Decision to widen funded access to lenalidomide for multiple myeloma

Medicines Decision

We're pleased to announce a decision to widen 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 an agreement with Celgene Pty Limited.

In summary the decision will result in the following changes from 1 April 2020:

  • lenalidomide (Revlimid) will 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 will be funded, to make dosage adjustments easier for any of the funded indications.

This decision will mean that around 120 patients who have undergone auto-SCT for newly diagnosed multiple myeloma will be able to access lenalidomide maintenance treatment each year.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 16 December 2019.

Following consultation feedback we have made some changes to the proposal we consulted on:

  • the funding requirement for lenalidomide maintenance to be commenced within 4 months of transplantation has been extended to up to 6 months post-transplant
  • applications will be able to be made by any relevant practitioner (as opposed to a medical practitioner) on the recommendation of a haematologist.

Who we think will be most 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 and DHB blood cancer services
  • Community and hospital pharmacies
  • Other organisations that have an interest in cancer treatment.

Details about this decision

A new lenalidomide 5 mg capsule and new 28 capsule pack sizes of the 10 mg and 15 mg capsules will 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

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 lenalidomide 10 mg and 15 mg, 21 capsule pack size presentations will 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

New 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 will be no change to the price and subsidy of the 25 mg capsule.

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

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

Access to lenalidomide (Revlimid) will 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
Initial application – (Relapsed/refractory disease) only from a haematologist or medical relevant 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 relapsed or refractory multiple myeloma with progressive disease; and
2. Patient has not previously been treated with lenalidomide; and
3. Either

3.1 Lenalidomide to be used as third line* treatment for multiple myeloma; or
3.2 Both:

3.2.1 Lenalidomide to be used as second line treatment for multiple myeloma; and

3.2.2 The patient has experienced severe (grade 3 or higher), dose limiting, peripheral neuropathy with either bortezomib or thalidomide that precludes further treatment with either of these treatments; and

4.Lenalidomide to be administered at a maximum dose of 25 mg/day in combination with dexamethasone.

Renewal – (Relapsed/refractory disease) only from a haematologist or medical relevant 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 stem cell transplant (SCT)) only from a haematologist or relevant 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 6 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 relevant 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) will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are set out below.

Theme

Comment

Requests for wider funded access to lenalidomide

Requests for the funding requirement for lenalidomide maintenance treatment being commenced within 4 months of transplantation to be lengthened to durations ranging from 6 months to 12 months or indefinite.

Advice from our clinical experts indicates that extending the time from 4 months, as originally proposed, to 6 months would be reasonable and that maintenance treatment used passed this timeframe would be a different indication to what is proposed and would need to be considered as a separate funding application.

The Special Authority criteria have been amended accordingly. We would be happy to consider a funding application for use of lenalidomide as maintenance treatment in the post 6-month transplant setting

Requests for the ECOG score of 0 to 1.0 to be widened to include those with a performance score of 2.0. Responders provided a number of references to published literature, including a recently published study by Jackson et al (Lancet Oncol. 2019;20:57-73), in support of this request.

The Special Authority criteria, and the requirement for an ECOG status of 0-1, are in line with our clinical advice, which considered a number of published studies.

We will, however, seek further advice on the recently published study by Jackson et al (Lancet Oncol. 2019;20:57-73), at the next meeting of the Cancer Treatments Subcommittee of PTAC (CaTSoP)(external link)

Requests for funding of lenalidomide for additional indications and other pharmaceuticals

Request to consider funding for other novel treatments for relapsed multiple myeloma, especially ones that would be effective in patients who progress on lenalidomide maintenance: carfilzomib and daratumumab.

CaTSoP considered funding applications for carfilzomib and daratumumab for refractory/relapsed multiple myeloma at its October 2019 meeting and recommended carfilzomib be funded with a medium priority, and daratumumab with a low priority. The next step in the process for both of these applications is for PHARMAC to conduct economic assessments of these applications and rank them against the other options for investment.

Full details of the advice we received is available from the application tracker:

Request to reconsider funding lenalidomide as a first-line treatment for patients with multiple myeloma who are auto-SCT eligible, noting that CaTSoP deferred making a recommendation until further evidence becomes available.

We would be happy to seek further clinical advice on this application should there be new published evidence since the time CaTSoP last reviewed this application (April 2018)(external link)

Request to fund people who require treatment for relapse, but who do not meet the criteria for funding for treatment of relapsed disease. Would like access to funded treatment in the 4th line setting or beyond.

Lenalidomide was funded in September 2014 for people with relapsed refractory myeloma who have not previously been treated with lenalidomide, in the third line(external link) setting or the second line(external link) setting for those unable to use bortezomib or thalidomide for specific clinical reasons.

If new evidence has become available since this funding decision, we would welcome a funding application to reconsider treatment of relapse in the 4th line setting or beyond. Details of the evidence that was considered is available in the application tracker from the links for third line and second line setting above.

Eligibility criteria

Some patients undergo tandem autologous stem cell transplantation. The time to commence maintenance treatment should be calculated from the time of the second transplant for those who will have tandem transplantation.

There is nothing in the Special Authority criteria that prevents funding for patients who have undergone tandem autologous transplant. The time to commence maintenance treatment can be calculated from the time of the second transplant in this setting. If an applicant applies in this scenario and all other criteria are met, then the application would be approved.

There are a number of patients currently self-funding lenalidomide for maintenance treatment in New Zealand and some may be receiving treatment overseas. Queries whether they would now be able to access funded lenalidomide.

If the Special Authority criteria where met at the time the patient was started on maintenance treatment, and provided the ongoing renewal requirements are met, patients will be able to access funded lenalidomide.

Patients who are self-funding their treatment or receiving treatment overseas will need to discuss their individual situation with their clinician. The clinician can then make a Special Authority waiver request to PHARMAC, and funded treatment will be considered on a case by case basis.

Information on how to make a Special Authority waiver request is available on the PHARMAC website.

Queries around whether or not funding will be provided until disease progression.

Funded treatment can be provided until disease progression. As per the Special Authority renewal criteria, treatment can be continued provided there is no evidence of disease progression, the treatment remains appropriate and the patient is benefiting from treatment.

System and resource impacts

Widening funded access is likely to increase clinic visits to monitor treatment.

PHARMAC includes costs to the wider health sector in its decision-making framework.

It is likely that more clinic visits will be required to monitor treatment; however, we consider that 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.

Nurse prescribers currently do not have access to ‘i-access’ with the Celgene programme to be able to prescribe lenalidomide or thalidomide. Should this change in the future, the use of the terminology ‘medical practitioner on the recommendation of a haematologist’ as per the Special Authority criteria would mean that nurse prescribers would not be able to apply for funding.

We have amended the Special authority criteria so that applications will be able to be made by any relevant practitioner, on the recommendation of a haematologist. Having any relevant practitioners able to apply is for both the widened access (1st-line treatment in patients who have undergone auto-SC) but also current access (2nd or 3rd-line treatment in relapsed or refractory multiple myeloma with progressive disease).

We have passed the ‘i-access’ feedback on to Celgene for consideration.

Price of lenalidomide

Concerns about the high price of lenalidomide, given the availability of generic lenalidomide overseas.

A confidential rebate arrangement exists for Revlimid, which reduces the net price paid by the Funder. PHARMAC’s assessment is that lenalidomide is cost effective at this net pricing in the funded indications.

There is uncertainty regarding the timing of generic lenalidomide being available in New Zealand, due to the existence of patents. This agreement for Revlimid does not preclude a listing of a generic product in the future, and will ensure all eligible New Zealanders will have access to a cost-effective, funded treatment at this time.

Other

Concerns raised with regards to the Therapeutics bill.

The proposed Therapeutic Products Bill is part of the Government’s work to replace the Medicines Act 1981 and Regulations.  The Ministry of Health is the agency responsible for this work and we encourage consumers to provide feedback directly to the Ministry(external link)

The period of time allowed for submissions on the consultation occurred over a holiday period; more time should be allowed for submissions.

The consultation period was open four calendar weeks from 16 December 2019 until 17 January 2020, to allow for submissions to occur before and after the Christmas and New Year’s public holidays. An extension to this time period would have meant that a funding date of 1 April 2020 would have not been possible.

We consider that, given the volume and range of submissions we received, the consultation period was sufficient. We are happy to receive and consider additional feedback in relation to the criteria, at any point in time.

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.