Proposal to fund lanreotide acetate for various indications and widen access to four cancer treatments (2024)

12 July 2024

MedicinesConsultation Closes 29 Jul

What we’re proposing

We are seeking feedback on a proposal to:

• Fund lanreotide acetate for neuroendocrine tumours, acromegaly, malignant bowel obstruction and other indications. The timing for this listing is still to be determined.
• Widen access to sunitinib for metastatic renal cell carcinoma with a good prognosis. We would also amend the eligibility criteria for pazopanib to enable people to access it if they cannot tolerate sunitinib. The timing for these changes is still to be determined.
• Widen access to bendamustine for relapsed or refractory chronic lymphocytic leukaemia (CLL) from 1 November 2024.
• Open-list pemetrexed from 1 November 2024.

Sunitinib was included in the 2023/24 Annual Invitation to Tender, where we sought bids for widened access. Lanreotide acetate was also included in this tender. As the tender is still in process, the brand name(s), pricing and timing for these are still to be determined.

We are not proposing any changes or contractual amendments to pazopanib, pemetrexed or bendamustine, however brand changes, new pricing and principal supply status for these medicines were awarded in ourJune Tender notification.

Consultation closes at 9am Monday 29 July 2024 and feedback can be emailed toconsult@pharmac.govt.nz

Lanreotide acetate for functional acromegaly and malignant bowel obstruction and other indications

What would the effect be?

Lanreotide acetate would be funded for people with neuroendocrine tumours, acromegaly, malignant bowel obstruction and other indications, subject to eligiblity criteria.

Pharmac currently funds one somatostatin analogue for the treatment of these conditions, calledlong-acting octreotide. Lanreotide acetate is another medicine in this class, and eligibility criteria for lanreotide would align with the currenteligibility criteriafor long-acting octreotide. This would provide an additional treatment option for these people.

Current eligibility criteria for long-acting octreotide [PDF](external link)

While we do not expect that this would provide additional health benefits, the medicine may be more suitable for some people due to its easier administration. As a prefilled syringe, we expect that preparation time for healthcare professionals would be reduced and some people may be able to self-administer this.

We estimate that approximately 40 to 50 people would start on this treatment each year.

Who we think will be interested

• People with neuroendocrine cancer, acromegaly or malignant bowel obstruction their whānau, friends and caregivers
• Healthcare professionals involved in the care of people with these conditions
• Health New Zealand | Te Whatu Ora Hospitals
• People or groups with an interest in treatments for neuroendocrine cancers acromegaly or malignant bowel obstruction
• Pharmacies and wholesalers
• Pharmaceutical suppliers

About lanreotide acetate

Lanreotide is a synthetic analogue of somatostatin, a hormone that is involved in several metabolic processes. Lanreotide lasts longer in the human body than somatostatin and produces more prolonged effects.

Lanreotide acetate isapproved by Medsafefor acromegaly, symptoms of carcinoid syndrome associated with neuroendocrine tumours, and treatment of well or moderately differentiated gastroenteropancreatic neuroendocrine tumours (GP-NETs) with unresectable or metastatic disease.

Lanreotide acetate datasheet - Medsafe [PDF](external link)

Lanreotide acetate comes as a prefilled syringe that is usually administered by a healthcare professional, but people could be trained to self-administer this at home. It is given by a deep subcutaneous injection into the buttock or outer thigh. We understand from our clinical advisors that this would be simpler to administer than the currently funded long-acting octreotide, while providing the same or similar health benefit.

Why we’re proposing this

Lanreotide acetate was recommended for funding by the Pharmacology and Therapeutics Advisory Committee (PTAC) inNovember 2004only if cost neutral to long-acting octreotide.

PTAC meeting record November 2004 [PDF, 97 KB]

Lanreotide acetate was included in the2023/24 Annual Invitation to Tender. We consider that we have received suitable tender bids which would allow us to list lanreotide acetate on the Pharmaceutical Schedule.

Details about our proposal

As part of Pharmac’s 2023/24 Annual Invitation to Tender, Pharmac sought bids for the supply of lanreotide acetate.

The funded brand(s), pricing and timeframes for listing would be confirmed as part of a tender decision and subsequent notification. Any products listed as a result of the 2023/24 Annual Invitation to Tender would have Principal Supply Status until 30 June 2027.

The eligibility criteria for lanreotide acetate would be similar to that oflong-acting octreotide, with the following changes:

• allow for applications from any relevant practitioner
• we are not proposing dosing restrictions for malignant bowel obstruction however understand that people might receive up to 120 mg every 4 weeks

Current eligibility criteria for long-acting octreotide [PDF](external link)

Lanreotide acetate would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Special Authority for Subsidy

Initial application – (Malignant Bowel Obstruction) from any relevant practitioner. Approvals valid for 2 months for applications meeting the following criteria:

All of the following:

1. The patient has nausea* and vomiting* due to malignant bowel obstruction*; and
2. Treatment with antiemetics, rehydration, antimuscarinic agents, corticosteroids and analgesics for at least 48 hours has failed.

Note: Indications marked with * are unapproved indications

Renewal – (Malignant Bowel Obstruction) from any relevant practitioner. Approvals valid for 3 months where the treatment remains appropriate and the patient is benefitting from treatment.

Initial application – (Acromegaly) from any relevant practitioner. Approvals valid for 3 months for applications meeting the following criteria:

Both:

1. The patient has acromegaly; and
2. Any of the following:
   1. Treatment with surgery, radiotherapy and a dopamine agonist has failed; or
   2. Treatment with lanreotide acetate is for an interim period while awaiting the effects of radiotherapy and a dopamine agonist has failed; or
   3. The patient is unwilling, or unable, to undergo surgery and/or radiotherapy.

Renewal – (Acromegaly) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Both:

1. IGF1 levels have decreased since starting lanreotide acetate; and
2. The treatment remains appropriate and the patient is benefiting from treatment.

Initial application – (Other Indications) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Any of the following:

1. VIPomas and Glucagonomas – for patients who are seriously ill, in order to improve their clinical state prior to definitive surgery; or
2. Both:
   1. Gastrinoma; and
   2. Either:
      1. Surgery has been unsuccessful; or
      2. Patient has metastatic disease after H2 antagonist (or proton pump inhibitors) have failed; or
3. Both:
   1. Insulinomas; and
   2. Surgery is contraindicated or has failed; or
4. For peri-operative control of hypoglycaemia and for maintenance therapy; or
5. Both:
   1. Carcinoid syndrome (diagnoses by tissue pathology and/or urinary 5HIAA analysis); and
   2. Disabling symptoms are not controlled by maximal medical therapy.

Renewal – (Other Indications) from any relevant practitioner. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefitting from treatment.

Initial application – (pre-operative acromegaly) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. Patient has acromegaly; and
2. Patient has a large pituitary tumour, greater than 10 mm at its widest; and
3. Patient is scheduled to undergo pituitary surgery in the next six months.

Similar eligibility criteria would also 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 outside of Medsafe approved indications would need to be in accordance with section 25 of the Medicines Act 1981. You can read more aboutsection 25 of the Medicines Act 1981 on the Medsafe website(external link).

Sunitinib and pazopanib for renal cell carcinoma

What would the effect be?

Sunitinib and pazopanib are currently funded for people with metastatic renal cell carcinoma (RCC) and an intermediate or poor prognosis.

Access to sunitinib would be widened for people with metastatic RCC who have a good prognosis, subject to eligibility criteria. We estimate that approximately 30 additional people would receive sunitinib each year.

Our clinical advisors have told us treatment with sunitinib could improve progression-free and overall survival outcomes for eligible people with a good prognosis, compared to the current approach of “watch and wait”.

We are also proposing to enable access to pazopanib for those who have stopped treatment within 3 months of starting sunitinib due to intolerance. This would ensure that people still have a treatment option available to them if sunitinib is not tolerated.

We expect a small increase in health system burden through an increase in appointments, blood tests, and the management of treatment related toxicities as a result of these changes.

Who we think will be interested

• People with advanced or metastatic kidney cancer their whānau, friends and caregivers
• Healthcare professionals involved in the care of people with kidney cancer
• Health New Zealand | Te Whatu Ora hospitals
• People or groups with and interest in treatments for kidney cancer
• Pharmacies and wholesalers
• Pharmaceutical suppliers

About renal cell carcinoma, sunitinib and pazopanib

RCC is the most common type of kidney cancer. The prognosis of RCC is determined using theInternational Metastatic RCC Database Consortium (IMDC) risk model(external link). People with advanced or metastatic disease and an intermediate or poorly favourable prognosis currently can receive targeted treatment with sunitinib or pazopanib.

There are no targeted treatment options funded in New Zealand for people with a good prognosis. We understand from our advisors that some people with this prognosis do not require targeted treatment. However, some people would have a need for targeted treatments, despite falling into the “good prognosis” category.

RCC is more common in men. Māori are often diagnosed at a younger age compared to non-Māori and are 1.5 times more likely to die of their cancer than non-Māori. People with RCC living in the most socioeconomically deprived areas have reduced survival compared to those from less deprived areas.

Sunitinib and pazopanib are types of medicine called tyrosine kinase inhibitors (TKI), which slow down the progression of some cancers and can help people live longer. They are currently funded for people with metastatic RCC who have an intermediate or poorly favourable prognosis, subject toeligibility criteria.

Current sunitinib eligibility criteria [PDF](external link)

Both sunitinib and pazopanib are approved by Medsafe for the treatment of advanced RCC as well as other indications.

Why we’re proposing this

Afunding applicationfor widened access to sunitinib and pazopanib(external link) for people with good prognosis was recommended for funding with a high priority by the Cancer Treatment Subcommittee (CaTSoP) inOctober 2020.

October 2020 CaTSoP meeting record [PDF, 636 KB]

InApril 2011we received advice from CaTSoP that pazopanib would not address any unmet health need where sunitinib is funded for metastatic RCC and that it should be funded only if cost-neutral to sunitinib. However, the Subcommittee recommended that pazopanib be funded if sunitinib is not tolerated.

April 2011 CaTSoP meeting record [PDF, 131 KB]

We appreciate that the funding application and recommendation was to widen access to both sunitinib and pazopanib. However, we have now received tender bids for sunitinib that would allow us to widen access to it. In addition, we are proposing to enable access to pazopanib for those with good prognosis that experience intolerable side effects from sunitinib.

While we are not proposing to widen access pazopanib for all people with good prognosis at this time, this proposal would not prevent us widening access to pazopanib at a later date.

Details about our proposal

As part of Pharmac’s2023/24 Annual Invitation to Tender, Pharmac sought bids from suppliers for the supply of sunitinib for both current and wider access.

The funded brand(s), pricing and timeframes for listing would be confirmed as part of a tender decision. Any products listed as a result of the2023/24 Annual Invitation to Tender would have Principal Supply Status until 30 June 2027.

The eligibility criteria for sunitinib for RCC would be amended in Section B of the Pharmaceutical Schedule as follows (additions inbold, deletions instrikethrough):

Special Authority for Subsidy

Initial application – (RCC) only from a relevant specialist ormedicalany relevantpractitioner on the recommendation of a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

1. The patient has metastatic renal cell carcinomaof predominantly clear cell histology; and
2. Any of the following:
   1. The patient is treatment naïve; or
   2. The patient has only received prior cytokine treatment; or
   3. The patient has only received prior treatment with an investigational agent within the confines of a bona fide clinical trial with has Ethics Committee approval; or
   4. Both:
      1. The patient has discontinued pazopanib within 3 months of starting treatment due to intolerance; and
      2. The cancer did not progress whilst on pazopanib; and
3. The patient hasgood performance status(WHO/anECOGperformance score ofgrade0-2); and
   4. The disease is of predominant clear cell histology; and
   The patient has intermediate or poor prognosis defined as
   5. The disease is of predominant clear cell histology; or
   5.1 Lactate dehydrogenase level > 1.5 times upper limit of normal; or
   5.2 Haemoglobin level < lower limit of normal; or
   5.3 Corrected serum calcium level > 10 mg/dL (2.5 mmol/L); or
   5.4 Interval of < 1 year from original diagnosis to start of systemic therapy; or
   5.5 Karnofsky performance score of less than or equal to 70; or
   5.6 2 or more sites of organ metastasis; and
4. 6 Sunitinib to be used for a maximum of 2 cycles.

Renewal – (RCC) only from a relevant specialist ormedicalany relevantpractitioner on the recommendation of a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

1. No evidence of disease progression; and
2. The treatment remains appropriate and the patient is benefitting from treatment.

Note: Sunitinib should be stopped if disease progresses.

Poor prognosis patients are defined as having at least 3 of criteria 5.1-5.6. Intermediate prognosis patients are defined as having 1 or 2 of criteria 5.1-5.6.

Similar eligibility criteria would also apply in Part II of Section H of the Pharmaceutical Schedule.

The eligibility criteria for pazopanib would also be amended in Section B of the Pharmaceutical Schedule as follows (additions inbold, deletions instrikethrough):

Special Authority for Subsidy

Initial application – (RCC) only from a relevant specialist ormedicalany relevantpractitioner on the recommendation of a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria:

Either

1. All of the following:
   1. The patient has metastatic renal cell carcinomaof predominantly clear cell histology; and
   2. Either:
      1. The patient is treatment naïve; or
      2. The patient has only received prior cytokine treatment;orand
         1. The patient has discontinued sunitinib within 3 months of starting treatment due to intolerance; and
         2. The cancer did not progress whilst on sunitinib; and
   3. The patient hasgood performance status (WHO/anECOGperformancescore ofgrade0-2); and
   4. The disease is of predominant clear cell histology; and
      The patient has intermediate or poor prognosis defined as
      Any of the following:
      1. Lactate dehydrogenase level > 1.5 times upper limit of normal; or
      2. Haemoglobin level < lower limit of normal; or
      3. Corrected serum calcium level > 10 mg/dL (2.5 mmol/L); or
      4. Interval of < 1 year from original diagnosis to start of systemic therapy; or
      5. Karnofsky performance score of less than or equal to 70; or
      6. 2 or more sites of organ metastasis; and
   5. Pazopanib to be used for a maximum of 3 months; or
2. All of the following:
   1. The patient has metastatic renal cell carcinoma of predominantly clear cell histology; and
   2. The patient has discontinued sunitinib within 3 months of starting treatment due to intolerance; and
   3. The cancer did not progress whilst on sunitinib; and
   4. Pazopanib to be used for a maximum of 3 months.

Renewal only from a relevant specialist ormedicalany relevantpractitioner on the recommendation of a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

1. No evidence of disease progression; and
2. The treatment remains appropriate and the patient is benefitting from treatment

Note: Pazopanib should be stopped if disease progresses. Poor prognosis patients are defined as having at least 3 of criteria 5.1-5.6. Intermediate prognosis patients are defined as having 1 or 2 of criteria 5.1-5.6.

Similar eligibility criteria would also apply in Part II of Section H of the Pharmaceutical Schedule.

Bendamustine for relapsed or refractory chronic lymphocytic leukaemia

What would the effect be?

From 1 November 2024, access to bendamustine would be widened for people with relapsed or refractory chronic lymphocytic leukaemia (CLL), subject to eligibility criteria.

This would provide eligible people a treatment option in the relapsed/refractory cancer setting, which could extend the time until further relapse.

We anticipate that up to five additional people would receive bendamustine each year as a result of this proposal.

While bendamustine is given as an intravenous infusion, we do not anticipate the additional usage to be significant. We welcome any feedback on the impacts this proposal could have to infusion services and the wider health sector.

Who we think will be interested

• People with CLL their whānau, friends and caregivers
• Healthcare professionals involved in the care of people with CLL
• Health New Zealand | Te Whatu Ora hospitals
• People or groups with and interest in treatments for CLL
• Pharmacies and wholesalers
• Pharmaceutical suppliers

About bendamustine and CLL

CLL is a type of slow-growing blood cancer affecting a type of white blood cell called B-cells. These B-cells cells multiply too quickly, live too long and can’t function properly. For many people with CLL, the condition can remain stable for many months or even years and may have little if any effects on lifestyle or general health.

Over time, an excess number of B-cells crowd the bone marrow and interfere with normal blood cell production, which can result in anaemia (causing persistent tiredness), recurrent infections and easy bruising.

Some people with CLL receive bendamustine as an initial treatment and receive venetoclax if their cancer relapses. Our clinical advisors have told us there remains a small number of people who receive a different chemotherapy regimen as an initial treatment and are not eligible for venetoclax when their cancer relapses.

Bendamustine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy medicine.

Bendamustine is currently funded for the first line treatment of CLL, Hodgkin lymphoma and for indolent, low grade non-Hodgkin lymphomas in both the first line and relapsed or refractory settings. This is subject to certainclinical criteria.

Current bendamustine funding criteria [PDF](external link)

Bendamustine is Medsafe approved for the first line treatment of CLL, previously untreated indolent non-Hodgkin lymphoma and mantle cell lymphoma, and for relapsed or refractory indolent non-Hodgkin lymphoma. Bendamustine is administered as an intravenous infusion, given over a period of 30 to 60 minutes.

For more details, see the Medsafe datasheet for Bendamustine [PDF](external link)

Why we’re proposing this

Pharmac currently funds bendamustine for people with CLL who have not previously been treated, as well as some types of lymphoma. We received consultation feedback to the2023/24 Annual Invitationto tender requesting wider access to bendamustine for people with relapsed or refractory CLL.

We sought further advice from the Cancer Treatments Advisory Committee (CTAC), who recommended a number of changes to the eligibility criteria (the record of this meeting is not yet available). They told us this would improve health outcomes for people who are young, fit, have IgHV mutated CLL and are ineligible for second-line venetoclax.

Our clinical advisors have also recommended removing the criterion for venetoclax for relapsed/refractory CLL which requires the disease to have relapsed within 36 months of previous treatment for eligibility (seeApril 2023 record). This proposal would not prevent progression of amendments to the venetoclax eligibility criteria at a later date.

April 2023 CTAC meeting record [PDF, 1.1 MB]

Details about our proposal

There would be no changes to the list price and subsidy of bendamustine as part of this proposal.

The eligibility criteria for bendamustine would be amended in Section B of the Pharmaceutical Schedule as follows (relevant criteria shown only, additions inbold, deletions instrikethrough):

Special Authority for Subsidy

Initial application— (treatment naiveCLL*)only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient hasBinet stage B or C, or progressive stage Achronic lymphocytic leukaemia requiring treatment; and
   2. The patient is chemotherapy treatment naive; and
   3. The patient is unable to tolerate toxicity of full-dose FCR; and
2. 4. Patient has ECOG performance status 0-2; and
   5. Patient has a Cumulative Illness Rating Scale (CIRS) score of < 6; and
3. 6Bendamustine is to be administered at a maximum dose of 100 mg/m²on days 1 and 2 every 4 weeks for a maximum of 6 cycles.

Notes:

Indication marked with a * includes indications that are unapproved.

'Chronic lymphocytic leukaemia (CLL)' includes small lymphocytic lymphoma (SLL).

Chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments.

Similar eligibility criteria would also 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 outside of Medsafe approved indications would need to be in accordance with section 25 of the Medicines Act 1981. You can read more aboutsection 25 of the Medicines Act 1981 on the Medsafe website(external link).

Pemetrexed open-listing

What would the effect be?

From 1 November 2024, the eligibility criteria for pemetrexed would be removed. This means clinicians would be able to prescribe it for anyone they think would benefit from treatment.

This would mean that pemetrexed could be used outside of non-small cell lung cancer and mesothelioma. We anticipate that any additional usage would be small and primarily in the treatment of non-small cell lung cancer. We understand there could be some usage as a treatment option for other cancers that have not responded to or progressed on standard of care treatments. We estimate that up to five additional people might benefit from this per year.

While pemetrexed is given as an intravenous infusion, we do not anticipate the additional usage to be significant. We welcome any feedback on the impacts this proposal could have to infusion services and the wider health sector.

Who we think will be interested

• People with cancer their whānau, friends and caregivers
• Healthcare professional involved in the care of people with cancer
• Health New Zealand | Te Whatu Ora hospitals
• People or groups with and interest in treatments for cancer
• Pharmacies and wholesalers
• Pharmaceutical suppliers

About pemetrexed

Pemetrexed is a type of chemotherapy that is chemically similar to folic acid (vitamin B9). It works by inhibiting DNA synthesis processes that are required for the growth and survival of both normal and cancer cells.

Pemetrexed is currently funded for advanced non-small cell lung cancer and for mesothelioma (a life-threatening cancer affecting particularly the lining of the lungs), subject toeligibility criteria.

Current funding criteria for pemetrexed [PDF](external link)

Pemetrexed is Medsafe approved for the treatment of mesothelioma and advanced non-small cell lung cancer, both in combination with cisplatin or as monotherapy. It is administered as an intravenous infusion over 10 minutes every 21 days.

For more details, see the Medsafe datasheet for bendamustine [PDF](external link).

Why we’re proposing this

We received a request from clinicians to remove the eligibility criteria for pemetrexed. We sought advice from CTAC regarding this request. Our advisors told us that the current funding criteria is aligned with pemetrexed’s regulatory approval and that any additional usage would be in unapproved indications, likely for people who have not responded to or progressed on other standard of care options (the record of this meeting is not yet available).

We consider that this would reduce administrative burden for clinicians as well as provide a treatment option for a small group of people.

Details about our proposal

There would be no changes to the list price and subsidy of pemetrexed as part of this proposal.

The Special Authority criteria for pemetrexed in Section B and the Hospital Indication restrictions in Part II of Section H would be removed from 1 November 2024.

The proposed open listing may allow wider funded access than the Medsafe approved indications. Prescribing outside of Medsafe approved indications would need to be in accordance with section 25 of the Medicines Act 1981. You can read more aboutsection 25 of the Medicines Act 1981 on the Medsafe website(external link).

The PCT only restriction would remain in Section B of the Pharmaceutical Schedule. This means that only Health New Zealand hospitals would be able to make subsidy claims.

To provide feedback

Send us an email:consult@pharmac.govt.nzby 9am Monday 29 July 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.