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Presented by The Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner and Katherine Ellen Foley | Presented by The Pharmaceutical Care Management Association | With help from Alice Miranda Ollstein
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Sen. Rand Paul said he'll talk about his committee ranking member options this week. | Pool photo by Greg Nash | DEMOCRATS LOCK UP SENATE CONTROL — With races called in Democrats’ favor in Arizona and Nevada, the Senate majority will remain in the party’s hands for the 118th Congress. The Biden administration is likely breathing a sigh of relief that Sen. Rand Paul (R-Ky.) won’t be wielding either the health or government affairs committee gavels that would have given him subpoena power over officials, such as Covid-19 adviser Anthony Fauci. Still, the Dems can count on being peppered with oversight inquiries into the Biden White House’s pandemic response by House Republicans, who look nearly certain to eke out a narrow majority over Democrats, POLITICO’s Zach Montellaro writes. Regarding Paul’s committee ranking member options, he told reporters Monday night that he’d have “something on that in the next day or two.” Are you a Hill staffer focused on health care? Do you work for the Energy and Commerce or Health, Education, Labor and Pensions committees? We want to hear from you about your boss’ priorities in the lame-duck session and the next Congress. Drop us a line. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. David is on vacation the rest of the month, but Lauren and Katherine will be holding down the pharma fort until his return. Send tips, feedback and vacation brags 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 , Megan Messerly talks with Grace Scullion about the military’s Covid-19 vaccine requirement, which could end if Republican senators succeed in amending the National Defense Authorization Act that’s expected to be taken up in the coming weeks. Plus, Carmen Paun discusses the U.N.'s recognition of a huge milestone: The earth’s population now totals 8 billion.
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Moderna's updated Covid-19 booster yielded positive results in a clinical trial. | Maddie Meyer/Getty Images | MODERNA RELEASES POSITIVE BOOSTER TRIAL RESULTS — Moderna’s Covid-19 vaccine updated to target the BA.4 and BA.5 Omicron strains provoked a “superior” antibody response against those variants compared with a booster dose of the original vaccine formula, the company said Monday. The data have yet to be published in a peer-reviewed journal. A dose of the updated shot increased the number of antibodies that neutralize those two subvariants 15-fold, Moderna said. The company added that, in an “exploratory analysis” of about 40 trial participants, both of its bivalent booster options — the other targeting BA.1 — “demonstrated robust neutralizing activity against BQ.1.1, an Omicron subvariant that’s gaining prevalence nationwide. Moderna developed two bivalent options, but only one is currently authorized in the U.S. Moderna’s update follows Pfizer’s and BioNTech’s announcement earlier this month that their Omicron-targeting shot also substantially boosts antibodies against the virus. Still, some early studies of the updated booster have found limited additional benefit compared with the original messenger-RNA vaccines. OMICRON SUBVARIANTS GAIN GROUND — Speaking of new variants, BQ.1 and BQ.1.1 have overtaken BA.5 as the dominant coronavirus strains in the U.S., representing about 44 percent of Covid infections, according to recently updated CDC data . Administration officials worry about the strains , offshoots of BA.5, because of their ability to evade protection offered by authorized monoclonal antibody treatments seen as critical tools to help protect immunocompromised people from severe illness.
| | | | 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. | | | | | | CALIFF: FEELING WELL AMID COVID RECOVERY — FDA Commissioner Robert Califf tweeted Monday that he’s “had a good recovery” from Covid after testing positive more than a week ago. He said that he had been “prescribed an antiviral” and tested negative for three consecutive days. “Given that I was fully vaccinated and up to date with the updated bivalent COVID vaccine when I got infected last week, and that I was prescribed an antiviral, my risk of dying in 2022 is less than 1/1000 based on recent literature,” he said , noting that his risk in 2020 as a 71-year-old — before vaccines and treatments — was about 1 in 70.
| | | ROCHE: ALZHEIMER’S DRUG CANDIDATE DIDN’T MEET ENDPOINTS — On Monday, Roche said that its Alzheimer’s drug candidate failed to adequately slow cognitive decline in participants in two Phase III clinical trials. The drug, called gantenerumab, is a monoclonal antibody that targets beta-amyloid, the misshapen protein thought to cause neurodegeneration related to the disease. According to topline data from Roche, gantenerumab lowered amyloid in participants’ brains less than expected, and the slowdown in cognitive decline was not statistically significant. Sound familiar? Gantenerumab is yet another anti-amyloid in the pipeline. Biogen’s and Eisai’s Aduhelm, which received FDA accelerated approval in 2021 amid controversy over whether the available data supported approval, also targeted beta-amyloid proteins, as did another candidate, called lecanemab, from the same companies. Preliminary results from a late-stage trial of lecanemab, however, showed the drug worked to slow cognitive decline and reduce beta-amyloid; researchers are conducting another clinical trial examining whether it can reduce the protein in the brains of participants who aren’t yet showing decreased cognitive function. What’s next: Roche and Biogen and Eisai will present more detailed findings at the Clinical Trials on Alzheimer’s Disease conference later this month.
| | | | 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 . | | | | | | | | INDUSTRY SEEKS TO DELAY CALIFORNIA FLAVORED-TOBACCO BAN — R.J. Reynolds, the maker of Newport menthol cigarettes, and several other tobacco manufacturers filed a complaint and requested a preliminary injunction against the state of California in the District Court of the Southern District of California after voters upheld a ban on the sale of most flavored tobacco products, Katherine reports. The companies primarily argue that California’s ban is unconstitutional because it effectively creates a new product standard — which only the FDA can do as the nation’s federal tobacco regulator. The tobacco industry has brought lawsuits in local jurisdictions in several states that have banned the sale of flavored tobacco, using a similar constitutional argument. In those cases, courts sided with jurisdictions, even after the industry appealed lower court rulings. But in the complaint against California, companies argue that the ban violates interstate commerce clause provisions by prohibiting the sale of products made outside of California — which hasn’t been litigated before. “It’s not that Reynolds thinks they can win on the dormant Commerce Clause, but what they need to do is get a court to put a hold on the law while that litigation happens,” he said. “It’s a delay tactic, if nothing else. They [tobacco companies] have nothing to lose,” says Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law.
| | | Caitlin Carroll had her last day as communications director for retiring Sen. Richard Burr (R-N.C.) and the Senate HELP Committee on Friday. She says she plans to announce her next move soon. Miles Lichtman is now the health policy director for the House Oversight and Reform Committee, where he will lead the Democratic staff’s investigative and legislative work on health care matters. Previously, he was the deputy health policy director for the committee.
| | | | A message from The Pharmaceutical Care Management Association:   | | | | | | For ProPublica , Duaa Eldeib documents that even though some stillbirths may be preventable, federal agencies have neglected to prioritize research to stop them from happening. Health systems are eyeing ways to cut back on real estate as they wrangle with inflation and the rise of telehealth, Tina Reed writes for Axios .
| | | | STAY AHEAD OF THE CURVE: Our Future Pulse newsletter will continue to bring you the biggest stories at the intersection of technology and healthcare, but now five times a week. Want to know what’s next in health care? Sign up for our Future Pulse newsletter. If you aren’t already subscribed, follow this link to start receiving Future Pulse . | | | | | | | | The FDA published final guidance on Monday regarding the agency’s approach to defining “device” and “counterfeit device” in official documents. The Department of Health and Human Services seeks comment on its plans to reduce infections associated with being in health care settings.
| | | | 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 | | | | |  |
