Becerra Tells Medicare To Review Premiums After Aduhelm Price Drop

Stat: Becerra Orders Medicare To Reconsider Premiums After Aduhelm Price Cut
Department of Health and Human Services Secretary Xavier Becerra on Monday took the highly unusual step of ordering Medicare to reconsider a historic hike in premiums after Biogen slashed the price for its controversial Alzheimer’s drug in half. “With the 50% price drop of Aduhelm on January 1, there is a compelling basis for CMS to reexamine the previous recommendation,” Becerra said in a written statement. It is highly unusual for Medicare to make changes to premiums after a plan year has begun, multiple Medicare policy experts said. Normally, if Medicare has extra premium funds, officials factor that into the next year’s premium calculations. (Cohrs, 1/10)

AP: Medicare Told To Reassess Premium Hike For Alzheimer's Drug
More than 50 million Medicare recipients who pay the $170.10 monthly “Part B” premium for outpatient care will see no immediate change to their costs, but Monday’s move could open the way for a reduction later in the year. The Department of Health and Human Services says it is reaching out to the Social Security Administration, which collects the premium, to examine options. Medicare’s standard premium is rising by about $22 this year, up from $148.50 in 2021 and one of the biggest annual increases ever. About half of that, $11, was attributed to the potential costs of having to cover Aduhelm at its original $56,000 price. Since Aduhelm is administered by infusion in a doctor’s office the cost is factored into Medicare’s outpatient coverage, not the separate prescription plan that pays for pharmacy medicines. (Alonso-Zaldivar, 1/10)

CNBC: Government May Scale Back Medicare Part B Premium Increase
A CMS spokesperson said the agency is “reviewing the secretary’s statement to determine next steps.” Aduhelm was approved by the Food and Drug Administration in June. The approval for the drug, manufactured by Biogen, came despite some objections in the scientific community about its effectiveness and side effects, which include brain swelling and bleeding. Medicare officials are expected this week to release a preliminary decision on coverage — i.e., whether it will cover Aduhelm at all or limit its use to certain patients under certain conditions. A final decision should come in the spring. (O'Brien, 1/10)

In more news about Aduhelm —

Stat: Biogen CEO: Company Was ‘Wrong’ About Initial Aduhelm Price
Biogen CEO Michel Vounatsos acknowledged Monday that the company was “wrong” to price its Alzheimer’s disease treatment Aduhelm at $56,000 a year, but added that its decision to later slash the cost nearly in half was “courageous.” Speaking virtually at the J.P. Morgan Healthcare Conference, Vounatsos described the company’s flagging revenue and the disastrous launch of Aduhem as “near-term challenges [that] are not defining Biogen,” and stressed “the company’s fundamentals are very strong.” (Garde and Feuerstein, 1/10)

The Washington Post: Medicare Is About To Make Its Most Important Coverage Decision In Years. Here’s How People With Alzheimer’s And Others Might Be Affected
It is a firestorm rarely seen in the world of drug regulation. Since June, when the Food and Drug Administration approved a controversial Alzheimer’s drug, critics have denounced the move, saying there is not enough evidence to show the drug works. Some have demanded that the agency take the drug off the market, citing potentially dangerous side effects. But the FDA and others have insisted the treatment might provide desperately needed help to patients with a fatal disease for which there are few alternatives. (McGinley, 1/10)

In other pharmaceutical industry news —

Stat: Sarepta's Duchenne Gene Therapy Improves Muscle Function, Data Show
Sarepta Therapeutics said Monday that its gene therapy improved muscle function for a group of patients with Duchenne muscular dystrophy — updated results from a mid-stage study the company believes ameliorates an initial negative outcome last year and might support accelerated approval. But the magnitude of the benefit shown by Sarepta’s one-time treatment was lower than some investors hoped to see. That concern, coupled with weaker financial guidance for the year, caused Sarepta’s stock price to drop. (Feuerstein, 1/10)

Stat: Hold Lifted On Cancer Studies Of Allogene Off-The-Shelf CAR-T Treatment
Allogene said Monday that clinical trials involving its off-the-shelf CAR-T therapies for blood cancer are resuming following a safety clearance by U.S. regulators. In October, the Food and Drug Administration placed five Allogene studies on hold after a single treated patient was found to have a “chromosomal abnormality.” But a three-month investigation conducted by Allogene concluded its CAR-T called ALLO-501A was not responsible for the chromosomal abnormality, and that it had no clinical significance for the patient. The FDA agreed with the findings of the safety investigation and removed the hold on Allogene’s clinical trials, the company said. (Feuerstein, 1/10)

Bloomberg: Rite Aid’s Insurer Chubb Is Off the Hook for Opioid-Suit Cost, Court Says
Rite Aid Corp.’s insurer, Chubb Ltd., won’t have to pay the cost of defending the pharmacy chain against lawsuits alleging it mishandled addictive opioid painkillers, an appeals court. The Delaware Supreme Court on Monday, in a 4-1 ruling, overturned a lower court finding that the language of Rite Aid’s insurance policies required Chubb units to cover the liability. States and municipalities across the U.S. sued the chain, along with other pharmacy owners, drug makers and distributors, seeking to recoup costs associated the opioid epidemic. (Feeley, 1/10)

The Wall Street Journal: Elizabeth Holmes’s Mixed Verdict Could Handicap An Appeal, Lawyers Say
Elizabeth Holmes’s conviction on four counts of fraud for intentionally deceiving Theranos Inc. investors is far from the end of the startup founder’s legal fight. Instead, the Jan. 3 verdict is expected to kick off a new round of legal maneuvering that will give her lawyers several chances to clear her name, and to continue to deploy what legal observers say is an intransigent defense strategy that became the team’s signature during the monthslong trial. One tactic will likely involve requesting that Ms. Holmes remain free on bail for the entirety of the appeal process, which could take years. (Randazzo, 1/10)