Biden drug czar plans naloxone roundtable

The White House is summoning naloxone manufacturers for a discussion on the medication's price, Rahul Gupta, the director of the White House Office of National Drug Control Policy, told STAT's Lev Facher.

The announcement comes amid continued criticism of pricing strategies from Emergent BioSolutions (which aims to price a two-pack of Narcan at $50) and other naloxone manufacturers. While advocates have long sought wider access for naloxone products, experts have warned that Narcan may remain out of reach for individual consumers despite its new over-the-counter status, Lev writes.

The arrival of newer, over-the-counter naloxone products like a nasal spray up for FDA approval this year should help drive down competitors prices, Gupta added, but "we are going to be monitoring the price. The drug czar also discussed his hopes for over-the-counter options and building public support for easy access. Read more here.

Drug policy

What do all these insulin changes mean for Civica?

Pharmaceutical companies often accuse pharmacy benefit managers of preferring high-cost, high-rebate drugs to cheaper versions, and last week's insulin hearing was no exception. So when Sen. Tim Kaine (D-Va.) asked PBM executives whether they'd commit to offering inexpensive biosimilar insulins, he had a specific situation and manufacturer, in mind.

Virginia-based Civica Rx announced last year that it would bring three low-cost interchangeable insulins to market starting in 2024. And even with all the policy changes on the table — from requiring rebate pass-throughs to eliminating spread pricing and installing monthly cost caps — the nonprofit (funded by a combination of government grants and philanthropies) still feels like its generic options have a place in the market.

"A bunch of things have changed and are changing," Allan Coukell, Civica's vice president of public policy, told D.C. Diagnosis. "Even though there's been some movement on list prices, we still think we need to be there as the conscience of the marketplace and to keep prices from going up in the future." The price caps — three versions of which are in negotiations — could have two effects, he added. "It means there are fewer people facing really high out of pocket costs, so that might mean fewer people who have motivation to go out and seek out a low-cost insulin. On the other hand, it means that the plans can't cost-shift … so it may mean that more health plans actually prioritize low costs and so on and or even prefer it."

SCOTUS

SCOTUS declines to hear 'skinny label' case

Generic drugmakers looking for clarity on so-called skinny labeling will have to wait even longer. The U.S. Supreme Court on Monday declined to hear an appeal on a generic drug case that throws into question a common tactic to bring cheaper rivals to market.

As Ed Silverman explains, skinny labeling is when a generic company seeks approval for a specific use — like one heart condition but not another — in an effort to avoid patent infringements for brand-name drugs. But a lower court put this approach on shaky ground six years ago when it ordered generic drugmaker Teva Pharmaceuticals to pay GSK patent infringement damages.

And while Teva has promised to keep fighting, some legal experts expressed shock at the court's decision Monday. A recent analysis found that between 2015 and 2020, skinny labeling saved Medicare $1.5 billion — or nearly 5% of the $30.2 billion spent by the health care program — on just five medicines during that period.

at the agencies

Biden makes it official

The president on Monday nominated National Cancer Institute Director Monica Bertagnolli to lead the National Institutes of Health, nearly a year and a half after Francis Collins stepped down.

The cancer surgeon has led NCI — NIH's largest institute — since last October and previously led Dana-Farber Cancer Institute's surgical oncology unit. If confirmed by the Senate, she would be the second woman to lead the agency.

Cancer and research groups applauded the announcement, calling Bertagnolli a gifted surgeon and experienced researcher who could jumpstart Biden's Cancer Moonshot initiative. But she is still likely to face a litany of questions during the confirmation process about NIH's funding and the government's Covid-19 response. (For more on that, here's my dispatch from the last big Senate hearing on the NIH's priorities.)

senate

What's next on insulin

I wrote in last week's D.C.D. that Sen. Bill Cassidy 'defended' spread pricing along with Sen. Rand Paul (R-Ky.) But while Cassidy asked PBM executives about spread pricing costs during Wednesday's hearing, he ultimately voted the next day to advance a bill that would ban the practice. He alsoThe committee's top-ranking Republican noted that the small business group the National Federation of Independent Businesses backs a ban.

However senators skipped over a major PBM reform the same day because the Congressional Budget Office hasn't yet scored its impact (as Cassidy demanded in an earlier markup). It's unclear when the committee will reconsider the bill, which would bar PBMs from charging higher administrative fees on more expensive drugs. But it's likely we won't hear much movement on this legislation and the competing insulin cap bills until after debt ceiling negotiations wrap. Here's more from my colleague John on that hearing.

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