New Findings from Optum in the Area of Health Insurance Described (Assessment of off-label use of denosumab 60 mg injection during the early…

New Findings from Optum in the Area of Health Insurance Described (Assessment of off-label use of denosumab 60 mg injection during the early postmarketing period using health insurance claims data)

By a News Reporter-Staff News Editor at Insurance Weekly News -- Fresh data on Health Insurance are presented in a new report. According to news originating from Waltham, Massachusetts, by VerticalNews correspondents, research stated, "Off-label use of denosumab 60 milligram (mg) injection was assessed within an administrative claims database. The completeness of claims to assess off-label use was investigated with medical record review."

Our news journalists obtained a quote from the research from Optum, "Potential denosumab 60 mg off-label use was observed based on claims, but many had evidence of on-label indications based on medical record review. Denosumab 60 mg injection is approved in the USA to treat patients at high fracture risk due to postmenopausal osteoporosis, male osteoporosis, and hormone therapy for the treatment of prostate and breast cancers. Its RANK ligand-inhibiting effect makes it a candidate for the off-label treatment of other conditions mediated by the rate of bone resorption by osteoclasts. To better understand its utilization patterns, we assessed off-label use of denosumab 60 mg within an administrative claims database. Definite, probable, and possible denosumab 60 mg users were identified during the early postmarketing period within a claims database of a US healthcare insurer. Medical record review confirmed a sample of these users. Off-label use among definite and probable users and all chart-confirmed users was classified using claims-derived age, dose interval, and diagnosis and treatment received relative to the administration date. Among chart-confirmed users classified as off-label, patient characteristics related to treatment indication were abstracted from medical records to investigate the completeness of claims to study off-label medication use. Off-label use was identified based on claims in approximately 25 % of definite and probable denosumab 60 mg users and 35 % of chart-confirmed users. Medical record review identified evidence of on-label indications in 81 % of chart-confirmed users classified as off-label in claims. Many of the off-label denosumab 60 mg users had diagnoses or treatment consistent with on-label indications based on medical record review, suggesting these are under-recorded in claims data."

According to the news editors, the research concluded: "It is warranted to be cautious when using administrative databases to assess off-label medication use."

For more information on this research see: Assessment of off-label use of denosumab 60 mg injection during the early postmarketing period using health insurance claims data. Osteoporosis International, 2016;27(4):1653-1658. Osteoporosis International can be contacted at: Springer London Ltd, 236 Grays Inn Rd, 6TH Floor, London WC1X 8HL, England. (Springer - www.springer.com; Osteoporosis International - www.springerlink.com/content/0937-941x/)

The news correspondents report that additional information may be obtained from V. Hoffman, Optum, Epidemiol, Waltham, MA, United States. Additional authors for this research include F. Xue, B. Gardstein, K. Skerry, C.W. Critchlow and C. Enger.

Keywords for this news article include: Waltham, Denosumab, Massachusetts, United States, Immunotherapy, Off-Label Use, Medical Records, Health Insurance, Records as Topic, Drug Prescriptions, Monoclonal Antibodies, North and Central America

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