Dáil Éireann Debate, Wednesday - 24 February 2021
847. Deputy Duncan Smith asked the Minister for Health the status of the plans his Department and the HSE have with regard to licensing the drug dupilumab for use by patients with severe eczema as of February 2021 given the HSE drugs group met on 12 January 2021; and if he will make a statement on the matter. [9741/21]
View answer870. Deputy Sorca Clarke asked the Minister for Health if dupilumab has been approved for use in patients with severe eczema. [9850/21]
View answerI propose to take Questions Nos. 847 and 870 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 HSE 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 17 December 2019. Following receipt of a rapid review dossier, the NCPE advised the HSE on 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 decision-making authority in the HSE is the HSE Executive Management Team (EMT). The HSE EMT decides on the basis of all the demands it is faced with (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 Health (Pricing and Supply of Medical Goods) Act 2013.
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 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 these applications.
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 the following defined subgroup of the full licensed indication: 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.
The HSE has further advised that the HSE EMT received this recommendation and supported the reimbursement of Dupilumab under High Tech Arrangements, subject to the implementation of a managed access programme and the restriction of reimbursement to the defined subgroup which was recommended by the HSE Drugs Group.
Under the 2013 Health Act, the HSE has statutory responsibility for the administration of the community drug schemes. Therefore, the matter has been referred to the HSE for direct reply to the Deputies in relation to the proposed managed access programme and the formalising of a final reimbursement decision.
