Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

I propose to take Questions Nos. 85 and 452 together.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the Health (Pricing and Supply of Medical Goods) Act 2013.

I am informed that the HSE received two applications for the reimbursement of dupilumab for the treatment of moderate to severe atopic dermatitis in patients who are candidates for systemic therapy: first in November 2017, for treating adult patients, and then in December 2019, for treating adolescents 12 years and older. The National Centre for Pharmacoeconomics, NCPE, conducted a full health technology assessment of the application for the adult population and in December 2019 recommended that dupilumab be considered for reimbursement if cost-effectiveness could be improved relative to existing treatments. The NCPE conducted a rapid review of the application for the adolescent group and in January of this year advised that a full health technology assessment was not proposed and that the drug should not be considered for reimbursement at the submitted price.

Having reviewed the NCPE's recommendations, the patient group submission and the outputs of commercial negotiations, the HSE drugs group recommended that the HSE executive management team not support the reimbursement of the drug for either the adult population or the adolescent population. On 21 August the applicant was notified of the proposed decision not to support reimbursement. On 18 September the applicant submitted representations concerning this proposed decision. Last month the HSE reviewed the applicant's representations and met with representatives from the company.

The HSE has advised that the process is still ongoing and that the matter will be included on the agenda for the HSE drugs group's meeting in January 2021. The HSE executive management team is the decision-making body for the reimbursement of medicines under the Health Act 2013 and will, on receipt of the outcome of the drugs group's deliberations, make the decision as to whether the drug will be reimbursed.

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