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 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 23 September 2019 an application was received for the reimbursement of Voretigene neparvovec (Luxturna) for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.
On 29 October 2019, following the completion by the NCPE of a rapid review, the HSE commissioned a full pharmacoeconomic assessment with respect to this indication.
On 3 April 2020, the NCPE received the applicant’s submission for this assessment. On 18 September 2020, the NCPE completed its assessment and recommended that Voretigene neparvovec not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.
The final HTA report will be reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations which took place in November 2020 and the patient group submission received during the HTA process. The HSE advises that Voretigene neparvovec is expected to be included on a Drugs Group agenda in early 2021.
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 Voretigene neparvovec will be reimbursed.
I can confirm that I have received representations in relation to this reimbursement application, including statements in relation to the early administration of this medicine. Under the 2013 Health Act, the Minister for Health has no role in reimbursement decisions.