Objectives
Since 29 July 2016, NICE has employed a new fast-track appraisal process for oncology drugs. The new approach aims for draft guidance to be published prior to market authorisation (MA) in the form of an Appraisal Consultation Document (ACD), and a Final Appraisal Determination (FAD) to be published within 90 days of MA. This study investigates whether these targets have been met for new cancer drugs receiving MA post-July 2016.
Methods
Publicly available sources were utilised to identify cancer drugs assessed through the new NICE oncology appraisal process (data cut-off 24th April 2018). For each drug, the publication dates of the ACD and FAD were identified, as well as European Medicine Agency MA date. The number of days between the MA date and ACD/FAD publication dates were then calculated. Multiple-technology appraisals, drugs with MA prior to 29 July 2016, and transition drugs from the old Cancer Drugs Fund were excluded, resulting in analysis of 13 drugs.
Results
In 77% of cases, NICE missed its 90-day FAD publication target. The median time from MA to FAD was 123 days (range: 30-337). Additionally, 12/13 drugs had ACDs published: 50% of these ACDs were published post-MA, missing NICE’s target.
Conclusions
The new NICE oncology appraisal process aims to enable fast-track appraisals, allowing earlier access to new treatments. In practice, FAD publication is taking 33 days longer than the 90-day stated target on average, and half of ACDs are published after MA. This could potentially be due to: NICE resource constraints; the complexity of appraisals; health economic insufficiencies; manufacturer delays or the large number of innovative medical treatment submissions. Manufacturers should adapt their market access strategy and pharmaceutical pricing to accommodate the expediated appraisal process. Later publication of NICE guidance delays reimbursement, and ultimately patient access.