Modification of the reimbursement conditions for circulatory assistance devices (DACM)
July, 19th: The HAS has updated the reimbursement conditions of long-term mechanical circulatory assistance devices (DACM*).
Active implantable medical devices of long duration of use (≥30 days) intended to supplement a major failure of the heart pump. These devices are used either for a temporary period while awaiting transplantation or myocardial recovery, or as definitive therapy (for patients not eligible for transplantation) in situations of heart failure (HF) with acute or chronic advanced life-threatening failure.
DACM currently registered on the LPP are:
- Intra-corporeal assist devices, single left ventricular, continuous flow: HEARTMATE III (ABBOTT), HEARTMATE II V2 (ABBOTT), HEARTWARE HVAD (MEDTRONIC), JARVIK 2000 (IST CARDIOLOGY),
- Mono or biventricular paracorporeal assistance devices with pulsatile flow: EXCOR (BERLIN HEART),
- orthotopic, biventricular, pulsatile flow assistance devices (total artificial heart): SYNCARDIA 70cc (IST CARDIOLOGY).
The evaluation of mechanical circulatory assistance in 2008 had led the HAS to validate and recommend its management by justifying a high level of therapeutic progress and an ASA I in relation to the absence of alternative, in indications of acute mono or biventricular failure in heart failure patients.
Given the data available after 10 years of DACM use and in particular the long-term results of the FRANCEMACS post-market study, evolutions of the recommendations published in 2008 are proposed.
This report also comes in the context of the simultaneous renewal of the registration of all the DACM currently registered on the LPP list.
The major points that emerge from this report:
Indications and contraindications
- No change in the indications retained in 2008.
- Possibility of implanting a patient aged 70 years or more under certain conditions: decision taken after multidisciplinary consultation and reflection including an opinion from an ethics committee, in order to select only those patients who can expect sufficient benefit.
- Elective situation: precision of the INTERMACS severity level for patients with advanced chronic heart failure with mono or bi ventricular failure, when life is threatened despite optimal treatment.
- Accredited cardiac transplant centers with experience and competence in long-term DACM implantation are to be kept as Level 1 category centers.
- Reinforcement of multidisciplinary management by giving full importance to the "Heart team", specialized in cardiogenic shock.
Minimum data requirements for future brand name claims
- No change in the clinical data requirements for renewal applications.
- For the listing of new DACM, CNEDIMTS expects the submission of specific comparative data.
- The current population reached is between 200 and 250 cases per year, all types of DACM combined.
- The target population for DACM is between 780 and 4,120 patients per year.
The report also highlighted a persistent French "underutilization" of this technology compared with other countries with, in particular, a later implementation of DACM in terms of profile severity.
For your convenience, please find the report link below: