SEATTLE, July 9 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that the Medicare Improvements for Patients and Providers Act of 2008, as passed by the U.S. House of Representatives on June 24, 2008 and the U.S. Senate on July 9, 2008, would continue the 2007 reimbursement methodology for therapeutic radioimmunotherapies for an additional 18 months with a start date of July 1, 2008. In December, Congress froze reimbursement rates at the 2007 level for six months after the Centers for Medicare & Medicaid Services (CMS) had released rates for 2008 that were lower than the acquisition cost for radioimmunotherapies like Zevalin(R) (Ibritumomab Tiuxetan). Manufacturers of radioimmunotherapies and CMS have been in discussion on a payment policy that more accurately reflects hospital costs associated with the therapy. These drugs are used to fight relapsed non-Hodgkin's lymphoma (NHL), and can provide some patients with additional therapeutic options.
On July 3, 2008 CMS posted the Hospital Outpatient Prospective Payment System proposed rulemaking for Calendar Year 2009. In the rulemaking, CMS proposed to pay Zevalin and other similar products based on the Average Sales Price (ASP) methodology which is currently used for drugs and biologicals. CTI plans to submit a public comment in support of the proposal.
"We are pleased law makers have listened to the voice of patients and healthcare providers who want access to these important anti-cancer therapies," said James A. Bianco, M.D., President and CEO of CTI. "We continue to work with Congress and CMS to establish a permanent payment methodology for reimbursing radioimmunotherapies, and look forward to the President signing the bill into law."
CTI purchased the U.S. sales, marketing, and development rights to Zevalin in late 2007 from Biogen Idec, Inc. Recently CTI reached an agreement with Bayer Schering Pharma, which has rights to Zevalin outside the United States, for access to pivotal trial data from the First-line Indolent Trial (FIT), which can potentially be used to expand the label in the U.S.
Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy. The Zevalin therapeutic regimen is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory follicular NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia, and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit http://www.zevalin.com for more information.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.CellTherapeutics.com.
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This press release includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could materially
and/or adversely affect actual future results. Specifically, the risks and
uncertainties that could affect the development of Zevalin include risks
and uncertainties related to the reimbursement rate for Zevalin including
the risk that the President may veto the Medicare Improvements for Patients
and Providers Act of 2008, and risks and uncertainties associated with
preclinical and clinical developments in the biopharmaceutical industry in
general and with Zevalin in particular including, without limitation, the
potential failure of Zevalin to prove safe and effective for treatment of
non-Hodgkin's lymphoma, determinations by regulatory, patent and
administrative governmental authorities, including determinations by CMS
and Congress regarding future reimbursement rates for drugs such as
Zevalin, competitive factors, technological developments, costs of
developing, producing and selling Zevalin, and the risk factors listed or
described from time to time in the Company's filings with the Securities
and Exchange Commission including, without limitation, the Company's most
recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by
law, CTI does not intend to update or alter its forward-looking statements
whether as a result of new information, future events, or otherwise.
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|SOURCE Cell Therapeutics, Inc.|
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