Decision to fund lenvatinib for thyroid, liver and kidney cancers and widen access to everolimus for kidney cancer
What we’re doing
We're pleased to announce that we have made the decision to fund lenvatinib for the treatment of three different types of cancer, from 1 December 2024, subject to eligibility criteria.
From 1 December 2024, lenvatinib will be funded for:
Metastatic differentiated thyroid cancer
Unresectable hepatocellular carcinoma (liver cancer)
Metastatic renal cell carcinoma (kidney cancer), in combination with everolimus
Access to everolimus will also be widened so it can be used in combination with lenvatinib for kidney cancer.
The Government provided additional funding to Pharmac in June 2024 to fund new medicines and widen access to medicines that are already funded. The funding increase covers medicines for both cancer and non-cancer health conditions. This proposal is one of many that we’re working on to put our budget increase into action.
Questions and answers on budget increase
Who we think will be interested
- People with thyroid, liver or kidney cancer, their whānau, and caregivers
- Gastroenterologists, endocrinologists, oncologists, specialist nurses, surgeons, radiologists, pathologists, general practitioners, and other health professionals involved in the care of people with thyroid cancer, hepatocellular cancer or renal cell carcinoma
- Groups who support and advocate for people with cancer
- Health New Zealand | Te Whatu Ora and the Cancer Control Agency | Te Aho o Te Kahu
- Pharmacies
- Pharmaceutical suppliers and wholesalers
Any changes to the original proposal?
This decision was subject to a consultation letter released on 18 September 2024. We received feedback from clinicians, advocacy groups and consumers.
We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process. It gives us the opportunity to listen to the voices of the community and acknowledge and respond to feedback. The feedback received was generally supportive of the proposal. We have made some changes to the proposals, based on the feedback.
Across all proposals, we have removed the requirement for a specialist or specialist recommendation to make a special authority application. This change minimises potential access barriers for New Zealanders.
Other changes specific to each cancer are outlined in their relevant section below.
Details about this decision
From 1 December 2024, lenvatinib (branded as Lenvima) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:
|
Chemical |
Formulation |
Brand |
Pack size |
Price and subsidy |
|---|---|---|---|---|
|
Lenvatinib |
Cap 4 mg |
Lenvima |
30 |
$3,407.40 |
|
Lenvatinib |
Cap 10 mg |
Lenvima |
30 |
$3,407.40 |
The wastage rule will apply to Lenvima. This means pharmacists will be able to claim for undispensed part packs.
A confidential rebate will apply to Lenvima that reduces the net price to Pharmac. Lenvima will have protection from delisting and subsidy reduction until 30 November 2027.
Differentiated thyroid cancer
What does this mean for people?
From 1 December 2024, lenvatinib (branded as Lenvima) will be funded for people with differentiated thyroid cancer, subject to eligibility criteria.
We anticipate that about 30 people with differentiated thyroid cancer will benefit from lenvatinib in the first year of funding.
Any changes to the original proposal?
We received some requests for amendments to eligibility criteria. Based on the feedback, we have made changes to align the criteria wording with the clinical trial inclusion criteria. This provides more clarity on the group of people eligible for funded access to lenvatinib. We have also made changes to allow people who currently self-fund lenvatinib to access funded treatment.
Eligibility criteria
The following Special Authority criteria will apply to lenvatinib in Section B of the Pharmaceutical Schedule from 1 December 2024. Changes following consultation are also shown (additions in bold, deletions in strikethrough):
Special Authority for subsidy
Initial application – (thyroid cancer) only from any relevant practitioner a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:
Either:
- Patient is currently on treatment with lenvatinib and met all remaining criteria prior to commencing treatment; or
- All of the following:
- The patient has locally advanced or metastatic differentiated thyroid cancer; and
3. The patient has radiologically determined progressive disease; and
4. The patient’s disease must be radioactive iodine (RAI) refractory; and - Either:
- Patient must have symptomatic progressive disease prior to treatment; or
- Patient must have progressive disease at critical sites with a high risk of morbidity or mortality where local control cannot be achieved by other measures; and
- Any of the following:
- A lesion without iodine uptake in a RAI scan; or
- Receiving cumulative RAI greater than or equal to 600 mCi; or
- Experiencing disease progression after a RAI treatment within 12 months; or
- Experiencing disease progression after two RAI treatments administered within 12 months of each other; and
- Patient has thyroid stimulating hormone (TSH) adequately repressed; and
- Patient is not a candidate for radiotherapy with curative intent; and
- Surgery is clinically inappropriate; and
- Patient has an ECOG performance status of 0-2.
- The patient has locally advanced or metastatic differentiated thyroid cancer; and
Renewal – (thyroid cancer) only from any relevant practitioner a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months where there is no evidence of disease progression.
Similar eligibility criteria will also apply in Part II of Section H of the Pharmaceutical Schedule.
Our response to what you told us
We’re grateful to those who took the time to respond to our consultation. Responses were supportive of the proposal.
|
Theme |
Pharmac Staff Comment |
|---|---|
|
Responses were generally supportive. They highlighted that funding lenvatinib for differentiated thyroid cancer (DTC) would reduce the financial burden on people who are currently self-funding their treatment. |
We appreciate this feedback and are pleased to be funding a medicine that would improve the lives of New Zealanders living with cancer. This feedback aligns with the positive funding recommendation from our expert advisors and our assessment of this proposal. Anyone who is self-funding lenvatinib for DTC and meets the eligibility criteria could receive funded treatment. |
|
Responses questioned if people privately funding lenvatinib would still qualify for funded treatment in situations where their disease had progressed due to using a reduced dose and to help manage privately funded costs. |
The intended population for funding is those who have not previously received lenvatinib. If someone is currently receiving lenvatinib and met all the eligibility criteria before they started on treatment, they can transition onto publicly funded treatment. Some people’s clinical circumstances meet the intent of the eligibility criteria, but not the exact wording. Prescribers could consider submitting a Special Authority waiver application if someone is self-funding and does not meet the exact wording of the eligibility criteria. |
|
Some responses considered the eligibility (Special Authority) approval timeframes too short. There may be delays in starting treatment after approval or treatment breaks for other health related reasons. Some individuals may have had dose reductions during the treatment period (eg to find the optimal dose for an individual). |
The approval period for lenvatinib is based on advice from our expert advisors. We have not changed the approval timeframe (6 months). Individuals will need to be reviewed every six months to determine if their clinical circumstances meet the renewal criteria. If someone’s circumstances do not meet the exact renewal criteria but meet the intent, a prescriber can consider applying for a Special Authority waiver. Pharmac website - Special Authority waivers We intend to monitor this following the funding of lenvatinib. This decision does not stop us from changing the approval period in future. |
|
Responses highlighted that funding lenvatinib for differentiated thyroid cancer would require increased clinical work to manage the administration and monitoring of lenvatinib. |
We acknowledge that funding lenvatinib for thyroid cancer will mean that more people will receive medical treatment. This will require support and monitoring by healthcare professionals. Our advisors have told us that lenvatinib would provide substantial benefits to individuals with thyroid cancer, and their families. A Cancer Medicines Implementation Planning programme is being established between Health New Zealand | Te Whatu Ora and the Cancer Control Agency | Te Aho o Te Kahu to support implementation of Pharmac’s cancer funding decisions. We are sharing key information from our assessments with the programme, to support sector planning. |
|
Responses highlighted a preference to fund lenvatinib using criteria that match the clinical trial inclusion criteria. Feedback indicated the eligibility criteria in Australia are the same as the clinical trial criteria. |
We sought advice on this feedback from our clinical advisors. Our advisors considered it would be helpful to include a similar level of detail to the Australian criteria to describe the intended population. This is consistent with the clinical trial population. We have updated the eligibility criteria to align more closely with the wording of the eligibility criteria in Australia. This does not change the group targeted for funding. We hope these changes provide clarity to prescribers. Our proposed eligibility criteria at consultation were recommended by our expert advisors, based on the clinical trial criteria. Consultation allows us to check whether our criteria are clear and describe the group of people we are trying to fund treatment for. This feedback has helped us to improve our proposal. |
Hepatocellular carcinoma
What does this mean for people?
From 1 December 2024, lenvatinib (branded as Lenvima) will be funded for people with hepatocellular carcinoma, subject to eligibility criteria.
We anticipate that about 75 people with hepatocellular carcinoma (HCC) will benefit from lenvatinib in the first year of funding.
Any changes to the original proposal?
We have not made any further changes to the eligibility criteria in response to consultation feedback.
We received some requests to consider funding lenvatinib in different stages, or treatment lines, for people with HCC. These requests were subject to the funding of atezolizumab with bevacizumab for hepatocellular carcinoma. Pharmac has not yet made any decision to fund atezolizumab and bevacizumab for unresectable hepatocellular carcinoma. If we do fund atezolizumab and bevacizumab, we would seek clinical advice on this feedback, to ensure that the eligibility criteria for medicines for HCC are appropriate.
A summary of the feedback and our responses to this are detailed below.
Eligibility criteria
The following Special Authority criteria will apply to lenvatinib in Section B of the Pharmaceutical Schedule from 1 December 2024. Changes following consultation are also shown (deletions in strikethrough):
Special Authority for subsidy
Initial application – (unresectable hepatocellular carcinoma) only from any relevant practitioner a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:
All of the following:
- Patient has unresectable hepatocellular carcinoma; and
- Patient has preserved liver function (Childs-Pugh A); and
- Transarterial chemoembolisation (TACE) is unsuitable; and
- Patient has an ECOG performance status of 0-2; and
- Patient has not received prior systemic therapy for their disease in the palliative setting.
Renewal – (unresectable hepatocellular carcinoma) only from any relevant practitioner a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months where there is no evidence of disease progression.
Similar eligibility criteria will also apply in Part II of Section H of the Pharmaceutical Schedule.
Our response to what you told us
We’re grateful to those who took the time to respond to our consultation. Responses were supportive of the proposal.
|
Theme |
Pharmac Staff Comment |
|---|---|
|
Responses were supportive. Some responses highlighted that an oral treatment would not impact New Zealand’s infusion centre resource. |
We appreciate this feedback and are pleased to be funding a medicine that will improve the lives of New Zealanders living with cancer. This feedback aligns with the positive funding recommendation from our expert advisors and our assessment of this proposal. We understand there are increasing demands for infusion centre resources. As lenvatinib is an oral treatment, this proposal will not impact infusion centre resources and will provide New Zealanders with HCC a treatment they can take at home. |
|
Respondents indicated atezolizumab with bevacizumab is the standard of care for HCC in guidelines and overseas. Respondents noted they would not want this decision to delay the funding for atezolizumab with bevacizumab. |
We understand New Zealanders would benefit from having access to atezolizumab with bevacizumab for HCC. We are currently working at pace on a procurement process for bevacizumab. As there are multiple potential suppliers, we have to run an open and competitive process, under the Government Procurement Rules. We are running a streamlined process to minimise delays to funded access. We released a Request for Tender for bevacizumab in September 2024 and have indicated to suppliers that we would prefer the treatment is available by April 2025. Access to atezolizumab would also be widened for HCC, if we have budget available. This decision has been progressed independently to our work on atezolizumab with bevacizumab for HCC and does not impact progression of the funding proposal for atezolizumab with bevacizumab. |
|
Requests to consider funding lenvatinib in different stages or lines of treatment for people with HCC (beyond those proposed in the consultation). These requests were subject to the funding of atezolizumab with bevacizumab for HCC:
|
Pharmac has not yet made any decision to fund atezolizumab and bevacizumab for HCC. If we are able to fund atezolizumab and bevacizumab, we will seek clinical advice on this feedback, to ensure that eligibility criteria for these treatments are appropriate. As noted above, we are working as quickly as we can to progress a Request for Tenders for bevacizumab. |
|
Responses highlighted that funding lenvatinib for HCC would require increased clinical work to manage the administration and monitoring of lenvatinib. |
We acknowledge that funding lenvatinib for HCC will mean that more people will receive medical treatment. This will require support and monitoring by healthcare professionals. Our advisors have told us that lenvatinib will provide substantial benefits to individuals with HCC, and their families. A Cancer Medicines Implementation Planning programme is being established between Health NZ | Te Whatu Ora and Cancer Control Agency | Te Aho o Te Kahu to support implementation of Pharmac’s cancer funding decisions. We are sharing key information from our assessments with the programme, to support sector planning. |
Renal cell carcinoma
What does this mean for people?
From 1 December 2024, lenvatinib (branded as Lenvima) and everolimus (branded as Afinitor) will be funded for people with renal cell carcinoma, subject to eligibility criteria.
We anticipate that about 7 people with renal cell carcinoma will benefit from lenvatinib in the first year of funding. This is lower than the number we provided in consultation as Pharmac has since made the decision to fund nivolumab for the same cancer from 1 November 2024. We expect that most people will receive nivolumab, however lenvatinib will be beneficial for people for whom nivolumab is unsuitable, particularly as it is an oral treatment that can be taken at home.
Any changes to the original proposal?
We received some requests to change the eligibility criteria. Based on the feedback, we have made changes so that people who have experienced intolerable side effects to nivolumab in the second line setting will also be eligible for treatment with lenvatinib and everolimus.
A summary of the feedback and our responses to this are detailed below.
Eligibility criteria
The following Special Authority criteria will apply to lenvatinib and everolimus in Section B of the Pharmaceutical Schedule from 1 December 2024. Changes following consultation are also shown (additions in bold, deletions in strikethrough):
Special Authority for subsidy
Initial application - (renal cell carcinoma) only from any relevant practitioner a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 4 months for applications meeting the following criteria:
Either:
- All of the following:
- The patient has metastatic renal cell carcinoma; and
- The disease is of predominant clear-cell histology; and
- The patient has documented disease progression following one previous line of treatment; and
- The patient has an ECOG performance status of 0-2; and
- [Lenvatinib/everolimus] is to be used in combination with [everolimus/lenvatinib]; or
- All of the following:
- Patient has received funded treatment with nivolumab for the second line treatment of metastatic renal cell carcinoma; and
- Patient has experienced treatment limiting toxicity from treatment with nivolumab;
- [Lenvatinib/everolimus] is to be used in combination with [everolimus/lenvatinib]; and
- There is no evidence of disease progression.
Renewal – (renal cell carcinoma) only from any relevant practitioner a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 4 months where there is no evidence of disease progression.
Similar eligibility criteria will also apply for both medicines in Part II of Section H of the Pharmaceutical Schedule.
Our response to what you told us
We’re grateful to those who took the time to respond to our consultation. Responses were supportive of the proposal.
|
Theme |
Pharmac Staff Comment |
|---|---|
|
Responses were supportive of the proposal |
We appreciate this feedback and are pleased to be funding a medicine that would improve the lives of New Zealanders living with cancer. This feedback aligns with the positive funding recommendation from our expert advisors and our assessment of this proposal. |
|
Responses highlighted that there would still be a substantial unmet health need for people with RCC, even if lenvatinib with everolimus were funded. Responders highlighted several other medicines and treatment lines which they considered would address the unmet health need, or would provide even more benefit to New Zealanders:
|
We understand that the funding of lenvatinib with everolimus will not address all the unmet health need for people with RCC. Pharmac has several funding applications for treatments for RCC (Application Tracker)(external link) (in addition to this proposal for lenvatinib):
We understand that not knowing which medicines may be funded or when may cause uncertainty. We are currently working as quickly as we can to fund a range of medicines, for both cancer and non-cancer indications. As many of these medicines require us to negotiate agreements, we are unable to confirm which medicines we are funding with the June 2024 Budget uplift. |
|
Some responses requested Pharmac consider funding lenvatinib with everolimus in the third-line setting as some people may benefit more from receiving nivolumab in the second-line, before lenvatinib + everolimus. |
We sought expert clinical advice on this feedback. Our clinical advisors told us that there is insufficient evidence to guide sequential use of treatments after second line treatment. The current evidence supports lenvatinib with everolimus as a second line treatment option. We acknowledge there is still unmet health need for people with RCC. Our advisors have told us that if immunotherapy were funded as a first line treatment, people would no longer be eligible for second line nivolumab and would need an alternative treatment such as lenvatinib. As a result, we have not made any changes to the eligibility criteria to address this at this time. We would be open to considering a funding application for wider access to lenvatinib in the future. |
|
Some responses requested Pharmac consider funding lenvatinib with everolimus for people who experience intolerable side effects to nivolumab, as the criteria consulted on would exclude them. |
We acknowledge that treatment in the second line setting should also include people who experience intolerable side effects to nivolumab. We have amended the proposed Special Authority Criteria to include this situation. |
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.