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Drug pricing drama to come in 2023, new drug negotiation staff at CMS, and the great voluntary licensing debate

 

D.C. Diagnosis

Good morning and happy Thursday, D.C. Diagnosis readers! Not sure if you all are resolution people, but I’m working on trying to read more books in the New Year. Pass along your news tips and favorite health care policy/business book recommendations to rachel.cohrs@statnews.com.

Mark your calendars for 2023’s drug pricing drama

As wild as a ride of last year was on drug pricing policy, this year has plenty of twists in store. I talked to some smart people to distill the three top drug pricing topics you’ll want to watch in the months ahead. 

Working for a drug company? We’ve got the details on when the new Medicare negotiation process kicks off in earnest. Doing oversight on the Hill? The piece highlights the dates you’ll need to pay attention to. Are you a patient taking insulin? We have one thing to watch for to make sure you’re getting the best deal at the pharmacy counter. 

One big event coming up this week will have huge impacts for drug pricing and the Medicare program is the FDA’s Friday deadline to decide whether to grant accelerated approval to a new Alzheimer’s drug developed by Eisai and Biogen. We don’t know how the medication will be priced or how Medicare will proceed in covering it, but we can tell you that the STAT team will be covering every twist and turn. For now, read up in advance to sound smart in all your meetings.

New Year, new staff for Medicare’s drug negotiation division

I’ve been following with acute interest Medicare’s progress in putting together its drug price negotiation division — an org chart that I scooped last year showed CMS expected there would be 95 positions available. 

There are now three employees officially listed in the division, according to the HHS staffing directory. The agency has hired University of Utah Professor Joey Mattingly as an advisor. Two internal hires will be health insurance specialists: Elisabeth Daniel, who was most recently a policy analyst for hospital and ambulatory policy at CMS, and Corey Rosenberg, who was most recently the Deputy Director of the division of financial risk at CMMI, per their LinkedIn profiles.

The agency has open postings in the Medicare Drug Rebate and Negotiations Group for more health insurance specialists, economists, pharmacists, and IT specialists.

The great voluntary licensing debate

Mike Reddy/STAT

You may have heard of compulsory licensing, a blunt instrument that forces drugmakers to let generic manufacturers make their patented drugs. Drug makers have posed a possible alternative of voluntary licensing instead to offer broader access to certain medicines.

A deal by Novartis last fall to let generic companies make a cancer drug for distribution to low- and middle-income companies for the very first time seemed like a breakthrough for the idea. But the deal didn’t quite live up to the hype, my colleague Ed Silverman reports from Annecy, France (a dateline I am more than a little jealous of).

The agreement has raised pointed questions about the extent to which voluntary licensing can successfully widen access to a wide array of medicines for those in need. There were high hopes that voluntary licensing would take off in a new way after the pandemic, but few deals have been reached in recent years. Ed breaks down the history, the few bright spots, and the obstacles to widespread adoption of voluntary licensing in a feature that’s worth the read.

A head-turning hire for Team Bernie

On a related note, Sen. Bernie Sanders’ Senate HELP team made a big hire for the new Congress — Zain Rizvi will be a new senior health counsel for the Senate HELP committee, focusing on access to medicines. Rizvi worked for Public Citizen on similar issues for the past four years.  

The hire is a signal that Sanders is planning to focus on pharmaceutical pricing during his tenure atop the HELP Committee, and his staff will have subpoena power to back it up. The Congressional Research Service has a good primer on committees’ subpoena power, which says the panel can issue subpoenas as long as the majority of the committee or subcommittee approves them.

What we're reading

  • Walgreens to pursue certification to provide abortion pills in pharmacies, STAT
  • Want a clue on health care costs in advance? New tools take a crack at it, Kaiser Health News
  • Medicare would have saved $3.7 billion on Part B drugs if inflationary rebates were around in a recent three-year period, STAT

  • ‘I know firsthand they failed’: Parents decry lack of FDA action on infant formula safety, Politico

Thursday, January 5, 2023

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