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2010-07-23 - Oncology Bills and who supported them
Oncology Bills and who supported them
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2010-07-23 - CMS’s Plans for the A/B Medicare Administrative Contractor
CMS’s Plans for the A/B Medicare Administrative Contractor “Round II” Procurements: Important Information for Potential Offerors Concerning -
• Consolidation of A/B MAC Jurisdictions
• Management of the A/B MAC Marketplace
• Responsibilities of the A/B MAC Medical Directors
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2010-07-23 - Community Oncology Cancer Care Practice Impact Report
• The Community Oncology Alliance (COA) has developed a tracking database on the adverse
impact of Medicare reimbursement on community oncology practices. The database was initially
compiled from private and public sources.
• Included in this report are a table of impacted practices by state and a map depicting the impact.
• As of the date of this update, 863 clinics/practices during the past three years have been impacted
as follows:
— 172 Clinics Closed — Denotes individual sites that have closed.
— 323 Practices Struggling Financially — Denotes practices (possibly comprising multiple
clinic sites) that are struggling to pay bills and/or stay open.
— 42 Practices Sending Patients Elsewhere — Denotes practices (possibly comprising
multiple clinic sites) that are sending all of their patients elsewhere for chemotherapy.
NOTE that numerous practices report sending some patients, especially Medicare patients
without adequate secondary insurance, elsewhere for treatment.
— 224 Acquired by Hospitals — Denotes practices (possibly comprising multiple clinic sites)
that have been acquired by a hospital.
— 102 Merged/Acquired by Another Entity — Denotes practices (possibly comprising
multiple clinic sites) that have merged or been acquired by a corporate entity.
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2010-07-16 - CRS report on Obamacare
Medicare is a federal program that pays for covered health services for most persons 65 years old
and older and for most permanently disabled individuals under the age of 65. The rising cost of
health care, the impact of the aging baby boomer generation, and declining revenues in a
weakened economy continue to challenge the program’s ability to provide quality and effective
health services to its 45 million beneficiaries in a financially sustainable manner.
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2010-07-07 - OIG Directive Allows Physicians to Waive Extra "Doc Fix" Medicare Coinsurance Amount
On the same day that President Obama signed H.R. 3962 into law, which postponed the 21.3% cut in Medicare reimbursement rates by 6 months and provided a small raise retroactive to June 1, the Office of the Inspector General (OIG) issued an advisory clarifying that physicians can legally waive the extra, retroactive co-insurance amount the patients owe as a result of the increased Medicare rates.
2010-06-25 - Oncology Practice Insider
It is hard not to become overwhelmed with the business of oncology practice today. Fewer resources, more patients, Medicare uncertainty are just a few of challenges we face. It is important - but frequently difficult - to keep our focus on the patients we care for and with that in mind, I strongly recommend Art of Oncology: Honest and Compassionate Responses to the Daily Struggles of People Living with Cancer , a compilation of articles written by doctors about caring for patients with cancer. Purchase it for your Kindle today and read these columns when you need a reminder about why we are in this important profession.
ASCO
2010-06-25 - Receive a FREE ASCO University Educational Module!
From oncology nurses to practice administrators to oncologists, every cancer care professional has a home at ASCO.
The American Society of Clinical Oncology knows that providing the best cancer care requires a team effort. Through multiple membership categories, ASCO works daily to deliver resources for the entire oncology staff.
2010-06-25 - SGR: Continuing Saga
ASCO joins the entire medical community in continued frustration with Congress\' inability to address the Medicare physician payment system. The failure to pass H.R. 4213 has kept American physicians and millions of Medicare beneficiaries on their 23-month roller coaster ride. Patients and doctors are the unwilling subjects of a grand experiment: if the SGR cuts are realized, how many physicians will no longer be able to keep their doors opened to these patients?
ASCO Alert
2010-06-25 - Proposed Medicare Physician Fee Schedule Released
This afternoon, the Centers for Medicare and Medicaid Services released its proposed Physician Fee Schedule and Revisions to Payment Policies for 2011. The rule which is titled "Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011" became available today, June 25, 2010 at 4:15 pm. It will publish on July 13, 2010. The comment period will close August 24, 2010.
ASCO
2010-06-25 - Oncology Practice Insider
Well, it's a good news/bad news story. The good news, of course, is that we finally have a Medicare payment patch, retroactive to June 1. And more good news is that this patch includes a 2.2% increase for the next six months. But the bad news is that this is only a six month fix and doesn't even take us through the end of the year. Keep SGR on your "to do list" - follow the updates from ASCO and other professional societies and be prepared to get involved when needed. Happy summer!
ASCO Alert
2010-06-24 - ASCO Cancer Policy Alert
Dear Oncology Practice Insider Subscribers: The following ASCO Cancer Policy Alert is the latest information on the SGR. You are being sent this message based on your OPI subscription in an effort to keep you informed of ASCO activities that impact your oncology practice or maybe pertinent to the oncology field. Please visit the Cancer Policy Alert webpage for up to date information.
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News Article
2010-06-18 - How Medicare’s Payment Cuts For Cancer Chemotherapy Drugs Changed Patterns Of Treatment
The Medicare Prescription Drug, Improvement, and
Modernization Act, enacted in 2003, substantially reduced payment rates
for chemotherapy drugs administered on an outpatient basis starting in
January 2005. We assessed how these reductions affected the likelihood
and setting of chemotherapy treatment for Medicare beneficiaries with
newly diagnosed lung cancer, as well as the types of agents they received.
Contrary to concerns about access, we found that the changes actually
increased the likelihood that lung cancer patients received chemotherapy.
The type of chemotherapy agents administered also changed. Physicians
switched from dispensing the drugs that experienced the largest cuts in
profitability, carboplatin and paclitaxel, to other high-margin drugs, like
docetaxel. We do not know what the effect was on cancer patients, but
these changes may have offset some of the savings projected from passage
of the legislation. The ultimate message is that payment reforms have
real consequences and should be undertaken with caution.
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FDA Approval
2010-06-18 - FDA Approves New Treatment for Advanced Prostate Cancer
FDA Approves New Treatment for Advanced Prostate Cancer The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.
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2010-06-18 - FDA Approves New Indication for Tasigna
FDA Approves New Indication for Tasigna Approval expands use in treatment of rare type of leukemia The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.
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News Article
2010-06-17 - MarketWatch Does Reimbursement Influence Chemotherapy Treatment For Cancer Patients?
Does Reimbursement Influence Chemotherapy
Treatment For Cancer Patients?
Medicare reimbursement has little effect on who gets cancer
treatment, but it does influence the kind of treatment received.
by Mireille Jacobson, A. James O’Malley, Craig C. Earle, Juliana Pakes,
Peter Gaccione, and Joseph P. Newhouse
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FDA Approval
2010-06-01 - FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women
The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.
Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.
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News Article
2010-05-12 - Health care law's massive, hidden tax change
An all-but-overlooked provision of the health reform law is threatening to swamp U.S. businesses with a flood of new tax paperwork.
Section 9006 of the health care bill -- just a few lines buried in the 2,409-page document -- mandates that beginning in 2012 all companies will have to issue 1099 tax forms not just to contract workers but to any individual or corporation from which they buy more than $600 in goods or services in a tax year.
FDA Approval
2010-05-07 - FDA Approves Drug Treatment for Rare Cancer
Cutaneous T-cell lymphoma affects about 1,500 Americans annually
The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).
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2010-04-16 - Erlotinib (Tarceva)
On April 16, 2010, the U. S. Food and Drug Administration (FDA) approved erlotinib (Tarceva) tablets for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
FDA
2010-01-26 - Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Takeda Oncology and FDA notified healthcare professionals about revisions to the Prescribing Information for Velcade, section 2.5, pertaining to patients with hepatic impairment at the start of Velcade therapy.
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PQRI Standards for Oncology
2010-01-21 - PQRI 2010 Standards for Oncology
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FDA
2009-09-16 - FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA's authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.
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2009-08-21 - FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs
The U.S. Food and Drug Administration published two rules today that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don't have other satisfactory treatment
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Medicare
2009-08-21 - Reporting Non-Tax Withholding Due to Federal Payment Levy Program (FPLP)
Reporting Non-Tax Withholding Due to Federal Payment Levy Program (FPLP)
Reference: Trans. 503, CR #6228, Pub. 100-20, MLN: MM6228
Published Online: 8/14/2009
Provider Types Affected
Physicians and providers who bill Medicare carriers, fiscal intermediaries (FI), and Medicare Administrative Contractors (MAC) for services provided to Medicare beneficiaries.
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CMS
2009-08-07 - updated policy from CMS regarding OncotypeDX- J1 MAC
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FDA Approval
2009-07-31 - FDA Approval for Avastin in Combination with Interferon Alfa
Bevacizumab (Avastin) in Combination with Interferon Alfa
On July 31, 2009 the U.S. Food and Drug Administration granted approval for the use of bevacizumab (Avastin, Genentech, Inc.) in combination with interferon alfa for the treatment of patients with metastatic renal cell carcinoma. The approval was based on results from the BO17705 trial which demonstrated a 5 month improvement in median progression-free survival (PFS) in bevacizumab-treated patients.
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2009-07-09 - FDA Approval for First Maintenance Drug For Lung Cancer (Alimta)
FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer
The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.
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2009-07-02 - Ferumoxytol (Feraheme) Injection
The safety and efficacy of ferumoxytol in the episodic treatment of iron deficiency anemia were assessed in three randomized, open-label, controlled clinical trials enrolling approximately 800 patients with CKD. In all three controlled trials, patients were randomized to either ferumoxytol or oral iron. Two trials evaluated patients with non-dialysis dependent CKD and a third assessed patients undergoing hemodialysis. These trials assessed hemoglobin alterations and clinical outcomes over 35 days. Ferumoxytol was administered as two 510 mg IV injections, with most patients receiving their second injection 3 to 8 days after their initial injection.
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FDA
2009-05-21 - Drug Shortages Update
Morphine Sulfate Oral Solution updated by FDA 5/20/2009
Roxane Laboratories (20mg/5ml and 10mg/5ml) - has product available
Mallinckrodt Inc. (20mg/ml) Customer Service number (1-800-325-8888) - increased demand due to another manufacturer leaving the market
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2009-05-18 - Drug Shortages
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Oplinc
2009-05-15 - Oplinc Newsletter
CORRECTION - CORRECTED EFFECTIVE DATE FOR CLINICAL PHARMACOLOGY COMPENDIA this week's Oplinc Fast Facts should have identified the effective date of July 2, 2008 for the Clinical Pharmacology Compendia. Please disregad the earlier issue and reference this corrected one.
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FDA
2009-05-11 - FDA MedWatch - Tarceva
OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva.
FDA Approval
2009-05-08 - Avastin for Glioblastoma
FDA Approves Drug for Treatment of Aggressive Brain Cancer
The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy.
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New Article
2009-04-01 - Health Reform Dialogue
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FDA Approval
2009-03-30 - U.S. Food and Drug Administration today approved Afinitor
FDA Approves Drug for an Advanced Form of Kidney Cancer
The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies.
Renal cell cancer, the most common type of kidney cancer, originates in the lining of the small tubules in the kidney that filter waste products from the blood. The cancer is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has spread to other parts of the body.
"Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib," said Robert Justice, M.D., director, Division of Drug Oncology Products in the FDA's Center for Drug Evaluation and Research. "Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing."
Afinitor belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib).
While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), Afinitor works by blocking a specific protein known as the mammalian target of rapamycin or mTOR. The protein blocking action disrupts the growth, division and metabolism of cancer cells.
A clinical trial studying the safety and effectiveness of Afinitor was discontinued after an interim analysis showed that, in patients receiving the drug, the growth or spread of the tumor was delayed when compared to patients who did not receive the drug. In addition, disease progression was delayed approximately five months in half of the patients who received Afinitor. In contrast, disease progression was delayed two months in patients who did not receive the drug.
The most frequent adverse reactions in the trial (occurring in at least 20 percent of patients) included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. Laboratory tests of blood samples determined that at least half of all patients experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.
Afinitor is manufactured by Novartis International AG of Basel, Switzerland. Sutent is manufactured by Pfizer Inc. of New York. Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany.
CDC
2009-02-18 - New Fact Sheet: Peanut Product Recall and Cancer Patients
New Fact Sheet: Peanut Product Recall and Cancer Patients
The Centers for Disease Control and Prevention (CDC) has been receiving reports of illnesses caused by a type of bacterium known as Salmonella enterica, strain Typhimurium. The U.S. Food and Drug Administration (FDA) has confirmed that peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) are sources of the illnesses. Due to this contamination, all peanut products produced by PCA on or after January 1, 2007 have been recalled.
Because cancer patients with impaired immune systems are more likely to become severely ill from a Salmonella infection than others, the National Cancer Institute (NCI) developed a new Fact Sheet, Peanut Product Recall and Cancer Patients, to address the special concerns of cancer patients and their healthcare providers.
• View NCI's Peanut Product Recall and Cancer Patients Fact Sheet:
http://www.cancer.gov/cancertopics/factsheet/Support/peanut-recall
• For a searchable list of recalled products, visit the FDA Web site:
http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm
For more additional information about this and other cancer-related topics, please visit the NCI Web site at http://www.cancer.gov or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).
Insurance News
2009-01-09 - UHC Herceptin Policy
UnitedHealthcare has removed the requirement to submit a pathology report to obtain coverage for trastuzumab. This change is effective for claims submitted after January 1, 2009. Herceptin claims that were submitted in 2008 that are pending payment will require the submission of the pathology report showing over expression of the HER2 gene. The pathology reports should be faxed to (915) 231-1970 and you should use the dedicated fax cover sheet.
Herceptin claims submitted after January 1, 2009, will continue to be subjected to two reimbursement policies that may impact the reimbursement: the National Comprehensive Cancer Network (NCCN) policy and the Maximum Dosage Edit policy. Both of these policies address Herceptin claims and are posted on the unitedhealthcareonline web site.
UnitedHealthcare launched the Herceptin policy requiring submission of pathology reports in early 2006 based on an audit showing that 12 percent of the patients being treated with trastuzumab did not have over-expression of the HER2 gene. Our last audit in September 2008, demonstrated that less than 1 percent of the submissions failed to show over- expression.
Our medical policy hasn\'t changed - treatment of patients with under-expression is still inappropriate. We believe the recent audit demonstrates that this quality parameter is being followed and no longer requires the quality check.
There are other critical issues with HER2 gene expression testing. Studies show that concordance between local laboratories and a central laboratory with quality controls can be poor.*
The College of American Pathology has established accreditation for HER2 gene testing, but participation in the accreditation process is voluntary.
UnitedHealthcare contracts with two national laboratories that meet the ASCO / CAP guideline recommendations and proficiency testing for HER2, Genezyme and Laboratory Corporation of America (LabCorp). We encourage the use of laboratories that meet these standards. If you don\'t know the accreditation status of your current lab for HER2, we would encourage retesting, or a second opinion, from either of these laboratories for your patients who are UnitedHealthcare enrollees.
*Reddy et al, Clin Breast Ca, 2006: 153-157
https://www.unitedhealthcareonline.com/b2c/CmaAction.do?channelId=59e12bb4510f0110VgnVCM100000c520720a____#
New Article
2009-01-08 - Reports of Increases in Melanoma Incidence are Real
Reports of Increases in Melanoma Incidence Are Real
By John Gever, Senior Editor, MedPage Today
Published: January 08, 2009
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.
FREMONT, Calif., Jan. 8 -- Increases seen in the annual incidence of melanoma appear real, not an artifact of better diagnosis of thinner lesions, researchers here said.
The overall rate of new diagnoses of malignant melanoma rose 3.1% a year from 1992 to 2004, with statistically significant increases for every histologic type and thickness, including lesions greater than 4 mm thick, reported Eleni Linos, M.D., M.P.H., of the Northern California Cancer Center, and colleagues online in the Journal of Investigative Dermatology.
The highest rates and the greatest mean annual increases were seen in white men 65 and older. New annual diagnoses in this group rose from about 74 per 100,000 in 1992 to 126 per 100,000 in 2004, a mean annual increase of 4.5% (P0.05).
Action Points
Explain to interested patients that malignant melanoma is the most dangerous form of skin cancer and is believed to result from exposure to ultraviolet light.
Explain that UV exposure also contributes to premature aging of the skin.
The results appear to debunk arguments that improved surveillance, diagnostic scrutiny, and regular screening are responsible for the rise in melanoma incidence reported in earlier studies.
Dr. Linos and colleagues also found that melanoma incidence was rising about equally in all socioeconomic status groups.
Because people at the lower end of the socioeconomic ladder have reduced access to healthcare, including skin cancer screening, a smaller increase in that group would be expected if the apparent incidence rates were dictated by the extent of screening and surveillance, Dr. Linos said in an interview.
That apparent incidences have risen equally among high- and low-status groups points to a genuine, biological increase in melanoma risk, she said.
The findings highlight "the need for continued, detailed surveillance of melanoma occurrence, which in turn underscores the importance of complete and accurate reporting . . . by hospitals and private physicians," the researchers wrote.
Some 291 million patient-years of data contained in the CDC's Surveillance Epidemiology and End Results (SEER) registry through 2004 served as underpinning for the study.
The researchers also drew on a SEER data subset in California that included socioeconomic data, which were not collected nationwide.
Some 93% of the 70,596 new cases of malignant melanoma recorded in the SEER registry occurred in non-Hispanic whites.
Rates in men were generally about 50% greater than in women, a difference that did not change appreciably during the 13-year study period.
Among non-Hispanic whites of all ages, the mean annual increase in diagnosis of melanoma tumors of 1 mm thickness or less was 4.84% in men and 4.68% in women.
The corresponding incidence increases for tumors thicker than 4 mm were 4.1% and 3.3%, respectively.
For whites younger than 65, increases in annual incidence appeared to be greater for thin lesions than for thick ones.
In men, the mean annual increase was 3.42% for tumors of 1 mm thickness or less versus 1.96% for lesions thicker than 4 mm.
Mean annual increases in women were 4.33% for the thinnest tumors and 1.40% for the thickest.
In the 65-and-older population, rates of increase did not differ markedly between thin and thick lesions, nor between men and women.
Significant increases in annual incidence were also seen for different histologic types, with the largest occurring for lentigo maligna melanomas:
Superficial spreading: 7.6 per 100,000 in 1992; 8.5 per 100,000 in 2004
Nodular: 1.5 per 100,000 in 1992; 1.7 per 100,000 in 2004
Lentigo maligna: 1.2 per 100,000 in 1992; 2.0 per 100,000 in 2004
But mortality rates did not mirror the increases in new diagnoses, Dr. Linos and colleagues found.
Age-adjusted death rates declined significantly for men and women younger than 65 (1.0% and 0.9%, respectively, P0.05).
They increased by 1.9% for older white men and 0.8% for older white women (P0.05 for both).
But these increases were substantially smaller than those seen in new diagnoses, which averaged 4.5% for older men and 3.8% for older women.
The researchers were at a loss to explain the lack of correlation between incidence rates and mortality.
They noted that treatment has not undergone major innovations. Moreover, they said, "although the influence of a stage distribution shift toward thinner, more curable tumors has occurred in recent decades, the incidence of thicker melanoma [accounting for most deaths] has not declined."
Dr. Linos and colleagues also had no explanation for the increased annual incidence over time, although they noted that it was consistent with trends reported in other countries.
Other researchers have contended that increased exposure to ultraviolet radiation, such as sun-tanning indoors and outdoors, are responsible.
Dr. Linos and colleagues said their data tend to refute explanations involving more efficient detection. But they do not shed light on other specific causal mechanisms.
The study was supported by the National Institutes of Health and the California Department of Public Health.No potential conflicts of interest were reported.
Primary source: Journal of Investigative Dermatology
Source reference:
Linos E, et al, "Increasing burden of melanoma in the United States," J Invest Dermatol 2009; DOI: 10.1038/jid.2008.423.
Find this article at:
http://www.medpagetoday.com/HematologyOncology/SkinCancer/12377
Medicare
2009-01-06 - Medicare Proposes Easing Rules for Cancer PET Scans
Greetings!
Medicare Proposes Easing Rules for Cancer PET Scans
By Aliza Marcus
Jan. 6 (Bloomberg) -- Medicare has proposed making it easier for cancer patients to get an advanced imaging test early to help guide their treatment, by lifting a data-gathering requirement.
Under the proposal announced today, Medicare would cover an initial examination with positron emission tomography, or PET scan, without requiring that doctors collect information on the patient and whether the exam helped improve treatment, Medicare said today in an e-mailed statement.
Evidence gathered since the requirement in 2005 convinced Medicare, the U.S. health program for the elderly and disabled, of the benefit of the scans. The revision for PET scans is the first time Medicare reviewed data from a new program called Coverage with Evidence Development, according to the statement.
"We look forward to patients gaining greater access to new technologies while enhancing the evidence physicians use to make treatment recommendations," said Kerry Weems, Medicare's acting administrator, in an e-mailed statement.
Medicare will make a final decision in April. Companies that make the scans include General Electric Co., based in Fairfield, Connecticut, and Siemens AG, based in Munich.
Images produced by the PET scans help give information about chemical activity inside organs and tissues, according to a definition on the Mayo Clinic's Web site. Medicare said the tests help cancer specialists determine whether a growth is benign or malignant and how much a tumor has grown.
To contact the reporter on this story: Aliza Marcus in Washington at amarcus8@bloomberg.net
FDA Approval
2008-12-24 - FDA Approval Degarelix
Greetings!
Degarelix On December 24, 2008, the U. S. Food and Drug Administration (FDA) approved degarelix for injection (Ferring Pharmaceuticals Inc., Parsippany, NJ), a new gonadotropin releasing hormone (GnRH) receptor antagonist, for the treatment of patients with advanced prostate cancer. This indication is based on degarelix's effectiveness in attaining and maintaining serum testosterone suppression to medical castration levels during 12 months of treatment in an open-label, randomized, multi-center, parallel-group study.
A total of 620 patients were randomized to receive one of two degarelix dosing regimens or leuprolide for one year: degarelix at a starting dose of 240 mg followed by monthly doses of 160 mg subcutaneously, degarelix at a starting dose of 240 mg followed by monthly doses of 80 mg subcutaneously, or monthly doses of leuprolide 7.5 mg intramuscularly. The primary objective was to demonstrate that degarelix is effective in achieving and maintaining testosterone suppression to castration levels ( ≤ 50 ng/dL) during 12 months of treatment.
The medical castration rates were 98.3% (95% CI: 94.8%; 99.4%) in the degarelix 240/160 mg arm, 97.2% (95% CI: 93.5%; 98.8%) in degarelix 240/80 mg arm, and 96.4% (95% CI: 92.5%; 98.2%) in the leuprolide 7.5 mg arm. The key secondary analyses showed that no testosterone surges were observed in the degarelix arms and that 96% of patients attained medical castration 3 days after the first degarelix dose compared to no patients receiving leuprolide.
The most commonly observed adverse reactions (frequency of <10%) in either degarelix arm included injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, weight increase, and increases in transaminases and gamma-glutamyltransferase. The majority of the adverse reactions were grade 1/2 in severity; grade 3/4 adverse reactions were uncommon. The injection site reactions were transient, with frequencies of 35-44% in the degarelix arms compared to a frequency of <1% in the leuprolide arm. Hepatic laboratory abnormalities were generally reversible, with grade 3 abnormalities in less than 1% of patients. There were no important differences in adverse reactions between the two degarelix arms, except for fewer injection site reactions in the 240/80 mg arm.
The recommended dosing regimen is a starting dose of 240 mg given as two subcutaneous injections of 120 mg each followed by monthly maintenance doses of 80 mg given as a single subcutaneous injection.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at http://www.fda.gov/cder/foi/label/2008/022201lbl.pdf.
2008-12-19 - FDA Approval Gleevec for Adjuvant Therapy of positive GIST
Imatinib mesylate On December 19, 2008, the U.S. Food and Drug Administration (FDA) approved imatinib mesylate tablets for oral use (Gleevec, Novartis Pharmaceuticals) for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumor (GIST).
Imatinib mesylate was investigated as an adjuvant treatment of GIST in a randomized, double-blind, placebo-controlled study enrolling 713 patients. Three hundred fifty-nine patients were randomized to receive imatinib mesylate and 354 to receive placebo. The primary objective of the clinical trial was to compare recurrence-free survival (RFS) of the two groups. Overall survival (OS) was a secondary objective. Eligible patients were > 18 years of age with a histological diagnosis of GIST (+KIT), resected tumor size > 3 cm, and a complete gross resection within 14-70 days prior to registration. Imatinib mesylate, 400 mg orally once daily, was administered for one year.
The study was terminated after the third protocol specified interim analysis. At the time of the final analysis of RFS, 100 events were confirmed by a blinded central independent review. With a median follow up of 14 months, 30 RFS events were observed in the imatinib group and 70 in the placebo group (HR=0.398, 95% CI: 0.259 - 0.610; two-sided p value < 0.0001). Based on these results, the trial was terminated. Patients still receiving placebo were allowed to cross over to imatinib mesylate. OS results are immature with 5 deaths in the imatinib mesylate group and 8 deaths in the placebo group.
Most patients in both groups experienced at least one adverse reaction and 31% in the imatinib group and 18% in the placebo group experienced adverse reactions of > grade 3. The most frequently reported adverse reactions (>20%) were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting and abdominal pain.
No new adverse reactions were reported in the adjuvant GIST treatment setting that had not been previously noted in other patient populations, including those with unresectable and/or malignant metastatic GIST. Drug was discontinued for adverse reactions in 17% and 3% of the imatinib and placebo-treated patients, respectively. Edema, gastrointestinal disturbances (nausea, vomiting, abdominal distention, and diarrhea), fatigue, low hemoglobin, and rash were the most frequently reported adverse reactions at the time of treatment discontinuation.
This current approval for adjuvant treatment of resected GIST is an accelerated approval with the requirement that follow-up of RFS and OS from this study and results of an ongoing study of 1 year vs. 3 years of adjuvant imatinib mesylate be submitted to FDA.
Imatinib mesylate was originally approved for the treatment of adult Ph+ chronic myelogenous leukemia in 2001 and pediatric Ph+ chronic myelogenous leukemia in 2003. Imatinib mesylate was approved for the treatment Kit+ unresectable and/or metastatic GIST tumors in 2002. Indications approved in 2006 include Ph+ acute lymphoblastic leukemia, myelodysplastic/myeloproliferative diseases, hypereosinophilic syndrome, aggressive systemic mastocytosis, and dermatofibrosarcoma protuberans.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at http://www.fda.gov/cder/foi/label/2008/021588s025lbl.pdf
FDA
2008-12-03 - Eltrombopag
Eltrombopag
On November 20, 2008, the U.S. Food and Drug Administration (FDA) granted accelerated approval for eltrombopag tablets (Promacta, GlaxoSmithKline 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.
Eltrombopag is an orally-administered thrombopoietin receptor agonist that stimulates bone marrow megakaryocytes to produce platelets. Data supporting this indication were derived from a controlled clinical study of patients treated over a six week period and a single arm extension study treating patients for multiple months. Continuing and recently completed studies will assess the long term safety and clinical benefit of eltrombopag.
The safety and efficacy of eltrombopag were evaluated in two double-blind, placebo-controlled clinical studies of 231 adult patients with chronic ITP who had completed at least one prior ITP therapy and who had baseline platelet counts < 30,000/mcL, including patients who may have undergone splenectomy. In one study, patients were randomized to either placebo or one of three doses of eltrombopag, 30, 50 or 75 mg. In the other study, patients were randomized to either placebo or eltrombopag 50 mg. Eltrombopag and placebo tablets were administered daily for six weeks. Eltrombopag was discontinued if platelet counts exceeded 200,000/mcL. Patients were observed for six weeks following discontinuation of the study drugs.
The primary endpoint in both studies was "response rate," defined as an increase from the baseline platelet count to a count > 50,000/mcL. Eltrombopag 50 mg administration resulted in response rates of 70 and 59% in each study, compared to placebo response rates of 11 and 16% (p < 0.01 for the treatment difference in each study). Eltrombopag response rates were similar irrespective of whether a previous splenectomy had been performed. Overall, seven patients (three in the placebo and four in the eltrombopag groups) underwent hemostatic challenges, such as surgical procedures. Additional ITP medications were required in all placebo patients and none of the eltrombopag patients.
Eltrombopag was administered to 109 patients in an open label, extension study; 74 received the drug for at least three months, 53 for at least six months and three for at least one year. At baseline, the median platelet count was 18,000/mcL. Median platelet counts were 74,000, 67,000 and 95,000/mcL, at three, six and nine month follow-up time points, respectively.
Overall, 313 patients with chronic ITP were exposed to eltrombopag. The clinical studies identified risks for hepatotoxicty, worsened thrombocytopenia (compared to baseline) and hemorrhage following eltrombopag discontinuation, and a risk for cataracts. Potential risks for TPO receptor agonists include bone marrow reticulin formation and marrow fibrosis during long term therapy and a risk for thromboses due to excessive platelet increases.
The risk for hepatotoxicity is cited as a boxed warning. In the controlled clinical studies, one patient experienced grade 4 (NCI Common Terminology Criteria for Adverse Events) elevations in serum liver test values during eltrombopag therapy, worsening of underlying cardiopulmonary disease, and death. No placebo group patients experienced grade 4 liver test abnormalities. Overall, serum liver test abnormalities (predominantly grade 2 or less in severity) were reported in 10 and 8% of the eltrombopag and placebo groups, respectively.
The controlled clinical studies also noted a risk for worsened thrombocytopenia and hemorrhage following eltrombopag discontinuation. Transient platelet count decreases to levels below baseline were observed following study drug discontinuation in 10% of the eltrombopag and 6% of the placebo groups. Serious hemorrhagic events requiring the use of supportive ITP medications occurred in 3 severely thrombocytopenic patients within one month following eltrombopag discontinuation; none were reported within the placebo groups.
In the controlled clinical studies, cataracts developed or worsened in 5% of the patients who received eltrombopag 50 mg daily and 3% of the placebo-group patients. Cataracts were also observed in non-clinical rodent toxicology studies.
The most common adverse reactions that occurred more frequently in the eltrombopag groups compared to the placebo groups consisted of nausea, vomiting, mennorrhagia, myalgia, paresthesia and cataracts. These reactions occurred in 3 to 6% of the eltrombopag patients and were generally mild to moderate severity.
The recommended starting dose of eltrombopag is 50 mg once daily for most patients. For patients of East Asian ancestry or patients with moderate or severe hepatic insufficiency, the starting dose is 25 mg once daily. The eltrombopag dose is adjusted to achieve platelet counts > 50,000/mcL as necessary to reduce the risk for bleeding. Eltrombopag should not be used in an attempt to normalize platelet counts. Only prescribers enrolled in the PROMACTA CARES Program may prescribe eltrombopag.
Full prescribing information, including details of the PROMACTA CARES restricted distribution program, clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at http://www.fda.gov/cder/foi/label/2008/022291lbl.pdf
FDA Approval
2008-12-01 - FDA approves Tapentadol hydrochloride
FDA Approves New Drug to Alleviate Moderate to Severe Pain
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain.
Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg.
\"This approval offers health care professionals an additional choice for treating moderate to severe acute pain,\" said John Jenkins, M.D., director of the office of new drugs in the FDA\'s Center for Drug Evaluation and Research.
Tapentadol acts in two ways, opioid (narcotic) and non-opioid. It affects the brain and body primarily by activating opioid receptors in the brain, spinal cord and gastrointestinal tract. In addition, Tapentadol inhibits the reuptake of the brain chemical norepinephrine which possibly has an analgesic effect.
Acute pain is a symptom of many medical conditions and can significantly interfere with a person\'s quality of life and general functioning. Opioids are considered safe and effective in selected patients but can cause dependence, abuse, and addiction. All patients treated with opioids require careful monitoring by their health care professional for signs of abuse and addiction, and to determine when opioid analgesics are no longer needed.
The most common side effects from Tapentadol are nausea, dizziness, vomiting, and sleepiness. The labeling for Tapentadol includes warnings about the risk of respiratory depression; addictive depressive effects on the central nervous system when taken with alcohol, other opioids, or illicit drugs; and abuse potential.
Tapentadol is manufactured by Janssen Ortho, LLC, Gurabo, PR.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01916.html
2008-12-01 - FDA approves Bendamustine Hydrochloride
Bendamustine Hydrochloride On October 31, 2008, the Food and Drug Administration (FDA) approved bendamustine hydrochloride (TREANDA, Cephalon, Inc.), an intravenously administered alkylating agent, for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
Bendamustine hydrochloride was evaluated in a single arm trial of 100 patients with indolent B-cell NHL. All patients had disease progression during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine hydrochloride was administered intravenously at a dose of 120 mg/m 2 infused over 60 minutes on days 1 and 2 of a 21-day treatment cycle for up to 8 cycles.
Efficacy was assessed by a blinded independent review committee using the modified International Working Group response criteria for NHL. The efficacy endpoints included overall response rate (complete responses, complete responses unconfirmed, or partial responses) and durations of response (DR). ORR and median DR were 74% (95% CI 64.3, 82.3) and 9.2 months (95% CI 7.1, 10.8), respectively. Complete responses were reported in 13%, complete responses unconfirmed in 4%, and partial responses in 57% of patients treated.
The safety of bendamustine hydrochloride was evaluated in the above study and an additional study. A total of 176 patients with B-cell NHL who had received prior rituximab (161 patients with indolent lymphoma and 15 with transformed NHL) were evaluated for safety.
The most frequently reported non-hematologic adverse reactions reported were nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%) and pyrexia (34%). The most frequently reported abnormal hematologic laboratory values were lymphopenia (99%), leukopenia (94%), anemia (88%), neutropenia (86%), and thrombocytopenia (86%).
Grade 3 or 4 adverse reactions were reported in 71% of the combined safety population. The most frequently reported non-hematologic Grade 3 or 4 adverse reactions were fatigue (11%), febrile neutropenia (6%), and pneumonia, hypokalemia and dehydration (each reported in 5% of patients). The most frequently reported grade 3 or 4 hematologic laboratory abnormalities were lymphocytopenia (94%), neutropenia (60%), leukopenia (56%), thrombocytopenia (25%), and anemia (11%).
Three patients died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with grade 3 thrombocytopenia, and pneumonia from a cytomegalovirus infection.
For patients with indolent NHL, bendamustine hydrochloride is administered as a 60 minute IV infusion on days 1 and 2 of a 21-day cycle for up to 8 cycles. The recommended dose is 120 mg/m 2 .
This dose, infusion duration, and cycle length of bendamustine hydrochloride is different from that approved dosing regimen for the chronic lymphocytic leukemia (CLL) indication. For patients with CLL, bendamustine hydrochloride is administered as a 30 minute IV infusion on days 1 and 2 of a 28-day cycle for up to 6 cycles. The recommended dose for the CLL indication is 100 mg/m 2.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at http://www.fda.gov/cder/foi/label/2008/022303lbl.pdf
CMS
2008-11-24 - CMS Instructions on Compendia
http://www.cms.hhs.gov/transmittals/downloads/R96BP.pdf is the Transmittal 96 Change Request 6191 dated October 24, 2008 and provides the long-awaited compendia implementation instructions to Medicare Fiscal Intermediaries, Carriers and Medicare Administrative Contractors (MACs). The effective dates are listed beside the compendia below, the implementation date of CR 6191 is November 25, 2008.
FDA
2008-11-20 - FDA Announcement of Current Drug Leucovorin
FDA Announcement of Current Drug Shortages 11/20/08
Leucovorin
11/20/2008
Teva Parenteral Medicines, Inc.
Leucovorin Calcium Lyophilized Powder for Injection, Preservative Free, Teva
Bedford Laboratories
Leucovorin Calcium Solution for Injection.
Leucovorin Calcium Lyophilized Powder for Injection, Preservative Free, Bedford
Manufacturing Delays
Please call 1-888-TevaUSA for additional information.
Bedford Customer Service 1-440-232-3320
Levoleucovorin (Fusilev) 50 mg single use vials.
11/20/2008
Spectrum Pharmaceuticals
1-877-387-4538 or 1-877-FUSILEV
See information in Related Information section.
Limited supplies continue to be available.
http://www.fda.gov/cder/drug/shortages/default.htm#Leucovorin
CMS
2008-11-03 - ESA Policy
Trailblazer has issued a final policy on ESA's. The full text of the information can be found at: http://www.trailblazerhealth.com/Tools/Notices.aspx?DomainID=1&ID=12758&referral=2782
FDA Approval
2008-10-31 - (FDA) approved bendamustine hydrochloride (TREANDA, Cephalon, Inc.)
Greetings!
Bendamustine Hydrochloride On October 31, 2008, the Food and Drug Administration (FDA) approved bendamustine hydrochloride (TREANDA, Cephalon, Inc.), an intravenously administered alkylating agent, for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
Bendamustine hydrochloride was evaluated in a single arm trial of 100 patients with indolent B-cell NHL. All patients had disease progression during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine hydrochloride was administered intravenously at a dose of 120 mg/m 2 infused over 60 minutes on days 1 and 2 of a 21-day treatment cycle for up to 8 cycles.
Efficacy was assessed by a blinded independent review committee using the modified International Working Group response criteria for NHL. The efficacy endpoints included overall response rate (complete responses, complete responses unconfirmed, or partial responses) and durations of response (DR). ORR and median DR were 74% (95% CI 64.3, 82.3) and 9.2 months (95% CI 7.1, 10.8), respectively. Complete responses were reported in 13%, complete responses unconfirmed in 4%, and partial responses in 57% of patients treated.
The safety of bendamustine hydrochloride was evaluated in the above study and an additional study. A total of 176 patients with B-cell NHL who had received prior rituximab (161 patients with indolent lymphoma and 15 with transformed NHL) were evaluated for safety.
The most frequently reported non-hematologic adverse reactions reported were nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%) and pyrexia (34%). The most frequently reported abnormal hematologic laboratory values were lymphopenia (99%), leukopenia (94%), anemia (88%), neutropenia (86%), and thrombocytopenia (86%).
Grade 3 or 4 adverse reactions were reported in 71% of the combined safety population. The most frequently reported non-hematologic Grade 3 or 4 adverse reactions were fatigue (11%), febrile neutropenia (6%), and pneumonia, hypokalemia and dehydration (each reported in 5% of patients). The most frequently reported grade 3 or 4 hematologic laboratory abnormalities were lymphocytopenia (94%), neutropenia (60%), leukopenia (56%), thrombocytopenia (25%), and anemia (11%).
Three patients died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with grade 3 thrombocytopenia, and pneumonia from a cytomegalovirus infection.
For patients with indolent NHL, bendamustine hydrochloride is administered as a 60 minute IV infusion on days 1 and 2 of a 21-day cycle for up to 8 cycles. The recommended dose is 120 mg/m 2 .
This dose, infusion duration, and cycle length of bendamustine hydrochloride is different from that approved dosing regimen for the chronic lymphocytic leukemia (CLL) indication. For patients with CLL, bendamustine hydrochloride is administered as a 30 minute IV infusion on days 1 and 2 of a 28-day cycle for up to 6 cycles. The recommended dose for the CLL indication is 100 mg/m 2.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at http://www.fda.gov/cder/foi/label/2008/022303lbl.pdf
2008-10-15 - approval of denileukin diftitox (Ontak®, Eisai Medical Research)
On October 15, 2008, the U. S. Food and Drug Administration converted the approval of denileukin diftitox (Ontak®, Eisai Medical Research) solution for intravenous use for the treatment of persistent or recurrent CD-25 positive cutaneous T-cell lymphoma from accelerated approval to regular approval following confirmation of an improvement in progression-free survival (PFS) and overall response rate (ORR).
Denileukin diftitox was originally approved in 1999 under the accelerated approval program for this indication based on durable, objective responses in an open-label study comparing two different doses. A further description of the FDA accelerated approval regulations is at http://www.fda.gov/cder/guidance/5645fnl.htm.
ASCO
2008-10-08 - ASCO letter regarding Medicare carrier coverage of new off-label compendia
Compendia Letter
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.
Read More...
CMS
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
2008-09-26 - 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
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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IRS
2008-09-19 - IR-2008-108: Louisiana Hurricane Ike Victims Qualify for IRS Disaster Relief
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2008-09-19 - IR-2008-108: Louisiana Hurricane Ike Victims Qualify for IRS Disaster Relief
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2008-09-19 - IR-2008-107: Texas Hurricane Ike Victims Qualify for IRS Disaster Relief
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FDA Approval
2008-09-19 - iobenguane I 123
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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CMS
2008-09-17 - ASP+6% Q4
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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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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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IRS
2008-09-03 - Hurricane Gustav Victims Qualify for IRS Disaster Relief
WASHINGTON — The Internal Revenue Service is providing tax relief to victims of Hurricane Gustav in affected areas of Louisiana.
The IRS is postponing until Jan. 5, 2009 deadlines for taxpayers who reside or have a business in the disaster area
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CMS
2008-08-29 - CMS Manual System
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2008-08-29 - CMS Manual System- Medicare Claims processing
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FDA Approval
2008-08-28 - 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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2008-08-22 - Romiplostim for Subcutaneous Injection
On August 22 2008 the Food and Drug Administration approved romiplostim for subcutaneous injection for the treatment of Thornbocytopenia in patients with Chronic immune thornbocytopenic purpura who have had insufficient response to corticosteriods, immnunoglobulins, or splenectomy.
Read More...
FDA
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.
Read More...
FDA Approval
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).
Read More...
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.
Read More...
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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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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FDA Approval
0000-00-00 - FDA Approves Drug that Boosts Stem Cells
December 18, 2008
FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants
The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer.
Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple myeloma or non-Hodgkin's lymphomas. Multiple myeloma is cancer of the plasma cell, a cell in the bone marrow that produces antibodies to help fight infection and disease. Non-Hodgkin lymphomas are a diverse group of blood cell cancers derived from lymphocytes, a type of white blood cell.
Prior to receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis in which blood stem cells are collected and stored for reinfusion after therapy. G-CSF is commonly administered to help release and collect stem cells from the bone marrow. Mozobil is an injectable drug that, when used in combination with G-CSF, boosts the number of stem cells released from the bone marrow into the blood stream.
"Collecting the millions of cells needed for a bone marrow transplant can take hours or days," said Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. "Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy."
In two randomized clinical trials - one in patients with non-Hodgkin's lymphoma, the other with multiple myeloma - Mozobil combined with G-CSF increased the number of stem cells available for collection and transplantation compared with patients receiving G-CSF alone.
The most commonly reported adverse reactions in these trials and other smaller studies were diarrhea, nausea, fatigue, injection site reactions, headaches, joint pain, dizziness and vomiting.
Mozobil is manufactured by Genzyme Corp., Cambridge, Mass.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01929.html
