OSCO News & Articles

Reach out to your Representatives on the ESA National Coverage Determination

2007-06-27

Comment letter that COA submitted to CMS regarding the proposed NCD

2007-06-27

Attached is the comment letter that COA submitted to CMS regarding the proposed NCD. This may be helpful background information in discussing this issue with your Representatives.

Oncology Bills and who supported them

2010-07-23

Oncology Bills and who supported them

Dr. Nadim Nimeh OSCO Board President

0000-00-00

Dr. Nadim Nimeh, medical director for the Cancer Centers of Southwest Oklahoma, has been named president of the Oklahoma Society of Clinical Oncology (OSCO), according to a news release from the society, making him the first society president from Lawton since its inception in 1996. "I am honored," Nimeh said. "I have been a board member for several years and have always wanted to serve in several capacities. This is an oppotunity to do more for the society and the state." As president, Nimeh will be the voice for oncologist and hematologist on a state and federal level. He said he will help to promote safety and quality to all members of the society, while keeping the patients best interest at mind. Another issue, he said is drug reimbursement. He said there are a number of times when a doctor will prescribe a drug that will help the patient, but the insurance provider will not cover it. He said all sides must be on the same page. "It's my job to make sure the patients receive treatment, the treatment is covered (by insurance) and they receive quality care," Nimeh said. His stint as president will last two years, and Nimeh has wasted no time getting started. His first order was to establish board members. Since its beginning, the society has restricted board inclusion to only hematologists and oncologists, but for this session's board, Nimeh has expanded the horizons and has welcomed specialized doctors within the fields of oncology and hematology to participate . "(It was opened to) Everyone who is interested in cancer and works with us on a daily basis," he said. "I feel that will make us stronger. We will have a unified voice on different subjects." The inclusion of specialized fields within oncology and hematology has only been done in one state (Alabama) and Nimeh said that Oklahoma's board will be "looked at with great interest by other states." Since the OSCO is a state affiliate for a national society, Nimeh will also be responsible for representing Oklahoma at national meetings. He said in today's era of medicine, his interest will be on the issue of expense pertaining to cancer care. He said he would like to begin working with different organizations to see what can be done about cutting costs. Among the other issues Nimeh said he will be discussing during his time as president are electronic records, issues dealing with the end of life for patients, peak an interest in education and promote clinical trials. For more information on the Oklahoma Society of Clinical Oncology, visit www.oscoOK.org. Written and Published By: Jacob Russell Lawton Constitution

Health Reform Dialogue

2009-04-04

Reports of Increases in Melanoma Incidence Are Real

2009-01-08

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.

MarketWatch Does Reimbursement Influence Chemotherapy Treatment For Cancer Patients?

2010-06-17

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

How Medicare’s Payment Cuts For Cancer Chemotherapy Drugs Changed Patterns Of Treatment

2010-06-17

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.

FDA grants approval for temsirolumus (TORISEL, Wyeth, Inc.)

2007-05-30

On May 30, 2007, the US Food and Drug Administration granted approval for temsirolumus (TORISEL, Wyeth, Inc.)for the treatment of advanced renal cell carcinoma (RCC).

FDA grants approval to doxorubicin HCI liposome injection (DOXIL, Alza Corporation)

2007-05-17

On May 17, 2007 the US Food and Drug Administration granted approval to doxorubicin HCI liposome injection (DOXIL, Alza Corporation) for the use in combination with bortezomib in patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

U. S. Food and Drug Administration (FDA) approved docetaxel ( Taxotere® Injection Concentrate

2007-09-28

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).

Bortezomib FDA Approval

2008-06-20

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.

romiplostim for subcutaneous injection (Nplate™, Amgen Inc.)

2008-08-22

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.

Erlotinib (Tarceva)

2010-04-16

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) approved bendamustine hydrochloride (TREANDA, Cephalon, Inc.)

2008-10-31

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

FDA approves Tapentadol hydrochloride

2008-12-01

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

FDA Approval Gleevec for Adjuvant Therapy of positive GIST

2008-12-19

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 Approves Drug that Boosts Stem Cell

2008-12-18

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

FDA Approval Degarelix

2008-12-24

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.

U.S. Food and Drug Administration today approved Afinitor

2009-03-30

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.

Ferumoxytol (Feraheme) Injection

2009-07-02

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.

Avastin for Glioblastoma

2009-05-08

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.

FDA Approval for First Maintenance Drug For Lung Cancer (Alimta)

2009-07-09

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.

Opioid Fentanyl

2009-07-16

FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan The U.S. Food and Drug Administration today approved Onsolis, medication intended for certain patients with cancer to help manage breakthrough pain - severe flares of pain that break through regular pain medication.

FDA Approval for Avastin in Combination with Interferon Alfa

2009-07-31

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.

Pralatrexate Injection (Folotyn)

2009-09-22

On September 24, 2009, the Office of Oncology Drug Products granted accelerated approval to pralatrexate injection (FOLOTYN, Allos Therapeutics, Inc.) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This approval was based on an overall objective response rate observed in a single-arm trial. As a condition of the accelerated approval, randomized, controlled trials are required post-approval to verify and describe the clinical benefit of pralatrexate in PTCL.

FDA Approves Drug Treatment for Rare Cancer

2010-05-07

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).

FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women

2010-06-01

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.

FDA Approves New Treatment for Advanced Prostate Cancer

2010-06-17

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.

FDA Approves New Indication for Tasigna

2010-06-18

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.

Medicare Proposes Easing Rules for Cancer PET Scans

2009-01-06

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

Reporting Non-Tax Withholding Due to Federal Payment Levy Program (FPLP)

2009-08-21

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.

Smoking Cessation

2011-06-20

ASP+6% Q4

2008-09-17

CMS Instructions on Compendia

2008-10-24

Greetings! 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.

ESA Policy

2008-11-03

Trailblazer has issued a final policy on ESA's. The full text of the information can be found at:

Medicare Issues Severe Cuts for Community Oncology

2009-07-02

CMS has just issued severe cuts to Medicare reimbursement, including a 6% payment cut for community cancer care and elimination of consultation codes. The CMS cut to cancer care is based upon the flawed survey data provided to CMS by the AMA, which is why COA was opposed to the AMA survey.

updated policy from CMS regarding OncotypeDX- J1 MAC

2009-08-07

CMS Offers Training Session on Electronic Health Record (EHR) Incentive Programs

2010-08-05

CMS Offers Training Session on Electronic Health Record (EHR) Incentive Programs The Centers for Medicare and Medicaid Services (CMS) will conduct a training conference call for individual practitioners detailing the specifics of the Medicare and Medicaid EHR incentive program on Tuesday, August 10, from 2:00 - 3:30 p.m. Read more. 2010 PQRI & Electronic Prescribing Incentive Program National Provider Call With Question & Answer Session The CMS Provider Communications Group is hosting a national provider conference call on the 2010 Physician Quality Reporting Initiative & Electronic Prescribing Incentive Program on Tuesday, August 17, 2010, from 3:00 - 4:30 p.m. EDT. Visit the CMS website to register for the call. Call participants can access a transcript one week after the call on the CMS website.

COA Endorsement of the Access to Medicare Imaging Act of 2007 (H.R. 1293)

2007-05-10

The Community Oncology Alliance (COA) readily endorses the Access to Medicare Imaging Act of 2007 (H.R. 1293)...

Community Oncology Cancer Care Practice Impact Report

2010-07-23

• 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.

ASCO Cancer Policy Alert

2010-06-24

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.

Proposed Medicare Physician Fee Schedule Released

2010-06-25

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.

FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample

2008-07-31

FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor.

Important Information for Physicians about Changes Affecting the FDA-Approved Use of Erythropoiesis Stimulating Agents (ESAs)

2008-07-30

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.

FDA Announcement of Current Drug Shortages Leucovorin

2008-11-20

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

FDA MedWatch - Tarceva

2009-05-11

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.

Drug Shortages Update

2009-05-21

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

FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs

2009-08-21

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

FDA Clears a Test for Ovarian Cancer

2009-09-16

FDA Clears a Test for Ovarian Cancer Test can help identify potential malignancies, guide surgical decisions The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

2009-09-16

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.

States Implement Health Reform

2011-04-12

New Rx for Health Plan: Split Bill

2009-08-21

By JONATHAN WEISMAN and NAFTALI BENDAVID The White House and Senate Democratic leaders, seeing little chance of bipartisan support for their health-care overhaul, are considering a strategy shift that would break the legislation into two parts and pass the most expensive provisions solely with Democratic votes

Erythropoietin Stimulating Agents (ESAs)

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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.

Procrit Voluntary Recall Information

2008-08-05

BRIDGEWATER, NJ (August 5, 2008) - Ortho Biotech is announcing that it is voluntarily recalling one manufacturing lot (P114942A) of PROCRIT® (Epoetin alfa) after having identified cracks in the necks of a small number of vials upon post-manufacturing inspection. No other lot of this product is affected by this recall. Approximately 44,292 vials of lot P114942A in the following packaging configurations were distributed between April 15, 2008 and July 17, 2008.

New Fact Sheet: Peanut Product Recall and Cancer Patients

2009-02-18

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).

UHC Herceptin Policy

2009-01-09

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____#

Oplinc Newsletter

2009-05-15

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.

Politics and Physicians Payments

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Oplinc Fast Facts

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2010 PQRI standards for oncology

2010-01-21

ASCO Summary of ACO Proposed Rule

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Oncology Practice Insider

2010-06-25

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!

CMS’s Plans for the A/B Medicare Administrative Contractor

2010-07-23

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

Part 2 of the CMS 2011 Proposed Rule and Stakeholder Comments

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This is the second in a two-part series summarizing the highlights of the Proposed Medicare Physician Fee Schedule Rule for calendar year 2011 and recent legislative updates, which together will help shape the structure of the 2011 Medicare Physician Fee Schedule.

Patient Assistance Practices

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On September 16, 2010, the U.S. Census Bureau published, Income, Poverty, and Health Insurance Coverage in the United States: 2009, reporting an increase in the number of people without health insurance to 50.7 million in 2009 from 46.3 million in 2008. In addition, the number of people covered by Medicaid is the highest since 1987 with 47.8 million people in 2009 up from 42.6 million in 2008.