Introduction
Methods
Results
Recommendations for the design and conduct of economic evaluations in osteoporosis
Type of economic evaluation • Cost-utility analysis using QALY as outcome | |
Method for the conduct of economic evaluation • A model-based economic evaluation | |
Modeling technique • Lifetime horizon • Markov model is appropriate (6 months/1 year cycle length) • Avoid hierarchy of fractures and restrictions after fracture events • Hip, clinical vertebral, and non-vertebral non-hip fracture | |
Base-case analysis and population • Multiple scenarios: age range, BMD, and fracture risk scenarios • At least a scenario including a 10-year risk of a major osteoporotic fracture equal to 20% or with a BMD T-score ≤ − 2.5 with or without fractures • The FRAX® or GARVAN® tools can be used to model fracture risk • Increased risk after fracture events within the model | |
Mortality • Excess mortality after hip fractures • Proportion attribute to the fracture (e.g., 25–30%) | |
Fracture costs and utility • Societal and/or healthcare payer perspective • Acute fracture costs • Long-term costs after hip fracture (attributable to the fracture) • First year and subsequent years’ effects of fractures on disutility • National ICUROS data if available • An additional effect (on costs and/or utility) after multiple fractures | |
Treatment characteristics • Treatment duration similar to guidelines or RCTs • Comparators: no treatment and relevant active osteoporotic agent(s) • Sequential therapy may be considered as intervention/comparators • Efficacy data from RCTs, (network) meta-analysis • In the absence of hip/wrist specific efficacy data, use of non-vertebral or clinical fracture efficacy data • Treatment effects after discontinuation depending on treatment • Medication adherence as sensitivity analysis • Drug costs and administration/monitoring costs • Adverse events |
Type of economic evaluation
Method for the conduct of economic evaluation
Modeling technique
Base-case analysis/population
Mortality
Fracture costs and utilities
Treatment characteristics
Model validation
Recommendations regarding the reporting of economic evaluations in osteoporosis
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Present disaggregated outcomes (such as fracture events, life years, therapy/drug costs, other healthcare costs) for the intervention and comparator(s)
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Present incremental costs and outcomes between intervention and comparator(s)
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Report incremental cost-effectiveness ratio (in terms of costs per QALY gained)
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Characterize uncertainty and heterogeneity by the conduct of:
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Single-case scenario (defined previously)
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Multiple scenarios (age segment; fracture risk)
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One-way sensitivity analyses presented in tables or tornado diagrams
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Probabilistic sensitivity analyses presented in cost-effectiveness acceptability curves.
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Item | Item no. | Recommendation | Reported on page no./line no. |
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Transition probabilities | 1 | Report the transition probabilities and how they were estimated (including increased fracture risk) | |
Excess mortality after fractures | 2 | Describe approaches and data sources used for the excess mortality after fractures | |
Fractures costs | 3 | Describe approaches and data sources used for fractures costs | |
Fractures effects on utility | 4 | Describe approaches and data sources used for the effects of fractures on utility | |
Treatment effect during treatment | 5 | Describe fully the methods used for the identification, selection, and synthesis of clinical effectiveness data (per fracture site) | |
Treatment effect after discontinuation | 6 | Describe fully the methods used for the treatment effect after discontinuation | |
Medication adherence | 7 | Describe approaches and data sources used for modeling medication adherence | |
Treatment costs | 8 | Describe approaches and data sources used for therapy costs | |
Treatment side effects | 9 | Describe approaches and data sources used for costs and utilities effects of adverse events |
Osteoporosis-specific reference case
1) Cost-utility analysis with QALY as outcome 2) Modeling technique (with limited restrictions) 3) Long-term (lifetime) horizon 4) Payer and/or societal perspective 5) At minimum hip and clinical vertebral fracture 6) Excess mortality after hip and clinical vertebral fractures 7) Short-term/long-term effects of fracture on utility 8) Long-term costs of hip fracture 9) Treatment characteristics*: effect on fractures during treatment and after discontinuation; medication adherence; side effects; therapy costs 10) Multiple scenarios (age, fracture risk, BMD) 11) Presentation of disaggregated outcomes, incremental costs, and outcomes for each intervention and incremental cost-effectiveness ratios 12) One-way and probabilistic sensitivity analyses |