OBJECTIVES Determine whether products with a positive early access to medicines scheme (EAMS) scientific opinion from the Medicines and Healthcare products Regulatory Agency (MHRA), increases their likelihood of receiving a positive recommendation from the National Institute for Health and Care Excellence (NICE) for reimbursement across England and Wales.

METHODS Identify and analyse all products that received a positive EAMS scientific opinion and a NICE recommendation, as well as all other products with a NICE recommendation within the same period (January 2014 to April 2021). Compare the likelihood of a positive NICE recommendation for the products that received a positive EAMS scientific opinion versus the products that were not part of the EAMS.

RESULTS Of the 38 products (cut-off May 2021) that received a positive EAMS scientific opinion, 22 products have been appraised by NICE. 95% of these products received a positive NICE recommendation in contrast to 90% positive NICE recommendations for products that were not part of the EAMS (N=332). Most of the EAMS products were oncology products (N=16, 73%) and all of them (100%) received a positive NICE recommendation, while only 86% of the products without an EAMS (N=179) received a positive recommendation from NICE. For both the products that were and were not part of the EAMS, a split of 75% recommended/optimised versus 25% Cancer Drug Fund NICE recommendations were approximately equal.

CONCLUSIONS This analysis finds that products with a positive EAMS scientific opinion have a higher likelihood receiving a positive NICE recommendation. Reasons may include rigorous review of the available data by the MHRA prior to a NICE appraisal, ability to collect UK specific data, and allowing clinicians and patients to gain experience with the product. Most products that were part of the EAMS are oncology products, highlighting the high unmet need.