Off-Label Use of Cancer Drugs Is Slowing, Survey Shows

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Off-Label Use of Cancer Drugs Is Slowing, Survey Shows

Elsevier Global Medical News. 2008 Dec 23, A Ault

WASHINGTON (EGMN) - Although oncologists are still actively using cancer

therapies off label, a growing number say they have cut back, largely

because of coverage and reimbursement issues, according to a survey

conducted by the Association of Community Cancer Centers.

Matt Farber, manager of provider economics and public policy at the

Rockville, Md.-based ACCC, presented the survey data at a meeting sponsored

by Avalere Health and the American Cancer Society in December. The study was

sponsored by the ACCC, the Pharmaceutical Research and Manufacturers of

America (PhRMA), and the Biotechnology Industry Organization (BIO). An

outside contractor conducted the survey in June 2008, sending out

solicitations to 3,500 office-based oncology practices.

A total of 165 practices responded, but it was a good mix of urban and

suburban practices, and of varying practice sizes, said Mr. Farber.

Respondents were asked 11 questions, the majority of which probed the

practices' off-label use of therapies and how this use is handled by payers.

The survey was conducted before the Centers for Medicare and Medicaid

Services (CMS) expanded its list of Part B-recognized drug compendia and a

list of acceptable peer-reviewed literature. These are used by Medicare's

local contractors to make coverage decisions, Mr. Farber said.

Of the respondents, 50% (82) said that off-label use was extremely

important. The three primary reasons cited for importance of an off-label

use were that the evidence supported the use; that there were no or few

approved treatments; and that other therapies already had been tried or

there were no other alternatives.

In all, 26% (42) of the practices said that their off-label use had

increased in the past 5 years, but that was down from 42% of respondents in

a 2005 survey, Mr. Farber said. The slowdown is due to more difficulty

getting coverage, according to the practices.

That is leading to some changes in practice, Mr. Farber said. A total of 45%

(74) of practices said they frequently or very frequently changed their

clinical decision making in response to Medicare reimbursement policies, and

40% (66) said the same in response to private payer policies.

Practices also are being denied coverage for uses that they believe should

be covered, Mr. Farber said. In all, 22% (36) of practices said Medicare had

denied coverage for uses listed as accepted in a compendia, and 25% (42)

said that private payers had denied coverage.

The problems with reimbursement are leading to treatment delays, the survey

found, with 71% (117) of respondents saying that off-label policies led to a

treatment delay of 8 days or more, out to as long as 90 days.

The practices reported that they use a variety of sources when making

off-label treatment decisions, with a large majority saying that

peer-reviewed medical literature, abstracts from medical meetings, and drug

compendia are the most important. Slightly fewer than half relied on

information from colleagues, and only 36% (59) said they used their own

clinical experience as a guide.

A total of 91% (150) urged the CMS to recognize multiple compendia as a base

for off-label coverage decisions. They also said that CMS should ensure that

local contractors know about current off-label coverage requirements, Mr.

Farber said. It is not clear yet whether the CMS' recent expansion of

acceptable sources for coverage decisions will have a positive effect on

oncology practices, but it should be monitored, he said.

Full survey results are available on the ACCC's Web site

(http://www.accc-cancer.org/public_policy/publicpolicy_coverageissues.asp .