Blood cancers

PBS offers flexibility on multiple myeloma drug listing restrictions

PBS gatekeepers have signalled a willingness to be flexible on restrictions that currently prevent clinicians from prescribing the best treatments for multiple myeloma such as protease inhibitor (PI) and immunomodulatory drug (IMiD) dual therapy.

In a meeting with stakeholders in May, the Pharmaceutical Benefits Advisory Committee (PBAC) said it understood the frustrations created by PBS restrictions on first line use of combination therapy such as bortezomib and lenalidomide.

The meeting heard from professional groups including the Medical & Scientific Advisory Group (MSAG) of Myeloma Australia and Haematological Society of Australia and New Zealand (HSANZ), who said that current choices of therapy for MM are dictated by PBS listings that do not always align with evidence-based therapies for best patients outcomes.

“In particular, the combined use of a protease inhibitor such as bortezomib and an immunomodulatory agent such as lenalidomide or thalidomide, is standard in international guidelines for first-line treatment of newly diagnosed MM patients. However [it] is not currently available through the PBS due to the restrictions in place,” the meeting outcome statement notes.

Other issues of concern raised by professional groups included inconsistent restrictions on lenalidomide as first line therapy depending on transplant eligibility and access to thalidomide in conjunction with other PBS-listed treatments.

The PBAC said the restrictions arose because pharmaceutical sponsors had not put in applications backed with good data to support cost effectiveness for the treatments in question. Problems also arose because PBS listing applications for dual therapy would require applications from two separate companies.

MSAG representatives told the meeting that access to first-line treatment with dual PI and IMiD should be a priority for improving patient survival in MM. There was also a need to consider access to triple therapy combinations that include new agents such as daratumumab or carfilizomib, the meeting was told.

Other key priorities identified for improving PBS access included making lenalidomide available as maintenance therapy post Autologous Stem Cell Transplant (ASCT), and simplification of restrictions in the relapsed and refractory setting.

“Clinicians raised concerns that the PBS restrictions do not allow switching of therapy from bortezomib to lenalidomide. For example, prior to progression, when it becomes evident through cytogenetic tests that patients will likely respond better to the alternative agent, prescribers currently cannot switch to the treatment until after the patient has progressed,” the outcome statement noted.

The chair of the PBAC, Professor Andrew Wilson, said the next step could involve a  simplified PBS listing of ‘Multiple myeloma’ for bortezomib and lenalidomide, which would address many of the suggested priorities.

“However, price reductions would be needed in order for PBAC to be able to recommend the implementation of this change,” the PBAC statement noted.

Addressing the priorities would also require negotiations with multiple pharmaceutical sponsors, an area in which industry lobby group Medicines Australia could play a role, the PBAC suggested.

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