Sacubitril/Valsartan (LCZ696): A Novel Treatment for Heart Failure and its Estimated Cost Effectiveness, Budget Impact, and Disease Burden Reduction in Germany

Abstract

Background

Heart failure affects over 1 million people in Germany and contributes to morbidity, mortality, and high healthcare costs. A recent large randomized controlled trial compared the novel compound sacubitril/valsartan (LCZ696) with the angiotensin-converting enzyme (ACE) inhibitor enalapril and found a 16% reduction in mortality hazard. In Germany, sacubitril/valsartan was launched at the beginning of 2016.

Objective

The purpose of this study was to conduct a post hoc analysis of the cost effectiveness, budget impact, and disease burden reduction of sacubitril/valsartan compared with ACE inhibitors for patients with heart failure from the perspective of the German social health insurance (SHI), based on the results of this trial.

Methods

A Markov (cohort) state transition model was constructed to simulate treatment over a remaining lifetime. Based on the Markov model, a dynamic population model was developed that projects the incidence, prevalence, mortality, and healthcare costs of heart failure in the SHI population from 2017 to 2060. The population model follows prevalent and incident cohorts over time. Each year a new cohort is added, while the existing cohorts age by 1 year or die. To test for sensitivity of results, a Monte Carlo simulation was run.

Results

Based on the price negotiated between manufacturer and representatives of the SHI, the base-case incremental cost-effectiveness ratio (ICER) of sacubitril/valsartan versus ACE inhibitors is €23,401 per life-year gained (in 2018 Euros). At a price of zero, the cost-effectiveness ratio is already €9594 per life-year gained due to high background costs of heart failure. Annual budget impact and reduction of disease burden reach a maximum at 4–8 years after launch (€221 million and 2.9%, respectively, in the base case).

Conclusions

The ICER of sacubitril/valsartan is projected to be at or below the level of other accepted interventions for the treatment of asymptomatic to severe heart failure in Germany. Projected budget impact leads to an increase in SHI expenditures by < 0.04% per year.

Appendix 1

Calculation of the probability of death under enalapril at age 65 years under real-world conditions

$$p_{\text{real world}} = p_{\text{trial}} \cdot \frac{{\sum\nolimits_{i = 1}^{4} {{\text{RR}}_{i} \cdot f_{{i,{\text{real world}}}} } }}{{\sum\nolimits_{i = 1}^{4} {{\text{RR}}_{i} \cdot f_{{i,{\text{trial}}}} } }},$$

where $p_{\text{trial}}$ is the probability of death under enalapril at age 65 years in the PARADIGM-HF trial, $i$ is the New York Heart Association (NYHA) class, ${\text{RR}}$ is the ‘rate ratio’ of the MAGGIC risk score (NYHA class II was set to 1.0) [3], and $f$ is the fraction of patients.