Claire Kerrane (Roscommon-Galway, Sinn Fein)
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632. To ask the Minister for Health if a drug (details supplied) can be made available under the HSE drugs scheme given the very high monthly cost of €7,600 which is out of reach, given this drug provides lifesaving treatment; and if she will make a statement on the matter. [67985/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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633. To ask the Minister for Health the reason for the continued failure to approve and purchase the drug selpercatinib as a targeted treatment for medullary thyroid cancer and small cell lung cancer for patients in Ireland; the number of patients undergoing treatment for these forms of cancer who would benefit from such treatment; the cost of providing it; if she will ensure the approval and funding are provided to facilitate the provision of this treatment in Ireland; and if not, if she will amend the criteria for the treatment abroad scheme to allow such patients to receive this medication elsewhere in the European Union or in the United Kingdom.; and if she will make a statement on the matter. [67988/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines.

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 terms of the specific details of the application for pricing and reimbursement of selpercatinib (Retsevmo®):

1. Medullary Thyroid Cancer
   • The HSE received a complete application for pricing and reimbursement on the 27th June 2025 from Eli Lilly (the applicant) for selpercatinib (Retsevmo®) indicated for adults and adolescents 12 years and older with advanced rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) (HTA ID 25034a).
   • Further information on the progress of selpercatinib (Retsevmo®) through the HSE assessment and approval processes for the above indication is available via the Pricing and Reimbursement Application tracker available at: www.hse.ie/eng/about/who/cpu/. HSE application ID HSE100051 has been assigned to this application.
2. Thyroid Cancer
   • The HSE received a complete application for pricing and reimbursement on the 27th June 2025 from Eli Lilly for selpercatinib (Retsevmo®) indicated for adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer (TC) who are radioactive iodine-refractory (if radioactive iodine is appropriate) (HTA ID 25034b).
   • Further information on the progress of selpercatinib (Retsevmo®) through the HSE assessment and approval processes for the above indication is available via the Pricing and Reimbursement Application tracker available at: www.hse.ie/eng/about/who/cpu/. HSE application ID HSE100052 has been assigned to this application.
3. NSCLC
   • The HSE received a complete application for pricing and reimbursement on the 27th June 2025 from Eli Lilly for selpercatinib (Retsevmo®) indicated as monotherapy for the treatment of adult patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor (HTA ID 25035).
   • Further information on the progress of selpercatinib (Retsevmo®) through the HSE assessment and approval processes for the above indication is available via the Pricing and Reimbursement Application tracker available at: www.hse.ie/eng/about/who/cpu/. HSE application ID HSE100050 has been assigned to this application.

The HSE operates the EU Treatment Abroad Scheme (TAS), for persons entitled under EU Regulation 883/04. The TAS is a consultant led scheme and allows for an Ireland-based public consultant to refer a public patient who is normally resident in Ireland for treatment in the public healthcare system of another EU member state, the UK or Switzerland. Subject to the EU Regulations and Guidelines, the TAS provides for the cost of approved public treatments in another EU/EEA member state, the UK or Switzerland through the issue of form S2 (IE) where the treatment is:

• among the benefits provided for by Irish legislation;
• not available in Ireland;
• not available within the time normally necessary for obtaining it in Ireland, taking account of the patient's current state of health and the probable course of the disease;
• medically necessary and will meet the patient’s needs;
• a proven form of medical treatment and not experimental or test treatment;
• provided in a recognised public hospital or other institution that will accept EU/EEA form S2 (IE) and;
• is under the control of a registered medical practitioner.