Clinical Insights: March 9, 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

    Azstarys™ (dexmethylphenidate and serdexmethylphenidate) Capsules – New Drug Approval – March 2, 2021 – KemPharm, Inc., a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for (NDA) Azstarys™ (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. Azstarys™ consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. Corium, Inc. (Corium), a portfolio company of Gurnet Point Capital (GPC), will lead the commercialization of Azstarys™ per the definitive collaboration and license agreement (the “License Agreement”) between KemPharm and an affiliate of GPC. Corium expects to make Azstarys™ commercially available in the U.S. as early as the second half of 2021. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Humira® (adalimumab) Injection – New Approved Indication – February 24, 2021 – AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Humira® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, Humira® induced clinical remission at Week 8 and maintained remission at Week 52 in patients who responded at Week 8. “Ulcerative colitis can have a profound effect on children and for too long, treatment options for pediatric patients have been limited,” said Brandee Pappalardo, vice president and head of U.S. immunology medical affairs, AbbVie. “This approval provides the first and only subcutaneous biologic for pediatric patients with ulcerative colitis that can be administered at home. This new indication for Humira® demonstrates AbbVie’s commitment to patients with inflammatory bowel diseases and reinforces our goal of reducing the burden of this disease for patients.” <Read More>

    New/Updated Drug Shortage

    March 05, 2021

    March 03, 2021

    March 02, 2021

    New Drug Recall and Safety Alerts

    Gamunex-C® (immune globulin [human]) by Grifols Therapeutics – New Voluntary Drug Recall – March 2, 2021 – This is to inform you that Grifols Therapeutics is initiating a voluntary withdrawal of one lot of Gamunex-CÒ 10%, as detailed below. As a precautionary measure, this voluntary withdrawal is being conducted due to a higher rate of allergic/hypersensitivity type reactions, a small number of which were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with IVIG products. This withdrawal is being conducted with the knowledge of the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. <Read More>

    New Generic/Biosimilar Approval and Launch

    Xulane® (ethinyl estradiol/norelgestromin) – First-time Generic Approval – February 26, 2021 – Amneal Pharmaceuticals, Inc. announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for 150 mcg/day Norelgestromin and 35 mcg/day Ethinyl Estradiol Transdermal System. In conjunction with its approval, Amneal received a Competitive Generic Therapy (CGT) designation by the FDA and has been granted 180 days of exclusivity. Amneal’s Norelgestromin and Ethinyl Estradiol Transdermal System is the generic version of the reference listed drug (“RLD”) Ortho Evra® and will be marketed under the proprietary name Zafemyä. Zafemyä is a 12.5 cm2 patch indicated for the prevention of pregnancy in women with a Body Mass Index of less than 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Zafemyä may be less effective in preventing pregnancy in women at or above 198 lbs (90 kg). The Company expects to begin commercialization activities on March 1, 2021. <Read More>

    Clinical and Pharmacy News

    Cardiac Arrest From Opioid Overdose has Unique Features Affecting Prevention and Treatment ­– March 8, 2021 – Out-of-hospital cardiac arrests triggered by opioid overdose are a significant cause of death among adults 25 to 64, according to a scientific statement from the American Heart Association, the nation’s largest voluntary health organization focused on heart and brain health for all. The statement published n the Association’s flagship journal Circulation. In the U.S., opioid use disorder affects an estimated 2 million people each year and costs more than $78 billion in health care expenses. The opioid epidemic, which spans more than three decades, accounted for approximately 128 deaths a day in 2018, mostly among adults ages 25 to 55. And, more than 15% of the opioid overdose emergency medical service cases in 2016 included cardiac arrest. <Read More>

    CDC Issues First Set of Guidelines on How Fully Vaccinated People Can Visit Safely with Others – March 8, 2021 – The Centers for Disease Control and Prevention (CDC) issued its first set of recommendations on activities that people who are fully vaccinated against COVID-19 can safely resume. The new guidance—which is based on the latest science — includes recommendations for how and when a fully vaccinated individual can visit with other people who are fully vaccinated and with other people who are not vaccinated. This guidance represents a first step toward returning to everyday activities in our communities. CDC will update these recommendations as more people are vaccinated, rates of COVID-19 in the community change, and additional scientific evidence becomes available. <Read More>

    Staying Current in Medicine – March 8, 2021 – Medicine is a constantly advancing field. And the advances have real implications and day-to-day application when it comes to patient care. Between discoveries that uncover disease risk factors to new medication approvals to advances in therapeutic technology, the only certainty in medicine is that the practice of every specialty will change substantially throughout a physician’s career. Many of the accepted diagnostic and treatment approaches that a doctor becomes proficient at during residency will be outdated by the time a physician reaches mid-career. So, staying updated is vital. But it can be challenging to learn how to apply the newest modalities to deliver patient care when keeping up with a busy practice and a busy life. There are several efficient ways to stay updated in medicine throughout your career. It may not be realistically possible to incorporate all of them, but maintaining a few consistent habits can keep a physician updated throughout the years. <Read More>

    Update to Asthma Guidelines Covers ICS, Lamas, Indoor Allergy Mitigation, More – March 5, 2021 – In December 2020, the National Asthma Education and Prevention Program (NAEPP) Coordinating Committee released a focused update to its 2007 asthma guidelines. The update covers select topics, such as intermittent use of inhaled corticosteroids (ICS), the role of long-acting muscarinic antagonists (LAMAs), indoor allergy mitigation, use of immunotherapy, bronchial thermoplasty, and fractional exhaled nitric oxide (FeNO) testing. <Read More>

    Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test – March 5, 2021 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription. “The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.” <Read More>

    How Will Patients React to Medications? The Answer May Be in Their Genes – March 5, 2021 – A recent study published in Psychiatry Research found that a combinational pharmacogenetic test was a better predictor of medication blood level and patient outcomes than single-gene testing alone. Common psychiatric medications for depression and anxiety can react with patients’ genes in ways that inhibit the drugs’ effectiveness. It is possible to test single genes for potential interactions, but Myriad Genetics has developed a test that analyzes gene combinations as well. The study found that testing variations in multiple genes led to better, more predictive results. <Read More>

    NCCN Guidelines for Histiocytosis Clarify Best Practices for Recently-Defined Cancers – March 5, 2021 – The National Comprehensive Cancer Network has published NCCN Guidelines for Histiocytosis. Histiocytoses are rare disorders characterized by a buildup of white blood cells called histiocytes, which leads to tissue damage. This group of disorders is diagnosed in a few thousand people every year across the United States. As a result of this low incidence rate, people are often diagnosed late and receive treatment from doctors who have limited or no prior experience with the disease. These new clinical practice guidelines from NCCN provide the latest evidence and expert-consensus for diagnosing and treating the three most-common forms of histiocytosis in adults: Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD), and Rosai-Dorfman disease. <Read More>

    ACG Revises CRC Screening Guidelines, Supports Starting Screening at 45 for Average-Risk Patients, Doesn’t Recommend Blood-Based Screening Test – March 4, 2021 – The American College of Gastroenterology updated its 2009 guidelines around colorectal cancer screening, making 21 total recommendations. ACG posed several key questions and developed practical recommendations for practice providers. The recommendations were crafted through a focused literature search and supplemented by existing guidelines and technical reviews of CRC screening by key organizations. The guidelines were then modified using a Grading of Recommendations, Assessment, Development and Evaluation methodology. <Read More>

    Tighter Rules: State Seeks to Regulate Pharmacy Benefit Managers – March 4, 2021 – It happened just last month at Topeka Pharmacy, a small drugstore about an hour north of Fort Wayne. A longtime customer needed a prescription filled for a 90-day supply of Lupron, an expensive hormone drug, for a daughter suffering from numerous medical conditions. The pharmacy’s owner, Trevor Thain, normally gets the drug from a longtime distributor, but that supplier was out of the medicine. So Thain began looking elsewhere. Two other distributors had higher prices on the drug, but Thain would have had to eat the difference, about $500. Why? Because a powerful but little-understood middleman, known as a pharmacy benefits manager, had negotiated terms on the price of drugs between his pharmacy and the drugmaker, giving Thain access to lots of customers and their insurance plans, but little flexibility in how to fill orders and how much he could get reimbursed. <Read More>

    Patient Safety and the Role of a Specialty Pharmacist in a Health System ­– March 4, 2021 – The specialty pharmacist has a unique role in medication safety. Not only are they responsible for ensuring safe, effective, appropriate use of specialty medications—and ensuring that the patient is educated on their therapy and can be adherent—but they also play a strong role in promoting a positive safety culture within their pharmacy setting. Due to the high-touch, high-risk nature of specialty medications, specialty pharmacies must incorporate robust programs to ensure proper medication usage and minimize the potential for error or adverse events. Engaging specialty pharmacy staff members in the importance of patient safety and creating a just culture can have a strong influence on patient safety and the reduction of errors. <Read More>

    Biosimilar Switches Work at Large and Small Centers – March 4, 2021 – Large health systems as well as small community hospitals can successfully convert to oncology biosimilars and achieve substantial savings, according to presentations at the ASHP 2020 Midyear Clinical Meeting and Exposition. University Hospitals (UH) Health System, in northeastern Ohio, achieved approximately $500,000 in savings annually by switching to the biosimilar filgrastim-sndz (Zarxio, Sandoz). Kalispell Regional Medical Center, a 288-bed hospital in northwestern Montana, had similar success converting to pegfilgrastim-cbqv (Udenyca, Coherus), netting the medical center close to $400,000 over 11 months. <Read More>

    When Disaster Strikes, Hospitals Call in Residents – March 4, 2021 – Lisa Glance Mostafavifar, PharmD, the PGY1 residency program director at The Ohio State University (OHSU) College of Pharmacy, in Columbus, always held her pharmacy residents in high regard. However, through their work during the COVID-19 pandemic, she realized just how essential their contributions are to helping the pharmacy department provide patient care services. “The commitment our pharmacy residents have shown to providing excellent patient care has never been as evident as it has [been] during the pandemic,” Mostafavifar said. “Plain and simple, we would not have the reach we have without our residents.” <Read More>

    Study: Biosimilar vs Originator Spending on Comparative Efficacy Trials ­– March 4, 2021 – A study of comparative clinical efficacy trials for biosimilars, often considered unnecessary, suggests that these trials are often larger and as rigorous as those done for originator products, and often are more costly than for new molecular entities. The study evaluated biosimilar trials conducted for products approved between January 2010 and October 2019. “When phase 3 efficacy trials were required (21 of 23 approved biosimilars), the median patient enrollment, treatment duration, and estimated costs often exceeded those reported in published studies of FDA pivotal trials required for new molecular entities,” authors of the study wrote. <Read More>

    WHO ‘Strongly’ Against Hydroxychloroquine Use for COVID-19 Prevention – March 4, 2021 – Laboratory-based studies and non-randomized preliminary studies in humans initially led researchers and public health officials to support the use of hydroxychloroquine as a potential preventive treatment for COVID-19. However, as researchers gathered more evidence, the Food and Drug Administration (FDA) eventually revoked their emergency use authorization for treating COVID-19. Now, based on the findings of a new analysis, an international panel of experts strongly advises against the use of hydroxychloroquine to prevent COVID-19. These recommendations could help reduce the risk of experiencing adverse side effects from taking hydroxychloroquine unnecessarily. The guidelines could also help encourage the exploration of other therapies with more promising results. <Read More>

    Orsini Specialty Pharmacy Selected By Sarepta Therapeutics as a Limited Distribution Partner for Amondys 45™ (casimersen) – March 4, 2021 – Orsini Specialty Pharmacy, the leading independent specialty pharmacy focused on rare diseases and gene therapies, announced that it has been selected by Sarepta Therapeutics, Inc. as a limited distribution partner for Amondys 45™ (casimersen). Amondys 45™ is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have genetic mutations on exon 45 of the dystrophin gene. For more information about Amondys 45™, please see the Full Prescribing Information.  Orsini is the only specialty pharmacy with access to all approved DMD therapies. <Read More> 

    The Biden Administration Plan for Treating Opioid Use Disorder in the US: Is There One? – March 3, 2021 – In late January 2021, just about a week after President Biden took office, more than a dozen major medical groups, including AMA and ASRA, published a letter to the Department of Health and Human Services urging that the new administration “take steps to eliminate federal policies that inhibit access to vital treatment” to the nation’s other ongoing crisis, the opioid epidemic. The vital treatment: buprenorphrine for opioid addiction. <Read More>

    Topical Anti-Inflammatories: Analgesic Options for Arthritis Beyond NSAIDs – March 3, 2021 – Topicals are growing in preference given their localized drug delivery and low systemic absorption. Both aspects result in a more favorable side effect profile for patients seeking pain relief. Topical medications differ from transdermal medications in that transdermal drug delivery systems are designed to deliver drugs systemically through cutaneous absorption from external application. Topical preparations are designed for localized effects, therefore minimizing systemic effects. <Read More>

    Utilizing Pharmacogenomics Information to Guide AML Treatment – March 3, 2021 – Pharmacogenomic testing plays a large role in selecting appropriate therapy for the treatment of acute myeloid leukemia (AML), a hematologic malignancy characterized by clonal expansion of myeloid hematopoietic precursors in the bone marrow and peripheral blood. There are specific treatment options patients may qualify for depending on the cytogenetic or molecular abnormality detected. AML accounts for about 80% of acute leukemias in adults. This cancer is most common in adults and is more common in men than women. The 5-year relative survival rate is about 25% for patients with AML 20 years and older, and less than 5% in those patients older than 65 years. <Read More>

    Study Evaluates Confidence, Reluctance, and Self-Reported Behaviors After Pharmacy Mental Health First Aid Training – March 3, 2021 – Mental Health First Aid (MHFA) is a course by the National Council for Behavioral Health designed for non-mental health care professionals to provide the knowledge and skills needed to identify, understand, and help people in distress with mental health and substance-use issues. This training gives people the tools needed to initiate uncomfortable conversations about mental health and substance use issues, dispelling stigma and myths through education, and providing people with an action plan to identify and connect people to care during a crisis. <Read More>

    Pharmacists Wish People Would Stop Calling Over and Over About Vaccines – March 3, 2021 – The retail pharmacy COVID-19 vaccine rollout has incited national public frustration. According to internet wisdom, the secret to getting an appointment is being “persistent” and “clicking incessantly.” When that doesn’t work, complaints of crashing appointment sites, ghost appointments, and calendars with no availability swarm social media feeds and flood pharmacy phones. But when you call a pharmacy, there’s a person on the other end of that line, fielding the complaints, desperate appointment attempts, and click storms. Slate talked to three pharmaceutical workers around the country to learn how they are handling the pressure. <Read More>

    Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial ­– March 3, 2021 – Eli Lilly and Company and Incyte announced top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s). There are currently no FDA-approved treatments for AA. <Read More>

    Becerra Nomination Moves to Full Senate After Panel’s Split Vote (1) – March 3, 2021 – Xavier Becerra, President Joe Biden’s pick to lead the Department of Health and Human Services, will be considered by the full Senate after the Finance Committee split its vote on his nomination. The Senate Finance Committee was split 14-14 along party lines on the nomination. Becerra’s nomination will now need four hours of debate and a majority vote by the Senate in order for it to be brought up for a final vote, according to Finance Committee spokesman Taylor Harvey. <Read More>

    Fentanyl Transdermal Patch: Variability is Key When Prescribing – March 2, 2021 – The fentanyl transdermal patch is a unique formulation that utilizes a transdermal system for providing sustained action with a short-acting medication such as fentanyl. This mechanism allows for the treatment of pain in opioid-tolerant individuals with stable chronic pain who require long-term analgesic therapy with an opioid…Physicians’ incomplete knowledge of transdermal fentanyl can be a source leading to potential error. From responses to a prescribing survey on opioid conversion calculations, Rennick et al found inconsistency and wide variability in opioid conversion calculations; an “alarming” result was for differences in conversions for fentanyl. Rennick’s team suggested that this may be a reflection of “overconfidence in equianalgesic tables, source inconsistency, and reliance on personal knowledge.” <Read More>

    Under Biden Administration, Will Federal Drug Pricing Transparency Efforts Continue to Outpace State Laws? ­– March 2, 2021 – During 2019 and 2020, states enacted fewer laws requiring drug manufacturers to disclose pricing and related information. Initially, the slowdown may have been due to federal actions to rein in drug prices through the Trump administration’s multiple executive orders. Thereafter, states were focused on responding to the pandemic and drug pricing was understandably placed on the back burner. Circumstances have since changed. We now have a new president and administration, and the country is hopefully turning the corner on the COVID-19 pandemic. <Read More>

    340B in the News

    Look for Drug Pricing, Other Government Changes–But be Prepared to Wait – March 4, 2021 – Political divisiveness on Capitol Hill, a focus on impeachment activity and financial relief for the COVID-19 pandemic, as well as delays in confirming President Joe Biden’s nominees for cabinet and subcabinet positions, so far have caused a slowdown in the new administration’s ability to make sweeping changes affecting health care, a policy expert said during the opening day of Informa’s HUB and SPP Model Optimization 2021 virtual event…Significant debates abound in the legal community regarding 340B drug pricing. One contentious issue is the use of third-party contract pharmacies by institutions that qualify for 340B drug pricing but do not have in-house pharmacies. The use of contract pharmacies can yield significant cost savings for these hospitals, but the practice has drawn the ire of drug manufacturers, many of which have sought to block these arrangements over the past year. The conflict has resulted in an administrative ruling by the U.S. Department of Health and Human Services (HHS) to uphold the rights of contract pharmacies to access 340B prices. <Read More>

    Spanberger Leads Bipartisan Effort to Save 340B Drug Pricing Program – March 3, 2021 – Abigail Spanberger is leading a bipartisan effort to defend the 340B Drug Pricing Program from changes that have led to prescription drug cost hikes for Virginia healthcare providers. The 340B Drug Pricing Program was enacted by Congress in 1992 with bipartisan support and is overseen by the U.S. Department of Health and Human Services. The program requires that pharmaceutical companies give safety-net and rural healthcare providers discounts on their drugs, in exchange for having their drugs covered by Medicaid…In December, HHS’s General Counsel published an advisory opinion that the manufacturers’ price hikes on safety net providers are unlawful under the 340B statute. In a letter sent to Acting HHS Secretary Norris Cochran, Spanberger, D-Va., and 225 of her congressional colleagues called on HHS to take immediate action against manufacturers that refuse to comply with their obligation to provide safety net and rural providers with discounted drugs and require manufacturers to refund the providers for months of unlawful overcharges. The group called on HHS to preserve covered entities’ access to upfront rebates, which would be consistent would longstanding program guidance. <Read More>

    Uncertainty of Government Pricing Policies, Evolution of PBMs, and 340B Program Expansion Identified as Top External Challenges for Pharma Pricing & Contracting Teams This Year – March 3, 2021 – Trinity Life Sciences, a leader in global life sciences commercialization solutions, is sharing findings from its latest TGaS annual Landscape report entitled, “2021 Trends & Considerations in Contract Management: Responding to Pricing Pressures in an Uncertain Environment.” The report, based on biopharma companies in varying stages of development, finds that uncertainty of government pricing policies, evolution of pharmacy benefit managers (PBMs) and 340B Program* expansion are the top challenges for contracting teams at biopharma companies this year. <Read More>

    Anti-Government Spending Group Attacks Discount Drug Program for the Poor – March 2, 2021 – Each year, thousands of patients at medical facilities that serve the poor are given free or discounted medications through an obscure federal program that pharmaceutical companies are required to participate in as a condition of having their drugs covered by Medicare. Passed by Congress in 1992, the program, known as 340B, has come under attack from the pharmaceutical industry for being too generous to the patients, medical facilities, and pharmacies that benefit from it…Before that letter was sent, the drug industry got lobbying support from a surprising source. Conservative anti-government spending group Council for Citizens Against Government Waste (CCAGW) sent House lawmakers a counter-letter, urging them not to add their names to the McKinley letter…Citizens Against Government Waste first began expressing concerns with the 340B program in 2014, the same year it began receiving contributions from PhRMA after a three-year break. Its PhRMA contributions have steadily increased every year since, starting at $15,000 in 2014 and going up to the $75,000 it received in 2019, the most recent year for which tax information is available. <Read More>

    Stop Businesses from Exploiting This Health Program for the Poor – March 2, 2021 – Over the decades, Congress has created a number of programs intended to help the poor, the sick, the downtrodden. As a result, certain businesses and industries find ways to exploit these efforts and profit in ways lawmakers never foresaw or intended — and even hurt the very people the program was supposed to help. That explains today’s rampant abuse of the 340B drug discount program. Congress created it in 1992 to make sure low-income and uninsured people could access prescription medicine at more affordable prices. But three decades on, thanks to loopholes and a lack of transparency, thousands of hospitals, clinics, and pharmacies exploit 340B discounts without sharing their take with needy patients. It’s time for Congress to get this well-intentioned program back on track, with strict limits on how health care providers can use 340B. <Read More>

    Kavita Patel: Drug Pricing, Care Access Priorities in Federal Health Care Policy – March 1, 2021 – As a new administration finds its footing, cancer care stakeholders are left questioning the futures of a number of federal policies that will impact health care on the whole as well as oncologists, payers, and patients. Kavita Patel, MD, MS, FACP, a fellow at the Brookings Institution Center for Health Policy, addressed a number of those policies to kick off the Association of Community Cancer Centers (ACCC) 47th Annual Meeting and Cancer Center Business Summit…She also hopes to see a rejuvenation of the debate surrounding the Medicare 340B Drug Pricing Program, which has seen bipartisan criticism and accusations of some facilities taking advantage of the program meant to provide drugs at a reduced cost in low-income communities. <Read More>