OBJECTIVES: Health Technology Assessment (HTA) frameworks used to assess new heath technologies vary between countries; some countries focus on clinical assessments (e.g. Germany), other countries focus on clinical efficacy and health economics evaluation (e.g. France and Canada). This study aimed to identify and compare HTA decisions for oncology products across France, Germany, and Canada.

METHODS: Oncology drugs approved in Europe between January 2015 and March 2018 were identified from the European Medicines Agency website. HTA decisions available for these products in France, Germany, and Canada were downloaded from HTA bodies websites and reviewed to identify HTA decisions and the main limitations criticized by HTA bodies.

RESULTS: Forty-two oncology products were approved in Europe. Canada’s HTA agency assessed 13 products and did not give any positive recommendations: 9 products were recommended with limitations and 4 products were not recommended. The main limitations were related to clinical efficacy, safety data, budget impact, economic model, and inappropriate extrapolation of immature overall survival data. In France, the French health authority did not issue any negative decision, 8 products were recommended with limitations and 8 products were recommended. Germany assessed almost half of the products: only 2 products had not been recommended, 13 products recommended with limitations and 8 were recommended. In France and Germany, the data challenged were mainly clinical efficacy, safety data, inappropriate trial design (open, label, non-comparative trial, inappropriate comparator, etc.), quality of life data, and transferability/generalizability.

CONCLUSIONS: New drugs in the field of oncology are increasingly being approved by regulators based on immature clinical data, leading to high uncertainty of the value for the payers and making HTA decisions uncertain. This uncertainty contributes to the divergence in HTA decisions as aversion to risk varies dramatically between agencies in different countries.