New Zealand to expand access to rituximab, possibly adalimumab

Biosimilars/General | Posted 01/10/2021 post-comment0 Post your comment

New Zealand’s Pharmaceutical Management Agency, Pharmac, has announced a decision to expand access to rituximab and has launched a proposal to expand access to adalimumab.

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From 1 August 2021, people with B-cell acute lymphoblastic leukaemia (ALL)/lymphoma who meet funding criteria will be eligible for funded access to rituximab in New Zealand.

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

Rituximab is currently approved in New Zealand for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis and granulomatosis. Pharmac’s extension for use in B-cell ALL is estimated to benefit around 20 people per year in New Zealand.

The decision follows a consultation letter issued in May 2021. Rituximab will specifically be available for patients diagnosed with B-cell ALL/lymphoma in combination with intensive chemotherapy and at a maximum total dose of 375 mg/m2 per dose, for a maximum of 18 doses. The funded rituximab will be Riximyo, a biosimilar developed by Novartis.

In similar news, on 26 August 2021 Pharmac launched a proposal to increase access to adalimumab, an antibody treatment for a range of autoimmune diseases. Adalimumab is a tumour necrosis factor alpha (TNF-alpha) inhibitor and has been sold under the brand name Humira by originator company AbbVie.

The proposal is to change the funded brand of adalimumab in New Zealand from the originator, Humira, to a (citrate-free) biosimilar called Amgevita, which is sold by Amgen.

If approved, the change would come into place from 1 February 2022 and would affect all people who start on adalimumab treatment after this date. People receiving treatment with Humira before 1 February 2022 would be required to switch to Amgevita before 31 August 2022 (with exceptions for clinical difficulties associated with switching). Amgevita would become the principal brand of adalimumab for all funded uses in New Zealand from 1 September 2022 until 30 June 2026.

The proposal would also expand access to adalimumab to include ulcerative colitis (first line), Crohn’s disease (dose escalation), undifferentiated spondylarthritis, inflammatory bowel disease-associated arthritis, rheumatoid arthritis (a reduction in the number of swollen joints required for treatment and removal of the requirement for C-reactive protein (CRP) to be > 15mg/L), Behçets disease (first line) and ocular inflammation (first line).

It would also remove dosing restrictions and extend special authority (the means by which a prescriber requests government subsidy) renewal periods from six months to two years.

Approximately 6,400 people received adalimumab treatment in New Zealand in 2020 and Pharmac says the switch to a biosimilar would release significant extra funds for it to invest in other medicines. Feedback on the consultation closed on 22 September 2021.

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Source: Pharmac

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