Decision to fund treatments for breast cancer and leukaemia

14 February 2024

Medicines Decision

On this page

Update 18 June 2024

We have amended the eligibility criteria for ribociclib and palbociclib in response to feedback received during consultation.

This will allow those receiving either CDK 4/6 inhibitor (ribociclib or palbociclib) to change to the other CDK 4/6 inhibitor if they experience an adverse reaction and have to stop treatment.

Updated access criteria

Updated “Our response to what you told us” section

Update 17 April 2024

We have amended the eligiblity criteria for ribociclib.

This will enable those receiving ribociclib prior to 1 July 2024 (eg. privately) to transition to publicly funded treatment if they met the criteria prior to initiating treatment. This will be in place for one year.

See the updated criteria in “Details about this decision”.

Clarification 14 February 2024

We have revised our response to feedback regarding ribociclib and switching between funded CDK4/6 inhibitors for people who experience adverse effects. See the updated response in 'Our response to what you told us' section

What we’re doing

We're funding two new treatments for advanced breast cancer and leukaemia from 1 July 2024 through an agreement with Novartis New Zealand Limited (Novartis):

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

The medicines will have protection from delisting and subsidy reduction until 30 June 2027.

As part of this decision, we’re making approvals for sacubitril with valsartan (branded Entresto), a treatment for heart failure, valid without renewal, which may improve access. The net price for Entresto will reduce via a confidential rebate and it will have protection from delisting and subsidy reduction until 28 February 2027.

We’re grateful for the feedback we received in response to the consultation on this proposal. A summary of the main themes raised for each part of this proposal, and our responses to these are detailed below.

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

What does this mean for people

From 1 July 2024, ribociclib will be funded for people with HR-positive, HER2-negative locally advanced or metastatic breast cancer, subject to eligibility criteria. Ribociclib will be the second funded CDK4/6 inhibitor, giving people and prescribers more treatment options for advanced breast cancer. Our clinical advisors have told us ribociclib would improve overall survival for people with advanced or metastatic breast cancer.

We expect 400 people with breast cancer will benefit from this treatment in the first full year of funding, increasing to approximately 800 people after 5 years. We understand around 17% of this population are Māori, who experience higher rates of breast cancer, are more like to get breast cancer at a younger age and experience worse outcomes once diagnosed.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 12 December 2023. We have not made changes to the proposal.

Overall, we received supportive feedback. We received some requests to allow people to switch between funded CDK4/6 inhibitors and have responded to this below.

Who we think will be most 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

Detail about this decision

Ribociclib (branded as Kisqali) will 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 will apply to Kisqali and it will have subsidy and delisting protection until 30 June 2027.

Ribociclib will be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria (June 2024 amended criteria additions in bold):

Special Authority for Subsidy

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

Either:

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. Any of the following:
  1. Disease has relapsed or progressed during prior endocrine therapy; or
  2. Both:
    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; or
  3. Both
    1. Patient commenced treatment with ribociclib in combination with an endocrine partner prior to 1 July 2024; and
    2. There is no evidence of progressive disease; and
5. Treatment must be used in combination with an endocrine partner; and
6. Patient has not received prior funded treatment with a CDK4/6 inhibitor; or
All of the following:
1. Patient has an active Special Authority approval for palbociclib; and
2. Patient has experienced a grade 3 or 4 adverse reaction to palbociclib that cannot be managed by dose reductions and requires treatment discontinuation; and
3. Treatment must be used in combination with an endocrine partner; and
4. There is no evidence of progressive disease since initiation of palbociclib.

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

Both:

Treatment to be used in combination with an endocrine partner; and
There is no evidence of progressive disease since initiation of ribociclib.

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

Similar eligibility criteria will apply for palbociclib in Section B and Part II of Section H of the Pharmaceutical Schedule.

Community pharmacies will be able to claim wastage in line with rule 6.4 of the Pharmaceutical Schedule.

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

Midostaurin for acute myeloid leukaemia with FLT3 mutation

What does this mean for people?

From 1 July 2024, midostaurin (branded as Rydapt) will be funded for people with de novo acute myeloid leukaemia (AML) that is FLT3 mutation positive, subject to eligibility criteria.

We expect that approximately 20 people each year will benefit from treatment with midostaurin. Our clinical advisors told us that midostaurin would improve event free and overall survival for people with FLT3 mutation positive AML.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 12 December 2023.

Following the consultation feedback, we have made the following changes to the eligibility criteria:

extend the Special Authority approval duration for midostaurin from six to nine months
minor amendments to clarify its intended use in combination with intensive chemotherapy only.

We received requests to fund midostaurin maintenance therapy following intensive chemotherapy induction and consolidation. We have responded to this feedback below.

Who we think will be most 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

Detail about this decision

Midostaurin (branded as Rydapt) will 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
Midostaurin	Rydapt	Cap 25 mg	56	$10,981.00

A confidential rebate will apply to Rydapt and it will have subsidy and delisting protection until 30 June 2027.

Rydapt will 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.

Midostaurin will 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 9 months for applications meeting the following criteria:

All of the following:

Patient has a diagnosis of acute myeloid leukaemia; and
Condition must be FMS tyrosine kinase 3 (FLT3) mutation positive; and
Patient must not have received a prior line of intensive chemotherapy for acute myeloid leukaemia; and
Patient is to receive standard intensive chemotherapy in combination with midostaurin only; and
Midostaurin to be funded for a maximum of 4 cycles.

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

Sacubitril with valsartan for heart failure

Any changes to the original proposal?

Following the consultation, we’ve removed the renewal criteria for sacubitril with valsartan, allowing people to continue treatment without further approval. This will reduce administrative burden for prescribers and we think it would improve ongoing access to the medicine.

We received feedback from clinicians requesting wider access to sacubitril with valsartan to allow for earlier use, and from industry regarding the period of subsidy and delisting protection for Entresto. We have responded to this in our feedback below.

Detail about this decision

Sacubitril with valsartan (branded as Entresto) will continue to be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the same price and subsidy.

A confidential rebate will apply to Entresto that will reduce the net price and it will have subsidy and delisting protection until 28 February 2027.

The eligibility criteria for sacubitril with valsartan will be amended in Section B of the Pharmaceutical Schedule from 1 March 2024 as follows (deletions in strikethrough):

Special Authority for Subsidy

Initial application — from any relevant practitioner. Approvals valid for 12 months without further renewal unless notified for applications meeting the following criteria:

All of the following:

Patient has heart failure; and
1. Patient Is in NYHA/WHO functional class II; or
2. Patient is in NYHA/WHO functional class III; or
3. Patient is in NYHA/WHO functional class IV; and
Patient has documented left ventricular ejection fraction of less than or equal to 35%; or
An ECHO is not reasonably practical, and in the opinion of the treating practitioner the patient would benefit from treatment; and
Patient is receiving concomitant optimal standard chronic heart failure treatments

Renewal application – from any relevant practitioner. Approvals valid for 12 months for applications where the treatment remains appropriate and the patient is benefiting from treatment.

Our response to what you told us

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. Responses were largely supportive of the proposal.

Ribociclib (branded as Kisqali) – updated 18 June 2024 (additions in bold)

Theme	Pharmac comment
Allow switching between funded CDK4/6 inhibitors for people who experience an adverse effect.	Adverse reactions can occur while on any treatment and these can be unpredictable. Our clinical advisors have indicated that most adverse reactions with CDK4/6 inhibitors can be managed with dose reductions or other interventions. They also advised that the type of adverse reactions that would require switching between medicines, and the timing of these, is uncertain. We will be seeking further advice from our clinical advisors on this request to switch between CDK4/6 inhibitors for people who experience an adverse effect at a future Cancer Treatments Advisory Committee meeting. We would like to further understand the impact of this requested change and appropriate eligibility criteria. In the interim, if a person experiences an adverse reaction or intolerance with a CDK4/6 inhibitor, where there is clinical information to suggest the intent of the criteria would otherwise be met, we would consider a Special Authority waiver Following advice received from our clinical advisors in April 2024 (records in draft), we have amended the criteria for CDK 4/6 inhibitors. This will allow people to change to another CDK4/6 inhibitor if they experience an adverse reaction that cannot be managed through dose reductions and need to stop treatment.
Allow switching between funded CDK4/6 inhibitors upon disease progression.	Our clinical advisors have told us that there is limited evidence to support the use of a second CDK4/6 inhibitor if there is disease progression following use of either palbociclib or ribociclib. Full details of the clinical advice we’ve received is available on the application tracker(external link). We’d welcome a funding application for wider access should evidence supporting clinical benefits of switching between funded CDK4/6 inhibitors upon disease progression becomes available. Information on how to submit a funding application is on the Pharmac website.

Theme

Pharmac comment

Allow switching between funded CDK4/6 inhibitors for people who experience an adverse effect.

Adverse reactions can occur while on any treatment and these can be unpredictable. Our clinical advisors have indicated that most adverse reactions with CDK4/6 inhibitors can be managed with dose reductions or other interventions. They also advised that the type of adverse reactions that would require switching between medicines, and the timing of these, is uncertain.

We will be seeking further advice from our clinical advisors on this request to switch between CDK4/6 inhibitors for people who experience an adverse effect at a future Cancer Treatments Advisory Committee meeting. We would like to further understand the impact of this requested change and appropriate eligibility criteria.

In the interim, if a person experiences an adverse reaction or intolerance with a CDK4/6 inhibitor, where there is clinical information to suggest the intent of the criteria would otherwise be met, we would consider a Special Authority waiver

Following advice received from our clinical advisors in April 2024 (records in draft), we have amended the criteria for CDK 4/6 inhibitors. This will allow people to change to another CDK4/6 inhibitor if they experience an adverse reaction that cannot be managed through dose reductions and need to stop treatment.

Allow switching between funded CDK4/6 inhibitors upon disease progression.

Our clinical advisors have told us that there is limited evidence to support the use of a second CDK4/6 inhibitor if there is disease progression following use of either palbociclib or ribociclib. Full details of the clinical advice we’ve received is available on the application tracker(external link).

We’d welcome a funding application for wider access should evidence supporting clinical benefits of switching between funded CDK4/6 inhibitors upon disease progression becomes available. Information on how to submit a funding application is on the Pharmac website.

Midostaurin (branded as Rydapt)

Theme	Pharmac comment
Supportive of the proposal, however, noted the time taken between regulatory approval and funding.	We empathise with people and their whānau who are waiting for a medicine to be funded. Midostaurin was ranked on our Options for investment list in December 2020, meaning was a medicine we wanted to fund when we had available budget. Our ability to fund a medicine is dependent on a variety of factors and we are pleased to be able to fund midostaurin following successful negotiations with the supplier.
Requested funding for one year of maintenance therapy post induction and consolidation in people not receiving an allogenic stem cell transplant.	We've received clinical advice on the funding criteria from our expert advisors on the Cancer Treatments Advisory Committee. The criteria ensure funding is targeted to those most likely to benefit, in line with the advice we have received. The Committee considered that the available evidence did not support a benefit from maintenance therapy with midostaurin. Full details of the clinical advice we have received is available on the application tracker(external link). We’d welcome a funding application for widened access to midostaurin for use as maintenance therapy. Information on how to submit a funding application is on the Pharmac website.
Amend access criteria from “eligible for intensive chemotherapy” to “while also receiving standard induction and consolidation chemotherapy”, to best capture target population.	We sought clinical advice about this request following the consultation. In response we have amended the Special Authority criteria to ensure clarity of the intended funded population.
Extend the approval period from six months to nine months, as some people may take longer to proceed through four cycles of intensive AML chemotherapy.	We have amended the eligibility criteria to enable initial approvals to remain valid for 9 months. We consider this would help ensure people can access all four funded cycles as intended.
List on the Hospital Medicines List only.	High-cost cancer medicines are listed on the Community Schedule (Section B) with a PCT only restriction. This means that only Te Whatu Ora hospitals are able to claim a subsidy, including wastage. This helps ensure claims for midostaurin are accurate. It is not intended that midostaurin be accessed via community pharmacies.

Sacubitril with valsartan (branded as Entresto)

Theme	Pharmac comment
Widen access to: People with left ventricular fraction (LVEF) less than 40% Allow for earlier treatment of heart failure with reduced LVEF, or open-list sacubitril with valsartan	We appreciate there is an unmet health need for people with heart failure. We would welcome a funding application for consideration of the use of sacubitril/valsartan for the treatment of heart failure with a LVEF less than 40% or other indications. This would enable us to consider the evidence to support earlier use of sacubitril/valsartan for a broader population. Information on how to submit a funding application is on the Pharmac website.
Allow Initial Special Authority approvals to remain valid without further renewal	We have amended the criteria to remove the requirement for renewal applications. We consider the change would reduce the administrative burden on prescribers and could improve ongoing access for people.
Opposed a period of subsidy and delisting protection as generic products could become available.	Subsidy and delisting protection for sacubitril with valsartan does not prevent a generic sacubitril with valsartan product from also being listed. We would welcome further discussions with potential suppliers of a Medsafe approved generic sacubitril/valsartan.

Theme

Pharmac comment

Widen access to:

People with left ventricular fraction (LVEF) less than 40%
Allow for earlier treatment of heart failure with reduced LVEF, or
open-list sacubitril with valsartan

We appreciate there is an unmet health need for people with heart failure.

We would welcome a funding application for consideration of the use of sacubitril/valsartan for the treatment of heart failure with a LVEF less than 40% or other indications. This would enable us to consider the evidence to support earlier use of sacubitril/valsartan for a broader population.

Information on how to submit a funding application is on the Pharmac website.

Allow Initial Special Authority approvals to remain valid without further renewal

We have amended the criteria to remove the requirement for renewal applications. We consider the change would reduce the administrative burden on prescribers and could improve ongoing access for people.

Opposed a period of subsidy and delisting protection as generic products could become available.

Subsidy and delisting protection for sacubitril with valsartan does not prevent a generic sacubitril with valsartan product from also being listed.

We would welcome further discussions with potential suppliers of a Medsafe approved generic sacubitril/valsartan.

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.