HAS is the key decision-making body in relation to evaluation of sufficiency of clinical evidence to establish add-on reimbursement for medical devices, development of new procedure (CCAM) and clinical biology (NABM) codes in France. Annual report provides valuable insights into evaluation landscape for medical device and IVD tests. MTRC has extracted key facts related to assessment of medical technologies from the report.
Add-on reimbursement (LPPR list)
- In 2016, HAS evaluated about 150 medical devices for registration and renewal of registration for add-on reimbursement via LPPR list
- 108 devices were evaluated for the first-time registration for LPPR list
- Sufficient expected clinical benefit (service attendu, SA) was established for 87 (81%) of applications, of which only 6 devices (7% of positive assessments) received important level of added clinical value (which corresponds to level II)
- The expected clinical benefit (l’amélioration du service attendu, ASA) is rated from I to V. This rating considers changes in treatment, changes in mortality, morbidity and quality of life, and ease of use for patients. Level I indicates major improvement and level V indicates no improvement
- Sufficient expected clinical benefit (service attendu, SA) was established for 87 (81%) of applications, of which only 6 devices (7% of positive assessments) received important level of added clinical value (which corresponds to level II)
- 27 devices were evaluated for renewal of registration. Only in 2 (7%) cases improvements in level of added value were detected. None of devices received unfavorable opinion, so it was possible to maintain add-on reimbursement status for all of applicants
- 108 devices were evaluated for the first-time registration for LPPR list
- HAS started review of LPPR applications for invasive non-implantable medical devices
- 7 products were reviewed in 2016, including devices for mechanical thrombectomy for stroke, coronary balloons and peripheral balloons, catheters for bronchial thermoplasty. Up to 30,000 patients can benefit annually was use of these devices
Evaluation of medical procedures to support development of new procedure (CCAM) and clinical biology (NABM) codes
- HAS performed 21 evaluations of medical technologies, which resulted in 43 opinions about change of nomenclature of services
List of evaluated technologies, connected to creation of specific procedure (CCAM) codes:
- Bronchial thermoplasty for uncontrolled asthma
- Colonic capsule
- Alternatives to scintigraphy to diagnose pulmonary embolism in pregnant women
- Voluntary termination of pregnancy
- Dental prosthesis (bridges)
- Intraoperative radiotherapy in breast cancer
- Radiotherapy under stereotactic conditions for liver tumors
- Mechanical thrombectomy for stroke
- Non-invasive coronary imaging
- Transcutaneous laser occlusion of saphenous vein
- Organization and clinical implications of robot-assisted prostatectomy
- Cryoablation for cardiac fibrillation
- Assessment of adverse events after implantation of breasts implants
List of evaluated diagnostic tests, related to development of clinical biology (NABM) codes:
- Gene amplification of herpes virus in people with skin and mucosa manifestations
- Gene amplification of herpes virus in people infected with HIV
- Detection of Zika virus
- Detection of Epstein-Barr virus in the management of the undifferentiated carcinoma of the rhino pharynx
- Detection of meningococci and streptococci in diagnosis of meningitis
- Detection of virus or by serology test herpes virus in mother-child setting
- Diagnosis of Clostridium difficile infection
- Diagnosis of Plasmodium infection
Engagement with industry
- HAS was actively engaged into confidential meetings with industry to advice of requirements for submission of information in relation to LPPR applications
Health economic evaluations
- In 2016, HAS published methodological guidance for budget impact analysis, as part of health economics assessments, selectively requested for medical devices by Economic and Public Health Committee (Commission évaluation économique et santé publique, CEESP)
Support of redesign of payment system (DRG system)
- HAS issued three reports to support revision of reimbursement via diagnosis-related groups by ATIH, including
- Utilization of coronary endoprostheses in France in 2014
- Endovascular stents (aortic, renal, iliac and femoral)
- Management of complex wounds with negative wound pressure therapy
- HAS performed evaluation of cardiac valve prosthesis
Read full report in French here.
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