Decision to increase access to lenalidomide and pomalidomide through a brand change for lenalidomide

2 July 2024

We're pleased to announce that we have made the decision to widen access to lenalidomide and fund pomalidomide through a brand change.

What we’re doing

We're pleased to announce that we have made the decision to widen access to lenalidomide and fund pomalidomide through a brand change. In summary:

Lenalidomide Viatris (supplied by Viatris) will be funded for the first-line treatment of people with either plasma cell dyscrasia (e.g. multiple myeloma) or myelodysplastic syndrome associated with a 5q deletion who have transfusion-dependent anaemia from 1 August 2024. Lenalidomide Viatris will be the principal funded brand of lenalidomide from 1 February 2025 until 31 January 2028.
Pomolide (supplied by Juno Pharmaceuticals), will be funded for people with relapsed/refractory plasma cell dyscrasia as second or later line treatment from 1 August 2024. Pomolide will be the principal funded brand of pomalidomide from 1 August 2024 until 31 July 2027
Any relevant practitioner will be able to apply for initial and renewal applications for lenalidomide and pomalidomide. This will ensure all relevant prescribers who care for people with plasma cell dyscrasia or myelodysplastic syndrome can apply for funded treatment.

This decision is the result of a competitive process for the Principal Supply of lenalidomide and pomalidomide. This decision releases signficant funds which we are investing in other medicines for the benefit of New Zealanders.

You can find more information about the RFP in the consultation letter and details about this decision follow.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 23 April 2024. We received feedback from clinicians, advocacy groups, suppliers and consumers. We appreciate everyone who took the time to give feedback. We appreciate the personal stories people shared with us about the devastating effects multiple myeloma has on their lives and the lives of their loved ones.

Responses ranged from supportive to wanting different blood cancer medicines to be funded. We understand there remains a high unmet health need for people with multiple myeloma and more funded treatments are needed. Unfortunately, we operate with a fixed budget, which means we have to make difficult choices about which medicines to fund, and for who, from within this budget.

We are not able to include funding for additional blood cancer medicines at this time. Some of the requested medicines are on our Options for Investment List. We are not yet able to name which specific medicines on the Options for Investment List will be taken forward for funding. We will be sure to publicly consult on any proposals we intend to progress.

Responders also requested wider access to lenalidomide and clarification of the proposed funding criteria for lenalidomide and pomalidomide. Because of what people told us, we have:

changed the indication for both lenalidomide and pomalidomide to “plasma cell dyscrasias” instead of “multiple myeloma”, to ensure that those who are expected to benefit from treatment will be eligible.
changed the eligibility criteria for lenalidomide to enable access for people who have previously experienced successful response to lenalidomide.
removed the renewal criteria for lenalidomide.

More detail on the requested changes and our response can be found below in the response to consultation feedback section.

Who we think will be most interested

People who have multiple myeloma or myelodysplastic syndrome, their whānau, and caregivers
Groups who support people with multiple myeloma and myelodysplastic syndrome
Haematologists, oncologists, specialist nurses, and other health professionals involved in the care of people with multiple myeloma and myelodysplastic syndrome
Community and Hospital pharmacists and wholesalers
Health New Zealand | Te Whatu Ora hospitals
Pharmaceutical suppliers

What does this mean for people?

Our clinical advisors have told us that funding lenalidomide in the first-line setting, would provide substantial benefits for all people, including Māori, with multiple myeloma, as they would be able to receive an oral regimen. Our clinical advisors have also told us that funding pomalidomide in the relapsed/refractory setting would provide a more effective second-line treatment than the current options in New Zealand.

We estimate that over 800 new people with multiple myeloma will access these treatments in the first year of funding, and that this will increase to over 3,900 people after five years of funding.

Lenalidomide

From 1 August 2024:

People with plasma cell dyscrasia – regardless of transplant eligibility – who meet the eligibility criteria will have access to lenalidomide (Lenalidomide Viatris).
People with myelodysplastic syndrome associated with a 5q deletion who have transfusion-dependent anaemia will be able to access lenalidomide (Lenalidomide Viatris).
People who are new to lenalidomide will receive Lenalidomide Viatris. Revlimid will not be funded for people new to lenalidomide treatment.
People who have been on Revlimid previously will need to transition to Lenalidomide Viatris and have until 31 January 2025 to do this. Transitioning to using Lenalidomide Viatris will need to be discussed between prescribers, individuals receiving treatment and their family, whānau and caregivers.

From 1 February 2025:

Lenalidomide Viatris will be the only listed brand of lenalidomide available in New Zealand.
Everyone needs to have transitioned to the Lenalidomide Viatris brand. Revlimid will only be available through our Exceptional Circumstances Framework for people who have transitioned to Lenalidomide Viatris and experienced an adverse reaction.

Pomalidomide

From 1 August 2024 people with relapsed/refractory plasma cell dyscrasia who meet the eligibility criteria will have access to pomalidomide (Pomolide).

Information for prescribers and pharmacists

We anticipate the lenalidomide brand transition will be led by prescribers; however, prescribers, pharmacists and individuals receiving lenalidomide treatment will need to work together to manage the transition from Revlimid to Lenalidomide Viatris. We encourage prescribers to engage with individuals receiving treatment at their earliest opportunity to discuss continuation of their lenalidomide treatment with Lenalidomide Viatris

Exceptional circumstances

Lenalidomide Viatris is a generic version of lenalidomide. This means it has the same active ingredient as the Revlimid brand and works in the same way. Our clinical advisors have told us that everyone currently receiving the funded Revlimid brand could transition to the Lenalidomide Viatris brand.

Our clinical advisors told us that it would be appropriate to consider ongoing funding of the Revlimid brand for people on an individual, case-by-case basis if they were to experience an adverse reaction to the Lenalidomide Viatris brand. An individual’s prescriber would need to apply via Pharmac’s Exceptional Circumstances framework for this. The application would need to demonstrate that the individual transitioned from the Revlimid brand of lenalidomide to the generic Lenalidomide Viatris brand, and then experienced a hypersensitivity reaction that could be reasonably attributable to the generic lenalidomide. Our clinical advisors have told us that this would be extremely rare. This application will be different to our Named Patient Pharmaceutical Applications (NPPA) pathway. We have confirmed supply and pricing with the supplier of Revlimid for access via this mechanism.

If a person experiences disease progression following a transition to the generic brand of lenalidomide, they will not be eligible to return to the Revlimid brand of lenalidomide through the Exceptional Circumstances pathway. Unfortunately, disease progression in multiple myeloma can happen when someone is receiving treatment. If this were to occur, people should discuss their available treatment options with their prescriber. People who experience disease progression while on lenalidomide will be eligible for pomalidomide.

Pregnancy Prevention programmes and educational support

Changing the funded brand of lenalidomide and initiating funding of pomalidomide, will result in two new risk management programmes (pregnancy prevention programmes) being introduced into the health system.

Healthcare professionals (either prescribing or dispensing these treatments) will have to register for access to these programmes. Pharmac will develop a webpage in the coming fortnight that provides more information to support access to these programmes.

You will need to register separately to each pregnancy prevention programme. Both suppliers (Viatris & Juno) are providing on-line and telephone support to help health care professionals.

Lenalidomide Viatris (Viatris) pregnancy prevention programme - link to be available on the Pharmac webpage before 1 August 2024.
Pomolide (Juno) pregnancy prevention programme link to be available on the Pharmac webpage following the launch of Juno’s risk management system in mid-July.

Educational materials for HCPs and patients will be available on both sites in a digital format with suppliers able to provide physical copies upon request.

Special authority changes

Lenalidomide Viatris and Revlimid will have different Special Authority numbers. The Revlimid brand will continue to be funded until 31 January 2025, providing a 6-month transition period. All new patients prescribed lenalidomide from 1 August 2024 will have only a Lenalidomide Viatris Special Authority number.

To avoid a potential risk of treatment interruption for those currently taking the Revlimid brand, we will work with Ministry of Health Sector Services staff to ensure these people are automatically provided with a Special Authority approval for Lenalidomide Viatris from the date of listing. This means that these people will have two Special Authorities running concurrently (Revlimid and Lenalidomide Viatris) for the duration of the transition period.

We will be applying a brand switch fee to Lenalidomide Viatris, which will be paid to pharmacies from the start of the Principal Supply period (from 1 February 2024). This is to support the time needed for pharmacists to counsel patients about a change to their next dispensing of lenalidomide.

Detail about this decision

Lenalidomide for the treatment of plasma cell dyscrasias and myelodysplastic syndrome

Lenalidomide (Lenalidomide Viatris) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2024 as follows:

Chemical	Formulation	Brand	Pack size	Price and subsidy
Lenalidomide	Cap 5 mg	Lenalidomide Viatris	21	$76.92
Lenalidomide	Cap 10 mg	Lenalidomide Viatris	21	$50.30
Lenalidomide	Cap 15 mg	Lenalidomide Viatris	21	$62.13
Lenalidomide	Cap 25 mg	Lenalidomide Viatris	21	$65.09

The current brand of lenalidomide (Revlimid) will remain listed in Section B and Part II of Section H of the Pharmaceutical Schedule until 31 January 2025. After which time, access to this will be considered via Pharmac’s exceptional circumstances framework.

This allows six months for people currently receiving Revlimid to transition to the new brand, Lenalidomide Viatris.

From 1 February 2025, a brand switch fee will apply at the pharmacy level to support this transition.

Lenalidomide Viatris (supplied by Viatris) will have Principal Supply Status from 1 February 2025 until 31 January 2028. This means it will be the only listed brand of lenalidomide available in New Zealand and will be guaranteed at least 95% of the funded market. Any funded use of an alternative brand will need Pharmac approval through our Exceptional Circumstances Framework.

The following eligibility criteria will apply to Lenalidomide Viatris in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2024:

Special Authority for Subsidy

Initial application - (Plasma cell dyscrasia) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Both:

Patient has plasma cell dyscrasia, not including Waldenström macroglobulinaemia, requiring treatment; and
Patient is not refractory to prior lenalidomide use.

Initial application - (Myelodysplastic syndrome) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

Patient has low or intermediate-1 risk myelodysplastic syndrome (based on IPSS or an IPSS-R score of less than 3.5) associated with a deletion 5q cytogenetic abnormality; and
Patient has transfusion-dependent anaemia.

Renewal – (Myelodysplastic syndrome) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Both:

Patient has not needed a transfusion in the last 4 months; and
No evidence of disease progression.

The eligibility criteria allow for wider funded access than the Medsafe approved indications. Prescribing of lenalidomide outside of the Medsafe approved indications will need to follow Section 25 of the Medicines Act 1981.

Pomalidomide for the treatment of relapsed/refractory plasma cell dyscrasia

Pomalidomide (Pomolide) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2024 as follows:

Chemical	Formulation	Brand	Pack size	Price and subsidy
Pomalidomide	Cap 1 mg	Pomolide	14	$47.45
Pomalidomide	Cap 1 mg	Pomolide	21	$71.18
Pomalidomide	Cap 2 mg	Pomolide	14	$94.90
Pomalidomide	Cap 2 mg	Pomolide	21	$142.35
Pomalidomide	Cap 3 mg	Pomolide	14	$142.35
Pomalidomide	Cap 3 mg	Pomolide	21	$213.53
Pomalidomide	Cap 4 mg	Pomolide	14	$189.81
Pomalidomide	Cap 4 mg	Pomolide	21	$284.71

Pomolide will have Principal Supply Status from 1 August 2024 to 31 July 2027. This means it will be the principal funded brand of pomalidomide available in New Zealand and will be guaranteed at least 95% of the funded market. Any funded use of an alternative brand will need Pharmac approval through our Exceptional Circumstances Framework.

Pomalidomide will be listed in Section B and Part II of Section H subject to the following eligibility criteria):

Initial application - (Relapsed/refractoryplasma cell dyscrasia) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

Patient has relapsed or refractory plasma cell dyscrasia, not including Waldenström macroglobulinaemia, requiring treatment; and
Patient has not received prior funded pomalidomide.

Renewal application – (Relapsed/refractory plasma cell dyscrasia) from any relevant practitioner. Approvals valid for 12 months where there is no evidence of disease progression.

The eligibility criteria allow for wider funded access than the Medsafe approved indications. Prescribing of pomalidomide outside of the Medsafe approved indications will need to follow Section 25 of the Medicines Act 1981.

Our response to what you told us

Thank you to everyone who took the time to respond to our consultation. We have summarised the main themes you raised, our responses, and changes we made after listening to you.

Theme	Pharmac staff comment
Support for the proposal
There is a high unmet health need for people with multiple myeloma. Having greater access to medicines like pomalidomide and lenalidomide would provide health benefit.	We are pleased this decision will improve the lives of people with multiple myeloma, their whānau, and communities.
The unmet health need for people with multiple myeloma
Other countries have greater funded access to medicines for myeloma, highlighting the lack of funding for other agents (eg. daratumumab, carfilzomib, and isatuximab) in New Zealand. Responses raised concern about the time it takes for myeloma treatments to be funded in New Zealand.	We appreciate the personal stories people shared with us about the devastating effects multiple myeloma has on their lives and the lives of their loved ones. We understand there remains a high unmet health need for people with multiple myeloma and more funded treatments are needed. Unfortunately, we operate with a fixed budget, which means we have to make difficult choices about which medicines to fund, and for who, from within this budget. We are not able to include funding for additional blood cancer medicines at this time. Some of the requested medicines are on our Options for Investment List. We are not yet able to name which specific medicines on the Options for Investment List will be taken forward for funding. We will be sure to publicly consult on any proposals we intend to progress. We have received multiple funding applications for two other multiple myeloma medicines, daratumumab and carfilzomib. There are four applications for daratumumab and two for carfilzomib that we have assessed and ranked against other treatments on our options for investment (OFI) list(external link). The items on this list are things we’d like to fund when we have budget available. We have another application for carfilzomib currently under assessment. You can find more information about where these applications are at in our funding process in the Application Tracker for daratumumab(external link) and carfilzomib(external link). We appreciate the benefit of treatment with daratumumab and have incorporated it into a Technology Assessment Report (TAR), which was shared with the myeloma community in July 2023. It is available on our website: Published TARs: daratumumab.(external link) We continue to engage with the suppliers of daratumumab and carfilzomib to help support potential progression of these applications. We have not received a funding application for isatuximab. We would be happy to receive an application for funding. Information on how to submit a funding application(external link) is on the Pharmac website.
Participation in clinical trials is limited by the medicines that are funded in New Zealand	We understand that a lack of funded treatments for multiple myeloma can impact participation in clinical trials and that there is a high unmet health need for people with multiple myeloma. As noted above, we have received and assessed funding applications for daratumumab(external link) and carfilzomib(external link), two treatments we know people with multiple myeloma would like funded. These treatments are on our options for investment (OFI) list, meaning they are things we’d like to fund. We are not yet able to name which specific medicines on the Options for Investment List will be taken forward for funding. We will be sure to publicly consult on any proposals we intend to progress.
The consultation document was misleading, as the document indicated the proposal would release signiﬁcant funds for myeloma treatments.	The estimated savings from changing brand of lenalidomide has enabled wider access to lenalidomide and funding of pomalidomide. We acknowledge that we do not ringfence money within our fixed budget and some of the savings will be used to support funding of other medicines. We apologise if the wording of our consultation was misleading.
Requests for changes to funded access and eligibility criteria
Clarification whether lenalidomide and pomalidomide would be funded when used as monotherapy without dexamethasone.	The eligibility criteria do not specify how lenalidomide and pomalidomide need to be used. Therefore, they could be prescribed and funded for use as a monotherapy.
Allow funding for re-treatment with lenalidomide	We have amended the eligibility criteria to allow re-treatment with lenalidomide for people who are not refractory to prior lenalidomide use. In addition, we have removed the renewal criteria for lenalidomide to remove any administrative burden.
Use the term ‘plasma cell dyscrasia requiring treatment’ in the eligibility criteria, rather than myeloma	We have amended the special authority criteria to enable lenalidomide and pomalidomide to be used for the treatment of plasma cell dyscrasia excluding Waldenstorms Macroglobulinemia, to ensure access is targeted appropriately.
Implementation support
Requests for information about eﬃcacy and safety data of the proposed brands	We will work closely with the suppliers to provide educational material and information on the new brands. Both brands have received approval from Medsafe and are bioequivalent to the innovator products. This means they have the same active ingredients and have the same effect on the body. Pomolide is already supplied and used in Australia.
A response highlighted the importance of a robust pregnancy prevention programme as exists with the current supplier	Having a pregnancy prevention programme approved by Medsafe was a requirement of the procurement process and our contracts with the suppliers. Medsafe has reviewed and approved pregnancy prevention programmes for both lenalidomide and pomalidomide. We understand Medsafe is satisfied with the robustness of the online verification system. The pomalidomide programme run by Juno Pharmaceuticals is already operating in Australia. Viatris has experience with risk management programmes for other treatments in New Zealand, such as clozapine. We have developed a comprehensive implementation plan and will work closely with both suppliers on education and training for HCPs.
A response highlighted the need to be able to exit the programme if necessary and informed by relevant clinicians	We have confirmed with both suppliers, Viatris and Juno, that their pregnancy prevention programmes allow for a reasonable exit process. This aligns with the current programme for lenalidomide (Revlimid).

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.