APPLICATION OF A ‘NICE POST-HOC B/S ANALYSIS' TO THE NICE APPRAISAL PROCESS

Author(s)

Macaulay R
HERON Commercialization, London, UK

OBJECTIVES: Post-hoc subgroup analyses are still used in clinical trials of medical technologies to identify patient populations in whom greatest benefits can be achieved, despite this being derided as an analytical approach. Indeed, using such an approach, aspirin has been shown to be ineffective versus placebo in acute myocardial infarction patients born under the star signs of Libra and Gemini (ISIS-2, 1988, Lancet) and endarterectomy is only efficacious in treating symptomatic stenosis patients born on a Monday, Wednesday, or Friday (ECST group, 1998, Lancet). This research aimed to determine what effect the name of a drug has on the National Institute of Health and Care Excellence (NICE) appraisal process by applying a post-hoc analysis that compares the rates of acceptance by the first letter of the drug or technology name using a Chi-squared test. METHODS: All final appraisal determinations resulting from Single Technology Appraisal (STA) or Multiple Technology Appraisal (MTA) processes were identified up to April 2014 from which the first letter of the generic name and the decision were extracted. RESULTS: CONCLUSIONS: Based on this ‘NICE post-hoc B/S analysis,’ manufacturers should consider lobbying the World Health Organization to give their new pharmaceuticals International Nonproprietary Names beginning with ‘B’ or ‘S’ to optimise success rates in the NICE appraisal process. Alternatively, regulators and HTA bodies should continue to view efficacy claims on the basis of post-hoc sub-group analyses with great scepticism.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP191

Topic

Organizational Practices

Topic Subcategory

Academic & Educational

Disease

Multiple Diseases

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