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Clinical Insights: November 9, 2021

Posted on November 9, 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

Scemblix® (asciminib) Tablets – New Orphan Drug Approval – October 29, 2021 – The Food and Drug Administration granted accelerated approval to asciminib (Scemblix®, Novartis AG) for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), and approved asciminib for adult patients with Ph+ CML in CP with the T315I mutation. <Read More>

Vuity™ (pilocarpine hydrochloride) Ophthalmic Solution – New Drug Approval – October 28, 2021 – Allergan, an AbbVie company, announced the U.S. Food and Drug Administration (FDA) approval of Vuity™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. Vuity™ is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population. <Read More>

Susvimo™ (ranibizumab) Injection – New Drug Approval – October 25, 2021 – Roche announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month. Susvimo™, previously called Port Delivery System with ranibizumab, is the first and only FDA-approved treatment for nAMD that offers as few as two treatments per year. <Read More> 

Xipere™ (triamcinolone acetonide) Injection – New Drug Approval – October 25, 2021 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. and Clearside Biomedical, Inc., a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced that the U.S. Food and Drug Administration (FDA) has approved Xipere™ (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation. <Read More> 

Zimhi™ (naloxone hydrochloride) Injection – New Drug Approval – October 15, 2021 – FDA has approved Zimhi™ (naloxone hydrochloride) injection as an additional option to treat opioid overdose. Zimhi™ is administered using a single-dose, prefilled syringe that delivers 5 milligrams (mg) of naloxone hydrochloride solution through intramuscular (in the muscle) or subcutaneous (under the skin) injection. FDA has previously approved injectable naloxone hydrochloride products in 0.4 mg and 2 mg doses under the trade name, Narcan®. <Read More> 

Seglentis® (celecoxib and tramadol hydrochloride) Tablets – New Drug Approval – October 15, 2021 – Esteve Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for Seglentis® (celecoxib and tramadol hydrochloride) for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. As part of an agreement with Esteve Pharmaceuticals, Kowa Pharmaceuticals America will commercialize Seglentis® in the United States, with a launch currently planned for early 2022. Seglentis® is a prescription, oral medication with a unique co-crystal formulation of celecoxib (a nonsteroidal anti-inflammatory drug) and tramadol (a Schedule IV opioid analgesic). <Read More>   

Tyrvaya™ (varenicline solution) Nasal Spray – New Drug Approval –  October 15, 2021 – Oyster Point Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Tyrvaya™ (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. Tyrvaya™ Nasal Spray is the first and only nasal spray approved for the treatment of dry eye disease. Tyrvaya™ Nasal Spray is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases. <Read More>

New Indication/Dosage/Formulation Approval

Dyanavel™ XR (amphetamine) Extended-Release Oral Suspension and Extended-Release Tablets – New Approved Dosage Form – November 4, 2021 – Tris Pharma, Inc. (“Tris”) announced that the U.S. Food and Drug Administration (“FDA”) has approved Dyanavel™ XR (amphetamine), extended-release oral suspension, CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years and older. With this approval, Dyanavel™ XR becomes the only once-daily, extended release amphetamine-based oral liquid approved for the treatment of ADHD in children. The approval is based on a Phase III randomized, placebo-controlled, laboratory classroom efficacy study conducted in 108 children (ages 6 to 12 years, who met DSM-IV® criteria for ADHD). <Read More>

New/Updated Drug Shortage

November 08, 2021

November 05, 2021

November 04, 2021

November 02, 2021

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Antara® (fenofibrate) Capsules – New Approved Authorized Brand Alternative – October 28, 2021 – Global pharma major Lupin Limited (Lupin) announced the launch of the authorized generic version of Antara® (Fenofibrate) Capsules, 30 mg and 90 mg, of Lupin Atlantis Holdings, S.A. Corporation, a wholly-owned subsidiary of Lupin. Fenofibrate Capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia. <Read More>

Clinical and Pharmacy News

NIH Scientists Identify Mechanism That may Influence Infectivity of SARS-Cov-2 Variants – November 5, 2021 – Scientists at the National Institutes of Health have found that a process in cells may limit infectivity of SARS-CoV-2, and that mutations in the alpha and delta variants overcome this effect, potentially boosting the virus’s ability to spread. The findings were published online in the Proceedings of the National Academy of Sciences. The study was led by Kelly Ten Hagen, Ph.D., a senior investigator at NIH’s National Institute of Dental and Craniofacial Research (NIDCR). <Read More> 

Health Plan Coverage for ART Varies Greatly Across U.S. – November 5, 2021 – Insurance coverage of single-tablet antiretroviral regimens (STRs) varies greatly across the United States, according to a study presented at the IDWeek 2021 virtual conference (poster 870). “We have this amazing plan in the U.S. for ending the HIV epidemic, and a key pillar of that plan is rapid initiation of ART [antiretroviral therapy],” said Rohan Khazanchi, MPH, a fourth-year medical student at the College of Medicine, University of Nebraska Medical Center, in Omaha. “But some insurance plans still hinder access to ART through discriminatory benefit designs.” <Read More>

Thirty Pharmacies Ranked by Customer Satisfaction – November 4, 2021 – Good Neighbor Pharmacy is the highest-ranked pharmacy in the U.S. in terms of customer satisfaction, according to consumer insight firm J.D. Power’s annual pharmacy satisfaction survey. The J.D. Power 2021 U.S. Pharmacy Study, released in July, measures customer satisfaction by surveying 12,646 pharmacy customers who filled a prescription in the three months before the survey period of September 2020 to May 2021. J.D. Power looks at metrics such as cost, customer service, and billing and payment services to determine its rankings. <Read More>

Tip of the Week: Move Pharmacy Practice Ahead at the Speed of Trust – November 4, 2021 – Pharmacy managers must be transparent and should work to establish an environment where people want to trust one another and feel good about doing so. Stephen Covey, well-renowned author in business and personal relationships, asserts that trust is “the most overlooked, misunderstood, underutilized asset to enable performance. Its impact, for good or bad, is dramatic and pervasive.” The reason trust is so important is that work gets done with and through people. If you trust someone, you will not be concerned about them trying to take credit for your idea or attempting to undermine you. You can share ideas much more readily with them. You can share confidences that you might ordinarily guard, and you can relax knowing that the person you trust will fulfill their obligations, thus allowing you to dedicate more time to the tasks and responsibilities under your more immediate purview. <Read More>

Opioid Taper and Overdose Risk: What Pharmacists Should Know – November 4, 2021 – In the ongoing aftermath of the opioid crisis, it’s common for physicians to attempt to wean some patients off opioids in favor of alternative means of pain management. But while the goal is increased safety for the patient, opioid tapering does not come without risks. A recent study in JAMA found a significant association between opioid dose tapering and both overdose and mental health crises. The risk of mental health crises—including anxiety, depression, and suicide attempts—more than doubled during periods of tapering compared to periods of consistent opioid use, according to the study findings. The risk of overdose nearly doubled during tapering periods as well. Overdose risk also increased with speed of dose reduction. <Read More>

Prime Therapeutics Joins Express Scripts in Moving Semglee® to Preferred Formulary Status – November 4, 2021 – Prime Therapeutics, a large pharmacy benefit manager (PBM) with 33 million Blue Cross and Blue Shield plan members, said it will put the insulin glargine biosimilar Semglee® on its preferred formulary. Semglee® was approved as an interchangeable biosimilar by the FDA in July 2021, and Prime’s decision to promote use of this agent follows a similar decision in October by Express Scripts, another PBM, which put the agent on its largest national formulary. Semglee® was originally launched in August 2020 by Biocon Biologics and Mylan (now Viatris) but did not obtain biosimilar and interchangeable status until July 2021. <Read More>

Eighty-Eight Million Americans at Risk for Type 2 Diabetes Can Change Their Outcome – November 4, 2021 – Prediabetes can be reversed – and the American Medical Association (AMA), the Centers for Disease Control and Prevention (CDC), and the Ad Council want people to know it. Type 2 diabetes is one of the chronic health conditions that poses a significant risk for complications to those who contract COVID-19. A recent studyexternal icon showed type 2 diabetes is one of the top comorbidities associated with COVID-19 severity and deaths. That’s why the AMA, the CDC, and the Ad council have launched a series of new public service announcements (PSAs) taking a serious look at prediabetes – a condition that if left unchecked often leads to type 2 diabetes. <Read More>

ACIP Recommends Recombinant Zoster Shot for Immunocompromised Adults – November 3, 2021 – Adults 19 years of age and older who are immunosuppressed due to disease or therapy should receive the recombinant zoster vaccine (RZV; Shingrix™, GlaxoSmithKline) in two doses given at least four weeks apart, the Advisory Committee on Immunization Practices (ACIP) recommended in a unanimous vote on Oct. 20. This population includes, but is not limited to, hematopoietic stem cell transplant (HSCT) recipients; patients with hematologic malignancies and solid tumor malignancies; solid-organ transplant recipients; people living with HIV; patients with primary immunodeficiencies, autoimmune and inflammatory conditions; and those taking immunosuppressive therapies. <Read More>

Pharmacy Owner Sentenced to 41 Months in Prison for Role in Multimillion-Dollar Illegal Kickback Scheme and Evading Taxes on Over $33 Million of Income – November 3, 2021 – The former co-owner of a Union City, New Jersey, pharmacy was sentenced to 41 months in prison for his role in a scheme to pay bribes to health care professionals and evading taxes on $33.9 million in income, Acting U.S. Attorney Rachael A. Honig announced. Igor Fleyshmakher, 59, of Holmdel, New Jersey, previously pleaded guilty before U.S. District Judge Michael A. Shipp to an information charging him with conspiring to violate the federal anti-kickback statute and tax evasion. Judge Shipp imposed the sentence in Trenton federal court. <Read More>

Aetna Expects to Add at Least 100K Members in ACA Exchange Plans for 2022 – November 3, 2021 – CVS Health CEO Karen Lynch told investors on Wednesday morning that Aetna is expecting to add at least 100,000 new members in 2022 through its slate of plans on the Affordable Care Act’s exchanges. The insurer has returned to the Affordable Care Act’s exchanges in eight states for 2022, and the insurer is expecting its plans, which include a co-branded offering with both Aetna and CVS, to have an immediate appeal in the individual market. Lynch described the new plan on the company’s second-quarter earnings call as one “that combines health insurance, pharmacy, our retail presence and behavioral health services.” <Read More>

Pfizer to Seek Interchangeable Status for Abrilada™ Biosimilar – November 3, 2021 – Pfizer officials said in an earnings call this week that they intend to seek interchangeable status for their adalimumab biosimilar (Abrilada™) in a filing with the FDA in December 2021. Interchangeable status has the potential to boost uptake of the product, which is scheduled to launch against 5 other adalimumab biosimilars in 2023. The interchangeable designation enables pharmacists to make the decision whether to dispense a biosimilar or a reference product rather than having to consult with the prescribing physicians. <Read More>

The Impact of Community Pharmacists on Social Determinants of Health – November 3, 2021 – Social determinants of health (SDoH) are “conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes” that contribute to many of these barriers. Healthy People 2030 include several barriers that prevent and limit people from having access to health care services. Some of these barriers include inadequate health insurance and limited availability of health care resources. The importance of addressing SDoH is vital and account for approximately 90% of health outcomes, whereas only 10%-15% is attributed to medical care. <Read More>

FDA Notification Regarding Isoxsuprine Hydrochloride Drug Products – November 3, 2021 – On July 15, 2020, FDA announced the final decision of the Commissioner of Food and Drugs, that Vasodilan™ containing isoxsuprine hydrochloride lacked substantial evidence, consisting of adequate and well-controlled studies, to be effective for specific indications. Vasodilan™ containing isoxsuprine hydrochloride was part of the Drug Efficacy Study Implementation process. FDA notified manufacturers and labelers of the products (see list below) on Aug. 9. 2021, to stop distributing their isoxsuprine hydrochloride drug products. As of Oct. 13, 2021, all the companies agreed to cease distribution of the unapproved isoxsuprine HCl drugs. <Read More>

Centene’s Pharmacy Benefits Management: A Timeline – November 3, 2021 – Centene announced Oct. 26 that it will begin using a third-party pharmacy benefits manager for its $30 billion in annual spending — a move that CFO Drew Asher said will be “a huge opportunity for an external PBM.” The move comes after a turbulent few years for Centene and its current PBMs. Below is a timeline of some of the key stories about Centene’s PBMs since 2018. <Read More>

81-Year-Old Delco Pharmacist Accused of Trading Painkillers for Sexual Favors – November 3, 2021 – An 81-year-old pharmacist in Media is facing criminal charges for allegedly distributing opioid painkillers and other drugs to women in return for sexual favors, Delaware County prosecutors said. Martin Brian, the owner of the Murray-Hill Pharmacy on State Street, was charged Monday with multiple offenses following a DEA investigation that began in April. The pharmacy ceased operations in June. The Media Borough Police Department received an anonymous tip on April 18 concerning two unconscious people who were found inside a parked car behind the pharmacy. When officers responded to the scene, a woman emerged from the pharmacy and quickly returned inside to inform Brian that police had arrived, according to investigators. <Read More>

Incorporation of Medication Synchronization in Community Pharmacy Workflow Enhances Delivery of Patient Care Services – November 2, 2021 – Pharmacists across the country are adopting medication synchronization (med sync) programs that enable patients to pick up their chronic medications at the pharmacy at once. Research shows that med sync programs improve medication adherence, a problem estimated to result in avoidable health problems for patients that cost the health care system approximately $300 billion a year. Med sync helps improve adherence by eliminating the need for patients to remember to request prescription refills. Additionally, it saves the patient multiple trips to the pharmacy. Med sync benefits the pharmacy by making the dispensing process workflow more efficient. <Read More>

Replacing Lost Revenue During the Pandemic – November 2, 2021 – With normal revenues severely constricted by the influx of critical COVID-19 patients, health systems and hospitals across the country have had to find other ways to replace vanished income streams. “One of the biggest challenges with COVID-19 has been the continuing downward pressure on the financials,” said James Jorgenson, MS, RPh, the CEO of Visante, a pharmacy consulting firm. “Operating margins for the average hospital right now are somewhere in the 1% to 3% range.” <Read More>

340B in the News

CMS Releases OPPS and PFS Final Rules – November 5, 2021 – There were no major surprises when the Medicare hospital outpatient prospective payment system (OPPS) and physician fee schedule (PFS) Final Rules were released on November 2, 2021, but there are still several financial and compliance areas that healthcare providers must prepare for as we head into 2022. Below is a brief summary of the key issues affecting the most providers across the country… Although heavily lobbied against by 340B Covered Entities, the full Medicare reimbursement reduction will remain in effect for 2022. There are still numerous pending lawsuits related to various aspects of the Program’s rules and enforcement thereof, but lower Medicare rates are here to stay for another year. <Read More>

Coherus BioSciences Announces CMS Has Extended Enhanced Medicare Reimbursement for Udenyca® in the 340B Hospital Setting Through Year-End 2022 – November 5, 2021 – Coherus BioSciences, Inc. announced that the Centers for Medicare & Medicaid Services (“CMS”) will continue to provide increased Medicare reimbursement in the 340B outpatient hospital setting through year-end 2022 for 28 drugs, biologics and devices impacted by the COVID-19 public health emergency, including Udenyca® (pegfilgrastim-cbqv). “We applaud CMS for continuing its support for patients, providers and hospitals impacted by the COVID-19 pandemic,” said Denny Lanfear, CEO of Coherus. After transitional pass-through payment status expires for Udenyca® on March 31, 2022, CMS will provide a separate payment through the end of 2022 to maintain the same reimbursement levels for Udenyca® in the 340B outpatient hospital setting as determined through the pass-through payment program. <Read More>

340Bs Push Back on Abuses Cited in COA Report – November 4, 2021 – The Community Oncology Alliance (COA) has accused some safety net hospitals of gaming a federal drug discount program to boost profits. The group says disproportionate share hospitals (DSH) participating in the 340B Drug Pricing Program charge nearly four times their acquisition costs for expensive oncology drugs, and pocket the margins. Since 1992, the 340B program has required drug manufacturers to provide significant discounts on outpatient drugs for qualifying institutions that serve high numbers of low-income and uninsured patients. DSH, which account for most 340B participating institutions, are supposed to receive a minimum 23.1% discount off the average sales price (ASP), but actual discounts are estimated to be upward of 34.7% on average. <Read More>

United Therapeutics Corp Management’s Discussion and Analysis of Financial Condition and Results of Operations – November 3, 2021 – The following discussion should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2020 (the 2020 Annual Report), and our consolidated financial statements and accompanying notes included in Part I, Item I of this Quarterly Report on Form 10-Q… The timing and outcome of ongoing litigation, including the lawsuit filed against us by Sandoz, Inc. (Sandoz) and Liquidia PAH, LLC (formerly known as RareGen, LLC) (RareGen); the lawsuit filed against us by MSP Recovery; our patent litigation with Liquidia Technologies, Inc. (Liquidia) related to its NDA for LIQ861, and with ANI Pharmaceuticals, Inc. (ANI) related to its abbreviated new drug application (ANDA) seeking FDA approval to market a generic version of Orenitram®; and our litigation with the U.S. Department of Health and Human Services (HHS) and the U.S. Health Resource Services Administration (HRSA) related to the Public Health Service’s 340B drug pricing program (the 340B program). <Read More>

Novo Nordisk A/S (NVO) Q3 2021 Earnings Call Transcript – November 3, 2021 – Thank you very much. Welcome to this Novo Nordisk call regarding our earnings for the first nine months of 2021 and outlook for the year. This call follows the early announcement of the high-level results and raised guidance published on Friday last week… what we do benefit from in ’21 is the 340B distribution policy change we did in the U.S. market, where we basically restricted distribution under the 340B program to covered entities. There we are getting a benefit. And as we’ve said in prior quarters, and there are no changes to that this quarter, then we’re getting a benefit. It’s less than three percent of U.S. sales, but I’m just reminding you that even three percent of U.S. sales is 1.5 percent of group sales. <Read More>

Community Access National Network Releases Third Policy Report on 340B Drug Pricing Program – November 2, 2021 – The word accountable is defined as “being required or expect to justify actions or decisions.” Accountability is often broadly discussed on a variety of levels about governmental and social issues, and the 340B Drug Pricing Program is certainly no exception. The 340B program exists to address the health care needs of a segment of society – social needs. As such, program accountability is of paramount importance since patient health depends on it. <Read More>