Clinical Insights: January 26, 2021

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. Contact us to learn more.

    New Drug Approval

    LupkynisTM (voclosporin) Capsules – New Drug Approval – January 22, 2021 – Aurinia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LupkynistTM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LupkynistTM is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LupkynistTM is now available to patients in the United States (U.S.). <Read More>

    CabenuvaTM (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged) – New Drug Approval – January 21, 2021 – The U.S. Food and Drug Administration approved CabenuvaTM (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month. The FDA also approved VocabriaTM (cabotegravir, tablet formulation), which should be taken in combination with oral rilpivirine (EdurantTM) for one month prior to starting treatment with CabenuvaTM to ensure the medications are well-tolerated before switching to the extended-release injectable formulation. <Read More>

    VerquvoTM (vericiguat) Tablets – New Drug Approval – January 19, 2021 – Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved VerquvoTM, a soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. The approval of VerquvoTM, by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review. VerquvoTM, (vericiguat) 2.5 mg, 5 mg, and 10 mg tablets is being jointly developed with Bayer AG. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    OpdivoTM (nivolumab) Injection – New Approved Indication – January 21, 2021 – The Food and Drug Administration approved  the combination of nivolumab (OpdivoTM, Bristol-Myers Squibb Co.) and cabozantinib (CabometyxTM, ExelixisTM) as first-line treatment for patients with advanced renal cell carcinoma (RCC). Efficacy was evaluated in CHECKMATE-9ER (NCT03141177), a randomized, open-label trial in patients with previously untreated advanced RCC. Patients were randomized to receive either nivolumab 240 mg over 30 minutes every 2 weeks in combination with cabozantinib 40 mg orally once daily (n=323) or sunitinib 50 mg orally daily for the first 4 weeks of a 6-week cycle (4 weeks on treatment followed by 2 weeks off) (n=328). <Read More>

    New/Updated Drug Shortage

    January 25, 2021

    January 22, 2021

    January 21, 2021

    January 19, 2021

    New Drug Recall and Safety Alerts

    Metformin HCl Extended Release Tablets, USP 750 mg by Nostrum Laboratories, Inc. – Expanded Voluntary Drug Recall – January 25, 2021 – Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2nd 2020. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Pfizer to Ship Fewer COVID-19 Vaccine Vials to US, Cites Extra December Doses – January 25, 2021 – Pharmacists discovered in December that Pfizer’s COVID-19 vaccine vials that were supposed to contain five doses sometimes contained an extra dose, and Pfizer now plans to count the sixth dose toward its deal with the federal government to supply the U.S. with 200 million doses of its vaccine by the end of July, The New York Times reports. But some pharmacists told the Times that getting the extra dose requires a specialty syringe, and not all sites have them. <Read More>

    Methamphetamine Overdose Deaths Rise Sharply Nationwide – January 25, 2021 –  In the United States, methamphetamine overdose deaths surged from 2011 to 2018, according to a report from the National Institute on Drug Abuse (JAMA Psychiatry 2021 Jan 20. doi: 10.1001/jamapsychiatry.2020.4321). Rapid increases were seen across all racial and ethnic groups, but American Indians and Alaska Natives were most affected. Deaths involving methamphetamines more than quadrupled among non-Hispanic American Indians and Alaska Natives from 4.5 to 20.9 per 100,000 people, with sharp increases for both men (from 5.6 to 26.4 per 100,000 during 2011-2018) and women (from 3.6 to 15.6 per 100,000 during 2012-2018) in those groups. <Read More>

    NCPA Urges Biden Administration to Consider Independent Pharmacies as Part of COVID-19 Strategy – January 25, 2021 – Following the release of the Biden administration’s National Strategy for the COVID-19 Response and Pandemic Preparedness, the National Community Pharmacists Association (NCPA) issued its support for the strategy and urged the government to also consider the need to engage independent pharmacies in the fight against coronavirus disease 2019 (COVID-19). “Small business neighborhood pharmacy has been engaged in the fight against the coronavirus from the start, jumping to action and installing plexiglass barriers, upping their delivery services, starting curbside pick-up, compounding hand sanitizer, and offering testing and, when possible, the COVID-19 vaccines. Similarly, the Biden administration is jumping quickly to work to join the battle, continue getting vaccines into people’s arms, and provide relief,” said NCPA CEO B. Douglas Hoey, PharmD, MBA, in the statement. <Read More>

    Point-of-Care Testing Offers New Opportunities – January 25, 2021 – In addition to dispensing and medication management, pharmacists are poised during the coronavirus disease 2019 (COVID-19) pandemic to provide preventive health services, including self-care recommendations and vaccinations.1 Many pharmacists may also use “waived” testing as designated by the FDA’s Clinical Laboratory Improvement Amendments (CLIA) to detect and aid in their decisions of disease management. Pharmacists have an excellent opportunity to further evolve their role via point-of-care testing (POCT), especially considering the pressure that COVID-19 has placed on the health care system.1,3 Proper training, certification, and advances in testing technology enable POCT to occur in any setting. <Read More>

    Groups Jointly Issue Guidelines for Von Willebrand Disease – January 25, 2021 – Recommendations are presented for the diagnosis and management of von Willebrand disease (VWD) in two clinical guidelines issued by the American Society of Hematology, International Society on Thrombosis and Haemostasis, National Hemophilia Foundation, and World Federation of Hemophilia and published online Jan. 12 in Blood Advances. <Read More>

    NCCN® Shares New Guidance Principles for Vaccinating People with Cancer Against COVID-19 – January 22, 2021 – The National Comprehensive Cancer Network® (NCCN®) put out new information to provide guidance for COVID-19 vaccinations in people with cancer. The nonprofit alliance of leading cancer centers created an NCCN® COVID-19 Vaccine Committee that includes top hematology and oncology experts with particular expertise in infectious diseases, vaccine development and delivery, medical ethics, and health information technology. These recommendations can help cancer care providers make informed decisions on how to protect their patients from the ongoing COVID-19 pandemic, based on available evidence plus expert consensus. The committee’s recommendations state that all people currently in active cancer treatment should get the vaccine, with some advice to consider regarding immunosuppression and timing. The full document can be found at NCCN.org/covid-19, along with other vital information about the impact of COVID-19 on cancer care. <Read More>

    Drug Topics® and Managed Healthcare Executive® Announce Partnership with Scientia Pharmacy Advisors – January 21, 2021 – Drug Topics®, a leading multimedia resource that has served the pharmacy field for more than 160 years, and Managed Healthcare Executive®, a multimedia platform that provides market intelligence and solutions to C-suite executives of health plans, are pleased to announce a partnership with Scientia Pharmacy Advisors. The partnership will offer educational opportunities in the areas of clinical practice, network distribution development and utilization management in oncology pharmacy. “We have worked with the founders of Scientia Pharmacy Advisors in several different capacities over the past decade, and we share the goal of advancing science and offering innovative health care solutions,” said Brian Haug, Executive Vice-President, Healthcare of MJH Life Sciences, parent company of Drug Topics® and Managed Healthcare Executive®. “Through this collaboration, we look forward to building upon that relationship and working together to serve as a trusted resource for pharma and healthcare professionals.” <Read More>

    High Court Decision on Arkansas PBM Law, ERISA Opens Door to State Laws – January 21, 2021 – The U.S. Supreme Court in December found an Arkansas law regulating rates pharmacy benefit managers can pay for drugs provided to beneficiaries of prescription drug pans was not preempted by ERISA. Health-care attorney Stuart Silverman says the decision opens the door for other states to enact similar legislation to control health-care costs. <Read More>

    A Clinical Practice Literature Review of Pediatric UTIs – January 21, 2021 – As one of the most common bacterial infections in children, urinary tract infection (UTI) is a familiar foe for most general pediatricians. In a recently released article in Pediatrics, Mattoo et al provides a state-of-the-art review of current literature regarding UTIs1 which compliments the AAP 2016 clinical practice guidelines (10.1542/peds.2020-012138). Their article is a wonderful refresher on some forgotten facts about UTIs and is sprinkled with clinical pearls I’ve found to be very useful in practice. <Read More>

    ASHP Requests Biden Administration Coordinate Federal Response to Expand COVID-19 Vaccination Efforts – January 21, 2021 – In a recent letter sent to President Joseph R. Biden, American Society of Health-System Pharmacists (ASHP) and more than 50 other health systems and provider organizations requested that the president activate federal resources—such as the Department of Defense, the Public Health Service Commissioned Corps, and the Federal Emergency Management Agency (FEMA)—to establish mass vaccination sites that would supplement current coronavirus disease 2019 (COVID-19) vaccination efforts at hospitals, long-term care facilities, and pharmacies. In the letter, the organizations explained that deploying federal resources to meet the needs of the public in the fight against COVID-19 is critical to ensuring the success of President Biden’s goal of vaccinating 100 million people during his first 100 days in office. <Read More>

    Inflammatory Conditions Help Drive Another Strong Year for Specialty – January 21, 2021 – Forty-eight percent of drug spending in pharmacy was for specialty medications in 2019, according to Express Scripts’ 2019 Drug Trend Report, the latest available report. Aimee Tharaldson, PharmD, a senior clinical pharmacist of Emerging Therapeutics at Express Scripts, predicted that specialty drugs would outpace traditional medications in 2020 and that trend would continue in 2021. Inflammatory conditions stood out in the Express Scripts report, Tharaldson noted during the AMCP Nexus 2020 virtual meeting. <Read More>

    Fact Check: COVID-19 Vaccines Will Not Make People Test Positive for the Disease – January 21, 2021 – A 56-minute video in which a doctor claims to tell “the truth about CV19 vaccine” contains various misleading claims, including that vaccines will make people test positive for COVID-19, thereby artificially increasing the number of new cases; that the disease was renamed as part of a cover-up; and that there are proven effective treatments for COVID-19 that the media is ignoring. There are numerous other claims in the video that are outside the scope of this fact check. <Read More>

    Here Are 7 of the Biggest Coronavirus Vaccine Myths Busted by Experts – January 21, 2021 – Vaccine skepticism and outright anti-vaccination sentiment have become rife in recent months, with more members of the public questioning not only the efficacy of vaccines, but their development practices, safety standards and their objectives. The rapid development of coronavirus vaccines over the past year, an urgent task given the devastation to lives and livelihoods being caused by the global pandemic, has made them a prime target for hesitancy and myth. But disinformation and misinformation that casts doubt over safety and efficacy can endanger lives. <Read More>

    ADA Releases Annual Guidelines for CVD Management in Diabetic Patients – January 21, 2021 – The American Diabetes Association (ADA) has updated its annual guidance on cardiovascular disease risk management in patients with diabetes…The guidelines list more than 40 recommendations related to blood pressure targets, screening and diagnosis, and overall cardiovascular disease risk management strategies. <Read More>

    Ohio Pharmacy Provider Suspended From Distribution After 890 COVID-19 Vaccine Doses Wasted  – January 21, 2021 – SpecialtyRx, a pharmacy provider in Columbus, Ohio, was suspended from distributing COVID-19 vaccines Jan. 20 after the state’s health department discovered the provider potentially mishandled and wasted 890 doses of Moderna’s COVID-19 vaccine. The Ohio Department of Health said the provider was given 1,500 vaccine doses to give to residents at eight long-term care facilities. The provider gave the first doses and had 890 left over. The company was looking into transferring the remaining doses to another provider when it discovered it failed to properly monitor the temperatures in its refrigerator and freezer holding the vaccines, the health department said. <Read More>

    NCCN Now Recommends Breast Cancer Index for Predicting Benefit from Extended Endocrine Therapy – January 20, 2021 – The Breast Cancer Index assay is the only of its kind to be recommended in the National Comprehensive Cancer Network Guidelines for the treatment of breast cancer as being predictive of extended adjuvant endocrine therapy. Breast Cancer Index (BCI), a molecular gene expression–based test used for determining which patients with early-stage, hormone receptor (HR)–positive breast cancer benefit from extended endocrine therapy, is now included in the National Comprehensive Cancer Network (NCCN) Guidelines for breast cancer, according to Biotheranostics, Inc. <Read More>

    ESMO: When to Order Next-Gen Cancer Sequencing – January 20, 2021 – In looking back on key oncology developments in 2020, clinicians should put new recommendations for using next-generation sequencing (NGS) in metastastic cancer on their short list, according to Jai Patel, PharmD, the chair of the Department of Cancer Pharmacology and Pharmacogenomics at Levine Cancer Institute, Atrium Health, in Charlotte, N.C. <Read More>

    Pharmacists Rise to the Challenge of Expanded Roles January 20, 2021 – The coronavirus disease 2019 (COVID-19) pandemic continues to put an immense burden on the nation’s health care system and has altered the delivery and practice of health care in many ways. Health care professionals, including pharmacists, are overcoming those challenges with dedication and ingenuity and continuing to provide quality care to patients. Pharmacists are, for example, addressing concerns from especially anxious, fearful patients amid the cold and influenza season. The CDC indicates that an estimated 90% of Americans live within 5 miles of a community pharmacy, providing easy access to patients.1 In a July 2020 report, the CDC indicated that despite the challenge of dealing with the pandemic, pharmacists have maintained the delivery of critical health services to patients, including those patient populations at greater risk for COVID-19–related complications.1 The CDC report also noted that pharmacists are in a vital position to deliver priority pandemic responses, including COVID-19 testing, point-of-care testing for chronic disease management, and vaccinations. <Read More>

    Physician-Pharmacist Partnerships May Help Expand Access to Opioid Addiction Treatment – January 20, 2021 – Most people with opioid use disorder don’t get treatment — and a lack of providers authorized by the U.S. government to prescribe anti-addiction medicines is a big part of the reason. Now, a new pilot project suggests it may be possible to treat far more people if community pharmacists can help care for these patients. People with opioid use disorder who get prescribed the anti-addiction medication buprenorphine by a physician may be able to continue this treatment regimen without repeat doctor visits if their local pharmacist can step in to manage their care, a new pilot study suggests. <Read More>

    Media Statement from Rochelle P. Walensky, MD, MPH, CDC Director and ATSDR Administrator – January 20, 2021 – Rochelle P. Walensky, MD, MPH officially began her post as the 19th director of the Centers for Disease Control and Prevention (CDC) and the ninth administrator of the Agency for Toxic Substances and Disease Registry (ATSDR). U.S. President Joe Biden selected Dr. Walensky to lead the agency in December. Dr. Walensky comes to CDC from Massachusetts General Hospital, where she served as Chief of the Division of Infectious Diseases from 2017-2020; and Harvard Medical School, where she served as Professor of Medicine from 2012-2020. Additional biographical information is available on the CDC website. <Read More>

    New Guidelines Would Make it Easier For Pediatricians to Prescribe Buprenorphine – January 19, 2021 – New practice guidelines from the U.S. Department of Health and Human Services (HHS) should make it easier for pediatricians to provide treatment for opioid use disorder in their offices. Under the guidelines, physicians with a Drug Enforcement Administration registration number no longer have to apply for a separate waiver (X-waiver) to prescribe buprenorphine, a partial opioid agonist. The exemption applies only to physicians (not other health care professionals) and does not cover methadone…Editor’s note:  With the change of the presidential administration, the new guidelines on buprenorphine prescribing have not taken effect. They may be delayed or revised. AAP News will continue to monitor the issue and update members. <Read More>

    American Society of Health-System Pharmacists and Tabula Rasa HealthCare Partner to Offer Vancomycin Bayesian Dosing Solution for Members – January 19, 2021 – American Society of Health-System Pharmacists (ASHP) and Tabula Rasa HealthCare (“TRHC”) announced the organizations have partnered to provide TRHC’s market-leading Bayesian Dosing platform, DoseMeRx™, to pharmacy professionals in small and rural hospitals. TRHC’s DoseMeRx is the most efficient and cost-effective means for small and rural hospitals to comply with the revised guideline for monitoring vancomycin in the treatment of serious methicillin-resistant Staphylococcus aureus (MRSA) infections. <Read More>   

    340B in the News 

    PhRMA Sues HHS to Overturn Dispute Resolution Rule for 340B Program – January 25, 20211 – The pharmaceutical industry wants to overturn a new rule that aims to resolve disputes between manufacturers and hospitals over the 340B drug discount program. The Pharmaceutical Research and Manufacturers of America sued the Department of Health and Human Services in federal court late Friday over a rule finalized late last year that creates an administrative dispute resolution (ADR) process for handling disputes. The lawsuit comes as several major drug companies have cut off access to discounted products to 340B covered entities’ contract pharmacies. “The Trump administration rushed to finalize a flawed ADR rule and ignored the program’s larger issues,” said James Stansel, the PhRMA executive vice president and general counsel. <Read More>

    HHS Freezes Rule Affecting Community Health Center’s 340B Drug Discounts – January 22, 2021 – The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021…Pursuant to the regulatory rule freeze, the Department of Health and Human Services (HHS) has frozen a final rule that would have blocked community health centers (i.e., federally qualified health centers) from receiving future grant funding unless the health centers provided a complete pass-through of 340B discounts on insulin and epi-pens to low-income patients (the 340B Insulin Pass-Through Rule). <Read More>

    340B Rollback Prompts Action By Stakeholders – January 19, 2021 – The dispute between drugmakers and covered entities under the 340B Drug Pricing Program has ramped up, as a number of hospital and pharmacy associations are suing the Department of Health and Human Services to undo manufacturer limitations on 340B discounts. Their efforts have paid off: On Dec. 30, HHS issued an advisory opinion stating that drug manufacturers are required to deliver 340B discounts on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities. Although advisory opinions do not carry the force of law, “they set out the agency’s current views on issues,” HHS said in a statement. “Those views may be reflected in the … enforcement and oversight powers the federal government has to run the 340B Program.” <Read More>

    AstraZeneca, Sanofi, Eli Lilly Sue HHS Over 340B Opinion – January 19, 2021 – Eli Lilly, Sanofi and AstraZeneca have all filed lawsuits asking courts to reverse an advisory opinion released by HHS stating that 340B discounts apply to contract pharmacies, Bloomberg Law reported. The drugmakers argue the advisory opinion, which HHS released Dec. 30, is unlawful and requires them to honor a practice that isn’t covered under the 340B statute. Advisory opinions don’t carry the force of a law, but they guide how HHS enforces the program The drug companies are worried that the alternative dispute resolution board will rely on the opinion when making decisions, according to Bloomberg Law. The Health Resources & Services Administration created the dispute resolution board in early December, designed to settle disputes between 340B hospitals and drugmakers. Because the panel consists of HHS representatives, it will “treat the advisory opinion as binding in any ADR proceeding, almost certainly find that Sanofi’s integrity initiative violates Section 340B as interpreted by HHS, and potentially impose crippling sanctions,” Sanofi said in its lawsuit. <Read More>