VELCADE® (Bortezomib) for Injection Based Regimens Result in Lower Costs and Less Patient Burden Than Other Commonly Used Multiple Myeloma Treatment

(BUSINESS WIRE)--Millennium: The Takeda Oncology Company today announced that two studies presented at the 51st American Society of Hematology (ASH) Annual Meeting found that VELCADE based regimens are more cost-effective for payers and reduced out-of-pocket costs for patients than other commonly used multiple myeloma treatments. The study found that VELCADE-melphalan-prednisone (VMP), a commonly used treatment in multiple myeloma, was more cost-effective compared to MP and delivered more cost-savings compared to melphalan-prednisone-thalidomide (MPT), another commonly used treatment regimen, based on a health economic model.

A second study based on claims data found patients with multiple myeloma treated with VELCADE:

* Incurred fewer out-of-pocket costs than patients treated with the oral drugs thalidomide and lenalidomide
* Did not require significantly more healthcare visits than patients prescribed thalidomide and lenalidomide.

“These studies support VELCADE’s overall cost-effectiveness and reduced out-of-pocket costs. As measured by the number of healthcare visits, VELCADE appears to be as convenient as oral multiple myeloma treatments,” said Dixie-Lee Esseltine, M.D., Vice President, Global Medical Affairs, Millennium. “This is valuable information for healthcare providers, patients and payers.”

The Cost-Effectiveness of Bortezomib for the Initial Treatment of Multiple Myeloma in the United States (Abstract #1379)

Based on a direct comparison of patient-level data, researchers projected that VMP would be cost-effective over a patient’s lifetime compared with MP in the United States. A second indirect comparison across different trials projected the combination of VMP would cost payers 17.7 percent less over a patient’s lifetime and generate better quality-adjusted life expectancy than MPT. Quality-adjusted life years are a measure of disease burden that take into account both the length and quality of life.

The incremental cost-effectiveness of VMP versus MP was found to be within the generally accepted cost-effectiveness range of $50,000-$100,000 per quality-adjusted life year. The projected overall survival years were greatest for patients treated with VMP versus those treated with MPT or MP (4.19, 4.14, and 2.86 years, respectively).

“Cancer can be a costly disease for both payers and patients, and this is certainly true in multiple myeloma,” said Professor Lou Garrison, a study co-author and Associate Director in the Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle. “It is therefore important to identify cost-effective therapies. This trial-based modeling study demonstrates that the first-line regimen using VELCADE is cost-effective compared to other commonly used regimens.”

To assess the relative costs and outcomes of different treatment combinations, study methodology generated modeling projections based on a direct comparison from the Phase III VISTA1 trial, which demonstrated superiority in overall survival of VMP versus MP (San Miguel et al, New England Journal of Medicine 2008) for treatment of multiple myeloma, as well as an indirect comparison of this trial with data published from the IFM 99-06 clinical trial for MPT (Facon et al, Lancet 2007). Costs included per-protocol drug and medical costs, treatment-related adverse events, second-line treatment, and resource utilization during treatment-free interval and progressive disease. Unit costs of medications were obtained from published literature.

Multiple Myeloma: Patient Out-Of-Pocket Costs and Health Care Utilization (Abstract #1366)

In the second study, researchers used data from one of the largest U.S. commercial healthcare plans to evaluate the number of healthcare visits and out-of-pocket costs for multiple myeloma patients being treated with various therapies. After adjusting for patient characteristics, line of treatment, and co-morbidities by multivariate analysis, data showed that patients receiving VELCADE did not have a significantly different number of healthcare visits than those receiving lenalidomide or thalidomide, two oral therapies. Additionally, direct out-of-pocket costs were found to be significantly lower for patients treated with VELCADE than patients treated with thalidomide or lenalidomide.

“There is a common perception that oral drugs are more convenient for patients, but these data show that, in terms of healthcare visits, that perception of convenience is false,” said study author Brett W. Pinsky, i3 Innovus researcher. “These data are consistent with the fact that patients with multiple myeloma typically require a great deal of care and resource utilization; therefore, most patients will not see a major difference in the number of healthcare visits regardless of whether their treatment is oral or infusion – but they may face a significantly higher out-of-pocket cost with oral medications.”

The total patient out-of-pocket costs for the year after treatment initiation were significantly less for patients treated with VELCADE ($3,504) than for those treated with either of the oral drugs thalidomide ($4,443, p<0.05) or lenalidomide ($4,766, p<0.05), after adjusting for patient characteristics, line of treatment, and co-morbidities by multivariate analysis. These differences were greatest for Medicare patients, with the adjusted patient costs nearly two and three times greater for thalidomide ($8,824) and lenalidomide ($12,568), respectively, compared with VELCADE ($4,395).

The study is a retrospective cohort study, which used claims data from a large national U.S. commercial health plan representing approximately 14 million members, and included a total of 2,642 treatment episodes for the 1,900 multiple myeloma patients.

Both studies were supported by Millennium Pharmaceuticals, Inc. The Wang study was also supported by Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.

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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.

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Data Presented at ASCO Finds REVLIMID as a Monotherapy is Effective and Well-Tolerated for Previously Treated Multiple Myeloma Patients

BUSINESS WIRE--The Moffitt Cancer Center today said findings from a clinical trial presented at the American Society of Clinical Oncology (ASCO) meeting evaluating REVLIMID (lenalidomide) as a monotherapy is both effective and well-tolerated in patients who have been previously treated for multiple myeloma with two or more therapies.

In the study, 26% of relapsed refractory multiple myeloma patients treated with REVLIMID as a single achieved an overall response, either complete or partial remission, and 66% of patients experienced stable disease. The median overall survival was 1.9 years with 41% of patients alive after three years. Prior to this innovative therapy the median overall survival was less than a year. Additionally, the duration of response was 13 months.

“REVLIMID is a novel, oral, targeted immune modulator cancer therapy with impressive clinical data in both newly diagnosed and previously treated multiple myeloma that shows REVLIMID can provide durable, long-lasting results for patients,” said Dr. Mohamad Hussein, Head Multiple Myeloma Section, Moffitt Cancer Center. “This study demonstrates that REVLIMID is effective in treating patients in which other therapies have failed without complimentary steroids or chemotherapy that can potentially cause serious side effects helping patients to live longer with a better quality of life.”

Multiple myeloma is a cancer of one of the immune cells that affects production of red cells, white cells and platelets. It is the second most prevalent and fastest growing of the blood cancers, affecting an estimated 750,000 people worldwide and 60,000 patients in the U.S.

REVLIMID is the newest of what are called immune modulators which have changed the outlook for patients with multiple myeloma and enable doctors to treat the previously incurable cancer as a chronic, manageable condition. It is an oral drug that can be taken at home and doesn’t have some of the difficult side effects associated with traditional chemotherapy because it targets the cancer cells directly along with the factors that support their growth.