Pfizer’s new Covid treatment approval

Presented by Express Scripts by Evernorth: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

May 26, 2023 View in browser   By David Lim and Katherine Ellen Foley Presented by Programming note: We’ll be off this Monday for Memorial Day but will be back in your inboxes on Wednesday.  Driving the day The FDA granted full approval to Pfizer's Paxlovid on Thursday. | Getty Images PAXLOVID FULLY APPROVED — The FDA on Thursday approved Covid-19 treatment Paxlovid for adults at high risk of progression to severe disease, but access to the medication is not changing in the short term because the government still has millions of doses on hand. “Paxlovid continues to be widely available for free and distributed by the U.S. government through all existing USG channels and retail pharmacies nationwide,” an HHS spokesperson said in an email. Since the antiviral treatment won FDA emergency use authorization in December 2021, about 9.3 million doses have been dispensed to patients, according to HHS. The U.S. still has 9.6 million doses on hand and an additional 4 million at health care provider locations nationwide. Clinical data: Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing, said that while there is no question that Paxlovid helps people at high risk of progression to severe Covid-19, providers are awaiting data from the United Kingdom’s PANORAMIC clinical trial to see the antiviral’s efficacy in a predominantly vaccinated population. The FDA said the approval was supported by a randomized clinical trial, which found that Paxlovid administered within five days of Covid symptom onset reduced hospitalization or death by 86 percent compared with a placebo among people who were not vaccinated or previously infected by Covid-19. “The price is going to influence how careful insurers are in determining who is going to get this drug,” Gellad said. “Almost no one is at high risk of progression — literally almost no one now that they’ve been quadruple and quintuple vaccinated.” Price point: When asked what the price of Paxlovid will be, Pfizer did not offer a number but said it expects to make the drug "commercially available later this year." Angela Hwang, president of Pfizer’s global biopharmaceuticals unit, told investors on a May 2 earnings call that the commercialized price will reflect the number of hospitalizations and deaths averted by Paxlovid treatment. IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Send your favorite Zelda discovery or tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with Carmen Paun, who explains why some Democrats say the HALT Fentanyl Act that the House passed yesterday is a distraction. Listen to today’s Pulse Check podcast   A message from Express Scripts by Evernorth: 60 million Americans live in rural areas. Yet less than 10 percent of physicians practice in those parts of the country. That’s half the number of physicians needed to provide essential care to those communities. Express Scripts by Evernorth is expanding health care access for rural communities by advocating for more pharmacy services and reimbursement opportunities. Making health care more accessible for all. Learn more.   In Congress Rep. Kay Granger, House Appropriations chair, announced that the committee will delay marking up four fiscal 2024 spending measures. | Francis Chung/POLITICO via AP Images NEGOTIATIONS CONTINUE — Momentum on some health care legislation is slowing while Republicans and the president hash out a debt ceiling deal. House Appropriations Chair Kay Granger (R-Texas) said the committee will postpone markups on four fiscal 2024 spending measures while debt ceiling negotiations continue. And there is little momentum for the Senate to quickly take up a bipartisan health care package. Some legislation is inching forward. The House Energy and Commerce Committee advanced six health-related pieces of legislation at a full committee markup this week, including a bill that would improve value-based purchasing agreements between drugmakers and states. And the House moved forward legislation to classify fentanyl as a Schedule 1 drug: The HALT Fentanyl Act passed 289-133 on Thursday, which would classify the synthetic opioid as one of the nation’s most dangerous drugs, POLITICO’s Carmen Paun reports. Schedule 1 drugs have no currently accepted medical use and pose a high potential for abuse, subjecting them to the highest levels of federal regulation and enforcement. Some Democratic lawmakers condemned the measure, saying it could disproportionately harm communities of color. But 74 Democrats joined Republicans to pass the bill.   GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE.     Eye on the FDA TOBACCO LAWSUITS ARE ‘DRAINING’ — FDA Commissioner Robert Califf lamented the agency’s ongoing litigation coming from several parts of the tobacco industry as the FDA struggles to adequately regulate the widespread popularity of e-cigarettes. It has been hit with more than 40 lawsuits from companies whose marketing applications were denied. “We are in a legal battle every single day, and it’s draining on the agency,” he said at the annual public meeting of the Reagan-Udall Foundation. “It has a big impact and a much bigger impact than I thought.” Califf said the agency was overwhelmed by the millions of e-cigarette marketing applications it received after Congress granted it the authority to regulate vapes. “None of us expected 27 million applications for vaping,” he said. Though the agency has decided on more than 99 percent of them, it has not decided the fate of some major market players, including products from R.J. Reynolds and NJOY. Enforcement is also an issue: Califf also noted that keeping illegal products off store shelves is difficult. “I find myself in the midst of really an epic struggle … when I think of how to enforce when you have an industry that is amazingly creative.” A panel of experts from the Reagan-Udall Foundation said in December that tobacco regulators need to improve enforcement — a feat that is a challenge for an agency that must partly rely on the Department of Justice to implement stiff penalties. Califf hinted that the FDA would meet with the DOJ soon to discuss enforcement but declined to say more. “Stay tuned on that one.” FDA DELAYS DECISION ON GENE THERAPY — The FDA said it would need an additional three weeks to review a novel gene therapy for Duchenne muscular dystrophy from Sarepta. The agency was supposed to make a decision by May 29, but it now expects to decide by June 22 after it considers whether the drug is appropriate for all ages, pending additional data. Independent advisers to the agency narrowly endorsed the drug’s approval earlier this month.   A message from Express Scripts by Evernorth:   Industry Intel ILLUMINA CHAIR OUSTED — Shareholders voted to remove Illumina board chair John Thompson on Thursday, a partial victory for the DNA sequencing firm in its proxy battle with activist investor Carl Icahn, who had sought three seats. Icahn argued the company was eroding value by closing its acquisition of multi-cancer early detection company Grail despite antitrust concerns instead of focusing on Illumina’s core business. But preliminary results suggest he won only one of three seats in the shareholder vote, meaning the company will continue to defend its acquisition, still being challenged by antitrust regulators in the U.S. and Europe.   DON’T MISS POLITICO’S HEALTH CARE SUMMIT: The Covid-19 pandemic helped spur innovation in health care, from the wide adoption of telemedicine, health apps and online pharmacies to mRNA vaccines. But what will the next health care innovations look like? Join POLITICO on Wednesday June 7 for our Health Care Summit to explore how tech and innovation are transforming care and the challenges ahead for access and delivery in the United States. REGISTER NOW.     Quick Hits Billionaires are mounting an unorthodox influence campaign against the lobbying clout of hospitals, STAT’s Rachel Cohrs reports. Document Drawer The FDA sent warning letters on Thursday to Shenzen Innokin Technology and Breeze Smoke for distributing unauthorized Esco Bars and Breeze products, which are popular vapes. The warning letters require the vape makers to stop selling, distributing and advertising the products promptly or face further enforcement actions. The FDA is soliciting feedback on the factors it should consider when reviewing proposed changes to third-party administrators that could alter the required risk evaluation and mitigation strategy for certain products. Drugmakers often hire vendors to help implement safety systems for certain drugs, and changing vendors can potentially to disrupt safety programs and negatively impact patient access to medications. The FDA published final guidance Thursday on lab performance testing for certain medical devices. The EPA extended the comment deadline from June 12 to June 27 on two proposals to place stricter regulations on the use of ethylene oxide in sterilizing millions of medical devices.   A message from Express Scripts by Evernorth: Express Scripts by Evernorth believes America’s rural communities, and independent pharmacies, deserve better. That’s why we’re leading the way with new ways to close gaps in care through partnerships with independent pharmacies across the U.S. We’re establishing the industry’s first Independent Pharmacy Advisory Committee to help pharmacies everywhere better support underserved communities. We’re making it easier to offer much-needed services like vaccinations, lifestyle counseling, and behavioral health screenings. And we’re increasing reimbursements paid to rural pharmacies for the essential services they provide today and well into the future. We invite all our partners and our competitors to follow our lead. And help improve the quality of care for all. Learn more.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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