Senate Resolution Asks CMS to Reconsider ESA Coverage Decision

September 12, 2007

The Senate passed a resolution asking the Centers for Medicare & Medicaid Services (CMS) to reconsider its determination for reimbursements of erythropoiesis-stimulating agents (ESAs).

The resolution, S. Res. 305, was passed by unanimous consent Sept. 4. The CMS issued a final coverage decision restricting reimbursement to low-dose levels of ESAs in cancer settings in July.

These restrictions include limiting initiation of ESA therapy to when a patient’s hemoglobin levels are less than 10g/dL, limiting the ESA treatment duration to a maximum of eight weeks after a chemotherapy session ends, limiting the starting dose to the FDA-recommended starting dose and limiting dose escalation levels, the CMS said.

The CMS proposed new limitations on its ESA reimbursement policies after the FDA issued a public health advisory on ESAs and required manufacturers to include a black box warning on the labels because of an increased risk of death and serious life-threatening side effects.

The final coverage decision concerns physicians and patients and could “severely compromise” the quality of cancer care in the U.S., the resolution says. It also asks for the CMS to consult with oncologists to determine appropriate revisions to the coverage decision.

There is a strong possibility that the resolution will not cause the CMS to change its national coverage decision, according to an analyst from Friedman, Billings, Ramsey (FBR). The analyst called the resolution “window dressing” and said the House would most likely not pass a similar resolution.

Sens. Thad Cochran (R-Miss.) and Kent Conrad (D-N.D.) asked other senators to sign a letter urging the CMS to reconsider its draft decision because it could reduce access to ESAs for cancer patients. Forty-six senators signed the letter, according to the FBR analyst, but the CMS still issued a “more onerous” final coverage decision than the draft decision.

Shares of Amgen, which manufacturers the ESA Aranesp (darbepoetin alfa), rose nearly 4 percent after the Senate resolution passed. U.S. sales of Aranesp fell 18 percent to $587 million in the second quarter of 2007, compared with the same period last year. Due to the sales losses, Amgen announced it would lay off 2,200 to 2,600 employees. — Emily Ethridge