Leukaemia and lymphoma drugs get PBS listing approval

Inotuzumab (Besponsa) has been recommended for PBS subsidy for patients with acute lymphocytic leukaemia (ALL) by the Pharmaceutical Benefits Advisory Committee (PBAC).

The new PBS listing will be for the treatment of relapsed or refractory CD22 positive B-cell precursor ALL.

At its November meeting the PBAC concluded that sequential use of inotuzumab and blinatumomab (in either order) “would be clinically appropriate in some patients given the differing mechanisms of action and the clinical role for additional therapeutic options for patients who are unable to receive a haematopoietic stem cell transplant (HSCT) or who progress after a HSCT.”

The committee also recommended venetoclax (Venclexta) for PBS listing in combination with rituximab for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). The PBAC noted that sequential use of venetoclax plus rituximab and ibrutinib was likely to occur and may be clinically appropriate given the different mechanism of action and the emerging evidence. It therefore recommended venetoclax be listed with the same restriction criteria as ibrutinib due to uncertain cost-effectiveness of this sequential use.

A PBAC recommendation was also made to amend the PBS listing of brentuximab vedotin (Adcetris) to include the treatment of refractory or relapsed (RR) CD30 positive cutaneous T-cell lymphomas (CTCL). The committee said it recognised the clinical need for effective treatments in this population and was satisfied that brentuximab vedotin provides, for some patients with the mycosis fungoides (MF), sézary syndrome (SS) and primary cutaneous anaplastic large cell lymphoma (pcALCL) subtypes of CTCL, a significant improvement in efficacy over methotrexate.

However it noted that the lymphomatoid papulosis CTCL subtype is not consistently defined as a cancer and most patients do not require treatment with brentuximab vedotin, and recommended that this subtype be excluded from the listing.

The PBAC also recommended the listing of the Fulphila biosimilar brand of pegfilgrastim for chemotherapy-induced neutropenia.The PBAC advised that the Fulphila, and Ristempa brands of pegfilgrastim should be considered equivalent to the reference brand Neulasta and for the purpose of substitution (i.e., ‘a’ flagged).

An unrestricted benefit listing for a new strength of iron injection ferric carboxymaltose (Ferinject )injection (1,000 mg/20 mL)  Injection 1,000 mg (iron) in 20 mL was recommended as an addition to the existing 500 mg/10 mL presentation, for the treatment of iron deficiency anaemia (IDA).

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