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Biotech takes issue with move to limit reimbursement.
Amgen and Johnson & Johnson continue to defend erythropoiesis stimulating agents (ESAs) as the Centers for Medicare and Medicaid Services (CMS) move to limit reimbursement of these lightening-rod agents.
Scientific debate has centered on whether the use of red-blood-cell boosters Aranesp (darbepoetin alfa) and Procrit (epoetin alfa) increases the risk of death in cancer patients. But CMS' move--and reverberations among commercial payers--may do more bottom-line harm than any black-box warning.
In its comments to CMS, Amgen urged the public payer not to overstep its bounds--implying that it might be acting out of turn in setting reimbursement restrictions before scientific conclusions have been reached.
"CMS should acknowledge the role of the FDA in its judicious evaluation of the safety profile of ESAs," officers wrote, "and avoid using coverage policy to play the role of the FDA by issuing prescribing instructions."
Both Amgen and J&J note that the problems have turned up only when investigators studied the drugs for experimental uses. Amgen also cautioned CMS to avoid "coverage parameters that have never been studied in clinical trials or utilized in clinical practice." It also refuted 10 of 18 CMS coverage recommendations.
The topic of ESAs was heavily anticipated at J&J's analyst meeting last week, too. In their joint presentation, group chair Kris Peterson and group president of R&D Jay Siegel defended the therapies as "safe and effective."
They presented several studies that showed no effect on either survival or tumor progression in patients with cancer who take the medications for chemo-related anemia--though they did acknowledge that the risk of blood clots is "well-known and reflected in the label." But they blamed the mortality risks on the medical conditions linked to these blood clots, like obesity and higher baseline levels of hemoglobin.
Amgen has been hardest hit by the ESA controversy, which has dogged the biotech all season and even overshadowed its R&D news at last week's big American Society of Clinical Oncology confab. The company has also gone on a bit of a shopping spree, snatching up San Franciso-based Ilypsa and Cambridge, MA-based Alantos, both with strength in nephrology.