tradeherpete
2年前
Biogen Accused of Baiting Patients With Illegal Drug Co-Pays
ByRobert Burnson
September 24, 2021, 9:57 PM EDT
Biogen Inc. was accused by a managed-care provider of illegally boosting sales of its pricey multiple sclerosis drugs by providing them free to patients on a temporary basis and then funneling money to them for co-payments so they can keep taking the medications.
The first part of the scheme involves “seeding” the drugs -- Tysabri, Avonex, and Tecfidera -- to multiple sclerosis sufferers who lacked medical insurance, according to the lawsuit filed Friday by Humana Inc.
After a few months, Biogen encourages the patients to sign up for government-funded healthcare and then funnels “illegal copayment assistance to those same patients under the guise of unrestricted charitable giving,” Humana said.
The money is funneled through a large specialty pharmacy and two medical charities who provide co-pay assistance, according to the suit.
“Given the high costs of the MS drugs here, copays can be thousands of dollars for any single patient,” Humana says in the suit.“But they are a tiny fraction of the total expense for the drugs. This means that if the manufacturer pays the copays itself, it can earn a major return from a minor investment.”
The drugs cost $50,000 to $80,000 a year, according to the suit.
Biogen didn’t respond after regular business hours to a request for comment.
tredenwater2
2年前
Unlike the patients heads, the share price “swelling” for Biogen always goes down. Another difference is Biogens Alzheimer’s amyloid platform never dies, just a few of their patients here and there in their trials.
Alzheimer’s is tough, didnt you know, just a little collateral damage, now hurry up and give me approval!
tradeherpete
4年前
The fallout has already been widespread. So far, three members of the FDA’s advisory committee have resigned, one of them calling the process a “sham.” Doctors who helped run Biogen’s clinical studies are speaking out, and others are penning editorials that they won’t be prescribing Aduhelm until they see evidence of effectiveness. But no one should hold their breath. When the FDA greenlit Aduhelm for use, it told Biogen it had nine years to run the confirmatory studies necessary to prove Aduhelm’s effectiveness. Nine years of people taking this drug that existing data suggests might not do anything meaningful. With Aduhelm poised to become among the biggest blockbuster drug in history—analysts estimate annual revenues could peak at $10 billion—Biogen probably isn’t in a hurry. But they might not even have to collect that extra data at all (for its part, Biogen said in an email to Slate, “We are working diligently to initiate the confirmatory trial”). Ross, the Yale FDA regulatory expert, looked at FDA approvals from 2005–12, and found that post-market confirmatory studies—ones that truly verified the clinical value of a surrogate outcome—only took place about 10 percent of the time. Despite this dismal compliance rate, according to Ross, the FDA has never fined a company for failing to do a confirmatory study and rarely uses its power to withdraw a drug later shown to be clinically ineffective. In an email to Slate, the FDA did not offer comment on whether it would use its power to withdraw Aduhelm should the drug ultimately prove clinically ineffective but “will carefully monitor trial progress and support efforts to complete this trial in the shortest possible timeline.”
https://slate.com/technology/2021/06/alzheimers-drug-aduhelm-fda-outcomes-plaques.amp