Medicare approval:
May 03, 2000 08:49
Medicare Approves PROSORBA Column for National Coverage for Rheumatoid Arthritis
SAN DIEGO--(BW HealthWire)--May 3, 2000--Cypress Bioscience Inc. (NASDAQ:CYPB) Wednesday announced that the Health Care Financing Administration (HCFA) has approved coverage for the PROSORBA(R) column for rheumatoid arthritis (RA).
The policy was the result of a review conducted under the recently established National Coverage Process. It will provide uniform coverage across the Medicare carriers and intermediaries, and Medicare managed care plans, that administer the Medicare program at the local level.
The PROSORBA column has been covered by Medicare for Idiopathic Thrombocytopenic Purpura (ITP) under a 1991 national coverage policy. The Food and Drug Administration (FDA) approved the Column in 1987 for the treatment of ITP, and in March 1999 for treatment of RA.
"Cypress is pleased that HCFA has recognized that the PROSORBA column treatment is an appropriate therapeutic option for severe rheumatoid arthritis patients who have failed DMARD therapy. The decision will improve access to treatment for Medicare patients with rheumatoid arthritis, representing nearly half of those who are affected with severe disease," said R. Michael Gendreau, M.D., Ph.D., executive vice president, chief medical officer, and chief scientific officer. "We expect the outcome of the HCFA decision will facilitate coverage for similar patients covered by private insurance plans, also."
About Cypress Bioscience Inc.
Cypress Bioscience Inc. markets the PROSORBA column for treatment of RA and ITP, and is engaged in the development of other novel therapeutic agents for the treatment of immune disorders. In March 1999, the company entered into an agreement that granted Fresenius AG and Fresenius Hemotechnology Inc. an exclusive license to manufacture and distribute the PROSORBA column in the U.S., Europe and certain other territories.
In April 1999, Cypress and Fresenius launched the sale of the PROSORBA column for the treatment of moderate to severe RA in the United States. European approval for the column was obtained in March 2000. The PROSORBA column was previously cleared by the FDA in 1987 for use in ITP, an immune bleeding disorder. In addition, Cypress is developing Cyplex(TM) (Infusible Platelet Membranes), which is positioned to become an alternative for traditional platelet infusions. For more information about the PROSORBA column and Cypress, visit the company's Web site at www.cypressbio.com.
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