Proposal to fund lenvatinib for kidney, thyroid and liver cancers and widen access to everolimus

Medicines Consultation Closed

What we’re proposing

We want to hear from you about a proposal to fund lenvatinib for the treatment of three different types of cancer, from 1 December 2024, subject to eligibility criteria. We are proposing to:

  • fund lenvatinib for kidney, thyroid and liver cancer from 1 December 2024.
  • widen access to everolimus for kidney cancer (in combination with lenvatinib) from 1 December 2024.

This is through a provisional agreement with Eisai New Zealand Limited for lenvatinib.

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.

Q&A on Pharmac's funding boost

Consultation closes at 4 pm, Wednesday 2 October 2024 and feedback can be submitted through our online form or emailed to consult@pharmac.govt.nz  

What would the effect be?

This proposal would mean that lenvatinib would be funded for people with:

  • differentiated thyroid cancer, and
  • advanced, unresectable hepatocellular carcinoma (liver cancer)
  • renal cell carcinoma (kidney cancer), in combination with everolimus.

We anticipate that around 180 people would receive lenvatinib in the first year of funding, approximately 15 people with thyroid cancer, 75 people with liver cancer and 90 people with kidney cancer. This would reduce to 145 people after five years. This reduction is because there are currently people with these cancers who would be eligible for treatment. After the first year, it is expected that only people who are newly eligible would start treatment with lenvatinib. The people receiving lenvatinib for kidney cancer would also receive everolimus.

Impact to health sector

Lenvatinib and everolimus are oral treatments, so there would be no additional impact on infusion services from this proposal.

We understand that people with liver cancer are usually managed by gastroenterologists rather than medical oncologists. Therefore, we expect an increase in people needing appointments with gastroenterologists and other relevant clinical and clinical support services. We do not anticipate a significant impact to medical oncology services.

Additional monitoring through radiology services such as CT scans and interpretation by radiologists would also be needed to assess the response to treatment.

Other treatments for liver cancer

We acknowledge that people would also like to see atezolizumab in combination with bevacizumab funded for advanced liver cancer. Pharmac has recently released a Request for Tender for bevacizumab. If we fund bevacizumab for liver cancer, access to atezolizumab would also be widened. We expect any decisions about funding bevacizumab with atezolizumab for advanced liver cancer would be made in early 2025. We consider that funding lenvatinib would provide an immediate treatment option for people with liver cancer requiring treatment.

Who we think will be interested

  • People with kidney, thyroid or liver 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 renal cell carcinoma, thyroid cancer or hepatocellular cancer
  • 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

About renal cell carcinoma, differentiated thyroid cancer, hepatocellular cancer and lenvatinib

Renal cell carcinoma

Renal cell carcinoma (renal cell adenocarcinoma, RCC) is the most common type of kidney cancer. Approximately 600 people are diagnosed with RCC each year in New Zealand.

RCC is more common in men than women. Māori are often diagnosed at a younger age compared to non-Māori and Māori are 52% more likely to die from RCC than non-Māori. People living in the most socioeconomically deprived areas have reduced survival compared to those living in less deprived areas. Currently, some people with advanced RCC receive sunitinib or pazopanib.

Nivolumab (an immunotherapy treatment, given as an intravenous infusion) will be funded from 1 November 2024 for people whose kidney cancer has progressed after initial treatment.

More information on the funding of nivolumab

Differentiated thyroid cancer

Differentiated thyroid cancer (DTC) is a type of thyroid cancer where the cancer cells look similar to normal thyroid cells and is the most common type of thyroid cancer. There are approximately 380 people diagnosed with thyroid cancer in New Zealand each year.

Thyroid cancer is usually treated with surgery and radioactive iodine. A person’s life expectancy significantly reduces when the cancer spreads to other parts of the body (metastasises) and stops responding to radioactive iodine. This is called differentiated, metastatic and radioiodine refractory disease. Only 4% of people diagnosed with thyroid cancer have differentiated, metastatic and radioiodine refractory disease.

Māori are more likely than non-Māori to be diagnosed with thyroid cancer and have a higher mortality rate from this compared to non-Māori. Pacific people have a higher rate of thyroid cancer compared with non-Pacific people.

Hepatocellular carcinoma

Hepatocellular carcinoma (HCC) is a type of cancer that affects the liver. There are around 400 people diagnosed with liver cancer in New Zealand each year. Approximately two thirds of people diagnosed with liver cancer have HCC. HCC is often diagnosed at a late stage in the disease. 40% of people diagnosed with HCC have intermediate or advanced disease. The risk of developing liver cancer is higher in people with long-term liver diseases, people with chronic hepatitis B or hepatitis C and people who drink large amounts of alcohol.

Currently, there are no treatments for advanced hepatocellular carcinoma, and survival outcomes are poor.

Māori, Pacific Peoples and other groups experiencing health inequities have a disproportionate risk of developing liver cancer. There are many different reasons for this which include:

  • reduced access to primary health services.
  • reduced access to secondary care and surveillance programmes.
  • a lack of culturally safe services and experiences of racism when accessing care.
  • reduced vaccination rates for hepatitis B compared to non-Māori, non-Pacific.
  • reduced access to curative hepatitis C treatments.

As a result, people experiencing the greatest health inequities are more likely to be diagnosed with advanced disease, are diagnosed at a younger age, and are more likely to die from liver cancer.

Lenvatinib

Lenvatinib belongs to a group of medicines called receptor tyrosine kinase (RTK) inhibitors. These medicines block some of the proteins involved in cancer growth, helping to stop the growth and spread of cancer cells.

Lenvatinib is oral medicine. It is available in 4 mg and 10 mg capsules, taken once daily. It has been approved by Medsafe in New Zealand for the treatment of a number of cancers, including:

  • progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer.
  • advanced renal cell carcinoma in adults, whose disease has progressed following one prior vascular endothelial growth factor targeted therapy, when used in combination with everolimus.
  • the first-line treatment of patients with unresectable hepatocellular carcinoma.

Medsafe datasheet – lenvatinib (Lenvima) [PDF](external link)

Why we’re proposing this

Funding applications for lenvatinib for second-line treatment of renal cell carcinoma, first-line treatment of differentiated thyroid cancer and first-line treatment of hepatocellular carcinoma  were considered by the Cancer Treatments Subcommittee of PTAC (CaTSoP, now the Cancer Treatments Advisory Committee [CTAC]) in October 2020.

Our advisors told us lenvatinib would improve outcomes for people with these cancers. The improvements include both progression-free survival and overall survival. This means people would live longer lives and have a better quality of life.

Application Tracker – second line treatment of renal cell carcinoma(external link)

Application Tracker – differentiated thyroid cancer(external link)

Application Tracker – first line treatment of hepatocellular carcinoma(external link)

Clinical advice records – Cancer Treatments Subcommittee of PTAC, October 2020 [PDF, 636 KB]

Since the application for kidney cancer was reviewed by our clinical advisors, Pharmac has funded nivolumab as a second-line treatment for renal cell carcinoma. We understand that most people with renal cell carcinoma needing second-line treatment would receive nivolumab (intravenously). This proposal would provide an oral option for people that experience intolerable side effects from nivolumab, have difficulty accessing infusion services or having infusions, or would prefer an alternative, oral treatment. 

Details about our proposal

From 1 December 2024, lenvatinib (brand name Lenvima) 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

Lenvatinib

Cap 4 mg

Lenvima

30

$3,407.40

Lenvatinib

Cap 10 mg

Lenvima

30

$3,407.40

A confidential rebate would apply to Lenvima that would reduce the net price to Pharmac. Lenvima would have protection from delisting and subsidy reduction until 30 November 2027.

The following eligibility criteria would apply to lenvatinib (Lenvima) in Section B of the Pharmaceutical Schedule from 1 December 2024:

Renal Cell Carcinoma                  

Special Authority for subsidy

Initial application - (renal cell carcinoma) only from 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:

All of the following:

  1. The patient has metastatic renal cell carcinoma; and
  2. The disease is of predominant clear-cell histology; and
  3. The patient has documented disease progression following one previous line of treatment; and
  4. The patient has an ECOG performance status of 0-2; and
  5. Lenvatinib is to be used in combination with everolimus.

Renewal – (renal cell carcinoma) only from 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.

Differentiated Thyroid Cancer

Special Authority for subsidy

Initial application – (thyroid cancer) only from 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:

  1. The patient has locally advanced or metastatic differentiated thyroid cancer; and
  2. The patient has radiologically determined progressive disease; and
  3. The patient’s disease must be radioactive iodine (RAI) refractory; and
  4. Any of the following:
    1. A lesion without iodine uptake in a RAI scan; or
    2. Receiving cumulative RAI greater than 600 mCi; or
    3. Experiencing progression after a RAI treatment within 12 months; or
    4. Experiencing progression after two RAI treatments administered within 12 months of each other; and
  5. Patient has thyroid stimulating hormone (TSH) adequately repressed; and
  6. Patient is not a candidate for radiotherapy with curative intent; and
  7. Surgery is inappropriate; and
  8. Patient has an ECOG performance status of 0-2.

Renewal – (thyroid cancer) only from 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.

Unresectable hepatocellular carcinoma

Special Authority for subsidy

Initial application – (unresectable hepatocellular carcinoma) only from 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:

  1. Patient has unresectable hepatocellular carcinoma; and
  2. Patient has preserved liver function (Childs-Pugh A); and
  3. Transarterial chemoembolisation (TACE) is unsuitable; and
  4. Patient has an ECOG performance status of 0-2; and
  5. Patient has not received prior systemic therapy for their disease in the palliative setting.

Renewal – (unresectable hepatocellular carcinoma) only from 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 would apply in Part II of Section H.

Everolimus for RCC

Eligibility for everolimus would be widened in Section B of the Pharmaceutical Schedule to include its use for renal cell carcinoma in combination with lenvatinib from 1 December 2024 as follows (new criteria shown only):

Renal Cell Carcinoma

Special Authority for subsidy

Initial application - (renal cell carcinoma) only from 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:

All of the following:

  1. The patient has metastatic renal cell carcinoma; and
  2. The disease is of predominant clear-cell histology; and
  3. The patient has documented disease progression following one previous line of treatment; and
  4. The patient has an ECOG performance status of 0-2; and
  5. Everolimus is to be used in combination with lenvatinib.

Renewal – (renal cell carcinoma) only from 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 would apply in Part II of Section H of the Pharmaceutical Schedule from 1 December 2024.

To provide feedback

Please submit feedback through our online form or email consult@pharmac.govt.nz by 4 pm, Wednesday 2 October 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.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.