| | | | |  | | By David Lim , Katherine Ellen Foley and Lauren Gardner | Presented by The Pharmaceutical Care Management Association | | | | | 
The drug lecanemab appears to reduce levels of the beta-amyloid protein that's been associated with Alzheimer's. | AP Photo/Courtesy of the National Institute on Aging/NIH | SAFETY, COST CONCERNS CLOUD DATA FOR ALZHEIMER'S CANDIDATE — Data presented this week for an Alzheimer's drug candidate already under FDA review did little to ease doubts about its safety and efficacy, Katherine reports. Trial results for lecanemab — Eisai and Biogen's latest offering targeting the disease — showed the drug eliminated one of the proteins thought to cause it and appeared to stave off cognitive decline more than the placebo. But the findings also raised safety concerns, with 14 percent of patients who took the drug developing adverse effects — including brain swelling and bleeding — and five of those patients receiving medical care for major brain bleeds. In an open-label extension of the trial, two patients died from brain bleeds, though Eisai has stated it believes those deaths were the result of underlying conditions. Cost questions: Eisai and Biogen have asked the FDA to consider the drug for accelerated approval using slightly older data from another trial. But it's unclear whether insurance would cover it if it gets the expedited green light. When Aduhelm, another Alzheimer's treatment from the companies, was granted accelerated approval, CMS said it would only cover the drug and others that worked like it — like lecanemab — for those enrolled in a clinical trial . "We believe this data provides a high quality of evidence regarding the safety and efficacy of lecanemab, and we hope CMS takes this into consideration … if it is approved," said Michael Irizarry, Eisai's senior vice president of clinical research. A traditional pathway: Eisai executives also discussed the possibility of re-applying for lecanemab's traditional approval with this week's data, depending on what happens in January. This tactic would likely move insurers to cover the drug more broadly. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Our Spotify Wrapped data included a hearty mix of bubblegum pop, indie and classical music — reflective of all our moods reporting this year. Send tips, feedback and your most embarrassing top 100 songs of 2022 to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ). TODAY ON OUR PULSE CHECK PODCAST , Ben Leonard talks with Ruth Reader about the brain-implant technology developed by Elon Musk's health tech company Neuralink.
| | | | | | | A message from The Pharmaceutical Care Management Association: During Diabetes Awareness Month, America's pharmacy benefit managers, PBMs, continue their specialized work helping diabetes patients take their drugs safely and affordably. With a PBM on her side, Kaeana's daughter, who lives with diabetes and a rare liver condition, gets her medications for $40 - not the $6,000 these prescription drugs would otherwise cost her. Hear Kaeana's Story. Learn more about how PBMs are working on behalf of all Americans living with diabetes. | | | | | | | 
PhRMA has recruited a lobbying firm to examine its failure to stop Democrats' drug-pricing measures. | Stan Honda/AFP/Getty Images | PhRMA CHARTS INTERNAL REVIEW — PhRMA, DC's most powerful pharmaceutical lobby, hired BGR Group to conduct a report to examine its failure to avert Democrats' signature drug-pricing measures in the Inflation Reduction Act from becoming law, POLITICO's Megan Wilson reports. Bob Wood, BGR Group's chair and CEO, is leading the report. POLITICO spoke with a half-dozen people familiar with the so-called after-action report, including four lobbyists who were granted anonymity due to the sensitivity of the issue. Three of the people with knowledge of the report said its findings would be announced at PhRMA's December board meeting in the coming weeks. A lobbyist for one of PhRMA's member companies said a survey sent to member companies asks whether the industry should have made a drug-pricing deal with the Trump administration, whether it should have supported a bipartisan bill from Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) on drug pricing, and what the organization could have done differently overall. The survey also asks respondents to comment on the association's relationship with Democrats and Republicans on Capitol Hill and its advocacy strategy throughout the drug-pricing debate. "Like most organizations, it's our standard operating procedure to do an after-action review following a large-scale, organization-wide advocacy effort," said Brian Newell, a PhRMA spokesperson, in an emailed statement to POLITICO.
| | | | GO INSIDE THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO is featuring a special edition of our "Future Pulse" newsletter at the 2022 Milken Institute Future of Health Summit from Dec. 6 to 8. The newsletter takes readers inside one of the most influential gatherings of health industry leaders and innovators solving the biggest global health issues to ensure a healthier, more resilient future for all. SUBSCRIBE TODAY TO RECEIVE EXCLUSIVE COVERAGE . | | | | | | | | FDA WEIGHS LESS RESTRICTIVE BLOOD DONATION POLICY — The FDA is developing a draft proposal that could lead to loosened restrictions on blood donations by gay and bisexual men by relying on individual screening questionnaires to reduce the risk of HIV transmission. The Wall Street Journal first reported the FDA was considering changing the blood donation guidelines, which currently ask men who have sex with men to abstain from sex for three months before giving blood. The FDA said it plans to publish draft guidance "in the coming months" based on the results from research it supported and "international developments in donor deferral policies." "Although we do not have a specific timeline for when our analysis will be complete, the agency believes the initial data from the study, taken in the context of other data available from blood surveillance in the U.S. and in other countries, will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of HIV transmission," the FDA said. Rep. David Cicilline (D-R.I.), who's long pushed for the FDA to update its policy, applauded the move as "a step in the right direction," adding that the proposal should "be based on real data and about individualized risk assessment, and not based on sort of old stereotypes or any other kind of stigma that is attached to our community."
| | | | A message from The Pharmaceutical Care Management Association:   | | | | | | GOP SENATORS DEMAND VACCINE MANDATE VOTE — Thirteen Republican senators told their leadership this week they'll oppose moving forward on the annual defense authorization bill if they don't get to vote on an amendment to end the military's Covid-19 vaccine mandate, POLITICO's Grace Scullion writes, citing recruitment challenges and the costs of recruiting and training troops. The branches have discharged 8,000 active-duty troops since Defense Secretary Lloyd Austin ordered service members to get vaccinated in August 2021, and up to 9,000 National Guard members face discharge next year if the mandate remains intact. Still, soldiers forced out over the mandate amount to less than 1 percent of each service branch, and about 98 percent of active-duty troops are fully vaccinated. ICYMI: NATIONAL AT-HOME COVID TEST REPORTING DATABASE LAUNCHES — The National Institutes of Health launched a website last week — MakeMyTestCount.org — where people can anonymously report their results from at-home Covid-19 tests. "While taking a rapid Covid-19 test has become commonplace, test results are not often reported," the NIH National Institute of Biomedical Imaging and Bioengineering said in a statement. "Covid-19 test results provide valuable data that public health departments can use to assess the needs and modify the responses in the local community, the state or the nation."
| | | | POLITICO APP USERS: UPGRADE YOUR APP BY DECEMBER 19! We recently upgraded the POLITICO app with a fresh look and improved features for easier access to POLITICO's scoops and groundbreaking reporting. Starting December 19, users will no longer have access to the previous version of the app. Update your app today to stay on top of essential political news, insights, and analysis from the best journalists in the business. UPDATE iOS APP – UPDATE ANDROID APP . | | | | | | | | TOBACCO INDUSTRY ASKS SCOTUS TO INTERVENE IN CALIF. FLAVORED-TOBACCO BAN — R.J. Reynolds and other tobacco and vape companies on Tuesday asked the Supreme Court for an emergency injunction that would stop a flavored-tobacco ban set to go into effect in California no later than Dec. 21, Katherine reports. The group first requested a preliminary injunction in the District Court of the Southern District of California the day after 62 percent of Californians voted to uphold a statewide ban on flavored-tobacco products in stores and vending machines. The high court filing comes after two lower courts, including the 9th U.S. Circuit Court of Appeals, denied stay requests from the industry. Supreme Court Justice Elena Kagan has until 5 p.m. on Tuesday to submit a response.
| | | HHS Secretary Xavier Becerra delegated responsibility to establish a public-private partnership for rare neurodegenerative diseases to the leaders of the NIH and the FDA.
| | | | A message from The Pharmaceutical Care Management Association: During Diabetes Awareness Month, America's pharmacy benefit managers, PBMs, continue their specialized work of helping diabetes patients get and take their prescription drugs affordably, conveniently and safely. Despite consistent manufacturer price increases on insulin products, PBM pharmacy experts help patients access and take medications as prescribed.
With a PBM on her side, Kaeana's daughter, who lives with diabetes and a rare liver condition, can obtain all of her medications for $40 – not the $6,000 these prescription drugs would otherwise cost her.
"Without help, we would be paying $6,000 a month for medication, but because we have a PBM, I'm only paying $40 out of pocket," Kaeana states. "It's very important to have access to affordable medication, because if we didn't, my child wouldn't be alive."
Hear Kaeana's Story and learn more about how PBMs are working on behalf of all Americans living with diabetes. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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