PBS changes from 1 February 2021
The Pharmaceutical Benefits Scheme (PBS) has provided information relating to new and amended PBS listings from 1 February 2021 as well as Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities System. This information relates to the administration of these listings by Services Australia.
Reminder: Active ingredient prescribing changes
From 1 February 2021, prescribers must include the active ingredient name on all eligible PBS/RPBS prescriptions. They may also include the brand if they believe it is clinically necessary. This will mean that most medicines will be prescribed by their active ingredient rather than the brand name. For example, a prescription for Endone must include Oxycodone as the active ingredient. The Department of Health has communicated these changes separately to peak bodies and published a news article on pbs.gov.au which includes additional information, exemptions, Fact Sheets and FAQs.
From 1 February 2021, changes will be made to the PBS listings for both romiplostim and eltrombopag for the treatment of severe idiopathic thrombocytopenia in adult patients. The changes will mean that once initial therapy has commenced with either eltrombopag or romiplostim, a change of therapy to the alternative agent will only be possible within the initial 24 weeks of treatment. Once a patient has completed the initial 24 weeks of treatment, a change in treatment to the alternative agent will not be subsidised on the PBS.
Patients who fail to demonstrate a response after 24 weeks of initial treatment with one agent and have not trialled the other agent within the first 24 weeks, will not be eligible for further PBS subsidy for either of these agents. Patients who have trialled both agents and have not demonstrated a response to either of them, will also not be eligible for further treatment subsidy.
Baseline and titration weeks will no longer be managed by Services Australia, it is suggested that prescribers document these details on the patient records to ensure that the patient meets the restriction eligibility criteria.
Authority applications for initial, first continuing or re-initiation of interrupted continuing treatment must be made in writing, for delayed assessment via mail or electronic upload. Applications for second or subsequent continuing treatment are available for immediate assessment via telephone.
Pulmonary arterial hypertension
From 1 February 2021, selexipag will be listed on the PBS for the treatment of Pulmonary arterial hypertension (PAH). This agent will be listed for triple therapy treatment, to be administered in combination with an ERA (ambrisentan, macitentan or bosentan) and a PDE-5i (sildenafil or tadalafil). Where a patient cannot receive treatment with either an ERA or a PDE-5i due to contraindications or intolerance, dual therapy with selexipag and an ERA or a PDE-5i may be approved in lieu of triple therapy.
This item is Authority Required for immediate/real time assessment via the Online PBS Authorities system or telephone, for patients who have received prior PBS subsidy with at least one PAH agent as listed in the restrictions.
Attention deficit hyperactivity disorder
As of 1 February 2021, changes will be made to the current lisdexamfetamine listings for the treatment of attention deficit hyperactivity disorder (ADHD), where the patient requires continuous coverage for over 12 hours. The restrictions have been expanded to include treatment of patients who are diagnosed after the age of 18. Restrictions for all long-acting ADHD medicines (Vyvanse, Concerta and Ritalin LA) have also changed to restrict use to a single strength for a patient (post dose titration). As a result, split daily dosing is no longer subsidised by the PBS and repeats should only be sought for the target strength.
This item is Authority Required for immediate/real time assessment via the Online PBS Authorities system or via telephone.
From 1 February 2021, carfilzomib, currently listed on the PBS for the treatment of Multiple Myeloma, will move to Authority Required (Streamlined). Amendments have been applied to allow weekly dosing, with an increase in the maximum amount from 120 mg to 160 mg.
From 1 February 2021, a new type of dosing device for terbutaline will be listed on the PBS for the treatment of bronchospasm. It will be administered under the same restrictions as the current inhaler presentation, but will be a changed device with a dose counter. This item is Authority Required (Streamlined).
For further information on broader PBS changes, please visit the PBS website.