Aug 26, 2019

Axios Vitals

Good morning. Thank you to everyone who gave me credit on Friday for my colleague Bob Herman's witty headline about fee-for-service (FFS).

Today's word count is 769, or ~3 minutes.

1 big thing: The fight over the future of our most expensive drugs

Illustration: Sarah Grillo/Axios

The market designed to create competition for biologics — typically our most expensive drugs — has been slow to take off, but some experts say that even its best-case scenario doesn't do enough to lower drug prices.

Why it matters: The argument is reflected in the political divide over whether enhanced drug competition or price regulation is the best way to address drug prices.

The big picture: Congress created the pathway for biosimilars to come to market knowing that they'd look different than small-molecule generics, and even their most ardent supporters say biosimilars will never achieve the steep discounts that generics do.

  • That's because biosimilars are much harder to make than normal generics.
  • Nevertheless, the Biosimilars Council says on its website that biosimilars could lead to more than $54 billion in savings over the next decade.

Yes, but: Some experts argue that that's not enough, and that biosimilars aren't the best way to control biologic prices.

  • Last week, Memorial Sloan Kettering Cancer Center's Peter Bach and MIT's Mark Trusheim published an editorial in the Wall Street Journal arguing that biosimilars don't produce enough savings and that the resources spent developing them would be better used to bring new, innovative drugs to market.
  • Bach and Trusheim proposed that the government instead regulate the price of older biologics after they've been on the market for a certain period of time, which they wrote could save around $50 billion a year.

The other side: Former FDA Commissioner Scott Gottlieb wrote an editorial in the WSJ yesterday in response, arguing that Congress should speed up the use and development of biosimilars instead of regulating prices.

The bottom line: This argument isn't just for the academics. The leading Democratic presidential candidates are also arguing for drug price regulation, a major shift left for the party.

2. J&J opioids ruling expected today

An Oklahoma judge is expected to rule today whether Johnson & Johnson can be held responsible for the state's opioid epidemic, which could have major implications for other lawsuits across the country, CNBC reports.

  • J&J has been accused of being the "kingpin" of the opioid crisis, my colleague Bob Herman reported in March.

The Drug Enforcement Administration applied the same label to another company, Mallinckrodt, saying in 2010 that the agency viewed it "as the kingpin within the prescription drug cartel," the Wall Street Journal reports.

  • Mallinckrodt produced 38% of the prescription opioids sold in the U.S. between 2006 and 2012, meaning it was the largest opioid manufacturer over that time frame, the Journal found.
  • It's among the drug manufacturers, drug distributors and pharmacies being sued in the giant consolidated lawsuit pending in Ohio federal court.
3. Vaping may have claimed its first life

Photo: Alastair Pike/AFP/Getty Images

The CDC, state health officials and the Food and Drug Administration are investigating 193 potential cases of a lung-related illness possibly linked to vaping, the CDC said on Friday.

The latest: In Illinois, 1 of those cases was fatal, my colleague Orion Rummler reports.

  • An adult Illinois resident died after being hospitalized with a severe respiratory illness after vaping recently, state officials said.

Details: Investigators have not identified a specific product or compound that is linked to all confirmed cases, per the CDC, and there is no evidence that an infectious disease is the culprit of the illnesses.

My thought bubble: This is bad news for vapers and bad news for Juul. The company has tried to pitch itself as an overall positive force for public health. Critics say it is responsible for the rise in youth vaping.

  • But if vaping is connected to serious illnesses in adults, that furthers an anti-Juul, anti-vaping narrative that's already taking shape — including among lawmakers and regulators.
4. Mental illness associated with higher health costs

Among patients with chronic illnesses, those with a mental health disorder cost nearly twice as much as those without one, according to a new study in JAMA Network Open.

  • The study looked at adults 18 and over in the Canadian province of Alberta between 2012 and 2015.

By the numbers: Over a 3-year period, chronic disease patients without a mental illness cost, on average, $22,280, while those with a mental illness cost $38,250.

  • Costs varied by mental health disorder as well.

Why it matters: "Our findings raise questions about optimizing the management of mental health disorders in patients with chronic disease," the authors write.

  • "Our results also raise the question of whether a different model of care for patients with mental health disorders and chronic disease needs to be developed," they add.
5. While you were weekending...
  • Democrats running for battleground Senate seats are avoiding being associated with Medicare for All, focusing instead on protecting the Affordable Care Act and Republicans' efforts to kill it, Politico reports.
  • Some addiction clinics are marketing expensive, unproven treatments, Kaiser Health News reports with Side Effects Public Media and NPR.
  • The New York Times profiles Jason Kander, a veteran and Democratic "rising political star," who is challenging politicians' common tendency to avoid talking about their psychiatric struggles.