Amgen Responds to Final CMS National Coverage Determination on Use of Erythropoiesis-Stimulating Agents in Oncology

CMS recently tried to glut tohe use of ESAs ESAs have had considerable backing in trial results EsAs situation is just a continuation of the reimbursement disaster being established by CMS with indemity plans to follow

The recent CMS guidelines restrict ESA use in all cancer patients ( including MDS) whose hemoglobin level is less than 10. This is quite reasonable, although some patients with considerable symptoms at higher hemoglobins may not benefit from ESA. A " bidding war" between JNJ and Amgen to get insurer contracts may lead to higher discounts and lower prices; a major benefit to patients.

My understading id medicare need to cover all FDA indicated drugs. Here CMS violating FDA indication for Aranesp and procrit

CMS's erythropoietin (Epo) guidelines have been released and Amgen is commenting and of course complaining.

Another example of the erosion of a physicians autonomy. While recent data has suggested some concerns with the use of ESA's in cancer patients, the risk of cardiovascular and thromboembolic events was associated with HgB>12. Certainly, in the past we were less cautios about the HgB. CMS has now mandated how we can use a drug, irrespective of the data that's published, and for only a certain amount...

Decrease use by 20-25% use of ESA. This may lead discounting and higher rebate from both amgen and orto-biotech to sustain market share. Since most of amgen contract with aranesp and neulasta use. It may effect use of neulasta. Next 6 month CMS may restrict use of Neulasta and neupogen for neutropenia associated with chemotherapy.