HeartMate 3 is an implantable left ventricular assist system device used as destination therapy, bridge to transplant or as bridge to recovery in patients with advanced heart failure.
HeartMate 3 was CE-marked in 2015 and first evaluated for add-on reimbursement in France in 2016. In 2016, the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) at National Authority for Health (HAS) performed first assessment and released negative decision in relation to inclusion of HeartMate 3 device into LPPR list.
The CNEDiMTS considered expected service (SA - first objective of the health technology assessment; second objective is to determine level of added value vs standard of care) as insufficient for HeartMate 3 due to lack of data transposable to the French situation.
The CNEDiMTS considered that degree of heart failure of the population included in the provided studies does not correspond to the profile of patients requiring ventricular assistance in France. It was noticed that this procedure is mainly proposed in France to patients waiting for a transplant. The data from prospective study of evaluation of efficacy and safety of HeartMate 3 device on French representative population including patients with INTERMACS 2 and 3 profile during at least 6 months was needed.
Second application for LPPR registration by St Jude Medical (now Abbott) provided evidence from two additional studies:
- Randomized controlled trial vs HeartMate II (MOMENTUM 3): was conducted in 69 centers in USA
- 294 patients were randomized
- The primary end point was a composite of survival free of disabling stroke (with disabling stroke indicated by a modified Rankin score >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove the device at 6 months after implantation
- In the intention-to-treat population, the primary end point occurred in 131 patients (86.2%) in the centrifugal-flow pump group (HeartMate 3) and in 109 (76.8%) in the axial-flow pump group (HeartMate II) (absolute difference, 9.4 percentage points; 95% lower confidence boundary, −2.1 [P<0.001 for noninferiority]; hazard ratio, 0.55; 95% confidence interval [CI], 0.32 to 0.95 [two-tailed P=0.04 for superiority])
- There were no significant between-group differences in the rates of death or disabling stroke, but reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (1 [0.7%] vs. 11 [7.7%]; hazard ratio, 0.08; 95% CI, 0.01 to 0.60; P=0.002)
- Suspected or confirmed pump thrombosis occurred in no patients in the centrifugal-flow pump group and in 14 patients (10.1%) in the axial-flow pump group
- Registry-based observational (ELEVATE), which was conducted in 50 centers including two centers in France
In the end of May of 2017, new submitted evidence allowed CNEDiMTS to conclude that HeartMate 3 device can be included into LPPR list for claimed indication.
The size of the target population is about 800-2000 patients annually.
Next step is pricing negotiation and decision. Start of reimbursement for the device can be expected in 1-1.5-years.
Interestingly enough, no added value was established by CNEDiMTS for HeartMate 3 vs early version of device, the HeartMate II. It means that it is unlikely that HeartMate 3 can receive better price in France compared with HeartMate II. Currently, HeartMate II has an add-on reimbursement tariff of 87,565 euros (LPP code 3414860)
This case study gives an interesting insight into how reimbursement authorities consider incremental improvements from developing medical technologies. Continuous improvement is an essential feature of medical device industry, but reimbursement authorities do not necessarily accept technologies and clinical improvements and do not translate them into reimbursement policies.
See full-text decision of first assessment in French here.
See full-text decision of second (latest) assessment in French here.
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