CMS issues decision on coverage of Erythropoiesis Stimulating Agents (ESAs), C3 Cited in Ruling

By Carlea Bauman, Executive Director

In May 2007, the Centers for Medicare and Medicaid Services (CMS) announced a proposal to discontinue coverage for Erythropoiesis Stimulating Agents (ESAs), a type of drug that plays a big role for some with colorectal cancer. See “Proposed Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications (CAG-00383N)”.

ESAs, better known under brand names, Procrit, Epogen and Aranesp, were approved by the Food and Drug Administration (FDA) to aid with chemotherapy-induced anemia.

C3 was concerned about several aspects of the proposed ruling and submitted comments to CMS on June 13, 2007. This past Monday, July 30th, CMS issued its final ruling on ESA coverage.

The concerns raised by C3 made a difference for the thousands of Americans who rely on Medicare for their colorectal cancer care. Every issue we raised in our comments impacted CMS’s final decision.

Our concerns with the proposal involved limiting ESA coverage for the following conditions:

Any anemia associated with radiotherapy. In our comments, we mentioned that radiotherapy for rectal cancer patients was often coupled with chemotherapy, so when such patients suffered from anemia, it was often chemo-related. We suggested the wording be changed to distinguish between patients that are being treated with radiation only or radiation and chemotherapy.

THE RESULT: CMS’s decision distinguishes that the coverage be limited to anemia only associated with radiotherapy. In fact, CMS stated that the point raised by C3 played a role in the modification (page 15 of 61 of “Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications ((CAG-00383N)”).

Patients with treatment regimens including anti-angiogenic drugs such as bevacizumab; and Patients with treatment regimens including monoclonal/polyclonal antibodies directed against the epidermal growth factor (EGF) receptor. We disagreed with CMS that there was evidence to conclude the ESAs caused harm to colorectal cancer patients using anti-angiogenic drugs and antibodies that inhibit the EGF receptor. We stated that ruling such would negatively impact the 50,000 plus colorectal cancer patients who turn to these treatments to help fight their metastatic disease each year.

THE RESULT: CMS removed these conditions from its decision.

We also had questions about the dosage and duration limits that CMS proposed. These limits were:

• ESA use should be initiated at hemoglobin levels <9 or <10 in patients with symptomatic ischemic disease;
• The maximum treatment duration is 12 weeks/year;
• A maximum four week dose is 126,000 units for erythropoietin alpha and 630 ug for darbepoietin; and
• Continued administration of the drug is not reasonable and necessary if there is a rapid rise in hemoglobin/hematocrit >1g/dl/>3% after two weeks of treatment.

We did not request specific changes; rather, we questioned the evidence that led to the proposal.

THE RESULT: CMS removed and/or modified the following limits:

• Hemoglobin initiation levels was set at <10;
• The 12 weeks/year max was eliminated;
• The max four week dosage was eliminated; and
• In the case of a rapid rise in hemoglobin/hematocrit, one 25% dose reduction will be allowed as long as the hemoglobin remains below or falls back to 10 g/dL.

C3 was specifically mentioned in the decision as one of only three patient groups who met with CMS to discuss the proposed ruling (page 7 of 61 of “Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications ((CAG-00383N)”).

This is clear evidence of the direct impact of C3 on the colorectal cancer community.

We are grateful for CMS’s willingness to work with the patient advocacy community on this issue.