HTA Quarterly | Summer 2019

Precision medicine has rapidly evolved in the field of oncology, with therapeutic interventions being specifically selected to target molecular features associated with malignancy. Although cancer genome sequencing is a relatively new endeavor, it already has great potential to impact the clinical care of patients with cancer from diagnosis through treatment. For this reason, it is important to understand the current reimbursement climate for genetic testing within oncology—in particular, next-generation sequencing (NGS).

Before being assessed by the Haute Autorité de Santé (HAS) committees, all medicinal products have to receive regulatory approval from the European Medicine Agency (EMA) or the local regulatory agency (Agence Nationale de Sécurité du Médicament et des produits de santé—ANSM). We examine the changes coming for the reimbursement and price of medicinal products in France.

Recent substantial advances in molecular diagnosis and testing of cancer, along with exponential growth in data-mining capabilities, have led to the development of targeted classes of therapeutic agents expected to confer benefit to patients whose cancer displays specific genetic molecular features. These molecularly tailored therapies are broadly termed precision or personalized medicine, and they facilitate the delivery of “the right medicine, at the right time, to the right patient.” We examine the challenges HTA bodies face following regulatory approval of these therapies.

With the rise in technological innovation and evolving treatment pathways, there is even greater need for early collaboration and dialogue among industry, patients, and regulatory/reimbursement bodies. The future of health technology assessments (HTAs) is also uncertain with the current emphasis in Europe on harmonization of processes across European Union states calling for joint clinical assessments. This requires manufacturers to adapt to legislative changes and carefully consider appropriate comparators across markets. Given this context, this article discusses how an early, forward-looking indirect treatment comparison (ITC) feasibility study can help to overcome some of the challenges in the era of complex technologies and an uncertain HTA landscape to optimize patient access to safe and effective treatment.