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Clinical Insights: November 8, 2023

Posted on November 8, 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

Voquezna® (vonoprazan) Tablets – New Drug Approval – November 1, 2023 – Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced the U.S. Food and Drug Administration (FDA) has approved Voquezna® (vonoprazan) tablets 10 mg and 20 mg, a novel potassium-competitive acid blocker (PCAB), as a new treatment for adults for the healing of all grades of Erosive Esophagitis, also known as Erosive GERD (gastroesophageal reflux disease), maintenance of healing of all grades of Erosive GERD, and relief of heartburn associated with Erosive GERD. <Read More>

New Indication/Dosage/Formulation Approval

Keytruda® (pembrolizumab) for Injection – New Label Expansion – November 1, 2023 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda®, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC)…This approval marks the sixth indication for Keytruda® in gastrointestinal cancers. <Read More>

Cosentyx® (secukinumab) Injection – New Label Expansion – October 31, 2023 – Novartis, a global leader in immuno-dermatology and rheumatology, announced that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults. Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS. <Read More>

Vabysmo® (faricimab-svoa) Intravitreal Injection – New Label Expansion – October 26, 2023 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication for Vabysmo®, in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Together, the three retinal conditions affect around 3 million people in the U.S. and are among the leading causes of vision loss. <Read More>

New Drug Shortage

November 06, 2023

November 03, 2023

November 02, 2023

November 01, 2023

October 31, 2023

Updated Drug Shortage

November 07, 2023

November 06, 2023

November 03, 2023

November 02, 2023

November 01, 2023

New Drug Recall and Safety Alerts

0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP by Nurse Assist, LLC – New Voluntary Recall – November 6, 2023 – Nurse Assist, LLC initiated a voluntary recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to the potential for a lack of sterility assurance, which could result in a nonsterile product. In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events. <Read More>

Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Cardinal Health, Inc. – New Voluntary Recall – November 1, 2023 – The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the consumer level. The Harvard Drug Group, LLC received information from FDA indicating investigator found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. <Read More>

Certain Leader™ Brand Eye Drops Supplied by Velocity Pharma, LLC Cardinal Health, Inc. – New Voluntary Recall – November 1, 2023 – Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. <Read More>

New Generic/Biosimilar Approval and Launch

Wezlana™ (ustekinumab-auub) Injection – New Biosimilar Approval – October 31, 2023 – The U.S. Food and Drug Administration approved Wezlana™ (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara® (ustekinumab) for multiple inflammatory diseases. Wezlana™, like Stelara®, is approved to treat the following indications: 1) Adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis, 2) Pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and active psoriatic arthritis. <Read More>

Clinical and Pharmacy News

‘Pharmageddon’ Walkouts End, With Impact Unclear – November 3, 2023 – A three-day walkout by pharmacists affiliated with CVS and Walgreens pharmacies to protest working conditions ended on Nov. 1, with executives for both chains claiming that the action had little impact on pharmacy operations. According to Reuters, CVS Health CEO Karen Lynch reported that employees had called in sick at a handful of stores during the period of the walkout, dubbed “Pharmageddon” by organizers, but there were no store closures or disruptions to shifts at its more than 9,000 retail locations. A spokesperson for Walgreens told Reuters that three of its more than 8,500 pharmacy sites had experienced temporary closures during the walkout, which was called for Monday, Oct. 30 through Wednesday, Nov. 1. <Read More>

The Pharmacists Who Revealed the Myth of ‘Decongestants’ – November 3, 2023 – Sixteen years after pharmacists from the University of Florida College of Pharmacy in Gainesville petitioned the FDA to require new efficacy studies of an ingredient in decongestants, their efforts came to fruition. In September, an FDA panel unanimously declared the ingredient ineffective. Oral phenylephrine — often found in drugs like Sudafed — was first approved as a decongestant in 1976, but since then data has revealed it is much less effective than initially thought. <Read More>

Five Ways Pharmacies Can Use Texting to Boost Patient Engagement – November 2, 2023 – Texting with patients can help to improve pharmacy processes while creating better user experiences. Pharmacists should be using a HIPAA-compliant texting platform to protect both the pharmacy and patients. Before a pharmacist can start texting with patients, the patient should be opted in to receive texts from the pharmacy. Make sure patients:  1) Sign up for texts at the point-of-sale system, 2) Text a keyword to the pharmacy number, such as ‘WELLNESS’, 3) Agree to receive texts via a contact form, 4) Text the pharmacy first for customer service, or anything else. <Read More>

Letter: Pharmacy Benefit Managers Have Devastated Pharmacies – November 5, 2023 – Regarding the letter to the editor “Pharmacy benefit managers create savings for patients” (Oct. 31): Before handing the PBMs the proverbial keys to the city, it is important to look at their collective body of work. They are middlemen, so they deal with drug manufacturers at the front end and pharmacies at the back end. My experience with PBMs was as a working pharmacist and not at all favorable. I was witness to the decline of a highly successful independent pharmacy, forced to close due to below cost reimbursements, preferred pharmacy networks and the deceptive direct and indirect remuneration fees, which allow PBMs to take back additional money weeks to months after transactions were completed. <Read More>

340B in the News

Major 340B Drug Pricing Program Developments Implicate Program Scope – November 6, 2023 – Last week, there were three major developments implicating the 340B Drug Pricing program: (1) a court decision addressing the 340B patient definition, (2) new litigation involving 340B “child” site eligibility, and (3) a final rule outlining a plan for the Centers for Medicare & Medicaid Services (CMS) to repay 340B covered entities for reimbursement reductions in prior years pursuant to a Supreme Court decision. We provide more details about these important developments below… <Read More>

Panelists Evaluate Cost-Lowering Efficacy of 340B Discount Program – November 2, 2023 – Panelists at AMCP Nexus 2023 provided a rundown of the 340B discount program and addressed whether it’s actually working to lower out-of-pocket costs for patients. Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting underscored the controversy surrounding the 340B Drug Pricing Program, including how the program has changed operationally over time and the gaps in research to understand the extent to which the initiative is working to lower costs. The session began with a brief history of the 340B program, summarizing its formation in 1992 as part of the Public Health Services Act. The program requires manufacturers who sell covered outpatient drugs to other entities to charge a price that will not exceed an amount determined under a statutory formula. The average discount of list price may exceed 50% and varies across medications. <Read More>

CMS has Finalized its Remedy for 340B Payments, and Hospitals are Not Happy – November 2, 2023 – The Centers for Medicare & Medicaid Services (CMS) has dropped the final rule to remedy the invalidated 340B-acquired drug payment policy for calendar years 2018 to 2022. Earlier in July, the federal government agreed to pay eligible hospitals in the 340B program $9 billion to offset payment cuts that the Supreme Court had previously ruled unlawful. The prescription drug payment cuts were made by the Department of Health and Human Services (HHS) in 2018 and subsequently opposed in the courts by the American Hospital Association (AHA) and other hospital groups. In 2022, the Supreme Court rejected the massive payment cuts, ruling them to be unlawful because HHS did not follow the proper procedure. <Read More>