PARIS – France’s Medical Device and Health Technology Evaluation Committee (CNEDiMTS), has published it latest annual activity report. This committee of the French National Authority for Health (HAS) evaluates medical devices with a view to their coverage by L’Assurance Maladie, the body which manages health care in France. “We are helping define the place of health care technology in France’s therapy, diagnostic and prevention strategy,” Isabelle Adenot, member of the HAS board and president for the last three years of CNEDiMTS, told BioWorld.

The committee’s latest annual report covers 308 verdicts issued in regard to 276 medical devices assessed with a view to their reimbursement. This is an increase of 78% over four years. “This number of verdicts issued represents the most Saint Denis, France-based CNEDiMTS has ever seen. We owe this impressive progress to efforts made with productivity when investigating cases in a very dynamic sector,” said Adenot.

Therapy sectors affected

Roughly 62% of the verdicts issued by the French committee involved initial applications and hence new medical devices. These initial applications have increased by 32.66% over the past two years. The majority of verdicts issued by CNEDiMTS (76%) relate to, in order of importance: orthopedic surgery and trauma (21%), interventional cardiology (14%), occupational therapy and equipment (12%), ENT disorders (11%), vascular surgery (9%) and cardiac rhythmology (9%). Diabetes management, interventional radiology, ophthalmology and urology each account for 3% of verdicts issued relating to reimbursement of medical technology in France.

The 29 members of the committee – surgeons, pulmonologists, engineers, pharmacists, radiologists, oncologists, dermatologists, diabetes clinicians, occupational therapy methodologists, nurses and user representatives – evaluate the performance expected or provided by a medical device. “Where the expected performance is adequate, they then specify the level of improvement in performance expected or delivered, according to five categories: lacking, minor, moderate, significant or major,” said Adenot. Adequate or inadequate performance is thus used to determine whether a medical device should be reimbursed or not. The classification into five levels of improvement has an impact on setting the price for the medical device, which manufacturers negotiate with the French health care products finance committee (CEPS).

Early dialogue for medical devices

CNEDiMTS has, over the last three years, recommended reimbursement for three out of every four med-tech applications. The exceptional increase in recognition for innovative medical technology is new, and something of a novelty. In one year, eight times more medical devices have been given the status of significant performance improvement expected. “Last year, 20% of reimbursement applications were able to achieve level 2, which refers to therapeutic progress. There is plenty of innovation in medical technology,” said Adenot.

Over the past three years, 76% of verdicts given refer to claims and assertions from med techs submitting dossiers considered by CNEDiMTS to be “well-argued, with a good level of evidence.”

“Sharing good practice, interaction, and establishing interfaces with medical technology manufacturers lie at the heart of the objectives behind my mandate,” said Adenot. Five types of meeting have been established to help manufacturers prepare dossiers as early as possible for submission to CNEDiMTS. Last year, the committee arranged information seminars, quarterly meetings with the French national association for the medical technology industry (SNITEM), 40 individual strategy meetings between manufacturers and the chair of CNEDiMTS, 20 early-stage meetings with the technical teams at HAS, and 20 pre-filing meetings with administrative departments. So many interaction opportunities make it possible to streamline the assessment process for medical technology with a view to its reimbursement in France. As a result, the average time taken to process initial registration applications is 88 days.

‘Forfait Innovation' ‒ an inspired bet for medical technology innovation

Over the past three years, HAS encouraged medical technology manufacturers to use the innovation deal. “This French scheme enables a med-tech to obtain financial support for a medical device as soon as a clinical or medico-economic study is set up that will establish proof of its effectiveness. This is an inspired bet, ”said Adenot. HAS, which assesses applications through CNEDiMTS, simplified the procedure, making dossier filing electronic by using its Sesame remote platform. HAS supports manufacturers and distributors in their approach thanks to early-stage meetings and pre-filing meetings.

This temporary finance scheme, which offers French patients access to technology at an early stage in its development, with or without CE marking, was agreed to by the ministers responsible for health and social security after consulting CNEDiMTS. Since 2015, 29 dossiers were received by HAS, and 57% of dossiers were eligible last year. This represents an annual increase of 50%.

For the last eight months, the Ministry of Health, like the HAS, has worked to tight deadlines of 75 days in total. HAS decides on the administrative and technical validity of the dossier, while the Ministry of Health assesses the estimated budget and overall cost if taken on by the Ministry of Health.

A decree published at the end of 2019 makes it possible to provide early support in France for specific medical technology demonstrating disruptive innovation intended to treat a serious or rare disease, “where there is no relevant comparator as concerns proven medical knowledge and where developing treatment cannot be postponed without presenting a serious and immediate risk to the health of patients.”

A turning point for connected medical devices and digital therapeutics

The last year also marked another turning point: the rise of connected medical devices and the emergence of digital therapeutics (DT) using emerging artificial intelligence. “This is why we have initiated a project to evaluate digital health care tools,” said Adenot. CNEDiMTS published a paper seven months ago recalling the specific aspects of evaluating connected medical devices with a view to their reimbursement. Indeed, manufacturers should demonstrate, depending on the device’s intended purpose, its therapeutic or diagnostic value, or how it compensates for disability, as well as its value to public health.

“The aim of this paper is to help manufacturers integrate clinical studies into their development strategy, which make it possible to determine the benefit of the connected medical device with a view to its reimbursement,” said Estelle Piotto, project manager at the medical devices evaluation department. The specifics of the clinical evaluation of connected medical devices mainly involve the very high speed at which technology is evolving, integrating expert decision-making systems that are sometimes self-learning, and the multiple interactions they allow between patients, caregivers and other devices. This requires the system to be evaluated in use.

“Particularly for systems providing data processing, we need an additional description to distinguish from medical devices not equipped with such technology,” said Cyril Olivier, also a project manager for health care technology assessment at HAS. The manufacturer should therefore include in his dossier all information explaining how the algorithm is constructed, and guarantee that the system will continue to perform over time.

CNEDiMTS has issued two verdicts concerning artificial intelligence applications, one for the mobile terminal and DBLG1 software for patients with diabetes, manufactured by Diabeloop, and the other for the Moovcare app for remotely monitoring patients with lung cancer from Israeli company Sivan Innovation Ltd. This latter struggled for a year before obtaining approval on July 29th, setting the rate for six months’ treatment at €1,000 (US$1,186). This is the first remote monitoring software to be reimbursed in France.

CNEDiMTS continues to adapt its assessment process for DT. “From October, 2020, the DT dossier submission paper will be expanded with a specific functional assessment grid. We are currently continuing our work on taking into account the organizational impact of DT on the health care system,” said Adenot.

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