ACC/AHA Statement on Cost/Value Methodology in Clinical Practice Guidelines and Performance Measures

Anderson, Jeffrey L.; Heidenreich, Paul A.; Barnett, Paul G.; Creager, Mark A.; Fonarow, Gregg C.; Gibbons, Raymond J.; Halperin, Jonathan L.; Hlatky, Mark A.; Jacobs, Alice K.; Mark, Daniel B.; Masoudi, Frederick A.; Peterson, Eric D.; Shaw, Leslee J.

doi:10.1161/cir.0000000000000042

Cited by 349 publications

(139 citation statements)

References 34 publications

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“…Per AHA/ACC guidance, a threshold of <$50k, $50-$150k and >$150k was utilized as the therapy providing high, intermediate and low economic value, respectively. [7] It should be noted that while the $50,000 threshold is often used, greater thresholds may be considered. [16,25,26] Results…”

Section: Discussionmentioning

confidence: 99%

“…However, from a U.S. health delivery system perspective, the ICER was just $22,057 per QALY gained, which is well below the $50,000 per QALY gained threshold for highly cost-effective according to AHA/ACC guidance. [7] The strengths of this analysis are that we utilized patientlevel data to the greatest extent possible, including resource use data, and we matched Hokusai-VTE cohort study characteristics to our model. While such an approach increases the internal validity of our results, there are limitations.…”

Section: Discussionmentioning

confidence: 99%

“…The incorporation of economic value information into treatment guidelines and performance measures has been proposed by the American Heart Association (AHA) and the American College of Cardiology (ACC) Task Force on Performance Measures and Task Force on Practice Guidelines. [7] The AHA/ACC proposal recommends the use of cost-effectiveness analysis comparing the new treatment with the relevant alternative to inform health-care decisions. [8] Based on U.S. gross domestic product (GDP) data in 2012, the AHA/ACC proposal considered interventions with cost-effectiveness analysis results expressed as an incremental cost-effectiveness ratio (ICER) of <$50,000 per quality adjusted life year (QALY) gained as high value.…”

Section: Introductionmentioning

confidence: 99%

“…Interventions with an ICER between $50,000 and $150,000 per QALY gained are of intermediate value, whereas interventions with an ICER > $150,000 per QALY gained are of low value. [7] The objective of the present analysis was to evaluate the costeffectiveness of edoxaban versus warfarin for the treatment of adults with VTE, based on the data from the Hokusai-VTE study.…”

Section: Introductionmentioning

confidence: 99%

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Cost-effectiveness of edoxaban for the treatment of venous thromboembolism based on the Hokusai-VTE study

et al. 2015

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Objective: Venous thromboembolism (VTE) is associated with almost 300,000 deaths per year in the United States. Novel oral anticoagulants (NOACs) offer an alternative to warfarin-based therapy without monitoring requirements and with fewer drug and food interactions. Edoxaban, a direct Xa inhibitor, is approved by the Food and Drug Administration (FDA), based upon results of the Hokusai-VTE Phase 3 trial. The trial demonstrated that edoxaban administered once daily after initial treatment with heparin was non-inferior in reducing the risk of VTE recurrence and caused significantly less major and clinically relevant non-major (CRNM) bleeding compared to warfarin. The objective of this study was to evaluate the cost-effectiveness of edoxaban versus warfarin for the treatment of adults with VTE. Methods: A cost-effectiveness model was developed using patient-level data from the Hokusai-VTE trial, clinical event costs from real-world databases, and drug acquisition costs for warfarin of $0.36 and edoxaban of $9.24 per tablet. Results: From a U.S. health-care delivery system perspective, the incremental cost-effectiveness ratio (ICER) was $22,057 per quality adjusted life year (QALY) gained. Probabilistic sensitivity analysis showed that edoxaban had an ICER <$50,000 per QALY gained relative to warfarin in 67% of model simulations. The result was robust to variation in key model parameters including the cost and disutility of warfarin monitoring. Conclusion: Despite its higher drug acquisition cost, edoxaban is a cost-effective alternative to warfarin for the treatment of VTE.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Cost-effectiveness of edoxaban for the treatment of venous thromboembolism based on the Hokusai-VTE study

et al. 2015

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“…In the US, there is no established WTPT. Per the recommendation from the Second Panel on Cost-Effectiveness in Health and Medicine 27 , a range of WTPTs were considered ($100,000-$200,000 per QALY gained), where a WTPT of $150,000 per QALY gained was used as the base case according to the ACC/AHA guideline on cost and value methodology and consistent with widespread practice 28,29 . We then estimated the value-based price range of evolocumab in populations with LDL-C !70 mg/dL and !100 mg/dL.…”

Section: Statistical Considerationsmentioning

confidence: 99%

Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context

Tóth

Danese²,

Villa

et al. 2017

Journal of Medical Economics

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Aim: To estimate real-world cardiovascular disease (CVD) burden and value-based price range of evolocumab for a US-context, high-risk, secondary-prevention population. Materials and methods: Burden of CVD was assessed using the UK-based Clinical Practice Research Datalink (CPRD) in order to capture complete CV burden including CV mortality. Patients on standard of care (SOC; high-intensity statins) in CPRD were selected based on eligibility criteria of FOURIER, a phase 3 CV outcomes trial of evolocumab, and categorized into four cohorts: high-risk prevalent atherosclerotic CVD (ASCVD) cohort (n ¼ 1448), acute coronary syndrome (ACS) (n ¼ 602), ischemic stroke (IS) (n ¼ 151), and heart failure (HF) (n ¼ 291) incident cohorts. The value-based price range for evolocumab was assessed using a previously published economic model. The model incorporated CPRD CV event rates and considered CV event reduction rate ratios per 1 mmol/L reduction in low-density lipoprotein-cholesterol (LDL-C) from a meta-analysis of statin trials by the Cholesterol Treatment Trialists Collaboration (CTTC), i.e. CTTC relationship. Results: Multiple-event rates of composite CV events (ACS, IS, or coronary revascularization) per 100 patient-years were 12.3 for the high-risk prevalent ASCVD cohort, and 25.7, 13.3, and 23.3, respectively, for incident ACS, IS, and HF cohorts. Approximately one-half (42%) of the high-risk ASCVD patients with a new CV event during follow-up had a subsequent CV event. Combining these real-world event rates and the CTTC relationship in the economic model, the value-based price range (credible interval) under a willingness-to-pay threshold of $150,000/quality-adjusted life-year gained for evolocumab was $11,990 ($9,341-$14,833) to $16,856 ($12,903-$20,678) in ASCVD patients with baseline LDL-C levels !70 mg/dL and !100 mg/dL, respectively. Conclusion: Real-world CVD burden is substantial. Using the observed CVD burden in CPRD and the CTTC relationship, the cost-effectiveness analysis showed that, accounting for uncertainties, the expected value-based price for evolocumab is higher than its current annual cost, as long as the payer discount off list price is greater than 20%. ARTICLE HISTORY

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Professional Organizations’ Role in Supporting Physicians to Improve Value in Health Care

Marcotte

Moriates

Milstein

2014

JAMA

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ACC/AHA Statement on Cost/Value Methodology in Clinical Practice Guidelines and Performance Measures

Cited by 349 publications

References 34 publications

Cost-effectiveness of edoxaban for the treatment of venous thromboembolism based on the Hokusai-VTE study

Cost-effectiveness of edoxaban for the treatment of venous thromboembolism based on the Hokusai-VTE study

Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context

Professional Organizations’ Role in Supporting Physicians to Improve Value in Health Care

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