France: An update on the transitional reimbursement mechanism for medical devices  

The aim of the transitional reimbursement mechanism (PECT) launched in February 2021, was to allow reimbursement of medical devices for a period of one year, the time required to collect results of clinical studies necessary for conventional reimbursement, whilst enabling rapid access to innovations for patients with a rare or serious disease. 

To be eligible medical devices obtaining transitional coverage are presumed to be innovative, falling within the scope of the List of reimbursable Products and Services (LPPR) and must meet the following prerequisites: 

1. CE marked 
2. Not already covered by LPPR 
3. Manufacturer must undertake an application for registration with the LPPR for the respective medical device within 12 months of its application to PECT 

The submitted application to Ministry of Health is assessed by the National Commission for the Assessment of Medical Devices and Health Technologies (CNEDiMTS), which determines whether the medical device meets the five eligibility criteria outlined below: 

1. Indicated for a serious or rare disease or compensates for a disability   
2. Meet a medical need that is not or is poorly covered   
3. Be likely to bring a significant improvement in the state of health or compensation for the patient’s disability which justifies rapid availability to avoid loss of opportunity 
4. Presumed to be innovative, presenting a novel mechanism in comparison to the health technologies used in the claimed indication  
5. Be likely, based on the results of clinical studies, to exhibit clinically relevant efficacy and significant effect in respect of which its potential adverse effects are acceptable  

Since February 2021, the French National Authority for Health (HAS) has recommended four medical devices are covered by the PECT, which are indicated in stable angina pectoris, uncontrolled arterial hypertension, intestinal insufficiency and symptomatic heart failure. On the other hand, an inability to demonstrate criteria 3 and 5 of the above list, has seen the refusal of transitional coverage to other devices. 

Currently, two applications for transitional reimbursement are under assessment by CNEDiMTS, highlighting the impact this new method of reimbursement is having in the field of medical devices. 

Sources 

1. https://www.has-sante.fr/upload/docs/application/pdf/2010-03/guide_dm_gb_050310.pdf ‘Pathway of medical devices in France’ 30/09/22 
2. https://www.has-sante.fr/jcms/p_3372157/en/innovation-point-d-etape-sur-le-mecanisme-de-prise-en-charge-transitoire-des-dispositifs-medicaux ‘Innovation – Progress report on the transitional reimbursement mechanism for medical devices’ 30/09/22