Does Not Reaching an Agreement on the Final Nice Scope Have Any Impact on The Final Apraisal Outcome?

Abstract

Identifying the right patient population, comparator and endpoints is key to increase the likelihood of reimbursement. Manufacturers do not always agree with payers’ views on these items. Disagreement may lead to funding rejection. We assessed the rate of mismatches between manufacturers and NICE and their impact on the final appraisal outcome. All manufacturer submissions (MS) from January 2011 until June 2014 were reviewed. For these submissions, the initial proposed scope, the manufacturer’s comments, and the final scope and appraisal outcome were analysed. All changes to the initial scope suggested by the manufacturer were recorded and their impact on final outcome investigated. In the time period reviewed there were 101 MS of which 7 were suspended and not included in our analysis, while comments were not available for another 18. Manufacturer comments are published for 76 MS. The manufacturer disagreed on ≥1 section of initial scope in 93% (71/76) of MS. The areas where manufacturers and NICE disagreed most commonly are the comparator (s) (43/71; 61%) and population (40/71; 56%) to be assessed. The final scope implemented all and some of the manufacturer’s comments in 56% (40/71) and 28% (29/71) of submissions, respectively. Rejection was more common for manufacturer’s comments on outcomes (6/8; 75%) and comparators (8/13; 61.5%). Rate of final recommendation by NICE was higher for those MS where all (29/40; 74%) or certain changes (14/20; 74%) requested by the manufacturer were implemented in the final scope than for those where NICE rejected all manufacturer requests (7/11; 64%), and similar to overall recommendation rate (66/91; 73%). These data highlight that the initial scope frequently does not meet manufacturer’s expectations. However, manufacturer’s suggestions are often incorporated in the final scope. NICE not implementing manufacturer’s suggestions to the final scope does not decrease the likelihood of being granted funding.