Horscroft J1, Casson J1, Sullivan W1, Ntais D2, Kiff C2, Tyas D2
1BresMed Health Solutions, Sheffield, UK, 2Bristol-Myers Squibb Pharmaceuticals Ltd, Uxbridge, UK
OBJECTIVES: A consistent approach to reimbursement decision-making at the National Institute for Health and Care Excellence (NICE) would add clarity for manufacturers developing submission materials and reduce the need for methodological adjustments during the technology appraisal (TA). Cancer immunotherapies, such as nivolumab, present a challenge to decision-makers, as they potentially provide substantial survival gains to a subset of patients beyond the usual duration of clinical trials, leading to greater uncertainty and the need for pivotal assumptions. Therefore, we set out to explore differences in decision-making approaches between previous NICE appraisals of nivolumab. METHODS: Publicly available data from all 10 completed NICE TAs of nivolumab were reviewed. RESULTS: Several themes were identified where variations in decision-making across appraisals were observed, including preferred assumptions around long-term treatment effect and survival, treatment duration, and patient utility. For example, preferred long-term treatment effect assumptions differed notably between appraisals for nivolumab in previously treated renal cell carcinoma (RCC) (TA417) and nivolumab and ipilimumab in untreated RCC (TA581). In TA417, the Committee “was willing to consider scenarios with predictions of better survival in its decision-making”, while in TA581, the Committee agreed with “removing the immunological effect” from the cost-effectiveness model, despite statements from clinicians supporting an immunological effect in both appraisals. CONCLUSIONS: These findings highlight key differences in decision-making approaches between NICE appraisals. Maintaining the freedom for NICE Committees to make independent decisions is important, as this prevents unjustified influence of precedent despite developments in evidence and methodology. However, inconsistent approaches may lead to slower, more costly appraisals and delays in patient access, impacting patient outcomes. Overall, greater use of NICE position statements to clarify Institute positions on issues that span multiple appraisals may lead to more desirable outcomes for manufacturers, Committees, and patients.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark