Last May, the Center for Medicare & Medicaid Services proposed limiting coverage, which worried Wall Street. But the agency then received more than 2,600 comments, many from doctors and patient groups who argued the proposal was draconian, lacked scientific evidence and could harm patients.
"CMS blinked," Geoff Porges, an analyst with Sanford Bernstein, tells Bloomberg News. "In the face of massive outcry from patients, cancer physicians and others in the cancer community, CMS backed up on the restrictions."
Medicareâ€™s final "national coverage determination" still retains significant restrictions - the program won't cover usage to treat the anemia caused by cancer itself, as opposed to anemia caused by chemo, The New York Times notes. And the meds are only approved only for the anemia from chemo, even though they'd been widely used by patients not getting chemotherapy. But other proposed restrictions have been lifted, such as barring reimbursement for use during chemo for certain types of cancer.
Medicare also relaxed requirements for beginning anemia treatment. In May, the agency proposed docs should wait until a patientâ€™s hemoglobin dropped below 9 grams per deciliter, close to the point at which blood transfusions would be considered. Now, the agency says treatment could begin when the hemoglobin level drops to 10.
Another analyst, Jim Reddoch of Friedman Billings Ramsey, says there's a big negative for Aranesp in the Medicare decision, and "that is to specify that the 10 grams per deciliter isn't just the threshold for initiating, but also the threshold for maintenance use. We, and our doctor consultants, had read the (coverage) draft as meaning that after the initiation, a patient would be managed in a 10-12 range, but this final (coverage) says less-than-10 is the initation level, but also the target. This, in itself, nets out the positives, and made the final (coverage determination) a net negative, albeit slight, to our Aranesp estimates."
Safety concerns and Medicare coverage have hurt sales of the EPO meds. Worldwide sales of Aranesp fell 10 percent in the second quarter from a year earlier, to $949 million, the Times notes. In the US, the decline was 19 percent, to $578 million. J&J's worldwide sales of Procrit fell 6 percent, to $758 million. In the US, sales plunged 14 percent, to $449 million.