ABSTRACT
Objectives: To descriptively analyse public assessment reports (PAR) published by the MHRA through their early access to medicines scheme (EAMS) to establish any trends in product characteristics granted a positive scientific opinion (SO), the impact of an SO on subsequent technology assessment (TA) by the National Institute for Health and Care Excellence (NICE), and the impact of the COVID-19 pandemic on the EAMS process. Methods: All available PARs and NICE TA documents were obtained from their respective websites, and data relating to drug, indication, justifications for positive SO, and NICE recommendation details extracted. Results: Of the 41 available PARs published between July 2015 and June 2021, oncology and genetic disorders were the most assessed indications with 24 (58.5%), and 9 (22%) related PARs respectively. The most frequent drug class were monoclonal antibodies, featuring in n=19 (46%) PARs. Of those granted an SO, n=28 underwent a NICE TA resulting in n=26 approvals, of which n=4 were recommended for use only within the cancer drugs fund. Of the recommended therapies, 20 (77%) had a commercial agreement such as a simple discount patient access scheme, in place. During the COVID-19 pandemic (April 2020-April 2021), 11 drugs were granted a positive SO versus 5 drugs in the previous 12 months. Monoclonal antibodies were the most common drug class in both time periods, with 3 (27%) and 2 (40%) granted an SO between April 2019-2020, and April 2020-2021 respectively. Conclusions: High rates of NICE TA approval (>90%) were observed in products granted an positive SO through EAMS however, most were subject to a commercial agreement, suggesting that engaging with the EAMS scheme doesn’t lead to preferential pricing. The COVID-19 pandemic appears to have had no impact on the EAMS scheme, with an increase noted in the number of positive SOs granted during the pandemic versus the previous year.