Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st November 2024.

This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit pbs.gov.au. Relevant information and authority application forms have been updated and can be accessed through the Services Australia website. 

Pre-symptomatic spinal muscular atrophy (SMA)

Risdiplam (Evrysdi®) (750 microgram/ml powder for oral liquid, 80 ml) is now listed on the PBS for the treatment of pre-symptomatic SMA with 3 copies of the survival motor neuron 2 (SMN2) gene. Authority applications for initial treatment can be made either using the Online PBS Authorities system or in writing. Authority applications for continuing treatment can be made either in real-time using the Online PBS Authorities system or by telephone.

Severe established osteoporosis

Romosozumab (Evenity®) (105 mg/1.17 ml injection, 2 x 1.17 ml syringes) is now listed on the PBS for the treatment of severe established osteoporosis as first-line therapy. Authority applications for initial, grandfather and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone. Flow-on changes have been applied to item code 12301K for consistency:

• Treatment phases have been updated to "Initial treatment - Second-line therapy" and "Continuing treatment - Second-line therapy".
• The clinical criteria "The treatment must not exceed a lifetime maximum of 12 months therapy" has been updated to "The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy".

Mycosis fungoides cutaneous T-cell lymphoma

Chlormethine (ledaga®) (0.016% (160 microgram/g) gel, 60 g) is now listed on the PBS for the treatment of mycosis fungoides cutaneous T-cell lymphoma. Authority applications for initial and continuing treatments can be made either in real-time using the Online PBS Authorities system or by telephone

Severe pain, cancer pain, severe disabling pain

Morphine (Anamorph®) (morphine sulfate pentahydrate 30 mg tablet) is now listed on the PBS for the treatment of severe pain, cancer pain, and severe disabling pain. Authority applications for severe disabling pain in palliative care treatment can be made either in real-time using the Online PBS Authorities system or by telephone. For the treatment of severe pain and cancer pain, it is listed as a restricted benefit.

Diabetes mellitus type 2

Dapagliflozin + sitagliptin (Sidapvia 10/100®) (dapagliflozin 10 mg + sitagliptin 100 mg tablet, 28) is now listed on the PBS for the treatment of diabetes mellitus type 2. Prescriptions for treatment are Authority required (STREAMLINED).

Acromegaly; Functional carcinoid tumour; Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

lanreotide (Mytolac®)(Somatuline Autogel®) (60 mg/0.5 ml injection, 0.5 ml syringe; 90 mg/0.5 ml injection, 0.5 ml syringe; 120 mg/0.5 ml injection, 0.5 ml syringe) has had an amendment to the restriction to allow the initiation of treatment under Sl 00 HSD Community Access arrangements.

Prescriptions for initial and continuing treatments are Authority required (STREAMLINED).

Stage IV (metastatic) Merkel Cell Carcinoma

Avelumab (Bavencio®) (200 mg/1O ml injection, 1O ml vial) has had an amendment to the clinical criteria to align with the dosing recommendations in the Product Information. Prescriptions for initial and continuing treatments are Authority required (STREAMLINED).

Treatment-resistant migraine; chronic migraine

Fremanezumab (Ajovy®) (225 mg/1.5 ml injection, 1.5 ml syringe; 225 mg/1.5 ml injection, 1.5 ml pen device) for the treatment of treatment-resistant migraine & galcanezumab (Emgality®) (120 mg/ml injection, 1 ml pen device) for the treatment of chronic migraine have had an amendment to the treatment criteria for initial treatment. Prescriptions for initial and continuing treatments are Authority required (STREAMLINED).

Phenylketonuria

Glycomacropeptide formula with amino acids and low phenylalanine (PKU GMPro MIX-IN®) (powder for oral liquid, 30 x 12.5 g sachets) is now listed on the PBS for the treatment of phenylketonuria. It is listed as a restricted benefit.

Glycomacropeptide formula with amino acids, vitamins, minerals, trace elements, carbohydrate, fat and low phenylalanine (PKU GMPro ULTRA®) (powder for oral liquid, 30 x 33.4 g sachets) is now listed on the PBS for the treatment of phenylketonuria. It is listed as a restricted benefit.

Climacteric symptoms after natural or surgical menopause

Estradiol (Sandrena®) (0.1% (1 mg/g) gel, 28 x 500 mg sachets) is now listed as an unrestricted benefit.

Chemotherapy and inflammatory conditions

Methotrexate (Methoblastin®) (10 mg tablet) 10 tablet pack size is now listed on the PBS for the treatment of chemotherapy and inflammatory conditions. It is listed as an unrestricted benefit.

Hypercholesterolaemia 

Ezetimibe and ezetimibe+statin fixed dose combination listings (various brands) have had amendments to the restriction level from Authority required (STREAMLINED) to unrestricted benefit, and 60 Day Prescription items have been amended to restricted benefit.

Menopausal Hormone Therapy 

Estradiol (Estramon (Germany)®) (37.5 microgram/24 hours patch, 24; 50 microgram/24 hours patch, 24; 75 microgram/24 hours patch, 24; 100 microgram/24 hours patch, 24) is now listed on the PBS for the current supply shortage under Section 19A. It is listed as an unrestricted benefit.

Assisted Reproductive Technology; infertility indications other than that of Assisted Reproductive Technology

Choriogonadotropin alfa (Ovidrel (USA)®) (250 microgram/0.5 ml injection, 0.5 ml syringe) is now listed

on the PBS for the current supply shortage under Section 19A. It is listed as an Authority required (STREAMLINED) benefit for Assisted Reproductive Technology, and as a restricted benefit for infertility indications other than that of Assisted Reproductive Technology.

Elevated intraocular pressure

Timolol (Timolol (Brown & Burk, UK)®) (0.5% eye drops) is now listed on the PBS for the current supply shortage under Section 19A. It is listed as an unrestricted benefit.

1 November 2024 delisted PBS listings Chronic hepatitis C infection

Ribavirin (lbavyr®) (200 mg tablet) has been delisted from the PBS with no supply only arrangement.

For more information about the Online PBS Authorities system visit www.servicesaustralia.gov.au/hppbsauthorities.

Services Australia has a broad range of educational resources on the Health Professional Education Resources website. This includes simulations, podcast and an infographic on the Online PBS Authorities system. Visit https://hpe.servicesaustralia.gov.au/pharmaceutical-benefits-scheme.html.

Visit servicesaustralia.gov.au/hpwrittenauthoritydrugs on the Services Australia website to find the most up to date authority application form for each drug, program or condition.

For more information go to servicesaustralia.gov.au/hpos.

To learn more about these updates, please contact Services Australia directly.

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