Investor jitters eased somewhat as the Centers for Medicare & Medicaid Services' plans for reimbursement of erythropoietin (EPO) stimulating agents (ESAs) became clearer, and backers of Amgen Inc. found cause for encouragement on two fronts.
CMS declared minimal changes in reimbursement for Amgen's anemia drugs Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), when used in kidney disease, but a decision regarding oncology isn't due until Aug. 12-and the plan there turned out to be a shocker.
The main policy revision for ESAs in kidney disease drops payments by half when hemoglobin levels reach 13 g/dL for three months in a row. The boundary line now is 13 g/dL for six months.
In May CMS said it wanted to pay at lower rates for ESAs for people with certain cancers and related neoplastic conditions, following advice from an FDA committee to curb their use. A "black box" warning went on the labels for Amgen and Aranesp as well as Procrit (epoetin alfa), the ESA marketed by Johnson & Johnson. (See BioWorld Financial Watch, May 2 1, 2007.)
Users are cautioned that the drugs boosted the risk of death and cardiovascular events, cut the time to tumor progression in patients with advanced head and neck cancer who got radiation therapy and shortened overall survival while increasing deaths because of disease progression at four months in metastatic breast cancer patients on chemo.
In cancer …
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