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Original Source: FD (FAIR DISCLOSURE) WIRE
. Arvind Sood, Amgen, VP IR . Kevin Sharer, Amgen, Chairman, CEO
. Roger Perlmutter, Amgen, EVP, R&D . Gene Mack, HSBC Securities, Analyst . George Morrow, Amgen, EVP, Global Commercial Operations
. Geoff Meacham, JP Morgan, Analyst . Joel Sendek, Lazard Capital Markets, Analyst . Michael Aberman, Credit Suisse, Analyst . Willam Sargent, Banc of America Securities, Analyst . Mike King, Rodman & Renshaw, Analyst . Eric Ende, Merrill Lynch, Analyst . Maged Shenouda, UBS, Analyst . Steve Harr, Morgan Stanley, Analyst . Richard Yeh, Citigroup, Analyst . Jim Birchenough, Lehman Brothers, Analyst . Jim Reddoch, FBR, Analyst
AMGN announced on 11/08/07 that it will submit new evidence to CMS in support of a formal reconsideration of National Coverage Decision for ESA use in oncology issued by CMS in July 2007. Co. will file formal request for reconsideration of National Coverage Decision in the next few days.
S1. ESA Labels & NCD Update (K.S.) 1. Highlights: 1. Has new ESA labels for the US and agreement on new labels for Europe.
2. Working closely with FDA and the European regulatory authorities to ensure that these new labels properly informs physicians and patients regarding the safety and efficacy of
AMGN's ESA medicines. 3. Has reviewed with FDA an extensive pharmacovigilance program, which Co. will immediately commence once it has agreement with FDA on the protocol details. 1. These pharmacovigilance efforts on addition to the earlier programs agreed to after 2004 ODAC. 2. Will promptly report FDA positions and patients with result of these programs as Co. achieves results. 4. Announced on 11/08/07 that AMGN will submit new evidence to CMS in support of a formal reconsideration of National Coverage Decision for ESA use in oncology issued by CMS in July 2007. 5. Shares CMS' commitment of patients and their desire to ensure that Medicare patients receive necessary and appropriate medical treatment. 6. To this end the oncology community, AMGN, and CMS have worked collaboratively to arrive at consensus-based, patient-centric
provisions for most aspects of the NCD. 1. Joins patients, physicians and medical societies including ASCO and ASH, all of whom have disagreed with the CMS decision to apply reimbursement cap for Medicare patients at a hemoglobin level of 10 grams per deciliter.
2. FDA and EMEA labels made clear that the safety sealing on
ESAs is a hemoglobin level of 12 grams per deciliter and permit position to use their clinical discretion in treating patients experiencing chemotherapy-induced anemia up to a level of 12 grams per deciliter.
7. Reimbursement cap in the National Coverage Decision removes
that discretion from positions and is inconsistent with best
medical practice guidelines. 8. National Coverage Decision also results in two classes of treatment. 1. [Luxury] standard of care for Medicare patients than for those patients covered by private cares. 9. Will file formal request for reconsideration of National Coverage Decision in the next few days. 1. Will ask the Medicare patients receiving chemotherapy and identified by their treating positions to be [supply constraints] and the symptoms of anemia, the eligible reimbursement up to a level of 12 grams per deciliter consistent with the FDA approved label in clinical practice
guidelines. 10. AMGN and CMS share the same goals. 1. Appropriate treatment for Medicare patients. 11. Looks forward to working with patient groups, physicians, ASCO/ASH, and CMS to ensure that outcome for Medicare patients suffering from chemotherapy-induced anemia are appropriate.
S2. ESA Label …