Market Access Implications of Early Access to Medicines Scheme in the UK

Speaker(s)

Jaiswal H1, Blake L2, D'Ausilio A3, Parkinson M4
1Evidera, part of PPD clinical research business, Thermo Fisher Scientific, Bethesda, MD, USA, 2Evidera, part of PPD clinical research business, Thermo Fisher Scientific, Cary, NC, USA, 3Evidera, part of PPD clinical research business, Thermo Fisher Scientific, San Felice Segrate, MI, Italy, 4Evidera, part of PPD clinical research business, Thermo Fisher Scientific, London, UK

Presentation Documents

OBJECTIVES: Early Access to Medicines Scheme (EAMS) enables patients to access investigational medicines usually after marketing authorisation and before the product is recommended by the National Institute for Care and Excellence (NICE). The objective of this study was to identify market access implications of EAMS in the UK.

METHODS: A systematic approach was used to identify select products with UK EAMS from 2018 to 2023 and these schemes impact on their NICE appraisals were analysed.

RESULTS: EAMS provides access to medicines for specified patients and the product is provided free of charge. Within the UK, pursuing an EAMS requires a 2-step evaluation process, which begins with a promising innovative medicine (PIM) designation and then requires a second step where a scientific opinion then approves an EAMS start. Regarding the first step in the EAMS process, a majority of applications were granted a PIM designation. Approximately half of the PIM designated products seek scientific opinion with the majority of product applications awarded a scientific opinion. Therapeutic areas included oncology, COVID-19, and rare diseases. Examples of oncology products included atezolizumab and pembrolizumab submissions which received accelerated patient access. Data collected during EAMS can be leveraged to support NICE submission process. Therapies administered under an EAMS allow patients and clinicians to gain treatment experience. Our research identified that supply commitments are critical for success and that manufacturers capping the number of patients who can access EAMS is strongly discouraged.

CONCLUSIONS: EAMS provide an opportunity for physicians and patients to gain experience with a new treatment in routine care, potentially providing useful insights to inform NICE appraisals. EAMS offer an opportunity for manufacturers to learn about and resolve supply issues. Overall, the decision to implement an EAMS should be weighed carefully for each therapy and indication, while considering market access implications of EAMS.

Code

HPR195

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Drugs