Clinical Insights: April 13, 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

    Qelbree™ (viloxazine hydrochloride) Extended Release Capsules – New Drug Approval – April 2, 2021 – Supernus Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) approved Qelbree™ (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. “Based on the efficacy demonstrated in the clinical program, we believe Qelbree™ offers a unique new alternative for the treatment of ADHD,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “Qelbree™ provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile. We are grateful to the patients, families and their caregivers who participated in and supported our research.” <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Praluent® (alirocumab) Injection – New Approved Orphan Indication – April 1, 2021 – FDA has approved PraluentÒ (alirocumab) injection for adult patients with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. Praluent® is not intended to be used alone but instead added to other treatments for HoFH. HoFH is a rare, life-threatening condition that occurs in approximately 1 in 250,000 individuals. Patients with HoFH have two mutations in a small group of genes that controls the way the body clears cholesterol. As a result, patients have extremely high circulating levels of low-density lipoprotein cholesterol (LDL-C), commonly known as “bad cholesterol.” These cholesterol levels can range as high as 500-1,000 mg/dL, more than four times the normal levels. <Read More>

    Tyvaso® (treprostinil) – New Approved Indication – April 1, 2021 –United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Tyvaso® (treprostinil) Inhalation Solution for the treatment of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. This is the second FDA-approved indication for Tyvaso®, which was first approved in July 2009 for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. “Adults living with both interstitial lung disease and pulmonary hypertension typically have a poor quality of life because of increased shortness of breath, poor exercise tolerance, and increased mortality. Until now, clinicians treating these patients did not have any approved treatment options,” said Aaron Waxman, M.D., Ph.D., Director of the Pulmonary Vascular Disease Program at Brigham and Women’s Hospital and the chair of the INCREASE Study Steering Committee. <Read More>

    Sarclisa® (isatuximab-irfc) Injection – New Approved Indication – March 31, 2021 – The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. “In the Phase 3 IKEMA study, the addition of Sarclisa® to carfilzomib and dexamethasone reduced risk of disease progression or death by 45%,” said Thomas G. Martin, M.D., Associate Director, Myeloma Program, The University of California, San Francisco, Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and co-leader of the Hematopoietic Malignancies Program, Helen Diller Family Comprehensive Cancer Center. “This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma.” <Read More>

    New/Updated Drug Shortage

    April 08, 2021

    April 07, 2021

    April 06, 2021

    New Drug Recall and Safety Alerts

    No new update. 

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Choice of Blood Pressure Medications Impacts Long-Term Heart Disease Risk in Patients With HIV – April 12, 2021 – For patients with HIV who develop high blood pressure, new research suggests that the type of medication chosen for their initial treatment can have a significant influence on their risk of heart disease, stroke, and heart failure, according to researchers from the Perelman School of Medicine at the University of Pennsylvania. People with HIV who are receiving antiretroviral therapy (ART) are more likely to develop hypertension and hypertension-related heart problems than people who do not have the virus, according to the researchers. They said their study is the first to examine how the choice of blood pressure medications influences the long-term risk of heart disease, stroke, and heart failure in this population. <Read More>

    Reversing Hospital Consolidation: The Promise of Physician-Owned Hospitals – April 12, 2021 – Economic theory holds that competition drives innovation, improves the quality of goods and services, and lowers prices for consumers. Health care delivery is no exception. The COVID-19 pandemic and resulting operational challenges in hospital care delivery have stimulated policy makers’ appetite to address longstanding problems in hospital market efficiency and consolidation. In large part because of mergers, the vast majority of US metropolitan residents now live in highly concentrated hospital markets…A problem acknowledged by both Democrats and Republicans, hospital consolidation, regardless of its causes, presents a vexing stumbling block to better care for Americans. In this post, we review policy interventions available to policy makers to combat hospital consolidation, focusing on the history, challenges, and promise of physician-owned hospitals (POHs). <Read More>

    Gridlock, Middleman Lobbying Cause Pharmacy Benefit Manager Reforms to Fail Again in New York Budget – April 12, 2021 – Many pharmacies and safety-net providers were preparing for the long-anticipated transition from Medicaid managed care to fee-for-service (FFS)—known as the carve-out—that was set to take effect on May 1, 2021. The time surrounding the passing of the New York state budget is always met with much anticipation from residents and businesses. There are often many items of interest tucked into the budget and this year was no different. In the wake of the US Supreme Court’s Rutledge decision in December 2020 that provided a path for states to regulate and control health care costs, many stakeholders believed that big changes were coming in the pharmacy industry in New York, especially after Governor Andrew Cuomo vetoed the bill last year signaling a desire to allow the SCOTUS Rutledge case to clear the path to state reforms. <Read More>

    NCCN Recommends Lenvima™ Plus Keytruda™ for First-Line Renal Cell Carcinoma: What Patients Should Know – April 9, 2021 – CURE spoke with Dr. Eric Jonasch about the National Comprehensive Cancer Network’s Category 1 recommendation for the combination use of Lenvima plus Keytruda for the treatment of front-line renal cell carcinoma. In particular, how it can impact a patient’s treatment journey. The combination use of Lenvima (lenvatinib) plus Keytruda (pembrolizumab) was added as a Category 1 recommendation by the National Comprehensive Cancer Network (NCCN) for the treatment of front-line renal cell carcinoma (RCC). While these recommendations are intended for oncologists to manage cancer care, it is key for patients to also understand why this regimen is preferred and, moreover, how it can impact their treatment journey. <Read More>

    Approaching the Process of Operationalizing Biosimilars in Cancer Care – April 9, 2021 – The first step toward operationalizing the uptake of biosimilars is having a program-level discussion that not only describes what biosimilars are, but also assesses how they impact the bottom line and could get incorporated into treatment plans, according to Sandeep Parsad, PharmD, MBA, BCOP, assistant director of pharmacy at Hematology/Oncology & Investigational Drug Services and director of the PGY2 Oncology Pharmacy Residency Program at the University of Chicago Medicine, during a session at Community Oncology Alliance Virtual 2021 Conference 2021. However, conducting this extensive conversation as a program has gotten easier over time as biosimilars have become more widely adopted. Yet, the discussion still requires a purposeful approach that incorporates the perspectives of all involved in the treatment process, Parsad explained. <Read More>

    Biosimilars Outlook and Why They Could be a Boon to a Strained U.S. Health Care System – April 8, 2021 – The history of generic drugs can be traced to the 1920s when the manufacturer of aspirin went to court to keep generic versions off store and pharmacy shelves. The company lost when the court learned “aspirin” had become the generic name for the product. This case and decades of legislative accomplishments since have paved the way for a thriving generics drug industry, which now accounts for 90% of prescriptions filled in the U.S. Generics have made more medicines accessible to more patients, saving health care systems trillions of dollars along the way. Now, the industry is hoping biosimilar medicines will follow in the footsteps of generic drugs. Biosimilars are Food and Drug Administration (FDA)-approved biologics that have undergone an extensive regulatory evaluation and approval process proving they match the reference medicine in terms of quality, safety, and efficacy. <Read More>

    Outpatient ASPs are Worth the Journey – April 8, 2021 – Antimicrobial stewardship program (ASP) development in the United States has expanded significantly over the past 2 decades, with 85% of acute-care hospitals demonstrating program that contain all of the CDC’s core elements of antimicrobial stewardship. Yet, despite an ever-expanding understanding of inpatient antimicrobial stewardship practices, approximately 80% to 90% of human antibiotic consumption takes place in the outpatient setting. The new ambulatory standard from the Joint Commission for the Accreditation of Healthcare Organizations (TJC) took effect January 1, 2020. Since then, ASPs have focused on the use of antimicrobials in the outpatient setting. The addition of an outpatient ASP to a facility’s armamentarium is both difficult and valuable, given several features of the setting that complicate efforts, including a lack of feasibility of tradition primary stewardship tactics, large volume of outpatient providers, and a vast array of services. <Read More>

    USP Compliance Remains a Focus of TJC Surveyors – April 8, 2021 – Like most things in 2021, this year’s Joint Commission compounding pharmacy surveys will take a different tack, based in part on the practice pressures of COVID-19. The main development is a continued delay in enforcing recent updates to USP’s Chapters on compounding and hazardous drug handling, along with a pandemic-related interim guidance issued for compounding pharmacies. <Read More>

    New Guidelines Issued After Blood Clots Linked to AstraZeneca Vaccine – April 8, 2021 – Several nations have issued new guidelines over the use of AstraZeneca’s COVID-19 vaccine after the European Union’s medical regulator announced a link between the vaccine and rare, possibly fatal blood clots. Britain, where the vaccine was developed jointly by the British-Swedish drugmaker and scientists at the University of Oxford, says it will offer alternatives for adults under 30. Oxford researchers have also suspended a clinical trial of the AstraZeneca vaccine involving young children and teenagers as British drug regulators conduct a safety review of the two-shot regimen. Reuters says Spain and the Philippines will limit the vaccine to people older than 60, while The Washington Post says Italy has issued similar guidelines. <Read More>

    Study: End-of-Life Care Remains Aggressive for Patients With Ovarian Cancer – April 8, 2021 – A recent study has found that patients with ovarian cancer frequently receive aggressive end-of-life care despite industry guidelines that emphasize quality of life for those with advanced disease. As of 2016, ICU stays and emergency department (ED) visits in the last month of life had become more common for patients with ovarian cancer than they were in 2007, the earliest year from which researchers analyzed data, according to the study, published by researchers at the University of Michigan. In addition, the proportion of non-Hispanic Black people who turned to the ED for care was even higher, double that of non-Hispanic whites. Black people were also approximately twice as likely to undergo intensive treatment, including life-extending measures, such as resuscitation or the insertion of a feeding tube. <Read More>

    NIH Experts Call for Accelerated Research to Address Concurrent HIV and COVID-19 Pandemics – April 8, 2021 – The COVID-19 pandemic is affecting people with or at risk for HIV both indirectly, by interfering with HIV treatment and prevention services, and directly, by threatening individual health. An effective response to these dual pandemics requires unprecedented collaboration to accelerate basic and clinical research, as well as implementation science to expeditiously introduce evidence-based strategies into real-world settings. This message comes from a review article co-authored by Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and colleagues published in the Journal of Infectious Diseases. <Read More>

    SPs Help Make HCV+ Organ Transplantation Safer – April 8, 2021 – Organ transplants from hepatitis C virus (HCV)-positive donors to HCV-negative recipients will continue to increase in frequency as more transplant centers develop protocols for their management, said experts from major transplant programs in a session at the ASHP 2020 Midyear Clinical Meeting and Exposition. Integrated specialty pharmacies have responded to this trend by playing a key role in assisting with the selection of medication, management of drug interactions, procuring medication (including insurance approval and financial assistance) and patient education. <Read More>

    NIH Begins Study of Allergic Reactions to Moderna, Pfizer-Biontech COVID-19 Vaccines – April 7, 2021 – A clinical trial is underway to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines. A systemic allergic reaction to a vaccine occurs in one or more parts of the body beyond the injection site. If such an allergic reaction occurs in study participants, investigators will assess whether the reactions are more frequent in participants who are highly allergic or have a mast cell disorder than in participants with no allergic history. In addition, investigators will examine the biological mechanism behind the reactions and whether a genetic pattern or other factors can predict who is at most risk. <Read More>

    Calcimimetic Agents for Treatment of Adults with Secondary Hyperparathyroidism – April 7, 2021 – Complications of chronic kidney disease (CKD) include hyperphosphatemia, impaired vitamin D activation, hypocalcemia, and increased parathyroid hormone (PTH) synthesis and secretion. Secondary hyperparathyroidism and other factors that include hyporesponsiveness to PTH and fibroblast growth factor 23 biology lead progressively to bone pain, fracture, and deformity; accelerated valvular and vascular calcification; myopathy; and itch. There is also an association between secondary hyperparathyroidism and all-cause and cardiovascular mortality. International clinical practice guidelines call for serum PTH levels being lowered toward a target range. <Read More> 

    Hospitals and Health System Pharmacists Urge FDA to Take a Closer Look at ‘White Bagging’ – April 7, 2021 – The practice known as “white bagging” is exacerbating supply chain security challenges and jeopardizing patient safety, the American Society of Health-System Pharmacists and the American Hospital Association told acting Food and Drug commissioner Dr. Janet Woodcock in a March 31 letter. ASHP and AHA strongly encouraged the FDA to consider the patient safety and supply chain security risks of white bagging, and take appropriate enforcement action, according to the March 31 letter sent by AHA executive vice president Thomas P. Nickels and Tom Kraus, vice president of government relations for the American Society of Health-System Pharmacists. <Read More>

    Hopkins Medicine Endocrinologist Publishes First Clinical Practice Review on Diabetes Management – April 7, 2021 – New medicines for people who have diabetes seem to pop up all the time. Drugs that help the body break down carbohydrates, drugs that increase excretion of glucose in the urine, drugs that help muscles respond to insulin and drugs that stimulate the pancreas to produce it -; the list of pharmaceutical options to treat diabetes gets longer and longer…Johns Hopkins Medicine endocrinologist and associate professor Rita Rastogi Kalyani, M.D., authored a clinical practice review article in the April 1 edition of The New England Journal of Medicine (NEJM) that distills the newest trial results and guidelines into a systematic approach for treating patients with diabetes and a risk of cardiovascular disease. Kalyani’s article is the first clinical practice review that the journal has published on diabetes management in almost a decade. <Read More>

    AGA’s New Clinical Guidelines Recommend the Use of IGB for Obese Patients – April 7, 2021 – Obesity is a global pandemic, affecting about 40% of adults in the United States. There is an enormous unmet need for an effective weight-loss solution. After a detailed review of available literature, the American Gastroenterological Association (AGA) has released new clinical guidelines recommending the use of intragastric balloons (IGB) for patients with obesity who have not been able to lose weight with traditional weight-loss strategies. <Read More>

    NICE: GPs Should ‘Encourage And Support’ Some Patients to Stop Taking Opioids for Chronic Pain – April 7, 2021 – The final publication of NICE’s first-ever guideline on chronic pain has recommended that GPs should ‘encourage and support’ patients to stop taking opioids in certain cases. It confirmed recommendations made in draft guidance, published in August, which said that GPs should not prescribe commonly-used medicines including opioids and gabapentinoids to patients with chronic primary pain because they could be ‘harmful’. GPs should consider alternatives such as certain antidepressants, an exercise programme, CBT or acupuncture, it reiterated. <Read More>

    Federal Grantees May Now Use Funds to Purchase Fentanyl Test Strips – April 7, 2021 – The Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that federal funding may now be used to purchase rapid fentanyl test strips (FTS) in an effort to help curb the dramatic spike in drug overdose deaths largely driven by the use of strong synthetic opioids, including illicitly manufactured fentanyl. FTS can be used to determine if drugs have been mixed or cut with fentanyl, providing people who use drugs and communities with important information about fentanyl in the illicit drug supply so they can take steps to reduce their risk of overdose. “This is a major step forward in the ongoing and critical work to prevent overdose and connect people who have substance use disorders to evidence-based treatment options,” said Acting Assistant Secretary for Mental Health and Substance Use Tom Coderre, the interim leader at SAMHSA. <Read More>

    Improve Care for Patients With Community-Acquired Pneumonia – April 7, 2021 – Empiric anti-MRSA therapy is an area of opportunity for antimicrobial stewardship in the treatment of CAP. Pneumonia is the leading infectious cause of mortality in the United States, with timely antibiotic therapy serving as the foundation of treatment. Appropriate risk assessment of patients presenting with community-acquired pneumonia (CAP) is imperative to guide empiric therapy. Given increasing resistance in the community, the term health care-associated pneumonia (HCAP) was created. This term was accompanied by increased use of broad-spectrum agents. When the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA) updated guidelines for treating adults with CAP in 2019, HCAP was eliminated in favor of assessment of local and patient-specific risk factors for Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus (MRSA). <Read More>

    Provider Perceptions of Pharmacists in Primary Care–Based Accountable Care Organizations – April 7, 2021 – Clinical pharmacists are in an ideal position to manage multiple aspects of patient care within value-based care models. In 2015, Nova Southeastern University College of Pharmacy founded the Accountable Care Organization Research Network, Services, and Education (ACORN SEED), a team of pharmacy practice faculty dedicated to using innovative approaches to patient care while providing unique learning experiences for pharmacy students by partnering with primary care–based accountable care organizations in the South Florida region. In this article, we describe our experiences with ACORN SEED, addressing provider perceptions and creating methods to overcome several challenges to clinical pharmacist integration, including (1) providing value, (2) collaborative practice, and (3) workflow disruption. Overcoming these challenges is critical for organizations aiming to expand pharmacist integration to improve patient outcomes and reduce health care costs. <Read More>

    Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System – April 6, 2021 – The U.S. Food and Drug Administration announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples. Samples collected at home are then sent to a Symbiotica, Inc. laboratory for analysis. <Read More> 

    CDC Awards $3 Billion to Expand COVID-19 Vaccine Programs – April 6, 2021 – The Centers for Disease Control and Prevention (CDC) has awarded funding to support local efforts to increase vaccine uptake by expanding COVID-19 vaccine programs and ensuring greater equity and access to vaccine by those disproportionately affected by SARS-CoV-2, the virus that causes COVID-19. The awards are part of $3 billion in funding that CDC has granted to 64 jurisdictions to bolster broad-based vaccine distribution, access, and administration efforts. The funding was made available by the American Rescue Plan and the Coronavirus Response and Relief Supplemental Appropriations Act and will provide critical support through CDC’s existing immunization cooperative agreements in communities around the country. <Read More>

    Cymbalta™  Withdrawal: What it is and how to get Through it – April 6, 2021 – As of 2019, over 50 million American adults live with a mental illness, and over 20 percent of American adults experience chronic pain. Cymbalta™ (duloxetine) is a drug commonly prescribed for these conditions, which include depression, anxiety, and certain chronic pain issues. As with all similar drugs, stopping Cymbalta™ can cause withdrawal side effects, some of which can be difficult to live with. Whether you’re planning to stop Cymbalta™ or are already weaning yourself off of it, there are steps you can take to minimize these symptoms. In this article, we’ll discuss more about Cymbalta™ withdrawal, including some of the common side effects and tips on how to manage during the withdrawal process. <Read More>

    New Clinical Guidance: Appropriate Use of Short-Course Antibiotics in Common Infections – April 6, 2021 – The American College of Physicians (ACP) has issued Best Practice Advice with recommendations for the appropriate use of antibiotics for four common bacterial infections, as overuse, resistance, and long and unnecessary use remain major health care issues. “Appropriate Use of Short Course Antibiotics in Common Infections: Best Practice Advice from the American College of Physicians,” published in Annals of Internal Medicine, addresses best practices for prescribing appropriate and short-duration antibiotics for patients presenting with these infections. <Read More>

    Glucarpidase Keeps CNS Lymphoma Rx on Track – April 6, 2021 – A new outpatient treatment regimen allowed patients with central nervous system (CNS) lymphoma to continue infusions during the height of the COVID-19 pandemic, and could change the way patients receive care after the current crisis subsides. Researchers at Memorial Sloan Kettering Cancer Center (MSKCC) in New York City found methotrexate could be coupled with repeated doses of glucarpidase (Voraxaze, BTG International), and patients could safely receive the two treatments in an outpatient setting, according to a study presented at the 2020 Society for Neuro-Oncology virtual annual meeting. <Read More>

    Our New Look Reflects APhA’s Style and Personality – April 6, 2021 – APhA is putting a new face forward. You might have noticed that APhA’s website has been completely transformed and modernized. The new is clean, contemporary, and designed with our members’ needs in mind. You’re too busy to spend 5 minutes or even 10 seconds navigating an information obstacle course, so the next generation of makes finding what you need a cinch. Our search function is first class. The uncrowded look means your online experience is simple and unfussy. It’s safe and accessible for people with disabilities. From education programs to practice resources to advocacy tools, everything APhA has to offer is a click away. The revamped APhA website was a labor of love for our members, but it’s just one piece of the launch of our new brand—an effort years in the making. The new brand will reintroduce APhA to its members, the pharmacy community, policymakers, the media, and the public at large. <Read More>

    Health System Owned Specialty Pharmacy Alliance: A Voice for Integrated Specialty Pharmacies – April 6, 2021 – Millions of high-touch patients, thousands of biopharmaceuticals, and hundreds of complex diseases and health systems that prescribe therapies. Integrated specialty pharmacies connect all of these to touch the lives of millions of patients and their loved ones every day. As the number of integrated specialty pharmacies continues to rise nationwide so too does their impact on patient care and outcomes, all within their own communities. How can this critically important sector continue to sustain the care model that improves patient outcomes? The industry has finally found the best way to answer that question: by organizing and unifying the voice of the burgeoning integrated specialty pharmacy sector so it can focus on establishing its own industry best practices and benchmarks, support patient access, and address health equity. <Read More>

    340B in the News

    New York State Budget Delays 340B ‘Carve-Out’ for Two Years – April 10, 2021 – The 2021 New York state budget will push the impending 340B “carve-out” to 2023, providing something of a victory for health care providers who had said they stood to lose millions of dollars. Federally Qualified Health Centers, or FQHCs, provide care for people of color, refugees, people living with HIV-Aids and the LGBTQ+ community. A federal program, known as 340B, allows FQHCs to get a discount on prescription drug prices for their Medicaid patients, and reinvest those savings into services. An impending state law passed last year, known as a 340B carve-out, would allow New York state to keep the savings for itself. However, the new state budget, passed by lawmakers this week, delays the carve-out for two years. Language in the state Health and Mental Hygiene budget bill says the New York State Department of Health cannot implement the carve-out before April 1, 2023. <Read More>

    Ted Okon Addresses Payment Reform in Oncology, Issues of 340B – April 8, 2021 – Ted Okon, MBA, is the executive director of the Community Oncology Alliance (COA)… ‘I think one of the biggest problems when we talk about drug pricing is 340B. The 340B advocates would basically tell you that it’s just money that’s doled out by the pharmaceutical companies, but I think if you look at the massive amounts of profits that hospital systems are making from drugs, especially those hospital systems that have 340B, it’s kind of shocking.” <Read More>