The following information is provided by the Association of Community Cancer Centers (ACCC). ANCO is an Institutional Member of ACCC. View this information online at http://www.accc-cancer.org/mediaroom/newsletters/media_drugupdate_061008.htm.
Zoledronic acid (Zometa) has been accepted by the American Hospital Formulary Service Drug Information (AHFS-DI) drug compendium as treatment for prevention of aromatase inhibitor-associated bone loss (AIBL) in postmenopausal women. The oncology determination table is available online. AHFS-DI is published by the American Society of Health-System Pharmacists (ASHP).
Bayer HealthCare Pharmaceuticals, Inc. (Wayne, N.J.) announced that a reformulation of the liquid Leukine® (sargramostim) 500 mcg vial has been approved by the FDA and is now available for patients and physicians in the U.S. The new formulation does not include EDTA (edetate disodium), which was in the product's liquid 500 mcg vial manufactured from January 2006 to January 2008.
In January 2008 Bayer withdrew the previously marketed liquid Leukine 500 mcg vial from the U.S. market in order to reformulate it to eliminate EDTA in light of an increase in spontaneous reporting of certain labeled adverse events, including syncope (fainting). The timing of increased reporting of these adverse events coincided with the change in the formulation of liquid Leukine to include EDTA in 2006. With the approval and relaunch of liquid Leukine in a non-EDTA formulation, Bayer is closing a special access program that reserved priority access to lyophilized Leukine 250 mcg vials, which do not contain EDTA, for patients with the greatest medical need. Sufficient supply of the new, non-EDTA liquid and lyophilized formulations of Leukine is now available to meet cancer care market demand.
The Centers for Medicare & Medicaid Services (CMS) announced its decision to recognize the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium™ as an additional source of information used to determine which drugs and biologics may be covered under Medicare Part B for patients with cancer. The NCCN Compendium will be used by CMS for national coverage determinations and by intermediaries and carriers for local determinations. The major application will be in determinations about coverage for the use of drugs and biologics in oncology beyond the FDA-approved indication.
CMS also announced the termination of the use of the American Medical Association Drug Evaluations (AMA-DE) Compendium, which has not been updated or published since 1995.
A Medicare law directs CMS to consider certain listed compendia when deciding whether or not the use of a drug is medically accepted for the treatment of cancer. The law also allows the agency to revise the list. Both of these revisions will be reflected in CMS' Medicare Benefit Policy Manual.
NCCN is developing a library of standard chemotherapy order templates. The information contained in the Templates is based on the NCCN Clinical Practice Guidelines in Oncology and the NCCN Drugs & Biologics Compendium. The Templates include chemotherapy, supportive care agents, monitoring parameters, and safety instructions. Special instructions for self-administered chemotherapeutic agents are also provided. The following Templates are now available: chronic myelogenous leukemia, as well as bladder, kidney, ovarian, and prostate cancers. Click here to visit the NCCN website.
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