ANALYSIS OF RECENT APPROVALS OF IMMUNO-ONCOLOGY DRUGS ACROSS ENGLAND, SCOTLAND, GERMANY AND FRANCE
Author(s)
Ziomek J1, El Mouaddin N2, Ng T1, Ovcinnikova O1, Taveau C3
1Mapi, London, UK, 2Mapi Group, Nanterre, France, 3Mapi, Nanterre, France
OBJECTIVES: Immuno-oncology (IO) is a rapidly evolving therapeutic area with promising clinical results. There are several hurdles that new IO drugs experience, such as failing to demonstrate overall survival and managing high budget impact. This research aims to explore recently appraised IO drugs in England, Scotland, Germany and France by their respective health technology assessment (HTA) bodies to identify key drivers behind their recommendations. METHODS: All publicly available appraisal reports from the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Agency (SMC), the Federal Joint Committee (G-BA) and the French National Authority for Health (HAS) between 1st January 2015 and 17th May 2017 for IO drugs were identified, from which clinical, health-economic outcomes and final decisions were extracted. RESULTS: Six IO technologies were assessed: 11 appraisals were completed by NICE, 15 by SMC, 14 by G-BA and 12 by HAS. Eight matched condition-intervention pairs were identified and recommended by HTA bodies. The decision was largely based on clinical effectiveness evidence (overall and progression-free survival) and the substantial unmet need addressed by the IO drug. Other factors contributed to the decision: patient access schemes and the views of patients’ representatives (SMC). For the economic assessment, significant differences of incremental cost-effectiveness ratios (ICERs) were found between several HTA bodies despite a similar final decision. The main reservations were related to the robustness of clinical and health economic analysis, the extrapolation methods of survival data and the justification of treatment costs CONCLUSIONS: Based on the provided evidence, the European HTA bodies tend to evaluate IO drugs favourably, potentially due to the high unmet clinical need and other influencing schemes allowing expedited access. Some reservations/weaknesses were highlighted which may be used by pharmaceutical companies to improve the quality of future HTA submissions and increase chance of successful reimbursement.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCN22
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology