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It’s official: Medicare must now decide how to cover Aduhelm. Here’s what we’re watching


Medicare announced it’s opening a so-called National Coverage Determination for Biogen’s divisive new Alzheimer’s drug, Aduhelm. As wonky as that sounds, the determination will set the rules for who can access the $56,000 drug through Medicare. And as my colleague Rachel Cohrs reports, if Medicare were going to pay for any Alzheimer’s patient’s treatment with Aduhelm, it likely would not need to use this regulatory tool.

Whatever CMS decides, it will likely have massive implications for those covered by private insurance, too. Typically private plans look to Medicare for guidance on what drugs to cover. And certain insurers are already anxious to find ways to limit access to the largely-unproven costly drug. A number of health plans affiliated with Blue Cross Blue Shield have already decided not to cover the drug because they view it as “investigational,” according to research from Tufts University. The blues appear to be the first plans pushing back on coverage, according to James Chambers, an associate professor at Tufts University who tracks insurance coverage of specialty drugs.

Biogen, you’ve got some explaining to do 


The two Democrats at the helms of the House Energy & Commerce and Oversight Committees wrote a letter to Biogen Monday probing Project Onyx, the company’s secretive campaign to influence the FDA that was exposed by a STAT’s investigation earlier this month, my colleague Rachel Cohrs writes.

The lawmakers are requesting “all internal and external documents and communications” related to Project Onyx and “the dates, times, locations, attendees, and any notes or minutes taken of all calls and informal and formal meetings” between the FDA and Biogen.

Major 👀. Looks like we are going to learn a lot more about Project Onyx in the next few weeks. More from Rachel here.

Speaking of which: I bet you can guess what I’ll be asking acting FDA Commissioner Janet Woodcock about first, when we sit down on Wednesday as part of STAT’s Breakthrough Science Summit.

After all, a lot has changed since Woodcock told me last month that the controversy around the FDA’s approval of Biogen’s Alzheimer’s drug Aduhelm would sort itself out as more information came to light about the approval.

In addition to STAT’s reporting on Project Onyx, my colleagues and I scooped last week that even top FDA officials were blindsided by the agency’s decision to approve the drug for all patients with Alzheiemer’s. The FDA announced it was narrowing the label for the drug last Thursday.

To watch my interview with Woodcock, as well as interviews with NIH Director Francis Collins, Eli Lilly CEO David Ricks, and the scientists at Pfizer and BioNTech behind the companies’ Covid-19 vaccine, register for the STAT Breakthrough Science Summit here.

Confused and worried about vaccine boosters? STAT has got you covered

Pfizer’s announcement last week that it would ask the FDA for authorization to sell Covid-19 vaccine boosters had everyone, including federal officials, with a lot of questions. Namely: “What the heck is the company doing?”

We still don’t know why Pfizer is intent on selling boosters, because independent scientists have not seen the data Pfizer has accumulated that the company says shows “based on the totality of the data we have to date, … a third dose may be needed within 6 to 12 months after full vaccination.”

But one thing is clear about the looming fight over boosters: The decision on whether those who are vaccinated need boosters will not rest with Pfizer or Moderna, it’ll be a decision made by federal regulators.

In a new story for STAT, our reporters unpack your biggest booster questions, including what we know about Pfizer’s new efficacy data, how the Delta variant might impact the need for boosters, and what the need for boosters might mean for Pfizer and Moderna’s balance sheets. More here.

Biden wants a drug pricing plan on his desk in 45 days. Who’s going to write it? 

President Biden signed an executive order Friday ordering HHS to come up with a drug pricing plan within 45 days. But there’s one problem: The administration hasn’t even said publicly who’s leading drug pricing policy within the federal health department.

STAT surveyed a number of Washington’s top drug pricing advocacy organizations and health care lobbyists — the types of people who would usually be coordinating or at least meeting with HHS on a drug pricing plan — and almost all of them failed to name a staffer at HHS charged with the task. However, clues are emerging.One lobbyist who spoke with STAT said they believe Stephen Cha, Sarah Despres, and Jennifer Friedman will be involved in drug pricing work because of the officials’ portfolios in their roles as counselors to HHS Secretary Xavier Becerra. A second advocate confirmed that Despres, who previously served as director of government relations at the Pew Charitable Trusts, is in charge of the drug pricing work.

HHS declined to answer STAT’s question about who’s taking the lead on the issue.

There is, however, a clear drug pricing lead at the White House. Several advocacy groups told STAT they met with Christen Linke Young, the deputy director of the Domestic Policy Council. She held a series of drug pricing-focused meetings with advocates this spring. Among those who snagged a slot on her calendar:  Social Security Works, Patients for Affordable Drugs, Families USA, and the Campaign for Sustainable Rx Pricing.

There’s a not-so-tiny loss for PhRMA tucked into Biden’s executive order

Biden’s forthcoming drug pricing plan might not actually be the biggest drug pricing news coming out of his Friday executive order. The order also includes a not-so-subtle rebuke of an effort unveiled in the final weeks of the Trump administration that would have forbidden the use of march-in-rights as a response to high drug costs.

Biden’s order, which technically directs the commerce secretary to “consider not finalizing” the proposal, is at least vaguely a loss for pharmaceutical companies, which had applauded the initiative. (Though the commerce department could try to buck the president’s orders, I wouldn’t count on it.)

The Trump proposal was fiercely criticized by a slew Democratic lawmakers who wrote to Biden in March calling the proposal “a grave misjudgment [that] would likely exacerbate the already exorbitant cost of prescription medicines.”

Want to dive deeper? STAT’s Ed Silverman has you covered here.

STAT stories you may have missed 

House Democrats are on the attack with a new report showing drug makers spent more on stock buybacks than research.

Purdue has reached a deal with 15 states over its role in the opioid crisis.

Full FDA approval of Covid-19 vaccines isn’t a magic bullet for combatting vaccine hesitancy.

Experts are divided on whether vaccine doses can be stretched to reach more people.

Menthol smokers have a harder time quitting, a new large study finds.

U.S. cancer drug prices were higher at launch than in three European countries — and just kept climbing.

This was the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.