ASH Comments on Medicare Proposed National Coverage Policy on Erythropoiesis-Stimulating Agents (ESAs)

June 13, 2007 – ASH submitted comments to the Centers for Medicare and Medicaid Services (CMS) in response to the agency’s proposed national coverage policy that would govern Medicare coverage of ESAs in cancer and related neoplastic conditions.

ASH’s comments stress the Society’s deep concern that CMS’s proposed coverage decision inappropriately restricts use of ESAs because a number of the proposals are not supported by scientific data, rely on poor quality data, or are in conflict with expert scientific analysis.

A complete copy of ASH’s comments can be found online. Major concerns about the proposed coverage decision include:

• The proposed policy does not take into consideration recommendations made by FDA’s Oncology Drug Advisory Committee during a May 10th meeting, particularly a determination that the anemia of myelodysplasia (MDS) should not be included in decisions for restricted use.
• The proposed policy conflicts with a CMS-approved quality measure for the Physician Quality Reporting Initiative (PQRI) involving the use of ESAs in MDS patients, contradicting the national consensus about appropriate quality care and demonstrating a lack of internal consistency within the agency.
• The proposed policy excludes use of ESAs to treat anemia of myelodysplasia. As ASH indicated in preliminary comments to CMS and to the FDA, there is evidence to support the use of ESAs in patients with anemia associated with MDS (less than 5 percent blasts in their bone marrow) to decrease the need for blood transfusions.
• The proposed policy maximum covered treatment duration of 12 weeks is without support in clinical evidence. ASH believes this proposal is arbitrary and could hurt Medicare beneficiaries who are prescribed chemotherapy regimens in excess of 12 weeks or who require multiple courses in a year.
• The proposed policy maximum covered treatment dose is inconsistent with the FDA-approved dosing regimen for ESAs.
• The proposed policy to discontinue use of ESAs in non-responders after four weeks is not based on scientific evidence.
• The proposed policy to all ESA therapy for beneficiaries with cancer only within clinical research studies is inappropriate and unprecedented for any Medicare covered drug or biological, and is not justified based on the multitude of published evidence supporting ESA use.

CMS has up to 60 days to review the public comments and issue a final decision. ASH plans to meet with CMS during this time to discuss the Society’s concerns and work with CMS to evaluate the evidence. ASH will keep its members apprised of new developments.