ASSESSMENT OF CLINICAL VALUE IN ONCOLOGY- COMPARATIVE ANALYSIS OF VALUE FRAMEWORKS AND HTAS
Author(s)
Niven C1, Hough NM2, Zhou AY1, Qin L3, Alexander R2
1IMS Consulting Group, Cambridge, UK, 2IMS Consulting Group, London, UK, 3IMS Consulting Group, Munich, Germany
OBJECTIVES: A number of non-profit organisations have recently developed frameworks to assess the value of pharmaceuticals in oncology. However, many countries in Europe already possess robust health technology assessment (HTA) processes. We therefore investigated whether assessments of clinical value align between frameworks and HTAs. METHODS: We applied the algorithm-based Magnitude of Clinical Benefit Scale (MCBS) and American Society of Clinical Oncology (ASCO) value framework (first version) to Phase III trials for novel oncology pharmaceuticals approved by the EMA from 2011-present, considering only launch indication. Data were extracted from product European Public Assessment Reports (EPARs), clinical trial manuscripts and Clinicaltrials.gov. Assessments by the French Transparency Commission (CT), German Federal Joint Committee (G-BA), UK National Institute for Health and Care Excellence (NICE) and Cancer Drugs Fund (CDF) were sourced from their respective websites. Assessments were standardised onto a four-point scale, generating a ‘clinical value score’ for each assessment, where a higher score represents greater clinical value. ‘HTA clinical value scores’ were produced by averaging CT and G-BA ‘clinical value scores’. RESULTS: The analysis included 40 products across 19 therapy areas. MCBS assessments showed greater alignment with HTAs than ASCO framework assessments. Considering only products with all assessments available, clinical value scores were 3-4 (‘moderately favourable’ to ‘favourable’) in 88% and 71% of assessments with the MCBS and ASCO frameworks respectively, compared to 37%, 44%, 34% and 44% of assessments by the CT, G-BA, CDF and NICE respectively. CONCLUSIONS: Overall, the frameworks produced more a favourable assessment of clinical value than HTAs. Frameworks, unlike HTAs, fail to account for totality of evidence, contextual factors or evidence quality, which may account for this discrepancy. Due to framework limitations, European payers will continue to leverage existing HTA processes in the short-term. However, payers with less robust assessment methods (e.g. sub-national payers) may consider framework scores among other factors.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PCN250
Topic
Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Prescribing Behavior
Disease
Oncology