To get up-to-date information on ACOA news, check out the latest articles. These articles are available online by clicking on one of the links below. You must have Adobe Reader to view most of the articles.
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2008-10-08 -ASCO letter regarding Medicare carrier coverage of new off-label compendia
Compendia Letter
2008-09-26 -Medicare Part B Drug and Biological Average Sales Price (ASP)
The Centers for Medicare & Medicaid Services (CMS) has made available the Medicare Part B Drug and Biological Average Sales Price (ASP) Payment Amounts for October 1, 2008 to December 31, 2008 on the CMS website at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/01a_2008aspfiles.asp#TopOfPage
2008-09-17 -ASP+6% Q4
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2008-08-28 -CMS Manual System
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2008-08-28 -CMS Manual System- Medicare Claims processing
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Drug Info
2008-09-12 -Rituxan Important Saftey Alert
Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurological manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.
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2008-09-10 -Monograph for Abraxane
The NCCN Compendium has updated its monograph for Abraxane® on September 2, 2008 to include non-small-cell lung cancer. I have attached a PDF copy in case you would like to share this information with your Society members.
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2008-09-10 -Abraxane Insert
The NCCN Compendium has updated its monograph for Abraxane® on September 2, 2008 to include non-small-cell lung cancer. I have attached a PDF copy in case you would like to share this information with your Society members.
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FDA
2008-10-07 -Nebion HLX-8 Magnetic Resonance Device
FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpal tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured discs, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.
2008-10-07 -VIDAZA
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VIDAZA safely and effectively. See full prescribing information for
VIDAZA.
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2008-07-30 -Important Information for Physicians about Changes Affecting the FDA-Approved Use of Erythropoiesis Stimulating Agents (ESAs)
On July 30, 2008, the U.S. Food and Drug Administration (FDA) sent a “Complete Response
and Safety Labeling Change Order” to the sponsors of the ESAs, ordering changes to the ESA
package inserts (“labels”). For the first time, the FDA used its statutory authority to order a
sponsor to make revisions to a product label.
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FDA Approval
2008-09-26 -Alimta® Injection
On September 26, 2008, the U. S. Food and Drug Administration (FDA) approved pemetrexed injection (Alimta® Injection, Eli Lilly and Company) for use in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Pemetrexed is not indicated for treatment of patients with squamous cell lung carcinoma.
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2008-09-19 -iobenguane I 123
The following is a message from the FDA's Office of Oncology Drug Products Director, Dr. Richard Pazdur: On September 19, 2008, the US Food and Drug Administration (FDA) approved iobenguane I 123 injection (AdreView, GE Healthcare), a diagnostic radiopharmaceutical, for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests
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2008-08-22 -Romiplostim Approved for Subcutaneous Injection
On August 22, 2008, the U.S. Food and Drug Administration (FDA) approved romiplostim for subcutaneous injection (Nplate™, Amgen Inc.) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
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2008-08-21 -VIDAZA(R) Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS
First and only drug to significantly extend survival for patients with higher-risk MDS
First drug approved by FDA for treatment of all MDS risk categories
First drug to achieve a transfusion independence rate of greater than 40 percent across all MDS risk categories
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2008-06-20 -Bortezomib for Injection
On June 20, 2008, the U.S. Food and Drug Administration approved bortezomib for injection (Velcade®, Millennium Pharmaceuticals, Inc., The Takeda Oncology Company, and Johnson and Johnson Pharmaceutical Research and Development) for the treatment of patients with multiple myeloma. This approval results from a clinical trial using Velcade® as an initial treatment for patients with multiple myeloma
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2008-03-20 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On March 20, 2008, the Food and Drug Administration (FDA) approved bendamustine hydrochloride (TREANDA®, Cephalon, Inc.), an intravenously administered alkylating agent, for the treatment of patients with chronic lymphocytic leukemia (CLL).
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2008-02-22 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On February 22, 2008, the U.S. Food and Drug Administration granted accelerated approval for bevacizumab (Avastin®, Genentech, Inc.) to be used in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer.
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2007-11-16 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On November 16, 2007, the U.S. Food and Drug Administration approved sorafenib (NEXAVAR®, Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc.), an orally administered kinase inhibitor, for the treatment of patients with unresectable hepatocellular carcinoma (HCC). Sorafenib was originally approved in December 20, 2005 for the treatment of patients with advanced renal cell carcinoma.
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2007-11-08 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On November 8, 2007, the U.S. Food and Drug Administration approved new Boxed Warnings and other safety-related product labeling changes for the erythropoiesis-stimulating agents Epogen, Procrit, and Aranesp. The revised labeling incorporates advice from an FDA advisory committee and expands upon labeling changes made in March, 2007.
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2007-11-08 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On November 8, 2007, the U. S. Food and Drug Administration (FDA) granted accelerated approval of a new dosing regimen of dasatinib (SPRYCEL™, Bristol-Myers Squibb) for the treatment of adults with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy, including imatinib mesylate.
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2007-10-29 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On October 29, 2007, the U. S. Food and Drug Administration granted accelerated approval to nilotinib (TASIGNA® Capsules, Novartis Pharmaceuticals Corporation) for use in the treatment of chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib.
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2007-10-16 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On October 16, 2007, the U.S. Food and Drug Administration approved ixabepilone for injection (IXEMPRA™, Bristol-Myers Squibb) for the following two indications:
• Ixempra™ is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.
• Ixempra™ is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.
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2007-10-02 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On October 2, 2007, FDA expanded labeling and granted regular approval for single-agent cetuximab (Erbitux®, ImClone Systems, Inc.) for the treatment of patients with EGFR-expressing metastatic colorectal cancer (mCRC) after failure of both irinotecan- and oxaliplatin-based chemotherapy regimens. Erbitux® was initially approved in 2004 under accelerated approval regulations and the study described below verifies the clinical benefit of single-agent Erbitux® in this patient population.
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2007-09-28 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On September 28, 2007, the U. S. Food and Drug Administration (FDA) approved docetaxel (Taxotere® Injection Concentrate, Sanofi-Aventis) for use in combination with cisplatin and fluorouracil (5-FU) for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
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2007-09-19 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On September 19, 2007, the U.S. Food and Drug Administration expanded labeling and granted regular approval for single-agent alemtuzumab (Campath®, Genzyme Corporation) for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath® was initially approved in 2001 under accelerated approval regulations and the study described below fulfills the post-marketing commitment to verify its clinical benefit.
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2007-09-06 -A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On September 6, 2007, the U.S. Food and Drug Administration approved dexrazoxane hydrochloride for injection (Totect™), equivalent to 500 mg dexrazoxane, for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
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2007-03-01 -Changes in the Avastin® Package Insert Regarding Warning and Dose and Administration for Non-Gastrointestinal Fistula Formation
This communication informs you of recent changes made to the Avastin® Injection prescription information. On March, 2007 the FDA was informed of the occurrence of two confirmed and one suspected cases of tracheoesophageal fistula in an investigator-sponsored trial using bevacizumab concurrently with chemoradiation in the treatment of limited-stage small cell lung cancer. Three cases were fatal. The trial was closed and a Dear Healthcare Provider letter was issued.
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Hurricane Info
2008-09-15 -Hurricanes Ike/Gustav – CMS Questions and Answers
Providers are encouraged to review the latest Medicare fee-for-service questions and answers concerning Hurricanes Ike and Gustav, located on the Hurricane Information Web page (http://www.cms.hhs.gov/Emergency/02_Hurricanes.asp) on the CMS Web site. Scroll to the Downloads section and click on the link entitled “Hurricane Ike/Gustav Medicare FFS Qs and As.” The link will take you to the most current document. The date included in the document file name will change as new information is added or existing information revised.
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Label Changes
0000-00-00 -Erythropoietin Stimulating Agents (ESAs)
The Food and Drug Administration (FDA) announced today the following proposed changes to the approved labeling for the use of erythropoietin stimulating agents (ESAs). The label will be final in 15 days, unless an administrative appeal is requested which could take "up to" 30 days before the label is complete. The manufacturers of ESAs may recommend further adjustments for FDA consideration during that time, but changes from today's proposal, if any, are expected to be minor.
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