Clinical Insights: October 5, 2021

    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

    No new update.

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Tecartus® (brexucabtagene autoleucel) Suspension for Intravenous Infusion – New Approved Indication – October 1, 2021 – Kite, a Gilead Company announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Following FDA Breakthrough Therapy Designation and a priority review, Tecartus® is the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (18 years and older) with ALL. There is a high unmet need, as half of this patient population will relapse, and median overall survival (OS) is only approximately eight months with current standard-of-care treatments. Patients can access Tecartus® through 109 authorized treatment centers across the U.S. <Read More>

    New/Updated Drug Shortage

    October 01, 2021

    September 30, 2021

    September 29, 2021

    September 28, 2021

    New Drug Recall and Safety Alerts

    Lotrimin® and Tinactin® Spray Products by Bayer – New Voluntary Recall – October 1, 2021 – Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers. <Read More> 

    Pure & Simple SPF 50 Spray (2021 Launch), Sport Mineral SPF 50 Spray (2021 Launch), and Travel-Size Coppertone® Sport Spray SPF 50 (1.6OZ) Aerosols Sunscreen Sprays by Coppertone® – New Voluntary Recall – September 30, 2021 – Coppertone®, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level.  Coppertone® has identified the presence of benzene in these lots of products. Twelve lots of Coppertone® spray products are impacted by this voluntary recall. <Read More>

    New Generic/Biosimilar Approval and Launch

    Chantix® (varenicline) – New Generic Launch – September 22, 2021 – Endo International plc announced that one of its operating companies, Par Pharmaceutical, Inc. (Par), has begun shipping the generic version of Pfizer’s Chantix® (varenicline), 0.5 mg and 1 mg tablets, following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Par’s varenicline is the first and currently the only available FDA-approved generic version of Chantix® in the U.S. “This important approval brings the first Chantix® generic to the U.S. market,” said Jon Holden, Senior Vice President and General Manager, Generics at Endo. “As a reliable, quality supplier, Par is proud to help people during this critical time while also expanding our product portfolio.” <Read More>

    Clinical and Pharmacy News

    NCCN® Meeting on Blood Cancers Empowers Interprofessional Care Teams – October 4, 2021 – The National Comprehensive Cancer Network® (NCCN®) will conduct a three-day, live virtual congress October 14-16, 2021 addressing the latest in therapeutic advances, updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), and treatment debates across the broad spectrum of blood cancers. Incorporating interactive polling and moderator-facilitated Q&A sessions, the NCCN Virtual Congress: Hematologic Malignancies™ is designed to meet the needs of the full interprofessional care team, including physicians, nurse practitioners, nurses, physician assistants, pharmacists, and other health care professionals who manage the care of patients with hematologic malignancies. <Read More> 

    Not so Different: How One Practice is Addressing Biosimilar Concerns Over Savings, Safety, and Efficacy – October 3, 2021 – Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, talks about the savings that biosimilars have led to within his practice and how he tackles patient and physician concerns over whether biosimilars work just as well as reference products. In the United States, biosimilar uptake has been slow, largely owing to 2 major concerns: that discounts for biosimilars are not substantial enough yet to contribute to significant savings and that physicians and patients are not fully convinced that biosimilars are as safe and effective as their reference product counterparts. Although there have been plenty of clinical studies and analyses to support the savings potential and comparative safety and efficacy of biosimilars, many are still looking for real world evidence. <Read More>

    How PBM “Rebate Walls” Impact Drug Spending, Patient Care and Competition – October 1, 2021 – This article examines pharmacy benefit manager (PBM) “rebate walls” and the impact on the United States drug supply chain.  The Federal Trade Commission head, Commissioner Rohit Chopra, recently issued a report on PBM rebate walls, and this can be seen as a pivotal industry moment.  Federal agencies and plan sponsors—the clients of PBMs—are beginning to explore perverse PBM incentives and are waking up to abusive PBM practices.  One of the Commissioner’s important is that “PBMs are incentivized to select higher list price drugs instead of lower list price drugs for their formularies in order to collect a higher rebate… Because rebating practices from drug companies to PBMs can make it more difficult for new, lower-priced drugs to succeed in the market place, PBMs may actually be causing drug prices to increase, rather than decrease.”  This so called “rebate wall” is, among other things, driving up drug spending and hindering patients’ access to their medications. <Read More> 

    WHO Prioritizes Access to Diabetes and Cancer Treatments in New Essential Medicines Lists – October 1, 2021 – WHO published the new edition of its Model Lists of Essential Medicines and Essential Medicines for Children, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials to treat serious bacterial and fungal infections. The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all. However, high prices for both new, patented medicines and older medicines, like insulin, continue to keep some essential medicines out of reach for many patients. <Read More>

    US House Approves Bill to Take on Biosimilar ‘Patent Dance’ – October 1, 2021 – The bill aims to reduce US drug prices and could limit IP strategies undertaken by reference biologic makers to ward off biosimilar competition. Having been first introduce to the House in April, H R 2884 was approved by the House Judiciary Committee yesterday as part of four bills aimed at tackling the high prices of drugs in the US. According to the text, the bill “limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug,” effectively helping to resolve patent infringement claims made by reference biologic makers against their biosimilar maker counterparts. <Read More>

    Uniting Clinical Teams Around Pharmacogenomics to Advance Patient Care – October 1, 2021 – Prescribers, pharmacists, nurses, lab technicians, and other health care professionals must work as a team to create awareness and understanding of pharmacogenomics integration. Serious adverse drug reactions (ADRs) are the sixth leading cause of death across the globe and the fourth leading cause in North America. Additionally, the historical efficacy rates of drug therapy for many common conditions are only 40% to 60%. Pharmacogenomics (PGx) has the potential to address these and other medication related concerns by improving the precision of drug therapy. Understanding PGx is essential for optimizing drug and dose selection and for reducing avoidable adverse reactions. <Read More>

    American Urological Association Announces New Journal – October 1, 2021 – The American Urological Association — the world’s leading professional association for the advancement of urologic patient care — is pleased to announce in early 2023, will be launching a new journal – (JU The Journal of Urology® Open Plus Open Plus). A fully open access journal, JU Open Plus will become a part of the AUA’s world-class family of journals. With an editorial goal to publish the best in class, not only in urology, but across scientific, technical and medical journals as a whole, JU Open Plus aims to serve the global urology community, as well as the broader medical research community, by making research findings and breakthrough discoveries more accessible to potential users throughout the world. JU Open Plus will stand as an international, peer-reviewed, open access online journal focused on high-quality research in all areas of urology. <Read More>

    Pharmacy Chains Face First Trial in U.S. Opioid Litigation, Judge Urges Settlement – October 1, 2021 – Four large pharmacy chains are set to face their first trial over the deadly U.S. opioid epidemic, creating new pressure to reach settlements with state and local governments who accuse them of contributing to the public health crisis. The Ohio counties of Lake and Trumbull allege that oversight failures at pharmacies run by Walgreens Boots Alliance Inc, CVS Health Corp, Walmart Inc and Giant Eagle Inc led to excessive amounts of opioid pills in their communities. <Read More>

    NCCN Publishes New Guide to Improving Knowledge and Quality of Life for Small Cell Lung Cancer Patients – September 30, 2021 – The National Comprehensive Cancer Network® (NCCN®) announced the publication of new NCCN Guidelines for Patients®: Small Cell Lung Cancer ( SCLC ), which is a neuroendocrine tumor type of lung cancer that is linked to smoking and tends to be aggressive. However, it is important to understand management options and ways to mitigate symptoms of the cancer and/or therapy. This guide is intended to empower patients and caregivers with the same expert treatment information as their doctors. It is free to view or download at NCCN.org/patientguidelines  and is funded by NCCN Foundation®. <Read More> 

    Pharmacists Play a Vital Role in Generic Drug Product Selection – September 30, 2021 – Approximately 9 out of 10 prescriptions in the United States are for generic drugs. The FDA Drug Competition Action Plan encourages market competition for these products and helps to remove barriers to generic drug development so that patients can access these affordable medications. Typically, generic drugs cost approximately 85% less than brand-name products. Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book, serves as the gold standard reference for generic drug substitution and is available as a free resource electronically and through a mobile app (Orange Book Express). <Read More>

    Tip of the Week: Professional Sabbatical Leave Could Help Alleviate Burnout – September 30, 2021 – Although it may not be feasible in all situations, professional sabbatical leave could be a win-win for both pharmacists and their employers. Despite the many opportunities and increasingly diverse career paths for pharmacists, burnout is a widespread issue. It can result in unhappiness, poorer patient care, and a lack of new and innovative ideas for how the pharmacy care process might be improved. The professional sabbatical is a concept we ordinarily think of for academic professors, but it is a potentially viable win-win for pharmacists and their employers. <Read More>

    Alerting Pharmacies About Cancelled Medications Can Prevent Errors – September 30, 2021 – Failing to inform pharmacies that a prescription medication has been discontinued could lead to significant safety issues, according to new data presented at ACC Quality Summit Virtual. In the study, researchers investigated why pharmacy communication on cancelled drugs was not always occurring and looked for new ways for pharmacy staff to find out about canceled medications. “Currently there is no ideal way to notify a pharmacy that a clinician has discontinued medication for a patient, often leading to a discontinued medication or incorrect dose to be refilled and causing confusion for the patient,” co-author Jeffrey A. Goss, FNP-c, MSN, a specialist at Intermountain Healthcare in Murray, Utah, said in a news release from the American College of Cardiology. “Patients are at risk for taking a medication that is no longer indicated or at the wrong dose, which has important medication safety indications.” <Read More>

    Youth E-cigarette Use Remains Serious Public Health Concern Amid COVID-19 Pandemic – September 30, 2021 – A study released from the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) estimated that more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021, with more than 8 in 10 of those youth using flavored e-cigarettes. The report, published in the Morbidity and Mortality Weekly Report, was based on data from the 2021 National Youth Tobacco Survey (NYTS), a cross-sectional, self-administered survey of U.S. middle (grades 6–8) and high (grades 9–12) school students. The study assessed current (used on one or more of the past 30 days) e-cigarette use; frequency of use; and use by device type, flavors and usual brand. <Read More>

    Amber Specialty Pharmacy and Hy-Vee Pharmacy Solutions to Expand Support of Lilly’s Monoclonal Antibody Treatment for COVID-19 – September 30, 2021 – Amber Specialty Pharmacy and Hy-Vee Pharmacy Solutions announce their available services for the infused medications bamlanivimab and etesevimab, also known as BAM. When combined, bamlanivimab and etesevimab is a monoclonal antibody treatment authorized by the FDA for emergency use for the treatment of mild to moderate COVID-19 in certain patients. Eligible patients include adults and adolescents (12 years of age or older who weigh at least 88 pounds), and who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization. Amber Specialty Pharmacy and Hy-Vee Pharmacy Solutions were part of the original pilot program through a partnership with the U.S. Department of Health and Human Services (HHS) and the National Home Infusion Association (NHIA). <Read More>

    FDA Schedules Public Meeting and Request for Comments on Biosimilar User Fee Act – September 29, 2021 – Last week, FDA issued a notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the Biosimilar User Fee Act (“BsUFA”) for fiscal years 2023 to 2027.  We have previously reported on BsUFA rates for the 2022 fiscal year.  The BsUFA authorizes FDA to collect user fees to support the review of biosimilar biological product applications. According to FDA, “the BsUFA is intended to provide additional revenues so that FDA can hire staff, improve systems, and continue a well-managed biosimilar biological product review process.”  The current legislative authority for BsUFA expires in September 2022, and without new legislation, FDA would no longer be able to collect user fees. <Read More>

    CDC Statement on Pregnancy Health Advisory – September 29, 2021 – The CDC issued an urgent health advisory to increase COVID-19 vaccination among people who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who might become pregnant in the future to prevent serious illness, deaths, and adverse pregnancy outcomes. The CDC health advisory strongly recommends COVID-19 vaccination either before or during pregnancy because the benefits of vaccination for both pregnant persons and their fetus or infant outweigh known or potential risks. Additionally, the advisory calls on health departments and clinicians to educate pregnant people on the benefits of vaccination and the safety of recommended vaccines. <Read More>

    Gilead, Bristol Myers Face Lawsuit From Major Pharmacies Over HIV Generic Drug Delays – September 29, 2021 – Major pharmacy chains CVS and Rite Aid recently sued Gilead Sciences, Teva and Bristol Myers Squibb, claiming the pharma companies deliberately stalled the introduction of cheaper generic versions of several blockbuster HIV drugs. The suit specifically goes after billions of dollars’ worth of reverse-payment agreements between the pharma companies that withheld from the market generic versions of HIV drugs Viread™, Atripla®, Truvada® and Evotaz®. “From 2004 to 2017, Gilead made tens of billions of dollars from HIV medications while introducing only a single new pharmaceutical compound,” the suit alleges. <Read More>

    Rehospitalization for CDI Common; Appropriate Patient Follow-up Often Lacking – September 29, 2021 – Recurrent Clostridioides difficile infection (rCDI) is common, yet few patients have confirmed CDI-specific follow-up appointments after hospital discharge, according to a presentation at the IDWeek 2021 virtual conference. The researchers also found that nearly 50% of patients with rCDI had to be rehospitalized due to their infection. “CDI is notorious for causing recurrent illness and potentially resulting in rehospitalization,” said lead author Emily Drwiega, PharmD, a second-year infectious diseases pharmacy fellow at the University of Illinois at Chicago. <Read More>

    The Value of a Hub in a Limited Distribution Specialty Pharmacy Network – September 29, 2021 – Although specialty pharmacies may be able to offer some of the services that a hub provider does, a hub can standardize patient and provider support across the network. “What is a hub?” “What does a hub do?” “Why is a hub needed?” “Why would a manufacturer select a hub as part of their network?” I find myself answering these questions often. For a non-industry native, I find it hard to provide a succinct answer. Fundamentally, a hub provider serves as an extension to the drug manufacturer and administers their branded support programs. In many instances, a hub proves to be extremely valuable in a network because it can provide unique program services. These services aim to enhance coordination of care, patient access, financial support, and patient and prescriber engagement. <Read More>

    Biden-Harris Administration Provides Nearly $1 Billion in American Rescue Plan Funds to Modernize Health Centers and Support Underserved Communities – September 28, 2021 – The U.S. Department of Health and Human Services (HHS) awarded nearly $1 billion in American Rescue Plan funding to nearly 1,300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects. These awards will strengthen our primary health care infrastructure and advance health equity and health outcomes in medically underserved communities, including through projects that support COVID-19 testing, treatment, and vaccination. The awards were made through the Health Resources and Services Administration. <Read More> 

    NIAID Issues New Awards to Fund “Pan-Coronavirus” Vaccines – September 28, 2021 – The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $36.3 million to three academic institutions to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants. The awards are intended to fuel vaccine research for a diverse family of coronaviruses, with a primary focus on potential pandemic-causing coronaviruses, such as SARS-CoV-2. “The available COVID-19 vaccines have proven to be remarkably effective at protecting against severe disease and death,” said NIAID Director Anthony S. Fauci, M.D. “These new awards are designed to look ahead and prepare for the next generation of coronaviruses with pandemic potential.” <Read More>

    What to Know About ‘Rebound Migraine’ – September 28, 2021 – Doctors no longer use the term rebound headaches or rebound migraine. Instead, they use the term medication overuse headache (MOH). Other terms that people may use to describe this condition include drug-induced headache and medication misuse headache. Rebound migraine is an outdated term for what healthcare professionals now refer to as MOH. MOH occurs when a person takes too much acute migraine medication too often, and a severe cycle of headaches starts. However, what constitutes overuse of a medication can vary from person to person and be partially based on the exact medication the person takes for their pain. <Read More>

    PBM Regulatory Landscape Roundup (Summer 2021): A Flurry of Regulations, Rutledge, and a Crucial 8th Circuit Decision – September 28, 2021 – As our colleagues predicted, the Supreme Court’s decision in Rutledge v. Pharmaceutical Care Management Association (PCMA) encouraged state efforts to expand regulation of pharmacy benefit managers (PBM) and related practices. And as expected, this year has already seen an aggressive round of state legislation that aims to expand regulation in this area. As a quick recap, in Rutledge, the Supreme Court held that the Employee Retirement Income Security Act of 1974 (ERISA) did not preempt an Arkansas statute regulating reimbursement levels paid by PBMs to pharmacies. <Read More>

    Tapering Opioids May Drive Overdose, Mental Health Crises – September 28, 2021 – Tapering of opioids was significantly associated with increased risk of overdose and mental health crisis in patients prescribed long-term, stable, higher-dose therapy, based on data from a retrospective study of more than 100,000 adults aged 18 years and older. Although CDC guidelines and other organizations have advised tapering doses of opioids in patients on long-term therapy, studies suggesting increased risk of suicidal ideation, overdose, and transition to illicit opioids prompted the FDA to issue a prescriber warning on the potential hazards of rapid tapering, wrote Alicia Agnoli, MD, of the University of California, Davis, Sacramento, and colleagues. <Read More>

    Genoa Healthcare Opens 600th Pharmacy Serving Community Mental Health Needs – September 28, 2021 – Genoa Healthcare, the leading provider of pharmacy services for people with mental illness, substance use disorders, and other complex, chronic conditions, has opened its 600th pharmacy amid a growing need for mental health and addiction services during the COVID-19 pandemic. The new pharmacy is located on site at Southwest Network’s San Tan clinic, in Chandler, Arizona. In partnership with community mental health clinics, Genoa provides pharmacy services to individuals in the same facility in which they receive their care, making it easier to obtain needed medications and leading to improved health outcomes. This approach to pharmacy care helps people stay on their medications at a rate of more than 90%, compared to 50% or less when retrieved through retail pharmacies. <Read More>

    Biosimilars Gain Traction with Regulators, Manufacturers – September 27, 2021 – The stars finally may be aligned for Americans to gain greater access to alternative biotech therapies in the coming months. FDA recently approved important new biosimilars for market, updated guidance on follow-on development, and reached agreement with industry on an agenda for advancing biosimilar testing and production over the next five years. Of note will be access to first biosimilar to treat macular degeneration, providing an important alternative for patients experiencing serious vision impairment from this and related eye diseases. That advance follows FDA authorization in July of the first interchangeable biologic, a new treatment for diabetes that can be substituted for widely used Lantus® insulin glargine. <Read More> 

    LTC Pharmacies Want Better Clarity as Booster Shot Rollout Begins – September 27, 2021 – After receiving a thumbs up from both the Food and Drug Administration and Centers for Disease Control and Prevention earlier this month, the work now begins for long-term care pharmacies to administer COVID-19 booster shots for nursing home residents and staff… Amber Rogotzke, president at Health Dimensions Group, said that vaccine distribution has been “cumbersome” at times with the additional paperwork, training and staff hours that’s been needed and was pleased to see that “co-administration” was available this time around. <Read More> 

    Orsini Specialty Pharmacy Selected by Sanofi as a Limited Distribution Partner for Nexviazyme®September 27, 2021 – Orsini Specialty Pharmacy, the leading independent specialty pharmacy focused on rare diseases and gene therapies, announced that Sanofi has selected it as a limited distribution partner for Nexviazyme® (avalglucosidase alfa-ngpt). Nexviazyme®, an enzyme replacement therapy (ERT), is used for treating patients one year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). This progressive and debilitating muscle disorder impairs a person’s ability to move and breathe. <Read More> 

    Pharmacy Owner Pleads Guilty to Federal Charge Involving the Vaccination of Minors Under 12 with the Pfizer-BioNTech Covid-19 Vaccine – September 27, 2021 – Liz Ann Banchs, the owner and president of Farmacia Gabriela, Inc. was charged and pleaded guilty on September  24, 2021 to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 with the Pfizer-BioNTech COVID-19 vaccine. The announcement was made by W. Stephen Muldrow, United States Attorney for the District of Puerto Rico and Scott Lampert, Special Agent in Charge for the United States Department of Health and Human Services, Office of Inspector General (HHS-OIG), New York Regional Office. <Read More>

    340B in the News

    PhRMA Sues Arkansas Over Law Requiring Companies to Offer Products to 340B Contract Pharmacies – September 30, 2021 – A top pharma lobbying group sued to strike down an Arkansas law that requires drugmakers to provide pharmaceuticals discounted under 340B to contract pharmacies. The lawsuit, filed Wednesday by the Pharmaceutical Research and Manufacturers of America (PhRMA), comes as six drugmakers have restricted sales of 340B products to contract pharmacies, which has prompted a legal clash with the federal government. PhRMA’s lawsuit, filed in the U.S. District Court for the Eastern District of Arkansas, wants the court to find a law passed by the state in May 2021 unconstitutional. In the 340B program, drugmakers agree to offer discounts to safety net providers in exchange for participation in Medicare and Medicaid. Drugmakers must provide the discounted products to 15 types of covered entities, which can include hospitals and community health centers. <Read More>

    AAMC Joins Letter Supporting the 340B Program – September 27, 2021 – The AAMC joined group letters on Sept. 24 with five other hospital associations to House and Senate leadership, House Energy and Commerce and Ways and Means Committee leadership, and Senate Finance and Health, Education, Labor and Pensions Committee leadership, expressing support for the 340B drug pricing program and urging that policies that would negatively impact the program not be included in the budget reconciliation package. The letters note, “As you consider policies to curb the growth in drug prices, it is important to remember that 340B has been proven to be a mechanism to constrain drug price increases. A recent study published in the Journal of the American Medical Association found that 340B has helped to slow the growth in drug prices for all drugs, including those purchased outside of the 340B program.” <Read More>