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Clinical Insights: November 1, 2023

Posted on November 1, 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

Loqtorzi™ (toripalimab-tpzi) Injection – New Drug Approval – October 27, 2023 – The Food and Drug Administration approved toripalimab-tpzi (Loqtorzi™, Coherus BioSciences, Inc.) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Efficacy of toripalimab-tpzi with cisplatin and gemcitabine was evaluated in JUPITER-02 (NCT03581786), a randomized, multicenter, single region, double-blind, placebo-controlled trial in 289 patients with metastatic or recurrent, locally advanced NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease. <Read More>

Agamree® (vamorolone) Oral Suspension – New Drug Approval – October 26, 2023 – Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX) reported that Santhera Pharmaceuticals (“Santhera”) has obtained U.S. Food and Drug Administration (“FDA”) approval for Agamree® (vamorolone) oral suspension 40 mg/mL for use in treating Duchenne Muscular Dystrophy (“DMD”) in patients aged two years and older. Agamree® offers a novel corticosteroid treatment option for DMD, addressing a significant unmet medical need. In July 2023, Catalyst secured the exclusive North American license and commercial rights for Agamree® from Santhera for DMD and other potential indications, bolstering its neuroscience commercial portfolio with a highly synergistic neuromuscular asset. As part of that transaction, Santhera will promptly transfer the approved New Drug Application for Agamree® to Catalyst. <Read More>

Omvoh™ (mirikizumab-mrkz) Injection – New Drug Approval – October 26, 2023 – Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Marking a significant milestone, Omvoh™ is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC. <Read More>

New Indication/Dosage/Formulation Approval

Tibsovo® (ivosidenib) Tablets – New Label Expansion – October 24, 2023 – The Food and Drug Administration approved ivosidenib (Tibsovo®, Servier Pharmaceuticals LLC) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. The FDA also approved the Abbott RealTime IDH1 Assay as a companion diagnostic device to select patients for ivosidenib. Approval was based on trial AG120-C-001 (NCT02074839), an open-label, single-arm, multicenter trial of 18 adult patients with relapsed or refractory MDS with an IDH1 mutation. IDH1 mutations were detected in peripheral blood or bone marrow by a local or central diagnostic test and confirmed retrospectively by the Abbott RealTime IDH1 Assay. <Read More>

New Drug Shortage

October 26, 2023

October 25, 2023

Updated Drug Shortage

October 30, 2023

October 26, 2023

October 25, 2023

New Drug Recall and Safety Alerts

Exela 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL, Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL, and Elcys™ (cysteine hydrochloride Injection), USP 500 mg/10 mL by Pharma Sciences, LLC – New Voluntary Recall – October 25, 2023 – Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples. 1) 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL, 50 mL Single Dose Vial, 2) Midazolam in 0.8% Sodium Chloride Injection, 100 mg/100 mL, 100 mL Single Dose Vial, 3) Elcys™ (cysteine hydrochloride Injection), USP, 500 mg/10 mL, 10 mL Single Dose Vial. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

CDC’s National Institute for Occupational Safety and Health Launches First Federal Campaign for Hospitals to Tackle Healthcare Workers Burnout – October 31, 2023 – The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) announced the launch of Impact Wellbeing. This new campaign provides hospital leaders with evidence-informed resources to improve workplace policies and practices that reduce burnout, normalize help-seeking, and strengthen professional wellbeing. “Even before the pandemic, healthcare workers faced challenging working conditions that lead to burnout. This includes long work hours, risk for hazardous exposures, stressful work, and high administrative burdens,” said John Howard, MD, Director of NIOSH. “Hospital leaders need support to implement organizational changes. Practical adjustments can reduce burnout and strengthen professional wellbeing within their hospitals.” <Read More>

Pharmacy Staff From CVS, Walgreens Stores in US Start Three-Day Walkout –October 30, 2023 – Some employees at CVS Health Corp (CVS.N) and Walgreens Boots Alliance’s (WBA.O) U.S. pharmacies launched a three-day walkout starting Monday to push the companies to improve working conditions and add more staff to their stores. The walkout, which has been dubbed “Pharmageddon” on social media platforms such as Meta’s Facebook where it was largely planned, started on Monday and led to the closing of some stores in New York City, two organizers told Reuters. <Read More>

Extreme Heat Projected to Increase Cardiovascular Deaths – October 30, 2023 –Cardiovascular-related deaths due to extreme heat are expected to increase between 2036 and 2065 in the United States, according to a study supported by the National Institutes of Health. The researchers, whose work is published in Circulation, predict that adults ages 65 and older and Black adults will likely be disproportionately affected. While extreme heat currently accounts for less than 1% of cardiovascular-related deaths, the modeling analysis predicted this will change because of a projected rise in summer days that feel at least 90 degrees. This heat index, which factors in what the temperature feels like with humidity, measures extreme temperature. Older adults and Black adults will be most vulnerable because many have underlying medical conditions or face socioeconomic barriers that can influence their health – such as not having air conditioning or living in locations that can absorb and trap heat, known as “heat islands. <Read More>

PhRMA, PBMs Spar Over Rising Drug Costs Amid Public Scrutiny – October 29, 2023 – The top pharmaceutical lobby group, PhRMA, and drug middlemen known as pharmacy benefit managers (PBM) have resumed their long-running battle over who is to blame for rising drug costs in the U.S. amid growing public scrutiny. The Biden Administration implemented the Inflation Reduction Act (IRA) this year, permitting the Centers for Medicare and Medicaid Services (CMS) to negotiate drug prices for the first time in history. The U.S. Congress has also stepped up efforts to rein in PBMs, which function as intermediaries between health plans, pharmaceutical manufacturers, and pharmacies. <Read More>

Congress Shines Another Harsh Light on PBM Practices – October 28, 2023 – In a rare show of bipartisanship, members of Congress from both sides of the aisle agreed that pharmacy benefit managers (PBMs) have too much power and provide too little transparency, during the second in a series of hearings on the role of PBMs in the healthcare industry. The meeting was held by the House Committee on Oversight and Accountability on Sept. 19, 2023. “Instead of fierce competition, now just three PBMs control 80% of the market, and each of the three major PBMs is owned by a major health insurer and owns or is owned by a pharmacy,” noted committee Chair James Comer (R-Ky.). <Read More>

Prescription for Disaster: America’s Broken Pharmacy System in Revolt Over Burnout and Errors – October 26, 2023 – Pharmacists with the nation’s largest retail pharmacy chain felt dangerously burned out. It was August 2020. The pandemic was in full swing, straining an already weary workforce hit by a decade of relentless budget cuts and rising demands. One by one, the pharmacists dialed into a weekly conference call with their boss. He could have empathized with them or addressed the reality of their pressure-cooker environment – one that breeds medication errors and creates missed opportunities to prevent potentially deadly mistakes. Instead, CVS District Leader Khalil Haidar turned up the heat. He harped on his Texas-and-Louisiana-based team to hit corporate quotas: Sell more store memberships. Push for more prescription pickups. Vaccinate more people. He threatened discipline and staff cuts unless pharmacists convinced at least five customers that week to get a flu shot before flu season had even officially started. <Read More>

Twelve Habits That Confident Pharmacists Avoid – October 26, 2023 – Confident pharmacists often possess a set of habits that contribute to their professionalism and effectiveness in their roles. Conversely, they also avoid certain habits or behaviors that could undermine their confidence and the quality of their work. Confident pharmacists tend to avoid:  1) Guessing or Speculating: Confident pharmacists avoid making assumptions or guesses when providing information or advice to patients. They rely on their knowledge and consult references when necessary, 2) Ignoring Continuing Education: Confident pharmacists understand that the field of pharmacy is constantly evolving. They stay updated with the latest research, medications, and guidelines by regularly attending seminars, workshops, and continuing education programs… <Read More>

Meeting the Challenges in Behavioral Health Care With Hybrid Pharmacy Approach – October 26, 2023 – The hybrid pharmacy model represents a significant step forward in providing the best possible care for individuals struggling with behavioral health conditions, ultimately improving their outcomes and overall well-being. The behavioral health industry is confronted with a multitude of hurdles that make it difficult to effectively respond to the escalating demand for services. From limited access to specialized pharmacies to staffing shortages and the critical issue of substance abuse, these challenges underscore the need for innovative solutions to improve the quality and accessibility of behavioral health services. <Read More>

Importance of Patient Navigation in Specialty Pharmacy – October 25, 2023 – A recent survey found that just 4% of Americans can correctly define the 4 terms that determine their yearly personal expenditure for services under their health plan: deductible, co-pay, coinsurance, and out of pocket maximum. This high health plan illiteracy may explain why approximately 60% of insured adults reported problems using their health care coverage in 2023. Moreover, nearly half of those who experienced issues reported they were never able to resolve the problem to their satisfaction. These are nonclinical, system-related barriers to care, and they have a significant impact on patient outcomes. Recent research indicates that financial, relational, social, and environmental factors influence up to 80% of health outcomes. <Read More>

340B in the News

The Exploited 340B Program is the Real Horror This Halloween | Guest Commentary – October 31, 2023 – There is no need to seek out ghosts, goblins, and ghouls for a fright this Halloween. Just look at the devilish 340B drug discount program. Congress created it in 1992 to fix a problem it had created two years earlier when an overreaching government implemented price controls in the Medicaid drug benefit program…The 340B program is a nightmare for taxpayers and patients. Congress should reform the program to comply with its original intent. There is no clear definition of a patient who should be considered an uninsured, low-income individual who does not qualify for Medicare or Medicaid. Duplicate discounting must be addressed with increased oversight. Improved reporting requirements would also help ensure patients are benefiting from the program as intended. <Read More>

HRSA Reinstating 340B Program’s Registration Requirements for Off-Site Hospital Facilities –October 27, 2023 – The federal government is rolling back a pandemic-era waiver that lowered the bar for 340B hospitals to dispense discounted drugs across additional outpatient sites, a decision hospitals said will “stifle” future efforts to expand access to underserved communities. In a notice published Friday in the Federal Register, the Health Resources and Services Administration (HRSA) announced that it would be ending the waiver implemented in June 2020 so that it may “more effectively administer the [340B] program and support program integrity efforts.” That waiver had removed the requirement that safety-net hospitals participating in the program list a new offsite location on a hospital’s most recent Medicare Cost Report and register it in the 340B Office of Pharmacy Affairs Information System (OPAIS) to qualify for discounted drugs. <Read More>

New Study Tracks the Number of Pharmacies Participating in 340B Drug Pricing Program – October 26, 2023 – For more than 30 years, section 340B of the Public Health Service Act has required drug manufacturers to sell outpatient drugs at discounted prices to certain safety-net hospitals and health care organizations that serve uninsured or low-income patients. 340B-eligible health care providers (called “covered entities”) contract with pharmacies to dispense the discounted drugs — a mutually beneficial relationship that increases revenue for providers and pharmacies. Today, about 40% of retail pharmacies across the country have at least one contract with a 340B-eligible health care provider. A new study from the University of Minnesota School of Public Health (SPH) examines recent trends in the relationship between pharmacies and 340B-eligible covered entities (CEs). The study takes an in-depth look at pharmacies’ relationship with health care providers by developing new measures to describe alternative forms of contract pharmacy growth beyond simple participation rates. <Read More>