Proposal to list bendamustine

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal to list bendamustine (Ribomustin) through a provisional agreement with Janssen-Cilag Pty Ltd.

Details of the proposal are set out below, in summary, if progressed, it would result in bendamustine being funded for chronic lymphocytic leukaemia and indolent, low-grade lymphomas subject to restrictions, from 1 July 2017.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm on Thursday, 1 June 2017 to:

Andrew Park
Therapeutic Group Manager
PHARMAC

Email: andrew.park@pharmac.govt.nz

PO Box 10 254
Wellington 6143

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.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld.  PHARMAC will give due consideration to any such request. 

Details of the proposal

  • Bendamustine (Ribomustin) would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 July 2017 at the following prices and subsidies (ex-manufacturer, excluding GST): 

Presentation

Pack size

Proposed price and subsidy

Inj 25 mg vial

1

$271.35

Inj 100 mg vial

1

$1085.38

Inj 1 mg for ECP

1 mg

$11.40*

*The proposed price and subsidy for the 1 mg for ECP presentation assumes 5% wastage based on the expected average dose, dosing schedule and number of patients treated.
  • A confidential rebate would apply to Ribomustin that would reduce its net price to the Funder.
  • Bendamustine would be listed in the Pharmaceutical Schedule as a Pharmaceutical Cancer Treatment only (PCT only – Specialist), meaning that only DHB hospitals would be able to claim for its use.
  • Bendamustine would be listed in Section B of the Pharmaceutical Schedule, for claiming purposes only, subject to the following Special Authority criteria:

Special Authority for Subsidy

Initial application — (treatment naïve CLL) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. The patient has Binet stage B or C, or progressive stage A chronic lymphocytic leukaemia requiring treatment; and
  2. The patient is chemotherapy treatment naive; and
  3. The patient is unable to tolerate toxicity of full-dose FCR; and
  4. Patient has ECOG performance status 0-2, and
  5. Patient has a Cumulative Illness Rating Scale (CIRS) score of <6; and
  6. Bendamustine is to be administered at a maximum dose of 100mg/m2 on days 1 and 2 every 4 weeks for a maximum of 6 cycles.

Note: ‘Chronic lymphocytic leukaemia (CLL) includes small lymphocytic lymphoma (SLL). Chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments.

Initial application — (Indolent, Low-grade lymphomas) – only from a relevant specialist or any other medical practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

Renewal — (Indolent, Low-grade lymphomas) – Applications only from a relevant specialist or any other medical practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

Both:

Note: ‘indolent, low-grade lymphomas’ includes follicular, mantle cell, marginal zone and lymphoplasmacytic/ Waldenström’s macroglobulinaemia.

  • The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
  • The initial Special Authority criteria for rituximab for chronic lymphocytic leukaemia would be amended in Section B and H of the Pharmaceutical Schedule from 1 July 2017 as follows to allow its use in combination with bendamustine (additions in bold):

Initial application — (Chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

Note: 'Chronic lymphocytic leukaemia (CLL)' includes small lymphocytic lymphoma. A line of chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments. 'Good performance status' means ECOG score of 0-1, however, in patients temporarily debilitated by their CLL disease symptoms a higher ECOG (2 or 3) is acceptable where treatment with rituximab is expected to improve symptoms and improve ECOG score to <2.

Renewal application – (Chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. The patients disease has relapsed following no more than one prior line of treatment with rituximab for CLL; and
  2. The patient has had a rituximab treatment–free interval of 36 months or more; and
  3. The patient does not have chromosome 17p deletion CLL; and
  4. It is planned that the patient receives full dose fludarabine and cyclophosphamide (orally or dose equivalent intravenous administration) or bendamustine; and
  5. Rituximab to be administered in combination with fludarabine and cyclophosphamide or bendamustine for a maximum of 6 treatment cycles.

Note: 'Chronic lymphocytic leukaemia (CLL)' includes small lymphocytic lymphoma. A line of chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments.

Background

Bendamustine is a is an alkylating antitumour agent with unique activity. The antineoplastic and cytocidal effect of bendamustine hydrochloride is based essentially on a cross-linking of DNA single and double strands by alkylation.

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

Bendamustine is administered by intravenous infusion over 30-60 minutes. More information regarding bendamustine dosing and administration can be found in the Medsafe datasheet(external link).

We expect approximately 130 patients with indolent non-Hodgkin’s lymphoma (including those with both treatment naïve and relapsed/refractory disease) would access treatment with bendamustine in the first year, with this number likely to double by the second year. In addition, approximately 30-35 new patients with treatment naïve chronic lymphocytic leukaemia patients would initiate bendamustine treatment each year.

An application from Lymphoma New Zealand and subsequent supplier applications for bendamustine in a wider population have been reviewed by our Pharmacology and Therapeutics Advisory Committee (PTAC) and the Cancer Treatments Subcommittee of PTAC (CaTSoP) on a number of occasions. More information, including links to PTAC and Subcommittee minutes, can be found in the records for bendamustine on PHARMAC’s Application Tracker at:  https://connect.pharmac.govt.nz/apptracker/s/global-search/bendamustine(external link)