Health technology management: the experience of a managed access approach to the reimbursement of dupilumab in Ireland

Abstract

Background Dupilumab was the first biological medicine to receive marketing authorisation, in Ireland, for the treatment of atopic dermatitis (AD). In 2019, Ireland’s National Centre for Pharmacoeconomics recommended that dupilumab not be reimbursed at the submitted price; it was not cost effective. Following confidential price negotiations, the Health Service Executive (HSE) reimbursed dupilumab subject to a HSE-Managed Access Protocol (MAP). Patients with refractory, moderate-to-severe AD were deemed eligible to receive treatment under the MAP; the cohort for which dupilumab is expected to be most effective and most cost effective (versus standard of care). Approval, for treatment, is granted on an individual patient basis by the HSE-Medicines Management Programme. Aims Applications for approval of treatment with dupilumab were analysed to determine the percentage of patients deemed eligible. Key characteristics of this population were investigated. Methods Data from individual patient applications were analysed. Key characteristics of the approved population were investigated using IBM SPSS Statistics® version 27. Data were derived from the HSE-Primary Care Reimbursement Service pharmacy claims database. The number of patients who received dupilumab over the study period was determined. Results In total, 96% of submitted applications were deemed eligible. Of these, 65% were male and 87% were adults. In the main, the approved patient population had severe refractory AD; the mean Eczema Area Severity Index score was 28.72. Conclusion The majority of applications submitted were approved. This work highlights how a MAP can facilitate access to treatment in patients who are deemed eligible whilst containing overall expenditure.