However, recent reductions and the consolidation of available compendia have fueled a growing desire for transparency. In the past, many compendia were used, from American Hospital Formulary Service Drug Information (AHFS-DI) and National Comprehensive Care Network (NCCN) to Clinical Pharmacology, United States Pharmacopeia Drug Information (USPDI), American Medical Association Drug Evaluations (AMA-DE), DrugPoints, and DRUGDEX. Therefore, a positive or negative listing can have a significant impact on whether or not a pharmaceutical product is covered, ultimately affecting prescribing decisions and patient access to medications. Through this process, experts may deem certain off-label uses as "acceptable" as a result of their review of the clinical data. Unlike disease treatment guidelines that are indexed by disease, these compendia should be indexed by drug or biologic. According to the Centers for Medicare and Medicaid Services (CMS), a compendium should include a summary of pharmacologic characteristics for each drug/biological that may include dosage and recommended uses. Drug compendia, defined as summaries of drug information, affect coverage and reimbursement decisions for pharmaceutical products, and as a result, it's important for pharmaceutical manufacturers and healthcare providers to understand the role and impact of compendia off-label listings.ĬURRENT MEDICARE AND MEDICAID COVERAGE CRITERIAĭrug compendia are defined as summaries of drug information that are compiled by experts who have reviewed clinical data on drugs. The current compendia landscape, though constantly in flux, impacts everything from payer approval of off-label use to manufacturer patient access initiatives. Most insurers, including Medicare, refer to compendia when making policy and coverage decisions, and therefore, a positive or negative listing can have a significant impact on whether or not a pharmaceutical product is covered-ultimately, affecting prescribing decisions and patient access to medication treatments. Several drug compendia are currently published to outline FDA-approved uses of medications and evaluations of non-FDA-approved uses. Although FDA approval process may not always be a feasible option for additional indications, guidance is needed to determine which uses are medically appropriate. In fact, between 50% and 75% of all chemotherapy agents are prescribed "off-label." As a result, off-label coverage has become an important component to patient access to medications. Due to the rapid advancement of drugs and biological agents, especially in oncology, physicians often prescribe drugs for uses other than what they have been approved for by FDA. Drug compendia, defined as summaries of drug information, affects coverage and reimbursement decisions for pharmaceutical products, and as a result, it's important for pharmaceutical manufacturers and healthcare providers to understand the role and impact of compendia off-label uses.
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