Proposal to widen access to empagliflozin for chronic heart failure

What we’re proposing

We want to hear from you about a proposal to widen access to empagliflozin for people with chronic heart failure with reduced ejection fraction (HFrEF) from 1 December 2024 through a provisional agreement with Boehringer Ingelheim.

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.

Media release: Funding boost means more medicines for more New Zealanders.

Feedback to this consultation will help us decide how we progress this proposal. Consultation closes at 4:00 pm, 13 September 2024 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

Empagliflozin is currently funded for people with Type 2 diabetes who meet certain criteria. This proposal would mean that access to empagliflozin (a SGLT-2 inhibitor) would be widened to include people with chronic heart failure with reduced ejection fraction, from 1 December 2024.

We anticipate around 18,000 additional people in New Zealand would access this medicine in the first year of funding. We expect these numbers would grow and after 5 years around 33,000 additional people would benefit from empagliflozin every year. 

Effects on the health sector

We expect that this proposal would reduce the number of hospitalisations and the amount of time people spend in hospital.

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.

About chronic heart failure and empagliflozin

About chronic heart failure

Chronic heart failure is a long-term condition that happens when the heart doesn’t pump blood around the body as well as it should. Symptoms of chronic heart failure include shortness of breath, tiredness, problems exercising, and swelling of the feet, ankles, and abdomen.  

Heart failure with reduced ejection fraction is a type of heart failure that happens when the heart's lower left chamber (left ventricle) doesn't pump blood to the body as well as it should. It's sometimes called systolic heart failure.

About heart failure - Healthify NZ(external link)

Māori and Pacific people are more likely to be diagnosed with heart failure and experience worse heart-failure related outcomes compared with non-Māori, non-Pacific people. This includes a higher risk of hospitalisation, and kidney disease.  

About empagliflozin

Empagliflozin belongs to a class of medicines called sodium glucose co-transporter 2 inhibitors (SGLT-2). These medicines limit the absorption of glucose (sugar) in the kidneys, increasing the amount of glucose that is removed from the body in the urine. This reduces the amount of glucose present in the blood. Empagliflozin has been shown to help protect the heart in people with chronic heart failure, and delay or slow down kidney failure.

Empagliflozin is an oral tablet that is taken once a day.

Further information about empagliflozin can be found in the Medsafe datasheet for Jardiance.

Medsafe datasheet for Jardiance [PDF](external link)

Why we’re proposing this

We received a funding application for empagliflozin for chronic heart failure with reduced ejection fraction in November 2021. We have received advice on this application from both the Pharmacology and Therapeutics Advisory Committee (PTAC) and the Cardiovascular Advisory Committee.

In June 2022, the Cardiovascular Advisory Committee recommended that empagliflozin be funded for people with heart failure with reduced ejection fraction.

June 2022 Cardiovascular Specialist Advisory Committee Record [PDF, 409 KB]

Our clinical advisors have told us that people with chronic heart failure with reduced ejection fraction have a high health need and this condition has a severe impact on the person and their whānau. They told us that the evidence shows that empagliflozin reduces the rate of hospitalisation and improves quality of life for people with chronic heart failure.

You can find more information about this application on the Application Tracker(external link).

We have also received a separate application for people with heart failure with preserved ejection fraction (HFpEF) which was considered by PTAC in May 2023(external link) who recommended that the application be declined. This remains under consideration and we intend to seek advice from the Cardiovascular Advisory Committee at its next meeting. You can find more information about this application on the Application tracker(external link).

We have also received funding applications for empagliflozin for other indications. These are at different stages in our assessment process. You can see all the funding applications we have for empagliflozin on the Application Tracker(external link).

Details about our proposal

Empagliflozin (with and without metformin) is currently listed in the Pharmaceutical Schedule and funded for people with type 2 diabetes who meet certain 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. As the SGLT-2 eligibility criteria apply to empagliflozin with and without metformin, we are proposing to widen access to SGLT-2 inhibitors to enable access to empagliflozin for chronic heart failure with reduced ejection fraction.

The eligibility criteria would be amended in Section B of the Pharmaceutical Schedule to include chronic heart failure with reduced ejection fraction from 1 December 2024 as follows (new criteria only are shown below):

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

Contractual amendments

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 proposal, Pharmac would 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 would reduce via a confidential rebate.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4:00 pm, 13 September 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.