LVAD as destination therapy in Belgium: unmet needs and political bias

Abstract

Abstract Objective To determine the impact, unmet needs and the role of left ventricular assist device (LVAD) treatment as destination therapy (DT) of heart failure (HF) in Belgium. At the moment, LVAD is only approved as “bridge to transplant” since health economical analysis calculated an unacceptable high price per QALY (84.00€). Design Retrospective epidemiological study on HF. Setting and parameters Parameters in advanced HF for Belgium, the UK (both non-DT adopters), Germany and the Netherlands (DT policies) are compared. Heart transplant (HTx) rates were consulted from (inter)national transplant organisations; implantation rates were requested from the 2 manufacturers.To quantify the impact of HF in Belgium, indirect measures on hospital admission were obtained by using the International Codes of Disease. Equity between HF and oncology was assessed by analysing approval of novel treatments. Timeframe is from 2009 till 2018. Results The last 10 years, mean HTx rates per million inhabitants are 6.8 in Belgium, 3.8 in Germany, 2.4 in the Netherlands and 2.5 in the UK. Transplant waiting lists are progressively exceeding the number of transplants – except in Germany. Combination of HTx and LVAD use show distinct patterns in advanced HF, with a 3-fold difference between the highest user (15,1: Germany in 2017) compared to the lowest user (4,9: UK in 2016). The need for advanced HF therapies is calculated at 14.9 per million. 8 additional LVAD implants were required in Belgium in 2018 to reach this goal. ICDcodings in Belgium show an upwards trend, indicating that the burden of HF is increasing in Belgium. Cardiovascular diseases are still the most important cause of death in Belgium according to the latest OECD report. From 2009 till 2016, 100 new cancer drugs were approved by the EMA. Only 18 of them showed a significant survival benefit as compared to standard treatment. From them, only 1 (trastuzumab) was evaluated in a health economical assessment for the Belgian health care system. Conclusions There is a growing discrepancy between supply and demand in advanced HF in Belgium. The additional number of LVADs and associated impact on total healthcare expenditure is calculated to be low due to a successful HTx program. LVAD as DT should therefore be considered to cover the needs for the Belgian population. The Netherlands and the UK are adopting “opt out” default organ donation legislations in 2020, and this could decrease the demand-supply mismatch in advanced HF. The lack of robust epidemiological data in HF could be the cause of political bias towards oncology as compared to cardiology. The ESC should therefore strive to improve registration of LVAD use to better monitor changing health care needs, promote epidemiological research and facilitate interaction with policy makers. Figure 1 Funding Acknowledgement Type of funding source: None