I propose to take Questions Nos. 300, 319 and 339 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.
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 29 November 2017 as per agreed processes. This assessment was completed on 12 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 13 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 17 December 2019. Following receipt of a rapid review dossier, the NCPE advised the HSE on the 17 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 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 was issued with notice of the proposed decision of the HSE EMT not to support reimbursement on 21 August 2020. On 18 September 2020, the applicant company submitted representations with respect to this application.
The HSE reviewed these representations, as is required in such circumstances under the 2013 Act, and has engaged in a meeting in November 2020 with the applicant company to discuss the submission. The HSE advises that Dupilumab will be included on the agenda for the December HSE Drugs Group meeting at which the two applications and the submitted representations will be reconsidered.
Dupilumab remains under consideration with the HSE and a final decision will be made in line with the 2013 Health Act.
