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

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.

Cost-effectiveness analysis of tapentadol immediate release for the treatment of acute pain.

BACKGROUND: Tapentadol immediate-release (IR) tablets are indicated for the treatment of moderate to severe acute pain. In clinical trials, tapentadol IR effectively reduced moderate to severe pain with improved tolerability compared with oxycodone IR at doses providing comparable analgesia. OBJECTIVE: This analysis compared the cost-effectiveness of tapentadol IR with doses of oxycodone IR providing comparable analgesia in the outpatient treatment of acute postsurgical and nonsurgical pain. The perspective was that of a US managed care health plan as third-party payer. METHODS: A Markov model was developed to simulate clinical-economic outcomes for tapentadol IR 100 mg compared with oxycodone IR 15 mg in the treatment of acute postsurgical pain (3 days) and for tapentadol IR 50 mg compared with oxycodone IR 10 mg in the treatment of acute nonsurgical pain (10 days). The model simulated changes in pain relief; occurrence of opioid-related adverse events (AEs); opioid switching, discontinuation, and dose change; and number of quality-adjusted life-days (QALDs). Data inputs for the model were obtained from clinical trials, claims databases, surveys, Medicare fee schedules, and other published sources. Only direct costs were included. Drug costs were based on the wholesale acquisition cost. Prescription copayments were set at $5 for oxycodone IR and $25 for tapentadol IR. All costs were in 2008 US dollars. Sensitivity analyses were conducted on key model parameters. RESULTS: The cost of pain medication per patient was higher for tapentadol IR than for oxycodone IR in both the surgical pain setting ($15.23 vs $9.57, respectively) and the nonsurgical pain setting ($57.17 vs $21.31). However, this cost difference was offset by reductions in pharmacy and medical costs associated with the treatment of AEs and opioid switching/discontinuation, resulting in a lower mean treatment cost per patient for tapentadol IR 100 mg compared with oxycodone IR 15 mg in the treatment of acute surgical pain ($52.90 vs $55.99) and for tapentadol IR 50 mg compared with oxycodone IR 10 mg in the treatment of acute nonsurgical pain ($139.48 vs $144.79). Tapentadol IR also was associated with a greater mean number of treatment days with ≥30% improvement in pain intensity without opioid-related AEs compared with oxycodone IR and a greater mean number of QALDs (surgical pain: 1.73 vs 1.68; nonsurgical pain: 6.03 vs 4.92). Because both doses of tapentadol IR were dominant (ie, lower treatment costs and greater effectiveness) relative to the corresponding doses of oxycodone IR providing com- parable analgesia, incremental cost-effectiveness ratios were not calculated. CONCLUSION: The results of this model suggest that at doses providing comparable analgesia, tapentadol IR is a cost-effective alternative to oxycodone IR for the treatment of acute surgical and nonsurgical pain.

Costs and outcomes of early versus delayed migraine treatment with sumatriptan.

OBJECTIVE: To evaluate the impact on costs and outcomes of early migraine treatment with sumatriptan while pain is mild versus sumatriptan treatment of moderate to severe pain. BACKGROUND: Migraines result in substantial pain, impairment, and costs. Recent clinical studies have shown that early treatment with sumatriptan when migraine pain is mild is more effective than sumatriptan treatment when pain is moderate to severe. DESIGN/METHODS: We developed a decision analytical model to assess the costs and outcomes per treated migraine attack, comparing early treatment while pain is mild versus delayed treatment when pain may become moderate/severe using 50 and 100 mg of sumatriptan. Parameters for the model were derived from published literature and analysis of migraine patient diary data. For each patient group the model determined the duration of mild and moderate/severe migraine pain, the proportion of patients pain free at 4 hours after initial therapy with no recurrence, medical care costs, and work loss costs (from migraine-related absenteeism and decreased productivity) during a 24-hour period. Total costs were calculated as the sum of medical care costs plus work loss costs. RESULTS: Early treatment with sumatriptan when migraine pain is mild resulted in substantially decreased total costs per treated attack as compared with treatment when pain is moderate/severe. Early treatment also resulted in decreased time with headache pain, an increased proportion of patients pain free at 4 hours without recurrence, and decreased physician and emergency department visits. Treatment with 100 mg sumatriptan resulted in better outcomes than did treatment with 50 mg sumatriptan, but outcomes with either dose for early treatment of mild pain were superior to those for either dose in delayed treatment when pain may be moderate/severe. CONCLUSIONS: Model-based results indicate that on a treated attack basis, early treatment of migraine with sumatriptan while pain is mild leads to decreased costs and improved outcomes compared to delayed sumatriptan treatment.