I propose to take Questions Nos. 447, 574 and 592 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 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 final HTA report and NCPE recommendations concerning Dupilumab were reviewed by the HSE Drugs Group, along with the outputs of the 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 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 Health Act, and engaged in a meeting in November 2020 with the applicant company to discuss the submission.
The HSE has advised that the HSE Drugs Group, having reviewed the above representations at their January 2021 meeting, supported reimbursement of Dupilumab for a defined subgroup of the full licensed indication. The Drugs Group recommendations have been progressed to the HSE EMT.
The HSE EMT will consider the HSE Drugs Group's recommendations and the applicant’s representations before making a final decision on whether Dupilumab will be approved for reimbursement, in line with the 2013 Act.