Development and Validation of a Markov Microsimulation Model for the Economic Evaluation of Treatments in Osteoporosis

Hiligsmann, Mickaël; Ethgen, Olivier; Bruyère, Olivier; Richy, Florent; Gathon, Henry-Jean; Reginster, Jean‐Yves

doi:10.1111/j.1524-4733.2008.00497.x

Cited by 71 publications

(94 citation statements)

References 74 publications

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“…[20] This assumption is supported by recent studies showing that the number of fractures is a significant determinant of QOL. [44][45][46] …”

Section: Utilitiessupporting

confidence: 71%

“…Using tracker variables, the restrictive assumptions regarding patient movements to health states used in cohort models are not needed. [20] A patient can therefore go back to the 'no fracture' state, even after a hip or clinical vertebral fracture. For an illustration on how the model integrates memory, please refer to Hiligsmann et al [20] Model Inputs…”

Section: Bmd Measurement 47mentioning

confidence: 99%

“…[22] Because women might be institutionalized later in life, regardless of their hip fracture, an adjustment was made to only include long-term costs attributable to the fracture itself. [20] Non-hip fractures were conservatively assumed to be not associated with long-term costs.…”

Section: Cost Datamentioning

confidence: 99%

“…[20] The effect of denosumab on fracture risk was derived from the 3-year results of the FREEDOM trial. [13] As compared with placebo, denosumab reduced the risk of hip fracture by 40% (RR 0.60, 95% CI 0.37, 0.97), the risk of clinical vertebral fracture by 69% (RR 0.31, 95% CI 0.20, 0.47) and the risk of other fracture (including wrist fracture) by 20% (RR 0.80, 95% CI 0.67, 0.95) using the estimated fracture risk reduction for non-vertebral fractures.…”

Section: Interventionsmentioning

confidence: 99%

“…An updated version of a recently published and validated Markov microsimulation model [20] was used to assess the cost effectiveness of denosumab. For the purpose of this analysis, a 6-month cycle length was considered and several data values were updated, including the long-term cost following hip fracture and mortality rates.…”

Section: Model Structurementioning

confidence: 99%

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Cost Effectiveness of Denosumab Compared with Oral Bisphosphonates in the Treatment of Post-Menopausal Osteoporotic Women in Belgium

Hiligsmann

Reginster

2011

PharmacoEconomics

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Background: Denosumab has recently been shown to be well tolerated, to increase bone mineral density (BMD) and to significantly reduce the risk of hip, vertebral and non-vertebral fractures in the FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) trial. It is becoming increasingly important to evaluate not only the therapeutic value of a new drug but also the cost effectiveness compared with the most relevant treatment alternatives. Objective: The objective of this study was to estimate the cost effectiveness of denosumab compared with oral bisphosphonates (branded and generic drugs) in the treatment of post-menopausal osteoporotic women in Belgium. Methods: Cost effectiveness of 3 years of treatment with denosumab was compared with branded risedronate and branded and generic alendronate using an updated version of a previously validated Markov microsimulation model. The model was populated with relevant cost, adherence and epidemiological data for Belgium from a payer perspective and the results were presented as costs per QALY gained (h, year 2009 values). Analyses were performed in populations (aged ‡60 years) in which osteoporosis medications are currently reimbursed in many European countries, i.e. those with BMD T-score of -2.5 or less or prevalent vertebral fracture. Patients receiving denosumab were assumed to have a 46% lower risk of discontinuation than those receiving oral bisphosphonates, and the effect of denosumab after treatment cessation was assumed to decline linearly to zero over a maximum of 1 year. Results: Denosumab was cost effective compared with all other therapies, assuming a willingness to pay of h40 000 per QALY gained. In particular, denosumab was found to be cost effective compared with branded alendronate and risedronate at a threshold value of h30 000 per QALY and denosumab was dominant (i.e. lower cost and greater effectiveness) compared with risedronate from the age of 70 years in women with a T-score of -2.5 or less and no prior fractures. The cost effectiveness of denosumab compared

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“…[20] This assumption is supported by recent studies showing that the number of fractures is a significant determinant of QOL. [44][45][46] …”

Section: Utilitiessupporting

confidence: 71%

Section: Bmd Measurement 47mentioning

confidence: 99%

Section: Cost Datamentioning

confidence: 99%

Section: Interventionsmentioning

confidence: 99%

Section: Model Structurementioning

confidence: 99%

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Cost Effectiveness of Denosumab Compared with Oral Bisphosphonates in the Treatment of Post-Menopausal Osteoporotic Women in Belgium

Hiligsmann

Reginster

2011

PharmacoEconomics

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Cost-effectiveness of bazedoxifene compared with raloxifene in the treatment of postmenopausal osteoporotic women

Hiligsmann

Sedrine

Reginster

2012

Journal of Bone and Mineral Research

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Bazedoxifene is a novel selective estrogen receptor modulator (SERM) for the prevention and treatment of osteoporosis. In addition to the therapeutic value of a new agent, evaluation of the cost-effectiveness compared with relevant alternative treatment(s) is an important consideration to facilitate healthcare decision making. This study evaluated the cost-effectiveness of bazedoxifene compared with raloxifene for the treatment of postmenopausal women with osteoporosis. The cost-effectiveness of treatment for 3 years with bazedoxifene was compared with raloxifene using an updated version of a previously validated Markov microsimulation model. Analyses were conducted from a Belgian healthcare payer perspective and, the base-case population was women (aged 70 years) with bone mineral density T-score À2.5. The effects of bazedoxifene and raloxifene on fracture risk were derived from the 3-year results of a randomized, double-blind, placebo-controlled and active-controlled study, including postmenopausal women with osteoporosis. The cost-effectiveness analysis based on efficacy data from the overall clinical trial indicated that bazedoxifene and raloxifene were equally cost-effective. When the results were examined based on the subgroup analysis of women at higher risk of fractures, bazedoxifene was dominant (lower cost for higher effectiveness) compared with raloxifene in most of the simulations. Sensitivity analyses confirmed the robustness of the results, which were largely independent of starting age of treatment, fracture risk, cost, and disutility. In addition, when the cost of raloxifene was reduced by one-half or when incorporating the raloxifene effects on reducing breast cancer, bazedoxifene remained cost-effective, at a threshold of s35,000 per quality-adjusted life-years gained, in 85% and 68% of the simulations, respectively. Under the assumption of improved antifracture efficacy of bazedoxifene over raloxifene in women with high risk of fractures, this study suggests that bazedoxifene can be considered cost-effective, and even dominant, when compared with raloxifene in the treatment of postmenopausal osteoporotic women. ß

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Inclusion of Compliance and Persistence in Economic Models

Kadambi¹,

Leipold²,

Kansal³

et al. 2012

Appl Health Econ Health Policy

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Economic models are developed to provide decision makers with information related to the real-world effectiveness of therapeutics, screening and diagnostic regimens. Although compliance with these regimens often has a significant impact on real-world clinical outcomes and costs, compliance and persistence have historically been addressed in a relatively superficial fashion in economic models. In this review, we present a discussion of the current state of economic modelling as it relates to the consideration of compliance and persistence. We discuss the challenges associated with the inclusion of compliance and persistence in economic models and provide an in-depth review of recent modelling literature that considers compliance or persistence, including a brief summary of previous reviews on this topic and a survey of published models from 2005 to 2012. We review the recent literature in detail, providing a therapeutic-area-specific discussion of the approaches and conclusions drawn from the inclusion of compliance or persistence in economic models. In virtually all publications, variation of model parameters related to compliance and persistence was shown to have a significant impact on predictions of economic outcomes. Growing recognition of the importance of compliance and persistence in the context of economic evaluations has led to an increasing number of economic models that consider these factors, as well as the use of more sophisticated modelling techniques such as individual simulations that provide an avenue for more rigorous consideration of compliance and persistence than is possible with more traditional methods. However, we note areas of continuing concern cited by previous reviews, including inconsistent definitions, documentation and tenuous assumptions required to estimate the effect of compliance and persistence. Finally, we discuss potential means to surmount these challenges via more focused efforts to collect compliance and persistence data.

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Development and Validation of a Markov Microsimulation Model for the Economic Evaluation of Treatments in Osteoporosis

Cited by 71 publications

References 74 publications

Cost Effectiveness of Denosumab Compared with Oral Bisphosphonates in the Treatment of Post-Menopausal Osteoporotic Women in Belgium

Cost Effectiveness of Denosumab Compared with Oral Bisphosphonates in the Treatment of Post-Menopausal Osteoporotic Women in Belgium

Cost-effectiveness of bazedoxifene compared with raloxifene in the treatment of postmenopausal osteoporotic women

Inclusion of Compliance and Persistence in Economic Models

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