How Do the Institute for Clinical and Economic Review’s Assessments of Comparative Effectiveness Compare With the German Federal Joint Committee’s Assessments of Added Benefit? A Qualitative Study

We compared the Institute for Clinical and Economic Review’s (ICER) ratings of comparative clinical effectiveness with the German Federal Joint Committee’s (G-BA) added benefit ratings, and explored what factors may explain the disagreement between the 2 organizations. We included drugs if they were...

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Veröffentlicht in:Value in health 2024-08, Vol.27 (8), p.1066-1072
Hauptverfasser: DiStefano, Michael J., Pearson, Steven D., Rind, David M., Zemplenyi, Antal
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container_end_page 1072
container_issue 8
container_start_page 1066
container_title Value in health
container_volume 27
creator DiStefano, Michael J.
Pearson, Steven D.
Rind, David M.
Zemplenyi, Antal
description We compared the Institute for Clinical and Economic Review’s (ICER) ratings of comparative clinical effectiveness with the German Federal Joint Committee’s (G-BA) added benefit ratings, and explored what factors may explain the disagreement between the 2 organizations. We included drugs if they were assessed by ICER under its 2020 to 2023 Value Assessment Framework and had a corresponding assessment by G-BA as of January 2024 for the same indication, patient population, and comparator drug. To compare assessments, we modified ICER’s proposed crosswalk between G-BA and ICER benefit ratings to account for G-BA’s certainty ratings. We also determined whether each pair was based on similar evidence. Assessment pairs exhibiting disagreement based on the modified crosswalk despite a similar evidence base were qualitatively analyzed to identify reasons for disagreement. Out of 15 drug assessment pairs matched on indication, patient subgroup, and comparator, none showed agreement in their assessments when based on similar evidence. Disagreement was attributed to differences in evidence evaluation, including evaluations of safety, generalizability, and study design, as well as G-BA’s rejection of the available evidence in 4 cases as unsuitable. The findings demonstrate that even under conditions where populations and comparators are identical and the evidence base is consistent, different assessors may arrive at divergent conclusions about comparative effectiveness, thus underscoring the presence of value judgments within assessments of clinical effectiveness. To support initiatives that seek to facilitate the exchange of value assessments between countries, these value judgments should always be transparently presented and justified in assessment summaries. •Several studies have documented disagreement in the comparative effectiveness assessments of the same drugs by different national health technology assessment (HTA) bodies. However, we are not aware of any studies that compare Institute for Clinical and Economic Review’s (ICER) comparative effectiveness assessments with those of other HTA bodies. Furthermore, existing studies have matched and compared comparative effectiveness assessments at the drug level or the indication and patient subgroup level only.•We identified 15 drug assessment pairs matched on indication, patient subgroup, and comparator treatment. Seven assessment pairs were based on similar evidence. Using a novel crosswalk to translate G-BA rati
doi_str_mv 10.1016/j.jval.2024.04.015
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We also determined whether each pair was based on similar evidence. Assessment pairs exhibiting disagreement based on the modified crosswalk despite a similar evidence base were qualitatively analyzed to identify reasons for disagreement. Out of 15 drug assessment pairs matched on indication, patient subgroup, and comparator, none showed agreement in their assessments when based on similar evidence. Disagreement was attributed to differences in evidence evaluation, including evaluations of safety, generalizability, and study design, as well as G-BA’s rejection of the available evidence in 4 cases as unsuitable. The findings demonstrate that even under conditions where populations and comparators are identical and the evidence base is consistent, different assessors may arrive at divergent conclusions about comparative effectiveness, thus underscoring the presence of value judgments within assessments of clinical effectiveness. To support initiatives that seek to facilitate the exchange of value assessments between countries, these value judgments should always be transparently presented and justified in assessment summaries. •Several studies have documented disagreement in the comparative effectiveness assessments of the same drugs by different national health technology assessment (HTA) bodies. However, we are not aware of any studies that compare Institute for Clinical and Economic Review’s (ICER) comparative effectiveness assessments with those of other HTA bodies. Furthermore, existing studies have matched and compared comparative effectiveness assessments at the drug level or the indication and patient subgroup level only.•We identified 15 drug assessment pairs matched on indication, patient subgroup, and comparator treatment. Seven assessment pairs were based on similar evidence. Using a novel crosswalk to translate G-BA ratings into ICER ratings that accounts for G-BA’s assessment of certainty, G-BA and ICER did not agree in their assessment for any of these 7 drugs.•The findings demonstrate that even when populations and comparators are identical and the evidence base is similar, different assessors may arrive at divergent conclusions about comparative effectiveness, thus underscoring the role of value judgments. To support initiatives seeking to facilitate exchange of value assessments between jurisdictions, value judgments should be transparently presented and justified in assessment summaries. 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Out of 15 drug assessment pairs matched on indication, patient subgroup, and comparator, none showed agreement in their assessments when based on similar evidence. Disagreement was attributed to differences in evidence evaluation, including evaluations of safety, generalizability, and study design, as well as G-BA’s rejection of the available evidence in 4 cases as unsuitable. The findings demonstrate that even under conditions where populations and comparators are identical and the evidence base is consistent, different assessors may arrive at divergent conclusions about comparative effectiveness, thus underscoring the presence of value judgments within assessments of clinical effectiveness. To support initiatives that seek to facilitate the exchange of value assessments between countries, these value judgments should always be transparently presented and justified in assessment summaries. •Several studies have documented disagreement in the comparative effectiveness assessments of the same drugs by different national health technology assessment (HTA) bodies. However, we are not aware of any studies that compare Institute for Clinical and Economic Review’s (ICER) comparative effectiveness assessments with those of other HTA bodies. Furthermore, existing studies have matched and compared comparative effectiveness assessments at the drug level or the indication and patient subgroup level only.•We identified 15 drug assessment pairs matched on indication, patient subgroup, and comparator treatment. Seven assessment pairs were based on similar evidence. Using a novel crosswalk to translate G-BA ratings into ICER ratings that accounts for G-BA’s assessment of certainty, G-BA and ICER did not agree in their assessment for any of these 7 drugs.•The findings demonstrate that even when populations and comparators are identical and the evidence base is similar, different assessors may arrive at divergent conclusions about comparative effectiveness, thus underscoring the role of value judgments. To support initiatives seeking to facilitate exchange of value assessments between jurisdictions, value judgments should be transparently presented and justified in assessment summaries. 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Assessment pairs exhibiting disagreement based on the modified crosswalk despite a similar evidence base were qualitatively analyzed to identify reasons for disagreement. Out of 15 drug assessment pairs matched on indication, patient subgroup, and comparator, none showed agreement in their assessments when based on similar evidence. Disagreement was attributed to differences in evidence evaluation, including evaluations of safety, generalizability, and study design, as well as G-BA’s rejection of the available evidence in 4 cases as unsuitable. The findings demonstrate that even under conditions where populations and comparators are identical and the evidence base is consistent, different assessors may arrive at divergent conclusions about comparative effectiveness, thus underscoring the presence of value judgments within assessments of clinical effectiveness. To support initiatives that seek to facilitate the exchange of value assessments between countries, these value judgments should always be transparently presented and justified in assessment summaries. •Several studies have documented disagreement in the comparative effectiveness assessments of the same drugs by different national health technology assessment (HTA) bodies. However, we are not aware of any studies that compare Institute for Clinical and Economic Review’s (ICER) comparative effectiveness assessments with those of other HTA bodies. Furthermore, existing studies have matched and compared comparative effectiveness assessments at the drug level or the indication and patient subgroup level only.•We identified 15 drug assessment pairs matched on indication, patient subgroup, and comparator treatment. Seven assessment pairs were based on similar evidence. Using a novel crosswalk to translate G-BA ratings into ICER ratings that accounts for G-BA’s assessment of certainty, G-BA and ICER did not agree in their assessment for any of these 7 drugs.•The findings demonstrate that even when populations and comparators are identical and the evidence base is similar, different assessors may arrive at divergent conclusions about comparative effectiveness, thus underscoring the role of value judgments. To support initiatives seeking to facilitate exchange of value assessments between jurisdictions, value judgments should be transparently presented and justified in assessment summaries. A recently published framework is 1 tool HTA bodies could use to organize and justify value judgments.</abstract><pub>Elsevier Inc</pub><doi>10.1016/j.jval.2024.04.015</doi><tpages>7</tpages></addata></record>
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subjects added benefit
comparative effectiveness
health technology assessment
transparency
value judgment
title How Do the Institute for Clinical and Economic Review’s Assessments of Comparative Effectiveness Compare With the German Federal Joint Committee’s Assessments of Added Benefit? A Qualitative Study
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