Dáil Éireann Debate, Wednesday - 23 September 2020
186. Deputy Kieran O'Donnell asked the Minister for Health if he will address a matter (details supplied) regarding access to the drug dupilumab for eczema sufferers; and if he will make a statement on the matter. [25752/20]
View answerThe 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 licenced 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 HSE has advised that it has received pricing and reimbursement applications for two indications of dupilumab (Dupixent®):
- For the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.- For the treatment of moderate-to-severe atopic dermatitis in adolescents 12 years and older who are candidates for systemic therapy.The HSE received an application for pricing / reimbursement of dupilumab in November 2017 from the manufacturer for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The HSE commissioned a full HTA on 29th November 2017 as per agreed processes. This assessment was completed in December 2019 with the NCPE recommending that dupilumab be considered for reimbursement if cost-effectiveness could be improved relative to existing treatments.Subsequently, the HSE received an application for the pricing / reimbursement of dupilumab on 13th December 2019 for the treatment of moderate-to-severe atopic dermatitis in adolescents 12 years and older who are candidates for systemic therapy.The HSE commissioned the rapid review process on the 17th December 2019. Following receipt of a rapid review dossier, the NCPE advised the HSE 17th January 2020 that a HTA was not recommended and that dupilumab not be considered for reimbursement for this indication at the submitted price.The HSE engaged in commercial negotiations with the company in February 2020 regarding both the adult and adolescent populations.The final HTA report concerning dupilumab was reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations, and the patient group submission received during the HTA process. The HSE Drugs Group considered all the evidence and gave a recommendation to the HSE Executive Management Team (EMT) not to support reimbursement of dupilumab for the treatment of moderate-to-severe atopic dermatitis in both adults and adolescents 12 years and older who are candidates for systemic therapy.
The HSE has confirmed that the applicant company has been issued with the notice of proposed decision of the HSE EMT not to support reimbursement. On 18 September 2020, the applicant company submitted representations with respect to this application. In such circumstances, under the 2013 Health Act, the HSE is required to consider such representations before making a final decision.The final decision-making authority in the HSE is the HSE EMT. Dupilumab remains under consideration with the HSE EMT and a final decision will be made in line with the 2013 Health Act.
