Proposal to fund treatments for people with breast cancer and leukaemia

What we’re proposing

We are seeking feedback on a proposal to fund new treatments for advanced breast cancer and leukaemia. As part of this proposal we would also amend the contractual terms for a treatment for heart failure through a provisional agreement with Novartis New Zealand Limited (Novartis).

The proposal would result in the following new treatments from 1 July 2024, which would have protection from delisting and subsidy reduction until 30 June 2027:

  • ribociclib (brand name Kisqali) for unresectable locally advanced or metastatic hormone-receptor positive (HR-positive), human epidermal growth receptor-2 negative (HER2-negative) breast cancer.
  • midostaurin (brand name Rydapt) for de novo acute myeloid leukaemia (AML) that is FMS‐like tyrosine kinase 3 (FLT3) mutation positive.

The agreement with Novartis would also include amendments to the contractual arrangements for sacubitril with valsartan (brand name Entresto). No changes would be made to the funding conditions of sacubitril with valsartan, however the net price would reduce via a confidential rebate, and it would have protection from delisting and subsidy reduction until 28 February 2027.

Consultation closes at 5pm, 10 January 2024 and feedback can be emailed to consult@pharmac.govt.nz

Ribociclib for HR-positive, HER2-negative locally advanced or metastatic breast cancer

What would the effect be?

From 1 July 2024, ribociclib would be funded for people with HR-positive, HER2-negative locally advanced or metastatic breast cancer, subject to eligibility criteria. We anticipate that approximately 350 people with breast cancer will benefit from this proposal in the first full year of funding rising to approximately 800 people after 5 years.

Pharmac currently funds one cyclin-dependent kinase 4/6 (CDK4/6) inhibitor for treatment of this form of breast cancer, calledpalbociclib (brand name Ibrance)(external link). Ribociclib is another medicine in this class and eligibility criteria would be aligned with the criteria for palbociclib, allowing people who have not been previously treated with a CDK4/6 inhibitor to access an alternative treatment option.

Our clinical advisors have told us that ribociclib would likely provide health benefits for those eligible for treatment. We anticipate that eligible individuals would benefit from having an additional treatment option. We are interested in feedback to help us better understand how many people would be likely start treatment with ribociclib compared to palbociclib.

We are also proposing to make amendments to the palbociclib eligibility criteria to align with the proposed ribociclib criteria. This would allow any relevant practitioner to apply for Special Authority approval, would remove grandparenting criteria that are no longer required and enable access to only one of the two CDK4/6 inhibitors per patient.

We do not anticipate that the availability of an additional treatment option for this group of patients would have an impact on sector capacity.

Who we think will be interested

  • People with breast cancer, their whānau, friends and caregivers
  • Healthcare professionals involved in the care of people with breast cancer
  • Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their whānau who are affected by breast cancer
  • People or groups with an interest in treatments for breast cancer
  • Pharmacies and wholesalers
  • Pharmaceutical suppliers of cancer treatments

About HR-positive, HER2-negative breast cancer and ribociclib

HR-positive breast cancer is a breast cancer that tests positive for either estrogen or progesterone receptors. HER2-negative breast cancer does not test positive for HER2, meaning targeted treatments such as trastuzumab cannot be used.

In New Zealand, each year approximately 600 people are diagnosed with locally advanced or metastatic breast cancer. Up to two thirds of people with advanced or metastatic breast cancer have HR-positive, HER2-negative disease.

Māori and Pacific women experience higher rates of breast cancer, are more like to get breast cancer at a younger age and are more likely to die from breast cancer compared to non-Māori. Māori and Pacific women are two and three times more likely(external link) to be diagnosed with metastatic breast cancer compared with non-Māori / non-Pacific New Zealand women, respectively.

In 2022, around 400 people started treatment with palbociclib. Approximately 17% of people currently receiving palbociclib are Māori.

Ribociclib belongs to a class of medicines called CDK4/6 inhibitors, that block the development of cancer cells. The recommended dose of ribociclib is 600 mg once daily for 21 consecutive days, followed by 7 days off treatment. CDK4/6 inhibitors are taken in combination with an endocrine partner, such as fulvestrant, tamoxifen or an aromatase inhibitor.

Ribociclib Medsafe Datasheet [PDF](external link)

Why we’re proposing this

Pharmac has funded palbociclib since 1 April 2020. This decision was made following a competitive process for CDK4/6 inhibitors for the treatment of HR-positive HER2-negative locally advanced or metastatic breast cancer.

In July 2023, the Cancer Treatments Advisory Committee (CTAC) reviewed updated published evidence [PDF, 529 KB] for CDK4/6 inhibitors and recommended that ribociclib be funded with a high priority in the context of treatment of malignancy, noting the reported differences in overall survival between ribociclib and palbociclib. We consider that there would be a benefit from the availability of this additional option for people.

CTAC also advised that there was insufficient evidence to support the use of a second CDK4/6 inhibitor after progression on another CDK4/6 inhibitor and that any eligibility criteria should limit use to one CDK4/6 inhibitor per person lifetime.

Details about our proposal

Ribociclib would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2024 at the following price and subsidy (ex-manufacturer, excluding GST): 

Chemical

 

 Brand

 

 Formulation

 

 Pack size

 

 Proposed price and subsidy

 
Ribociclib

 

 Kisqali

 

 Tab 200 mg

 

 21

 

 $1,883.00

 
42

 

 $3,767.00

 
63

 

 $5,650.00

 

 A confidential rebate would apply to this ribociclib (Kisqali). Kisqali would have subsidy and delisting protection until 30 June 2027.

Kisqali (ribociclib) would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Special Authority for Subsidy

Initial application – from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Patient has unresectable locally advanced or metastatic breast cancer; and
  2. There is documentation confirming disease is hormone-receptor positive and HER2-negative; and
  3. Patient has an ECOG performance score of 0-2; and
  4. Either:
    1. Disease has relapsed or progressed during prior endocrine therapy (second or subsequent line setting); or
    2. Both:
       first-line setting
      1. Patient is amenorrhoeic, either naturally or induced, with endocrine levels consistent with a postmenopausal or without menstrual-potential state; and
      2. Patient has not received prior systemic endocrine treatment for metastatic disease; and
  5. Treatment to be used in combination with an endocrine partner; and
  6. Patient has not received prior funded treatment with a CDK4/6 inhibitor.

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

All of the following:

  1. Treatment to be used in combination with an endocrine partner; and
  2. There is no evidence of progressive disease; and
  3. The treatment remains appropriate and the patient is benefitting from treatment.

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

The eligibility criteria for palbociclib (Ibrance) would be amended from 1 July 2024 in both Section B and Part II of Section H of the Pharmaceutical Schedule to be the same as the criteria for ribociclib. 

Midostaurin for acute myeloid leukaemia with FLT3 mutation

What would the effect be?

From 1 July 2024, midostaurin would be funded for people with de novo acute myeloid leukaemia (AML) that is FLT3 mutation positive, subject to eligibility criteria. We estimate that around 20-25 people each year would be eligible for treatment with midostaurin under the proposed eligibility criteria.

We expect that this proposal would result in improvements in event free and overall survival for those eligible for treatment.

While midostaurin is an oral treatment, its use would be alongside induction chemotherapy. We therefore do not anticipate that this proposal would have a substantial impact on the sector capacity, as people will still require the use of infusion services.

Who we think will be interested

  • People with leukaemia, their whānau, friends and caregivers
  • Healthcare professionals involved in the care of people with leukaemia
  • Te Whatu Ora – Health New Zealand hospitals and other organisations who deliver services and support for people, and their whānau who are affected by leukaemia
  • People or groups with an interest in treatments for leukaemia
  • Pharmacies and wholesalers
  • Pharmaceutical suppliers of cancer treatments

About AML with FLT3 mutation and midostaurin

AML is a type of blood cancer that starts with immature white blood cells (called blasts) in the bone marrow. In AML, the bone marrow produces white blood cells that grow and divide too fast. These abnormal white blood cells build up in the bone marrow, reducing the body’s ability to produce healthy blood cells. These abnormal white blood cells then spread to other parts of the body.

Māori and Pacific peoples have an increased risk of AML and experience worse outcomes once diagnosed. The FLT3 mutation occurs in around one-third of people with AML. People with this mutation experience more frequent and earlier disease relapse leading to poorer survival. Testing for this mutation is routinely available in New Zealand. We are uncertain of the relative prevalence of the FLT3 mutation in Māori or Pacific peoples with AML.

Midostaurin is a targeted cancer therapy. Midostaurin is an oral treatment that is used in combination with standard chemotherapy for people with newly diagnosed AML who are FLT3 mutation positive.

Midostaurin is Medsafe approved(external link) for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive. Midostaurin is taken as two 50 mg capsules, twice daily on days 8 to 21 of each 28-day cycles.

Why we’re proposing this

A supplier application for the funding of midostaurin for AML for up to six cycles with intensive chemotherapy and funding for up to 12 cycles of maintenance therapy was considered by the Cancer Treatments Subcommittee of Pharmacology and Therapeutics Advisory Committee (CaTSoP) [PDF, 481 KB], now the Cancer Treatments Advisory Committee (CTAC) in July 2020.

The Committee recommended that midostaurin be funded for the treatment of de novo acute myeloid leukaemia that is FLT3 mutation positive, for a maximum of four cycles, with a high priority. Our clinical advisors considered that the incremental benefit of six cycles of midostaurin over four cycles in combination with intensive chemotherapy was not sufficient to warrant the additional two cycles, and that the available evidence did not support a benefit of midostaurin maintenance in this patient population.

Full details of the clinical advice we have received(external link) about this is available from the Pharmac Application tracker.

Details about our proposal

Midostaurin would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2024 at the following price and subsidy (ex-manufacture, excluding GST): 

Chemical

Brand

Formulation

Pack size

Proposed price and subsidy

Midostaurin

Rydapt

Cap 25 mg

56

$10,981.00

 A confidential rebate would apply to midostaurin (Rydapt). Rydapt would have subsidy and delisting protection until 30 June 2027.

Rydapt would be listed as a PCT-only pharmaceutical in Section B of the Pharmaceutical Schedule. This means only Te Whatu Ora hospitals would be able to make a subsidy claim. We consider this to be appropriate as the four funded cycles would be given alongside induction chemotherapy and its substantial list price means it is less suitable to go through the usual pharmacy-wholesaler distribution channels.

Rydapt (midostaurin) would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Special Authority for Subsidy – PCT only

Initial application — from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Patient has a diagnosis of acute myeloid leukaemia; and
  2. Condition must be FMS tyrosine kinase 3 (FLT3) mutation positive; and
  3. Patient must not have received a prior line of intensive chemotherapy for acute myeloid leukaemia; and
  4. Patient must be considered eligible for standard intensive chemotherapy; and
  5. Midostaurin to be funded for a maximum of 4 cycles.

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

Sacubitril with valsartan

Sacubitril with valsartan (Entresto) is funded subject to eligibility criteria(external link). There would be no changes to the list price and subsidy, or current eligibility criteria for Entresto as part of this proposal.

As part of the proposal, the net price for all strengths of sacubitril with valsartan (brand name Entresto) would reduce via confidential rebate from 1 March 2024 and there would be subsidy and delisting protection for Entresto until 28 February 2027.

To provide feedback

Send us an email at: consult@pharmac.govt.nz by 5pm, 10 January 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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