Cost-effectiveness of romosozumab for the treatment of postmenopausal women with severe osteoporosis at high risk of fracture in Sweden

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Abstract

Summary

Romosozumab is a novel bone-building drug that reduces fracture risk. This health economic analysis indicates that sequential romosozumab-to-alendronate can be a cost-effective treatment option for postmenopausal women with severe osteoporosis at high risk of fracture.

Purpose

To estimate the cost-effectiveness of sequential treatment with romosozumab followed by alendronate (“romosozumab-to-alendronate”) compared with alendronate alone in patients with severe osteoporosis at high risk of fracture in Sweden.

Methods

A microsimulation model with a Markov structure was used to simulate fractures, costs, and quality-adjusted life years (QALYs), for women treated with romosozumab-to-alendronate or alendronate alone. Patients aged 74 years with a recent major osteoporotic fracture (MOF) were followed from the start of treatment until the age of 100 years or death. Treatment with romosozumab for 12 months was followed by alendronate for up to 48 months or alendronate alone with a maximum treatment duration of 60 months. The analysis had a societal perspective. Efficacy of romosozumab and alendronate were derived from phase III randomized controlled trials. Resource use and unit costs were collected from the literature. Cost-effectiveness was estimated using incremental cost-effectiveness ratio (ICER) with QALYs as effectiveness measures.

Results

The base case analysis showed that sequential romosozumab-to-alendronate treatment was associated with 0.089 additional QALYs at an additional cost of €3002 compared to alendronate alone, resulting in an ICER of €33,732. At a Swedish reference willingness-to-pay per QALY of €60,000, romosozumab-to-alendronate had a 97.9% probability of being cost-effective against alendronate alone. The results were most sensitive to time horizon, persistence assumptions, patient age, and treatment efficacy.

Conclusion

The results of this study indicate that sequential romosozumab-to-alendronate can be a cost-effective treatment option for postmenopausal women with severe osteoporosis at high risk of fracture.

Supplementary Information

The online version contains supplementary material available at 10.1007/s00198-020-05780-8.

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Most cited references 30

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Osteoporosis in the European Union: medical management, epidemiology and economic burden

E. Hernlund, A Svedbom, M Ivergård … (2013)

Summary This report describes the epidemiology, burden, and treatment of osteoporosis in the 27 countries of the European Union (EU27). Introduction Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risk of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for affected patients and substantial costs to society. The aim of this report was to characterize the burden of osteoporosis in the EU27 in 2010 and beyond. Methods The literature on fracture incidence and costs of fractures in the EU27 was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Results Twenty-two million women and 5.5 million men were estimated to have osteoporosis; and 3.5 million new fragility fractures were sustained, comprising 610,000 hip fractures, 520,000 vertebral fractures, 560,000 forearm fractures and 1,800,000 other fractures (i.e. fractures of the pelvis, rib, humerus, tibia, fibula, clavicle, scapula, sternum and other femoral fractures). The economic burden of incident and prior fragility fractures was estimated at € 37 billion. Incident fractures represented 66 % of this cost, long-term fracture care 29 % and pharmacological prevention 5 %. Previous and incident fractures also accounted for 1,180,000 quality-adjusted life years lost during 2010. The costs are expected to increase by 25 % in 2025. The majority of individuals who have sustained an osteoporosis-related fracture or who are at high risk of fracture are untreated and the number of patients on treatment is declining. Conclusions In spite of the high social and economic cost of osteoporosis, a substantial treatment gap and projected increase of the economic burden driven by the aging populations, the use of pharmacological interventions to prevent fractures has decreased in recent years, suggesting that a change in healthcare policy is warranted.

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Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis.

C M Klotzbuecher, P. D. Ross, P B Landsman … (2000)

Numerous studies have reported increased risks of hip, spine, and other fractures among people who had previous clinically diagnosed fractures, or who have radiographic evidence of vertebral fractures. However, there is some variability in the magnitudes of associations among studies. We summarized the literature and performed a statistical synthesis of the risk of future fracture, given a history of prior fracture. The strongest associations were observed between prior and subsequent vertebral fractures; women with preexisting vertebral fractures (identified at baseline by vertebral morphometry) had approximately 4 times greater risk of subsequent vertebral fractures than those without prior fractures. This risk increases with the number of prior vertebral fractures. Most studies reported relative risks of approximately 2 for other combinations of prior and future fracture sites (hip, spine, wrist, or any site). The confidence profile method was used to derive a single pooled estimate from the studies that provided sufficient data for other combinations of prior and subsequent fracture sites. Studies of peri- and postmenopausal women with prior fractures had 2.0 (95 % CI = 1.8, 2.1) times the risk of subsequent fracture compared with women without prior fractures. For other studies (including men and women of all ages), the risk was increased by 2.2 (1.9, 2.6) times. We conclude that history of prior fracture at any site is an important risk factor for future fractures. Patients with a history of prior fracture, therefore, should receive further evaluation for osteoporosis and fracture risk.

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Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis

Andreas Grauer, Paul D Meisner, Michelle Fan … (2017)

Romosozumab is a monoclonal antibody that binds to and inhibits sclerostin, increases bone formation, and decreases bone resorption.

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Author and article information

Contributors

E. Söreskog: emma.soreskog@quantifyresearch.com

Journal

Journal ID (nlm-ta): Osteoporos Int

Journal ID (iso-abbrev): Osteoporos Int

Title: Osteoporosis International

Publisher: Springer London (London )

ISSN (Print): 0937-941X

ISSN (Electronic): 1433-2965

Publication date (Electronic): 6 January 2021

Publication date PMC-release: 6 January 2021

Publication date (Print): 2021

Volume: 32

Issue: 3

Pages: 585-594

Affiliations

[1 ]Quantify Research, Stockholm, Sweden

[2 ]GRID grid.11835.3e, ISNI 0000 0004 1936 9262, University of Sheffield, ; Sheffield, UK

[3 ]GRID grid.411958.0, ISNI 0000 0001 2194 1270, Mary MacKillop Institute for Health Research, Australian Catholic University, ; Melbourne, Australia

[4 ]Lund University, Skåne University Hospital, Malmö, Sweden

[5 ]GRID grid.421932.f, ISNI 0000 0004 0605 7243, UCB Pharma, ; Brussels, Belgium

[6 ]GRID grid.8761.8, ISNI 0000 0000 9919 9582, Geriatric Medicine, Department of Internal Medicine and Clinical Nutrition, , Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, ; Gothenburg, Sweden

[7 ]GRID grid.1649.a, ISNI 000000009445082X, Geriatric Medicine Clinic, , Sahlgrenska University Hospital, ; Mölndal, Sweden

[8 ]GRID grid.4714.6, ISNI 0000 0004 1937 0626, Karolinska Institutet, ; Stockholm, Sweden

[9 ]UCB Pharma, Stockholm, Sweden

Article

Publisher ID: 5780

DOI: 10.1007/s00198-020-05780-8

PMC ID: 7929944

PubMed ID: 33409591

SO-VID: 1f552364-22e7-4e9e-96fc-8622379e8f9b

License:

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 27 August 2020

Date accepted : 4 December 2020

Funding

Funded by: UCB Pharma

Funded by: FundRef http://dx.doi.org/10.13039/100002429, Amgen;

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ScienceOpen disciplines: Orthopedics

Keywords: cost-effectiveness,economic evaluation,imminent fracture risk,markov-microsimulation model,osteoporosis,recent fracture

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ScienceOpen disciplines: Orthopedics

Keywords: cost-effectiveness, economic evaluation, imminent fracture risk, markov-microsimulation model, osteoporosis, recent fracture

Cost-effectiveness of romosozumab for the treatment of postmenopausal women with severe osteoporosis at high risk of fracture in Sweden

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Most cited references 30

Osteoporosis in the European Union: medical management, epidemiology and economic burden

Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis.

Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis

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