FDA Updates for the Week of Sept. 12, 2022
September 17th 2022The FDA has approved new therapies for psoriasis and kidney dysfunction. The agency has also scheduled an advisory committee meeting for nonprescription birth control and accepted applications for longer-acting aripiprazole, Rett syndrome drug, and an enzyme replacement therapy. Additionally, Clovis has submits supplemental applications for Rubraca.
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Weight-Loss Drugs: Why This Time It May Be a Different Story | 2022 PBMI Annual National Conference
September 14th 2022The harm caused by weight-loss drugs have overwhelmed any benefit they may have. The repurposed diabetes drugs like Wegovy (semaglutide) have a strong safety profile, said presented at the annual Pharmacy Benefit Management Institute meeting.
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WellDyne's David Skomo Highlights the Need to Reframe How Obesity Is Viewed
September 14th 2022Payers need to reframe how they view obesity as not just a health and wellness issue, but as a progressive chronic disease that needs medication, explained David Skomo, RPh, chief operations officer at WellDyne.
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A Real-Time Benefit Check Success Story | 2022 PBMI Annual National Conference
September 13th 2022Executives at Arrive Health and OptumRx say they have ironed out many of the problems with real-time benefit checks, which delivers out-of-pocket cost and prior approval information at the time a prescription is being written.
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Nicole Bulochnik of Abarca Health Talks Alternative Cost Management at PBMI
September 13th 2022Nicole Bulochnik, Vice President of Drug Pricing and Network Strategy at Abarca Health delivers her presentation, "PBM-Payer Partnerships: Insight into Alternative Cost Management Strategies Across Common PBM Levels," during this year's PBMI National Annual Conference in Orlando, FL.
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Gregory Warren Discusses Measuring Value and Scaling Up Value-Based Contracting
September 13th 2022Thus far, value-based contracts for prescription drugs has not been transformative because of the scalability challenge for payers, explained Gregory Warren, FSA, FCA, MAAA, partner and consulting actuary with Axene Health Partners.
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Cate Lockhart Presents on the Uptake of Biosimilars at PBMI 2022
September 13th 2022Cate Lockhart, MS, PharmD, PhD, Executive Director at the Biologics and Biosimilars Collective Intelligence Consortium covers her presentation "New mAbs on the Block: A Rocking Research Update on Biosimilar Uptake and Benefit Design" which she delivered at this year's PBMI national conference.
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Digital Therapeutics: The Promise and Some Pitfalls |2022 PBMI Annual National Conference
September 12th 2022Some of the evidence for digital therapeutic suffers from selection bias and relatively short studies, panelists at the Pharmacy Benefit Management Institute said today. They also discussed making the flood of data from the digital therapeutics accessible and useful to payers and clinicians.
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Michael Agostino Reflects on His Career as a Pharmacy Leader during PBMI
September 12th 2022Michael Agostino, RPh, a registered pharmacist and entrepreneur of Onesto One Advisors, LLC, addressed how his career has been spent over the last few decades during his presentation Sept. 12 at this year's PBMI Annual National Conference in Orlando.
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FDA Updates for Week of Sept. 5, 2022
September 10th 2022In COVID-19 news, the FDA indicated Eiger’s treatment not supported by data. An advisory committee switched its vote to yes for new ALS drug. The FDA approved Stimufend, a biosimilar to Neulasta, as well as Imfinzi for biliary tract cancer, a longer-lasting treatment for frown lines, an oral suspension for gastric ulcers, and generics of Revlimid. The agency accepted applications for novel dry eye disease and alopecia therapies. Additionally, Seres completed rolling BLA for microbiome therapeutic.
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FDA Advisory Committee Supports Approval of AMX0035 for ALS
September 8th 2022In a second committee meeting, FDA advisors supported approval of AMX0035 after the company presented additional analysis of phase 2 data of AMX0035 to treat patients with ALS. The Prescription Drug User Fee Act (PDUFA) target action date is Sept. 29, 2022.
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Patients With Moderate-to-Severe Atopic Dermatitis Experience Impaired QOL, Feel Disease Burden
September 7th 2022A national study in Germany identified the baseline characteristics of patients with moderate-to-severe atopic dermatitis (AD) to understand how they are usually treated with Dupixent in the real world.
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FDA Updates for Week of Aug. 29, 2022
September 3rd 2022In COVID-19 news, the FDA authorized updated boosters. The agency also approved several new therapies, including Xenpozyme for a rare genetic disorder, and Pemazyre for myeloid/lymphoid neoplasms, Spevigo for rare type of psoriasis flare. The FDA also expanded Imbruvica’s indication for young children with GVHD and granted priority review for weekly hemophilia A therapy.
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Management of EoE May Need to Be Rethought to Reduce Treatment Burden, Impact on Quality of Life
September 2nd 2022Therapeutic goals of reducing eosinophil counts below a certain level in eosinophilic esophagitis (EoE) has a marginal benefit for the impact on quality of life and treatment burden.
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Jim Graham of Prime Therapeutics Discusses a Digital Transformation Management System in Healthcare
August 31st 2022In this week's episode, MHE Editor Briana Contreras and Managing Editor Peter Wehrwein met with CIO of Prime Therapeutics, Jim Graham to discuss the process of an organization’s digital transformation from a traditional Pharmacy Benefit Manager to a complete data-driven drug management system. Graham addressed the risks an organization may come across to successfully transition to this system, but also mentioned the benefits to come.
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A Health Plan’s “No Regret” Strategy to Open Enrollment
August 29th 2022This year, health plans need to focus on the following smart, “no regret” investments in the enrollment process that have low risk, high reward, and ultimately deliver an exceptional member experience while simultaneously reducing costs and improving data quality.
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