Duncan Smith (Dublin Fingal, Labour)
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798. To ask the Minister for Health the plans his Department and the HSE have with regard to licensing the drug dupilumab for use by patients with severe eczema in Ireland; and if he will make a statement on the matter. [44840/20]

Brendan Griffin (Kerry, Fine Gael)
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903. To ask the Minister for Health his views on a matter (details supplied); and if he will make a statement on the matter. [1010/21]

Róisín Shortall (Dublin North West, Social Democrats)
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930. To ask the Minister for Health if a decision on the reimbursement of dupilumab, a drug to treat severe atopic eczema, was reached at the December 2020 HSE drugs group meeting; and if he will make a statement on the matter. [1116/21]

Michael Healy-Rae (Kerry, Independent)
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938. To ask the Minister for Health when the drug dupilumab will be made available here (details supplied); and if he will make a statement on the matter. [1133/21]

Eoin Ó Broin (Dublin Mid West, Sinn Fein)
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1003. To ask the Minister for Health the status of the assessment of the atopic eczema treatment known as dupilumab; and when the treatment will be available to eczema patients here. [1342/21]

David Cullinane (Waterford, Sinn Fein)
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1019. To ask the Minister for Health if the HSE drug group has met to date in January 2021; when the group will next meet; if the drug dupilumab will be approved for reimbursement; and if he will make a statement on the matter. [1444/21]

Gerald Nash (Louth, Labour)
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1053. To ask the Minister for Health the status of the assessment of the drug dupilumab, which has been life-changing for many persons living with severe atopic eczema; when he expects this assessment to be completed; if he will ensure equitable access to dupilumab for eczema patients; and if he will make a statement on the matter. [1642/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 798, 903, 930, 938, 1003, 1019 and 1053 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 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 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 a Drugs Group meeting did take place in December 2020, at which point it was not possible to discuss Dupilumab due to time constraints.

The HSE has advised that a HSE Drugs Group’s meeting has been scheduled for the afternoon of 12th January 2020, subject to the confirmed quorum being achieved. The HSE has indicated that there is a risk that it will not be possible to achieve the necessary quorum, as contributing clinicians are under significant pressures with competing priorities due to the pandemic. In the event that the quorum is not maintained, this meeting will need to be rescheduled.

The HSE EMT will, on receipt of the outcome of the Drugs Group's deliberations, make the decision on whether Dupilumab will be reimbursed.