PBS Changes from 1 November 2024

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

The information below relates to the administration of these listings by Services Australia. For further information, please download the Frequently Asked Questions. For information on broader PBS changes, please visit the PBS website. 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.

 

Delisted PBS Listings from 1 November 2024

Chronic hepatitis C infection

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

 

PBS Authorities Changes from 1 November

Having timely access to PBS-subsidised medicines can be critical to patient care. Services Australia and the Department of Health and Aged Care are working together to increase the number of PBS medicines that can be requested and approved in ‘real time’ using the Online PBS Authorities system.

From 1 November 2024, you will be able to use the system to apply for authority approval and provide evidence digitally for the following medicines. You no longer need to submit written authority applications, details of the proposed prescriptions and test results for certain medicines and treatment phases.

Treatment of spinal muscular atrophy (SMA)

• Nusinersen & risdiplam: authority applications for initial treatment can now be made either using the Online PBS Authorities system or in writing. Authority applications for continuing or change of treatment can be made either in real-time using the Online PBS Authorities system or by telephone.
• Onasemnogene abeparvovec: Authority applications for treatment can now be made either using the Online PBS Authorities system or in writing.

It's important to note that as of 1 November 2024 the forms for SMA have been revamped. Please use the most recently published written authority application form when applying for PBS-subsidised medicines for SMA and any other PBS program. To align with PBS listing changes, forms are updated on the first of the month.

 

Reminders

Esomeprazole 40 mg to treat complex gastro-oesophageal reflux disease (GORD)

PBS-subsidised prescriptions for esomeprazole 40 mg enteric tablets and capsules for the treatment of complex GORD must only be written by a gastroenterologist; or a surgeon with expertise in the upper gastrointestinal tract. GPs and other prescribers cannot write PBS-subsidised prescriptions for esomeprazole 40 mg tablets/capsules for complex GORD. Do not refer patients to their GPs to request these prescriptions as the authority request will be rejected.

 

More Information

For more information about the Online PBS Authorities system visit the Services Australia website.

Services Australia has a broad range of educational resources on the Health Professional Education Resources website. This includes simulations, podcasts, and an infographic on the Online PBS Authorities system. 

Visit the Services Australia website to find the most up-to-date authority application form for each drug, program or condition.