In a major boost for troubled Amgen, the US Senate has called on Medicare to reassess a recent decision to restrict coverage of the US biotechnology company's anaemia drugs.
The Senate passed a resolution requesting that the Centers for Medicare & Medicaid Services start reconsidering the final National Coverage Determination issued on July 30 on anaemia drugs for cancer patients, including Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa).
"The Centers for Medicare and Medicaid Services should begin an immediate reconsideration" of its decision "as soon as feasible and provide a briefing to Congress," said the resolution co-sponsored by Senators Arlen Specter, a Republican, and Democrat Frank Lautenberg.
The Medicare decision in July has hit Amgen’s sales and profit and in part led to the company’s recent announcement that it is restructuring to the extent that it will cut up to 14% of its workforce. The company previously described the move as unreasonable, impractical and “incompatible with good clinical practice".
In a bid to reverse the decision, Amgen has hired high-profile lobbyists with relationships to senior legislators and has canvassed Capitol Hill looking for help to put pressure on Medicare. The firm also received the support last week of the American Society of Clinical Oncology which said the new guidelines interfere with physicians' ability to treat patients.
Epogen and Aranesp generated nearly $7 billion in sales for Amgen last year, almost half its revenues.
Patent court case with Roche begins
Meantime, Roche’s chief executive Franz Humer says he remains confident of prevailing in a legal tussle with Amgen, which began yesterday and sees the US biotechnology company trying to stop the Swiss firm from selling rival anaemia drug Mircera (continuous erythropoietin receptor activator).
Last month, a US judge ruled that Mircera infringes a patent belonging to Amgen and limited some of Roche's challenges to the validity of the patent and four others owned by Amgen that are the subject of a trial. Mr Humer added that Roche would be “able to cope with” any restrictions that might be imposed on anaemia drugs by US regulators.