Speaker: John M. Brooks, PharmD, Associate Professor of Pharmacy, College of Pharmacy, The University of Iowa, Iowa City, Iowa.

Neutropenia is a common and costly complication of combination chemotherapy in patients with newly diagnosed non-Hodgkin’s lymphoma (NHL). It occurs most often during the first two cycles of treatment and has a significant effect on inpatient Medicare costs.

The national Surveillance, Epidemiology, and End Results (SEER) program and Medicare-linked databases were used to estimate the average Medicare cost of neutropenia hospital-ization for elderly patients with NHL over the first course of chemotherapy and to determine whether the total neutropenia hospitalization costs varied by patient factors at the baseline evaluation. Included in the analysis were patients in the linked SEER and Medicare databases with a first primary diagnosis of NHL between 1991 and 1999, who were 66 years of age or older at the time of diagnosis, and who had continuous Part A and B Medicare benefits outside a health maintenance organization one year before diagnosis through the first course of chemotherapy. tadacip 20

A total of 7,516 of 35,063 patients met the study entry criteria. Of these patients, 1,895 underwent a total of 2,484 hospi-talizations for neutropenia covering a period of 23,379 days. The mean cost for one hospital stay was $7,691. Among the 1,895 patients, 451 had multiple hospital stays as a result of neutropenia. The average total hospitalization cost for each NHL patient was $2,542. The cost of all of these hospitalized patients was $10,081.

Baseline clinical characteristics (e.g., type of chemotherapy, diagnosis year, SEER registry, presence of renal disease, and disease stage) affected total costs of hospitalization resulting from neutropenia. All of these baseline characteristics, plus being female, affected inpatient length of hospital stay for neutropenia.

Although granulocyte-colony-stimulating factor (G-CSF) (filgrastim) (Neupogen®, Amgen) does lower the incidence and duration of febrile neutropenia for patients undergoing chemotherapy, results from a related SEER study2 indicate that rates of early G-CSF use varied across the country and that giving less than the recommended duration of G-CSF therapy was common in clinical practice. Such inadequate dosing of G-CSF has been associated with first-course neutropenia hospitalization and suboptimal patient outcomes.

Palifermin for Oral Mucositis

Speaker: Christos Emmanoulides, MD, Adjunct Assistant Professor of Hematology and Oncology, Division of Hematol-ogy/Oncology, Department of Cancer Services, University of California, Los Angeles, Medical Center, Los Angeles. canadian antibiotics

The administration of palifermin (Amgen), a recombinant form of human keratinocyte growth factor, has been shown to reduce the incidence and duration of severe oral mucositis. The agent also decreases patient-reported mouth and throat soreness, resulting in significant reductions in the use of health care resources, specifically days of hospitalization, the need for analgesics, and the incidence of parenteral feeding.

Oral mucositis is considered one of the most debilitating side effects of high-dose chemotherapy with or without total body irradiation and peripheral blood progenitor cell transplants used to treat patients with hematologic malignancies. In a recent phase 3 trial, palifermin therapy was shown to lower the incidence of severe oral mucositis, compared with placebo, and to reduce the duration of the event by almost one week (3.7 days) compared with placebo (10.4 days).

Palifermin therapy also helped to protect patients from grade 4 mucositis, the most severe form of this condition. Three times fewer palifermin-treated patients (20%) experienced this debilitating side effect, compared with patients receiving placebo (62%).

To assess the value of palifermin treatment in decreasing health-utilization costs, the researchers performed an additional analysis of the data from this phase 3 clinical trial. The use of resources included the number of days of hospitali-zation, the number of days of analgesic use, the incidence and number of days of parenteral feeding, the incidence of intubation, and the incidence of infections and number of days of anti-infective therapy. These evaluations were made, without adjustments for multiple comparisons, in patients with all baseline measures who received at least one dose of the study drug during the trial. This included all 212 patients who had originally been enrolled in the study.

These additional data from the phase 3 trial demonstrated that by reducing the severity and duration of oral mucositis with palifermin therapy, patients experienced shorter hospital stays (15.3 days) than those given placebo (17.3 days). Palif-ermin-treated patients required opioid analgesic agents for only 6.8 days; the placebo group needed them for 11.8 days.

The palfermin patients were also less likely to need paren-teral nutrition for severe oral mucositis (11% versus 43% for the placebo patients) and were less likely to need intubation (0.9% versus 3.8% for patients receiving placebo).

Cost-effectiveness of Fondaparinux After Hip Fracture Surgery

Speaker: Sean D. Sullivan, MD, Associate Professor, Departments of Pharmacy and Health Services, and Director, Pharmaceutical Outcomes Research and Policy Program, School of Pharmacy and Public Health/Community Medicine, University of Washington, Seattle, Washington.

Extended thromboprophylaxis with fondaparinux (Arixtra®, Sanofi-Synthelabo) after hip fracture surgery appears to be more cost-effective and to achieve greater clinical benefit than does therapy with enoxaparin (Lovenox®, Aventis).
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The first of the specific inhibitors of factor Xa, fondaparinux is approved for the prevention of venous thromboembolism (VTE) in patients who are undergoing major orthopedic surgery, including extended prophylaxis following hip fracture surgery. A cost-effectiveness analysis was performed to compare extended prophylaxis with fondaparinux versus enoxaparin on the basis of efficacy and safety data drawn from head-to-head clinical trials and the published literature.

The cost-effectiveness analysis was carried out from the perspective of U.S. health care payers. Costs were obtained from U.S. health care databases and were adjusted to 2003 dollars. Drug costs were based on wholesaler acquisition costs as of May 2003. The analysis took into account efficacy and long-term safety outcomes at 30 days, 90 days, one year, and five years after patient discharge. The main outcome measure was the prevention of VTE, defined as symptomatic deep vein thrombosis (DVT) and nonfatal pulmonary embolism (PE).

For a hypothetical cohort of 10,000 patients with hip fracture undergoing surgery and treated for 28 days with fondaparinux instead of enoxaparin, it was assumed that an additional 204 symptomatic venous thromboembolism events would be pre­vented at 30 days after surgery. These figures comprise 82 prevented deaths caused by PE, 45 nonfatal PE events, and 77 DVTs prevented.
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The incremental cost of fondaparinux that would be gained by the use of extended prophylaxis per life-year with fonda-parinux over that with enoxaparin is $694 at 30 days, -$512 at 90 days, -$940 at one year, and -$2,573 at five years. At 30 days, the incremental cost of fondaparinux per life year saved falls well within acknowledged parameters for reasonable health care expenditures. At 90 days, one year, and five years after hip fracture surgery, fondaparinux was a dominant therapy compared with enoxaparin.

Category: Diseases / Tags: Hematology, Lymphoma, Pregnancy Loss, Tipfarnab

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