BioCentury
ARTICLE | Regulation

Pragmatic appraisals

ABPI, NICE agree agency needs shorter process for drugs with similar efficacy, price

May 30, 2016 7:00 AM UTC

The U.K.'s NICE will be seeking comments on a proposal for an abbreviated appraisal process that is intended to relieve the agency of a small portion of its increasing workload while providing drug sponsors more predictable access to market for medicines that are as good as or better than covered drugs - and priced the same or cheaper.

By virtue of their similarity on therapeutic benefit and price compared with drugs that NICE already recommends, new drugs reviewed under the abbreviated technology appraisal (ATA) pathway would be assumed to meet NICE's cost-per-QALY threshold. Companies therefore would not need to submit a cost utility analysis or economic models. ...