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The QALY debate is back, a take on Bernie Sanders’ latest drug pricing idea, & how fentanyl spurred a naloxone boom

March 28, 2023
Reporter, D.C. Diagnosis Writer
Hello and happy Tuesday, D.C. Diagnosis readers! Who is ready for Thursday's Senate hearing on pharmacy benefit managers? Let me and the team know what you're hearing at sarah.owermohle@statnews.com, rachel.cohrs@statnews.com and john.wilkerson@statnews.com. And thank John for the D.C. Diagnosis cameo last week!

DRUG PRICES

Could this drama over QALYS muck with Medicare negotiation? 

Congressional Republicans are scrambling to limit federal agencies from using certain metrics to calculate drugs' values. And while the bill once had Democrats' support, they're balking at broad language that they argue could hobble Medicare's efforts to negotiate prices before its even begun. 

Most everyone has agreed that the agency shouldn't use a controversial value metric known as quality-adjusted life years, or QALYs — not even Medicare officials have signaled they want to use that approach, which disability rights advocates argue devalues the lives of disabled people. But it's one other little phrase in the bill, H.R. 485, that has Democrats pumping the brakes: "Similar measures."

House legislative aides and drug pricing advocates told D.C. Diagnosis that the sweeping little phrase could spell litigation and barriers for Medicare to use other metrics that they say don't discriminate based on disabilities, like the equal value life year gained metric (I know, rolls off the tongue.) Supporters of H.R. 485 meanwhile argue that the bill is simply extending already-existing Obamacare language that limited the mandate of a little-known initiative, the Patient Centered Research Outcomes Institute, right from the start. More on that from me here.


RESEARCH

Bernie's big drug pricing idea

Sen. Bernie Sanders (I-Vt.) hasn't been bashful about calling for aggressive health care reforms like Medicare for All. But my colleague Matt Herper writes in a new column that maybe, just maybe, Sanders isn't being ambitious enough on prescription drug pricing. 

In Matt's view, Sanders' quick reference in a recent hearing with Moderna's CEO to the idea that the federal government could fund more drug research could be a winning idea. He's got more about the history of government-funded medical research, other industries where similar models work, and how the government could absorb some risk in a space where 90% of medicines that start clinical trials don't reach the market. Read it here.


ADDICTION

How fentanyl panic fueled a naloxone boom 

With fentanyl overdoses and deaths spiking across the U.S., the pharmaceutical industry sprung into motion, churning out what STAT's Lev Facher calls a dizzying array of new naloxone products. But what may seem like an obvious answer — flood the market with antidotes to dangerous opioids — is not so altruistic, Lev writes.

The range of new products (like a mechanized injector with audio commands, a prefilled syringe pen, and an ultra-high dose nasal spray) also come with high price tags. That's despite substance use researchers and recovery advocates saying the solution could be much simpler: An abundant supply of cheap naloxone in easy packaging and standardized doses.

Instead, the advent of new and high-priced naloxone products has schools, nonprofits, policy departments and public health agencies diverting resources to the next-big-thing and not vast supplies of the cheaper options, advocates argue. It's a "fear-based market," as one said. Read more from Lev here.



PATENTS

Clearing thick patent brush

A small but diverse and bipartisan group of House lawmakers is urging the U.S. Patent and Trademark Office to take a new tack in the fight against drug patent gaming that delays generic and biosimilar competition. 

Pharma has long argued that patents for even incremental improvements to drugs are good, even if there are several dozens of them for the same drug, but a study released last fall makes the case that brand drug makers often file several patents for the same drug feature. When patent examiners reject patents as "non-patentably distinct," brand drug makers are allowed to keep those patents on the books as long as they don't run longer than the patents that they duplicate. That means makers of generics and biosimilars must challenge all duplicate patents, which takes a lot of time and money. Reps. Jodey Arrington (R-Tex.), Michael Burgess (R-Tex.), Lloyd Doggett (D-Tex.) and Ann McLane Kuster (D-NH) are asking the Patent and Trademark Office to institute a policy that would cause all duplicate patents to fall when the original patent that they're based on is invalidated.

"In other words, non-distinct patent claims could 'rise or fall together,'" according to a March 24 letter from the lawmakers to the patent office. 


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What we're reading

  • Under protest, FDA to convene advisory panel to review controversial cell therapy for ALS, STAT

  • Drug middlemen accused of price fixing by Ohio Attorney General, The Wall Street Journal

  • Wary of changes to Medicare Advantage, health insurers put up a fight — and exaggerate the stakes, STAT

  • How Cigna saves millions by having its doctors reject claims without reading them, Pro Publica 

  • As states ban gender-affirming care, Minnesota aims to be a refuge for trans youth, STAT

Thanks for reading! More on Thursday,


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