Mounting evidence suggests that a 2007 Medicare coverage decision has severely curtailed the use of ESAs for chemotherapy-induced anemia. And, despite continued support for ESA use among major professional associations such as ASCO and ASH, the CMS curbs are now hitting the patients of private payers as well.

Under the stringent new guidelines, CMS (Centers for Medicare & Medicaid Services) now covers ESAs (erythropoiesis-stimulating agents) only to prevent anemia-related blood transfusions, not to treat chemotherapy-induced quality-of-life symptoms such as fatigue.

Many viewed CMS's national coverage determination (NCD) on ESAs as a convenient maneuver to curb Medicare's burgeoning budget. CMS countered that its decision was evidence-based. CMS spoke, now what?

Apparently, CMS got what it wanted; the NCD has already cut deeply into ESA use by Medicare recipients, saving the agency millions of dollars. Shortly after the final NCD was announced, leading oncology organizations became worried that major private payers would follow Medicare's reimbursement template, further grinding ESA usage to a halt.

Echoing their trepidation, several US senators, including Arlen Specter (R-Penn), introduced a resolution stating that CMS should consult with leaders in the oncology community and revise the NCD according to their recommendations. CMS stood firm, refusing to alter the guidelines.

Usage drops

According to anecdotal data and judging from the market's response, it seems the oncology community's concern was well founded. By the third quarter of 2007, Amgen reported that use of darbepoetin (Aranesp) had dropped a staggering 36% in the United States.

In The RPM Report, Amgen's executive vice president of commercial operations, George Morrow, noted that use of ESAs in chemotherapy-induced anemia patients is down 30% to 40%, even though no private payers have adopted payment policies as restrictive as those of CMS.