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

May 18, 2007 – On May 14th, the Centers for Medicare and Medicaid Services (CMS) posted a proposed national coverage policy that would govern Medicare coverage of ESAs in cancer and related neoplastic conditions.

Of paramount importance to ASH is to ensure that all coverage decisions are guided by the best available scientific evidence to ensure the highest degree of patient safety and to protect against not only the overuse of ESAs, but their underuse and misuse as well. Consequently, the Society is deeply concerned 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. 

In addition, ASH notes that 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. As FDA is the agency responsible for evaluating drugs for safety and efficacy, the Society believes CMS has overstepped its authority by attempting to make scientific judgments and issuing its proposal prior to FDA’s final decisions on this issue.

ASH will be commenting on the proposed policy and is planning a meeting with CMS to discuss concerns, in particular:

• Exclusion of use of ESAs to treat anemia of myelodysplasia. MDS is a bone marrow failure syndrome that can lead to leukemia. Effective treatment options for MDS are limited. 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 low-risk MDS (less than 5 percent blasts in their bone marrow) to decrease the need for blood transfusions.
• Maximum covered treatment duration of 12 weeks/year. ASH believes that the treatment recommendation should be based upon the disease. For chronic anemia of MDS, for example, the patient may require chronic treatment for 52 weeks. In patients who require repeated sessions of chemotherapy, 12 weeks is also an artificial limitation.
• Continued use of the drug in non-responders after four weeks of treatment. ASH believes the literature reflects that ESAs should not be continued after eight weeks in the absence of response, assuming the appropriate dose increase has been attempted in low-responders.
• Other proposed limitations of use of ESAs concerning continued administration. ASH believes these proposals are not clear or scientifically based, and should be excluded from coverage limitations.

ASH believes CMS’s proposed policy would have significant adverse consequences for patients with hematologic malignancies, particularly MDS. The Society will share its scientific justifications and recommendations with CMS by June 14 – the close of the public comment period, and hopes that the final policy will address its concerns. ASH’s Committee on Practice will also be meeting with key congressional offices on May 22nd to discuss these concerns.