Cost-Effectiveness of Sacubitril/Valsartan in Germany: An Application of the Efficiency Frontier

Abstract

Using the German HTA guidelines, the ICER is not taken into consideration. Instead, the efficiency frontier was introduced as an alternative, to avoid the use of QALYs and the setting of willingness-to-pay thresholds. • We conducted the first direct comparison of the German efficiency frontier methodology to the conventional ICER, using sacubitril/valsartan, a new treatment for patients with chronic heart failure with a reduced ejection fraction. • Sacubitril/valsartan has a favourable ICER in the German setting, comparable to other European countries. However, using the efficiency frontier, the results would inform decision makers that a considerable discount needs to be negotiated.

Sacubitril-Valsartan Compared With Enalapril for the Treatment of Heart Failure: A Decision-Analytic Markov Model Simulation in China

“…Several studies have compared the cost-effectiveness of Sac-Val and enalapril in developed countries. Owing to the high WTP threshold, Sac-Val is cost-effective in countries like United States ( Gaziano et al, 2016 ; King et al, 2016 ; Sandhu et al, 2016 ), Netherlands ( van der Pol et al, 2017 ), United Kingdom ( McMurray et al, 2018 ) and other European countries ( Zanfina et al, 2017 ; Gandjour and Ostwald, 2018 ; McMurray et al, 2018 ; van der Pol et al, 2019 ), even with high estimated ICERs. In contrast, opposite conclusions were drawn in similar studies conducted in Singapore ( Liang et al, 2018 ) and Thailand ( Krittayaphong and Permsuwan, 2018 ).…”

“…Apart from the therapeutic effects, the results from PARADIGM-HF have also been used for evaluating the economic viability of Sac-Val ( Liu et al, 2020 ), especially in the developed countries ( Gaziano et al, 2016 ; King et al, 2016 ; Sandhu et al, 2016 ; van der Pol et al, 2017 ; Zanfina et al, 2017 ; Gandjour and Ostwald, 2018 ; Krittayaphong and Permsuwan, 2018 ; Liang et al, 2018 ; Zueger et al, 2018 ; Park et al, 2019 ; van der Pol et al, 2019 ). Owing to the high willingness-to-pay (WTP) threshold, Sac-Val is likely to be cost-effective compared to enalapril in United States ( Gaziano et al, 2016 ; King et al, 2016 ; Sandhu et al, 2016 ), United Kingdom ( McMurray et al, 2018 ) and some other European countries ( Zanfina et al, 2017 ; Gandjour and Ostwald, 2018 ; McMurray et al, 2018 ; van der Pol et al, 2019 ) despite the higher acquisition cost. However, few studies have evaluated the pharmaco-economics of Sac-Val in the low and middle-income Asian countries.…”

Defining Comparators According to IQWiG’s Efficiency-Frontier Method

“…Van der Pol et al 1 present a decision model that assesses the cost-effectiveness of sacubitril/valsartan compared with both enalapril and candesartan (plus concomitant therapy in each arm) for patients with heart failure in Germany. To this end, the authors apply the efficiency-frontier (EF) method, which was developed by the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) to inform negotiations on reimbursement prices in the German social health insurance system (according to §130b (8) Sentence 3 Social Code -Book V).…”

“…Regarding other approved drugs for heart failure such as diuretics and beta-blockers, the authors state that "these treatments cannot really be considered true alternatives in the context of the EF and were therefore not included as comparators to sacubitril/valsartan." 1 Nevertheless, the IQWiG's methods paper is unambiguous on this issue. On page 103 of the English version, 4 it discusses "2 special constellations in which, despite complete information, a recommendation for a new intervention cannot be directly inferred on the basis of the efficiency frontier."…”

“…We would like to thank the author for taking the time to formulate a response to our article. 1 It raises an important topic, namely, the choice of comparators when applying the German efficiency frontier (EF) approach. In any economic evaluation, defining the comparators will greatly influence the results and conclusions.…”