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

Medicines

Decision

We're pleased to announce a decision to widen funded access to bendamustine hydrochloride for the treatment of people with relapsed or refractory Hodgkin’s lymphoma.

What we’re doing

We're pleased to announce a decision to widen funded access to bendamustine hydrochloride (Ribomustin) from 1 May 2021 for the treatment of people with relapsed or refractory Hodgkin’s lymphoma.

We estimate that approximately 10-15 people will benefit from this decision each year.

What does this mean for people?

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)

These criteria will be changed from 1 May 2021 to include the indication for relapsed or refractory Hodgkin’s lymphoma.

This decision means that from 1 May 2021, people with relapsed or refractory Hodgkin’s lymphoma who meet the funding criteria will be eligible for funded access to bendamustine.

Bendamustine hydrochloride is not registered for use in patients with relapsed or refractory Hodgkin’s lymphoma.

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

Any changes to the original proposal?

This decision was subject to a consultation letter dated 15 March 2021.

 All consultation feedback was supportive and no changes have been made as a result of this feedback.

Who we think will be most interested

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

Detail about this decision

The criteria for funded access to bendamustine hydrochloride (Ribomustin) will 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 (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.

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

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. All feedback on this proposal was supportive and we are pleased to be widening access to bendamustine in a way that addresses the current unmet need.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.