WASHINGTON _ The American Academy of Neurology (AAN)issued a "practice advisory" on May 13 for the use of Betaseron to treatmultiple sclerosis (MS). Although erroneous reports last weeksuggested that the AAN would endorse significantly broader use ofBetaseron, the organization's recent advisory broadened the drug'spatient population only moderately.A practice advisory is defined as "strategies for patient management forwhich there is unclear clinical certainty (ie, based on inconclusive orconflicting evidence or opinion)." It does not imply the same strengthof recommendation as "standards" or "guidelines," two more definitivetypes of AAN statements.Betaseron is manufactured by Chiron Corp., of Emeryville, Calif., andmarketed by Schering AG unit Berlex Laboratories of Richmond,Calif. The drug received FDA approval last year for the treatment ofrelapsing remitting MS patients, those with a moderate form of thedisease. Some analysts believed that the AAN would endorse the use ofBetaseron for the severe form of MS, chronic progressive MS.The AAN practice advisory does state that although no clinical trialevidence exists, experts agree that Betaseron could be helpful forrelapsing/remitting MS patients over 50 years of age with a specificdisease severity and for patients with "relapsing/progressive disease"who meet certain criteria. These patient categories go beyond thepopulation indicated in the FDA-approved label for the product andrepresent a broader group of patients than was tested in the Phase IIIclinical trial supporting licensure of the drug.Analysts speculated last week that an endorsement from a respectedmedical group such as the AAN might encourage neurologists toprescribe Betaseron more broadly thus increasing the drug's potentialmarket.The AAN practice advisory gave a nod to health care reform. "Giventhe newness and high cost of Betaseron, neurologists differ as to whichpatients should be treated with the drug," the AAN document states."Theoretical and laboratory evidence suggests that Betaseron may offersubstantial prospects for improving health outcome of MS patients.""In addition, other therapies for MS (eg., steroids, azathioprine,plasmapheresis) are expensive and may require hospitalization, whichitself is costly . . . the initiative of government to reduce health carecosts while broadening health care availability makes a considerationof a practice advisory for this new costly treatment for MS timely."The average cost of Betaseron per year is between $8,000 and $10,000.

-- Lisa Piercey Washington Editor

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