Biotechnology Healthcare - July/August 2008 - (Page 9)

HEALTH PLAN CONFIDENTIAL Is There a Better Way To Guide Payers On Off-Label Coverage? Amanda Brower, Senior Contributing Editor P erhaps nowhere is off-label use of prescription information a certain credibility because an article “has drugs more common than in oncology, where undergone an evaluation by independent, authoritative clinadvances in research outpace the U.S. Food and icians and [has] been judged to be relevant, truthful, and not Drug Administration’s regulatory process. In fact, misleading,” Scott Gottlieb, MD, resident fellow at the as much as 75 percent of all anticancer treatments are used American Enterprise Institute and a former FDA senior ofoff label, according to National Comprehensive Cancer ficial, argued recently in his Health Affairs blog. Perhaps Network estimates. Since 1993, Medicare has been remore importantly for Centers for Medicare & Medicaid Serquired to pay for an off-label use when it is cited in at least vices and private payers, the change would give official one of the compendia listed in Medicare law.1 sanction to a library of real-world evidence from which to draw from for off-label coverage decisions. “To a great extent, health plans have shied away from trying to manage oncology agents because of the sensitivity BECAUSE IT SAYS SO Most payers, including Medicare, require that an of the issue and the limited information off-label use be listed in one of the recognized available regarding the safety and efficacy compendia before they will cover that use. But the of using certain oncology agents to treat system of relying on the compendia to make reimvarious types of cancer,” says Renee bursement and utilization decisions is flawed, conRizzo Fleming, RPh, MBA. Fleming is tends Elan Rubinstein, PharmD, MPH, principal of principal of East Amherst, N.Y.-based EB Rubinstein Associates, in Oak Park, Calif. “PayPRN Managed Care Consulting Services, ers are having doctors depend on the compendia as and is a former MCO pharmacy director. “CMS has made a to when to use the drug, but the compendia are not The FDA approves a drug for a specific very conscious deciuse. It does not regulate how medicine is sion” to review safety necessarily very trustworthy, consistent, or strong in how they develop the evidence in the first place.” practiced, one reason why manufacturers data, and private Those shortcomings were illustrated in “Commay not feel compelled to seek new FDA health plans have pendia for Coverage of Off-Label Uses of Drugs and indications. If a drug is prescribed widely quickly followed suit, says Renee Rizzo Biologics in an Anticancer Chemotherapeutic Regand effectively off label, the manufacturer Fleming, RPh, MBA. imen,” a report released last year by the U.S. Agency may have no incentive to seek FDA apfor Healthcare Research and Quality. The AHRQ report proval, says Jessica Berg, JD, professor of law and bioethics found that, often, the literature cited in the compendia2 is at Case Western Reserve University in Cleveland. Nor, she not the most recent or most valid available, and that a “lack adds, is the FDA equipped to handle an influx of applicaof transparency makes it difficult to determine whether tions to convert off-label uses to approved indications. omitted references had been identified but excluded … or That may be one reason why the FDA recently proposed never identified and considered.” Moreover, the compendia guidance for manufacturers on sharing information about are organized by drugs rather than by clinical presentation off-label uses. In what is widely seen as an acknowlor disease — the way clinical practice guidelines are orgaedgement that many such uses become standard medical nized — thus negating the opportunity to compare therapractice before the FDA can give formal approval, the peutic choices. Finally, the report found discrepancies agency has proposed “good reprint practices” — standards among versions of the same compendia — not just in print allowing manufacturers to use medical journals in some versus electronic versions, but also between electronic vercases to present evidence of the effectiveness of an offsions of the same compendium. The authors did not make label use. Publication in a peer-reviewed journal gives the recommendations for improving compendia or for bringing 1 The compendia listed in Medicare law are the American Hospital uniformity to their methods, nor did they suggest alternate Formulary Service-Drug Information, United States Pharmacopoeia-Drug Information (USP-DI), and the American Medical Association Drug Evaluation. The AMA compendium was later folded into USP-DI, which last year was succeeded by Drug Points. 2 The report evaluated USP-DI, Facts & Comparisons, NCCN Drugs and Biologics Compendium, Clinical Pharmacology, Drugdex, and the American Hospital Formulary Service-Drug Information. JULY/AUGUST 2008 · BIOTECHNOLOGY HEALTHCARE 9

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - July/August 2008

Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

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