Denis Naughten (Roscommon-Galway, Independent)
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533. To ask the Minister for Health further to Parliamentary Question Nos. 840 and 847 of 3 February 2021; the status of same; and if he will make a statement on the matter. [44480/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 final decision-making authority in the HSE is the HSE Executive Management Team (EMT). The HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the 2013 Health Act.

The HSE has advised that, following two full pharmacoeconomic assessments by the NCPE and commercial engagements with the applicant company, Dupilumab (Dupixent) is available for reimbursement under the High Tech arrangements from 1 of April 2021 for moderate-to-severe atopic dermatitis in refractory adults and adolescents 12 years and older for whom immunosuppressant treatment has failed, or is not tolerated or is contraindicated.

In accordance with the conditions outlined in the approval decision of the HSE EMT, a Managed Access Protocol is in place for Dupilumab. The protocol outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of Dupilumab under High Tech Arrangements. Further information on how this managed access protocol is implemented is available online: www.hse.ie/eng/about/who/cspd/ncps/medicines-management/managed-access-protocols/dupilumab/

The HSE further advises that on 27 August 2021 it received a license extension application for pricing / reimbursement of Dupilumab for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.

The first step in the process is the submission of a rapid review dossier. The HSE commissioned the rapid review process on 30 August 2021.

This application remains under assessment and a final decision will be made in accordance with the 2013 Act.