Healthy Skepticism Library item: 1201
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Kocs D, Fendrick AM.
Effect of off-label use of oncology drugs on pharmaceutical costs: the rituximab experience.
Am J Manag Care 2003 May; 9:(5):393-400
http://web.archive.org/web/20070527141019/http://www.cbc.ca/disclosure/archives/040217_adr/resources.html
Abstract:
BACKGROUND: While the off-label use of oncology interventions is widespread, the factors influencing off-label use and the resultant influence on oncology drug expenditures are not well understood. STUDY DESIGN: To assess the indications for rituximab use, a retrospective review was undertaken at a single academic center between September 1998 and June 2001. METHODS: Patient diagnoses were linked to pharmacy records, and each administration of rituximab was classified as either on-label or off-label as defined by FDA-approved indications. The resultant utilization patterns were the foundation for a conceptual model designed to identify factors that influence off-label use of oncology-related therapeutics and forecast the effect of off-label use on aggregate oncology drug expenditures. RESULTS: One hundred one patients received a total of 428 rituximab administrations during the study period. Most (320, 75%) of the administrations were for off-label indications. Although the extent of off-label and on-label use grew at a similar rate initially, off-label utilization increased nearly exponentially over time as on-label uses lessened. A conceptual model that describes factors that promote, inhibit, or have a mixed influence on off-label use may help predict future patterns of off-label utilization and allow better forecasting of oncology drug expenditures. CONCLUSIONS: The off-label use of rituximab is substantial. Projections of oncology-related patterns of care and drug expenditures must account for the potential for off-label use.
Keywords:
Academic Medical Centers
Antibodies, Monoclonal/adverse effects
Antibodies, Monoclonal/economics
Antibodies, Monoclonal/therapeutic use*
Antineoplastic Agents/adverse effects
Antineoplastic Agents/economics
Antineoplastic Agents/therapeutic use*
Cancer Care Facilities
Drug Approval
Drug Costs*
Drug Labeling*
Drug Utilization Review*
Education, Pharmacy, Continuing
Female
Health Services Research
Hospital Costs*
Humans
Male
Middle Aged
Neoplasms/classification
Neoplasms/drug therapy*
Retrospective Studies
United States
