Lawmakers scrutinize Amgen dialysis drug

Lawmakers scrutinize Amgen dialysis drug

By Matthew Perrone, AP Business Writer | June 25, 2007

WASHINGTON --Biotech drug developer Amgen plans to release dosage data for its top-selling anemia drug to try and head off congressional action that could threaten sales.

The House Ways and Means Subcommittee on Health is scheduled to meet Tuesday to scrutinize how Medicare pays for Amgen's drug Epogen, which is used to treat anemia in patients on dialysis. Democratic Chairman Pete Stark, D-Calif., and other lawmakers have argued that Medicare's current payment system creates an incentive for doctors to over-prescribe the drug in order to collect more money from the government.

But Amgen, which is not scheduled to testify at the hearing, said it will release data on Tuesday showing that doctors have scaled back their use of the drug in recent months.

Last year, the government spent about $2 billion on the drug, which posted annual sales of $4.12 billion for Amgen Inc..

Members of Congress have gained more leverage for changing the Medicare payment system in recent months after studies showed that over prescribing anemia drugs can increase risk of death. In March FDA added new labeling to Epogen and other anemia treatments warning doctors to prescribe the drugs at the lowest levels appropriate.

"Health risks associated with higher doses and well-documented flaws in a payment system that encourages higher dosing highlights that this issue is ripe for re-examination," Stark said, in a statement issued ahead of the hearing.

Amgen executives say recent figures gathered from dialysis clinic operators like DaVita Inc. show a more conservative approach to prescribing the treatment. Given this change in use, Amgen's Vice President for Reimbursement Josh Ofman argues there is no need for Medicare to rework its payment method.

"Amgen will support any payment policy that better supports the health of dialysis patients," Ofman said in an interview. "But based on our analysis, we do not see a compelling policy reason or clinical rationale for Congress to mandate a change right now."

Congressional advisers have suggested Medicare should move to a bundled payment system, in which Epogen payments would be lumped into reimbursement for all other services provided to dialysis clinics.

However, Amgen argues such a system could actually cause doctors to under utilize Epogen, putting dialysis patients at risk.

http://www.boston.com/business/technology/biotechnology/articles/2007/06/25/lawmakers_scrutinize_amgen_dialysis_drug/