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Pembrolizumab - information for patients

Page last updated: 1 September 2015

Pembrolizumab has been listed on the Pharmaceutical Benefits Scheme (PBS) via a Managed Entry Scheme (MES). This MES provides a mechanism to address the uncertainty over the size of the additional clinical benefit of pembrolizumab while providing early access to those patients for whom there is a high clinical need. Information about the benefits of pembrolizumab in clinical practice will be collected, analysed and presented to the Pharmaceutical Benefits Advisory Committee (PBAC) for consideration in the near future.

Prescribers and patients must be aware that if a medicine listed via an MES does not prove as beneficial in clinical practice as appeared in the clinical data presented to the PBAC, it may subsequently have its restriction modified or be removed from the PBS by the Commonwealth, or at the request of the sponsor.

For more information on Managed Entry Schemes, please visit the 'Framework for the introduction of a Managed Entry Scheme for submissions to the Pharmaceutical Benefits Advisory Committee' page.

In the case of pembrolizumab, the relevant information is being collected from an ongoing clinical trial outside the PBS.

For more information on the PBAC’s consideration of this medicine and its MES, please see its Public Summary Document (PSD) from the March 2015 PBAC Meeting.