Comparing and Contrasting Early Access Opportunities Across the EU4 and UK
Thomas M1, Morris L1, Craddy P2, Foxon G1
1Remap Consulting UK Ltd, Alderley Edge, CHE, UK, 2Remap Consulting GmbH, ZUG, ZG, Switzerland
Early access programs (EAPs) have clear benefits for patients, healthcare providers, payers and pharmaceutical companies. However, manufacturers can struggle to identify EAPs and understand the opportunities that would best complement their pricing and reimbursement (P&R) strategies. We have scoped EAPs across the EU4 and the United Kingdom (UK) to establish the eligibility criteria and timelines, identify resource requirements and evidence generation possibilities, and ultimately assess the opportunity for manufacturers.
EAPs available in the EU4 and UK were identified through secondary research; extraordinary single patient requests were excluded as deemed not commercial opportunities. Eligibility criteria, resource requirements, evidence generation possibilities and timelines were extracted for each EAP. The relative opportunity value of each EAP for manufacturers was evaluated.
Nine early access programs were identified across EU4 and UK. Of these, France, Germany, Italy and Spain all had two program options and the UK had one. The programs identified all provided compassionate use for a cohort of patients. Fundamental to all schemes was the condition that the therapy is to treat a debilitating or life-threatening disease and met a therapeutic need, although innovation was not a criterion for all identified programs. Both France’s Early access authorisation (AAP) and UK’s Early Access Medicines Scheme (EAMS) provided data collection opportunities that could be utilised in their respective HTA bodies’ assessment procedures. Additionally, only France’s AAP and Italy’s 648 program offered paid Early Access for manufacturers.
There are multiple opportunities for EAPs for manufacturers across the EU4 and the UK. Through undertaking this analysis, we have been able to populate a framework for early access opportunities, showing variation in qualifying criteria and evidence collection possibilities. The limited number of EAPs that offer paid access could significantly limit the number of manufacturers able to provide early access to potentially life-saving medicines for patients.
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Health Policy & Regulatory
Coverage with Evidence Development & Adaptive Pathways, Pricing Policy & Schemes, Reimbursement & Access Policy
SDC: Oncology, SDC: Rare & Orphan Diseases, STA: Genetic, Regenerative & Curative Therapies, STA: Personalized & Precision Medicine