Résumé
Cancer is a growing burden, both in terms of public health and in terms of economy. At the same time, the therapeutic arsenal intended to treat cancer has evolved, and pharmaceutical companies have continued to innovate to offer more effective solutions, more adapted to the target population and with fewer side effects. To fund innovation, health systems have evolved towards a values-based approach. But, given rising health costs, and with a limited budget, it is essential for policy makers and payers to determine criteria for allocating the available health budget. To inform decision-making in order to promote an equitable, effective, and value-based health system, health technology assessment (HTA) emerged and evolved as a multidisciplinary process for determining the value of a drug. HTA is a tool used to manage financial and clinical uncertainty. In France and Germany, countries that are pioneers in the use of HTA, HTA agencies evaluate a new oncology drug based on its relative clinical effectiveness and/or efficiency in order to determine if this product offers the best cost-result. Access to these two European markets is therefore subject to a strict and rigid evaluation of clinical evidence and is not always accompanied by a high price to reward innovation and the medical need covered. Specific to each country, the methods used by HTA agencies can lead to differing pricing and reimbursement recommendations. Therefore, to commercialize a new oncology drug in these two countries, pharmaceuticals companies must not only consider regulatory requirements during development, but also generate evidence that meets the needs for HTA. Companies have refined their internal structures and development strategies to integrate these HTA perspectives into clinical development.