Preliminary Favorable Opinion on Conditional Coverage of Robotic-Assisted Bronchoscopy in France

The assessment concerns the use of robotic-assisted bronchoscopy in patients requiring a biopsy of a small peripheral pulmonary nodule (≤20 mm) suspected of lung cancer.

HAS considered the technology innovative, with potential clinical benefit in diagnosing small or difficult-to-access peripheral pulmonary nodules. However, the authority identified several methodological limitations in the proposed evidence-generation study protocol.

The applicant is required to revise the protocol in accordance with HAS's comments and submit the amended version within 30 days of receiving the opinion. HAS will subsequently issue a second opinion following its review of the revised protocol.

The Forfait Innovation program, established in 2015, is a French conditional coverage mechanism designed to support early access to innovative medical technologies while generating additional evidence required for regular reimbursement. The program covers medical devices, medical procedures and in vitro diagnostic technologies. The objective of the program is to provide early support for breakthrough innovations and generate the missing evidence needed for regular reimbursement. The scheme involves a government-co-sponsored study. The budget comes from three sources: the Ministry of Health (experimental arm), regular statutory health insurance (control arm), and an applicant (study infrastructure).

Eligibility for Forfait Innovation is assessed by HAS against several criteria, including the innovative nature of the technology and the methodological appropriateness of the proposed clinical study protocol.

A favorable HAS opinion does not constitute a final coverage decision. The Ministry of Health is responsible for the final decision following HAS's assessment.

What does it mean for the industry?

The preliminary favorable opinion represents an important development for robotic-assisted technologies in France, where robotic surgery lacks formal recognition within the reimbursement system. As the first potential Forfait Innovation project involving robotic surgery, this case could provide an early indication of the potential role of Forfait Innovation as a market-access and evidence-generation pathway for robotic-assisted and other innovative invasive technologies in France. The outcome of this case may provide further insights into the pathway's opportunities and limitations.

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