Good morning. This is awful.
Illustration: Sarah Grillo/Axios
The first FDA approval of a multi-million dollar drug is expected any day now, sparking a new national debate over what we're willing to pay for medical breakthroughs.
Why it matters: The future of medicine is in personalized and scientifically advanced drugs, meaning that Zolgensma's imminent approval is just the beginning of the seven-digit price tag era. While drug companies say the drugs' effectiveness justifies their costs, some experts are pushing back.
Driving the news: The approval of Zolgensma, a gene therapy with the potential to cure spinal muscular atrophy, "could come any day," said Dave Lennon, president of Novartis-acquired AveXis.
The big picture: The list price drugmakers set isn't the price insurance plans will actually pay. Still, their decisions about how to cover Zolgensma could have a ripple effect: 68 gene therapies are expected to launch by 2024, according to Evaluate.
What they're saying: "Outcomes-based arrangements are not a panacea to the root problem of excessively high drug prices," a spokeswoman for America's Health Insurance Plans said. "As with any new drug or therapy, insurance providers will evaluate the evidence to make coverage policy decisions."
The Trump administration's proposal to change how the federal poverty level is calculated would cut millions of people's health benefits, according to a new analysis by the left-learning Center on Budget and Policy Priorities.
By the numbers: After 10 years, the change would result in:
Mallinckrodt announced yesterday that it is suing the Centers for Medicare & Medicaid Services and the Department of Health and Human Services for changing the way Medicaid rebates are calculated for its pricey H.P. Acthar Gel medication.
Why it matters: The drug company expects the change will eliminate 10% of its Acthar sales, and that it will have to pay up to $600 million in retroactive rebates — news that sent the company's stock plunging by 24% Tuesday to a record-low $9.87 per share.
Reality check: Acthar has been under the gun for several years now. Independent experts say the drug, which is a half-century old and treats multiple sclerosis and infantile spasms, is excessively priced and isn't any better than cheaper alternatives.
The bottom line: Mallinckrodt is fighting tooth and nail to protect Acthar because it is the lifeblood of the company. The drug makes up 35% of Mallinckrodt's revenue.
Photo: Ronen Tivony/SOPA Images/LightRocket via Getty Image
Comcast is working on an in-home device to monitor people's health, with the intention of rolling it out next year, CNBC reports.
The big picture: Comcast joins a host of other tech companies that are experimenting with in-home health care.
The FDA yesterday sent an updated letter to doctors and surgeons to let them know the Impella RP heart pump is OK only for specific types of patients — such as those who haven't been in cardiogenic shock for more than 2 days or who haven’t suffered cardiac arrest, Bob reports.
There are still a lot of asterisks for safe use of this heart pump, made by Abiomed. And the updated letter still doesn't change the fact the device went to market with very little data proving its safety and efficacy.
Enjoy your Wednesday!