• There is a need to adjust HTA decision frameworks to ensure that the patent-centric benefits of value added medicines can be appropriately assessed.
  • Robust research on adjusted methodologies and health technology assessment policy frameworks is key to ensure patient access to value added medicines in Europe.
  • The Value Added Medicines Group is committed to working with patients, healthcare professionals, policy makers and payers to improve sustainable access to this innovation.

A new study “Value Added Medicines: Time to Adjust the HTA Decision Frameworkswas launched today in Brussels with the support of the Value Added Medicines Group, a sector group of Medicines for Europe. The study, conducted by Mondher Toumi, Professor of Public Health at Aix-Marseille University, highlights the need for adjustments in HTA decision frameworks to ensure that European patients can benefit from value added medicines. Professor Mondher Toumi emphasised that “value added medicines represent an opportunity for increasing the cost-effectiveness of treatments or services that may bring substantial value to individual patients and society. However, the current European HTA decision frameworks represent various challenges for the full value recognition of these products, which need to be addressed.

According to the study, which counted on the important feedback of key HTA experts across Europe, value added medicines make a major contribution to patients’ quality of life, health outcomes or adherence, and address a number of medicine-related healthcare inefficiencies, improving healthcare provision and organisation while contributing to the sustainability of healthcare systems.  The study underlines the importance of the eligibility of value added medicines for HTA, whenever requested, in order to demonstrate these relevant improvements. There is a need to adjust HTA decision frameworks to ensure that all benefits of value added medicines are appropriately captured and to ensure a patient-centric assessment. The manufacturers of value added medicines should also have the opportunity to get early HTA advice in order to better shape their clinical development plan. Professor Toumi commented that “taking into consideration the specific benefits of value added medicines will need efforts both on the research and policy fronts, but also the involvement of a broad range of stakeholders in the decision-making process”. Ten key recommendations are put forward in the report to ensure that value added medicines can be rightfully assessed by HTA decision frameworks in the future.

Umberto Comberiati, Chair of the Value Added Medicines Group ad interim, commented: ‘Research on known molecules is a valuable untapped opportunity for European patients and healthcare professionals alike. There is an urge to support research and adjust the HTA policy frameworks to encourage industry to invest in medicines with high potential value to patients and society and capitalise on healthcare professionals’ expertise. We are ready to work together with patients, healthcare professionals, policy makers and payers on how to ensure patients can benefit from value added medicines in Europe.”