CMS is asking its Medicare Evidence Development and Coverage Advisory Commission to examine the use of erythropoiesis stimulating agents to manage anemia in patients with chronic kidney disease and the use of pharmacogenomic testing in the diagnosis and treatment of cancer.

In an Aug. 20 announcement on the agency Web site, CMS says it has called the March 24, 2010, meeting of the panel, noting, "Medicare currently does not have a national coverage determination for the use of ESAs for anemia in patients who have CKD."

The announcement notes that it is "common practice" to administer ESAs to CKD patients who have anemia, but not necessarily only to those who are at risk for transfusion." The agency says those at risk of transfusion were the recipients when ESAs were introduced in 1989.

"Currently, over 95 percent of end-stage renal disease patients receive ESAs," the agency continues. "It is unclear how many pre-ESRD CKD patients receive ESAs for anemia."

This is not the first time CMS has broached the concept of exploring the use of the national coverage determination process to examine the use of ESAs in the renal setting. In a July 30, 2008, posting on its Web site, the subject was included in a list of potential NCD topics (Also see "As Amgen Drops Some ESA “Overhangs,” New Payment Threat Appears" - Pink Sheet, 4 August, 2008.). In response to the list, ESA manufacturer Amgen, along with industry and patient advocacy groups, called on CMS to back away from considering an NCD until data suggests the need for a closer look (Also see "NCD On ESAs In Renal Setting Opposed By Physicians, Patients, And Amgen" - Pink Sheet, 13 October, 2008.).

A CMS spokesman did not have any further clarity on what prompted the agency to ask MedCAC to take a closer look. He said more information would be available when the agenda for the meeting, including the specific questions the agency wants answered, is published, although no timeframe for that was given.

Of Amgen's two ESAs, Aranesp (darbepoetin alfa) and Epogen (epoetin), the latter is primarily used for treating anemia in the renal setting. The company's ESA franchise took a hit in 2007 when CMS restricted coverage of ESA usage in the non-renal setting (Also see "Medicare ESA Coverage Will Not Experiment With Clinical Trial Approach" - Pink Sheet, 6 August, 2007.). The company also could be facing greater competition from competitors as well as more pressure on sales under forthcoming CMS rules that will bundle dialysis drugs and services.

Johnson & Johnson's the ESA Procrit (epoetin alfa), which is primarily marketed for use outside of the renal setting.

Pharmacogenomic Testing In Cancer Meeting In January

The agency also asked MedCAC "to consider and make recommendations to CMS regarding the evidence that supports the use of pharmacogenomic testing in the diagnosis and treatment of cancer," according to a separate Aug. 20 meeting announcement.

"Evidence from clinical studies suggests that tumor genetic factors may be significant markers or predictors for tumor's development and sustained growth, and for its likely response to certain anti-cancer agents," CMS says in the announcement for the meeting scheduled for Jan. 27, 2010. "It may be possible to extrapolate from such evidence that pharmacogenomic testing might benefit Medicare beneficiaries with malignancies by providing: better and timelier diagnostic and prognostic information to guide treatment decisions; improved prediction of the more effective anti-cancer agent(s) for an individual; and more informed patient-specific guidance on minimizing adverse effects of chemotherapy."

The request comes on the heels of a CMS decision that it will cover genetic testing related to the blood thinner warfarin only within controlled clinical studies because there was not enough evidence to show improved beneficiary health outcomes with testing (Also see "CMS Will Cover Warfarin Gene Tests In Clinical Trials, But That's It" - Pink Sheet, 10 August, 2009.).

For pharmacogenomic testing in cancer, the agency says it wants "to ensure that Medicare beneficiaries have access to any demonstrated improved health outcomes of pharmacogenomic testing, and are protected from inaccurate or inappropriate pharmacogenomic testing that could compromise therapy or increase the risks of adverse events during therapy."

-Gregory Twachtman (g.twachtman@elsevier.com)

MedCAC To Examine ESAs In Chronic Kidney Disease, Pharmacogenomic Testing In Cancer

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