Tablet 4 mg

Oral

30

5

Cabaser

Powder for injection containing epirubicin hydrochloride
50 mg

Injection/intravesical

4

. .

Hospira Pty Limited

Injection (human analogue) 100 units per mL, 10 mL

Injection

5

2

Apidra

Sachet containing granules, 1.5 g per sachet

Oral

60

5

Salofalk

Tablet 20 mg (as mesilate)

Oral

30

5

Paroxetine generichealth

Eye drops 4 mg-3 mg per mL, single dose units 0.7 mL, 28

Application to the eye

3

5

Systane

Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28

Application to the eye

2

5

Systane

Tablet (modified release) 50 mg (as fumarate)

Tablet (modified release) 200 mg (as fumarate)

Tablet (modified release) 300 mg (as fumarate)

Tablet (modified release) 400 mg (as fumarate)

Oral

Oral

Oral

Oral

60

60

60

60

5

5

5

5

Seroquel XR

Seroquel XR

Seroquel XR

Seroquel XR

Tablet (extended release) containing tramadol hydrochloride 100 mg

Oral

10

. .

Durotram XR

Tablet (extended release) containing tramadol hydrochloride 200 mg

Tablet (extended release) containing tramadol hydrochloride 300 mg

Oral

Oral

10

10

. .

. .

Durotram XR

Durotram XR

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient with a World Health Organisation (WHO) performance status of 2 or less, who has progressive disease, who has received at least 1 prior therapy (other than thalidomide), who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily; and

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient with a World Health Organisation (WHO) performance status of 2 or less, who has progressive disease, who has received at least 1 prior therapy (other than thalidomide), who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily; and

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

 Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

 Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and

Carbomer 980

Ocular lubricating gel 2 mg per g, 10 g

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

GelTears

PAA

Viscotears Liquid Gel

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, 15 mL

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Refresh Tears Plus

Eye drops containing carmellose sodium 10 mg per mL, 15 mL

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Refresh Liquigel

Dasatinib

Tablet 20 mg

Chronic myeloid leukaemia

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who:

Oral

60

2

Sprycel

 (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR-ABL greater than 1% on the international scale); and

 (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as:

 (i) lack of response to initial imatinib therapy, defined as either:

 —  failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or

 —  failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or

 —  failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or

 (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or

 (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test); or

 (iv) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where:

 (1) accelerated phase is defined by the presence of 1 or more of the following:

 —  percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

 —  percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or

 —  peripheral basophils greater than or equal to 20%; or

 —  progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or

 —  karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and

 (2) blast crisis is defined as either:

 —  percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

 —  extramedullary involvement other than spleen and liver; or

 (v) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or

 (vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and

 where the authority application includes:

 (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and

 (b) a signed patient acknowledgement; and

 (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 1% on the international scale, and the date of the relevant pathology report; and

 (d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement; or

 (2) details of Grade 3 or 4 non-haematological imatinib related toxicity;

for patients with imatinib related toxicities, leukaemia activity does not need to be demonstrated

Tablet 20 mg

Chronic myeloid leukaemia

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to dasatinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and

Oral

60

5

Sprycel

 where the following conditions apply:

 a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;

 a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;

 response to PBS-subsidised treatment with dasatinib is assessed by:

 (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or

 (2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale;

 the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:

 (i) between 10 and 18 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and

 (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained;

 the authority application includes:

 (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and

 (2) demonstration of continued response to treatment as evidenced by:

 (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or

 (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and

 (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis;

 a patient who has previously received PBS-subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment

Tablet 50 mg

Chronic myeloid leukaemia

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who:

Oral

60

2

Sprycel

 (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR-ABL greater than 1% on the international scale); and

 (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as:

 (i) lack of response to initial imatinib therapy, defined as either:

 —  failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or

 —  failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or

 —  failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or

 (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or

 (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test); or

 (iv) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where:

 (1) accelerated phase is defined by the presence of 1 or more of the following:

 —  percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

 —  percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or

 —  peripheral basophils greater than or equal to 20%; or

 —  progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or

 —  karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and

 (2) blast crisis is defined as either:

 —  percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

 —  extramedullary involvement other than spleen and liver; or

 (v) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or

 (vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and

 where the authority application includes:

 (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and

 (b) a signed patient acknowledgement; and

 (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 1% on the international scale, and the date of the relevant pathology report; and

 (d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement; or

 (2) details of Grade 3 or 4 non-haematological imatinib related toxicity;

for patients with imatinib related toxicities, leukaemia activity does not need to be demonstrated

Tablet 50 mg

Chronic myeloid leukaemia

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to dasatinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and

Oral

60

5

Sprycel

 where the following conditions apply:

 a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;

 a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;

 response to PBS-subsidised treatment with dasatinib is assessed by:

 (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or

 (2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale;

 the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:

 (i) between 10 and 18 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and

 (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained;

 the authority application includes:

 (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and

 (2) demonstration of continued response to treatment as evidenced by:

 (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or

 (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and

 (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis;

 a patient who has previously received PBS-subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment

Tablet 70 mg

Chronic myeloid leukaemia

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who:

Oral

60

2

Sprycel

 (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR-ABL greater than 1% on the international scale); and

 (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as:

 (i) lack of response to initial imatinib therapy, defined as either:

 —  failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or

 —  failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or

 —  failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or

 (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or

 (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test); or

 (iv) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where:

 (1) accelerated phase is defined by the presence of 1 or more of the following:

 —  percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

 —  percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or

 —  peripheral basophils greater than or equal to 20%; or

 —  progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or

 —  karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and

 (2) blast crisis is defined as either:

 —  percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

 —  extramedullary involvement other than spleen and liver; or

 (v) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or

 (vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and

 where the authority application includes:

 (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and

 (b) a signed patient acknowledgement; and

 (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 1% on the international scale, and the date of the relevant pathology report; and

 (d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement; or

 (2) details of Grade 3 or 4 non-haematological imatinib related toxicity;

for patients with imatinib related toxicities, leukaemia activity does not need to be demonstrated

Tablet 70 mg

Chronic myeloid leukaemia

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to dasatinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and

Oral

60

5

Sprycel

 where the following conditions apply:

 a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;

 a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;

 response to PBS-subsidised treatment with dasatinib is assessed by:

 (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or

 (2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale;

 the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:

 (i) between 10 and 18 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and

 (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained;

 the authority application includes:

 (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and

 (2) demonstration of continued response to treatment as evidenced by:

 (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or

 (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and

 (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis;

 a patient who has previously received PBS-subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment

Hypromellose

Eye drops 3 mg per mL, 15 mL

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Genteal

In a Wink Moisturising

Eye drops 5 mg per mL, 15 mL

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Methopt

Hypromellose with Carbomer 980

Ocular lubricating gel 3 mg-2 mg per g, 10 g

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Genteal gel

HPMC PAA

Hypromellose with Dextran

Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Poly-Tears

Tears Naturale

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with a PDGFRB fusion gene-positive myelodysplastic or myeloproliferative disorder who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes:

 (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and

 (b) a copy of the full blood examination report which demonstrates a complete haematological response; and

 (c) a statement that the disease has not progressed on imatinib therapy

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with aggressive systemic mastocytosis confirmed to carry the FIP1L1-PDGFRA fusion gene, who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes:

 (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and

 (b) a copy of the full blood examination report which demonstrates a complete haematological response; and

 (c) a statement that the disease has not progressed on imatinib therapy

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with a PDGFRB fusion gene-positive myelodysplastic or myeloproliferative disorder who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes:

 (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and

 (b) a copy of the full blood examination report which demonstrates a complete haematological response; and

 (c) a statement that the disease has not progressed on imatinib therapy

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

 Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with aggressive systemic mastocytosis confirmed to carry the FIP1L1-PDGFRA fusion gene, who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes:

 (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and

 (b) a copy of the full blood examination report which demonstrates a complete haematological response; and

 (c) a statement that the disease has not progressed on imatinib therapy

Nilotinib

Capsule 200 mg (as hydrochloride monohydrate)

In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with nilotinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to nilotinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and

Oral

112

5

Tasigna

 where the following conditions apply:

 a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;

 a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;

 response to PBS-subsidised treatment with nilotinib is assessed by:

 (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or

 (2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale;

 the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:

 (i) between 10 and 18 months of the commencement of treatment with nilotinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and

 (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained;

 the authority application includes:

 (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and

 (2) demonstration of continued response to treatment as evidenced by:

 (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or

 (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and

 (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis;

 a patient who has previously received PBS-subsidised treatment with nilotinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment

Paraffin

Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

2

11

Duratears

Poly Visc

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Ircal

Lacri-Lube

Poly Visc

Polyethylene Glycol 400 with Propylene Glycol

Eye drops 4 mg-3 mg per mL, 15 mL

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Systane

Polyvinyl Alcohol

Eye drops 14 mg per mL, 15 mL

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Liquifilm Tears

PVA Tears

Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative)

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Vistil

Eye drops 30 mg per mL, 15 mL

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Liquifilm Forte

PVA Forte

Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative)

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Application to the eye

1

11

Vistil Forte

Sulfasalazine

Tablet 500 mg

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Oral

200

11

Salazopyrin

Tablet 500 mg (enteric coated)

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Oral

200

11

Pyralin EN

Salazopyrin-EN

Tablet (extended release) containing tramadol hydrochloride 100 mg

In compliance with authority procedures set out in subparagraph 11 (d):

Severe disabling pain not responding to non-narcotic analgesics

Oral

20

..

Durotram XR

Tablet (extended release) containing tramadol hydrochloride 200 mg

In compliance with authority procedures set out in subparagraph 11 (d):

Severe disabling pain not responding to non-narcotic analgesics

Oral

20

..

Durotram XR

Tablet (extended release) containing tramadol hydrochloride 300 mg

In compliance with authority procedures set out in subparagraph 11 (d):

Severe disabling pain not responding to non-narcotic analgesics

Oral

20

..

Durotram XR

Tablet (extended release) containing tramadol hydrochloride 100 mg

Oral

10

..

Durotram XR

Tablet (extended release) containing tramadol hydrochloride 200 mg

Oral

10

..

Durotram XR

Tablet (extended release) containing tramadol hydrochloride 300 mg

Oral

10

..

Durotram XR