Thursday, 24 September 2020

Ceisteanna (268)

Michael Moynihan


268. Deputy Michael Moynihan asked the Minister for Health the status of the availability of imfinzi for advanced lung cancer; and if he will make a statement on the matter. [26189/20]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

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. 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 28 March 2019 an application was received for the reimbursement of durvalumab (Imfinzi®) as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.In May 2019, the HSE commissioned a full pharmacoeconomic assessment with respect to this indication. On 30 August 2019, the NCPE received the applicant’s submission for this assessment. On 7 May 2020, the NCPE completed its assessment and recommended that durvalumab be considered for reimbursement if cost effectiveness can be improved relative to existing treatments.The final HTA report was reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations which took place in June 2020. In July 2020, the HSE Drugs Group made a recommendation to support reimbursement of durvalumab.The final decision-making authority in the HSE is the HSE Executive Management Team (EMT). The HSE EMT decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new uses 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 remains under consideration with the HSE.