Proposal to widen funded access to lenalidomide for multiple myeloma

Medicines

Consultation Closed

We are seeking feedback on a proposal to widened funded access to lenalidomide (Revlimid) to include:

maintenance treatment for people with newly diagnosed multiple myeloma (a type of blood cancer) who have undergone autologous stem cell transplant (auto-SCT), through a provisional agreement with Celgene Pty Limited.

In summary, the proposal would result in the following changes from 1 April 2020:

  • lenalidomide (Revlimid) would be funded as maintenance treatment for people with newly diagnosed multiple myeloma who have undergone autologous stem cell transplant.
  • a new 5 mg capsule strength of lenalidomide would be funded, to make dosage adjustments easier for any of the funded indications.

Lenalidomide would continue to be funded for all the existing funded multiple myeloma indications.

Consultation closes at 5 pm on Friday, 17 January 2020 and feedback can be emailed to consult@pharmac.govt.nz.

Who we think will be interested

  • People with newly diagnosed multiple myeloma who are eligible for auto-SCT and their whānau
  • Leukaemia and Blood Cancer New Zealand, Myeloma New Zealand and other groups who support people living with multiple myeloma
  • Haematologists/oncologists
  • Community and hospital pharmacies
  • Other organisations that have an interest in cancer treatment

What would the effect be?

This proposal would mean that funded access to lenalidomide would be widened to include maintenance treatment for people with newly diagnosed multiple myeloma who have undergone auto-SCT. In addition, there would be a new 5 mg lenalidomide capsule funded and pack sizes of 28 capsules would be funded to align with the treatment cycles for this particular indication. The funding of a 5 mg capsule would mean that dose adjustments, for any of the funded indications, are easier to administer.

For some people with newly diagnosed multiple myeloma, an auto-SCT is an appropriate treatment option. Unfortunately, many of these people will eventually experience disease relapse. Maintenance treatment after an auto-SCT aims to delay relapse. There is currently no funded maintenance treatment for people with newly diagnosed multiple myeloma who have undergone auto-SCT.

The clinical advice we have received indicates that treatment with lenalidomide can provide a survival benefit for patients in this maintenance setting when compared with no treatment.

We estimate that there would be 120 new patients per year who would receive treatment as a result of this proposal. Taking into account time on treatment we anticipate there could be up to 300 patients on treatment after 3 years of funding.

Lenalidomide is an orally administered treatment; however, it is likely that more clinic visits would be required to monitor treatment. There may be an overall reduction in cost to DHBs as improving progression-free survival may reduce the number of hospital admissions for illness related to progression of disease.

About lenalidomide and multiple myeloma

Lenalidomide is a medicine that comes in capsule form and is used in the treatment of multiple myeloma.

Lenalidomide is an analogue of thalidomide. Lenalidomide works in a number of different ways to slow the growth and limit the survival of myeloma cells.

Lenalidomide is approved by Medsafe for use in certain types and stages of multiple myeloma including maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone auto-SCT.

Multiple myeloma is cancer of plasma cells, a type of white blood cell normally responsible for the production of antibodies. Multiple myeloma is not curable, therefore treatment is aimed at delaying disease progression, extending duration of life, and/or improving quality of life. Management of multiple myeloma also involves symptom control and treatments to prevent complications.

The age-standardised incidence rate of multiple myeloma is higher in Maori compared to non-Māori; and there are significant ethnic disparities in survival with poorer outcomes for Māori than non-Māori.

Information regarding lenalidomide dosing, administration and safety is available from the Medsafe datasheet.

> New Zealand data sheet for Revlimid (lenalidomide) – Medsafe's website(external link)

Lenalidomide is currently funded for use as a second-line or third-line treatment in patients with relapsed or refractory multiple myeloma subject to clinical criteria being met.

Why we’re proposing this

A funding application for lenalidomide for people with newly diagnosed multiple myeloma who have undergone auto-SCT was considered by the Cancer Treatments Subcommittee of the Pharmacology and Therapeutics Advisory Committee (CaTSoP) at its April 2018 meeting.

> Download the minutes from the meeting [PDF, 306 KB]

CaTSoP recommended funding with a medium priority and PTAC agreed with this priority at its August 2018 meeting. More information including links to the PTAC and Subcommittee meeting records can be found in the Application Tracker record for lenalidomide – multiple myeloma, maintenance following frontline auto-SCT.

> Check the record in Application Tracker(external link)

CaTSoP and PTAC have also considered funding for lenalidomide in other treatment settings for multiple myeloma. CaTSoP and PTAC recommended that:

  • Lenalidomide as first-line treatment for people with multiple myeloma who are ineligible for auto-SCT should be funded only if cost-neutral to the health sector when compared with bortezomib containing regimens.
  • The application for funding of lenalidomide as first-line treatment in people with multiple myeloma who are eligible for auto-SCT should be deferred until additional data are available.

More information including links to the PTAC and Subcommittee meeting records can be found in the Application Tracker records from the hyperlinks above.

This proposal is for funding of lenalidomide for maintenance treatment for people with newly diagnosed multiple myeloma who have undergone auto-SCT, in line with the recommendations from our clinical advisors.

Details about our proposal

A new 5 mg capsule and new 28 capsule pack sizes of the 10 mg and 15 mg capsules would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 April 2020 at the following subsidies and prices (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Proposed price and subsidy

Lenalidomide

Cap 5 mg

Revlimid

28

$5,122.76

Lenalidomide

Cap 10 mg

Revlimid

28

$6,207.00

Lenalidomide

Cap 15 mg

Revlimid

28

$7,239.18

The price and subsidy of the 10 mg and 15 mg, 21 capsule pack size presentations would be reduced in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 April 2020 to the following prices (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Current price and subsidy

Proposed price and subsidy

Lenalidomide

Cap 10 mg

Revlimid

21

$6,207.00

$4,655.25

Lenalidomide

Cap 15 mg

Revlimid

21

$7,239.18

$5,429.39

Lenalidomide

Cap 25 mg

Revlimid

21

$7,627.00

$7,627.00*

*Note there would be no change to the price and subsidy of the 25 mg capsule.

A confidential rebate would apply to Revlimid (both the currently listed 21 capsule pack sizes and the new 28 capsule pack sizes) that would reduce the net price to the Funder.

Revlimid would have protection from delisting and subsidy reduction until 31 March 2023. This protection would not preclude other brands of lenalidomide from being listed during this period.

Access to lenalidomide (Revlimid) would be amended in Section B of the Pharmaceutical Schedule from 1 April 2020 to include people with newly diagnosed multiple myeloma who have undergone auto-SCT as follows (deletions in strikethrough, additions in bold):

Special Authority for Subsidy

Special Authority for Subsidy
Initial application – (Relapsed/refractory disease) only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

Renewal – (Relapsed/refractory disease) only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria.

Both:

  1. No evidence of disease progression; and
  2. The treatment remains appropriate and patient is benefitting from treatment.

Initial application – (Maintenance following first-line autologous SCT) only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

  1. Patient has newly diagnosed symptomatic multiple myeloma and has undergone first-line treatment that included an autologous stem cell transplantation; and
  2. Patient has at least a stable disease response in the first 100 days after transplantation; and
  3. Lenalidomide maintenance is to be commenced within 4 months of transplantation; and
  4. The patient has ECOG performance score of 0-1; and
  5. Lenalidomide to be administered at a maximum dose of 15 mg/day.

Renewal – (Maintenance following first line autologous SCT) only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria.

Both:

  1. No evidence of disease progression; and
  2. The treatment remains appropriate and patient is benefitting from treatment.

Note: Indication marked with * is an unapproved indication. A line of treatment is considered to comprise either: a) a known therapeutic chemotherapy regimen and supportive treatments or b) a transplant induction chemotherapy regimen, stem cell transplantation and supportive treatments. Prescriptions must be written by a registered prescriber in the lenalidomide risk management programme operated by the supplier.

Equivalent changes to the restrictions for lenalidomide (Revlimid) would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5pm on Friday 17 January 2020.

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.