Proposal to widen access to bendamustine for people with relapsed or refractory Hodgkin’s lymphoma

Consultation Closed

We are seeking feedback on a proposal to widen funded access to bendamustine hydrochloride (Ribomustin).

What we’re proposing

We are seeking feedback on a proposal to widen funded access to bendamustine hydrochloride (Ribomustin) from 1 May 2021 for the treatment of people with relapsed or refractory Hodgkin’s lymphoma.

Consultation closes at 4 pm Monday 29 March 2021 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

This proposal would mean that from 1 May 2021, funded access to bendamustine hydrochloride would be widened to include the treatment of people with relapsed or refractory Hodgkin’s lymphoma.

We estimate that approximately 10-15 patients would benefit from this proposal each year.

Who we think will be interested

  • People with blood cancers and their whānau
  • Haematologists and oncologists
  • Hospital pharmacists
  • Other organisations with an interest in the treatment of cancer

About bendamustine hydrochloride and Hodgkin’s lymphoma

Bendamustine hydrochloride is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy medicine.

Bendamustine hydrochloride is currently funded for the first line treatment of chronic lymphocytic leukaemia (CLL) and for indolent, low grade lymphomas in both the first line and relapsed or refractory setting.(external link)

Bendamustine hydrochloride is registered for the first line treatment of CLL (Binet stage B or C), indolent non-Hodgkin’s lymphoma and mantle cell lymphoma (in combination with rituximab in CD20 positive patients), and for relapsed or refractory indolent non-Hodgkin’s lymphoma.

Bendamustine hydrochloride is not registered for the indications covered by this proposal.

This means that bendamustine hydrochloride would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981 when used in these unapproved indications.(external link)

Hodgkin’s lymphoma is a cancer of the lymphatic system, a part of the immune system, and mainly affects the lymphocytes. Patients with relapsed or refractory disease have not benefitted from treatment or have deteriorated after a response to chemotherapy. Patients with relapsed or refractory transplant-eligible Hodgkin’s lymphoma then receive further chemotherapy, which aims to achieve a complete response with as few different chemotherapy regimens as possible before proceeding to autologous stem cell transplant.

Bendamustine hydrochloride is administered as an intravenous infusion, given over a period of 30 to 60 minutes. Treatment as part of the BeGeV regimen (in combination with gemcitabine and vinorelbine) is administered for four cycles, every 21 days. Our clinical advisors have indicated that it would be used to prepare patients for autologous stem cell transplant.

Response rate prior to autologous stem cell transplant represents the strongest prognostic factor in relapsed or refractory Hodgkin’s lymphoma. Bendamustine as part of the BeGeV regimen will help patients to achieve a complete response prior to autologous stem cell transplant.

Why we’re proposing this

A funding application for bendamustine hydrochloride for relapsed/refractory Hodgkin’s lymphoma was reviewed PHARMAC’s Cancer Treatments Subcommittee (CaTSoP) in October 2020.(external link)

CaTSoP recommended that bendamustine hydrochloride be funded for the treatment of relapsed or refractory Hodgkin’s lymphoma with a medium priority within the context of treatment of malignancy, subject to the below Special Authority access criteria.(external link)

The Subcommittee considered there to be evidence of persistent long-term benefits when bendamustine is used as part of the BeGeV regimen.

Details about our proposal

The criteria for funded access to bendamustine hydrochloride (Ribomustin) would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2021 to include people with relapsed or refractory Hodgkin’s lymphoma (proposed new criteria shown only):

Special Authority for Subsidy

Initial application – (Hodgkin’s lymphoma) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Patient has Hodgkin’s lymphoma requiring treatment; and
  2. Patient has a ECOG performance status of 0-2; and
  3. Patient has received one prior line of chemotherapy; and
  4. Patient’s disease relapsed or was refractory following prior chemotherapy; and
  5. Bendamustine is to be administered in combination with gemcitabine and vinorelbine (BeGeV) at a maximum dose of no greater than 90 mg/m2twice per cycle, for a maximum of four cycles.

Note that “ECOG performance status” above is a measure of patients' general well-being and activities of daily life; the higher the score, the worse their general well-being and activities of daily life.

There are no proposed changes to other existing Special Authority criteria or hospital restrictions for bendamustine hydrochloride.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4 pm Monday 29 March 2021.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

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