IQWiG’s methods for the cost–benefit assessment

Abstract

Standardization of international health economic guidelines has been repeatedly requested. In this context, an international reference case was proposed, which constitutes an agreed approach for the key elements of health economic evaluation including study perspective, comparators, source of effectiveness data, role of modeling, main (economic) outcome, source of utilities, characterizing uncertainty. It is, however, questionable whether such a reference scenario can reasonably be applied across all health care systems. Our analysis pursues the question to which degree the Institute for Quality and Efficiency in Health Care's (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) "General methods for evaluating the relation between cost and benefit" comply with the key elements of the reference case. In case of divergences, they will be described and discussed in light of the German social legislation and in consideration of current scientific evidence. In conclusion, the analysis revealed that IQWiG complied with the reference case in almost all aspects. Differences were found only with respect to the choice of main (economic) outcome and the source of utilities. These differences seem justified and well explained in the context of the German social legislation as well as in view of the weaknesses of the quality-adjusted life year (QALY) concept.

Die probabilistische Effizienzgrenze: eine Wirtschaftlichkeitsanalyse von Therapieoptionen im Indikationsgebiet Hepatitis C

“…Die berechneten Nutzenwerte einer Alternative wurden auf der vertikalen Achse (y) und die jeweiligen Kosten (Preis der Therapie in Euro) auf der horizontalen Achse (x) des Koordinatensystems abgetragen. Eine Intervention gilt als effizient, wenn im Vergleich mit anderen Behandlungsalternativen der Nutzen bei gleichen Kosten größer ist oder wenn die Kosten bei gleichem Nutzen geringer sind [2,19]. Die Steigung der verschiedenen linearen Abschnitte zwischen den Alternativen zeigt das inkrementelle Kosten-Nutzen-Verhältnis (IKNV).…”

A systematic review of moral reasons on orphan drug reimbursement

“… Appropriateness of cost-effectiveness criteria Some authors argued against special status, stating that OMPs could and should meet the same cost-effectiveness criteria as any other drug [ 38 , 45 , 53 , 62 , 73 , 78 , 82 , 85 , 90 , 104 , 105 , 111 , 114 , 127 , 134 , 135 , 142 , 150 , 194 ]. However, other authors mentioned that OMPs were unlikely to meet traditional cost-effectiveness criteria [ 24 , 35 , 36 , 38 , 41 , 43 , 45 , 54 , 57 , 59 , 62 , 64 , 65 , 68 , 72 , 73 , 75 , 87 , 89 , 109 , 116 , 118 , 120 , 122 , 128 , 140 , 143 , 144 , 151 – 153 , 155 – 158 , 162 , 178 , 196 , 199 – 201 , 206 , 208 , 220 ...…”

Cost-effectiveness of early rhythm control vs. usual care in atrial fibrillation care: an analysis based on data from the EAST-AFNET 4 trial

“…Comparability of the results with other studies is furthermore limited by the fact that QALYs were not used as effect measure in this study. This was due to the following reasons: (1) health-related quality of life was only assessed at baseline and at 2-year follow-up, where no significant or clinically relevant between-group difference was observed; (2) against the background of the German social legislation and weaknesses of the QALY concept, the IQWiG, which is substantially involved in informing reimbursement decisions in Germany, currently deviates from the international reference scenario for cost-effectiveness analyses by not supporting QALYs as primary measure of benefits; 23 , 58 , 59 and (3) the EAST-AFNET 4 trial was not powered for between-group differences in quality of life. Instead, the EAST-AFNET 4 primary composite outcome was used.…”