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CMS to restrict coverage of Biogen’s controversial Alzheimer’s drug to only clinical trials

by ZACHARY BRENNAN CMS on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials. In a draft national coverage decision, which insurers nationwide are likely to follow, CMS said it’ll be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition...

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Biogen reverses course on compassionate use for ALS drug tofersen with plans to open program in July

Josh Sullivan Associate Editor De­spite im­mense pres­sure from the ALS com­mu­ni­ty, Bio­gen had re­peat­ed­ly re­fused to open in­ves­ti­ga­tion­al drug tofersen for use out­side of clin­i­cal tri­als. But now, cav­ing to that de­mand, Bio­gen has re­versed its stance. With a piv­otal Phase III study in ALS on­go­ing and da­ta ex­pect­ed to read out lat­er this year, Bio­gen just...