(BUSINESS WIRE) — IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) announced today that the Centers for Medicare and Medicaid Services (CMS) has informed the company that the previously assigned C-codes and billing rate for the Zevalin(TM) (ibritumomab tiuxetan) therapeutic regimen became effective on October 1, 2002. CMS has further clarified that for the remainder of this year, it will reimburse hospitals at the 2002 standard rate of 78 percent of published Average Wholesale Price (AWP) for the Zevalin therapeutic regimen, similar to other single source drugs eligible for transitional pass-through payment.
Coding Instructions for Indium-111 Zevalin and Yttrium-90 Zevalin were issued to Medicare Intermediaries and Carriers in a Program Memorandum (AB-02-120) dated August 21, 2002. The Company has been informed by CMS that providers will be reimbursed for the full amount used and billed by the radiopharmacy (not to exceed 40 mCi) of Yttrium-90 Zevalin, the therapeutic agent in the regimen. In addition, providers will be reimbursed for 5 mCi of Indium-111 Zevalin, the imaging agent in the Zevalin therapeutic regimen. According to the Zevalin package insert, patients first receive a 5 mCi dose of Indium-111 Zevalin, then patients with acceptable biodistribution receive a dose of Yttrium-90 Zevalin, up to a maximum of 32 mCi, based on patient body weight and platelet count.
“By clarifying 2002 payment status, CMS has assured access to this important new therapy for those Medicare beneficiaries with relapsed or refractory, low grade non-Hodgkin’s lymphoma who are appropriate candidates for Zevalin therapy,” said William R. Rohn, President and Chief Operating Officer, IDEC Pharmaceuticals.
In November 2002, CMS is due to release its final Hospital Outpatient Prospective Payment System (OPPS) rule, which will outline how CMS will reimburse hospitals for Zevalin as of January 1, 2003.
In February 2002, Zevalin became the first in a new class of cancer treatments called radioimmunotherapies to receive FDA approval. It is indicated for the treatment of relapsed or refractory low grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma (NHL), including patients with Rituxan(R) (Rituximab) refractory follicular NHL.
Radioimmunotherapies are made by linking monoclonal antibodies to radioactive isotopes. When infused into a patient, these radiation-carrying antibodies circulate in the body until they locate and bind to the surface of specific cells, and then deliver their cytotoxic radiation directly to malignant cells. Zevalin, a monoclonal antibody linked to the radioisotope Yttrium-90, targets the CD20 antigen on the surface of mature B cells and B-cell tumors, inducing cellular damage in the target and neighboring cells.
About IDEC Pharmaceuticals
IDEC Pharmaceuticals Corporation is a leader in the discovery, development, and commercialization of targeted immunotherapies for the treatment of cancer and autoimmune diseases. IDEC discovered and developed the first commercially available radioimmunotherapy product (Zevalin) approved in the United States and, with co-promotion partner Genentech, Inc., the first monoclonal antibody product (Rituxan) approved in the United States, both for the treatment of cancer. IDEC is a San Diego based, integrated biopharmaceutical company with multiple products in clinical stage development and strategic alliances in a variety of research platforms. For a menu of IDEC’s current news releases and quarterly reports or to retrieve a specific release, call (888) 329-2309. On the Internet check the News Center at IDEC’s website: http://idecpharm.cdmail.biz.
The statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ from IDEC’s expectations. For example, the timing, success and cost of preclinical research and clinical studies, the timing, acceptability and review periods for regulatory filings, the timing of and ability to obtain regulatory approval of products, the achievement of future product sales, the level of manufacturing performance, changes in healthcare reimbursement policies, and the risk factors listed from time to time in IDEC’s SEC filings including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2001 and Form 10-Q for the quarter ended June 30, 2002, may affect the actual results achieved by IDEC. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
IDEC Pharmaceuticals and Rituxan are registered U.S. trademarks of the company and Zevalin is a trademark of the company. IDEC’s headquarters are located at 3030 Callan Road, San Diego, CA 92121.CONTACT: IDEC Pharmaceuticals Corporation Vince Reardon, Director, Corporate Communications 858/431-8656
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