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Clinical Insights: October 11, 2023

Posted on October 11, 2023 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug/Vaccine Approval

No new update.

New Indication/Dosage/Formulation Approval

Cosentyx® (secukinumab) Injection – New Label Expansion – October 6, 2023 – Novartis, a global leader in immuno-dermatology and rheumatology, announced that the US Food and Drug Administration (FDA) has approved an intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Cosentyx® is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. The IV formulation of Cosentyx® offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring.1 The new IV administration option will be available in Q4 of 2023. <Read More>

Zoryve® (roflumilast) Cream – New Label Expansion – October 5, 2023 – Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) to expand the indication of Zoryve® (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children ages 6 to 11 years. Zoryve®, a once-daily, steroid-free cream that is effective, safe, and well tolerated, is designed to simplify management of plaque psoriasis.  <Read More>

Abrilada™ (adalimumab-afzb) Injection – New Label Expansion – October 4, 2023 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has designated Abrilada™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The interchangeable designation applies to all approved indications of Abrilada™, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.  <Read More>

Empaveli® (pegcetacoplan) Injection – New Label Expansion – October 2, 2023 – Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that the U.S. Food and Drug Administration (FDA) has approved the Empaveli® Injector. The Empaveli® Injector is a compact, single-use, on-body device designed to enhance self-administration of Empaveli® (pegcetacoplan), which is approved for adults with paroxysmal nocturnal hemoglobinuria (PNH). <Read More>

New Drug Shortage

October 06, 2023

October 04, 2023

Updated Drug Shortage

October 04, 2023

New Drug Recall and Safety Alerts

Betaxolol Tablets, USP 10 mg  by KVK-Tech, Inc. – New Voluntary Recall – October 3, 2023 – Newtown, Pennsylvania, KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisects “13” on one side and plain on the other side” to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance after the subject batch was packaged. KVK has not received any reports of foreign tablet in any bottle of Betaxolol Tablets, USP 10 mg (Batch Number 17853A) at this time. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

The PBM Unbundling Has Begun: How Blue Shield of California and Others are Embracing New Models – October 10, 2023 – Recently, major health insurer Blue Shield of California announced it would drop its traditional pharmacy benefit manager (PBM) and instead partner with innovative companies to save $500 million overall when offering its 4.8 million members pharmacy benefits. This news represents a major shift in the health care landscape. Finally, the unbundling and disintegration of the PBM market has a path forward to unlock the value that ultimately belongs to those who need the medication. <Read More>

CarelonRx: Collaboration Between Payers, Specialty Pharmacies Can Help People Lead Healthier Lives – October 10, 2023 – We all know someone affected by a complex illness. Cancer. Crohn’s disease. Multiple sclerosis. Each of these illnesses need active clinical management, medication education and logistical support for administering and optimizing medications. That’s where collaboration within healthcare is needed to help patients lead healthier lives. Payers and specialty pharmacies have the privilege to come together to help change lives for the better. Collaboration between specialty pharmacies and payers is crucial to improving health outcomes for patients with complex illnesses. So where do payers and specialty pharmacies converge and what can each bring to the table to offer support? <Read More>

Tips for Effective 503B Partnerships – October 9, 2023 – Your health-system pharmacy has decided to partner with a new 503B sterile compounding outsourcing facility, or the time has come to audit one of your contract 503Bs. There’s just one problem: How do you know what to look for? If you do your own patient-specific compounding under section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act, as most hospital and health-system pharmacies do, you should be familiar with the requirements of USP General Chapters <795> and <797> governing compounding of nonsterile and sterile products—but that’s an entirely different world from the Current Good Manufacturing Practices (CGMP) required of 503B compounders. <Read More>

Walgreens Pharmacy Employees Plan Walkout at US Stores, CNN Reports – October 8, 2023 – Pharmacy employees at some U.S. Walgreens (WBA.O) stores, including pharmacists, technicians and support staff, plan a walkout between Monday and Wednesday, CNN reported on Friday, citing an organizer. Some employees plan to walk out for one day, while others expect to close their pharmacies for all three, the network said, citing employees in three states. The walkout is in response to what pharmacy employees call burdensome prescription and vaccination expectations placed on pharmacists, the report said. <Read More>

Not Many Pharmacists Provide OTC Syringes – October 7, 2023 – Most pharmacists fully recognize the clinical benefits of providing OTC syringes to people who use drugs, particularly in reducing transmission of HIV and hepatitis C. But according to research findings from JAPhA published July 8, 2023, pharmacists may communicate this understanding while at the same time actively creating barriers to access in their practice settings, such as unfairly interrogating patients about their need for syringes or requiring extra steps to sell them syringes. “If we’re following the evidence—and the law—these actions don’t make any sense,” said lead author Jordan R. Covvey, PharmD, PhD, associate professor of pharmacy administration at Duquesne University School of Pharmacy. <Read More>

Pharmacists Can Capture High-Value Interventions That Go Unnoticed – October 6, 2023 – Standard progress notes within an electronic health record (EHR) miss many interventions that critical care pharmacists make for intensive care patients, according to a study published earlier this year (J Am Coll Clin Pharm 2023;6:848-855). Standard notes capture such tasks as renal dose adjustments or medication reconciliation, wrote researchers at The Ohio State University Wexner Medical Center (OSUWMC), in Columbus. But they might miss other interventions such as discontinuing unwanted therapies, non-renal dose adjustments or initiation of nonantibiotic therapy. Pharmacists at OSUWMC captured these kinds of adjustments via a dedicated intervention tracking tool known as iVent, which is embedded in patient EHRs. The result was more than a 500% increase in previously unrecorded interventions at the institution. <Read More>

Biosimilars Are Bringing Affordability and Accessibility – October 6, 2023 – Lower costs, increased availability, and assistance programs are “game changers” for patients. When biosimilars come to market, they bend the cost curve quickly and significantly, which makes cancer care more affordable, according to Andre Harvin, PharmD, MS, MBA. Harvin is the chief pharmacy officer and vice president of pharmacy services at Cone Health in Greensboro, North Carolina. However, he noted, there are challenges related to the finances of biosimilars, and decision makers need to understand how they pay for these products, whether there are any rebates or contractual arrangements in place, how much they’re charging for the products, and how they’re being reimbursed. <Read More>

The Role of Complementary and Alternative Medicine in Pharmacy – October 5, 2023 – It’s crucial to be openminded about these approaches, and to convey accurate information to patients in a nonjudgmental manner. Pharmacists are often the most accessible health care professionals, and for many Americans, their expertise can be particularly valuable when it comes to counseling on complementary and alternative medicines (CAM). CAM is an umbrella term encompassing a wide variety of treatments and practices that can range from supplements to vitamins to herbal products. Thanks in part to the COVID-19 pandemic, the popularity of these products has risen dramatically in recent years. <Read More>

How Baptist Health is Centralizing its Pharmacy Supply Chain –October 5, 2023 – Louisville, Ky.-based Baptist Health is centralizing its supply chain operations to establish a consolidated pharmacy service center, according to an Oct. 4 news release. The health system is now using a supply chain management software platform developed by Tecsys to streamline processes and workflows related to its pharmacy operations. The move is part of the health system’s goal “to streamline Baptist Health’s growing pharmacy services across the system’s nine hospitals located throughout Kentucky and Southern Indiana — ultimately helping patients access more medications, and receive their medications quickly and efficiently,” according to a Sept. 2022 announcement that detailed Baptist’s plan to build a 90,000-square foot Central Pharmacy Service Center. <Read More>

340B in the News

AHF Thanks Gov. Newsom for Signing PBM Reform Bill – October 9, 2023 – AIDS Healthcare Foundation (AHF) thanked California Governor Gavin Newsom for signing SB 786, a bill which will make it illegal for pharmacy benefit managers (PBMs) to discriminate against 340B Drug Pricing Program participants. AHF also thanked Senator Anthony Portantino (D-Burbank), who authored and successfully carried the bill. The legislation, which will now protect thousands of organizations serving low-income Californians across the state, cleared the California State Senate with unanimous support in early September. “PBMs should not be allowed to steal the savings intended for safety net providers for themselves. SB 786 effectively stops pharmacy benefit managers from being able to pickpocket safety net providers,” said Michael Weinstein, founder and president of AHF. “Reining in PBM abuse remains a nonpartisan issue which continues to pick up steam nationwide. We thank Senator Portantino for authoring and carrying this bill and Governor Newsom for signing it.” <Read More>

COA: Inflation Cut Value of Medicare Payments by 28% Over Decade – October 6, 2023 – The value of Medicare payments to independent community oncology practices fell by at least 28% over the past decade, as the effects of inflation took their toll on reimbursement rates that were largely flat or even reduced, according to an analysis released October 5, 2023. Avalere Health conducted the analysis on behalf of the Community Oncology Alliance (COA), which advocates for community practices and has drawn contrasts between CMS’ payment policies toward their members and oncology reimbursement policies for hospitals… COA has highlighted hospitals use of the 340B Drug Pricing Program, which was set up to assist hospitals that primarily treated underserved patients. Over time, health systems that include a single 340B qualified hospital have relied on these facilities to purchase cancer drugs at discount, and then bill them at much higher prices across their systems, even if most clinics or facilities are located far from the underserved patient populations. <Read More>

What Your Medicaid Pharmacy Administrator is Working On – October 5, 2023 – We spent a couple lovely days with the Western Medicaid Pharmacy Administrators Association members in Tucson, Arizona. The following is a summary of key focus areas for many of the member states…Dealing with 340B drugs – The states are in various stages of grappling with the 340B Drug Pricing Program. Some are requesting survey information from 340B covered entities. Others are implementing specific modifiers for use in billing. For instance, Arkansas added mandatory medical modifiers that, reportedly, many covered entities are getting wrong, as discovered via focused audits. <Read More>