The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies criteria for decisions on the reimbursement of medicines.
In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the new medicine added to the reimbursement list.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
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 whether a drug is cost-effective as a health intervention for each specific indication.
I am advised by the HSE that it has received an application for the reimbursement of nivolumab in combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.
A rapid review for this indication was completed by the NCPE on 11 December 2018. A full pharmacoeconomic assessment was commissioned by the HSE on 19 December 2018 and the NCPE received a submission from the applicant on 1 April 2019. The NCPE assessment is ongoing.