Clinical Insights: July 6, 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

    Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) Injection – New Drug Approval – June 30, 2021 – Jazz Pharmaceuticals plc announced the U.S. Food and Drug Administration (FDA) approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze™ is the only recombinant erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment, and it was developed by Jazz to address the needs of patients and healthcare providers with an innovative, high-quality erwinia-derived asparaginase with reliable supply. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New/Updated Drug Shortage

    July 02, 2021

    July 01, 2021

    June 30, 2021

    June 29, 2021

    New Drug Recall and Safety Alerts

    Topotecan Injection 4 mg/4 mL (1 mg/mL) by Teva Initiates – Voluntary Drug Recall – July 1, 2021 – Teva Pharmaceuticals has initiated a voluntary recall of lot 31328962B of Topotecan Injection 4 mg/4 mL (1 mg/mL), to the retail/institutional level in the United States. This voluntary recall was initiated based on a complaint received from a pharmacy after a single glass particle was observed inside one vial. After further examination of the complaint sample, two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber. <Read More>

    New Generic/Biosimilar Approval and Launch

    Brovana®, Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials – New Approved Generic – June 24, 2021 – Glenmark Pharmaceuticals Ltd has received final approval by the United States Food & Drug Administration (U.S. FDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials, the generic version of Brovana® Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc. Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company’s North American manufacturing facility based in Monroe, North Carolina, and marks the company’s first nebulizer approval. <Read More>

    Perforomist®, Formoterol Fumarate Inhalation Solution, 20 mcg/2 ML – New Approved Generic – June 22, 2021 – Teva Pharmaceuticals announced its U.S. launch of the first generic version of twice daily Perforomist formoterol fumarate inhalation solution, 20 mcg/2 ML, indicated to treat bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. <Read More>

    Clinical and Pharmacy News

    Increased Rates of Non–Guidance-Based Treatment Identified in Female, Black, and Hispanic Populations with RCC – July 3, 2021 – New findings indicate that historically underserved patient populations with renal cell carcinoma are more likely to receive non–guidance-based treatment. Notable disparities in treatment decision making for female, Black, and Hispanic patients with renal cell carcinoma (RCC) highlight a need to further examine the underlying reasons for these disparities and implement further consideration when selecting therapies, according to a retrospective cohort study published in JAMA Network Open. Findings from a cohort study identified that in the overall study population, female patients were treated more aggressively vs their male counterparts, with statistically significantly lower adjusted odds of undertreatment (odds ratio [OR]. 0.82; 95% CI, 0.77-0.88; P <.001) and higher adjusted odds of overtreatment (OR, 1.27; 95% CI, 1.24-1.30; P <.001). Moreover, Black race was also associated with a statistically significantly higher adjusted odds of both undertreatment (OR, 1.42; 95% CI, 1.29-1.55; P <.001) and overtreatment (OR, 1.09; 95% CI, 1.05-1.13; P <.001) vs White race. An association with undertreatment (OR, 1.20; 95% CI, 1.06-1.36; P = .004) and overtreatment (OR, 1.06; 95% CI, 1.01-1.11; P = .01) was also identified in patients with Hispanic ethnicity. <Read More>

    SVS Releases Updated Clinical Practice Guidelines on Extracranial Cerebrovascular Disease – July 2, 2021 – The Society for Vascular Surgery (SVS) has released updated clinical practice guidelines accompanied by an implementation document on the management of patients with extracranial carotid artery disease. The documents, both published in the Journal of Vascular Surgery, aim to use the existing clinical evidence to ensure patients with atherosclerotic occlusive disease in the carotid arteries receive appropriate treatment and care. <Read More>

    Why Startup PBM Capital Rx Wants to Break The Industry’s ‘Roulette Wheel of Pricing’ – July 2, 2021 – When Capital Rx launched its “clearinghouse” model in 2019, it aimed to cut out the “roulette wheel of pricing” that some patients can face at the pharmacy counter. CEO A.J. Loiacono told Fierce Healthcare in an interview that the goal is to inject some much-needed transparency into the black box that is pharmacy benefit management pricing models. “The reason why we observe this artificial volatility is because middlemen players, unfortunately, are changing the price for profitability reasons,” he said. “It’s a game of winners and losers. You show up at the register and are you today’s big winner or, unfortunately, the loser?” <Read More>

    Few Doctors Follow Best Practices for Treating Low Back Pain, Even with Reminders, New Study Finds – July 1, 2021 – Up to 80 percent of adults will experience one episode of acute low back pain (LBP) in their lifetime and many of those people will first seek care from their primary care physicians. Despite the prevalence of acute low back pain– and a lack of evidence for effective interventions – few PCPs are following existing clinical guidelines to prevent patients from developing chronic LBP, according to a new University of Pittsburgh study recently published in The Lancet. <Read More>

    New Practice Guideline Includes Recommendations for Reducing Blood Loss During Heart Surgery – July 1, 2021 – Four leading medical specialty societies released a new clinical practice guideline that includes recommendations for reducing blood loss during heart surgery and improving patient outcomes. The document, a multidisciplinary collaboration among The Society of Thoracic Surgeons, the Society of Cardiovascular Anesthesiologists, the American Society of ExtraCorporeal Technology, and the Society for the Advancement of Patient Blood Management, is available online in The Annals of Thoracic Surgery and two other journals. <Read More>

    Mylan Sues Generic Rival Teva Over ‘Sophisticated Scheme’ to Block Copaxone™ Copycats – July 1, 2021 – Teva Pharmaceutical is facing down plenty of lawsuits. Now, one of its chief rivals in the generics field is adding another case to Teva’s plate. Mylan, which has merged with Pfizer’s Upjohn to form Viatris, is taking Teva to court over claims the Israeli-American drugmaker used anticompetitive practices to guard its branded multiple sclerosis med Copaxone™ from generics. In the lawsuit, Mylan charges Teva with orchestrating a “comprehensive and sophisticated scheme” to scupper the entry of copycats. The suit claims Teva accomplished this by misleading doctors about the efficacy of Copaxone™ generics, shifting the market to a higher-dose formulation and forging deals with specialty pharmacies and pharmacy benefit managers (PBMs) to keep Copaxone™ generics off prescribing lists. Mylan filed the suit this week in a New Jersey federal court. <Read More>

    ACMG Publishes its First Evidence-based Clinical Guideline: Exome and Genome Sequencing for Pediatric Patients with Congenital Anomalies or Intellectual Disability – July 1, 2021 – The American College of Medical Genetics and Genomics (ACMG) has released its first Evidence-based Clinical Practice Guideline (EBG), “Exome and genome sequencing for pediatric patients with congenital anomalies or intellectual disability: an evidence-based clinical guideline of the American College of Medical Genetics and Genomics.” The EBG was published in ACMG’s official journal, Genetics in Medicine. Based on a Systematic Evidence Review, the Guideline makes a strong recommendation to support the use of Exome/Genome Sequencing (ES/GS) as either a first- or second- line test in patients with CA/DD/ID. ES/GS demonstrates clinical utility for patients and their families with limited evidence for negative outcomes and the ever-increasing emerging evidence of therapeutic benefit. The authors also hope that the framework used helps accelerate the process for the consideration of other test modalities in the future. <Read More>

    States Step up Push to Regulate Pharmacy Drug Brokers – July 1, 2021 – Under pressure to rein in skyrocketing prescription drug costs, states are targeting companies that serve as conduits for drug manufacturers, health insurers and pharmacies. More than 100 separate bills regulating those companies, known as pharmacy benefit managers, have been introduced in 42 states this year, according to the National Academy for State Health Policy, which crafts model legislation on the topic. The flood of bills comes after a U.S. Supreme Court ruling late last year backed Arkansas’ right to enforce rules on the companies. At least 12 of the states have adopted new oversight laws. But it’s not yet clear how much money consumers will save immediately, if at all. <Read More>

    Hospital Chargemaster Prices for Generics up to 6,000% More Than Pharmacies, Research Finds – June 30, 2021 – Chargemaster prices for generic drugs in hospitals can be 6,000 percent higher than the price of the same drug in a pharmacy, according to an analysis by GoodRx, a pharmacy discount company.  GoodRx analyzed chargemaster prices for 12 common generic drugs at 16 geographically diverse hospitals across the U.S. and compared the prices to cash prices at pharmacies. The company said cash prices are readily available and provide a good benchmark for the “fair” price consumers should pay for a generic drug. <Read More>

    Recent PBM Regulations Could Save Insurers Money, Not Patients – June 30, 2021 – Lawmakers across the country are trying to pull back the curtain on the processes pharmacy benefit managers use to negotiate drug prices, but it’s unclear if mandating greater transparency from PBMs will result in patients paying less for their prescriptions, Kaiser Health News reported June 30. In April, Montana passed a measure that will require PBMs to get a state license and publicly report how much money they receive, beginning in 2022. The measure also controls what information PBMs give to other companies when negotiating. <Read More>

    New ASCO Guideline Recommends Adjuvant Olaparib for Patients with Hereditary Breast Cancer – June 30, 2021 – Updated American Society of Clinical Oncology (ASCO) guidelines advise offering patients with high-risk, early-stage human epidermal growth factor receptor 2 (HER2)-negative breast cancer and germline BRCA mutations 1 year of adjuvant therapy with olaparib (Lynparza™) following completion of neoadjuvant chemotherapy and local treatment, including radiation. The recommendation follows a new ASCO initiative intent on providing clinicians with updated and timely guidelines that represent the latest practice-changing research. ASCO, the American Society for Radiation Oncology (ASTRO), and the Society of Surgical Oncology (SSO) will be updating their guidelines in accordance with the new recommendation. <Read More>

    Finding an Opportunity to Advance Pharmacy Practice During a Pandemic – June 30, 2021 – The COVID-19 pandemic caused by SARS-CoV-2 spread rapidly throughout the world, with more than 33 million reported cases leading to over 2.2 million hospital admissions. Similar to many countries around the world, the health care system in the United States was stretched to its limit. Like many health care providers, pharmacists have been on the frontlines throughout the pandemic providing much needed support to a strained health care system. The COVID-19 pandemic has led to significant health care innovation, ranging from the use of investigational therapies—such as the antiviral remdesivir and the interleukin-6 inhibitor tocilizumab— to the development of new antibody cocktails. Many of these novel therapies required robust monitoring to ensure safety and efficacy. <Read More>

    NIH-Funded Study Finds Liraglutide, Insulin Better Than Other Options for Maintaining A1C  – June 29, 2021 – The study was launched the same month as the first US approval of a sodium-glucose co-transporter 2 inhibitor, and the failure to include a drug from this class was viewed by a commentator as a weakness of GRADE. With so many choices in type 2 diabetes (T2D) care, the question in recent years has been: After metformin, what’s next? If maintaining glycated hemoglobin (A1C) levels over time is the primary consideration, then the best options are liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin, a mainstay of diabetes care that has seen many evolutions since its discovery 100 years ago. Those are the preliminary findings of GRADE (Glycemia Reduction Approaches in Diabetes: a comparative effectiveness study), funded by the National Institutes of Health and presented late Monday during the 81st Scientific Sessions of the American Diabetes Association. <Read More>

    Steroid Injection Therapy Does Not Compromise COVID-19 Vaccine Efficacy, New Guideline Suggests – June 29, 2021 – The American Society of Pain and Neuroscience (ASPN) issued a new set of recommendations to guide clinicians in the safe and appropriate use of steroid injections for pain management in patients who are receiving the COVID-19 vaccine (J Pain Res 2021;14:623-629). “The central question that we wanted to deduce and answer is whether a local steroid injection might potentially reduce the efficacy of the COVID-19 vaccine, which relies upon a robust and potent immune response that primes the body to fight the virus,” said lead author Krishnan Chakravarthy, MD, PhD, an assistant clinical professor of anesthesiology at the University of California, San Diego. <Read More>

    Actionable Mutations in Hematologic Malignancies – June 29, 2021 – Precision oncology has ushered in a new era in cancer diseases. The use of high throughput technologies has revolutionized the understanding of the cancer genome. In hematological malignancies, the application of these genomic studies have led to diagnosis, accurate prognostic stratification, and tailored treatment strategies to precisely target the molecular alteration underlying the disease. Genetic techniques frequently used in hematological malignancies include:  1) Conventional cytogenetics (Karotyping), 2) Fluorescent in-situ hybridization (FISH), 3) Polymerase chain reaction (PCR), 4) Next generation sequencing (NGS). <Read More>

    SVS Releases Clinical Practice Guidelines on Popliteal Artery Aneurysms – June 29, 2021 – The Society for Vascular Surgery (SVS) has released new clinical practice guidelines to ensure that patients with popliteal artery aneurysms receive appropriate treatment and care. Aneurysms of the popliteal artery are the most common aneurysms outside of the brain and abdominal aorta. <Read More>

    Experts Confused by FDA Alzheimer’s Drug Approval – June 29, 2021 – As news of the FDA’s decision to approve aducanumab for Alzheimer’s disease under its accelerated approval pathway spread, critics were just as rapid in expressing their astonishment that the agency could have given its nod to a drug with such spotty clinical trial data. Coupled with major concerns about cost, including steep copays for patients and a projected billion-dollar annual price tag for Medicare, the approval promises to stir continued debate. <Read More>

    National Alliance of State Pharmacy Associations and American Pharmacists Association Release Updated 2020 State Fact Sheets – June 29, 2021 – Pharmacists are among the most accessible and trusted health care professionals. Over the past 50 years, the role of the pharmacist has evolved dramatically beyond traditional dispensing duties. Pharmacists now play an integral role as medication experts of the health care team, ensuring optimal medication use and improving patient health outcomes… However, some patients and policymakers may be unaware of pharmacists’ training and skills to provide these clinical services. Therefore, advocacy is necessary to advance the pharmacy profession and expand the pharmacist’s role in delivering essential patient care services. <Read More>

    Seven Big Moves Pharmacy Chains Made in 2021 – June 29, 2021 – Below are seven key moves Walmart, CVS and Walgreens have made in 2021, listed in the order they were reported by Becker’s Hospital Review: 1) Walmart launched a less expensive, private label version of analog insulin for diabetes patients who struggle to afford their medication. Novo Nordisk will manufacture the insulin, called ReliOn NovoLog. 2) Walmart began offering a prescription drug savings program to members of its Walmart+ program. The program, called Walmart+ Rx for less, offers discounts of up to 85 percent on thousands of commonly prescribed drugs, including heart health, mental health, allergy and diabetes drugs. 3)Walgreens Boots Alliance completed the sale of its wholesaling arm, Alliance Healthcare, to AmerisourceBergen for $6.5 billion. <Read More>

    340B in the News

    US Supreme Court to Hear Cases on 340B Cuts, DSH Payment Calculation – July 6, 2021 – The U.S. Supreme Court will take up two key healthcare cases, one that challenges cuts to the 340B Drug Discount Program and one that challenges the calculation used to determine Medicare payments to providers, the highest court said July 2. Both cases will be heard in the next term, which begins in October. American Hospital Association v. Becerra, the case challenging the 340B payment cuts, centers on whether CMS has the authority to make cuts to the program under its Medicare Outpatient Prospective Payment System. Under the payment rule, HHS cut the reimbursement rate for covered drugs by 28.5 percent, but it later lowered the reimbursement rate cut to 22.5 percent. <Read More>

    340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies Amid Ongoing Litigation – July 2, 2021 – Now approaching a year-long battle, drug manufacturers and 340B covered entities, which includes hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to dispute the issue of whether drug manufacturers are required to give 340B Participants discounts on drugs dispensed through contract pharmacies.  The most recent point of contention involves the U.S. Health Resources and Services Administration’s (“HRSA”) May 17, 2021 letters sent to six drug manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for 340B Participants who dispense drugs through contract pharmacies is in direct violation of Section 340B of the Public Health Service Act (also referred to as the “340B Statute”).  The letters also included HRSA’s demand that the manufacturers immediately begin offering their drugs at discounted prices to these 340B Participants as well as credit or refund all 340B Participants for overcharges that resulted from the limiting policies, or be subject to civil monetary penalties.  As anticipated, certain drug manufacturers, including Eli Lilly, have filed motions in federal court to stop the HRSA from placing monetary penalties based on their refusal to provide 340B discounts to contract pharmacies. <Read More>

    Supreme Court Agrees to Hear Hospital Lawsuit Challenging HHS’ 340B Cuts – July 2, 2021 – The Supreme Court agreed to hear a major dispute between the hospital industry and the federal government over cuts to 340B hospitals. The court agreed to hear the case during its next term that begins in October, according to an order list released on Friday. A decision could be rendered sometime next year. The case called American Hospital Association v. Becerra centers on the Medicare reimbursement rate paid for outpatient drugs and whether the Department of Health and Human Services singled out 340B-covered entities. HHS traditionally set reimbursement rates for drugs based on the average sales price and applied it across all hospital groups. But the lawsuit said that practice changed in 2018 when HHS singled out 340B hospitals, the lawsuit argues. <Read More>