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Clinical Insights: December 7, 2021

Posted on December 7, 2021 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 Approval

PreHevbrio™ (hepatitis B vaccine (recombinant)) Injection – New Vaccine Approval – November 30, 2021 – VBI Vaccines Inc., a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, announced that the U.S. Food and Drug Administration (FDA) has approved PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults aged 18 years and older. PreHevbrio™ contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S. <Read More>

New Indication/Dosage/Formulation Approval

Rituxan® (rituximab) – New Expanded Indication – December 3, 2021 – The Food and Drug Administration approved rituximab (Rituxan® , Genentech, Inc.) in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). <Read More>

Darzalex Faspro™, Kyprolis® , and Dexamethasone – New Expanded Indication – December 1, 2021 – The Food and Drug Administration approved daratumumab + hyaluronidase-fihj (Darzalex Faspro™, Janssen Biotech, Inc.) and carfilzomib (Kyprolis® , Amgen, Inc.) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Efficacy was evaluated in a single-arm cohort of PLEIADES (NCT03412565), a multi-cohort, open-label trial. <Read More>

New/Updated Drug Shortage

December 03, 2021

December 02, 2021

December 01, 2021

New Drug Recall and Safety Alerts

Enoxaparin Sodium Injection, USP 40mg/0.4 mL by Sandoz, Inc. – New Voluntary Drug Recall – December 1, 2021 – Sandoz Inc. is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injection Lot SAB06761A was shipped to customers in the months of September and October 2021. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Pharmacy Leaders Can Design Effective Work From Home Programs – December 5, 2021 – A case study from investigators at Emory University Hospital examining the efficacy of long-term work from home (WFH) programs, presented at ASHP Midyear 2021, found that pharmacy leaders can be equipped to make effective decisions to support a successful work experience, regardless of work setting. The investigators said that guides to managing remote teams using collaboration technology such as Zoom, maintaining a safe work environment, and managing any safety concerns can be successfully provided by managers in the process of implementing future WFH programs. <Read More>

Ire Over Pharmacy Middlemen Fuels Lobbying Blitz – December 4, 2021 – Lobbyists for drugmakers, pharmacists and large employers are blanketing Congress with calls, emails and advertisements, pressing lawmakers to rein in pharmaceutical middlemen, who they say are behind soaring drug costs. The effort to paint pharmacy benefit managers as villains has sparked a multimillion-dollar campaign to influence Democrats, who are racing to finish their massive social spending bill and eager to show they are taking on the powerful drug industry and lowering out-of-pocket costs for Americans. <Read More>

Frazzled Workers, Temporary Closures: How Staff Shortages and Vaccine Demand are Squeezing US Pharmacies – December 4, 2021 – A rush of vaccine-seeking customers and staff shortages are squeezing drugstores around the U.S., leading to frazzled workers and temporary pharmacy closures. Drugstores are normally busy this time of year with flu shots and other vaccines, but now pharmacists are doling out a growing number of COVID-19 shots and giving coronavirus tests. The push for shots is expected to grow more intense as President Joe Biden urges vaccinated Americans to get booster shots to combat the emerging omicron variant. The White House said Thursday that more than two in three COVID-19 vaccinations are happening at local pharmacies. <Read More>

Industry Trend Report Shows COVID-19 Impact on Pharmacy Claims, Community Pharmacy Access – December 3, 2021 – The 2021 Industry Trend Report in Pharmacy Quality sponsored by Pharmacy Quality Solutions (PQS) focuses on COVID-19’s impact on pharmacy claims and community pharmacy access during 2020. This report tracks prescription trends from the announcement of the COVID-19 public health emergency (PHE) through the remainder of the year and highlights associated mitigation approaches that may have impacted pharmacy and medication utilization patterns. The 3-section report covers changes in pharmacy utilization, patterns of utilization among hypothesized treatments for COVID-19, and medication utilization patterns impacted by COVID-19. <Read More>

Pharmacy Forecast Report Predicts Ongoing COVID-19 Impact in 2022 – December 3, 2021 – Pharmacists will continue to become more involved in patient care, technology, and emergency preparedness next year, according to the 2022 American Society of Health-System Pharmacists (ASHP) and ASHP Foundation Pharmacy Forecast Report, which was released in advance of the ASHP Midyear Clinical Meeting and Exhibition. The report is intended as a strategic planning tool to help pharmacists and practitioners prepare for the upcoming year and how they can best position themselves for success, according to a press release. The new report notes that the experiences of the COVID-19 pandemic may still impact the health care landscape, medication use, and the pharmacy profession over the next 5 years. <Read More>

The Omicron Variant: How Companies Should Respond – December 3, 2021 – The emergence of the Omicron variant of Covid-19 has dimmed hopes that the pandemic will soon fade away and once again has employers pondering how they can fulfill their difficult obligations to keep their workforce safe and to meet their business needs. The good news is that as the virus has evolved, employers have honed their strategies to keep infections in check. By continuing to be creative, flexible, and adaptive in their approaches, they can contain the threat now and handle other outbreaks if other variants arise — a significant possibility given the low levels of vaccinations in many parts of the world, including some areas of the United States. Here are some broad measures they can apply. <Read More>

FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns – December 3, 2021 – The U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes bamlanivimab and etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death. <Read More> 

Practical Considerations for Implementation of Biosimilars in Oncology – December 2, 2021 – The FDA approval of filgrastim-sndz (Zarxio, Sandoz) in March 2015 marked a major milestone in drug development—the first agent approved under the Biologics Price Competition and Innovation Act of 2009.1,2 Since then, 28 more biosimilars have reached the US market.2,3 Although the introduction of additional biosimilars in oncology comes with the hope of significant health care savings, individual institutions are faced with growing challenges related to formulary management. This article focuses on the practical management and uptake of biosimilars in oncology practice, covering factors related to product selection, information technology (IT) integration, and the role of pharmacist in educating providers and patients about these agents. <Read More>

Federal Jury Convicts Pharmacy Owner of Conspiracy, Mail Fraud, and Misbranding for Role in Multi-Million Dollar Telemedicine Pharmacy Fraud Scheme – December 2, 2021 – Following a month-long trial, a federal jury convicted Peter Bolos, 44, of Tampa, Florida, of conspiracy to commit health care fraud, 22 counts of mail fraud, and felony misbranding of a medication.  Sentencing for Bolos has been set for May 19, 2022 at 10:30 am, before the Honorable J. Ronnie Greer, in the United States District Court for the Eastern District of Tennessee at Greeneville. According to court documents and evidence presented at trial, Bolos, Andrew Assad, Michael Palso, Maikel Bolos, Larry Smith, Scott Roix, HealthRight LLC, Mihir Taneja, Arun Kapoor, and Sterling Knight Pharmaceuticals, as well as various other companies owned by them, conspired to defraud pharmacy benefit managers (PBMs), such as Express Scripts and CVS Caremark out of millions of dollars. <Read More>

Omnicell to Acquire ReCept – December 2, 2021 – Omnicell, Inc., a leading provider of medication management solutions and adherence tools for health systems and pharmacies, announced it has entered into a definitive agreement with ReCept Holdings, Inc., a leading provider of specialty pharmacy management services for health systems, clinics, and physician groups, to acquire its business for total aggregate cash consideration of $100 million, subject to customary adjustments. The acquisition will broaden Omnicell’s portfolio of capabilities and services to address the significant need to improve access to and care coordination for complex medications. <Read More>

PBMs’ Profits are Increasing While Their Revenue Sources Remain Unclear, Report Says – December 2, 2021 – Between 2017 and 2019, pharmacy benefit managers’ gross profit increased by 12 percent despite PBM retention of manufacturer rebates decreasing during this period, according to a report released Dec. 2 by the PBM Accountability Project. The report showed that the PBM gross profit increased from $25 billion to $28 billion between 2017 and 2019. It also showed that the sources of these profits changed significantly. During this time, gross profit from administrative fees paid by manufacturers for services provided by PBMs increased 51 percent, from $3.8 billion to $5.7 billion. Gross profit from PBM-owned mail-order and specialty pharmacies increased more than 13 percent, from $8.9 billion to $10.1 billion. <Read More>

Pharma Grapples With Best Price Accumulator ­– December 2, 2021 – The Centers for Medicare & Medicaid Services (CMS) has been busy on the copay front, with several of the agency’s recent decisions affecting how copay programs influence the cost of medications. But three main stakeholders with skin in the game—patients, providers and manufactures—are expressing concern about the unintended consequences of these actions. CMS’s “best price copay” and copay accumulator policies seem to be at the center of the debate, based on sessions at InformaConnect’s 2021 annual Coupon & Copay Conference. <Read More>

High Drug Prices: How We Got Here and How We Achieve Affordability – December 2, 2021 – Affordability in drug pricing can be addressed by bringing the manufacturer and plan sponsor to negotiate costs and determine fair compensation for product and service providers in the supply chain. The current state of the pharmacy system is challenged by rising list prices, the affordability of new brand and specialty products coming to market, and intermediaries whose interests are not always aligned with their clients. The blame lies across a variety of players. The problem is complex, which creates confusion among lawmakers, regulators, and the public, with a resolution to this issue seeming elusive. <Read More>

Effective Communication Can Make or Break Your Business – December 2, 2021 – Good communication is perhaps more important in health care than in any other field. According to the National Healthcareer Association’s (NHA) 2021 Industry Outlook, employers stated effective communication as 1 of the 3 most important soft skills for pharmacy technicians to have. That’s because as a pharmacist, it’s your job to provide the best possible care for your clients. With that comes the need for clear, effective communication between you and your pharmacy technicians. When communication breaks down, it can cause serious patient safety issues. A study of 10 years’ worth of medical errors found that 66% were caused by ineffective team communication. <Read More>

CDC Tightens Testing Requirement for International Travel to the US to One Day – December 2, 2021 – The Centers for Disease Control and Prevention (CDC) is revising the current Global Testing Order to shorten the timeline for required testing for all international air travelers to one day before departure to the United States. This revision strengthens already robust protocols in place for international travel, including requirements for foreign travelers to be fully vaccinated. As we learn more about the Omicron variant, this new one-day testing policy will help to protect travelers and the health and safety of American communities from COVID-19. These Orders put in place a stringent and consistent global international travel policy that is guided by public health. <Read More>

Ten Tips for Adding Quality to Your 503As and 503Bs – December 1, 2021 – ‘What is tested is not sold; what is sold is not tested.” That’s an observation from Ian F. Deveau, PhD, the division director of the FDA’s Center for Drug Evaluation and Research Office of Manufacturing Quality. And it’s why pharmacies that do sterile compounding cannot rely solely or even primarily on testing of their compounded sterile preparations to ensure sterility and potency, said Amy Summers, PharmD, a consultant to the compounding industry, during a session at the 2021 Compounding Pharmacies Grand Salon, held virtually. <Read More>

Social Media Has the Power to Revolutionize the Scope of the Pharmacist’s Impact in Health Care – December 1, 2021 – Social media has revolutionized the way health care professionals and patients interact with each other. It provides powerful tools to allow health care professionals to actively engage with their patients and address common misconceptions about health care news online. With COVID-19 hitting the nation and more individuals connected to their laptop and phone screens than ever before, now is the time for pharmacists to take action and modernize their approach to educating the public through the use of social media. <Read More>

Tip of the Week: Improving Efficiency Benefits Everyone – December 1, 2021 – Although pharmacists may be busy during seemingly every moment of the day, it is important to realize that there are opportunities where time can be saved. Effective time management is a challenge for most people, but it may be particularly difficult for community pharmacists. Pharmacists in the community setting have the added pressure of ensuring patient safety while multitasking between prescription verification, managing staff members, and patient consultations. Burnout, increased workload, and enhanced responsibilities despite the lack of time and resources are issues that face many pharmacists. <Read More>

Changes Coming to TRICARE Network Pharmacies – December 1, 2021 – Changes are coming to TRICARE’s network of retail pharmacies. Beginning Dec. 15, CVS will join the network and Walmart, Sam’s Club, as well as some community pharmacies will leave the TRICARE network. Walgreens will also remain in TRICARE’s retail pharmacy network. These changes will provide nearly 90 percent of beneficiaries with access to a network pharmacy within five miles of their home. <Read More>

Updated ACG Reflux Disease Guidelines: 6 Recommendations for GI Surgeons – November 30, 2021 – The American College of Gastroenterology published an update to the association’s 2013 clinical guidelines on the diagnosis and management of gastroesophageal reflux disease online in The American Journal of Gastroenterology on Nov. 22. Six key recommendations for ASC gastroenterologists: 1) Diagnostic endoscopy is recommended for patients with classic GERD symptoms that do not respond adequately to an eight-week trial of proton pump inhibitors, or whose symptoms return when PPIs are discontinued. Endoscopy should be performed after proton pump inhibitors are stopped for two to four weeks, 2) Endoscopy is recommended as the first test for evaluation of patients presenting with dysphagia or other serious symptoms such as weight loss and gastrointestinal bleeding. It’s also recommended as the first test for evaluation for patients with multiple risk factors for Barrett’s esophagus… <Read More>

Spoken Rx™ “Talking” Prescription Labels Now Available in All CVS Pharmacy Locations – November 30, 2021 – CVS Pharmacy is now offering Spoken Rx™, its proprietary audio prescription label solution, in all its nearly 10,000 pharmacy locations nationwide, including more than 1,700 CVS Pharmacy locations within Target. Developed in collaboration with the American Council of the Blind, Spoken Rx is a technology that allows patients to have their prescription information read aloud, designed for those with visual impairments and those who cannot read standard print labels. It is available at no extra cost to patients. <Read More> 

340B in the News

340B Advocates Urge HHS to Step up Enforcement After Amgen Aims to Cut Off Access to Contract Pharmacies – December 2, 2021 – An advocacy group for covered entities under the 340B program is calling for the federal government to do more to stop drugmakers from cutting off sales of discounted products to contract pharmacies. 340B Health called on the Biden administration to do more after reports that Amgen plans to cut off sales to contract pharmacies early next year. If the change goes through, Amgen would become the 10th drugmaker to install such a restriction. “It is long past time for these unlawful actions to stop,” said Maureen Testoni, president and CEO of 340B Health, which represents more than 1,400 hospitals. “For the companies that the courts have ruled to be in noncompliance with the 340B law, we call on the administration to escalate enforcement actions in line with those decisions.” <Read More>

Amgen Becomes 10th Drugmaker to Restrict 340B Discounts to Safety Net Hospitals – December 2, 2021 – Beginning Jan. 3, Amgen will curtail drug discounts to safety net hospitals’ contract pharmacies under the federal 340B program, Endpoints News reported Dec. 2. Moving forward, the drugmaker will allow 340B hospitals to select only one pharmacy location. This excludes federal grantees as well as contract pharmacies owned entirely by a 340B hospital or that have common ownership with a health system. “The current policy primarily applies to self-administered, pharmacy benefit Amgen products, specifically Repatha® , Enbrel® , Otezla®  and Aimovig® ,” the drugmaker wrote in a letter to hospitals. “The policy does not currently apply to medical benefit products and Amgen does not intend to change that in the future.” <Read More>

New Study Confirms 340B Program is Exploited – December 2, 2021 – A new study released by Xcenda, “340B and Health Equity: A Missed Opportunity in Medically Underserved Areas,” provides further evidence of how the 340B safety-net program is being exploited.  The November 2021 report shows how the program is not being used as intended to help low income and vulnerable individuals get access to low-cost prescription drugs.  Instead, it is boosting hospitals’ coffers and their contract pharmacies’ profits that are largely located in areas that do not serve low-income people. Citizens Against Government Waste (CAGW) has been concerned about the misuse of the 340B drug discount program since 2014 when we wrote, “ The Federal 340B Discount Drug Program Needs Reform.” <Read More>

340B “Saga” Works Its Way Through the Courts: What Manufacturers Need to Know – December 1, 2021 – It’s a dispute lasting years seeking to define the exact contours of the authority of the Health Resources and Services Administration (HRSA) to interpret the 340B Statute concerning (i) participating Covered Entities’ use of “contract pharmacies”, (ii) whether participating drug manufacturers are required to recognize such pharmacies, and (iii) the ability of participating drug manufacturers to place their own administrative conditions on Covered Entity contract pharmacy agents in order to receive drugs at the heavily discounted 340B price on behalf of Covered Entities. However, just like any good saga, there is still much of the story yet to be revealed. <Read More>

Supreme Court Justices Grill HHS in Lawsuit Surrounding Nearly 30% Cut to 340B Payments  – December 1, 2021 – Several Supreme Court justices questioned key parts of the Department of Health and Human Services’ (HHS’) decision to cut Medicare reimbursements to 340B hospitals by nearly 30%. The Supreme Court heard oral arguments Tuesday in American Hospital Association (AHA) vs. Becerra, centering on a 2018 decision to cut outpatient Medicare drug reimbursements to 340B facilities by nearly 30%. AHA and other hospital groups have sued to halt the cuts, and an appellate court sided with HHS that it has the power to make the cuts. HHS has argued the cuts are needed to reimburse those hospitals for the actual acquisition costs of the drugs, but hospital groups sued over the cuts. <Read More>