Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings from 1 April 2021. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities System is also attached. This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit the PBS website.

Adalimumab
From 1 April 2021, biosimilar brands for adalimumab have been listed across several conditions/indications including:

These items are available for either delayed assessment (in-writing only via mail or electronic upload), or immediate/real time assessment (via telephone or online channels) depending on the stage of treatment (initial, continuing etc). Second or subsequent continuing applications for biosimilar brands of adalimumab are Authority Required (Streamlined). Some indications have removed the requirement to submit patient assessments such as the BASDAI calculation sheet, however the assessment tool has been retained as part of the form for ease of access.

Substitution is permitted between Humira®, Hadlima®, Amgevita®, Hyrimoz® and Idacio®, of the same strength and dosage form, where written/digital authority has been obtained under the Initial 1, Initial 2, Initial 3, First Continuing or Subsequent Continuing treatment phases and the presciber has not indicated ‘no brand substitution permitted’. Substitution is permitted between biosimilar brands Hadlima®, Amgevita®, Hyrimoz® and Idacio®, of the same strength and dosage form, where a streamlined authority prescription has been written under the Subsequent Continuing treatment phase, where the prescriber has not indicated ‘no brand substitution permitted’.

Severe Asthma
Two strengths of Dupilumab will be listed as of 1 April 2021 for the treatment of either severe eosinophilic asthma or severe allergic asthma, with or without oral corticosteroid dependence. These items are Authority Required - delayed assessment (in-writing only via mail or electronic upload) for all treatment phases.

Fixed dose combinations of indacaterol, glycopyrronium and mometasone will be available on the PBS for treatment of severe asthma. These items will be available via immediate/real time assessment (via telephone or online channels).

Severe Active Rheumatoid Arthritis
From 1 April 2021, baracitinib will no longer be PBS subsidised for patients wishing to commence treatment under the Grandfathered PBS restriction.

Non-radiographic Axial Spondyloarthritis
As of 1 April 2021, secukinumab has been listed as a biological agent eligible for PBS subsidy for the treatment of non-radiographic axial spondyloarthritis. Applications for the Initial and Grandfather treatment phases will be Authority Required - delayed assessment (in-writing only via mail or electronic upload), while all other treatment phases will be Authority Required - immediate/real time assessment (via telephone or online channels).

Chronic Hepatitis C Infection
From 1 April 2021, a new listing to include an 8-week treatment option for Glecaprevir & Pibrentasvir is available for treatment naïve patients with chronic hepatitis C with compensated cirrhosis. This item will be Authority Required - immediate/real time assessment (via telephone or online channels).

Severe Established Osteoporosis
Romosozumab has been listed on the PBS as of 1 April 2021 for the treatment of severe established osteoporosis, alongside the existing listing for teriparatide. This item is Authority Required - immediate/real time assessment (via telephone or online channels), and has a lifetime limit of 12 months subsidised treatment. Patients who have received treatment with teriparatide are ineligible for PBS subsidise romosozumab treatment, unless they developed intolerances necessitating permanent teriparatide withdrawal within the first 6 months of treatment.

Locally Advanced or Metastatic Breast Cancer
A new restriction for ribociclib has been added from 1 April 2021, to allow treatment of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant. This item is Authority Required - immediate/real time assessment (via telephone or online channels), while fulvestrant is Authority Required (Streamlined).

Mabthera
The 100mg/10mL and 500mg/50mL solutions for IV infusion for treatment of Stage III or IV CD20 positive follicular B-cell non-Hodgkin’s lymphoma will be delisted from the PBS as of 1 April 2021.

Prescriber Bag items
Oral furosemide 20mg will be available as a Prescriber Bag item from 1 April 2021.

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

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