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Rivaroxaban plus aspirin for the prevention of ischaemic events in patients with cardiovascular disease: a cost-effectiveness study.

ABSTRACT: BACKGROUND:Dual pathway inhibition with 2.5?mg rivaroxaban twice daily plus 100?mg aspirin once daily may be a promising alternative to 100?mg aspirin antiplatelet therapy for the prevention of cardiovascular events in patients with coronary artery disease and/or peripheral arterial disease. However, treatment costs and bleeding risks are higher, and there is another treatment option for peripheral arterial disease, 75?mg clopidogrel. A comprehensive assessment of benefits, risks and costs of dual pathway inhibition versus standard of care is needed. METHODS:We used a state transition model including cardiovascular, ischaemic limb and bleeding events to compare dual pathway inhibition to aspirin antiplatelet therapy in coronary artery disease, and additionally to clopidogrel antiplatelet therapy in peripheral arterial disease patients. We calculated the incremental cost-effectiveness ratio from costs and quality-adjusted life-years of lifelong treatment, and the cost-effectiveness probability at a €50,000/quality-adjusted life-year threshold. RESULTS:Quality-adjusted life-years and costs of dual pathway inhibition were highest, the incremental cost-effectiveness ratios versus aspirin were €32,109 in coronary artery disease and €26,381 in peripheral arterial disease patients, with 92% and 56% cost-effectiveness probability, respectively (clopidogrel was extendedly dominated). Incremental cost-effectiveness ratios were below €20,000 in comorbid peripheral arterial disease patients and coronary artery disease patients younger than 65 years, incremental cost-effectiveness ratios were above €50,000 in carotid artery disease patients and coronary artery disease patients older than 75 years. CONCLUSION:Lifelong preventive treatment of coronary artery disease and peripheral arterial disease patients at risk of cardiovascular events with dual pathway inhibition improves health outcomes and seems overall cost-effective relative to aspirin antiplatelet therapy and also to clopidogrel antiplatelet therapy for peripheral arterial disease, particularly in comorbid patients, but not in older patients and in carotid artery disease patients. These findings may warrant a targeted approach.

SUBMITTER: Petersohn S

PROVIDER: S-EPMC7457457 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Rivaroxaban plus aspirin for the prevention of ischaemic events in patients with cardiovascular disease: a cost-effectiveness study.

Petersohn Svenja S Pouwels Xavier X Ramaekers Bram B Ten Cate-Hoek Arina A Joore Manuela M

European journal of preventive cardiology 20200329 13

<h4>Background</h4>Dual pathway inhibition with 2.5 mg rivaroxaban twice daily plus 100 mg aspirin once daily may be a promising alternative to 100 mg aspirin antiplatelet therapy for the prevention of cardiovascular events in patients with coronary artery disease and/or peripheral arterial disease. However, treatment costs and bleeding risks are higher, and there is another treatment option for peripheral arterial disease, 75 mg clopidogrel. A comprehensive assessment of benefits, risks and cos ...[more]

PMID: 32223323

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Project description:ImportanceIn the Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) trial, the anti-inflammatory monoclonal antibody canakinumab significantly reduced the risk of recurrent cardiovascular events in patients with previous myocardial infarction (MI) and high-sensitivity C-reactive protein (hs-CRP) levels of 2 mg/L or greater.ObjectiveTo estimate the cost-effectiveness of adding canakinumab to standard of care for the secondary prevention of major cardiovascular events over a range of potential prices.Design, setting, and participantsA state-transition Markov model was constructed to estimate costs and outcomes over a lifetime horizon by projecting rates of recurrent MI, coronary revascularization, infection, and lung cancer with and without canakinumab treatment. We used a US health care sector perspective, and the base case used the current US market price of canakinumab of $73 000 per year. A hypothetical cohort of patients after MI aged 61 years with an hs-CRP level of 2 mg/L or greater was constructed.InterventionsCanakinumab, 150 mg, administered every 3 months plus standard of care compared with standard of care alone.Main outcomes and measuresLifetime costs and quality-adjusted life-years (QALYs), discounted at 3% annually.ResultsAdding canakinumab to standard of care increased life expectancy from 11.31 to 11.36 years, QALYs from 9.37 to 9.50, and costs from $242 000 to $1 074 000, yielding an incremental cost-effectiveness ratio of $6.4 million per QALY gained. The price would have to be reduced by more than 98% (to $1150 per year or less) to meet the $100 000 per QALY willingness-to-pay threshold. These results were generally robust across alternative assumptions, eg, substantially lower health-related quality of life after recurrent cardiovascular events, lower infection rates while receiving canakinumab, and reduced all-cause mortality while receiving canakinumab. Including a potential beneficial effect of canakinumab on lung cancer incidence improved the incremental cost-effectiveness ratio to $3.5 million per QALY gained. A strategy of continuing canakinumab selectively in patients with reduction in hs-CRP levels to less than 2 mg/L would have a cost-effectiveness ratio of $819 000 per QALY gained.Conclusions and relevanceCanakinumab is not cost-effective at current US prices for prevention of recurrent cardiovascular events in patients with a prior MI. Substantial price reductions would be needed for canakinumab to be considered cost-effective.

Project description:BackgroundPatients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) have increased risks for cardiovascular (CV)-related morbidity and mortality. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) clinical trial of such patients, rivaroxaban plus aspirin demonstrated a significant reduction in major adverse CV events (MACE), a composite of stroke, myocardial infarction, and CV death, and major adverse limb events (MALE), a composite of chronic and acute limb ischemia, and major amputation resulting from vascular events, versus aspirin alone.ObjectiveTo estimate the 1-year economic implications of preventing MACE and MALE with the use of rivaroxaban plus aspirin versus aspirin alone among patients with chronic CAD and/or PAD in a US commercial health plan.MethodA cost-consequence model was developed to evaluate the economic impact of rivaroxaban plus aspirin in a hypothetical 1-million-member health plan. The model inputs were taken from the COMPASS study (ie, the efficacy and safety of rivaroxaban plus aspirin vs aspirin), Optum Integrated Database (ie, the prevalence of chronic CAD and/or PAD, incidence rates, and healthcare costs of MACE, MALE, and major bleeding), and the RED BOOK (ie, wholesale drug acquisition costs). The cost inputs were in 2019 US dollars. One-way sensitivity analyses and subgroup analyses were conducted.ResultsA 1-year treatment with rivaroxaban plus aspirin resulted in reductions of MACE and MALE, which balance the increased risk for bleeding versus aspirin alone and indicate a net health benefit for this drug regimen. These reductions were achieved at an incremental per-member per-month (PMPM) cost of $0.16, mainly because of rivaroxaban's acquisition cost. In patients with ≥2 MACE or MALE risk factors, the incremental PMPM cost was $0.09, given the increased offset in rivaroxaban's acquisition cost by reduced rates of MACE or MALE.ConclusionsIn an era of emerging thrombocardiology, treatment with rivaroxaban plus aspirin offers an effective thrombotic risk management strategy for healthcare stakeholders in the management of chronic CAD and/or PAD. The contribution of rivaroxaban would be greater in patients with ≥2 risk factors for MACE or MALE.

Project description:ImportanceThe proprotein convertase subtilisin/kexin type 9 inhibitor evolocumab has been demonstrated to reduce the composite of myocardial infarction, stroke, or cardiovascular death in patients with established atherosclerotic cardiovascular disease. To our knowledge, long-term cost-effectiveness of this therapy has not been evaluated using clinical trial efficacy data.ObjectiveTo evaluate the cost-effectiveness of evolocumab in patients with atherosclerotic cardiovascular disease when added to standard background therapy.Design, setting, and participantsA Markov cohort state-transition model was used, integrating US population-specific demographics, risk factors, background therapy, and event rates along with trial-based event risk reduction. Costs, including price of drug, utilities, and transitional probabilities, were included from published sources.ExposuresAddition of evolocumab to standard background therapy including statins.Main outcomes and measuresCardiovascular events including myocardial infarction, ischemic stroke and cardiovascular death, quality-adjusted life-year (QALY), incremental cost-effectiveness ratio (ICER), and net value-based price.ResultsIn the base case, using US clinical practice patients with atherosclerotic cardiovascular disease with low-density lipoprotein cholesterol levels of at least 70 mg/dL (to convert to millimoles per liter, multiply by 0.0259) and an annual events rate of 6.4 per 100 patient-years, evolocumab was associated with increased cost and improved QALY: incremental cost, $105 398; incremental QALY, 0.39, with an ICER of $268 637 per QALY gained ($165 689 with discounted price of $10 311 based on mean rebate of 29% for branded pharmaceuticals). Sensitivity and scenario analyses demonstrated ICERs ranging from $100 193 to $488 642 per QALY, with ICER of $413 579 per QALY for trial patient characteristics and event rate of 4.2 per 100 patient-years ($270 192 with discounted price of $10 311) and $483 800 if no cardiovascular mortality reduction emerges. Evolocumab treatment exceeded $150 000 per QALY in most scenarios but would meet this threshold at an annual net price of $9669 ($6780 for the trial participants) or with the discounted net price of $10 311 in patients with low-density lipoprotein cholesterol levels of at least 80 mg/dL.Conclusions and relevanceAt its current list price of $14 523, the addition of evolocumab to standard background therapy in patients with atherosclerotic cardiovascular disease exceeds generally accepted cost-effectiveness thresholds. To achieve an ICER of $150 000 per QALY, the annual net price would need to be substantially lower ($9669 for US clinical practice and $6780 for trial participants), or a higher-risk population would need to be treated.

Dataset Information

Rivaroxaban plus aspirin for the prevention of ischaemic events in patients with cardiovascular disease: a cost-effectiveness study.

Publications

Rivaroxaban plus aspirin for the prevention of ischaemic events in patients with cardiovascular disease: a cost-effectiveness study.

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