THE INFLUENCE OF PATIENT COMPLIANCE ARGUMENTS IN NICE TECHNOLOGY APPRAISALS

Author(s)

Brown AP1, Chauhan D2, Guarnieri C1, Philips Z11Abacus International, Manchester, United Kingdom, 2Takeda, London, United Kingdom

OBJECTIVES: To identify, using HTAinSite, if and how manufacturers have used improved patient compliance as a value argument for their product in submissions to the National Institute for Health and Clinical Excellence (NICE). We analysed if and how compliance data were presented, how they were received by NICE, and if they were an influential factor in NICE’s decision making.   METHODS: A key phrase search in HTAinSite was used to identify instances of ‘compliance’ and ‘adherence’ in manufacturer submissions and NICE technology appraisal (TA) documents. After review for relevance, information was extracted and used to conduct a qualitative analysis. RESULTS: Fifteen manufacturer’s submissions and 12 TAs reported an improvement in compliance as a value argument for their drug. Factors used to justify improved compliance included improved convenience, a reduction in adverse events, increased treatment choice, and improved route of administration. In 8 of 13 TAs (relating to 11 manufacturer submissions), NICE state that the compliance argument was considered by the Committee. In the remaining 5 TAs, despite inclusion of a compliance argument by manufacturers in their submissions, the Committee made no reference to it in the TA. Interestingly, only three manufacturers explicitly reported evidence supporting their compliance argument; however, the Committee discussed this in all of the associated TAs. The impact of improved compliance on clinical outcomes or cost-effectiveness was frequently not clearly reported by manufacturers or NICE.  NICE did not explicitly cite compliance as an influential factor in their final decision in any TAs. CONCLUSIONS: The committee are more likely to consider a compliance argument if there is a clear clinical rationale and it is accompanied by supporting data. Although compliance arguments are considered by the Committee, NICE have not explicitly stated to have used them to influence final decisions.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP151

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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