In 2015, the French National Authority for Health (HAS) published a report of the assessment of risk/benefit ratio of fractional flow reserve measurement during coronary angiography in comparison with coronary angiography without FFR measurement in patients with suspected stable angina or acute coronary syndrome. The evaluation was initiated by the application from the French Society of Cardiology.
Review of evidence showed that FFR measurement has a favorable risk/benefit ratio in patients with stable coronary disease in cases of multi-vessel lesions or intermediate lesions where previous examinations could not be performed. In the same time, no conclusions were possible to be drawn in relation to risk/benefit ratio for use of FFR measurement during coronary angiography in patients with STEMI or NSTEMI.
Then in the beginning of 2017 two FFR devices (Verrata & Verrata More, Philips Volcano; Pressurewire (Certus - Aeris – X), St Jude Medical) received a positive assessment by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) with moderate improvement vs. standard of care (ASA level III). Add-on reimbursement has not been formally established yet (negotiation about pricing level takes place after the recommendation of CNEDiMTS).
In June 2017, new FFR guidewire Comet (Boston Scientific) was positively evaluated by CNEDiMTS for inclusion into LPPR List (for 3 years) with ASA level as V (no improvement) in comparison to other FFR devices for following indication:
- FFR measurement during coronary angiography in stable coronary artery disease, multivessel lesions or mono-lesions with intermediate stenosis, when preliminary myocardial ischemia tests cannot be performed or contraindicated
It should be noticed that there were no clinical data specific to Comet submitted by the applicant and this device was approved on the basis of technical equivalence with other FFR devices. This is unusual for brand-specific applications, for which either equivalence or superiority should be demonstrated using clinical evidence.
When reimbursement for FFR guidewires is formally established, important insights can be developed for all participants on the French market. MTRC will keep its auditory updated about potential considerations related to LPPR List brand-specific applications for me-too products.
See decision by CNEDiMTS for Comet in French here.
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