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Clinical Insights: January 4, 2022

Posted on January 4, 2022 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

Adbry™ (tralokinumab-ldrm) Injection – New Drug Approval – December 27, 2021 – Leo Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Adbry™ (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry™ can be used with or without topical corticosteroids. Adbry™ is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms. <Read More>

New Indication/Dosage/Formulation Approval

Cosentyx® (secukinumab) Injection – New Approved Expanded Indication – December 22, 2021 – Novartis, a leader in rheumatology and immuno-dermatology, announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older. Cosentyx® is now the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx® in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology. <Read More>

New/Updated Drug Shortage

December 28, 2021

December 27, 2021

New Drug Recall and Safety Alerts

Metformin HCl Extended-Release Tablets, USP 750 mg by Viona Pharmaceuticals Inc. – New Voluntary Recall – December 28, 2021 – Viona Pharmaceuticals Inc., is voluntarily recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. Reason for the recall is an out of specification result observed for the said product, Lot number M008132, “N-nitrosodimethylamine (NDMA) (By GC-MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. As a precautionary measure firm voluntarily recall all the marketed 33 batches having valid shelf life. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals Inc. <Read More>   

Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes by Taro Pharmaceuticals U.S.A. – New Voluntary Recall – December 27, 2021 – Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product are impacted. Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing. <Read More> 

Nitroglycerin Lingual Spray by Padagis – New Voluntary Recall – December 27, 2021 – Padagis US LLC announced it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market due to a complaint received that a unit may not dispense. There is a remote risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. This recall applies only to the 12g spray bottle and not the 4.9g spray bottle of this medication. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

FDA Expands Use of Pfizer Vaccine, OKs Boosters for Kids 12-15 – January 3, 2022 – The FDA authorized Pfizer-BioNTech’s COVID-19 booster shots for 12- to 15-year-olds. The agency also shortened the length of time between the completion of a primary vaccination series and receiving a Pfizer booster dose from six months to five months for everyone 12 and older, and authorized a third dose for certain immunocompromised children 5 to 11, such as solid organ transplant recipients. “Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines.” <Read More>

ISMP’s New Best Practices Includes BCMA Tips – January 3, 2022 – The Institute for Safe Medication Practices (ISMP) has introduced three new Targeted Medication Safety Best Practices for 2022-2023, one of which encourages hospitals to expand barcoding and thus limit the risk for errors in medication administration in areas such as the emergency department. “Barcoding prior to medication administration is something that’s widely utilized in hospitals in the United States but less commonly used in outpatient care areas,” said Christina Michalek, RPh, the administrative coordinator of ISMP’s Medication Safety Officers’ Society, who shared the new best practices at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. <Read More>

FDA Allows Marketing of Virtual Reality Device for Chronic Low Back Pain – January 3, 2022 – Pharmacists interested in educating patients and providers about non-pharmacologic options for treating low back pain (LBP) should heed an announcement from the FDA authorizing marketing of the immersive virtual reality (VR) device EaseVRx™ (Applied VRx). EaseVRx™ is authorized for the treatment of LBP in patients 18 years of age and older and requires a prescription for use. The device uses the principles of cognitive-behavioral therapy (CBT), including deep relaxation, attention shifting, interoceptive awareness and perspective taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization, knowledge of pain and rehabilitation. The device is used in a program of 56 brief (two to 16 minutes) VR sessions over eight weeks. CBT has been shown to reduce pain and pain intensity, and to improve function in LBP patients. <Read More>

Centene (CNC) Receives DMHC Approval for Magellan Acquisition – December 31, 2021 – Centene Corporation’s CNC acquisition deal with Magellan Health, Inc. MGLN recently received a green signal from the medical watchdogs in California. The California Department of Managed Health Care (“DMHC”) approved the deal with some conditions. Magellan Health, being the parent body for two licensed health plans by DMHC, namely Human Affairs International of California (HAI-CA) and Magellan Health Services of California, Inc. – Employer Services (MHSC), required regulatory approval for vending the health plans. The conditions from DMHC are aimed at protecting consumers and keeping the state’s healthcare delivery system stable. The regulatory authority expects them to control healthcare costs. <Read More>

The Top 5 Biosimilars Legal Stories of 2021 – December 31, 2021 – The top legal stories in biosimilars over the past year concerned etanercept and adalimumab biosimilars and access to insulin. The year 2021 ended with a final decision in the case of Immunex v Samsung Bioepis regarding their dispute over etanercept (Enbrel®) patents, with a ruling in favor of the reference drug companies, which included Immunex, Amgen, and Roche. Enbrel® is indicated for the treatment of autoimmune disease, specifically rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis. The upshot was that Samsung Bioepis effectively will not be able to bring its etanercept biosimilar (Eticovo™) to the US market until 2029. <Read More>

AAN Updates Guideline for Treatment of Painful Diabetic Neuropathy – December 30, 2021 – The American Academy of Neurology (AAN) has issued a practice guideline update on oral and topical treatments for painful diabetic neuropathy (PDN); a summary of the update has been published in the Jan. 4 issue of Neurology. Raymond Price, M.D., from the University of Pennsylvania in Philadelphia, and colleagues conducted a systematic review of the medical literature from January 2008 to April 2020 to update the AAN guidelines on the treatment of PDN. <Read More>

Pharmacists are Moderately Satisfied With Salary, Job Satisfaction, Survey Shows (Part 1)  – December 30, 2021 – Compensation Was a Positive, While Workload, Management, and Lack of Work/Life Balance Are the Top Reasons for Dissatisfaction. Pharmacists are moderately happy with their compensation and jobs, according to the results of the 2021 Pharmacy Times® Salary and Job Satisfaction Survey. When asked to rate their satisfaction with their annual total compensation on a scale of 1 to 7 (with 1 being “not at all” and 7 being “extremely”), the average response of the 135 respondents was 4.42. When asked to rate their overall job satisfaction on the same scale, the average was 4.07 compared with 4.53 in 2020. The top 3 reasons pharmacists gave for their dissatisfaction were the same as in the 2021 survey: workload, management, and work/life balance. The top driver of job satisfaction was compensation, chosen by 18.4% of respondents. <Read More>

The Latest Worker Shortage may Affect Your Health: Pharmacies Don’t Have Enough Staff to Keep up With Prescriptions – December 30, 2021 – Heidi Strehl worked as a pharmacy technician at a Rite Aid in the Pittsburgh suburbs for more than 16 years. She loved her customers, enjoyed her job and thought of her co-workers as family. But this fall, Strehl abruptly quit, walking out in the middle of a shift — one of many in a wave of pharmacy technicians who are doing the same. Most of the people behind pharmacy counters who count pills and fill medication bottles are pharmacy technicians, not pharmacists — low-wage workers in positions that don’t require college degrees. Working in a pharmacy was always fast-paced, Strehl said, but in recent years the workload and stress had increased to unsustainable levels, while staffing and pay failed to keep up. <Read More>

Walmart, Sam’s Club Pharmacies to Start Dispensing COVID-19 Antivirals This Week – December 30, 2021 – Select Walmart and Sam’s Club pharmacies are ready to begin dispensing COVID-19 antivirals this week. Pfizer’s Paxlovid™ and Merck’s Molnupiravir — both authorized by the FDA earlier this month — will be available at certain Walmart and Sam’s Club locations in a limited number of states until supplies expand, according to a Dec. 29 news release. The companies did not specify in which states the medications would be available but did provide a store locator tool that allows users to find the nearest location carrying the antivirals. The statement said Walmart worked closely with the federal government and state partners to identify where the prescription-only treatments are needed most. <Read More>

Omicron Cases Soar, But Deaths on the Decline, White House Says – December 29, 2021 – Cases of the highly transmissible Omicron variant continue to skyrocket, but hospitalizations and deaths remain much lower by comparison — another sign that Omicron is less deadly than previous strains, White House officials said on Wednesday. “The rapid increase of cases we’re seeing across the country is, in large part, a reflection of the exceptionally transmissible Omicron variant,” CDC Director Rochelle Walensky, MD, said at a White House briefing. “While our cases have substantially increased from last week, hospitalizations and deaths remain comparatively low right now.” <Read More>

Omnicell Completes Acquisition of ReCept – December 29, 2021 – Omnicell, Inc., a leading provider of medication management solutions and adherence tools for health systems and pharmacies, has completed the previously announced acquisition of ReCept Holdings, Inc. The addition of ReCept’s specialty pharmacy management services for health systems, provider groups, and federally qualified health centers (FQHCs) expands Omnicell’s Advanced Services portfolio to address the growing and complex specialty pharmacy market. ReCept provides implementation and managed services for health systems and other provider organizations to optimize their specialty pharmacy programs and the related pharmaceutical aspects of patient care. <Read More>

Bristol Myers Squibb, Amgen and Pfizer Approach Steepest Patent Cliffs Among Large Drugmakers – December 29, 2021 – Biopharma companies are constantly combating patent expirations. But three large drugmakers in particular will be the most negatively impacted from expected exclusivity losses by 2030. Among 19 large U.S. and European biopharma companies, Bristol Myers Squibb, Amgen and Pfizer will face two major issues. All three companies will have a large portion of their 2025 revenues exposed to generic or biosimilar competition, and they will also see those revenues erode quickly, an SVB Leerink team led by analyst Geoffrey Porges said in a Monday note to clients. BMS, Amgen and Pfizer will likely see copycats eat away 47%, 29% and 28% of their respective anticipated 2025 total revenues by 2030, Porges said. By contrast, Vertex, Sanofi and Novo Nordisk are expected to have the smallest erosion of 4%, 1% and 2% in growth, respectively. <Read More>

Industry Grapples With how to Cover Gene Therapy – December 29, 2021 – Members, as well as health plans, pharmacy benefit managers, plan sponsors, and reinsurers want to know how to fund these expensive treatments to ensure positive outcomes. Gene therapies cure or treat a condition by inactivating, introducing, or replacing a modified or new gene. These therapies carry life-preserving and life-saving benefits, profoundly affecting recipients and their families. But they are also extremely expensive. A new therapy might save a loved one, while simultaneously bankrupting a household or causing other significant financial strain. These extremes have led to some recent innovations outside the therapies themselves, specifically related to financing and payment models. From members to health plans, pharmacy benefit managers (PBMs), plan sponsors, and reinsurers, the entire industry is grappling with how to cover, fund, and ensure the best outcomes for these new treatments. <Read More>

Updated C. Difficile Infection Guidelines Incorporate New Trials – December 28, 2021 – Infectious Disease Society of America and Society for Healthcare Epidemiology of America make 3 new treatment recommendations for adults. Clostridioides difficile is a gram-positive, spore-forming, toxin-producing anaerobic bacterium that causes antibiotic-associated diarrhea…The Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America began updating the clinical practice guidelines for the management of C. difficile in early 2019 to incorporate new randomized control trials that compared C. difficile agents. This update contains 3 new recommendations for the treatment of CDI and is strictly limited to adults, while the previous guidelines were for both adult and pediatric populations. <Read More>

Steep Cuts in Opioid Prescribing ‘Raises More Questions’ – December 28, 2021 – Several studies in recent years have documented how opioid prescribing has declined significantly in the United States, with per capita consumption of opioid medication recently falling to its lowest level in two decades. For the first time, a new study by the RAND Corporation breaks the decline down by medical specialty, showing that some doctors may have gone too far in their effort to reduce opioid prescribing and lower the risk of abuse and addiction. “Oftentimes when I do studies, I think we have a clear answer. This one in my mind raises more questions,” says Bradley Stein, MD, a senior physician researcher at RAND and lead author of the study published in the Annals of Internal Medicine. <Read More>   

How ePrescribing EHR Integrations can Mitigate Clinician Burden – December 28, 2021 – As clinician burden rises to a record high, ePrescribing EHR integrations are a key tool to combat burnout. Healthcare organizations have widely implemented EHR systems in efforts to streamline clinical documentation processes and enhance care coordination. However, organizations have not brought all aspects of healthcare delivery up-to-speed in terms of modern health IT. Take prescribing, for example. The use of archaic fax technology for data exchange between prescribers and pharmacists can add to clinician burden, which is a growing concern as providers face significant burnout challenges related to COVID-19, such as chaotic work environments and after-hours workloads. <Read More>

CDC Updates and Shortens Recommended Isolation and Quarantine Period for General Population – December 27, 2021 – Given what we currently know about COVID-19 and the Omicron variant, CDC is shortening the recommended time for isolation for the public. People with COVID-19 should isolate for 5 days and if they are asymptomatic or their symptoms are resolving (without fever for 24 hours), follow that by 5 days of wearing a mask when around others to minimize the risk of infecting people they encounter. The change is motivated by science demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after. <Read More>

FDA Urges Manufacturers to Develop Solutions for iPLEDGE REMS Website – December 23, 2021 – FDA is aware that patients, prescribers, and pharmacies are experiencing difficulties with the implementation of the modified iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program, including the inability of many participants to log in to the website or long call center wait times, resulting in disrupted access to treatment for many isotretinoin patients. We understand and share the frustration caused by these challenges and are urging the isotretinoin manufacturers to develop and implement a workable solution as soon as possible. <Read More>

340B in the News

Alliance of Community Health Centers Sues State, Seeks to Halt Plan to Exclude Them from Federal 340B Drug Pricing Program – December 30, 2021 – The Community Health Center Alliance for Patient Access (CHCAPA) renewed its suit in federal court contesting the state’s Medi-Cal Rx plan and is seeking a temporary restraining order to halt implementation of the plan scheduled for January 1, 2022. The request for an emergency order was made necessary by last-minute agency action taken yesterday, which confirmed that Medi-Cal Rx could and would indeed “go live” on January 1, 2022, rendering the case ready for judicial review. Ten individual health centers joined the complaint and TRO motion. Medi-Cal Rx, which would drain hundreds of millions of dollars from community health centers, “turns the Medi-Cal reimbursement program for pharmacy benefits on its head. No longer will Medi-Cal managed care plans and Federally Qualified Health Centers (FQHCs) be able to manage and track patient medication usage and compliance and no longer will FQHCs be able to benefit from the savings created by prescribing drugs through the 340B discounted drug program (‘340B Program’) as Congress intended. Any such savings will now go directly to the State instead,” the complaint states. <Read More>

Hospital Reimbursement Opportunity Remains After CMS Decides Not to Finalize DSH Payment Calculations Changes – December 30, 2021 – The Centers for Medicare & Medicaid Services (CMS) released the fiscal year (FY) 2022 inpatient prospective payment system (IPPS) final rule. In light of the significant volume of comments, CMS declined to adopt any modifications to the current disproportionate share hospital (DSH) payment regulations. In the FY 2022 IPPS proposed rule and in response to several recent court cases, CMS had proposed modifications to its regulations that would explicitly exclude Medicaid patient days associated with state section 1115 waiver programs from the Medicare DSH payment calculation. This change, in effect, would reduce the number of patient days that are utilized in the DSH payment calculation. CMS’s decision not to finalize the changes to its current regulations may open the door for hospitals to include patient days associated with approved state Medicaid section 1115 waiver programs on their Medicare cost reports. This in turn may qualify hospitals for a DSH payment adjustment or increase a hospital’s Medicare DSH payment adjustment. <Read More> 

AbbVie to Restrict 340B Discounts to Safety Net hospitals – December 30, 2021 – AbbVie said it will stop offering safety net hospitals 340B drug-pricing program discounts on drugs dispensed at contract pharmacies if the hospitals fail to turn over patient claims data for those pharmacies to the drugmaker. AbbVie will begin the initiative Feb. 1, according to a Dec. 29 letter the drugmaker sent to safety net hospitals. This move makes AbbVie the 11th drugmaker to restrict 340B discounts. It joins Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Novo Nordisk, Sanofi, UCB and United Therapeutics. <Read More>

HHS Appeals Judge’s Ruling That Drugmakers can cut off 340B Sales to Contract Pharmacies – December 29, 2021 – The Biden administration is appealing a federal ruling that said drugmakers have the authority to restrict sales of 340B-discounted products to contract pharmacies. The Department of Justice filed an appeal Tuesday to a lawsuit brought by Novartis and United Therapeutics over drugmakers’ ability to cut off sales to contract pharmacies. It also appealed several aspects of other rulings in separate lawsuits brought by Eli Lilly, Sanofi and Novo Nordisk. Advocates for the 340B program, which requires drugmakers to give discounts to safety net providers in exchange for participation in Medicare and Medicaid, applauded the decision to appeal the November ruling. <Read More>