PBS Changes from 1 March 2023

Information relating to the new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st arch 2023 can be found below.

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 Crohn’s disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn’s disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa
Adalimumab (Yuflyma®) (injection 40 mg in 0.4 mL pre-filled pen, injection 40 mg in 0.4 mL pre-filled syringe) has had a new biosimilar listed on the PBS for the treatment of severe Crohn’s disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn’s disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa. Authority applications for initial and first continuing treatments can be made in writing. Authority applications for subsequent continuing treatment are streamlined.

Paroxysmal nocturnal haemoglobinuria
Ravulizumab (Ultomiris®) (1.1 g in 11 mL injection 11 mL vial, 300 mg in 3 mL injection 3 mL vial) has had an amendment to the existing listing to remove the requirement that the LDH:ULN ratio must be at least 1.5 in the first continuing phase for the treatment of paroxysmal nocturnal haemoglobinuria. Authority applications for first continuing treatment can be made in writing.
Eculizumab (Soliris®) (300 mg in 30 mL injection 30 mL vial) has had an amendment to the existing listing to remove the requirement that the LDH:ULN ratio must be at least 1.5 in the first continuing phase for the treatment of paroxysmal nocturnal haemoglobinuria. Authority applications for first continuing treatment and balance of supply can be made in writing.

Mantle cell lymphoma
Zanubrutinib (Brukinsa®) (capsule 80 mg) has had an amendment to remove the grandfather restriction. 

Unresectable stage III or stage IV malignant melanoma
Nivolumab with ipilimumab (Opdivo®, Yervoy®) (nivolumab: Injection concentrate for I.V. infusion 100 mg in 10 mL, Injection concentrate for I.V. infusion 40 mg in 4 mL, ipilimumab: Injection concentrate for I.V. infusion 200 mg in 40 mL, Injection concentrate for I.V. infusion 50 mg in 10 mL) has had an amendment to the listing to allow patients who experience disease recurrence either while receiving or within 6 months of completing adjuvant anti-programmed cell death protein-1 (PD-1 inhibitor) treatment to receive nivolumab combined with ipilimumab for the treatment of unresectable stage III or stage IV malignant melanoma. Authority applications for initial and continuing treatments are streamlined.

Asthma
Salbutamol (Asmol CFC-FREE®) (100 mcg/actuation 200 dose) for the treatment of asthma has had an amendment to delete item codes 8288F and 3495Y due to the new dose counter version available as an unrestricted benefit on the PBS. No Supply Only arrangement.

Antipsychotic
Chlorpromazine (Largactil®) (10 mg 100 tablets) has had an amendment to delete item code 1196Y. Supply Only arrangement for 6 months.

Hypertension
Losartan (Cozavan®) (25 mg, 50 mg, 30 tablets) for the treatment of hypertension has had an amendment to delete item codes 5452Y and 8203R. Supply Only arrangement for 6 months.
Propranolol (Deralin®) (160 mg 50 tablets) has had an amendment to delete item code 2899N. Prescribers can request an authority for the 40 mg tablets if a higher dose is required. Supply Only arrangement for 6 months.

Dry eyes
Polyethylene glycol (Systane®) (28 x 0.8 mL unit doses) for the treatment of dry eyes has had an amendment to delete item codes 5532E and 9170P as the pack of 30 x 0.8 ml is listed on the PBS as a streamlined authority. Supply Only arrangement for 6 months.
Polyvinyl alcohol (Liquifilm Tears®, PVA Tears®) (15 mL bottle) for the treatment of dry eyes has had an amendment to delete item codes 2682E, 5526W and 9220G. Supply Only arrangement for 6 months.

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&As will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.

For more information, visit the Summary of Changes page on the PBS website.

Access the Frequently Asked Questions for the Online PBS Authorities System.