In 2019, Nuvaira was accepted into a unique program developed by the Haute Autorité de Santé (HAS, the French health technology assessment agency), the Forfait Innovation Program. We spoke to Nuvaira’s CEO Dennis Wahr to learn more.
Can you summarise the Forfait Innovation Program and its objectives?
The Forfait Innovation is a program to expedite market adoption and reimbursement for innovative medical therapies. It represents a novel approach to industry engagement by providing financial subsidy and establishment of coding infrastructure to allow for additional data to be collected in France. The concept is one of an “enlightened wager” on therapies with high likelihood of clinical benefit and improved quality of care.
What are the requirements to apply for the program?
The program requirements are quite strict. The therapy must address an unmet medical need from the French Ministry of Health’s perspective, which means it must be supported by key opinion leaders in France. The therapy must have completed feasibility trials with sufficient data to demonstrate safety and potential benefit. Finally, the industry partner must offer a study protocol which the Ministry of Health believes will confirm clinical effectiveness and longer-term outcomes.
What made Nuvaria a good candidate for the program?
Nuvaira’s clinical development program was ideally suited for the Forfait Innovation. Nuvaira had invested in robust, well-designed, and published feasibility trials which demonstrated safety and a compelling efficacy signal in a population with established unmet need (COPD patients at risk for future exacerbation). Nuvaira had built relationships with pulmonary thought-leaders in France who were willing to partner with Nuvaira in the Forfait Innovation process. And Nuvaira offered the AIRFLOW-3 protocol which was validated by the Ministry of Health with its acceptance of TLD into the Forfait Innovation program.
What does the Forfait Innovation Program acceptance mean for Nuvaira in the future?
The Forfait Innovation establishes the AIRFLOW-3 trial as a national healthcare priority in France and shines a national spotlight on the challenges of COPD management and on TLD as a potential therapeutic solution. Importantly, once AIRFLOW-3 enrolment has ended, the Forfait Innovation program will continue to subsidize treatment of patients who meet AIRFLOW-3 criteria until the pivotal trial data are available, meaning that today’s investment in developing TLD referral networks in France will not be disrupted by conclusion of trial enrolment. This continued access to the market is the most valuable aspect of the Forfait Innovation for Nuvaira. In the mid-term, we anticipate announcement of a transition to permanent, national reimbursement in France based solely on outcomes of the AIRFLOW-3 trial. Because the procedure and device codes and payment flows between government, hospitals and Nuvaira will have already been established, we expect a rapid and seamless transition to the commercial phase of our business.