In a move that could further cut the sales of Amgen and Johnson & Johnson's pricey anemia drugs, the Centers for Medicare and Medicaid Services are reviewing their use to treat patients with kidney disease. The agency will take comments and documents till July 16, with a decision coming sometime this fall.
It's just the latest chapter of a long saga of safety concerns. Various studies and analyses have suggested that the class of drugs--including Epogen and Aranesp from Amgen and J&J's Procrit--can cause tumor growth in cancer patients, could cause heart and vascular problems when used at high dosages, and, most recently, may boost the risk of heart problems in kidney patients.
It's this latter analysis that prompted the latest Medicare move: An expert panel assembled by CMS recently concluded that the drugs could harm kidney patients, RBC Capital Markets analyst Michael Yee told Reuters. The drug at highest risk from a Medicare coverage change is Epogen, which is primarily marketed for use in kidney patients; Aranesp and Procrit are primarily used for cancer patients, though some $300 million of Aranesp's sales comes from kidney patients.
Medicare has already curtailed these drugs once, when it set a lower ceiling for the hemoglobin targets used to govern their use. Those restrictions effectively lowered doses--and sales. Amgen says it believes the current, restricted range of 10-12 grams per deciliter is still supported by the evidence (and by the drugs' current FDA labeling). The company plans to submit commentary and documents to CMS during the comment period, Reuters reports.
Meanwhile, FDA may gather its own expert panel later this year to consider these meds, Yee said. CMS might actually hold off on making any big changes until after the FDA weighs in, the analyst said.
- read the Reuters story