Decision making in Germany: Is health economic evaluation as a supporting tool a sleeping beauty?

Gerber-Grote, Andreas; Sandmann, Frank; Zhou, Min; Thoren, Corinna ten; Schwalm, Anja; Weigel, Carolin; Balg, Christiane; Mensch, Alexander; Mostardt, Sarah; Seidl, A.; Lhachimi, Stefan K.

doi:10.1016/j.zefq.2014.06.018

Cited by 19 publications

(9 citation statements)

References 18 publications

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“…On June 1, 2019, among the 97 disclosed efficiency opinions, 59 opinions were free of major methodological limitations and available for estimating a reference value for a QALY. Price regulation of drugs in France is achieved3 by ensuring a balance between price cutting for drugs that are already reimbursed and reimbursing new drugs at negotiated prices. This is in line with savings objectives fixed annually by law.…”

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confidence: 99%

Value of a QALY for France: A New Approach to Propose Acceptable Reference Values

et al. 2020

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France has included health economic assessment (HEA) as an official criterion for innovative drug pricing since 2013. Until now, no cost-effectiveness threshold (CET) has been officially proposed to qualify incremental cost-effectiveness ratios (ICERs). Although the French health authorities have publicly expressed the need for such reference values, previous initiatives to determine these have failed. The study aims to propose a locally adapted method for estimating a preference-based value for a quality-adjusted life-year (QALY) based on a rational approach to public policy choices in France. Methods: We used the official French value of statistical life (VSL) of V3 million (USD 3.25 million), proposed in 2013 by the French General Commission on Strategy and Prediction. We first estimated the value of life-year (VoLY) by age category according to life expectancy and official discounts recommended for HEA in France. We then estimated a value of statistical QALY (VSQ) by weighting VoLYs with demographic data and French EQ-5D-3L tariffs. Results: The estimated average VoLYs and VSQs were V120 185 (USD 130 000) and V147 093 (USD 159 022), respectively, assuming a discount rate of 2.5% and V166 205 (USD 179 681) and V201 398 (USD 217 728), respectively, assuming a discount rate of 4.5%. Conclusion: Assuming that, as in other public domains, equity in access to healthcare across all disease areas and between all users is desirable, we propose an estimate of VSQ that is consistent with this goal. Our estimates of V147 093 (USD 179,681) to V201 398 (USD 217 728) should be perceived as breakeven costs for a QALY rather than a market access threshold. Such VSQs could be used as reference values for ICERs in HEA in France.

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confidence: 99%

Value of a QALY for France: A New Approach to Propose Acceptable Reference Values

et al. 2020

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“…So far this has never happened, likely due to the disincentives for either party; payers benefit from lower prices of the "blunt" IRP system [17], while manufacturers face the entire financial burden when commissioning an economic evaluation of uncertain outcome to them and possibly negative impact in case a lower price was recommended. Thus, unsurprisingly, no economic evaluation has been commissioned since AMNOG was introduced in 2011 (as of June 2018) [85].…”

Section: Expert Commentarymentioning

confidence: 99%

“…From a societal perspective, it seems obvious to us that it would be desirable to have a similar rigorous system for the costs of drugs, and the relationship of cost-to-benefits between different drugs. For the time being, the optimists among us hence hope for health economic evaluation being only a "sleeping beauty" in Germany [85]. However, for as long as the financial and political pressure is not strong enough (as in the build up to the 1989 reform), the current system in Germany is unlikely to change soon.…”

Section: Expert Commentarymentioning

confidence: 99%

“…Moreover, it will need sufficient political will to change the current system in order for society to benefit from cost-effectiveness considerations as a whole. To achieve this goal, the procedure for economic evaluations may need to change to raise the appeal and perceived usefulness for policy makers: The conventional IRP is conducted in Germany on an annual basis [82][83][84], while the comparative effectiveness assessment is usually also concluded within one year [85]. It will thus need a rapid assessment of the health economic aspects to appeal to decision makers, with a short-cut having been proposed before [52,53].…”

Section: Five-year Viewmentioning

confidence: 99%

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The efficiency-frontier approach for health economic evaluation versus cost-effectiveness thresholds and internal reference pricing: combining the best of both worlds?

Sandmann

Mostardt

Lhachimi

et al. 2018

Expert Review of Pharmacoeconomics & Outcomes Research

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The efficiency-frontier approach (EFA) to health economic evaluation aims to benchmark the relative efficiency of new drugs with the incremental cost-effectiveness ratios (ICERs) of non-dominated comparators. By explicitly considering any differences in health outcomes and costs, it enhances the internal reference pricing (IRP) policy that was officially endorsed by Germany as the first country worldwide in 1989. However, the EFA has been repeatedly criticized since its official endorsement in 2009. Areas covered: This perspective aims to stimulate the debate by discussing whether the main objections to the EFA are technically valid, irrespective of national contextual factors in Germany with reservations towards using cost-per-quality-adjusted life year (QALY) thresholds. Moreover, we comparatively assessed whether the objections are truly unique to the EFA or apply equally to IRP and cost-effectiveness thresholds. Expert commentary: The plethora of objections to the EFA (n = 20) has obscured that many objections are neither technically valid nor unique to the EFA. Compared with cost-effectiveness thresholds, only two objections apply uniquely to the EFA and concern intended key properties: (1) no external thresholds are needed and (2) the EFA is sensitive to price changes of comparators. Combining these policies and developing them further are under-utilized research areas.

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“…With such interventions, IQWiG seeks price reductions such that the interventions move to the frontier. The approach assists in defining indication-specific willingness-to-pay thresholds, 2 expressly avoiding fixed thresholds (for the legal and political reasons motivating the methodological choice, see Gerber-Grote et al 3 and Sandmann et al 4 and the references therein). The detailed setup of an efficiency frontier within the German 5 and other settings 6–14 has been described elsewhere.…”

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confidence: 99%

Cost Recommendation under Uncertainty in IQWiG’s Efficiency Frontier Framework

et al. 2016

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Decision making in Germany: Is health economic evaluation as a supporting tool a sleeping beauty?

Cited by 19 publications

References 18 publications

Value of a QALY for France: A New Approach to Propose Acceptable Reference Values

Value of a QALY for France: A New Approach to Propose Acceptable Reference Values

The efficiency-frontier approach for health economic evaluation versus cost-effectiveness thresholds and internal reference pricing: combining the best of both worlds?

Cost Recommendation under Uncertainty in IQWiG’s Efficiency Frontier Framework

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