The Impact of the COVID-19 Pandemic on the MHRA’s Early Access to Medicines Scheme
Author(s)
Ruane P1, Brown R2, Francis LE3, Sam L4
1PHMR Ltd., Newcastle upon Tyne, NBL, UK, 2PHMR Ltd, London, UK, 3PHMR Ltd., London, UK, 4PHMR Ltd, Newcastle, UK
Presentation Documents
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.
Conference/Value in Health Info
2021-11, ISPOR Europe 2021, Copenhagen, Denmark
Value in Health, Volume 24, Issue 12, S2 (December 2021)
Code
POSA279
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling, Decision & Deliberative Processes
Disease
Drugs