Patrick Costello
Question:539. Deputy Patrick Costello asked the Minister for Health his plans to offer gene cell therapy for patients with certain conditions via the HSE; and if he will make a statement on the matter. [29908/21]
View answerTuesday, 6 July 2021
Questions (539)
Written answers
As the Deputy will be aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.
In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.
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). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.
While the 2013 Health Act does not include provision for a different ruleset when assessing cell and gene therapies, the criteria that apply to the evaluation process allow the HSE to take account of evidence of the benefits associated with each given medicine.
A number of gene therapies approved by the EMA are currently at various stages of the pricing/reimbursement assessment process and will be assessed by the HSE in line with the 2013 Act.