| | | | |  | | By David Lim and Lauren Gardner | Presented by Pharmaceutical Care Management Association | | | | | | 
Drugmakers are competing to get their vaccines into pharmacies. | Marcio Jose Sanchez/AP | VAX COMPETITION HEATS UP — Vaccine makers targeting respiratory illnesses are ramping up efforts to convince pharmacies to carry their shots — and persuade patients to get jabbed — in the next winter season in a market with more competition than ever. Two shots by GSK and Pfizer for respiratory syncytial virus are available for people 60 and older — Pfizer’s can also be used in pregnant people — and Moderna’s RSV vaccine could win FDA approval by May. GSK is taking a “three-pronged approach,” targeting the consumer, the provider and the pharmacist, Rob Truckenmiller, senior vice president of U.S. vaccines at GSK, said. If the patient doesn’t know the vaccine exists, he added, a provider is unlikely to recommend it, and a pharmacist won’t administer it. But retailers face limitations on how many choices they can offer consumers. Contract pricing plays a major role in driving what pharmacies stock, as does community demand and insurance coverage. “They don’t have unlimited capital to have sitting in their refrigerator and their freezers,” Dr. Michelle Fiscus, chief medical officer at the Association of Immunization Managers, said. Cost and ease of administration will be key factors for clinics contracting with companies, given the capital pharmacies and physician practices have to spend upfront, especially since insurers don’t always cover at the cost originally paid, Fiscus said. Pharmacies that didn’t have to worry about reimbursement for Covid vaccines during the pandemic are now more closely scrutinizing which shots to stock based on wholesaler contracts, anticipated reimbursement and patient demand, pharmacists say. Low reimbursement rates across medications affect pharmacies’ bottom lines, which can constrain vaccination resources. Will it last? GSK and Pfizer plan to expand their vaccines’ indications to cover more adults at high risk for severe disease from RSV, pending FDA approval. The more people a vaccine could reach, the more a pharmacy might be interested in carrying that shot. While competition can drive those changes, it can also lead to a winnowing of the field if data shows one vaccine performs better than others, as has happened with shingles and HPV immunizations. “Because the vaccine industry is expensive and the margins often aren’t as big as they are with other drugs, I think the herd will thin itself,” Fiscus said. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Are you White House Office of Management and Budget Director Shalanda Young? We want to hear from you! Send news and tips about pending FDA regulations to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
| | | | A message from Pharmaceutical Care Management Association: Pharmacy Benefit Managers (PBMs) work to provide patients with a higher quality, lower cost pharmacy experience, which includes supporting independent pharmacies in rural areas nationwide through innovative programs to increase reimbursements on prescription drugs and expanding payments for clinical services. Learn more about PBM support for rural pharmacies and patients. | | | | | | | 
FDA Commissioner Robert Califf faced Congress on Thursday to make his case for additional funding for the agency. | Anna Moneymaker/Getty Images | CALIFF RETURNS TO THE HILL — FDA Commissioner Robert Califf visited Capitol Hill on Thursday to pitch the House Appropriations subcommittee in charge of FDA funding on boosting his agency’s budget in fiscal 2025. The agency requested $157 million in additional budget authority. The panel’s top Democrat, Rep. Sanford Bishop (D-Ga.), told POLITICO it is “more than likely” that liberals will push for increased funding despite Chair Andy Harris’ (R-Md.) warning that more money needs “to come with accountability measures.” A week after a grueling multihour appearance before the House Oversight Committee, Califf encountered a friendlier slate of lawmakers who pressed the FDA leader on issues including tobacco regulations, foreign inspections and a litany of food policies. Foreign inspections: Califf told lawmakers the FDA has conducted almost 100 unannounced inspections in India and “double digits” in China. An unannounced inspection can cost more than two times as much as an announced inspection because of logistics, travel support and staffing needs, according to Califf. Menthol rule: Multiple lawmakers pressed Califf on why the Biden administration has not yet issued the FDA’s final rule prohibiting menthol cigarettes. “It’s one of our top priorities, so I would sure hope so,” Califf said when Rep. Barbara Lee (D-Calif.) asked whether the regulation would be released by the end of the year. Flavored e-cigarettes: Califf told both Republicans and Democrats that the FDA wants to work with Congress to get more authority to quickly detain illicit flavored e-cigarettes being mailed from China into the U.S. in packages labeled as different items. “We need to work with Congress to come up with a way to deal with this specific problem that cuts all of the red tape,” Califf said, citing an example of when a box of vaping products was labeled as lanterns to delay prompt action. “That creates a legal problem for us.” CARTER EYES E&C HEALTH SUBCOMMITTEE — The race to succeed House Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) is starting to have downstream effects. Rep. Buddy Carter (R-Ga.) told POLITICO Thursday that either Rep. Brett Guthrie (R-Ky.) or Rep. Bob Latta (R-Ohio) would be a good selection as the top Republican on the powerful committee next Congress. The pharmacist wants to make a move of his own: to lead the E&C Health Subcommittee — a role Guthrie holds in the current Congress. “Either one of them would do a wonderful job,” Carter said. “Not to be self-serving, but we certainly are looking at the health subcommittee.” BIOSECURE PROSPECTS — There’s still momentum behind legislation that would effectively prohibit Chinese biotech companies from doing business in the U.S. — even though the bill’s House champion, Republican Mike Gallagher (R-Wis.), is heading for the exit, POLITICO’s Megan R. Wilson reports. Many U.S. and European drugmakers rely on companies covered by the legislation, such as WuXi AppTec, during the research, development and manufacturing of their medicines. The legislation could force an overhaul of how the industry brings drugs to market and raise overall costs. But more than a dozen policymakers, congressional staffers and lobbyists said the BIOSECURE Act stands a good chance of crossing the finish line this year. There’s a push for a House Oversight Committee markup, but nothing has been scheduled. A Senate panel advanced the bill last month.
| | | | THE GOLD STANDARD OF POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries—finance, defense, technology, healthcare, energy—equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists.
Our newsroom is deeper, more experienced, and better sourced than any other—with teams embedded in the world’s most active legislative and regulatory power centers. From Brussels to Washington, New York to London, Sacramento to Paris, we bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY. | | | | | | | | | FROM WEIGHT LOSS TO SLEEP APNEA — Eli Lilly plans to apply for a new indication by midyear for its weight-loss drug Zepbound after announcing positive results from a study of people with obesity and moderate-to-severe obstructive sleep apnea, the company said Wednesday. If the FDA were to approve it, Zepbound could become the first drug for sleep apnea, a breathing disorder in which the upper airway completely or partially collapses during sleep. The drug significantly decreased the number of airflow restrictions per hour of sleep, Lilly said. COMBATING CHOLERA — The World Health Organization endorsed a new oral cholera vaccine on Thursday by EuBiologics, which is expected to increase the vaccine supply as a global upsurge of cholera outbreaks has led to unmet demand, POLITICO’s Carmen Paun reports.
| | | | A message from Pharmaceutical Care Management Association:   | | | | | | North Carolina’s health insurance plan for state workers recently decided to stop covering expensive weight-loss drugs, reflecting a struggle playing out across the country as public payers try to limit costs linked to the pricy treatments, POLITICO’s Kelly Hooper writes. Former FDA Principal Deputy Commissioner Janet Woodcock will advise nonprofit Haystack Project on helping rare disease organizations “encourage creativity in drug development programs,” Pink Sheet’s Sarah Karlin Smith reports.
| | | | POLITICO IS BACK AT THE 2024 MILKEN GLOBAL CONFERENCE: POLITICO will again be your eyes and ears at the 27th Annual Milken Institute Global Conference in Los Angeles from May 5-8 with exclusive, daily, reporting in our Global Playbook newsletter. Suzanne Lynch will be on the ground covering the biggest moments, behind-the-scenes buzz and on-stage insights from global leaders in health, finance, tech, philanthropy and beyond. Get a front-row seat to where the most interesting minds and top global leaders confront the world’s most pressing and complex challenges — subscribe today. | | | | | | | | | The FTC, HHS and the DOJ launched a portal for the public to report “health care practices that may harm competition.” The Health Resources and Services Administration released a final rule laying out the 340B Program’s administrative dispute resolution process. The FDA’s Center for Devices and Radiological Health released two annual reports on medical device safety and innovation.
| | | | A message from Pharmaceutical Care Management Association: PBMs work on behalf of health plans and patients to reduce drug costs, support access to quality pharmacy care, and enable better health outcomes in every community, especially rural communities.
While PBMs are working every day to reduce drug costs for patients, PBMs are also committed to working with pharmacies to support patients’ access to prescription drugs. In rural communities, PBMs are offering innovative programs to support increasing pharmacy reimbursements including expanding reimbursements for clinical services performed at rural independent pharmacies for rural patients. A strong relationship between PBMs and rural pharmacies means a better experience and more affordability for patients.
Each year, PBMs save patients and the U.S. health care system an average of $1,040 per person. Without PBMs, employers and health plans would be forced to go it alone on pharmacy benefits, which would result in significantly higher drug costs for patients.
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