A PBS listing has been recommended for midostaurin (Rydapt) in the treatment of FLT3 mutation positive acute myeloid leukaemia (AML).
At its July meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) made a positive recommendation for a Section 100 (Highly Specialised Drugs Program) Authority Required listing of midostaurin for the treatment of patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3) mutation positive AML
In assessing the request for listing, the PBAC agreed there was a high unmet clinical need for effective treatment with an uncommon disease that has high rates of fatality (five year survival rate of 24%).
The PBAC said it based its recommendation on results from the the RATIFY trial which demonstrated that midostaurin improved overall survival versus placebo in patients aged under 60 years.
At its July meeting the PBAC also agreed to ease the restriction on prescribing of obinutuzumab (Gazyva) for Chronic lymphocytic leukaemia (CLL). The Committee agreed to a request to change the restriction from Written Authority to Streamlined.
The PBAC said it was satisfied that a Streamlined Authority was appropriate based a drug utilisation analysis showing that PBS usage of obinutuzumab over the first two years of listing was significantly lower than that predicted in the original submission. It also took into account the recent listing of two other drugs on the PBS for patients with CLL who cannot tolerate a fludarabine based regimen (ofatumumab and rituximab).
And to address a supply shortage of zoledronic acid, the PBAC also approved a temporary listing of an alternative product, Claris Lifescience Zoledronic Acid.