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Clinical Insights: November 15, 2023

Posted on November 15, 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

Ixchiq® (chikungunya vaccine, live) Injection – New Vaccine Approval – November 9, 2023 – The U.S. Food and Drug Administration approved Ixchiq®, the first chikungunya vaccine. Ixchiq® is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. <Read More>

Adzynma™ (ADAMTS13, recombinant-krhn) – New Drug Approval – November 9, 2023 – The U.S. Food and Drug Administration approved Adzynma™, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder. The very rare, inherited blood clotting disorder called cTTP is caused by a disease-causing mutation in the ADAMTS13 gene, which is responsible for making an enzyme, also named ADAMTS13, that regulates blood clotting. <Read More>

Zepbound™ (tirzepatide) Injection – New Drug Approval – November 8, 2023 – The U.S. Food and Drug Administration approved Zepbound™ (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, type 2 diabetes or high cholesterol) for use, in addition to a reduced calorie diet and increased physical activity. Tirzepatide, the active ingredient in Zepbound™, is already approved under the trade name Mounjaro™ to be used along with diet and exercise to help improve blood sugar (glucose) in adults with type 2 diabetes mellitus. <Read More>

Fruzaqla™ (fruquintinib) Capsules – New Drug Approval – November 8, 2023 – The Food and Drug Administration approved fruquintinib (Fruzaqla™, Takeda Pharmaceuticals, Inc.) for adult patients with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. Efficacy was evaluated in FRESCO-2 (NCT04322539) and FRESCO (NCT02314819).  FRESCO-2 (NCT04322539), an international, multicenter, randomized, double-blind, placebo-controlled trial, evaluated 691 patients with mCRC who had disease progression during or after prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, an anti-VEGF biological therapy an anti-EGFR biological therapy if RAS wild type, and at least one of trifluridine/tipiracil or regorafenib. <Read More>  

New Indication/Dosage/Formulation Approval

No new update.

New Drug Shortage

November 09, 2023

November 08, 2023

Updated Drug Shortage

November 14, 2023

November 13, 2023

November 09, 2023

November 08, 2023

November 07, 2023

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

More Than One in Three Americans are at Increased Risk for Type 2 Diabetes, but Changing the Outcome is Possible – November 14, 2023 – More than 1 in 3 adults – about 98 million Americans — has prediabetes, and 81% of them don’t know they have it. CDC and the Ad Council are launching new public service announcements (PSAs) as part of the ongoing “Do I Have Prediabetes?” initiative to encourage people to learn their risk of prediabetes. The new “Be Your Own Hero” PSAs, developed by creative agency Subject Matter+Kivvit, encourages viewers to take the 1-minute prediabetes risk test so they can take steps to delay or prevent type 2 diabetes. If someone receives a high-risk score, the campaign provides additional resources and encourages them to speak with their doctor about getting a blood test to confirm a diagnosis of prediabetes. <Read More>

Biden’s Limit on Drug Industry Middlemen Backfires, Pharmacists Say – November 14, 2023 – The Biden administration’s first major step toward imposing limits on the pharmacy benefit managers who act as the drug industry’s price negotiators is backfiring, pharmacists say. Instead, it’s adding to the woes of the independent drugstores it was partly designed to help. The so-called PBMs have long clawed back a fee from pharmacies weeks or months after they dispense a drug. A new rule, which governs Medicare’s drug program, is set to take effect Jan. 1 and requires PBMs to take most of their “performance fees” at the time prescriptions are filled. The clawbacks have ballooned from about $9 million in 2010 to $12.6 billion in 2021, according to the Medicare Payment Advisory Commission, an agency created to advise Congress on the program for people who are 65 and older or have disabilities. <Read More> 

A Shortage of Hospital Pharmacists is on the Horizon, Leaders Say – November 10, 2023 – As applications for pharmacy schools and residency programs wither, hospital pharmacy leaders are warily preparing for a shortage of clinical pharmacists. Hospitals have struggled to employ enough pharmacy technicians for years, but increasingly, acute clinical pharmacists and ambulatory pharmacists are becoming harder to come by, according to a McKinsey survey of 80 health system pharmacy leaders. In April, 81% of survey respondents reported understaffing of pharmacy techs, 41% indicated a shortage of acute clinical pharmacists, and 34% said they were short on ambulatory clinical pharmacists and acute pharmacists. “There is already a technician shortage for the last 10, 15 years. Now, to add a pharmacist shortage, it’s really going to cause some pain,” Nilesh Desai, chief pharmacy officer of Baptist Health System in Louisville, Ky., told Becker’s. <Read More>

Pharmacists Grapple With Questions, Confusion Around Abortion Access – November 9, 2023 – Pharmacists should consult state boards of pharmacy and local, state, or national associations to understand how regulations apply to them. Abortion has been a major topic of discussion among health care providers and the general public in recent years, particularly following the June 2022 US Supreme Court decision in Dobbs v Jackson Women’s Health Organization, which upended decades of precedent holding that there was a constitutional right to abortion in the United States. The decision led to a multitude of questions, including legal debates around access to drugs commonly used in medication abortion, access to contraception, and unintended consequences for women’s health. <Read More> 

Five Growth Areas for Health System Pharmacy Leaders: McKinsey – November 9, 2023 – Hospital and health system pharmacy leaders might be missing out on big-picture goals in “emerging frontiers” as they extinguish long-standing issues, such as rising healthcare costs and a pharmacy technician shortage, according to an Oct. 7 article from McKinsey. The consulting agency surveyed 80 health system pharmacy leaders in 2021 and 2023 to conclude which five areas hospital pharmacy leaders should focus on:  1) Inflation – Most hospital pharmacy leaders are planning for a 4% to 6% increase in inflation in the next 12 months. Compared to a 2021 survey, there was an uptick in executives predicting inflation growing more than 7% in a 2023 survey. With this financial pressure in mind, survey respondents said they plan to lower costs through a higher utilization of generics and biosimilars, and reducing drug waste. Another goal is formulary management, but pharmacy executives are struggling to gain buy-in from service line leaders and physicians. A strong management of formularies, such as instituting one pharmacy committee that manages drug purchases in each service line, can help health system pharmacies save 5% to 10% of total drug spend, McKinsey said… <Read More>

340B in the News

Six Recent Hospital Lawsuits, Settlements – November 13, 2023 – From a jury awarding $261 million to a family that sued a Johns Hopkins hospital in a case made famous by a Netflix documentary, to Rady Children’s facing a lawsuit alleging it secretly recorded a patient and her family, here are six hospital lawsuits, settlements and legal developments Becker’s has reported since Nov. 7:  1) A jury awarded an additional $50 million to a family that sued a Johns Hopkins children’s hospital in a case made famous by a Netflix documentary, bringing the total damages to $261 million, 2) A group of health systems from across the country is seeking to block the Health Resources and Services Administration from reinstating a registration policy for offsite clinics of 340B-eligible hospitals they allege will cost billions if left unchecked… <Read More>

Health Systems Sue Over 340B Policy Reversal – November 13, 2023 – A group of health systems from across the country is seeking to block the Health Resources and Services Administration from reinstating a registration policy for offsite clinics of 340B-eligible hospitals they allege will cost billions if left unchecked. The HRSA notice filed in late October states that offsite, outpatient facilities must be listed as reimbursable on the hospital’s Medicare cost report prior to participating in the 340B program. It also states that they must be registered and listed in the 340B Office of Pharmacy Affairs Information System prior to participation. The policy was waived during the COVID-19 public health emergency. <Read More> 

‘Stunning’ Court Ruling Broadens Hospitals’ 340B Use, Calls HRSA’s Enforcement Authority Into Question – November 7, 2023 – A recent federal district court ruling against the office overseeing the 340B Drug Pricing Program has opened the doors for hospitals to more broadly claim discounts, healthcare legal experts say. The decision in Genesis Healthcare, Inc. v. Becerra, handed down Friday by the U.S. District Court of South Carolina, establishes that “at least some of [the] interpretative policies surrounding the 340B definition of patient are inconsistent with the 340B statute,” Anil Shankar, a partner at Foley & Lardner, told Fierce Healthcare. “This is a stunning decision that will have the attention of every 340B stakeholder,” he said. “… This creates new opportunities for 340B-covered entities to purchase 340B for their patients and suggests that [the Health Resources and Services Administration’s (HRSA’s)] audit processes will need to change.” <Read More>