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Compendia Decisions Impact Off-Label Coverage

Butcher, Lola

doi: 10.1097/01.COT.0000326167.89228.b6

In the first major review of its coverage-policy source documents in 15 years, the Centers for Medicare & Medicaid Services (CMS) has added the National Comprehensive Cancer Network Drugs and Biologics Compendium and DrugDex, published by Thomson Micromedex, as new sources of coverage decisions for off-label use of cancer drugs.

CMS, the nation's largest payer for cancer care, also decided not to add DrugPoints, also published by Thomson Micromedex, as an authorized compendium. One more decision—whether to include Clinical Pharmacology, is expected around July 2.

The changes to CMS's list of compendia are coming in the first of what will become an annual review process. The decisions may influence private payers, who frequently follow CMS's lead in developing their own coverage policies.

Decisions about new compendia are important because at least 50% of cancer treatment is off-label, said David Silk, a manager at Avalere Health who tracks drug coverage issues. This forces payers, who generally base coverage policy on Food and Drug Administration labels, to use other sources of information to decide which treatments will be covered.

By law, CMS is required to use approved compendia and peer-reviewed journals to inform its payment policies for off-label indications of anti-cancer drugs, and some private payers generally follow suit. The reliability of some peer-reviewed journals is being called into question amid revelations that studies they published were tainted by scientists' questionable financial ties.

Thus, payers—just like oncologists—are hungry for new sources of guidance about which drugs and biologics are appropriate for which indications. While payers are driven largely by the goal of limiting expensive therapies that are unlikely to work, they also want to know which treatments are more likely to harm a patient they help.

“I don't think this is simply a case of ‘Are we diverting resources that might be used for something else and the patient might get something they didn't need but ha, ha, so what?,’” Louis B. Jacques, MD, Director of CMS's Division of Items and Devices, said during an audioconference hosted by Avalere.

“The world wastes a lot more money than we will in any particular chemotherapy regimen. Frankly, these drugs can kill people. To expose the Medicare beneficiary or anyone else to a toxin without a reasonable expectation that the exposure will result in a health benefit is unconscionable.”

The recent decisions affect only the compendia that CMS uses to make coverage determinations for anti-cancer chemotherapy drugs. But the agency also wants to update the list of compendia used to determine covered drugs under the Medicare Part D program and Medicaid program, and is exploring options for doing so.

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Today's Situation

Since 1993, the Medicare program has been required to pay for the off-label use of a cancer treatment if it is listed in an approved drug compendia or if at least two articles in approved peer-reviewed journals give it a thumbs-up. Additionally, the local Medicare carrier medical director may also extend coverage to drugs on its own authority.

Of the original three compendia authorized in the 1993 law, only one—the American Hospital Formulary Service Drug Information, or AHFS DI—is still available. The American Medical Association Drug Evaluations (AMA DE) merged with U.S. Pharmacopoeia Drug Information, or USP DI, several years ago, and the resulting compendium, subsequently purchased by a new owner, ceased publication in 2007. According to the publisher, Thomson Healthcare, USP DI has been rolled into a successor publication called DrugPoints.

Last year, Medicare announced a new annual process for changing the list of compendia approved for use in determining coverage for off-label cancer drugs. Each year requests for changes to the list can be made between January 15 and February 15, and decisions will be made mid-year.

CMS is evaluating the compendia based on a list of desirable characteristics outlined during a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC), an advisory body to CMS on coverage decisions and policy (see box).

CMS sought public comment as part of the review process and plans to publish the basis for its decisions when they are announced. Thus, private payers may use CMS's decision-making process to help with their own.

“It will be interesting to see if private payers are going to be more aggressive in adopting this trend, given that everyone is aware of the analysis that CMS went through to decide,” said Mandy Bazile, a director at Avalere Health.

One of the highest priorities, Dr. Jacques said, is to ascertain whether the compendia listing can be trusted.

“The area of conflict of interest surrounding not only compendia but also medical journal articles and the recent retractions due to incomplete disclosure and conflicts of interest are something that we are very much aware of,” he said. “In fact, the Congressional word that we got suggested that this could be the prime criteria by which we would view this.”

The American Society of Health-System Pharmacists officially recommended that CMS bolster the MedCAC list of desirable characteristics by adding “demonstrated independence from pharmaceutical manufacturers, health insurances, and pharmacy benefits managers” and “demonstrated evidence-based objectivity.”

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What Private Payers Do

Most private payers currently use multiple compendia to inform their coverage policies and decision-making, said Gary M. Owens, MD, a former health plan executive who now owns his own company, Gary Owens Associates.

About 57% of private payers current use a combination of DrugPoints, AHFS-DI and the National Comprehensive Cancer Network (NCCN) compendia, Dr. Owens said at the Avalere audioconference, citing unpublished results of a survey of 60 health plans with more than 90 million members:

  • ▪ 13% of plans used DrugPoints and AHFS-DI.
  • ▪ 13% used AHFS-DI only.
  • ▪ 9% used DrugPoints only.
  • ▪ 6% used the NCCN compendium only.

In March, UnitedHealthcare, one of the nation's largest private payers, made news when it chose the NCCN Compendium to be its official reference for off-label use of chemotherapy drugs used in outpatient settings. In doing so, United said it will automatically approve claims consistent with the NCCN Drugs & Biologics Compendium.

Citing the fact that the NCCN uses guidelines developed by oncologists as the basis for its compendium listings, Lee Newcomer, MD, UnitedHealthcare's Senior Vice President for Oncology, said that the new policy essentially transfers the decisions about appropriate therapies away from United to oncologists.

Another reason for the move, Dr. Newcomer said, was to make the information about UnitedHealthcare coverage policy more accessible to patients and physicians, who could look it up on the NCCN Web site.

Dr. Derek van Amerongen, Chief Medical Officer of Humana Health Plan of Ohio, expects other private payers will take a long look at UnitedHealthcare's experience with the strategy before they jump to follow.

“It really impacts the flexibility of payers to make decisions,” said Dr. Amerongen, also a participant in the Avalere audioconference. “When you have a black-and-white scenario, that sounds great in theory, but there are going to be so many situations where a case doesn't fit neatly into the black-and-white division.”

While he suspects that UnitedHealthcare hopes to diminish appeals by using a single compendium, Dr. Amerongen said he is doubtful that will happen:” The fact that there is one single compendium that's recognized does not mean that you're going to avoid this ‘battle of compendia’ or ‘my evidence versus your evidence,’” he said.

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What Compendia Should Include, According to MedCAC, the Medicare Evidence Development and Coverage Advisory Committee

  • ▪ Extensive breadth of listings.
  • ▪ Quick throughput from application for inclusion to listing.
  • ▪ Detailed description of evidence reviewed for every individual listing.
  • ▪ Use of pre-specified published criteria for weighing evidence.
  • ▪ Use of prescribed published process for making recommendations.
  • ▪ Publicly transparent process for evaluating therapies.
  • ▪ Explicit “not recommended” listing when validated evidence is appropriate.
  • ▪ Explicit listing and recommendations regarding therapies, including sequential use or combination in relation to other therapies.
  • ▪ Explicit “equivocal” listing when validated evidence is equivocal.
  • ▪ Process for public identification and notification of potential conflicts of interest of the compendia's parent and sibling organizations, reviewers, and committee members, with established procedure to manage conflicts.
© 2008 Lippincott Williams & Wilkins, Inc.
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