Managed Access Agreements in the UK: A Detailed Analysis of NICE's Utilization and Impact on Access

OBJECTIVES: The data provided to NICE is not always sufficient to make long term decisions on clinical effectiveness or value for money of new treatments and indications. Since coming into play in 2016, Managed Access Agreements (MAAs) ensure access to life saving medicines whilst allowing further time for manufacturers to collect long term data, in order to address any clinical uncertainties.

METHODS: Publicly available Managed Access Agreements (MAAs) currently ongoing between NHS England and manufacturers as of 22/06/2023 were identified and key data extracted.

RESULTS: Guidelines stipulate the period of the MAA would be as short as possible, normally up to two years, but can be longer depending on the issues of uncertainty highlighted. Our analysis found the average length a drug stayed in a MAA was 3 years. 72% were issued with a data collection time frame of more than two years. 87% were oncology products, and the majority, 83% were entered into the MAA for data collection of OS and PFS. 90% of the primary data source was from an ongoing clinical trial supported by real world data, typically a registry. As of June 2023, 8 drugs have exceeded their pre-specified data collection windows on the MAA.

CONCLUSIONS: Analysis of MAAs suggests that the scheme is a highly attractive proposition for manufacturers. The immaturity of data in the clinical trial setting was the key uncertainty sighted in the majority of MAAs, with most of these arising from immature OS and PFS data. MAAs could be better facilitated by understanding the prospective post-marketing data required by NICE.