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Clinical Insights: October 4, 2023

Posted on October 4, 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

Rivfloza™ (nedosiran) Injection – New Drug Approval – September 29, 2023 – Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Rivfloza™ (nedosiran) injection 80 mg, 128 mg, or 160 mg, a once-monthly subcutaneous ribonucleic acid interference (RNAi) therapy, to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function. <Read More>

Exxua™ (gepirone hydrochloride) Extended-release Tablets – New Drug Approval – September 28, 2023 – Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company committed to developing novel therapies to address unmet needs in psychiatry and neurology, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Exxua™ (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults. Exxua™ represents a new class of antidepressant; the first and only approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion. <Read More>

Opfolda™ (miglustat) and Pombiliti™ (cipaglucosidase alfa-atga) Capsules – New Drug Approval – September 28, 2023 – Amicus Therapeutics (Nasdaq: FOLD) announced that the U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules. This two-component therapy is indicated for adults living with late-onset Pompe disease (LOPD) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). <Read More>

Ryzumvi™ (phentolamine mesylate) Ophthalmic Solution – formerly Nyxol – New Drug Approval – September 25, 2023 – Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders and Viatris Inc. (NASDAQ: VTRS), a global healthcare company, announced that the U.S. Food and Drug Administration (FDA) has approved Ryzumvi™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. Ryzumvi™ is expected to be commercially available in the U.S. in the first half of 2024. <Read More>

New Indication/Dosage/Formulation Approval

Entyvio® (vedolizumab) Injection – New Label Expansion – September 27, 2023 – Takeda announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) administration of Entyvio® (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with Entyvio® intravenous (IV). Entyvio® SC is expected to be available in the U.S. as a single-dose pre-filled pen (Entyvio® Pen) by the end of October. Additionally, a Biologics License Application for an investigational SC administration of Entyvio for the treatment of adults with moderately to severely active Crohn’s disease is currently under review by the FDA. <Read More>

Bosulif® (bosutinib) Tablets and Capsules – New Label Expansion – September 26, 2023 – On September 26, 2023, the Food and Drug Administration approved bosutinib (Bosulif®, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg. Efficacy was evaluated in the BCHILD trial (NCT04258943), a multicenter, nonrandomized, open-label trial conducted to identify a recommended bosutinib dose in pediatric patients with ND CP Ph+ CML and R/I CP Ph+ CML, to estimate the safety and tolerability and efficacy, and to evaluate bosutinib pharmacokinetics in this patient population. <Read More>

New Drug Shortage

October 2, 2023

September 29, 2023

Updated Drug Shortage

October 03, 2023

October 02, 2023

September 29, 2023

September 28, 2023

September 27, 2023

New Drug Recall and Safety Alerts

4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP by Hospira, Inc – New Voluntary Recall – October 2, 2023 – Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10mL vial; 1% Lidocaine HCl Injection, USP, 50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated due to the potential for presence of glass particulate matter. <Read More>

ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray Products by Biomic Science – New Voluntary Recall – September 29, 2023 – Biomic Sciences is voluntarily recalling all lots of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray products to the consumer level. FDA testing found the product to contain microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp (these microorganisms are generally non-pathogenic). <Read More>

Brexafemme® (ibrexafungerp tablets) by Scynexis – New Voluntary Recall – September 27, 2023 – Scynexis, Inc. is conducting a voluntary nationwide recall of 2 lots of Brexafemme® (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a non- antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the Brexafemme® tablets. During a review of manufacturing equipment and cleaning activities at a supplier, Scynexis was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance. <Read More>

New Generic/Biosimilar Approval and Launch

Tofidence™ (tocilizumab-bavi) Injection – New Actemra® Biosimilar Approval – September 29, 2023 – Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved Tofidence™ (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra®. The Tofidence™ intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. <Read More>

Clinical and Pharmacy News

Four Tips for Pharmacists Looking to Join Hospital C-Suites – October 3, 2023 – Compared to COOs and CFOs, the pathway from pharmacy leader to a hospital C-suite is less established. Here’s how four hospital C-suite executives with pharmacy backgrounds rose through the ranks. What lessons from pharmacy work best prepared you for your current C-suite role? Rob Adamson, PharmD. Executive Vice President and Chief Information Officer of RWJBarnabas Health (West Orange, N.J.): When health systems create strategic plans and investments, a pharmacist is uniquely poised to be a successful in the C-suite due to the multi-faced role medications play within the health system. A pharmacist needs to collaborate with a myriad of care teams and multiple services lines, such as laboratory, research, finance, facilities, human resources and the like. Due to the comprehensive nature of the pharmacist role, they are armed with a skill set that allows them to have a broad understanding of the entire ecosystem of integrated delivery networks, which makes them natural strategic thinkers and leaders. <Read More>

Six Pressing Drug Shortages, Per Pharmacy Technicians – October 2, 2023 – More than 9 in 10 pharmacy technicians are experiencing workflow challenges and about 45 percent said they’re unable to administer prescriptions because of drug shortages, according to a recent survey. The Pharmacy Technician Certification Board surveyed 74 certified pharmacy technicians in August about which drug shortages are affecting their work. Sixty-two percent of the respondents work in health systems, 14 percent in community pharmacies and 24 percent in other settings. Pharmacy techs pointed to shortages of drugs for cancer, attention-deficit/hyperactivity disorder, weight loss and diabetes — such as Mounjaro™, Ozempic® and Wegovy® — and local anesthetics. <Read More>

Pharmacy Orgs Unveil Strategies to Bolster Pharmacy Workforce – October 2, 2023 – The American Pharmacists Association, the American Society of Health-System Pharmacists and the National Association of Boards of Pharmacy shared a new report including actions to implement solutions to improve pharmacy workplace conditions. Workplace problems are leading to high stress levels and occupational burnout across various pharmacy practice settings. APhA, ASHP and NABP undertook a collaborative effort to address these challenges head-on during a recent invitation-only event, and identified transformative and actionable changes for the pharmacy and related communities. <Read More>

Pharmacists Work to Sustain Care in Health Care Deserts – September 29, 2023 – When rural areas lose hospitals and primary care clinics, residents must turn to pharmacies to receive the care they need. Health care deserts, which are areas with poor access to hospitals, clinics, primary care, and other health care services, are a growing problem. As the US population ages and shifts to more urban and suburban settings, rural areas are losing health care access. When Kennett, Missouri, lost its only hospital in 2018, infant mortality increased, as did maternal mortality and deaths from cardiovascular causes, strokes, accidents, and other treatable events that had previously been handled in the emergency department, explained independent pharmacist Jenna Hawkins, PharmD. <Read More>

CVS Pharmacists Voice Concern Over Working Conditions – September 27, 2023 – Some CVS pharmacists in Kansas City are calling out of work Sept. 27 to bring attention to increasingly difficult working conditions, USA Today reported. Kansas City organizers have encouraged CVS pharmacists across the nation to join them in the protest. It is unclear how many pharmacists are participating. Mike DeAngelis, executive director of corporate communications for CVS, told Becker’s the company was experiencing normal pharmacy operations nationwide and in its Kansas City market Sept. 27. The protest is the second in less than a week. On Sept. 21, nearly two dozen pharmacists called out of work, forcing about 10 CVS locations in eastern Kansas and western Missouri to close, according to a separate USA Today report. All locations resumed normal operations Sept. 23. <Read More>

VCU Energizes its Pharmacy Plan – September 26, 2023 – CU Health is doubling down on its pharmacy strategy and mail-order medication services, according to Michael Roussos, president of VCU Medical Center. After labor costs, pharmacy is the second or third most expensive service line for health systems across the nation because of rising drug costs, Mr. Roussos said, which is spurring VCU Health’s efforts into growing its pharmacy footprint and expanding access to its mail-order pharmacy. “In the past, lots of pharmacy services have been order gets put in, the pharmacy checks the order and provides the medication,” he said. “But now, we’re getting into much more innovative times where we can expand the services of our pharmacy programs.”<Read More>

Three Ways to Strengthen Proposed Pharmacy Benefit Manager Regulation – September 26, 2023 – Congress appears poised to pass bipartisan legislation in the coming months that would create new regulations for pharmacy benefit managers (PBMs). PBMs are organizations that negotiate drug prices with pharmaceutical manufacturers and manage prescription drug benefits for an employer or health insurance plan. The core functions of a PBM include setting up a prescription drug “formulary” (a list of which drugs are covered and at what cost), processing pharmacy claims, and managing pharmacy networks and reimbursement. Most PBMs also operate their own mail-order and specialty pharmacies. The three largest PBMs control 80 percent of the market and are each owned by a large insurance company. <Read More>

340B in the News

Health System Execs Add Revenue With Clinical Innovation – October 2, 2023 – Hospital and health system executives are looking for ways to add revenue as costs continue to increase and margins stay tight. Many see boosting clinical care services, outcomes and value-based care initiatives as the path to a stronger financial situation. David Reich, president of The Mount Sinai Hospital and Mount Sinai Queens in New York said the system is focused this year on patient care innovations linked to revenue opportunities, including 340B program optimization and other pharmacy initiatives, cell-based therapies and novel antibody therapies for oncology care, and complex procedural services growth. Digital transformation enhancements coupled with a renewed focus on clinical services is making a difference. <Read More>

Better 340B-elieve It – September 29, 2023 – The 340B Drug Pricing Program is always of interest, and this week a new report emerged about the program’s growth in 2022. Adam Fein of Drug Channels Institute has obtained records from the Health Resources and Services Administration (HRSA) on the 340B Program’s growth last year, with some surprising details. Let’s dive in and explore the data…In 2022, HRSA documents show that the purchases through wholesalers (HRSA data does not include direct manufacturer sales) at discounted prices totaled $53.7 billion. That’s a 22.3 percent increase over 2021, where discounted purchases totaled $43.9 billion. It should be noted that the wholesale acquisition cost (WAC, or list price) of these 340B drugs was $106 billion in 2022 – meaning CEs received a total discount of more than 50 percent. The total savings, $52.3 billion, are $2.6 billion higher than the 2021 savings on list price. <Read More>

Senator Probes Cleveland Clinic, Bon Secours Over 340B Program – September 29, 2023 – Louisiana Sen. Bill Cassidy, MD, opened an investigation Sept. 28 into how Cleveland Clinic and a Bon Secours hospital is involved in the 340B drug pricing program. 340B is a federal drug pricing program that has seen scrutiny from drugmakers and support from participating hospitals. The program allows eligible hospitals and healthcare facilities that serve uninsured, low-income and rural patients to buy drugs at discounted prices. The senator asked Cleveland Clinic and Bon Secours’ Richmond (Va.) Community Hospital to share how they use savings from the 340B program to improve patient care. For Cleveland Clinic, Dr. Cassidy questioned why its flagship hospital was deemed a rural referral center in April 2020 “even though it is located near central Cleveland,” according to a letter he sent to the hospital. <Read More>