

in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding

in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs

Clotrimazole

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person

Coal Tar - Prepared

—

Codeine Phosphate

—

Codeine Phosphate with Paracetamol

—

Colchicine

—

Colestipol Hydrochloride

—

Copper Sulfate

—

Cortisone Acetate

—

Cyclophosphamide

—

Cyclosporin

In compliance with authority procedures set out in subparagraph 14 (d):

Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application

Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate, where therapy remains under the supervision and direction of a dermatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the dermatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application

Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life, where therapy remains under the supervision and direction of a dermatologist or specialised unit reviewing the patient and where the name of the dermatologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application

Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with nephrotic syndrome in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired, where therapy remains under the supervision and direction of a nephrologist or specialised unit reviewing the patient and where the name of the nephrologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application

Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate, where therapy remains under the supervision and direction of a rheumatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the rheumatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application

Management (which includes initiation, stabilisation and review of therapy) by dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate

Management (which includes initiation, stabilisation and review of therapy) by dermatologists of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life

Management (which includes initiation, stabilisation and review of therapy) by rheumatologists or clinical immunologists of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate

Cyproheptadine Hydrochloride

Prevention of migraine

Cyproterone Acetate

In respect of the tablet 50 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

Moderate to severe androgenisation, of which acne alone is not a sufficient indication, in non-pregnant women

Advanced carcinoma of the prostate

To reduce drive in sexual deviations in males

In respect of the tablet 100 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

Advanced carcinoma of the prostate

To reduce drive in sexual deviations in males

Cytarabine

—

Dalteparin Sodium

—

Danazol

In compliance with authority procedures set out in subparagraph 14 (d):

Endometriosis, visually proven

Hereditary angio-oedema

Treatment, for up to 6 months, of intractable primary menorrhagia

Treatment, for up to 6 months, of severe benign (fibrocystic) breast disease or mastalgia associated with severe symptomatic benign breast disease in patients refractory to other treatments

Dantrolene Sodium

Treatment of chronic spasticity

Dapsone

—

Desmopressin Acetate

In respect of the intranasal solution 100 micrograms per mL, 2.5 mL dropper bottle:

In compliance with authority procedures set out in subparagraph 14 (d):

Cranial diabetes insipidus

In respect of the tablet 200 micrograms and nasal spray (pump pack) 10 micrograms per actuation, 60 actuations, 6 mL:

In compliance with authority procedures set out in subparagraph 14 (d):

Primary nocturnal enuresis:

in patients aged 6 years or older who are refractory to an enuresis alarm, where, if the application is for the tablet presentation of this drug, a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for the tablet presentation of this drug for this purpose

in patients aged 6 years or older for whom an enuresis alarm is contraindicated, where the reason for the contraindication is included in the authority application, and where, if the application is for the tablet presentation of this drug, a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for the tablet presentation of this drug for this purpose

Cranial diabetes insipidus

Dexamethasone

—

Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin

—

Dexamethasone Sodium Phosphate

—

Dexamphetamine Sulfate

In compliance with authority procedures set out in subparagraph 14 (d):

Use in attention deficit hyperactivity disorder, in accordance with State/Territory law

Narcolepsy

"Dialamine"

Gyrate atrophy of the choroid and retina

Urea cycle disorders

Diazepam

—

Diclofenac Sodium

In respect of the tablet 25 mg (enteric coated) and tablet 50 mg (enteric coated):

Chronic arthropathies (including osteoarthritis) with an inflammatory component

Bone pain due to malignant disease

In respect of the suppository 100 mg:

—

Dicloxacillin Sodium

In respect of the capsule equivalent to 250 mg dicloxacillin and capsule equivalent to 500 mg dicloxacillin:

Serious staphylococcal infections

In respect of the powder for injection equivalent to 500 mg dicloxacillin and powder for injection equivalent to 1 g dicloxacillin:

—

"Digestelact"

In compliance with authority procedures set out in subparagraph 14 (d):

Acute lactose intolerance in children aged 1 year and over, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose

Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet

Digoxin

—

Dihydroergotamine Mesylate

—

Diltiazem Hydrochloride

—

Diphenoxylate Hydrochloride with Atropine Sulfate

—

Diphtheria and Tetanus Vaccine - Adsorbed

—

Diphtheria and Tetanus Vaccine - Adsorbed (Diluted)

—

Dipivefrine Hydrochloride

—

Dipyridamole

Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events:

in patients receiving therapy with low-dose aspirin

in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding

in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs

Dipyridamole with Aspirin

Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events

Disodium Etidronate

In compliance with authority procedures set out in subparagraph 14 (d):

Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to lack of efficacy

Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to unacceptable side effects

Heterotopic ossification

Disodium Etidronate and Calcium Carbonate

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug

Disodium Pamidronate

In compliance with authority procedures set out in subparagraph 14 (d):

Symptomatic Paget's disease of bone

Disopyramide

—

Docetaxel

In compliance with authority procedures set out in subparagraph 14 (d):

Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide

Advanced breast cancer after failure of prior therapy which includes an anthracycline

Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound

Locally advanced or metastatic non-small cell lung cancer

Treatment of HER2 positive early breast cancer in combination with trastuzumab

Dolasetron Mesylate

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy

Domperidone

—

Donepezil Hydrochloride

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, and where:

(1) improvement in cognitive function is demonstrated by:

(a) in the case of patients with a baseline MMSE or SMMSE score of 10 or more and less than 25 — an increase of at least 2 points from baseline on the MMSE or SMMSE; or

(b) in the case of patients with a baseline MMSE or SMMSE score of at least 25 points — an increase of at least 2 points from baseline on the MMSE or SMMSE, or, if a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) was submitted with the application for initial treatment, a decrease of at least 4 points from baseline on the ADAS-Cog; and

(2) the relevant result from the MMSE, SMMSE or ADAS-Cog is included in the authority application for continuing treatment

In compliance with authority procedures set out in subparagraph 14 (d):

Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:

Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;

Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;

Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;

Intellectual (developmental or acquired) disability;

Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;

Prominent dysphasia, out of proportion to other cognitive and functional impairment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:

Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;

Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;

Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;

Intellectual (developmental or acquired) disability;

Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;

Prominent dysphasia, out of proportion to other cognitive and functional impairment

Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial PBS-subsidised therapy, based on a rating of "very much improved" or "much improved" on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment

In compliance with authority procedures set out in subparagraph 14 (d):

Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

Dorzolamide Hydrochloride

—

Dorzolamide Hydrochloride with Timolol Maleate

Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL

Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL

Dothiepin Hydrochloride

—

Doxepin Hydrochloride

—

Doxorubicin Hydrochloride

—

Doxorubicin Hydrochloride - Pegylated Liposomal

In compliance with authority procedures set out in subparagraph 14 (d):

Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen

Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane

Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated

Doxycycline Hydrochloride

In respect of the tablet equivalent to 50 mg doxycycline and capsule equivalent to 50 mg doxycycline (containing enteric coated pellets):

Bronchiectasis in patients aged 8 years or older

Chronic bronchitis in patients aged 8 years or older

Severe acne

In respect of the tablet equivalent to 100 mg doxycycline and capsule equivalent to 100 mg doxycycline (containing enteric coated pellets):

—

Doxycycline Monohydrate

In respect of the tablet equivalent to 50 mg doxycycline:

Bronchiectasis in patients aged 8 years or older

Chronic bronchitis in patients aged 8 years or older

Severe acne

In respect of the tablet equivalent to 100 mg doxycycline:

—

Drotrecogin Alfa (activated)

In compliance with authority procedures set out in subparagraph 14 (d):

Adult patients with severe sepsis who have a high risk of death as determined by acute dysfunction in at least 2 organs or modified Acute Physiology and Chronic Health Evaluation II score of at least 25, where acute organ dysfunction is defined as follows:

 For cardiovascular-system dysfunction, an arterial systolic blood pressure of less than or equal to 90 mmHg or mean arterial pressure of less than or equal to 70 mmHg for at least 1 hour despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic blood pressure of greater than or equal to 90 mmHg or a mean arterial pressure of greater than or equal to 70 mmHg;

 For kidney dysfunction, urine output of less than 0.5 mL per kg of body weight per hour for 1 hour despite adequate fluid resuscitation;

 For respiratory-system dysfunction, a ratio of partial pressure of oxygen in arterial blood (in mmHg) to the percentage of oxygen in the inspired air (expressed as a decimal) of less than or equal to 250;

 For haematologic dysfunction, a platelet count of less than 80,000 per cubic millimetre or which has decreased by 50 percent in the previous 3 days;

 In the case of unexplained metabolic acidosis, a pH of less than or equal to 7.30 or a base deficit of greater than or equal to 5.0 mmol per L in association with a plasma lactate level of greater than 1.5 times the upper limit of the normal value for the reporting laboratory

"Duocal"

Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae

Dydrogesterone

—

"Easiphen"

Phenylketonuria

Efalizumab

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:

(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and

(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and

(c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and

(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:

(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or

(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or

(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or

(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;

unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and

where biological agent means efalizumab or etanercept; and

where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrable in the patient at the time of the authority application;

a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;

the most recent PASI assessment is no more than 1 month old at the time of application;

if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

(i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and

(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and

(iii) a copy of the signed patient acknowledgement form;

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with efalizumab as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:

(a) have a documented history of severe chronic plaque psoriasis; and

(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and

(c) have not failed PBS-subsidised therapy with efalizumab for the treatment of this condition more than once in the current Treatment Cycle; and

where biological agent means efalizumab or etanercept; and

where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

patients who have previously demonstrated a response to PBS-subsidised treatment with efalizumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised efalizumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;

patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept and wish to transfer to treatment with efalizumab are not eligible to commence treatment with efalizumab until they have completed a period free from biological agent treatment of at least 12 weeks duration, immediately following cessation of the etanercept treatment course;

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

(i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;

a course of initial treatment within a Treatment Cycle is limited to a maximum of 16 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, with efalizumab as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of efalizumab for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over who:

(a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with efalizumab prior to 10 November 2005; and

(b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with efalizumab; and

(c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and

(d) have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with efalizumab; and

where biological agent means efalizumab or etanercept; and

where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

(i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of efalizumab therapy) and the most recent PASI assessment; and

(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and

(iii) a copy of the signed patient acknowledgement form;

the most recent PASI assessment is no more than 1 month old at the time of application;

the course of treatment is limited to a maximum of 24 weeks of treatment;

patients are eligible for PBS-subsidised treatment under the above criteria once only

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis, who were receiving non-PBS-subsidised treatment with efalizumab prior to 10 November 2005, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:

(a) who have a documented history of severe chronic plaque psoriasis; and

(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and

(c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and

where biological agent means efalizumab or etanercept; and

where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to efalizumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, after at least 12 weeks of efalizumab treatment, when compared with the baseline value for this Treatment Cycle established prior to biological agent treatment;

the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;

patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

(i) the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course; and

(ii) the response assessment is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased;

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams along with the date of the assessment of the patient's condition;

a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:

(a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and

(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and

(c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and

(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:

(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or

(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or

(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or

(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;

unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and

where biological agent means efalizumab or etanercept; and

where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response is demonstrable in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:

(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or

(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;

a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;

the most recent PASI assessment is no more than 1 month old at the time of application;

if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

(i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and

(iii) a copy of the signed patient acknowledgement form;

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with efalizumab as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:

(a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and

(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and

(c) have not failed PBS-subsidised therapy with efalizumab for the treatment of this condition more than once in the current Treatment Cycle; and

where biological agent means efalizumab or etanercept; and

where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

patients who have previously demonstrated a response to PBS-subsidised treatment with efalizumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised efalizumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;

patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept and wish to transfer to treatment with efalizumab are not eligible to commence treatment with efalizumab until they have completed a period free from biological agent treatment of at least 12 weeks duration, immediately following cessation of the etanercept treatment course;

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

(i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;

a course of initial treatment within a Treatment Cycle is limited to a maximum of 16 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, with efalizumab as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of efalizumab for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over:

(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with efalizumab prior to 10 November 2005; and

(b) whose disease, prior to treatment with efalizumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and

(c) who have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and

(d) who have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with efalizumab; and

where biological agent means efalizumab or etanercept; and

where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

(i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of efalizumab therapy) and the most recent PASI assessment; and

(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and

(iii) a copy of the signed patient acknowledgement form;

the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;

the most recent PASI assessment is no more than 1 month old at the time of application;

the course of treatment is limited to a maximum of 24 weeks of treatment;

patients are eligible for PBS-subsidised treatment under the above criteria once only

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who were receiving non-PBS-subsidised treatment with efalizumab prior to 10 November 2005, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:

(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and

(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and

(c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and

where biological agent means efalizumab or etanercept; and

where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to efalizumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline values established prior to biological agent treatment; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline value established prior to biological agent treatment;

the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;

patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

(i) the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course; and

(ii) the response assessment is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased;

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;

a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

Eformoterol Fumarate Dihydrate

Patients with frequent episodes of asthma who are currently receiving treatment with oral corticosteroids

Patients with frequent episodes of asthma who are currently receiving treatment with optimal doses of inhaled corticosteroids

"EleCare"

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application

Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

Enalapril Maleate

—

Enalapril Maleate with Hydrochlorothiazide

Hypertension in patients who are not adequately controlled with 20 mg enalapril maleate

"Energivit"

Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae

Enoxaparin Sodium

—

Entacapone

In compliance with authority procedures set out in subparagraph 14 (d):

Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect

Epirubicin Hydrochloride

—

Eplerenone

In compliance with authority procedures set out in subparagraph 14 (d):

Initial therapy subsidised under the Pharmaceutical Benefits Scheme (PBS) for heart failure with a left ventricular ejection fraction of 40% or less occurring within 3 to 14 days following an acute myocardial infarction, where the date of the acute myocardial infarction is included in the authority application, and where the treatment commences within 14 days of the acute myocardial infarction or continues treatment which was commenced in a hospital within 14 days of the acute myocardial infarction

Continuation of therapy for heart failure with a left ventricular ejection fraction of 40% or less occurring following an acute myocardial infarction, where the patient has previously been issued with a PBS authority prescription for eplerenone

Eprosartan Mesylate

—

Eprosartan Mesylate with Hydrochlorothiazide

Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or eprosartan mesylate monotherapy

Eptifibatide Acetate

In compliance with authority procedures set out in subparagraph 14 (d):

Patients undergoing non-urgent percutaneous intervention with intracoronary stenting

Erythromycin

—

Erythromycin Ethyl Succinate

—

Erythromycin Ethyl Succinate with Water - Purified BP

—

Erythromycin Lactobionate

—

Escitalopram Oxalate

In respect of the tablet equivalent to 10 mg escitalopram and tablet equivalent to 20 mg escitalopram:

Major depressive disorders

In respect of the oral solution equivalent to 10 mg escitalopram per mL, 28 mL:

Major depressive disorders

In compliance with authority procedures set out in subparagraph 14 (d):

Major depressive disorders, where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme

Major depressive disorders, where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme

Major depressive disorders, where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme

Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance

Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences

Esomeprazole Magnesium Trihydrate

In respect of the tablet (enteric coated), equivalent to 20 mg esomeprazole:

Initial treatment of gastric ulcer

Maintenance of healed gastro-oesophageal reflux disease

In respect of the tablet (enteric coated), equivalent to 40 mg esomeprazole:

Healing of gastro-oesophageal reflux disease

Esomeprazole Magnesium Trihydrate and Clarithromycin and Amoxycillin Trihydrate

Eradication of Helicobacter pylori associated with peptic ulcer disease

Etanercept

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:

(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and

(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and

(c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and

(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:

(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or

(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or

(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or

(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;

unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and

where biological agent means efalizumab or etanercept; and

where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrable in the patient at the time of the authority application;

a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;

the most recent PASI assessment is no more than 1 month old at the time of application;

if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

(i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and

(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and

(iii) a copy of the signed patient acknowledgement form;

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 12 weeks of treatment

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):