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Presented by the Pharmaceutical Care Management Association (PCMA): Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim and Lauren Gardner | Presented by the Pharmaceutical Care Management Association (PCMA) | With help from Katherine Ellen Foley. | | | — Who exactly can get Covid-19 booster shots and when? Your co-host helps break it down for readers. — FDA approves interchangeable biosimilar to the blockbuster drug Humira, opening the door for pharmacists to swap out the brand-name drug for a cheaper option for patients. — Senate appropriators released their fiscal 2022 spending bill for the Department of Health and Human Services, with less funding for the president’s proposed health innovation agency than the White House requested. It’s Tuesday. Welcome back to Prescription Pulse. Your authors appreciate that they can get a laugh from The Onion’s semiregular FDA beat writer. Send tips 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 the Pharmaceutical Care Management Association (PCMA): Congress is considering repealing the Medicare prescription drug rebate rule. If not repealed, the rule will increase Medicare Part D premiums 25% and cost taxpayers $170 billion. The federal government should repeal this rule and instead focus on policies that would reduce prescription drug costs. | | | | | | A COVID BOOSTER FIELD GUIDE — It’s been a long, winding road to Boosterville, but it looks like those of us who got the Moderna or Johnson & Johnson vaccines are almost there. With FDA authorization and CDC signoff expected this week, your co-host and POLITICO’s Lauren Morello pulled together a handy guide on what’s what. The big unanswered question, of course, is whether people will be allowed to receive boosters made by a company different from the one that made their initial vaccine series. Based on the independent FDA advisory committee meeting Friday, it sounds like either FDA or CDC could opt to include language in a future emergency use authorization or vaccine fact sheet allowing recipients to select their preferred boosters based on their circumstances. There also seemed to be some confusion about how that could play out, though, so we’ll be watching this week to see if and how FDA and/or CDC address the mix-and-match question. ICYMI: The advisory committee collectively held their nose and voted to recommend a J&J booster at least two months post-initial dose to those who originally received that vaccine. Members had few qualms about its safety or the need for J&J recipients to get additional protection from the virus, but many had issues with the data’s robustness. The experts also largely agreed the vaccine should have been a two-dose series when it was first rolled out. Already questions percolating: West Virginia Covid czar Clay Marsh pointed out to Lauren that his state will have to determine how much J&J vaccine to make available if it’s the only option for those original recipients to get a second dose. If FDA and CDC steer clear of mix-and-match boosters this week but green-light J&J boosters for all adults, states will need to evaluate their on-hand J&J doses to see how many more they may need to offer boosters to those individuals — and to what extent those people may hold off until they can get mRNA boosters instead, which early data has shown is more effective at inducing antibodies. Then there’s also the question of whether FDA wades into the consensus that emerged from the advisory committee (and co-signed by Biden chief medical adviser Anthony Fauci): That the J&J shot should have always been a two-dose regimen. That also influences how a state like West Virginia conducts outreach to J&J recipients who live in remote areas or are transient, Marsh added. The New York Times reported late Monday that FDA is expected to allow mix-and-match boosters as soon as this week. CDC DROPS PEDIATRIC IMMUNIZATION PLAN — CDC released guidance late last week on vaccinating children under 12 against Covid-19 once shots are made available to them. The pediatric vaccines will be packaged differently from the adult doses (the kids’ dosage is one-third that for teens and adults), and once vials are opened, they’re anticipated to be good for six hours. States can order initial doses beginning Wednesday, with shipments going out once FDA authorizes the pediatric immunizations. INTRIVO LAUNCHING AT-HOME TEST — Diagnostics manufacturer Intrivo is launching its over-the-counter at-home Covid-19 test today. The company, Amazon and Walmart are distributing the test, called On/Go, in two packs for $34.95. Company Co-CEOs Ron Gutman and Reeve Benaron declined to give detailed production capacity numbers in an interview, but said millions of the tests are initially available. | | | | A message from the Pharmaceutical Care Management Association (PCMA):   | | | | | | FDA APPROVES FIRST INTERCHANGEABLE BIOSIMILAR TO HUMIRA — The agency approved the first interchangeable biosimilar version to AbbVie’s blockbuster biologic Humira on Friday, Katherine reports. Humira, a monoclonal antibody that treats certain forms of arthritis, psoriasis and Crohn’s disease, is the largest drug by global sales. Cyltezo, manufactured by Boehringer Ingelheim, earned FDA approval as a biosimilar to Humira in 2017. The agency designated Cyltezo as interchangeable for Humira, which means that pharmacists can officially swap out the lower-cost biosimilar for Humira without consulting a health care provider. But patients will need to wait for savings to materialize: Boehringer Ingelheim signed an agreement with AbbVie that would delay U.S. sales of Cyltezo until 2023. And although FDA has also approved Amjevita as a Humira biosimilar, its sale is wedged in lawsuits between its manufacturer, Alvotech, and AbbVie. FDA OK’S TREATMENT TO COUNTERACT OPIOID OVERDOSE — Regulators approved another naloxone brand Monday, providing a new emergency treatment option for users who overdose on opioids. ZIMHI is an injectable like Narcan, which is widely used by first responders and within communities to reverse the an overdose’s effects. | | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | SENATE APPROPRIATORS RELEASE HHS BILL — Senate Democrats released the nine remaining fiscal 2022 appropriations bills Monday, including one funding the Department of Health and Human Services. The legislation, which includes nearly $221 billion in discretionary spending for the department, would fund CDC at $9.7 billion and direct $2.4 billion to President Joe Biden’s ARPA-H proposal, less than half what he called for in his budget blueprint. DUCKWORTH, BLACKBURN, CASEY PUSH CMS ON POWERED WHEELCHAIRS — Three bipartisan senators are pushing CMS Administrator Chiquita Brooks-LaSure to classify standing and seat elevation systems in powered wheelchairs as durable medical equipment. Sens. Tammy Duckworth (D-Ill.), Marsha Blackburn (R-Tenn.) and Bob Casey (D-Pa.) also write in the letter that they want CMS to cover such systems under Medicare. | | | SINEMA RAKES IN PHARMA CASH — Sen. Kyrsten Sinema (D-Ariz.) saw her biggest fundraising haul last quarter, with the pharmaceutical and financial industries cutting the moderate senator’s biggest checks, POLITICO’s Hailey Fuchs reports. Sinema has been at the center of negotiations over leadership’s massive social spending bill and has resisted certain drug pricing proposals. | | | TUESDAY: The Medical Device Innovation Consortium holds a webinar on threat modeling medical device cybersecurity at 2 p.m. EST. THURSDAY: The CDC’s Advisory Committee on Immunization Practices meets to discuss Covid-19 vaccines at 10 a.m. EST. | | | Brad Tallamy is now executive director for policy and government relations at Merck. He most recently was senior director for government affairs at AmerisourceBergen. CJ Mahler is now a legislative assistant handling health care policy for Rep. Lloyd Smucker (R-Pa.). He was previously a senior health policy specialist at Arnold & Porter. | | | VALNEVA EXPECTS UK DECISION ON COVID-19 VACCINE CANDIDATE — French biotech Valneva reported positive Phase 3 results in a trial that pitched it against the Oxford/AstraZeneca jab, setting it up for potential U.K. authorization by year’s end, POLITICO Europe’s Carlo Martuscelli and Helen Collis report. Valneva’s Covid-19 is a whole, inactivated virus, similar to the Sinopharm and Sinovac vaccines. In a trial of more than 4,000 participants, it protected participants against contracting Covid-19 just as well as AstraZeneca’s vaccine and caused slightly fewer instances of side effects. The biotech began a rolling review in August with the U.K.’s Medicines and Healthcare products Regulatory Authority (MHRA) and plans to finalize its submission in November. But it’s not clear what kind of market it will have in the U.K.: Britain last month terminated its contract to buy 190 million doses, alleging that Valneva was in breach of its obligations under the supply agreement. The company denied these claims. | | | | BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now. | | | | | | | | GOP GOVERNORS FIGHT VAX MANDATES DESPITE LOW COVID APPROVALS — New research shows that governors of states without Covid vaccine mandates have “significantly lower” approval ratings for their handling of the pandemic than their counterparts, POLITICO’s Lisa Kashinsky writes. Those Republican governors remain popular but have seen their overall ratings dip recently as Covid cases surged. Still, the Republican voter base is anti-mandate, and those state leaders defend their actions as in line with constituents’ views. | | | Generic drug approvals, submissions fell in FY2021 — New data reported by FDA’s Office of Generic Drugs show the agency approved fewer generic products and received fewer submissions in fiscal year 2021 than in the prior four years, according to a review by AgencyIQ . The FDA fully approved 679 generic drugs in FY2021, and also tentatively approved another 157 generic drugs (i.e., the drugs are just awaiting the expiration of patent or marketing exclusivity). The number of approvals is less than FDA approved in FY2020 (737 full approvals, 172 tentative approvals) and FY2019 (935 full, 236 tentative). The submission of applications for generic drug approval also declined for the fourth consecutive year in FY2021. FDA only received 808 applications for approval in FY2021, down from 865 in FY2020, 909 in FY 2019, 1044 in FY2018 and 1306 in FY2017. The steady decline indicates that generic drug approvals are unlikely to increase next year, either. | | | The Atlantic’s Derek Thompson talks with BioNTech founders Uğur Şahin and Özlem Türeci about the development and future of mRNA technology. MedTech Dive’s Ricky Zipp examines how FDA’s medical device recall system can leave patients without timely information about defective products. | | | FDA reminded diagnostic manufacturers Monday clinical investigations of medical devices that involve humans require Institutional Review Board review, including studies that use de-identified human specimens. The Government Accountability Office released a report Monday on the direct and direct costs of rare diseases. | | | | A message from the Pharmaceutical Care Management Association (PCMA): Congress has shown bipartisan support to delay the Medicare prescription drug rebate rule and avoid increasing Medicare premiums by 25%. Now Congress should permanently repeal this rule to avoid disrupting Medicare beneficiaries’ affordable Part D prescription drug coverage and to save taxpayers $170 billion. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
