3312. Deputy Marie Sherlock asked the Minister for Health if consideration has been given to providing injectable PrEP for clinically suitable individuals for whom this form of administration would be greatly beneficial; and if she will make a statement on the matter. [55776/26]

The HIV Pre-Exposure Prophylaxis scheme is available to people ordinarily resident in Ireland who are deemed at risk of HIV and likely to benefit clinically from its prevention. PrEP can be accessed through public PrEP clinics or through approved private PrEP providers; more details are available on the HSE website:

https://www2.hse.ie/conditions/hiv/about-prep/

Those who may need to access free PrEP will need to access it through one of the Drugs Payment, GMS (medical) card or long-term illness card schemes. The Drugs Payment Scheme is open to anyone ordinarily resident in Ireland with a PPS number - details of how to apply are on the website linked above. Tenofovir and emtricitabine, taken in combination, are the current PrEP medications available on the Reimbursement List and available, free of charge, to those prescribed PrEP through the free PrEP scheme in Ireland.

Injectable, longer-lasting forms of PrEP, lenacapavir and cabotegravir, have recently been approved at European level.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority (HPRA).

In line with the 2013 Act and the national framework agreed with industry, a company must apply to the HSE to have a new medicine added to the formal Reimbursement List. The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.

The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.

There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.

The HSE considers the following criteria prior to making any decision on pricing/reimbursement, in line with the Health (Pricing and Supply of Medical Goods) Act 2013:

(1) The health needs of the public;

(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services;

(3) The availability and suitability of items for supply or reimbursement;

(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks;

(5) The potential or actual budget impact of the item or listed item;

(6) The clinical need for the item or listed item;

(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety;

(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies); and

(9) The resources available to the HSE.-

In respect of Lenacapavir (Sunlenca®), Gilead, the marketing authorisation holder, applied for pricing and reimbursement on 22/07/2025 for use of the medicines in combination with other anti-retroviral(s). Reimbursement of Lenacapavir (Sunlenca®) in this indication under a Managed Access Protocol was approved in June 2026. It is approved for the treatment of adults with multidrug resistant human immunodeficiency virus-1 for whom it is not possible to construct a suppressive anti-viral regimen; applications must be approved at consultant level.

The HSE, as one of the initiatives to manage expenditure on medicines, develops managed access protocols (MAPs) to support access to high-cost medicines, while providing oversight, governance and budgetary certainty to the payer. A MAP imposes the eligibility criteria attached to reimbursement support of a medicine. This is primarily driven by the licensed indication for the drug which refers to a patient sub-population. Criteria applied include controls on prescribing authority, clinical diagnostic and severity criteria, previous lines of treatment, concomitant treatments, outcome data collection, and validations within the reimbursement claims system.

In respect of Cabotegravir (Apretude®), GSK, the marketing authorisation holder applied for pricing and reimbursement on 30/12/2025. In a Rapid Review commissioned by the HSE and completed on 28/01/2026, the NCPE recommends that cabotegravir (Apretude®) not be considered for reimbursement at the submitted price. This process remains ongoing and the HSE cannot comment on possible outcomes.

As this is a service matter, and the HSE may have additional information, I have also asked the HSE to respond directly to the Deputy, as soon as possible.