I propose to take Questions Nos. 1509, 1523, 1525 and 1526 together.
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.
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 could be improved relative to existing treatments.
The HSE engaged in commercial negotiations with the applicant company in November 2020.
The HSE Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members and clinicians.
The HSE Drugs Group considered Voretigene neparvovec at its February 2021 meeting, and 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 Executive Management Team (EMT) regarding reimbursement of Voretigene neparvovec.
The HSE has advised that, on 23 March 2021, the RDTRC held a meeting at which Voretigene neparvovec was the main agenda point.
The Committee met on 26 August and concluded its patient and clinician engagement with respect to Voretigene neparvovec. The Committee submitted a statement in December regarding this review for the Drugs Group’s consideration.
The Drugs Group has specifically requested a Prescribing Guideline to inform their deliberations. This guideline is currently under development. The Drugs Group will review the output of the RDTRC and the Prescribing Guideline with a view to making a recommendation at the earliest opportunity to the HSE EMT.
The HSE EMT 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 HSE Drugs Group's deliberations, make the decision on whether Voretigene neparvovec will be reimbursed.