Amgen Cites Study on Its Anemia Drug
When it comes to defending its anemia drug business, Amgen Inc. of Thousand Oaks is betting that less is more.
Over the weekend, the biotech giant released data from a large clinical trial suggesting that patients who take shots of its drug Aranesp every two weeks do as well as those who take weekly shots of Procrit, a drug from Johnson & Johnson.
Amgen hopes the study will persuade Medicare to raise payments for Aranesp, which is reimbursed at a lower rate than Procrit in hospital outpatient clinics. Such clinics account for 10% of Aranesp sales.
Amgen and J&J; are heated rivals in the anemia drug business, and Medicare payments for anemia drugs used by cancer patients exceed $1 billion annually. The rivalry dates to the 1980s, when Amgen licensed Procrit to J&J.; Aranesp is a longer-acting version of Procrit that Amgen is using to take back the business it ceded to J&J.;
Medicare said Tuesday that it had received Amgen’s data and was “looking at it.” However, a spokesman for the agency noted that the research hadn’t been published in a “peer-reviewed medical journal;” such studies typically have more weight with the agency.
Amgen presented its results at the annual meeting of the American Society of Clinical Oncology in Chicago. The Amgen study involved 1,173 anemic cancer patients, many of them women with breast cancer. They received Aranesp shots every other week for 15 weeks.
At the end of the trial, hemoglobin levels in 71% of patients rose by 2 grams per deciliter. The outcome is similar to that in patients in previous tests who received weekly Procrit doses, said Douglas W. Blayney of Wilshire Medical Oncology Group, an investigator in the Amgen-sponsored trial.
Hemoglobin, a protein in the blood that carries oxygen, is used to measure anemia, which is caused by a lack of red blood cells. Chemotherapy treatments can deplete red blood cells in cancer patients and Aranesp and Procrit boost the production of those cells.
J&J; disputed Amgen’s contention that one dose of Aranesp equals two doses of Procrit. Hemoglobin rises faster in patients who receive the standard weekly dose of Procrit, said Scott McKenzie, a research director for J&J; unit Ortho-Biotech.
Amgen’s study is part of an effort to persuade Medicare to revise the formula it uses to calculate reimbursement for anemia drugs. The current payment formula considers a weekly dose of Procrit the “functional equivalent” of a weekly dose of Aranesp. Amgen argues that the ratio is wrong, but until now did not have a large research study to use as evidence.
However, Medicare said it wanted to see well-controlled, head-to-head studies comparing the two drugs. The National Cancer Institute plans to launch such a study for Medicare but it won’t be completed by fall, when the agency must set its drug reimbursement rates for next year.
