1. The whole of this instrument

1 May 2025

1 May 2025

Tablet containing adefovir dipivoxil 10 mg (S19A)

Oral

Adefovir Dipivoxil Tablets 10 mg (SigmaPharm Laboratories)

C4490 C4510

60

5

Azacitidine SXP

C12439 C12983 C12986 C13010 C13011 C13012 C13015 C13029

See Schedule 2

See Schedule 2

Bosentan Viatris

C11229 C13495 C13496 C13497 C13499 C13571 C13582 C13632

See Schedule 2

See Schedule 2

Edaravone

Solution concentrate for I.V. infusion 30 mg in 20 mL

Injection

Radicava

C16435 C16479

P16479

20

2

C16435 C16479

P16435

28

0

Esketamine

Nasal spray device 28 mg in 2 actuations

Nasal

Spravato

C16416 C16419 C16421 C16422 C16438 C16454 C16460 C16470 C16477

P16421 P16460

4

5

C16416 C16419 C16421 C16422 C16438 C16454 C16460 C16470 C16477

P16477

8

0

C16416 C16419 C16421 C16422 C16438 C16454 C16460 C16470 C16477

P16438 P16470

8

5

C16416 C16419 C16421 C16422 C16438 C16454 C16460 C16470 C16477

P16416 P16419

12

5

C16416 C16419 C16421 C16422 C16438 C16454 C16460 C16470 C16477

P16422

16

0

C16416 C16419 C16421 C16422 C16438 C16454 C16460 C16470 C16477

P16454

24

0

Macitentan with tadalafil

Tablet containing 10 mg macitentan with 40 mg tadalafil

Oral

Opsynvi

C16433 C16457

See Schedule 2

See Schedule 2

TENOFOVIR/EMTRICITABINE 300/200 APX

C6985 C6986

60

5

Vutrisiran

Injection 25 mg (as sodium) in 0.5 mL pre-filled syringe

Injection

Amvuttra

C16408 C16434 C16446

See Schedule 2

See Schedule 2

Macitentan with tadalafil

C16433 C16457

1 pack

5

Vutrisiran

C16408 C16434 C16446

1

1

C15227

Moderate to severe pruritus (itching) associated with chronic kidney disease

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND

Patient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS-subsidised supply was commenced, the patient: (i) was on optimised haemodialysis; (ii) was on haemodialysis for at least 3 months; (iii) had a condition confirmed based on both physical examination and patient history to exclude any factors that may be triggering the pruritus; (iv) had experienced itch that persists for at least 6 weeks despite best supportive care; (v) had a 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) of more than 4 at baseline; AND

Patient must have demonstrated an adequate response to the most recent non-PBS-subsidised treatment with this drug for this condition, including at least a 3-point improvement from baseline in 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score.

Must be treated by a nephrologist.

Patient must be at least 18 years of age.

Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 5 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4.

Compliance with Authority Required procedures

Edaravone

C16435

P16435

Amyotrophic lateral sclerosis

Initial treatment

The condition must be/have been diagnosed by a neurologist; AND

Patient must not have had symptoms for more than 2 years prior to commencing therapy with this drug; AND

Patient must have at least 80 percent of predicted forced vital capacity (FVC) or slow vital capacity (SVC) within the 2 months prior to commencing therapy with this drug; AND

Patient must not require assistance with eating or ambulation; AND

Patient must have at least two points on each individual item of the ALS Functional Rating Scale - Revised (ALSFRS-R) score prior to commencing therapy with this drug; AND

Patient must not have undergone a tracheostomy; AND

Patient must not have experienced respiratory failure.

The date of diagnosis, the date and results of spirometry (in terms of percent of predicted forced vital capacity or slow vital capacity) must be supplied with the initial authority application.

Compliance with Authority Required procedures

C16479

P16479

Amyotrophic lateral sclerosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have undergone a tracheostomy; AND

Patient must not have experienced respiratory failure.

Compliance with Authority Required procedures

C15174

Severe aplastic anaemia

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements - First line treatment

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND

The condition must be severe aplastic anaemia; AND

Patient must not have received treatment with immunosuppressive therapy for this condition prior to initiating non-PBS-subsidised treatment; AND

The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND

Patient must be considered ineligible for haemopoietic stem cell transplant; AND

Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime.

If the application is submitted through HPOS form upload or mail, it must include:

(i) A completed authority prescription form; and

(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

A patient may qualify for PBS-subsidised treatment under this restriction once only.

Compliance with Authority Required procedures

C15191

Severe aplastic anaemia

First line treatment

The condition must be severe aplastic anaemia; AND

Patient must not have received treatment with immunosuppressive therapy for this condition; AND

The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND

Patient must be considered ineligible for haemopoietic stem cell transplant; AND

Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime.

If the application is submitted through HPOS form upload or mail, it must include:

(i) A completed authority prescription form; and

(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Authority Required procedures

C16455

Severe aplastic anaemia

First line treatment

The condition must be severe aplastic anaemia; AND

Patient must not have received treatment with immunosuppressive therapy for this condition; AND

The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND

Patient must be considered ineligible for haemopoietic stem cell transplant; AND

Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Authority Required procedures

Esketamine

C16416

P16416

Treatment resistant major depression

Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this indication prior to 1 May 2025; AND

The condition must have been inadequately responsive to at least two anti-depressant drug therapies prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND

The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND

Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records).

Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND

Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.

The listed quantity of 12 units of nasal spray is intended for a dosage of 84 mg per treatment administration for patients transitioning from non-PBS to PBS-subsidised treatment.

Compliance with Authority Required procedures

C16419

P16419

Treatment resistant major depression

Non-induction treatment

The treatment must be to continue existing PBS-subsidised treatment for this indication; AND

The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND

Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records).

Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND

Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.

The listed quantity of 12 units of nasal spray is intended for a dosage of 84 mg per treatment administration in the non-induction treatment setting.

Compliance with Authority Required procedures

C16421

P16421

Treatment resistant major depression

Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this indication prior to 1 May 2025; AND

The condition must have been inadequately responsive to at least two anti-depressant drug therapies prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND

The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND

Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records).

Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND

Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.

The listed quantity of 4 units of nasal spray is intended for a dosage of 28 mg per treatment administration for patients transitioning from non-PBS to PBS-subsidised treatment.

Compliance with Authority Required procedures

C16422

P16422

Treatment resistant major depression

Induction treatment

The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies.

Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND

Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.

The following must apply if reinitiating treatment:

(i) at least four-week gap from last treatment course to reinitiation of treatment; and

(ii) evidence, documented in the patient's medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and

(iii) evidence, documented in the patient's medical record using a structured rating scale, of a relapse in depression.

The listed quantity of 16 units of nasal spray is intended for a dosage of 56 mg per treatment administration in the induction treatment setting.

Compliance with Authority Required procedures

C16438

P16438

Treatment resistant major depression

Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this indication prior to 1 May 2025; AND

The condition must have been inadequately responsive to at least two anti-depressant drug therapies prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND

The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND

Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records).

Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND

Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.

The listed quantity of 8 units of nasal spray is intended for a dosage of 56 mg per treatment administration for patients transitioning from non-PBS to PBS-subsidised treatment.

Compliance with Authority Required procedures

C16454

P16454

Treatment resistant major depression

Induction treatment

The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies.

Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND

Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.

The following must apply if reinitiating treatment:

(i) at least four-week gap from last treatment course to reinitiation of treatment; and

(ii) evidence, documented in the patient's medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and

(iii) evidence, documented in the patient's medical record using a structured rating scale, of a relapse in depression.

The listed quantity of 24 units of nasal spray is intended for a dosage of 84 mg per treatment administration in the induction treatment setting.

Compliance with Authority Required procedures

C16460

P16460

Treatment resistant major depression

Non-induction treatment

The treatment must be to continue existing PBS-subsidised treatment for this indication; AND

The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND

Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records).

Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND

Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.

The listed quantity of 4 units of nasal spray is intended for a dosage of 28 mg per treatment administration in the non-induction treatment setting.

Compliance with Authority Required procedures

C16470

P16470

Treatment resistant major depression

Non-induction treatment

The treatment must be to continue existing PBS-subsidised treatment for this indication; AND

The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND

Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records).

Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND

Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.

The listed quantity of 8 units of nasal spray is intended for a dosage of 56 mg per treatment administration in the non-induction treatment setting.

Compliance with Authority Required procedures

C16477

P16477

Treatment resistant major depression

Induction treatment

The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies.

Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND

Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.

The following must apply if reinitiating treatment:

(i) at least four-week gap from last treatment course to reinitiation of treatment; and

(ii) evidence, documented in the patient's medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and

(iii) evidence, documented in the patient's medical record using a structured rating scale, of a relapse in depression.

The listed quantity of 8 units of nasal spray is intended for a dosage of 28 mg per treatment administration in the induction treatment setting.

Compliance with Authority Required procedures

Macitentan with tadalafil

C16433

Pulmonary arterial hypertension (PAH)

Continuing treatment of combination therapy (triple therapy with selexipag)

The treatment must be part of triple combination therapy consisting of: (i) macitentan, (ii) tadalafil, (iii) selexipag.

Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND

Patient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (triple therapy with selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.

This treatment is not PBS-subsidised for the use as initial therapy

The authority application for selexipag must be approved prior to the authority application for this agent.

Compliance with Authority Required procedures

C16457

Pulmonary arterial hypertension (PAH)

Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)

The treatment must be dual combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil; OR

The treatment must be part of triple combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil, (iii) one prostanoid.

Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND

Patient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (dual or triple therapy, excluding selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.

This treatment is not PBS-subsidised for the use as initial therapy

For the purposes of PBS subsidy, a prostanoid is one of: (a) epoprostenol, (b) iloprost

Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as 'combination' therapy.

Compliance with Authority Required procedures

Vutrisiran

C16408

Hereditary transthyretin amyloidosis

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received treatment with this drug for this condition prior to 1 May 2025; AND

Patient must continue to demonstrate clinical benefit; AND

Patient must have had a Polyneuropathy Disability (PND) score description of either I, II, IIIA, IIIB prior to commencing non-PBS-subsidised therapy; OR

Patient must have had a Familial Amyloid Polyneuropathy (FAP) stage description of 1 or 2 prior to commencing non-PBS-subsidised therapy; AND

Patient must not have exhibited heart failure symptoms (defined as New York Heart Association [NYHA] class III or IV) prior to commencing non-PBS-subsidised therapy; AND

Patient must not have previously undergone a liver transplant; AND

Patient must not be permanently bedridden; OR

Patient must not be receiving end-of-life care.

Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; AND

Patient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders).

Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.

If the application is submitted through HPOS form upload or mail, it must include:

(a) details of the proposed prescription; and

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C16434

Hereditary transthyretin amyloidosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must continue to demonstrate clinical benefit; AND

Patient must not have previously undergone a liver transplant; AND

Patient must not be permanently bedridden; OR

Patient must not be receiving end-of-life care.

Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; AND

Patient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders).

Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.

If the application is submitted through HPOS form upload or mail, it must include:

(a) details of the proposed prescription; and

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C16446

Hereditary transthyretin amyloidosis

Initial treatment

Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND

The condition must be hereditary transthyretin amyloidosis confirmed by genetic testing; AND

Patient must have a Polyneuropathy Disability (PND) score description of either I, II, IIIA, IIIB; OR

Patient must have a Familial Amyloid Polyneuropathy (FAP) stage description of 1 or 2; AND

Patient must not have previously undergone a liver transplant; AND

Patient must not exhibit heart failure symptoms (defined as New York Heart Association NYHA class III or IV).

Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; AND

Patient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders).

Patient must have either: (i) stage 1 polyneuropathy, (ii) stage 2 polyneuropathy; AND

Patient must be at least 18 years of age.

PND scores in the context of this PBS restriction are:

Stage 0 - No symptoms;

Stage I - Sensory disturbances but preserved walking capability;

Stage II - Impaired walking capacity but able to walk without stick or crutches;

Stage IIIA - Walking with help of one stick or crutch;

Stage IIIB - Walking with help of two sticks or crutches;

Stage IV - Confined to wheelchair or bedridden.

FAP stage in the context of this PBS restriction are:

Stage 0 - No symptoms;

Stage 1 - Unimpaired ambulation;

Stage 2 - Assistance with ambulation required;

Stage 3 - Wheelchair-bound or bedridden.

Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.

If the application is submitted through HPOS form upload or mail, it must include:

(a) details of the proposed prescription; and

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures