Problem Statement: In Ireland, new medicines are increasingly reimbursed for sub-populations of the licensed indication, due to high-cost, budgetary constraints and low quality clinical evidence. Health Technology Assessment (HTA) can identify sub-populations where reimbursement may bring greatest benefits; health technology management (HTM) protocols are developed around these recommendations to ensure utilisation is limited to the approved population.

Description: The Health Services Executive (HSE) in Ireland manages medicines expenditure within the publically funded health system. A variety of HTM processes have been developed to implement managed access to medicines including the following:

• automated validations implemented via the national reimbursement claims system;
• reimbursement application systems;
• managed access protocols; and
• managed access protocols including outcome data collection.

Choice of process is determined by clinical aspects of the treatment and target population, setting and route of administration, feasibility, existing controls in the therapeutic area, commercial terms etc., which are largely informed by the HTA report. The final process is determined in conjunction with some or all of the (i) HSE-Corporate Pharmaceutical Unit, (ii) HSE-Primary Care Reimbursement Service, (iii) HSE-Acute Hospitals Drug Management Programme, (iv) relevant HSE-National Clinical Programme.

The HSE-Medicines Management Programme (HSE-MMP) will present case studies of each approach, demonstrating (i) how HTA reports inform HTM approaches, (ii) which approaches are most suitable for particular drug types, (iii) IT infrastructure supporting the approach, and (iv) lessons learned in implementation to date. Case studies include medicines for atopic dermatitis, migraine, obesity, cardiovascular disease and dermatology and rheumatology indications.

Lessons Learned: HTM provides an effective mechanism to facilitate access to high-cost medicines for targeted patient groups, while providing increased oversight and budgetary certainty. Cost certainty provided by HTM permits avoidance of HTA in certain therapeutic areas. Early consideration of the HTM approach during the HTA process supports subsequent successful implementation post-reimbursement.

Stakeholder perspective: HSE-Payer/Government Organisation