Utilising Health Technology Assessment to Develop Managed Access Protocols to Facilitate Drug Reimbursement in Ireland.

The Health Service Executive, responsible for operating the Irish health service, has introduced health technology management (HTM) initiatives to manage expenditure on medicines. One such approach is managed access protocols (MAPs) to support access to high-cost medicines, while providing oversight, governance and budgetary certainty to the payer. Herein we describe the development and operation of MAPs, using case studies of liraglutide (Saxenda®), dupilumab (Dupixent®) and calcitonin gene-related peptide monoclonal antibodies. A MAP imposes the eligibility criteria attached to reimbursement support of a medicine. Criteria applied include controls on prescribing authority, clinical diagnostic and severity criteria, previous lines of treatment, concomitant treatments, outcome data collection, and validations within the reimbursement claims system. The choice of criteria are specific to each medicine, dictated by the areas of uncertainty highlighted in the health technology assessment report, such as the place in treatment, population, duration of treatment, etc., the commercial arrangements reached with the marketing authorisation holder, and specific recommendations made by the decision maker. By December 2023, there were 28 medicines reimbursed subject to a MAP in Ireland. Across the three case studies outlined, over 3000 patients were accessing novel treatments for chronic illnesses in September 2023. Managed access protocols can provide some cost certainty for the payer by aligning utilisation and expenditure with committed funds, while enabling access where unmet need is highest. Managed access protocols are now established in the drug reimbursement process in Ireland, meeting the needs of both payers, patients and industry, and are likely to remain a feature of the reimbursement landscape.

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

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.