Pearson I, Stevenson A, Krieger T, Ling C. What is the role of the company evidence submission in National Institute for Health and Care Excellence (NICE) multiple technology appraisals? Poster to be given at the ISPOR 2019 European Conference; November 5, 2019. Copenhagen, Denmark. [abstract] Value Health. 2019 Dec; 22(S3).

OBJECTIVES: NICE’s multiple technology appraisal (MTA) process evaluates the clinical and cost-effectiveness of multiple health technologies or a single technology for multiple indications. In MTA, reviews of clinical and economic evidence and de novo economic modelling are done by an independent Assessment Group (AG). Companies may provide evidence submissions in addition to the AG, but this is not an essential requirement and no template is provided. This review examines the type of evidence submitted by companies in recent MTAs, as the role of the company submission is unclear.

METHODS: Published NICE MTAs (excluding withdrawn/terminated and reappraisals) from the last 10 years were reviewed on the NICE website up to May 2019. Key data were extracted, including number and type of technologies appraised, final recommendations, and type of evidence included in the company submission (submissions from biosimilar/generics companies were excluded). Descriptive statistics relating to possible sources of variability were calculated.

From May 2009 to May 2019, 49 MTAs were published, providing 144 recommendations on drugs and devices. Interim analyses show the proportion of positive recommendations was high, with 47% recommended, 26% optimised, 1% in research, and 26% not recommended. A total of 134 originator technologies were reviewed; 81% of companies provided an evidence submission, while 19% did not submit any evidence. Of the companies that submitted evidence, the type of evidence varied: 87% provided a full submission including an economic model and 13% submitted partial dossiers of clinical evidence only.

CONCLUSIONS: The lack of requirement for a company submission in the MTA process does not preclude companies from submitting their own evidence, with a high proportion submitting a full or partial dossier for consideration. The influence of this evidence is unclear, as 19% of companies did not submit any evidence, yet 54% of these companies gained a positive/optimised NICE recommendation.

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