James Geoghegan (Dublin Bay South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

382. To ask the Minister for Health further to Parliamentary Question No. 1542 of 22 January 2025, to ask the HSE to issue a reply;; and if she will make a statement on the matter. [7111/25]

Kieran O'Donnell (Limerick City, Fine Gael)
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 decisions on the pricing and reimbursement of medicines and medical devices, therefore I requested an update from the HSE in this matter.

The HSE has advised it 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 must robustly assess 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 Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) the HSE has advised the following:

The HSE received a complete application for pricing and reimbursement on the 9th January 2023 from Advanced Accelerator Applications, a Novartis Company (the applicant) for Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition indicated for the treatment of adult patients with progressive prostate specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy:

• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 9th January 2023.
• The NCPE Rapid Review assessment report was received by the HSE on the 10th February 2023. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) compared with the current standard of care.
• The HSE commissioned a full HTA on the 1st March 2023 as per agreed processes.
• The NCPE Health Technology Assessment Report was received by the HSE on the 12th August 2024. The NCPE recommended that Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) not be considered for reimbursement.
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. The HSE CPU has met with the applicant to discuss this application.
• The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. The pharmacoeconomic report will be reviewed by the HSE Drugs Group along with the outputs of any commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Leadership Team.
• The decision making authority in the HSE is the HSE Senior Leadership Team. The HSE Senior Leadership Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.