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

New Data Released at ASH Examine Convenience and Cost-Effectiveness of Common Multiple Myeloma Treatment Regimens

NEW ORLEANS--(BUSINESS WIRE)--Dec 6, 2009 - 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.

About VELCADE

VELCADE is co-developed by Millennium Pharmaceuticals, Inc. and Ortho Biotech Oncology Research & Development, a unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and approved worldwide. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. VELCADE is approved in more than 87 countries worldwide.

Important Safety Information

In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma. VELCADE also is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron or mannitol. VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.

Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension throughout therapy, cardiac and pulmonary disorders, reversible posterior leukoencephalopathy syndrome, gastrointestinal adverse events, thrombocytopenia, neutropenia, tumor lysis syndrome and hepatic events. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Nursing mothers are advised not to breastfeed while receiving VELCADE. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with no risk factors for decreased left ventricular ejection fraction. There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these events have been fatal. There have been reports of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Patients who are concomitantly receiving VELCADE and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy. Patients on oral antidiabetic medication while receiving VELCADE should check blood sugar levels frequently.

Adverse Reaction Data

Safety data from Phase II and III studies of single-agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the Phase III, VELCADE plus DOXIL® [doxorubicin HCl liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia and headache (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo) (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of ‰¥Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

In the Phase 3 VELCADE + melphalan and prednisone study, the safety profile of VELCADE in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse events for VELCADE in combination with MP vs MP, respectively, were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%).

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. (“Takeda”, TSE: 4502) in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.

Editors' Note: This press release is also available under the Media section of the Company's website at: www.millennium.com.

1 VELCADE as Initial Standard Therapy: Assessment with melphalan and prednisone

 

Contact: Millennium: The Takeda Oncology Company Manisha Pai, 617-551-7877 Manisha.Pai@mpi.com Lauren Musto, 617-551-7848 Lauren.Musto@mpi.com

 

 

Posted: December 2009

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