MedicalResearch.com Interview with:
Charles L.Shapiro MD
Professor of Medicine
Director of Translational Breast Cancer Research
Director of Cancer Survivorship
Division of Hematology/Oncology
Tisch Cancer Institute
New York, NY
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The new 2017 ASCO guidelines for the use bone-modifying in individuals with bone metastases recently endorsed every 3-month zoledronic, because of high level evidence from three randomized trials, including our trial (published in Jama in Jan 2017, first author Himelstein et al) that giving zoledronic acid every 3-months was non-inferior to the standard of monthly zoledronic. The guidelines also concluded that there was not one preferred bone modifying agent of the other, despite the fact the comparing monthly zoledronic to monthly denosumab in women with bone metastases, denosumab delayed the time to first skeletal-related event (pathological fractures, necessity for radiation or surgery, and spinal cord compression) and subsequent events by 23% (or in absolute terms about 3 months) . Zoledronic acid became generic in 2013, whereas monthly denosumab is still patented until 2022-25.
MedicalResearch.com: What should readers take away from your report?
Response: With this as background we performed a cost-effectiveness analysis comparing every 3-month zoledronic acid to monthly denosumab. The total costs of treatment strategy (which include costs of drug, administration, and costs of SRE) are $5,667.00 and $57,200.00/year, for generic every 3-month zoledronic acid and monthly denosumab, respectively. In other words, monthly denosumab is 9-fold more expensive than generic every 3-month zoledronic acid. In a set of sensitivity analyses, where we assumed that probability of skeletal-related events on denosumab were reduced 50%, 75%, and 90% relative to every 3-month zoledronic acid, the costs of monthly denosumab per mean skeletal-related event avoided ranged between $162,918.00 and $347,655.00.
Strengths of study: this is one of the only cost-effectiveness studies not sponsored by companies that make zoledronic acid (Novartis) and denosumab (Amgen). As one can imagine the sponsor who made the drug concluded that their drug was more cost-effective.
Potential weakness: As in all studies of this kind using Markov modeling, the model chosen and the assumptions made can influence the results. Also, this study only considered two-year time period. No prior study and the current study did incorporate patient preferences. For example, patient preferences for subcutaneous injections (denosumab) versus IV administration (zoledronic acid).
MedicalResearch.com: Is there anything else you would like to add?
Response: The bottom line as we move toward a value-based health care model (simply stated as the benefit to patient/over the costs of treatment) every 3-month zoledronic acid is more cost-effective and viable option to monthly denosumab when costs are considered. Everyone acknowledges that health care costs are going up, but in US where any physician can essentially prescribe any drug, without regard to what it costs, these kind of cost-effectiveness analysis may have influence on physician choice of drug. This system is not sustainable and we can’t keep on ignoring the cost of drugs.
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Cost-Effectiveness Analysis of Monthly Zoledronic Acid, Zoledronic Acid Every 3 Months, and Monthly Denosumab in Women With Breast Cancer and Skeletal Metastases: CALGB 70604 (Alliance)
Charles L. Shapiro, James P. Moriarty, Stacie Dusetzina, Andrew L. Himelstein, Jared C. Foster, Stephen S. Grubbs,
DOI: 10.1200/JCO.2017.73.7437 Journal of Clinical Oncology – published online before print October 12, 2017
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