| | | | |  | | By Lauren Gardner and Katherine Ellen Foley | Presented by The Pharmaceutical Care Management Association | | | | | 
The Pharmaceutical Care Management Association is preparing for a year of Congressional oversight overtures. | Anna Rose Layden/Getty Images | PBMS PREPARE FOR RAMPED-UP HILL OVERSIGHT — The common thread among health-centric lawmakers in both parties looking ahead to the 118th Congress is an increased focus on pharmacy benefit managers and the role they play in setting U.S. drug prices. While few specifics have been revealed about how members will dig into the industry, its main lobbying group, the Pharmaceutical Care Management Association, is preparing for a year of oversight overtures. PCMA President and CEO JC Scott recently sat down with your co-host and POLITICO's Megan R. Wilson to preview the group's 2023 strategy. Here are some highlights: — The Inflation Reduction Act engagement with CMS and HHS is ongoing. "Our job is to negotiate with drug manufacturers to help drive down costs," Scott said, "and they need some of that expertise as they go through implementation. "What we would hope is, as they identify the criteria for which drugs are going to be subject to negotiation — as they identify the process to off-ramp those drugs back to the private market system — that we can make sure that the off-ramp is relatively expeditious and that the criteria are truly targeting those drugs where there's no competition, and which we would think would be the sort of the root of the problem that they're trying to get at," he added. — PBMs are hoping for 'a large reset' post-IRA. Scott said PCMA will work to "broaden the understanding" among lawmakers of what PBMs do, including "the clinical expertise, the pharmacy expertise, the patient-facing work that our companies do to make our experience at the pharmacy counter better." But the organization also aims to more generally tout the benefits of the private market system that will continue to determine drug prices for the millions of Americans not covered by Medicare, Scott said. Political sniping among PBMs, other pharmacy groups and drugmakers "creates the perception that the system is dysfunctional and that the government needs to intervene," he said. — The election results didn't change their expectations for heightened attention. "Our expectation before the [midterm] elections was kind of regardless of the outcomes, there will continue to be a focus on drug pricing," Scott said. "We would expect oversight activity at a minimum; there will probably be bills introduced again, just as they have been in the past. The new variable, of course, is watching IRA implementation and how that rolls out. The variables don't change a ton based on who's holding the gavels in each chamber." IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. We'll be rooting for team USA in the World Cup this afternoon. Send tips, feedback and World Cup predictions 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 ). TODAY ON OUR PULSE CHECK PODCAST, POLITICO's Emily Schultheis talks with Ruth Reader about the doctors, researchers and women's activists who convened in Riga, Latvia, to explore ways to use pills to circumvent anti-abortion laws.
| | | | | | | A message from The Pharmaceutical Care Management Association: During Diabetes Awareness Month, America's pharmacy benefit managers, PBMs, continue their specialized work helping diabetes patients take their drugs safely and affordably. With a PBM on her side, Kaeana's daughter, who lives with diabetes and a rare liver condition, gets her medications for $40 - not the $6,000 these prescription drugs would otherwise cost her. Hear Kaeana's Story. Learn more about how PBMs are working on behalf of all Americans living with diabetes. | | | | | | | 
Biogen and Eisai will unveil their clinical trial findings for their new Alzheimer's drug today. | Steven Senne/AP Photo | ALL EYES ON BIOGEN AT AD CLINICAL TRIAL CONFERENCE THIS WEEK — Biogen and Eisai will present detailed trial results today on a new Alzheimer's disease drug candidate at the Clinical Trials on Alzheimer's Disease Congress in San Francisco, Calif., Katherine reports. Earlier this year, the companies said their candidate, lecanemab, successfully reduced malformed amyloid proteins — thought to be the cause of Alzheimer's disease — in the brains of participants in a late-stage clinical trial and slowed the progression of cognitive decline. They applied under the accelerated approval pathway, and the FDA is slated to make a decision on the drug by Jan. 6. If approved, lecanemab would be the second amyloid-targeting antibody for Alzheimer's disease on the market. The first, Aduhelm, is also from the two companies and was granted accelerated approval in 2021 to a slew of controversy over contradictory results in late-stage clinical trials. So far, it has performed poorly on the market, leading Biogen to slash its program for the drug and oust its CEO. A potential patient death: On Sunday, Science reported that, according to an unpublished case study, a second patient enrolled in a lecanemab clinical trial had passed away. Although it's not certain that the experimental treatment caused her death, some researchers involved in the case believe it could have. Another patient in the trial died in June, and the cause of death is still under investigation. "The well-being of the patients enrolled in our clinical studies is always Eisai's top priority," said Libby Holman, a company spokesperson, in a statement. "It can be difficult to determine what contributed to the death in any given patient, in particular when they are elderly, have multiple medical problems and may have recently received a concomitant treatment or intervention for an acute condition. … All the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause." ROCHE, SAREPTA'S GENE THERAPY FOR DMD CLEARED FOR PRIORITY REVIEW — On Monday, Sarepta said the FDA had accepted its application for the accelerated approval of the first gene therapy targeting Duchenne muscular dystrophy made in partnership with Roche. The agency also granted the drug priority review and aims to have a decision on the therapy by May 29. Duchenne muscular dystrophy is a fatal condition that appears in the first years of life. The FDA has already granted accelerated approval to three other DMD treatments from Sarepta. This new drug, however, will be a one-time treatment for children that helps muscle tissue create dystrophin, a vital protein that patients with Duchenne cannot produce. Sarepta asked the FDA to approve its new gene therapy based on trials that included more than 80 participants. It has also fully enrolled another trial with 125 participants from ages 4 to 7, which the company has proposed as a potential postmarketing trial should the FDA approve the treatment.
| | | | GO INSIDE THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO is featuring a special edition of our "Future Pulse" newsletter at the 2022 Milken Institute Future of Health Summit from Dec. 6 to 8. The newsletter takes readers inside one of the most influential gatherings of health industry leaders and innovators solving the biggest global health issues to ensure a healthier, more resilient future for all. SUBSCRIBE TODAY TO RECEIVE EXCLUSIVE COVERAGE . | | | | | | | | FDA APPROVES FIRST GENE THERAPY FOR BLOOD DISORDER — Last week, the FDA approved the first gene therapy to treat hemophilia B in adults, Lauren writes for Pros. The drug, marketed as Hemgenix by CSL Behring, is administered as a one-time intravenous infusion and intended to replace regularly scheduled prophylactic infusions of a clotting protein. CSL is setting the therapy's price at $3.5 million, a figure a company spokesperson said accounted for "the clinical, societal, economic and innovative value represented" by the novel drug. One-time gene therapies are usually pricier than conventional drugs taken over a patient's lifetime, and it's not yet known to what extent public and private insurers will cover Hemgenix.
| | | | A message from The Pharmaceutical Care Management Association:   | | | | | | RESEARCH ALLIANCE PRESSES CONGRESS TO BOOST RESEARCH FUNDING — Research!America, a nonprofit whose members include top U.S. universities, hospitals and drug companies, is calling on congressional appropriators to increase funding for scientific research in the budget for the rest of fiscal 2023, POLITICO's Carmen Paun reports. The group sent a draft letter to Democratic and Republican members of the House and Senate appropriations committees urging lawmakers to increase funding for the National Institutes of Health and the nation's other research agencies in the fiscal 2023 omnibus spending bill slated to be voted on next month.
| | | | POLITICO APP USERS: UPGRADE YOUR APP BY DECEMBER 19! We recently upgraded the POLITICO app with a fresh look and improved features for easier access to POLITICO's scoops and groundbreaking reporting. Starting December 19, users will no longer have access to the previous version of the app. Update your app today to stay on top of essential political news, insights, and analysis from the best journalists in the business. UPDATE iOS APP – UPDATE ANDROID APP . | | | | | | | | The FDA published final guidance Monday on how it plans to use enforcement discretion, in limited circumstances, over investigational new drug application requirements for the use of fecal microbiota for transplantation to treat C. difficile infection that doesn't respond to standard therapies. The FDA said Monday that it would convene its external advisory committee on antimicrobial drugs on Jan. 24 to discuss a new drug application from Cidara Therapeutics for a treatment for invasive Candidiasis, a fungal infection.
| | | | A message from The Pharmaceutical Care Management Association: During Diabetes Awareness Month, America's pharmacy benefit managers, PBMs, continue their specialized work of helping diabetes patients get and take their prescription drugs affordably, conveniently and safely. Despite consistent manufacturer price increases on insulin products, PBM pharmacy experts help patients access and take medications as prescribed.
With a PBM on her side, Kaeana's daughter, who lives with diabetes and a rare liver condition, can obtain all of her medications for $40 – not the $6,000 these prescription drugs would otherwise cost her.
"Without help, we would be paying $6,000 a month for medication, but because we have a PBM, I'm only paying $40 out of pocket," Kaeana states. "It's very important to have access to affordable medication, because if we didn't, my child wouldn't be alive."
Hear Kaeana's Story and learn more about how PBMs are working on behalf of all Americans living with diabetes. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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