The Australian Pharmaceutical Benefits Advisory Committee (PBAC) has amended its process for reviewing positive PBAC recommendations that have not been accepted by applicants.

The PBAC is an independent committee of experts that makes recommendations to the Minister for Health regarding medicines that it considers should be made available as part of the Pharmaceutical Benefits Scheme (PBS).

If a company makes an application for a positive recommendation that its medicine should be listed on the PBS, and is successful, the company is not required to immediately accept this recommendation and proceed to list that product on the PBS.  Previously, the PBAC would take note of unimplemented recommendations 2 years after recommendation and revoke unimplemented recommendations after 5 years.  Under the reformed process, the PBAC will re-examine positive PBS listing recommendations that have not been accepted 2 years after recommendation.

In a news update, the PBAC stated that its decision to implement this reform “recognises the increasing speed with which new evidence and new technologies are becoming available” as a recommendation based on information from 2 years previously may not take account of new circumstances, such as new therapeutic agents.  It noted that the Therapeutic Goods Administration (TGA) has also moved towards defining shorter periods of time in which particular decisions remain valid.

The PBAC have outlined the revised process in a flowchart and a FAQs document.  Applicants have two options once their recommendation has been identified by the PBAC for review:

1. advise the department that they no longer wish to proceed with the listing; or
2. respond by week 6 of the PBAC cycle* either confirming that they are not proceeding with the listing or justifying why the recommendation should remain.  Note that applicants are notified at week 1 of the PBAC cycle that their unimplemented recommendation will be reviewed by the PBAC (i.e. applicants have approximately 5 weeks to respond to the PBAC).

In justifying why the recommendation should remain, the PBAC requires applicants to provide the following information:

• an explanation as to why they have not pursued the recommended listing;
• why the recommendation should remain including demonstration that the recommendation is still valid (i.e. nothing has changed);
• an outline of their proposal for implementation of the recommendation if it remains;
• a date for when they intend to proceed with the listing; and
• assurance that circumstances contributing to the estimates of cost effectiveness when the initial recommendation was made remain unchanged and that the assessment of cost effectiveness remains valid.

Submissions that are being reviewed by the PBAC will be included in the agenda on the PBS website and if the PBAC decides to retain a recommendation, this information will also be published on the PBS website as part of the PBAC outcomes.  Outcomes are provided to the applicant by week 20 of the PBAC cycle (i.e. about 3 months after an applicant provides their response).

If the PBAC decides to retain a positive PBAC recommendation and it remains inactive 4 months after review (being 28 months after the initial application), the applicant will be notified that their recommendation has been revoked.

The reforms were implemented following consultation with the industry and after receiving written feedback.  However, the announcement has been met with some negative reaction, including from Medicines Australia (an organisation representing the “research-based medicines industry of Australia”).

The PBAC did not announce when the reviews would officially begin however, it is possible that the first review will occur at the July 2021 PBAC meeting.

*The PBS calendar outlines the dates of the PBAC cycle.

The full news update from the PBAC can be found here.