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| Presented By the Healthcare Distribution Alliance |
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| Axios Vitals |
| By Tina Reed · Feb 06, 2023 |
| Happy Monday, Vitals readers. Today's newsletter is 951 words or a 3½-minute read. 🍻 On tap this week: The GOP-controlled House Energy and Commerce Committee on Wednesday will grill Biden administration health officials on the pandemic response. The Senate Judiciary Committee on Thursday marks up a series of bills dealing with drug pricing and the patent system. - Earnings reports this week include CVS Health, Amgen and Tenet Healthcare.
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| 1 big thing: Health experts want safety review of fast-tracked Alzheimer's drug |
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| Illustration: Aïda Amer/Axios |
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| Doctors and scientists are urging the FDA to convene an expert panel to review safety concerns around an Alzheimer's drug that won fast-track approval in January, Axios' Oriana Gonzalez writes. The big picture: It's the latest concern over whether the FDA is cutting corners evaluating Alzheimer's drugs, prompted by its controversial 2021 approval of Biogen's Aduhelm, which came over the objections of an advisory panel and without evidence the drug actually slowed the decline of memory and brain function. - Doctors and scientists worry that the FDA isn't doing enough to address questions about Eisai's lecanemab — including three patient deaths during its clinical trials — noting the FDA didn't follow its customary process and convene an advisory panel before green-lighting the accelerated approval.
What's happening: Some health experts believe the agency should next convene a public discussion on Eisai's drug, which would cost $26,500 per year for the average patient, before deciding whether it should get a full approval based on its actual clinical benefit. Catch up quick: The FDA in early January granted accelerated approval to lecanemab — marketed at Leqembi — which showed in large clinical trial results that it slowed progression of the disease by 27%, as well as the rate of cognitive decline over 18 months. What they're saying: "[C]ritical questions remain as to whether the benefits outweigh the risks reported of brain swelling, brain bleeding and death among patients who received this drug," the independent advocacy group Doctors for America said in a statement. Yes, but: "I think this data doesn't require it," said Liana Apostolova, a neurologist at the Indiana University School of Medicine and member of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee. - "Very positive results in the trial on multiple outcomes and biomarkers don't historically go to an advisory committee," she added.
Go deeper. |
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| 2. Hospital transparency rule compliance remains low |
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| Illustration: Gabriella Turrisi/Axios |
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| Only a quarter of hospitals studied were fully compliant with a federal price transparency rule, according to a new report by Patient Rights Advocate — but compliance is a spectrum, Axios' Caitlin Owens writes. Why it matters: The findings come as Congress has expressed bipartisan concern over compliance with the Trump administration rule and potential interest in legislating on the topic. By the numbers: Only 24.5% of the 2,000 hospitals studied were in full compliance with the rule, per the report. But there were instances of outright noncompliance and partial compliance. - 5.8% of hospitals were in total noncompliance.
- Just over half of the hospitals posted negotiated prices clearly associated with payers and plans, while the other half failed to meet the study's definition of compliance because the majority of pricing data was missing or incomplete.
Zoom in: None of the hospitals owned by HCA Healthcare, Tenet Healthcare, Christus Health, Providence, Bon Secours Mercy Health, UPMC, Mercy Health, UnityPoint Health, and Avera Health were deemed compliant. The other side: The American Hospital Association has also argued that compliance is much higher than some reports have suggested, including an earlier version by Patient Rights Advocate. Share this story. |
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| 3. Apple Watches have a false alert problem |
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| Photo: Jakub Porzycki/NurPhoto via Getty Images |
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| Sometimes, there's a fine line between a rough day on the slopes and a medical emergency. Consider the flurry of false automated 911 calls from Apple Watches worn by skiers in Colorado. Driving the news: Since last fall, the wearables came equipped with technology meant to detect car crashes automatically call for help. But it's mistaking people engaging in certain activities — in particular, skiers — of being in distress, the New York Times reports. - The result is 911 call centers are inundated with false alarms.
What they are saying: "Apple needs to put in their own call center if this is a feature they want," Trina Dummer, interim director of Summit County's emergency services, told the Times. The other side: An Apple spokesman told the Times when the emergency feature is triggered, it buzzes and makes a sound, giving the user 10 seconds to cancel the call. - He also said a software update was released last year to reduce the number of false calls.
The bottom line: There have been some incredible examples of how this technology has saved lives. But like all tech, it has its limitations. |
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| A message from the Healthcare Distribution Alliance |
| Making the pharmaceutical supply chain more resilient |
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| A more resilient supply chain requires enhanced collaboration between the public and private sector. What you need to know: Healthcare distributors have been working with supply chain and government partners to build on our collective strengths and identify ways to enhance resilience. Read more. |
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| 4. More pressure on generic drugs |
| Amazon's new RxPass prescription service further increases the downward pressure on the cost of generic drugs, the Wall Street Journal reports. Driving the news: Last month, Amazon announced the new benefit to its Prime subscription service, allowing members access to unlimited prescriptions for generics for more than 80 conditions for $5 a month. Between the lines: Combined with its purchase of Amazon's One Medical last year, "it makes clear that the tech juggernaut intends to build a serious healthcare vertical," per WSJ's David Wainer. It notably joins Mark Cuban's Cost Plus Drug Co., which is using a different strategy to drive down prices by offering a transparent pricing scheme. The intrigue: While the response to RxPass was underwhelming, it was a "tricky, good move," according to Betsy Stanley, senior director at business strategy consultancy firm Pinkston Strategy. - "I think RxPass is more of a stepping stone into normalizing Amazon's brand into health care," Stanley said. "Compared to previous efforts Amazon made in health care, this is getting a reaction of 'This just makes sense. This doesn't feel like a big deal' ... We're all normalizing health care and Amazon."
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| 5. While you were weekending |
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| Illustration: Aïda Amer/Axios |
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| 🚨 A measles outbreak among kids in Ohio has officially been declared over. (CNN) 💻 Exclusive: OSTP official Alondra Nelson to step down. (Axios) 💰 Senate Democrats look for a way forward on marijuana banking bill. (The Hill) 🥪 The USDA proposes new nutrition standards for school meals. (Axios) |
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| A message from the Healthcare Distribution Alliance |
| Transitioning to COVID-19 vaccine commercialization |
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| The federal government has primarily coordinated COVID-19 response efforts with help from the private sector. Looking ahead: This responsibility is expected to transition to the commercial market — as soon as this quarter. Learn the key role healthcare distributors will play. |
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| Did someone forward this email? Subscribe here. Thanks for reading, and thanks to senior editor Adriel Bettelheim and senior copy editor Bryan McBournie for the edits. |
 | | Your personal policy analyst is here. | | |
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