Dáil Éireann Debate, Wednesday - 20 September 2023
1015. Deputy Noel Grealish asked the Minister for Health if he will make the drug Vydura (rimegepant), available on the DPS scheme; if there is any other scheme available to help an individual with the cost of this drug; and if he will make a statement on the matter. [40546/23]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available to it.
The HSE robustly assesses applications for pricing and reimbursement to make sure it can stretch available resources as far as possible and to deliver 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, on the advice of the National Centre for Pharmacoeconomics (NCPE). 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.
In terms of the specific details of the application for pricing and reimbursement of Rimegepant (Vydura®):
• The HSE received a complete application for pricing and reimbursement of Rimegepant (Vydura®) on the 13th July 2022 from Pfizer (the applicant) indicated for the acute treatment of migraine with or without aura in adults; and for the preventive treatment of episodic migraine in adults who have at least four migraine attacks per month.
• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Phamacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 13th July 2022.
• The NCPE Rapid Review assessment report was received by the HSE on the 12th September 2022. A full HTA was recommended to assess the clinical effectiveness and cost effectiveness of Rimegepant (Vydura®) compared with the current standard of care. (www.ncpe.ie/rimegepant-vydura-hta-id-22051/)
• The HSE commissioned a full Health Technology Assessment (HTA) on the 28th September 2022 as per agreed processes.
• The NCPE Health Technology Assessment report was received by the HSE on the 18th May 2023. The NCPE recommended that Rimegepant (Vydura®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments and that a managed access programme is introduced. (www.ncpe.ie/wp-content/uploads/2022/09/Rimegepant-technical-summary-22051.docx.pdf)
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. CPU engaged in commercial negotiations with Pfizer in July 2023 regarding their application for Rimegepant (Vydura®).
• 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 commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Executive Management Team.
• The decision making authority in the HSE is the HSE Executive Management Team. The HSE Executive Management 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.
The application for Rimegepant (Vydura®) remains under consideration. The HSE cannot make any comment on possible outcomes from the ongoing process.
