Amgen: anemia franchise faces challenges despite reassurances22nd August 2007
By Tijana Ignjatovic
Amgen's executives have attempted to reassure investors by suggesting that private insurers are unlikely to follow Medicare and Medicaid and reduce their coverage for anemia drugs. However, most insurers are reassessing their policies following the Centers for Medicare & Medicaid Services' decision to tighten usage and dosage for these products, which could further damage the company's revenues.
As a result of studies suggesting a link between erythropoietin (EPO) treatment and increased risk of death in cancer patients, the FDA introduced a black box warning for all Epo products in March this year. Consequently, sales of Amgen's top anemia drug, Aranesp, fell 19% in the second quarter of 2007. A further blow to Amgen then came following a decision by the US Centers for Medicare & Medicaid Services (CMS) to restrict reimbursement of these drugs to patients covered by their programs. Although CMS backed off its original drastic plan it still introduced some restrictions.
With roughly 40% of Amgen's EPO sales coming from Medicare, the CMS's decision made a considerable dent in Amgen's revenues. As Amgen is heavily reliant on its Epo franchise and the US market, changes in reimbursement policies of both government and private payers can have an enormous impact on its revenues. Amgen recently announced plans to cut up to 14% of its workforce in an effort to maintain its profits.
Amgen is currently hoping that private insurers will be reluctant or at least slow to follow the CMS's decision to restrict reimbursement. However, while private insurers may be slower to introduce restrictions on EPO, they are usually led by CMS's practice. Amgen is banking on the fact that private insurers are more likely to follow American Society of Clinical Oncology guidelines and that oncologists have the greater power to influence private insurers rather than Medicare.
This is not an end to Amgen's problems: its EPO products are facing competition. With the likely approval of Roche's Mircera (pegylated continuous erythropoietin receptor activator, CERA) for anemia associated chronic kidney disease, Amgen will be pushing very hard to prevent it from being marketed in the US based on patent infringement claims.
September will be an important month for Amgen. Its patent infringement court case is set to start and the FDA's Cardiovascular and Renal Drugs Advisory Committee is meeting to discuss risks and benefits of erythropoeisis-stimulating agents used in the treatment of anemia due to chronic renal failure. Amgen will be watching out for the FDA's decision and any changes in the reimbursement policies of private insurers or further restrictions by CMS very closely.
http://www.pharmaceutical-business-review.com/article_feature.asp?guid=B3F71F8B-A8D6-4CD6-87BC-6A66C2C7FDFF
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