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Group Calls for Off-Label Drug Claims Reimbursement Guide

A single guide on what off-label drug uses qualify for federally-funded claims reimbursement would improve care delivery, researchers say.

By Jacqueline LaPointe

- The federal government should develop a single resource that clarifies what off-label drug uses would qualify for federally-funded claims reimbursement, researchers stated in a recent study in the Journal of the American Medical Association.

Providers need a single guide on what off-label drugs uses would receive claim reimbursement, researchers say

CMS currently uses five approved compendia to make federal payment decisions regarding the use of off-label drugs, but researchers at the University of North Carolina Lineberger Comprehensive Cancer Center reported that the separate reference guides developed by third-parties often use “weak quality” evidence when approving some off-label uses. The report also stated that there are many inconsistencies between and within the guides.

“The quality and consistency of these very important compendia resources is not what it should be, given the level of scrutiny that's appropriate for highly toxic and expensive cancer drugs,” said Ethan Basch, MD, MSc, Director of the University of North Carolina’s Lineberger Comprehensive Cancer Center's Cancer Outcomes Research Program. “We could be causing substantial suffering for cancer patients because of the sometimes cavalier use of off-label drugs. A new, more rigorous approach is warranted in order to protect our patients."

CMS determines if its healthcare programs will reimburse providers for the off-label use of prescription drugs based on the five approved compendia. If the off-label cancer drug is supported by at least one of the compendia, then CMS will provide coverage.

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  • “Thus, the compendia, as the major source for federal payment decisions for off-label cancer drugs, have an influential role in the cost of cancer treatment,” wrote the authors of the study. “However, there is limited transparency about how compendia are assembled or about conflicts of interest on the part of their contributors, and there are substantial inconsistencies both between and within these resources.”

    While the CMS-approved compendia apply to Medicaid and Medicare reimbursement requirements, private payers also use the third-party guides to support coverage decisions. However, the compendia usually differ from the CMS-approved guides as well as by state and within payer organizations, the study stated.

    In addition to inconsistencies in the use of compendia to make healthcare payment decisions, researchers also found that the compendia themselves contain evidence that is “less rigorous than the standards supporting FDA-approved drugs.”

    “Evidence cited by the compendia was often not up-to-date and differed from evidence retrieved through an independent search by the authors,” stated the study. “This raises concern that payers may be compelled to cover inadequately proven treatments for which the risks outweigh benefits. Despite the findings of this systematic review, this issue has not been addressed since then.”

    For example, the study showed that erlotinib, a tyrosine kinase inhibitor used to treat non-small lung and pancreatic cancer, had no off-label indications in the American Hospital Formulary Service guide, one indication in the Clinical Pharmacology resource, eight indications in the DrugDex compendium, and three indications in the National Comprehensive Cancer Network guide. However, CMS would still reimburse providers for off-label use of the drug because there is at least one indication.

    “Development of the compendia-based model for coverage decisions originated in an era when fewer drugs were available for patients, the cost of oncology drugs was lower, there was less appreciation of the potential long-term harms of treatments, and views on evidentiary standards differed from today,” the authors wrote. “Given changes in the landscape of cancer treatment and costs, this model should be reassessed.”

    Researchers advised the federal government to create a single pharmaceutical resource that can be used to determine federally-funded claims reimbursement. The guide should use clear methodological standards for assessing evidence and developing indications for off-label coverage. The resource should be publicly available for free to ensure providers have access to the information.

    The resource should also reject all contributors that may have a financial relationship with the pharmaceutical industry to promote healthcare transparency and prevent manufacturers from lobbying for claims reimbursement coverage, the study recommended.

    “Although this work would entail substantial effort, it would undoubtedly be less than the current compendia efforts and would likely lead to more rigorous indications,” wrote the authors. “This approach also could alleviate concerns about conflicts of interest among current compendia contributors and would likely engender greater transparency.”

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