Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1^st August 2022. Frequently Asked Questions (FAQs) relating to access.

This information relates to the administration of these listings by Services Australia. For further 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. 

Severe chronic plaque psoriasis

Risankizumab (Skyrizi®) a grandfather restriction has been added to allow eligible patients with severe chronic plaque psoriasis to transition to PBS supply. Authority applications for risankizumab can be made in writing.

Ankylosing spondylitis / severe psoriatic arthritis / severe chronic plaque psoriasis / refractory fistulising Crohn's Disease / severe Crohn’s Disease / severe active rheumatoid arthritis / moderate to severe ulcerative colitis

Infliximab (Remsima SC) 120mg/mL injection (syringe) and 120mg/mL injection (pen device) is now listed on the PBS for the treatment of ankylosing spondylitis, severe psoriatic arthritis, severe chronic plaque psoriasis and refractory fistulising Crohn's Disease. As of 1 August 2022, patients will no longer be able to commence infliximab SC treatment under the grandfathered PBS restrictions for severe Crohn's disease, severe active rheumatoid arthritis and moderate to severe ulcerative colitis. Applications for initial and continuing treatments can be made in writing. Authority applications for Balance of Supply can be made either in real time using the Online PBS Authorities system or by telephone.

Spinal muscular atrophy

Nusinersen (Spinraza®) 12mg/5mL injection is now listed on the PBS for the treatment of adults diagnosed with 5q spinal muscular atrophy with symptom onset prior to 19 years of age (≤18 years of age). Authority applications for initial and grandfather treatments can be made in writing. Authority applications for continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Locally advanced or metastatic breast cancer

Palbociclib (Ibrance) has a new indication for an already PBS listed medicine. Authority applications for initial and continuing treatment can be made either in real time using the Online PBS Authorities system or by telephone.

Unresectable Stage III, non-small cell lung cancer

Durvalumab (AstraZeneca Pty Ltd) has a change to the maximum quantity and repeats. This change is to allow an additional dosing regimen of durvalumab (fixed-dose 1500 mg every 4 weeks). Authority applications for initial and continuing treatment is Authority Required (STREAMLINED).

Multiple sclerosis

Diroximel Fumarate (Vumerity®) 231mg capsule is now listed on the PBS for the treatment of Multiple Sclerosis. Authority applications for initial and continuing treatment is Authority Required (STREAMLINED).

Schizophrenia

Paliperidone (invega Hafyera) 700mg/3.5mL modified release inject (syringe) and 1g/5mL modified release injection (syringe) is now listed on the PBS for the treatment of schizophrenia. Authority applications for initial and continuing treatment is Authority Required (STREAMLINED).

1 August 2022 delisted PBS listings

Fotemustine – Muphoran – Servier Laboratories

For the treatment of Metastatic malignant melanoma has been delisted from the PBS.

Cromoglycic acid (Intal CFC-Free) Sanofi-aventis Pty Ltd

The prophylactic treatment of bronchial asthma has been delisted from the PBS with “Supply Only” arrangement.

Ledipasvir with sofosvuvir – Harvoni – Gilead Sciences

For the treatment of Chronic Hepatitis C infection has been delisted from the PBS with “Supply Only” arrangement.

Nifedapine 10mg, 20mg – Adefin10, Adefin 20 – Alphapharm Pty Ltd

For the treatment of hypertension has been delisted from the PBS with “Supply Only” arrangement.

Rivaroxoban 10mg 10 tab – Xarelto – Bayer Australia Pty Ltd

For the prevention of venous thromboembolism has been delisted from the PBS with “Supply Only” arrangement.

Roxithromycin 50mg soltab – Rulide D – Sanofi-aventis Pty Ltd

For the treatment of infections in children has been delisted from the PBS with “Supply Only” arrangement.

Selecting the correct restriction in the Online PBS Authorities system

Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. New questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS for multiple Authority Required (Written) programs to ensure prescribers are selecting the correct restriction and treatment phase to determine their patient’s eligibility. These Q&A’s will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.

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

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