Proposal to increase access to lenalidomide and pomalidomide through a brand change for lenalidomide
What we’re proposing
We want to hear from people about a proposal to widen access and change the funded brand of lenalidomide for the treatment of multiple myeloma and myelodysplastic syndrome (MDS), and to fund a new treatment called pomalidomide for people with multiple myeloma.
This proposal would give people greater access to treatments for multiple myeloma and MDS. People with multiple myeloma who have not yet received lenalidomide could receive it as a first line treatment and pomalidomide would be funded for people with relapsed/refractory multiple myeloma.
If the proposal is approved, the following changes would occur:
Multiple myeloma
- Another brand of lenalidomide (Lenalidomide Viatris, supplied by Viatris) would be funded from 1 August 2024. It would be the principal funded brand from 1 February 2025 until 31 January 2028.
- Funded access to lenalidomide (Lenalidomide Viatris) would be widened from 1 August 2024 to include anyone with multiple myeloma who has not yet received lenalidomide.
- Pomalidomide (Pomolide, supplied by Juno New Zealand Limited) would be funded from 1 August 2024 for people with relapsed or refractory multiple myeloma. It would be the principal funded brand from 1 August 2024 until 31 July 2027.
- Any relevant practitioner would be able to apply for initial and renewal applications for lenalidomide and pomalidomide. This would ensure all relevant prescribers who care for people with multiple myeloma or MDS could apply for funded treatment.
MDS associated with a 5q deletion
- Funded access to lenalidomide (Lenalidomide Viatris) would be widened from 1 August 2024 to include people with MDS associated with a 5q deletion who have transfusion-dependent anaemia.
This proposal results from a competitive procurement process for the Principal Supply of lenalidomide and pomalidomide. Changing the funded brand of lenalidomide would enable increased access to treatments for people with multiple myeloma and MDS and result in cost savings.
Consultation closes at 4 pm on Friday 17 May 2024. Feedback can be emailed to consult@pharmac.govt.nz.
Who we think will be interested
- People who have multiple myeloma or MDS, their whānau, and caregivers
- Groups who advocate for and support people with multiple myeloma and MDS
- Haematologists, oncologists, specialist nurses, and other health professionals involved in the care of people with multiple myeloma and MDS
- Community and Hospital pharmacists and wholesalers
- Te Whatu Ora hospitals
- Pharmaceutical suppliers
What would the effect be?
Lenalidomide
Multiple Myeloma
Lenalidomide (branded as Revlimid) is currently funded as maintenance therapy in the first line setting for people who have received an autologous stem cell transplant (ASCT). For people with multiple myeloma who haven’t received an ASCT, lenalidomide is currently funded as a third line treatment option. Approximately 950 people are currently receiving funded treatment with lenalidomide. This includes 100 Māori and 34 Pacific peoples.
From 1 August 2024 lenalidomide (branded as Lenalidomide Viatris) supplied by Viatris would be funded for anyone with multiple myeloma who has not previously received funded treatment with lenalidomide. This means people would be able to access lenalidomide treatment earlier in the course of their disease, without having to try other funded treatments or receive a stem cell transplant first.
Lenalidomide Viatris would become the principal funded brand from 1 February 2025 until 31 January 2028. It is anticipated that widening of access for lenalidomide would result in over 400 new people receiving funded treatment in the first 12 months.
The currently funded lenalidomide (branded as Revlimid) would be listed on the Pharmaceutical Schedule until 31 January 2025, so people receiving lenalidomide would have time to transition to the principal funded brand.
MDS associated with a 5q deletion
Lenalidomide is currently funded via Pharmac’s Named Patient Pharmaceutical Assessment (NPPA) pathway for people with MDS associated with a 5q deletion who meet certain criteria.
From 1 August 2024 lenalidomide (branded as Lenalidomide Viatris) supplied by Viatris would be funded for anyone with low or intermediate-1 risk MDS associated with a deletion 5q cytogenetic abnormality who have transfusion-dependent anaemia, through the Pharmaceutical Schedule. This means people would be able to access lenalidomide more easily. It would also reduce the administrative burden on prescribers.
Pomalidomide
From 1 August 2024 pomalidomide (branded as Pomolide) supplied by Juno New Zealand Limited would be funded for people with relapsed or refractory multiple myeloma. This would be the principal funded brand of pomalidomide until 31 July 2027. It is anticipated that 430 people would start funded treatment with pomalidomide in the first 12 months.
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. 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 would be different to our Named Patient Pharmaceutical Applications (NPPA) pathway. We would provide more information about this process, if this proposal is approved.
If a person experiences disease progression following a transition to the generic brand of lenalidomide, they would 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. If this proposal were approved, people who experience disease progression while on lenalidomide would be eligible for pomalidomide.
Support that would be provided
Support for people with multiple myeloma or MDS
Pharmac would work alongside advocacy and support groups and the suppliers of lenalidomide (Viatris) and pomalidomide (Juno) to provide information and resources about these treatments to support the transition and new listing. This would include educational material about lenalidomide and pomalidomide in English, Māori and Pacific languages. We would have a dedicated webpage on the Pharmac website for people with multiple myeloma and MDS that would include the key dates for the transition and where to find more information.
We are interested to hear what other activities would support a smooth transition for people to Viatris Lenalidomide and the introduction of Pomolide.
Support for healthcare professionals
Pharmac and the suppliers of these treatments would work together to provide specific information about the proposed brands (Lenalidomide Viatris and Pomolide), including:
- clinical data about efficacy and safety
- practical prescribing / dispensing information including risk management programme support.
We would have a dedicated webpage on the Pharmac website for healthcare professionals. This would include information regarding the transition to a new risk management programme. It would also include the key dates for the transition, where to find more information, and how to apply to our Exceptional Circumstances Framework for individuals who may need to return to the previously funded brand of lenalidomide (Revlimid).
As part of this proposal, any relevant practitioner would be able to apply for initial and renewal applications for lenalidomide and pomalidomide. This would ensure all relevant prescribers who care for people with multiple myeloma and MDS can apply for funded treatment.
We want to know what other information about lenalidomide and pomalidomide would help healthcare professionals in supporting this transition.
About multiple myeloma, myelodysplastic syndrome, lenalidomide and pomalidomide
Multiple myeloma
Multiple myeloma, also known as myeloma, is a blood cancer that forms in plasma cells, a type of white blood cell normally found in the bone marrow. When plasma cells become cancerous and grow out of control, they crowd out the healthy blood cells. This can cause people to become anaemic, meaning they are more susceptible to infections and bleeding, and bruise more easily.
In New Zealand, around 400 new cases of multiple myeloma are diagnosed each year. Māori and Pacific peoples who develop myeloma are diagnosed at a younger age but are less likely to receive first-line treatment or an autologous stem cell transplant (ASCT). They experience poorer outcomes than non-Māori and non-Pacific populations.
Lenalidomide is currently funded as maintenance therapy for those people eligible for an autologous stem cell transplant (ASCT). For those who do not receive an ASCT, lenalidomide is currently funded as a third-line treatment.
Myelodysplastic syndrome (MDS)
Myelodysplastic syndromes (MDS) are a group of disorders that occur when the bone marrow does not make enough healthy blood cells. The unhealthy blood cells do not grow properly and often die prematurely. This results in lower numbers of normal red blood cells, white blood cells and platelets being produced. The blood cells that do survive are often poor quality and unable to function properly. In MDS associated with a deletion 5q cytogenetic abnormality, the development of red blood cells is particularly affected leading to a shortage of these cells (anaemia).
People with MDS often have a very active bone marrow but a low number of circulating blood cells. Without enough red blood cells, white blood cells and platelets you can become fatigued, more susceptible to infections, and can bleed and bruise more easily.
Lenalidomide and pomalidomide
Lenalidomide is an immunomodulatory drug that is indicated for the treatment of multiple myeloma and myelodysplastic syndrome (MDS) associated with a deletion 5q cytogenetic abnormality. It works by stimulating part of the immune system to attack the cancer cells and stop them developing. It is supplied as an oral capsule and is used in combination with a medicine called dexamethasone as part of a 28-day cycle.
Further information can be found in the lenalidomide Medsafe Datasheet [PDF](external link).
Pomalidomide works in a similar way to lenalidomide. It is a more potent medicine than lenalidomide. It is indicated for the treatment of people with relapsed and refractory multiple myeloma. It is also supplied as an oral capsule and is used in combination with dexamethasone as part of a 28-day cycle.
Further information is provided in the pomalidamide Medsafe Datasheet [PDF](external link).
Generic lenalidomide and pomalidomide products are commonly used overseas. Both Lenalidomide Viatris and Pomolide have been evaluated and approved for use in New Zealand by Medsafe. Pomolide is already funded in Australia.
Pregnancy prevention programme
These medicines are teratogenic agents which means they can harm a baby’s development during pregnancy. They require a pregnancy prevention programme (sometimes known as a risk management system) to ensure they are prescribed, dispensed and administered safely.
There is a programme in place for the current Revlimid brand of lenalidomide. This proposal would require a new programme to be implemented for each of the proposed products (Lenalidomide Viatris & Pomolide). This would mean there would be three separate pregnancy prevention programmes used in New Zealand. However, we don’t anticipate many people would use the Revlimid programme after the transition period.
Our clinical advisors have advised us on how we could support healthcare professionals to use these systems. We would work closely with the suppliers to ensure a smooth implementation of these programmes. Both suppliers would provide educational resources and on-call support to assist with any queries prior to the listing.
We want feedback on the support that would be required for successful implementation of these programmes.
Why we’re proposing this
There are several brands of lenalidomide and pomalidomide approved by Medsafe for use in Aotearoa New Zealand. A generic medicine has the same active ingredient and works the same way as the original reference brand. When there are generic brands available, Pharmac can use the opportunity to promote competition. This can release significant funds to increase access to more medicines.
On 24 August 2023, Pharmac released a Request for Proposals (RFP) for the supply of lenalidomide and pomalidomide. As a result of the RFP, Pharmac has entered into provisional agreements with Viatris and Juno New Zealand Limited for the Principal Supply of lenalidomide and pomalidomide, respectively.
We understand there would still be unmet health needs for people with multiple myeloma, even if we widen access to lenalidomide and pomalidomide. We would continue to assess funding applications for other treatments for multiple myeloma and engage with suppliers about their treatments. Read more about the funding process on the Pharmac website.
Clinical advice on a competitive process
In October 2022, we sought advice from the Cancer Treatments Advisory Committee [PDF, 355 KB] (CTAC) about undertaking a competitive process that could result in a change to the funded brand of lenalidomide. The Committee supported progressing a competitive procurement process that could result in a principal funded brand of lenalidomide and pomalidomide.
Based on the clinical advice received everyone currently being treated with lenalidomide would be able to transition to the generic brand.
As a result of this competitive process, and the eligibility criteria proposed, a number of funding applications for lenalidomide(external link) and pomalidomide(external link) are being progressed. Further details of these applications can be found on our application tracker.
Clinical advice on myelodysplastic syndrome (MDS)
We sought clinical advice from CTAC regarding the other populations [PDF, 355 KB] that would benefit from widened access to lenalidomide. One of these was those with MDS associated with a 5q deletion. We currently fund lenalidomide for a small group of people with MDS associated with a 5q deletion through Pharmac’s Exceptional Circumstances framework. We have sought additional advice to understand the population that would receive the greatest benefit from access to lenalidomide. The proposed eligibility criteria are included below. We consider that this proposal would remove a current barrier to treatment for some people with MDS.
Details about our proposal
Lenalidomide
From 1 August 2024, Viatris Lenalidomide would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:
| Chemical | Formulation | Brand | Pack size | Proposed 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 |
Key dates for the proposed changes for lenalidomide:
1 August 2024
- People taking lenalidomide (branded as Revlimid) before 1 August 2024 could start to transition to the new brand Lenalidomide Viatris from this date. Revlimid would continue to be funded until 31 January 2025 for people to complete their transition.
- People starting on lenalidomide from 1 August 2024 would receive the new brand, Lenalidomide Viatris.
1 February 2025
- Lenalidomide Viatris would be the only listed brand of lenalidomide available in New Zealand. It would be guaranteed at least 95% of the funded market.
- Revlimid would be delisted from the Pharmaceutical Schedule.
- All people taking funded lenalidomide through the Pharmaceutical Schedule would need to take Lenalidomide Viatris as it would have Principal Supply Status from this date until 31 January 2028.
- Funded access to an alternative brand would require Pharmac approval via our Exceptional Circumstances Framework.
To support the transition, all people currently receiving Revlimid would be issued a new Special Authority approval for Lenalidomide Viatris.
Lenalidomide Viatris would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:
Multiple myeloma
Initial application – (Multiple myeloma) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:
Both:
- Patient has multiple myeloma requiring treatment; and
- Patient has not received prior funded lenalidomide.
Renewal application – (Multiple myeloma) from any relevant practitioner. Approvals valid for 12 months where there is no evidence of disease progression.
The proposed eligibility criteria may allow wider funded access than the Medsafe approved indications. Prescribing of lenalidomide outside of the Medsafe approved indications would need to follow Section 25 of the Medicines Act 1981.
You can read more about section 25 of the Medicines Act 1981 on the Medsafe website(external link)
Myelodysplastic syndrome (MDS)
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 application – (Myelodysplastic syndrome) from any relevant practitioner. Approvals valid for 12 months applications meeting the following criteria:
Both:
- Patient has not needed a transfusion in the last 4 months; and
- No evidence of disease progression.
Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Pomalidomide
From 1 August 2024, the Pomolide brand of pomalidomide would be listed in Section B and Part II of Section H on the Pharmaceutical Schedule as follows:
| Chemical | Formulation | Brand | Pack size | Price and subsidy |
|---|---|---|---|---|
| Pomalidomide | Cap 1mg | Pomolide | 14 | $47.45 |
| Pomalidomide | Cap 1mg | Pomolide | 21 | $71.18 |
| Pomalidomide | Cap 2mg | Pomolide | 14 | $94.90 |
| Pomalidomide | Cap 2mg | Pomolide | 21 | $142.35 |
| Pomalidomide | Cap 3mg | Pomolide | 14 | $142.35 |
| Pomalidomide | Cap 3mg | Pomolide | 21 | $213.53 |
| Pomalidomide | Cap 4mg | Pomolide | 14 | $189.81 |
| Pomalidomide | Cap 4mg | Pomolide | 21 | $284.71 |
From 1 August 2024 until 31 July 2027, Pomolide would have Principal Supply Status. This means it would be the principal funded brand of pomalidomide available in New Zealand and would be guaranteed at least 95% of the funded market. Any alternative brand would require Pharmac approval via our Exceptional Circumstances Framework.
Pomolide would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:
Initial application – (Relapsed/refractory multiple myeloma) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:
Both:
- Patient has relapsed or refractory multiple myeloma with progressive disease; and
- Patient has not received prior funded pomalidomide.
Renewal - (Relapsed/refractory multiple myeloma) from any relevant practitioner. Approvals valid for 12 months where there is no evidence of disease progression.
Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
The proposed eligibility criteria may allow wider funded access than the Medsafe approved indications. Prescribing of pomalidomide outside of Medsafe approved indications would need to follow Section 25 of the Medicines Act 1981.
You can read more about section 25 of the Medicines Act 1981 on the Medsafe website(external link)
To provide feedback
Send us an email: consult@pharmac.govt.nz by 4 pm, Friday 17 May 2024
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.
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