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 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.
I am advised by the HSE that it received an application on 22 November 2018 for the reimbursement of burosumab (Crysvita®) for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.
In January 2019, a full HTA was commissioned by the HSE. This assessment was completed in March 2020, with the NCPE recommending that burosumab not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
The HSE Drugs Group is the national committee in place to make recommendations on the pricing and reimbursement of medicines. The decision-making authority in the HSE is the HSE Executive Management Team (EMT).
The HTA report with respect to burosumab was reviewed by the HSE Drugs Group, along with the outputs of commercial discussions with the applicant which took place in June 2020, and the patient group submission received during the HTA process.
The HSE Drugs Group have requested patient and clinician engagement input via the Rare Diseases Technology Review Committee (RDTRC) to assist the group in making its recommendation to the HSE EMT regarding the reimbursement of burosumab.
The application for burosumab remains under consideration with the HSE and is being assessed in line with the 2013 Health Act.