CV3 - COST-EFFECTIVENESS OF SACUBITRIL/VALSARTAN IN GERMANY: APPLYING THE EFFICIENCY THRESHOLD

Abstract

After sacubitril/valsartan was approved by the European Medicines Agency, pharmacoeconomic evaluations have been published for many European countries. However, no evaluation was published for Germany. The guidelines for pharmacoeconomic evaluations in this country differ fundamentally from most other European countries due to its focus on the efficiency threshold. We adapted a previously published model for the Dutch market to study the differences regarding the methodology and the conclusions that can be drawn by decision makers. A probabilistic Markov model was used to compare sacubitril/valsartan to enalapril for the treatment of heart failure patients with a reduced ejection fraction (HFReF). Clinical outcomes were simulated using data from the PARADIGM-HF trial and German costs data were incorporated using the healthcare payer’s perspective. Outcomes reported were the incremental cost-effectiveness ratio (ICER) and cost-effectiveness acceptability curve (CEAC). As specified by the German guidelines an efficiency frontier was created, using placebo as an additional reference drug. Additionally, to be able to assess the parameter uncertainty, a price-acceptability curve was created. The base case ICER is €16,000, with sacubitril/valsartan having a probability of cost-effectiveness of over 90% at a willingness-to-pay threshold of €30,000. For outcomes specifically constructed using the German guidelines, enalapril dominated placebo in over 55% of simulations, as enalapril is very inexpensive, reduces hospitalizations and prevents deaths. In the 45% of cases where an efficiency frontier could be constructed, sacubitril/valsartan was cost-effective in none of the simulated results. The price-acceptability curve showed that the probability of sacubitril/valsartan being cost-effective was around 25% if priced at the same level as enalapril. While sacubitril/valsartan can be considered cost-effective using internationally-used methods (e.g. ICERs and CEACs), the efficiency frontier, mainly used for Germany, results in the treatment not being cost-effective. This can lead to fundamentally different conclusions by decision makers.