| | | | | |  | | By Sarah Owermohle | Presented by the Pharmaceutical Care Management Association | With Zachary Brennan, David Lim and Gabrielle Wanneh | | | — Pharmaceutical industry wins in a divided election and a split Senate. — Major Alzheimer's drug meeting today is sure to spark debate. — What does the new HHS rule do? Experts are split. It's Friday, welcome back to Prescription Pulse. In case you missed it in the crush of election news, the U.S. topped 117,000 Covid-19 cases in a single day, another record high. As always, send pharma tips and news to sowermohle@politico.com or @owermohle. Loop in David Lim (dlim@politico.com or @davidalim) and Zachary Brennan (zbrennan@politico.com or @ZacharyBrennan)! | | | | A message from the Pharmaceutical Care Management Association: Amid the ongoing COVID-19 pandemic, PBM mail-service pharmacies are taking all the necessary steps for patients to continue to receive their medications on time and avoid any disruptions in care. PBMs' top priority remains enabling patients to access prescription drugs safely, conveniently and cost-effectively. Learn more about PBMs and mail-service pharmacies at OnYourRxSide.com. | | | | | | PHARMA WINS IN DIVISIVE ELECTION — While the fight over the presidency promises to drag on in court battles and recounts, there is at least one clear winner in this week's elections: The pharmaceutical industry. Though Joe Biden looks increasingly likely to be the nation's 46th president, he'll likely assume office with a GOP-led Senate, a slim House majority and a pile of bills between them that can't find bipartisan support. On the Hill, Democrats held out hope that flipping the Senate would rejuvenate an ambitious agenda to restructure health care and slash drug costs. But not only has the GOP defended most of its Senate seats (we await crucial Georgia runoffs), it also made gains in the House. There is little hope now for meaningful drug pricing reform coming out of the Hill. That means more gridlock on drug pricing bills that stalled during the Trump presidency like S. 2543 (116) — which both sides accused each other of abandoning earlier this year — and House Speaker Nancy Pelosi's bill to let the government negotiate certain prices, H.R. 3 (116), that has a snowball's chance of a Senate vote with Majority Leader Mitch McConnell fresh off reelection. Meanwhile, Sens. Richard Burr (R-N.C.) and Rand Paul (R-Ky.) are contenders to take over the health committee's gavel. In the agencies, Biden could kill some of President Donald Trump's most ambitious plans, like rules to eliminate rebates, help import cheaper medicines or tie payments to lower costs abroad. Even if Biden decided to keep some of those around, they would have a long road to actual implementation (or even final rule status) and big questions about how they would work. Biden talked on the campaign trail about wanting to implement a review board much like Germany's IQWiG that would assess medicines' values based on existing options and force drugmakers to justify their costs. But he wouldn't be able to broadly implement that plan without Congress to clear the way for commercial insurers. Even if his administration rolled it out as a demo model for government plans, it could clash with best price requirements in Medicaid. Confusion sows fortune. "The biggest threat to the sector," Raymond James analyst Chris Meekins wrote in a note to investors, "was Democrats sweeping to power and having greater than 53 Democratic senators." But the chance of big drug pricing action and a public option "no longer appears to be a threat." In some ways the Senate divide is more important for sweeping biopharmaceutical reforms than who is president, writes SVB Leerink analyst Geoffrey Porges (though he adds that a Biden administration might have more appreciation for science.) With that "worst-case scenario" of major Senate wins off the table, so is massive reform, he says. | | | | KEEP UP WITH THE PEOPLE AND POLITICS DRIVING GLOBAL HEALTH IN GLOBAL PULSE: This year has revealed just how pivotal it is to keep up with the politics and policy driving global health. Our Global Pulse newsletter connects leaders, policymakers, and advocates to the people and politics making an impact on our global health. Join the conversation and subscribe today. | | | | | | | | FDA SIGNALS SUPPORT FOR ALZHEIMER'S DRUG — The FDA on Wednesday said it may support approval of Biogen's Alzheimer's drug aducanumab, opening the door for the agency to approve the first treatment for the disease since 2004 — and the first ever for its earlier stages, Zachary Brennan writes. One of two studies run by Biogen was "highly persuasive" and "appeared to be a strongly positive study on many distinct clinical measures," the FDA said in documents released ahead of a meeting Friday of independent experts reviewing the drug. But one of the agency's statistical reviewers noted "conflicting phase 3 evidence" with another study that failed to show the drug works. And an FDA approval of aducanumab could make it tougher for companies developing other Alzheimer's drugs to recruit trial participants, the reviewer said. Michael Carome, director of Public Citizen's Health Research Group, is expected to tell the FDA committee today that ignoring the negative study "is seriously biased and unscientific." Others say the FDA may approve the drug even if the advisory committee doesn't fully support it. "Given the agency's implicit position in favor of approval, a split vote [from the FDA advisory committee] may be good enough to support approval," Bernstein biotech analyst Ronny Gal told investors in a note. | | | |   | | | EXPERTS SPLIT ON HHS SUNSET RULE — HHS on Wednesday rolled out a proposed rule that would require its agencies, including the FDA, to review all regulations within two years and determine if any can be cut, Zachary writes. FDA's workload may be lessened by a review it did in response to Trump's 2017 executive order requiring agencies to cut two regulations for every new regulation added. But experts are divided on whether the latest policy will have a major effect on the agency's work or public health. "There's not a lot of fat here," said Kurt Karst, a lawyer focused on FDA regulations at Hyman, Phelps & McNamara. FDA's regulations are "carefully woven together" with the agency's guidance, Karst said, and "if you cut in one area, you could untangle everything." FDA regulations "are just high level implementations of statute, and frankly not very useful but also not very frustrating," said Bradley Merrill Thompson, a medical device attorney at Epstein Becker Green. "All the real meat is in guidance, and at least as I read it, it doesn't appear to me that this initiative extends to guidance." But others think the HHS rule could be potentially tricky for the FDA. "When I was at FDA and we were doing the 2-for-1 analysis, it was very difficult to identify which regulations to get rid of because those regulations are in place to protect patients," said Aaron Josephson, a senior director at the consulting group ML Strategies and former senior policy adviser at FDA. "You end up in kind of a Sophie's Choice situation or you ask for an exemption." | | | UK TRIAL OF REGENERON DRUG TO RESTART — A U.K.-based clinical trial evaluating Regeneron's Covid-19 antibody drug in hospitalized patients will resume, the data monitoring committee overseeing the study said Thursday. Regeneron halted the enrollment last week of some hospitalized patients in another trial of the antibody. The company, which has submitted an application to FDA for emergency authorization for the drug in nonhospitalized patients, said that the pause was based on "a potential safety signal and an unfavorable risk/benefit profile" in trial data on patients requiring high-flow oxygen or a ventilator. In a quarterly earnings call on Thursday, Regeneron CEO Len Schleifer said he expects FDA's decision on the emergency authorization in the "relatively near future." The company is on track to complete its Phase III trial in nonhospitalized Covid-19 patients and submit an application for full approval in the first half of next year. ASTRAZENECA EXPECTS VACCINE DATA BY END OF 2020 — AstraZeneca could know if its coronavirus vaccine works by the end of the year, CEO Pascal Soriot said Thursday on a quarterly earnings call. Data collection has been delayed because the company halted all trials of the vaccine worldwide in early September due to safety concerns that were later cleared, and because there was a drop in U.K.-based coronavirus infections over the summer, Soriot said. The company has finished enrolling a total of 23,000 participants in late-stage trials in the U.K., Brazil and South Africa. Its U.S. trial, which restarted in late October, is still recruiting volunteers; the enrollment goal has risen from 30,000 to 40,000 participants. Soriot added that he expects to have hundreds of millions of vaccine doses by January. | | | | NEW EPISODES OF POLITICO'S GLOBAL TRANSLATIONS PODCAST: The world has long been beset by big problems that defy political boundaries, and these issues have exploded in 2020. Are world leaders and political actors up to the task of solving them? Is the private sector? Our Global Translations podcast, presented by Citi, unpacks the roadblocks to smart policy decisions and examines the long-term costs of the short-term thinking that drives many political and business decisions. Subscribe for Season Two, available now. | | | | | | | | PELOSI ANNOUNCES EXPANDED TESTING FOR CONGRESS — Pelosi told lawmakers Thursday the Air Force will be providing up to 2,000 PCR tests per week to Congress, POLITICO's John Bresnahan and Heather Caygle report. The announcement comes partially in response to a D.C. order by Mayor Muriel Bowser that requires most visitors to the city get tested for Covid-19. | | | VOTERS WEIGH IN ON TOBACCO, 'SHROOM POLICIES — Voters in several states this week decided on ballot measures related to tobacco and drugs, writes Gabrielle Wanneh. — In Colorado , voters overwhelmingly approved a $2 per pack increase in the cigarette tax over the next seven years. The money will be used to help pay for universal preschool, tobacco education, housing and health care. Similarly, Oregon will also raise its tobacco tax by $2 per pack and levy a new 65 percent tax on e-cigarettes and vaping products to help fund public health programs. — Oregon voters have also decided in favor of Measure 110 to decriminalize the possession of small amounts of illicit drugs, reduce the penalty for the possession of larger amounts and reallocate funding from the state's marijuana tax revenue towards drug treatment programs. Oregon is also the first state to legalize psilocybin — the active ingredient in hallucinogenic mushrooms — for mental-health treatment. — On the flip side, voters in Oklahoma decided against decreasing the amount of funding sent to the Tobacco Settlement Endowment Fund, which would have dropped the amount of money deposited from 75 percent to 25 percent and reallocated some funding towards the state's Medicaid program. | | | — FDA Commissioner Stephen Hahn has come under fire for authorizing Covid-19 drugs based on limited data — but his critics are coming around after he recently stood up to the White House, The Wall Street Journal reports. — Vaccine developer Novovax has gone from a tiny, unknown company to a coronavirus vaccine frontrunner, with billions in U.S. government funding, Science explains. — The New York Times Magazine breaks down who should get a Covid-19 vaccine first, and what criteria should be used to allocate vaccines. | | | FDA offers updates on industry discussions related to the next reauthorization of prescription drug user fees from 2023 to 2027. Group purchasing organization Vizient announced Thursday it has agreed to acquire competitor Intalere from Intermountain Healthcare. The company says it plans to close the deal in the first quarter of 2021. | | | | A message from the Pharmaceutical Care Management Association: Patients using PBM mail-service pharmacies have more affordable drug options and are often more adherent to their medication regimen. Throughout the public health emergency brought on by COVID-19, PBMs' mail-service pharmacies have continued to be a safe, convenient and reliable way for patients to get their maintenance medications and other essential prescription drugs.
Learn more about how PBMs and mail-service pharmacies help patients at OnYourRxSide.com. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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