Decision to widen access to empagliflozin for chronic heart failure
What we’re doing
We’re pleased to announce that we have made the decision to widen access to empagliflozin for people with chronic heart failure with reduced ejection fraction (HFrEF) from 1 December 2024.
As a part of the agreement with Boehringer Ingelheim NZ Limited (Boehringer Ingelheim), the Sole Supply Status for Jardiance and Jardiamet will be extended until 30 June 2026.
The Government provided additional funding to Pharmac in June 2024 to fund new medicines and widen access to medicines that are already funded. This proposal is one of many that we’re working on to put our budget increase into action.
Media release: Funding boost means more medicines for more New Zealanders
What does this mean for people?
Empagliflozin (with or without metformin) is currently funded for people with type 2 diabetes who meet eligibility criteria.
From 1 December 2024, empagliflozin will also be funded for people with chronic heart failure with reduced ejection fraction, subject to eligibility criteria. Empagliflozin has been shown to slow down the progression of heart failure, protect the heart, and delay kidney failure.
We anticipate around 18,000 additional people in New Zealand will benefit from this decision in the first year of funding, increasing to around 37,000 additional people after five years of funding.
Who we think will be interested
- People with chronic heart failure, their whānau, friends and caregivers.
- Healthcare professionals who are involved in the treatment of chronic heart failure.
- Other organisations who deliver services and support for people with chronic heart failure.
- Health New Zealand | Te Whatu Ora hospitals.
- Pharmacies and wholesalers.
- Pharmaceutical suppliers.
Any changes to the original proposal?
This decision was subject to a consultation letter released on 20 August 2024. We received feedback from clinicians, advocacy groups, suppliers, consumers, and health sector stakeholders.
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 largely supportive of the proposal. As a result of the feedback we have made some minor changes to the proposal.
We received feedback regarding the note limiting access to either a GLP-1 agonist or empagliflozin (with or without metformin) for type 2 diabetes. In response to feedback, we have clarified that concurrent treatment with empagliflozin (with or without metformin) and a GLP-1 agonist is only intended for people who meet the eligibility criteria for both indications (type 2 diabetes and heart failure with reduced ejection fraction).
We have also removed the reference in the criteria to the WHO functional class as it is not relevant with the NYHA class being the primary classification of heart failure disease severity.
A summary of the feedback we received, and our responses to this can be found below.
Details about the decision
Empagliflozin (with or without metformin) is currently listed in the Pharmaceutical Schedule and funded for people with type 2 diabetes who meet eligibility criteria. The current eligibility criteria applies to both empagliflozin (brand name Jardiance) and empagliflozin with metformin (brand name Jardiamet).
We understand that empagliflozin (10 mg tablet) would be used for the treatment of chronic heart failure with reduced ejection fraction.
However, from 1 December 2024 the eligibility criteria for empagliflozin (with or without metformin) in Section B of the Pharmaceutical Schedule will include the heart failure with reduced ejection fraction indication as follows (new criteria only shown below; amendments following consultation in bold for additions, in strikethrough for deletions):
Initial application – (heart failure reduced ejection fraction) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:
All of the following:
- Patient has heart failure; and
- Patient is in NYHA/WHO functional class II or III or IV; and
- Either:
- Patient has a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; 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.
Note: Funded [empagliflozin / empagliflozin with metformin hydrochloride] treatment is not to be given in combination with a funded GLP-1 unless receiving (empagliflozin / empagliflozin with metformin hydrochloride] for the treatment of heart failure.
Similar eligibility criteria will also apply in Part II of Section H of the Pharmaceutical Schedule.
Other contractual changes associated with this proposal
Jardiance and Jardiamet were awarded Sole Supply Status from February 2021 until 30 June 2024 as a result of a request for proposals.
As a part of this decision, Pharmac will exercise its option to extend the Sole Supply Status for Jardiance and Jardiamet until 30 June 2026.
From 1 December 2024, the net price of empagliflozin 10 mg tablets will reduce via a confidential rebate.
Our response to what you told us
We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.
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Theme |
Pharmac Comment |
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Feedback was largely supportive of the proposal. Responders considered that this decision would:
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We appreciate this supportive feedback and are pleased to be progressing a proposal that would improve the lives of people with heart failure. Our advisors have told us that funding empagliflozin would provide a meaningful improvement for eligible individuals and reduce the impact of chronic heart failure management on the New Zealand health system. |
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We received several requests to amend the proposed eligibility criteria to include people with a preserved ejection fraction, or to specifically include patients with “severe heart failure” with an ejection fraction above 40% (including those with diuretic resistance or for those with transthyretin amyloid cardiomyopathy), noting a lack of effective treatment options for these individuals. Responders were pleased that Pharmac was seeking additional advice from the Cardiovascular Advisory Committee regarding the funding application for mildly-reduced or preserved ejection fraction, however, some considered that this should be expedited ahead of any final decision. |
We have not amended the criteria to include people with a preserved ejection fraction as this would have a significant budgetary impact and needs to be considered as part of our usual funding process. Pharmac operates with a fixed budget. We must make difficult choices about what medicines are funded and for who. The funding criteria are based on the clinical advice we have received from our expert clinical advisors (the Cardiovascular Advisory Committee). The proposal to widen access to people with heart failure with preserved ejection fraction was considered by the Pharmacology and Therapeutics Advisory Committee (PTAC) in May 2023 [PDF, 1.2 MB], who recommended that the application be declined. However, this remains under consideration and we intend to seek advice from the Cardiovascular Advisory Committee at its next meeting. A separate application for empagliflozin for the treatment of Chronic Kidney Disease (CKD) was recommended for funding by PTAC in 2023. This application is under assessment. Empagliflozin for chronic kidney disease | Application Tracker(external link) |
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Some requested clarification on whether the Schedule rule preventing the funded of GLP-1 agonists and SGLT-2 inhibitors at the same time will remain in place. |
We appreciate this feedback. After seeking advice, we have amended the note in the eligibility criteria for SGLT-2 inhibitors to clarify this. The note now specifies that concurrent treatment with a GLP-1 agonist and an SGLT-2 inhibitor will only be funded for people who meet the funding criteria for GLP-1 agonists, and the SGLT-2 inhibitor funding criteria for heart failure with reduced ejection fraction. |
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We received requests to remove the Special Authority criteria for heart failure and for empagliflozin (all presentations). |
We have not amended the criteria further or removed criteria as this would have a significant budgetary impact and needs to be considered as part of our usual funding process. Pharmac operates with a fixed budget. We must make difficult choices about what medicines are funded and for who. The funding criteria are based on the clinical advice we have received from our expert clinical advisors (the Cardiovascular Advisory Committee). We would welcome a funding application for the open listing of empagliflozin. However, we note that consideration of open listing empagliflozin would likely occur after the applications currently under consideration for funding. |
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Responders noted that the proposed eligibility criteria contained language around ‘WHO functional class’, which is not necessary. |
We appreciate this feedback and have amended this criterion, changing ‘WHO/NYHA functional class’ to ‘NYHA functional class’ only. |
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.