OBJECTIVES: To understand the impact of European Medicines Agency (EMA) Conditional Marketing Authorisation (CMA) and the Accelerated Assessment (AA) process on HTA outcomes and the time between licensing and reimbursement.

METHODS: We reviewed the assessment outcomes and timelines of all National Institute for Health and Care Excellence (NICE) appraisals of products granted CMA or AA from 2014-2018 (inclusive). We compared these to the outcomes and timings for all products over this period to determine the impact of CMA or AA. Exceptional Marketing Authorisation was also investigated, but the low number of resulting HTA appraisals meant meaningful analysis was not possible.

RESULTS: For both CMA and AA products, a smaller proportion received full recommendation (33% and 25% respectively versus 40% for standard Market Authorisation, MA) or non-recommendation (8% and 10% versus 19% for MA).

Of all CMA products assessed, half were recommended via the Cancer Drugs Fund (CDF), with another 8% with non-CDF restrictions. Of AA products assessed, 65% received a restricted recommendation.

The median time taken for NICE appraisal of CMA products (306 days) and AA products (325 days) was significantly shorter than for all products (864 days).

Similar analyses were conducted for Scotland (through the Scottish Medicines Consortium, SMC) and Germany (via the Gemeinsamer Bundesausschuss, G-BA).

In Scotland, AA was not observed to affect HTA outcome, while CMA products received a higher number of negative appraisal outcomes and fewer restricted recommendations.

In Germany, benefit assessments of both AA and CMA products were more likely to result in non-quantifiable benefit than for other products.

CONCLUSIONS: Products receiving CMA or undergoing AA do not necessarily receive worse HTA outcomes than those with a standard MA. However, these products have usually been submitted with limited data, which then has a higher likelihood of resulting in fewer positive outcomes.