Abstract
ContextThe National Institute for Health and Care Excellence (NICE) has an explicit mandate to include patient and public involvement in the appraisal of medicines to be available for funding on the NHS. NICE involves an appraisal committee who are required to take on board experiential evidence from patient experts alongside population‐based evidence on clinical and cost‐effectiveness when making a decision whether to fund a drug.ObjectiveThis paper considers how NICE Single Technological Appraisal (STA) committees attempt to incorporate the views of patients in making decisions about funding medicines on the NHS.MethodsA prospective design was employed to follow three pharmaceutical products involving three different appraisal committees. Three data collection methods were used: analysis of documentary evidence sent by NICE, non‐participant unstructured observations of the open and closed sessions of meetings and qualitative interviews.Settings and participantsUnstructured non‐participant observations were carried out at nine STA meetings, and 41 semi‐structured interviews were undertaken with committee members from NICE's STA committees, patient experts, analysts from NICE's project team and drug manufacturers.ResultsOur analysis showed how the committees displayed a preference for an ideal‐type of patient representative, disagreement among the committee when weighing‐up patient statements in the STA process and more pre‐preparation support for patient involvement.ConclusionsAlthough NICE has attempted to adopt an approach flexible to patients and carers through formal decision‐making arrangements that incorporate patient views, nonetheless, the processes of the STAs can in fact undermine the very evidence collected from patient representatives.
Highlights
The role of the National Institute for Health and Care Excellence (NICE) is to improve the quality of health and social care in England, including making recommendations about the value-for-money of new and existing medicines
This paper considers how NICE Single Technological Appraisal (STA) committees attempt to incorporate the views of patients in making decisions about funding medicines on the NHS
The study used an ethnographic research approach using three distinct methods of data collection: first, an analysis of documents released by NICE on each drug/therapy made available to the public online, documents submitted by the pharmaceutical company and review documents prepared by independent academic advisors
Summary
The role of the National Institute for Health and Care Excellence (NICE) is to improve the quality of health and social care in England, including making recommendations about the value-for-money of new and existing medicines The goal behind this latter task is to assure the consistency of equitable access of drugs to patients across the entire NHS, as well as to ensure the efficient use of public finances by regulating NHS consumption of expensive drugs, and evaluate “novel” medicines against the criteria of cost-effectiveness.[1,2] Through NICE, the Department of Health has sought to regulate the introduction of new and existing medicines and treatments within the NHS, basing its decisions on a review of clinical and economic evidence principally, at least for single technological appraisals (STAs), provided by the drug manufacturer.
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