Brendan Griffin
Question:1187. Deputy Brendan Griffin asked the Minister for Health his views on a matter (details supplied) regarding a case; and if he will make a statement on the matter. [42046/21]
View answerThursday, 9 September 2021
Questions (1187)
Written answers
The 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.
I fully appreciate the desire of patients to access all potential treatments for their condition as soon as possible. However, Section 6 of the HSE Governance Act 2013 bars me as the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
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 licenced indications which have been granted market authorisation by the European Medicines Agency 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 HSE has advised that on 8 March 2021 it received an application for the reimbursement of Cemiplimab (Libtayo) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.On 31 March, following the completion by the NCPE of a rapid review, the HSE commissioned a full health technology assessment (HTA) with respect to this indication, as per agreed processes. When completed, the HTA report will be an important input into the decision-making processes of the HSE.The HSE Executive Management Team is the decision-making body for the reimbursement of medicines under the Health Act 2013 and it will, following receipt of the outcome of the Drugs Group's deliberations, make the decision on whether Cemiplimab will be reimbursed.
Question No. 1188 answered with Question No. 1180.