Objectives: Managed access agreements (MAAs) allow patients access to new treatments while long term data are collected and before final reimbursement decisions are made. The National Institute for Health and Care Excellence (NICE) first approved a MAA for a Highly Specialised Technology (HST) appraisal in November 2015, and in July 2016 the Cancer Drugs Fund (CDF) MAA process started. An analysis of MAAs' characteristics can provide information that aid future MAA development, but has yet to be reported. The objective therefore was to determine the number and characteristics of NICE approved MAAs. Methods: The NICE website was searched using the terms "managed access agreement“, “managed entry agreement” and “commercial access agreement”. Information on the process, timelines and content for completed appraisals up to December 2017 were extracted from the retrieved documents. Results: Fifteen MAAs have been approved by NICE: one in 2015, two in 2016 and twelve in 2017. Eleven were within the CDF process, three within the HST programme and one for a single technology appraisal. Guidance on processes and timelines were available from the NICE website for CDF appraisals, but no formal MAA guidance were retrieved for other appraisal routes. Key appraisal uncertainties in clinical outcomes drove the MAA duration, data sources and data collection elements. Long term survival (n=11), treatment duration (n=10) and health-related quality of life (n=7) were the most requested outcomes, collected from disease registries (n=14), ongoing clinical trials (n=10) or both (n=10). Data collection periods ranged from <5 months to 4 years. All MAAs offered a simple discount patient access scheme and/or a reduced drug cost commercial access agreement. Conclusions: New NICE approved MAAs increased each year since 2015, were characterised by a standard format structured around the data required to answer key uncertainties and always included financial agreements to minimise NHS treatment costs during the MAA period.
Marsh, S. E. (2018). PHP365 - TRENDS AND CHARACTERISTICS OF MANAGED ACCESS AGREEMENTS APPROVED BY NICE. Value in Health, 21, S212–S213. https://doi.org/10.1016/j.jval.2018.09.2864