Written answers

Tuesday, 28 July 2020

Department of Health

Medicinal Products

Photo of Violet WynneViolet Wynne (Clare, Sinn Fein)
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1089. To ask the Minister for Health when the recommendation by an organisation (details supplied) will be implemented for dupilumab to be licensed under the primary care reimbursement service for the one in five children and one in ten adults with eczema and other skin disorders; and if he will make a statement on the matter. [19113/20]

Photo of Stephen DonnellyStephen 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 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.

I am advised by the HSE that it has received pricing and reimbursement applications for the following indications for dupilumab (Dupixent):

1. Treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy;

2. Treatment of moderate-to-severe atopic dermatitis in adolescents 12 years and older who are candidates for systemic therapy.

1) The HSE received an application for pricing/reimbursement of dupilumab (Dupixent) on 10 November 2017 from the applicant company for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.  The HSE commissioned the rapid review process on the 13 November 2017 and the NCPE advised the HSE on 24 November 2017 that a full Health Technology Assessment (HTA) was required for this medicine.

The HSE commissioned a full Health Technology Assessment on 29 November 2017 as per agreed processes.  This assessment was completed in December 2019 with the NCPE recommending that dupilumab (Dupixent) be considered for reimbursement if cost-effectiveness could be improved relative to existing treatments

2) The HSE received an application for pricing / reimbursement of dupilumab (Dupixent) 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 National Centre for Pharmacoeconomics (NCPE) advised the HSE on 17 January 2020 that a HTA was not recommended and that dupilumab (Dupixent) not be considered for reimbursement at the submitted price. 

The HSE Corporate Pharmaceutical Unit (CPU) 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. The final HTA report 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 made a recommendation to the HSE Executive Management Team not to support reimbursement of dupilumab (Dupixent) 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 final decision making authority in the HSE is the HSE Executive Management Team.  Dupilumab (Dupixent) remains under consideration with the HSE Executive Management Team.

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