Cost-effectiveness of denosumab vs zoledronic acid for prevention of skeletal-related events in patients with solid tumors and bone metastases in the United States

Stopeck, Alison; Rader, Michael; Henry, David H.; Danese, Mark D.; Halperin, Marc; Cong, Ze; Qian, Yi; Dansey, Roger; Chung, Karen

doi:10.3111/13696998.2012.675380

Cited by 50 publications

(80 citation statements)

References 40 publications

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“…In addition, a recent cost-effectiveness analysis using data from the pivotal phase III study of denosumab versus zoledronic acid in patients with breast cancer showed reductions in SREs and increased quality-adjusted life years (QALY) with denosumab. In patients with breast cancer and bone metastases, the cost per SRE avoided was $13,557 and the cost per QALY gained was $78,915, which is commonly considered good value in the United States (25). The skeletal complications experienced by patients with advanced breast cancer and bone metastases often require aggressive management, including radiation to bone for treatment of pain and treatment or prevention of pathologic fractures.…”

Section: Discussionmentioning

confidence: 99%

Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

Martín

Bell

Bourgeois

et al. 2012

Clinical Cancer Research

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121

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Purpose: Denosumab was shown to be superior to zoledronic acid in preventing skeletal related events (SRE) in patients with breast cancer and bone metastases in a randomized, double-blind phase III study. We evaluated further results from this study related to skeletal complications and health-related quality of life (HRQoL).Experimental Design: Patients were randomized 1:1 to receive subcutaneous denosumab 120 mg (n ¼ 1,026) and intravenous placebo, or intravenous zoledronic acid 4 mg (n ¼ 1,020) and subcutaneous placebo every 4 weeks. Analyses reported here include the proportion of patients with one or multiple onstudy SREs, time to first radiation to bone, time to first SRE or hypercalcemia of malignancy, and change in HRQoL (functional assessment of cancer therapy-general).Results: Fewer patients receiving denosumab than zoledronic acid had an on-study SRE (31% vs. 36%, P ¼ 0.006). The incidence of first radiation to bone was 12% (n ¼ 123) with denosumab versus 16% (n ¼ 162) with zoledronic acid. Denosumab prolonged the time to first radiation to bone by 26% versus zoledronic acid (HR, 0.74; 95% confidence interval [CI], 0.59-0.94, P ¼ 0.012) and prolonged the time to first SRE or hypercalcemia of malignancy by 18% (HR, 0.82; 95% CI, 0.70-0.95; P ¼ 0.007). Ten percent more patients had a clinically meaningful improvement in HRQoL with denosumab relative to zoledronic acid, regardless of baseline pain levels.Conclusions: Denosumab was superior to zoledronic acid in reducing bone-related complications of metastatic breast cancer and maintained HRQoL, providing an efficacious, well-tolerated treatment option for patients with bone metastases from breast cancer.

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Section: Discussionmentioning

confidence: 99%

Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

Martín

Bell

Bourgeois

et al. 2012

Clinical Cancer Research

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121

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“…Esto podría suponer una sobreestimación de los costes asociados al manejo de estos eventos al no considerarse que algunos ERE podrían ser consecuencia de otros, por ejemplo una intervención quirúrgica consecuencia de una fractura patológica. Por otro lado, el uso de tasas de ERE procedentes de ensayos clínicos realizados en poblaciones con criterios de inclusión restrictivos supondría una infraestimación de la tasa de estos eventos frente a las observadas en condiciones de prác-tica clínica habitual [24]. Esta premisa subestima el ahorro producido con la introducción de denosumab.…”

Section: Discussionunclassified

“…Adicionalmente se evaluó un escenario en el que se consideraron las tasas anuales de ERE observadas en práctica clínica [24], un escenario en que se consideró un precio neto para AZ igual a 0,00 € y otro que incluyó el coste de manejo de los AA asociados a denosumab y AZ. Los AA incluidos fueron los de toxicidad renal, hipocalcemia y osteonecrosis mandibular por su relevancia clínica y económi-ca.…”

Section: Análisis De Sensibilidadunclassified

Análisis del impacto presupuestario de denosumab para la prevención de eventos relacionados con el esqueleto en adultos con metástasis óseas de tumores sólidos en España

Seguí

Durán

Roldán

et al. 2014

PharmacoEcon Span Res Artic

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“…Denosumab also delayed the first occurrence of substantial pain compared to ZA and maintained health-related quality of life in patients [23]. Based on clinical outcomes, denosumab is more effective for inhibiting osteoclast-induced bone resorption, as bone turnover markers were significantly suppressed [11].…”

Section: Discussionmentioning

confidence: 99%

Safety of Denosumab Versus Zoledronic Acid in Patients with Bone Metastases: A Meta-Analysis of Randomized Controlled Trials

Chen¹,

Pu²

2016

Oncol Res Treat

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Introduction: Bone metastases lead to local bone destruction and skeletal complications. Bisphosphonates, particlulaly zoledronic acid (ZA), play a central role in the treatment of bone metastases. Some studies have shown that denosumab may delay and prevent SREs in metastatic bone disease more effectively than ZA; therefore, we systematically reviewed and assessed the safety of denosumab and ZA. Methods: The PubMed, EMBASE, Cochrane Library, Web of Science with Conference Proceedings, Elsevier, and China National Knowledge Infrastructure (CNKI) databases were searched up to October 2015. 2 independent reviewers extracted data from each eligible study using a standard protocol, and both fixed-effects and random-effects models were used to analyze and evaluate the data extracted from eligible articles. Results: 6 randomized controlled trials enrolling 13,733 patients were included. Occurrences of adverse events were generally similar between the denosumab and ZA groups except anemia and anorexia in patients with bone metastases and back pain and bone pain. However, occurrences of serious adverse events such as hypocalcaemia , renal adverse events , and new primary malignancy were significantly different between the denosumab and ZA groups. Only the occurrence of osteonecrosis of the jaw showed no significant difference between the denosumab and ZA groups in patients with bone metastases. Conclusion: Denosumab was safer in delaying or preventing skeletal-related events in patients with bone metastases and prevented pain progression compared to ZA in this meta-analysis.

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Cost-effectiveness of denosumab vs zoledronic acid for prevention of skeletal-related events in patients with solid tumors and bone metastases in the United States

Abstract: Denosumab is a cost-effective treatment option for the prevention of SREs in patients with advanced solid tumors and bone metastases compared to ZA. The overall value of denosumab is based on superior efficacy, favorable safety, and more efficient administration.

Cited by 50 publications

References 40 publications

Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

Análisis del impacto presupuestario de denosumab para la prevención de eventos relacionados con el esqueleto en adultos con metástasis óseas de tumores sólidos en España

Safety of Denosumab Versus Zoledronic Acid in Patients with Bone Metastases: A Meta-Analysis of Randomized Controlled Trials

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