Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes. The 2013 Health (Pricing and Supply of Medical Goods) Act is a clear, robust, statutory framework under which all new medicinal products must be assessed by the HSE. The HSE is the statutory decision-maker for the reimbursement of such products, and the Act ensures that these decisions are made on an objective and scientific basis.

The HSE approved reimbursement of Entresto® (Sacubitril/Valsartan) in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (HF-rEF), under the Community Drug Schemes. The product was added to the formal Reimbursement List on 1st December 2017.

The HSE Medicines Management Programme (MMP) operates a Managed Access Protocol (MAP) for Entresto® via an online reimbursement application system. Clinicians are required to apply for reimbursement approval on an individual patient basis for Entresto®. This has been operational since 1st December 2017.

To be eligible for reimbursement of Entresto®, patients must meet the following criteria at the time of application:

- Left ventricular ejection fraction of ≤ 35%

- Symptomatic with NYHA functional class II to IV symptoms

- Receiving optimal medical therapy for heart failure (HF) including an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker (and other HF therapies including a beta-blocker and mineralocorticoid receptor antagonist as necessary)

- Systolic blood pressure ≥ 100 mmHg

- Serum potassium ≤ 5.4 mmol/L

Further information on the HSE-MMP Managed Access Protocol for Entresto® is available at: www.hse.ie/eng/about/who/cspd/ncps/medicines-management/managed-access-protocols/sacubitril-and-valsartan-entresto/.

As part of Budget 2023, I announced €32.2 million in funding for Women’s Health Initiatives in 2023, to include dedicated funding for Cariban. The dedicated funding for Cariban will help women who experience hyperemesis gravidarum, a severe form of morning sickness, during pregnancy.

The HSE asked the Medicines Management Programme to examine the appropriateness and feasibility of a patient specific arrangement for the product. The HSE Medicines Management Programme assessment for Cariban has now been completed, and their recommendations will be followed in providing access to patients. Cariban will be funded from January 1st 2023.