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Presented by UnitedHealth Group: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner , David Lim and Katherine Ellen Foley | | | | | | — The president’s Covid rebound case highlights a dearth of data on positive tests after antiviral treatment and confusing messaging on isolation protocols. — Senate Majority Leader Chuck Schumer is pushing to vote on Democrats’ reconciliation package this week. — The FDA is ill-equipped to regulate an onslaught of illegitimate online pharmacies scamming patients who seek abortion pills. It’s Tuesday. Welcome to Prescription Pulse. Are you FREYA, the boat-sinking walrus of Norway ? We admire your pursuit of the perfect lounging spot. Send tips and feedback 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 ).
| | A message from UnitedHealth Group: Starting in 2023, we’re eliminating out-of-pocket costs for eligible UnitedHealthcare members on five critical medications, including insulin and epinephrine. Learn how we’re working to make prescription drugs more affordable for the patients who rely on them most. | | | | | | | 
President Joe Biden's Covid-19 rebound has raised questions about CDC isolation guidelines and the frequency of post-Paxlovid rebounds. | Jim Watson/Pool | BIDEN’S COVID REBOUND RAISES TREATMENT, ISOLATION QUESTIONS — President Joe Biden’s positive tests following a five-day course of Paxlovid, the Pfizer drug the White House has touted as one of its Covid-19 success stories, have raised questions about the frequency of the rebound phenomenon and the length of the isolation period after people test positive again for the virus, Lauren writes. “There’s just a lot we don’t know about Paxlovid,” said Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing. How often does it happen? White House Covid-19 Response Coordinator Ashish Jha estimated the rebound rate at around 5 percent, based on real-world evidence gathered to date from large health systems. Pfizer spokesperson Sharon Castillo said the company is “very confident in Paxlovid’s clinical effectiveness at preventing severe outcomes from Covid-19 in patients at increased risk,” pointing to the drugmaker’s study suggesting that less than 5 percent of Covid patients experience viral load rebound and it may be part of the disease’s course regardless of treatment. Whither isolation? Biden’s positive tests also illustrate the muddled messaging that continues around isolation protocols for Covid-positive patients. Centers for Disease Control and Prevention guidance recommends that presumed and confirmed cases stay home and isolate from others “for at least 5 full days” and wear a mask in public for another five days. The president’s rebound case was detected only because he was taking daily rapid tests “both to protect people around him and to assure early detection of any return of viral replication,” per White House physician Kevin O’Connor. Some infectious disease experts have called on the CDC to recommend a “test to return” to public life standard, arguing that’s the best way to limit disease spread. But Biden’s testing cadence isn’t replicable among all Americans, as some may have limited access to tests or can’t afford to miss more than a week of work. A White House spokesperson didn’t respond to a request for comment on when Biden plans to exit isolation. Céline Gounder, an epidemiologist and editor-at-large for public health at Kaiser Health News who advised the Biden transition on Covid, said her understanding is that he’ll wait until he’s received two negative test results. “I think that is the correct thing to do,” she said. Leana Wen, a former Baltimore health commissioner, argued that the CDC must “completely rethink” its isolation guidance because people aren’t testing amid fears of having to isolate. If the U.S. is trying to minimize disruption as people return to work and students reenter school, it should figure out when it “can treat Covid like other viral illnesses,” she said. FEDS PURCHASE 66M DOSES OF MODERNA’S OMICRON BOOSTER SHOT — On Friday, the Department of Health and Human Services said it had procured 66 million doses of Moderna’s bivalent booster shot for $1.74 billion, Katherine reports. Combined with the 105 million Omicron booster doses feds purchased from Pfizer for $3.2 billion last month, HHS has purchased 171 million bivalent boosters ahead of the expected fall and winter surges. The supply isn’t enough to cover all U.S. adults, but the federal agreements with the companies leave room to purchase 300 million more doses from each, pending sufficient congressional funds.
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Sen. John Cornyn has tested positive for Covid-19 but pledges he'll be back in the Senate to vote on the reconciliation package. | Francis Chung/E&E News/POLITICO | SCHUMER: SENATE PURSUING RECONCILIATION THIS WEEK — Senate Majority Leader Chuck Schumer is telling his caucus to prepare to work through the weekend to pass a bolstered reconciliation package negotiated with Sen. Joe Manchin (D-W.Va.), POLITICO’s Marianne Levine and Caitlin Emma report . As of Monday, Democratic and Republican staffers were preparing for the possibility of back-to-back private meetings with the Senate parliamentarian through Wednesday. “Our timeline has not changed, and I expect to bring this legislation to the floor to begin voting this week,” Schumer said on the floor Monday. “We’re excited and eager to pass this bill through the Senate as soon as we can.” Covid considerations: Sen. John Cornyn (R-Texas) disclosed a positive test on Monday but pledged to return to the Senate for a reconciliation vote “consistent with CDC guidelines.” But the public health agency recommends individuals who test positive for Covid-19 isolate for at least five days, even if they never develop symptoms.
| | | | A message from UnitedHealth Group:   | | | | | | THE FDA STRUGGLES TO REGULATE WEB SALES OF ILLEGITIMATE ABORTION PILLS — As some states begin to cut off access to safe abortions, pregnant people are turning to the web to find the medications to terminate unwanted pregnancies at their own risk, POLITICO’s Ruth Reader reports. Rogue online pharmacies sometimes sell counterfeit or expired drugs, don't fill orders or steal credit card numbers — and the FDA lacks the subpoena powers that would help reveal who’s behind websites so they can be taken offline. “Counterfeit criminals go to where there’s demand — and there’s demand and there's access challenges,” said Libby Baney, a senior adviser to the Alliance for Safe Online Pharmacies, an advocacy group, of the market for abortion pills. “That creates criminal opportunity and a major patient safety risk.” Illicit pharmacies are adept at circumventing Google’s rules and rising to the top of search results. And Google says it’s usually unable to determine when sites are breaking the law, though it will remove them from search results when the government asks. “There are a majority of U.S. consumers who think that if they see medical care listed on Google on the first page, that it's been vetted or validated by some authority in the U.S.,” said John Hertig, an associate professor of pharmacy practice in the Butler University College of Pharmacy and Health Sciences. “And that’s absolutely not the case at all.”
| | | | INTRODUCING POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don’t miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY . | | | | | | | | FIRST IN RxP: ADVAMED PROACTIVELY LOBBIES CMS ON TCET — The largest medical device lobby isn’t waiting for a new Biden administration proposal to replace the Trump administration’s push for four years of automatic Medicare coverage of breakthrough medical devices. On Monday, AdvaMed sent the Center for Medicare and Medicaid Services a letter, urging the agency to stick to a national coverage approach for emerging technologies that would last at least four years in its forthcoming Transitional Coverage of Emerging Technology proposed rule. “CMS could propose to end the transitional coverage period before the conclusion of the four-year period if evidence generation ceases or alternatively permanent national coverage is provided through a National Coverage Determination with evidence showing clear benefit for Medicare beneficiaries,” wrote Chandra Branham, AdvaMed senior vice president and head of payment & health care delivery policy. “Additionally, CMS could end the transitional coverage period early if safety concerns become apparent.”
| | | ALS DRUGMAKERS GEAR UP FOR A BUSY FALL — Despite setbacks in the first half of 2022, the makers of drugs targeting amyotrophic lateral sclerosis are slated to have an eventful fall and winter season. Currently, two drugs in the U.S. are cleared to treat the fatal disease. Last month, Biogen announced that the FDA accepted the application for its ALS drug candidate and granted it a priority review with an advisory committee meeting scheduled for the fall. And next month, advisers to the FDA will convene for a second time to discuss a candidate from Amylyx that will include fresh data from the company after the same group voted against the approval of its drug in the wake of a dearth of data showing the drug’s benefits. “Survival is the sort of very final outcome, but along the way, there’s also the question of ‘How are people doing?’” Justin Klee, the co-founder and co-chief executive of Amylyx, told Prescription Pulse. Klee noted that the additional data his company submitted to the agency highlighted how the experimental therapy delayed certain negative milestones associated with the disease, such as hospitalization or tracheotomy, which he argues would meaningfully improve patients’ lives even if they don’t live significantly longer.
| | | Sarah Arbes is joining AstraZeneca as head of federal affairs and policy. A Trump and Bush administration alum, she was most recently vice president of federal affairs, alliance development and policy at bluebird bio.
| | | The U.S. did not replenish stockpiles of a liquid-frozen form of Bavarian Nordic’s smallpox vaccine that had expired as it invested in a freeze-dried version with a longer shelf life, Joseph Goldstein reports for The New York Times . The CDC’s difficulty effectively responding to monkeypox demonstrates why it should be reformed and empowered to focus “on its core mission of outbreak response,” former FDA Commissioner Scott Gottlieb writes in a New York Times op-ed .
| | A message from UnitedHealth Group: Beginning in 2023, eligible UnitedHealthcare members will pay $0 out of pocket on five critical medications: Insulin for diabetes, Epinephrine for allergic reactions, Glucagon for hypoglycemia, Naloxone for opioid overdoses, and Albuterol for acute asthma attacks.
This is an important step to help drive affordability for patients and combat the high price of prescriptions, which are set and raised by drug manufacturers. We are committed to continuing to use our capabilities to help lower out-of-pocket costs for consumers. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
