Problem Statement: Historically Ireland has had low uptake of generic and biosimilar medicines. The Health Services Executive-Medicines Management Programme (HSE-MMP) was tasked with increasing the prescribing and utilisation of biosimilar medicines for the TNF-α inhibitors adalimumab and etanercept, to 80% market share. TNF-α inhibitors are initiated by hospital prescribers but funded through the community care budget in Ireland. Automatic substitution by pharmacists is precluded by law. A change in prescriber behaviour was therefore required to increase utilisation.

Description: The HSE-MMP published a roadmap for the prescribing of best-value biological (BVB) medicines. This defined criteria to identify preferred biosimilar products for a reference biological medicine. Marketing authorisation holders were encouraged to submit evidence to support their designation as BVB medicines. In addition to identifying a BVB, the HSE-MMP in conjunction with the HSE-Corporate Pharmaceutical Unit and HSE-Primary Care Reimbursement Service:

• Developed and implemented a reimbursement policy ensuring exclusive use of BVB medicines in patients initiating treatment.
• Implemented a gain-share incentive to support investment of a portion of the savings into the clinical service responsible for those savings, to encourage switching of patients established on originator brands.
• Integrated BVB medicine prescribing recommendations into the national reimbursement claims software.
• Engaged clinicians and developed support materials for clinical teams.

Lessons Learned: Since June 2019 over 24,500 patients have been prescribed a BVB medicine for adalimumab or etanercept, with associated savings in excess of €80 million. Operation of the gain-share incentive was critical in changing prescriber behaviour, resulting in almost €10 million reinvested in clinical services. Interdepartmental cooperation across the HSE and integration into software systems was critical to success. The BVB programme is now the formally recognised mechanism for biosimilar introduction in the framework agreements between the HSE, Department of Health and industry representative bodies in Ireland.

Stakeholder perspective: Health Services Executive Ireland-Payer/Government Organisation