Osteoporosis Working Group Creates Recommendations for Economic Evaluations

Economic evaluations play an increasing role in pricing and reimbursement decisions when making treatment choices, but in the osteoporosis field, the variable quality and considerable heterogeneity of the evaluations often limit their comparability and use by decision makers.

To address that issue, a working group convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), and the International Osteoporosis Foundation (IOF) established recommendations for the design and conduct of economic evaluations in osteoporosis, as well as guidance for reporting these evaluations. The group also created a set of minimum criteria for evaluations and an osteoporosis-specific checklist of items to incorporate in economic reports.

The group said that if the osteoporosis health economics community followed the recommendations, it would improve the transparency, quality, and comparability of economic evaluations of osteoporosis interventions, possibly increasing their use by decision makers.

Recommendations on the type of economic evaluation, methods for economic evaluation, modeling aspects, base-case analysis and population, excess mortality, fracture costs and disutility, treatment characteristics, and model validation were provided.

Recommendations were also made for reporting economic evaluations in osteoporosis, and an osteoporosis-specific checklist was designed that includes items to report when performing an economic evaluation in osteoporosis. In addition, 12 minimum criteria for economic evaluations in osteoporosis were identified and 12 methodologic challenges and needs for further research were discussed.

"These osteoporosis-specific recommendations should be viewed as supplemental to general and national guidelines for economic evaluations,” said lead author Mickael Hiligsmann, PhD, MPH, associate professor in health economics and health technology assessment at CAPHRI Care and Public Health Research Institute of Maastricht University, in a statement. He said the study is the first that creates a list of recommendations and minimum requirements for the design, conduct, and reporting of an osteoporosis-specific economic evaluation.

The group recommended the following when creating evaluations in osteoporosis:

• Use quality-adjusted life years (QALYs) as the outcome in an economic evaluation.
• For an economic evaluation, use a model-based economic evaluation.
• Use a model-based economic evaluation with a lifetime horizon to capture the long-term consequences of interventions in terms of costs and outcomes. Avoid a hierarchy of fractures and restrictions after fracture events, and include hip, clinical vertebral, and nonvertebral nonhip fractures that are associated with osteoporosis.
• Create a base-case analysis and population using multiple scenarios: age range, bone mineral density, and fracture risk scenarios.
• Model national probabilities of death and apply a relative risk increase due to fracture events; include excess mortality after hip fractures and clinical vertebral fractures.
• Include fracture costs, such as the societal perspective from healthcare, patient, and family costs and productivity losses as well as acute costs of managing a fracture. Include the direct costs of hip fractures associated with increased admission to nursing homes.
• Model an antiosteoporotic treatment for duration of time similar to randomized controlled trials, indications, or guidelines (eg, 3 or 5 years for antiresorptive, 12 to 24 months for anabolics). If sequential data are available, longer treatment may be considered with an anabolic followed by antiresorptive. The list of comparators should include “no treatment” (since that is still the current standard of care in most cases) and active comparators that are relevant for decision makers. Sequential therapy may be considered as intervention/comparators. Include efficacy data.
• Include the use of real-world medication adherence in an alternative scenario, as well as sensitivity analyses varying adherence levels. In real life, adherence to antiosteoporosis medications could be poor and affect clinical and economic outcomes.
• Include treatment effects after discontinuation, depending on treatment.

When reporting economic evaluations, the group said to:

• Present disaggregated outcomes (such as fracture events, life years, therapy/drug costs, other healthcare costs) for the intervention and comparator(s).
• Present incremental costs and outcomes between intervention and comparator(s).
• Report incremental cost-effectiveness ratio (in terms of costs per QALY gained).

Reference

Hiligsmann M, Reginster JY, Tosteson A, et al. Recommendations for the conduct of economic evaluations in osteoporosis: outcomes of an experts’ consensus meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the US branch of the International Osteoporosis Foundation [published online October 31, 2018]. Osteoporos Int. doi: 10.1007/s00198-018-4744-x.