Blood cancers

PBS listings approved for haematological cancer drugs and biosimilars

Patients with mantle cell lymphoma may soon gain access to ibrutinib (Imbruvica) on the PBS.

At its March 2018 meeting the Pharmaceutical Benefits Advisory Committee (PBAC) recommended expansion of the PBS listing for the immune therapy to include patients with relapsed/refractory mantle cell lymphoma (MCL).

The PBAC said its recommendation for MCL “reflected the high clinical need in a condition that affects a small number of patients.”

However the committee knocked back a request by manufacturer Janssen-Cilag to have the PBS criteria for ibrutinib expanded to include first-line treatment of chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

The committee said it accepted the clinical claim for ibrutinib’s superior comparative efficacy and non-inferior safety compared with rituximab plus chlorambucil in CLL and SLL. But the PBAC did not accept the cost effectiveness estimates for the drug, and said it wanted to see more long term data on progression free survival.

At the same meeting the PBAC recommended the PBS listing of a biosimilar brand of rituximab, Riximyo, for the same haematological cancer indications as its originator brand MabThera.

Sponsor Sandoz requested a PBS listing for the biosimilar brand to cover conditions including CD20 positive follicular B-cell non-Hodgkin’s lymphoma; CD20 positive non-Hodgkin’s lymphoma; Low-grade B-cell non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia.

The PBAC recommended that Riximyo and Mabthera brands of rituximab be marked as equivalent (‘a’ flagged) for all indications and also recommended biosimilar uptake measures such as a note encouraging prescribing of the biosimilar brand to treatment naïve patients.

However it advised against lowering the benefit level of the oncology indications for rituximab from a Streamlined Authority to a Restricted Benefit, “as it is expected that this would have minimal effect on prescribing behaviours and may inadvertently lead to an increase in prescribing beyond the current restrictions.”

PBS listing has also been recommended for a new lower strength form of carfilzomib (Kyprolis) for use in patients with multiple myeloma. This will cover a 10 mg vial of carfilzomib for IV infusion, to be used in combination with dexamethasone for the treatment of patients with multiple myeloma who have failed at least one prior line of treatment.

The drug – marketed by Amgen – will be listed as a PBS Section 100 – Efficient Funding of Chemotherapy benefit with the same restriction conditions as the currently listed 30 and 60 mg vial forms of carfilzomib

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