Many patients receive immunotherapy prescriptions for off-label treatment, potentially contributing to unnecessary health care expenditures.
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Immunotherapies such as nivolumab (Opdivo, Bristol-Myers Squibb) and pembrolizumab (Keytruda, Merck) are indicated for specific disease states, or for patients with actionable genetic mutations. These therapies carry a high financial burden, and are recommended for use by appropriately selected patients only.
Jonas A de Souza, MD, assistant professor of medicine at University of Chicago Medicine (Chicago, IL), and colleagues analyzed insurance claims for nivolumab and pembrolizumab to determine the percentage of patients receiving off-label prescriptions, as well as the downstream effect of such prescriptions on the health care system, payers, and patients.
Researchers accessed the focalPoint database, which collects information from 168 oncology practices in the United States, representing more than 2000 oncologists. Using International Classification of Diseases codes, off-label prescriptions were defined as prescriptions codes for malignancies other than melanoma, non-small cell lung cancer, or head and neck cancer, as well as prescriptions for those malignancies prior to approval by the Food and Drug Administration. The researchers had access to primary insurance data, including amounts paid by insurance and patients’ fiscal responsibilities.
Between January 2015 and September 2016, 1570 patients were prescribed either nivolumab or pembrolizumab, representing 7687 distinct claims. Of these, 18% (n = 285) were deemed off-label, representing 978 distinct claims.
The costs associated with off-label immunotherapy prescriptions totaled $13.36 million, and ranged from $125,000 for patients covered by Medicaid (n = 5) to $7.74 million for patients covered by private insurance (n = 111). Patient responsibility totaled $1.06 million, with an average of $3 731 per patient; out-of-pocket costs ranged from $0 for patients covered by Medicaid to $7436 for patients covered by Original Medicare.
“The costs to the health care system, payers, and patients warrant increased efforts to regulate their use in off-label settings lacking sufficient scientific evidence, or while clinical trials are in progress,” Dr de Souza said.
