Clinical Insights: June 23, 2020

    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

     GimotiTM (metoclopramide) Nasal Spray – New Drug Approval June 19, 2020 – Evoke Pharma, Inc., a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Gimoti™ (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. <Read More> 

    Tacrolimus Inhalation Powder – New Orphan Drug Approval June 18, 2020 – TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Tacrolimus Inhalation Powder for prophylaxis of lung allograft rejection. <Read More> 

    Crysvita® (burosumab-twza) Injection – New Drug Approval June 18, 2020 – The U.S. Food and Drug Administration approved Crysvita® (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones. The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels. <Read More>

    Lyumjev™ (insulin lispro-aabc) – New Drug Approval June 15, 2020 – The U.S. Food and Drug Administration (FDA) has approved Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company’s new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. LyumjevTM is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C levels. As a rapid-acting mealtime insulin, LyumjevTM controls high blood sugar levels after meals in adults with diabetes, similar to how natural insulin works after meals in people without diabetes. <Read More> 

    Zepzelca™ (lurbinectedin) – New Orphan Drug Approval June 15, 2020 – Jazz Pharmaceuticals plc announced along with its partner PharmaMar that the U.S. Food and Drug Administration (FDA) approved Zepzelca™ (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Zepzelca™ was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.  <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    Cosentyx® (secukinumab) Injection – New Expanded Indication June 17, 2020 – Novartis, a leader in rheumatology and immuno-dermatology, announced that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx® efficacy in addressing the axial spondyloarthritis (axSpA) disease spectrum. <Read More> 

    Ilaris® (canakinumab) Injection – New Expanded Indication June 16, 2020 – The U.S. Food and Drug Administration approved Ilaris® (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Ilaris® was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. <Read More> 

    Gardasil® 9 (human papillomavirus 9-valent vaccine, recombinant) – New Expanded Indication June 12, 2020 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Gardasil® 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The trial is currently underway. <Read More>

    New Drug Shortage

    June 17, 2020

    New Drug Recall and Safety Alerts

    Selected Robitussin Products by GSK Consumer Healthcare – New Drug Recall – June 18, 2020 – GSK Consumer Healthcare is voluntarily recalling to the retail level two lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children’s Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children’s Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation. <Read More>


    New Generic Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Clinical Guidelines for Primary CVD Prevention May Not Fully Capture CAD Susceptibility – June 22, 2020 – Current clinical guidelines for the prevention of cardiovascular disease were not found to fully take into account to the polygenicity underlying coronary artery disease (CAD) susceptibility, according to a study published in the Journal of the American College of Cardiology. <Read More>

    Four Ways PBMs are Changing – June 22, 2020 – Pharmacy benefit managers (PBMs) argue that they play a vital role in the labyrinth of U.S. healthcare as pharmaceutical company intermediaries, serving purchasers (such as employers) and payers (such as Medicare and commercial health insurers). Critics, however, contend that PBMs serve the needs of pharmaceutical companies at the expense of purchasers, payers and, ultimately, patients. <Read More> 

    Average Pharmacist Salaries, By State – June 22, 2020 – California, Alaska and Vermont top the list of states with the highest annual salaries for pharmacists, according to data from the U.S. Bureau of Labor Statistics. At the bottom of the list are Oklahoma, Montana and North Dakota, according to the bureau’s May 2019 data, the most recent available. <Read More> 

    APhA Announces Task Force and Campaign to Address Structural Racism in Pharmacy – June 22, 2020 – The APhA Board of Trustees has taken a critical next step in addressing structural racism in pharmacy by appointing a diverse group of APhA members to provide input and guidance to the APhA Board and staff. The task force will recommend actions driving short- and long-term strategies to eliminate racism, discrimination, injustice, and the marginalization of individuals within the profession and communities that APhA members serve. <Read More>

    ASH Releases New Clinical Practice Guidelines on Management of Pain in Sickle Cell Disease – June 19, 2020 – The American Society of Hematology (ASH), the world’s largest professional society dedicated to furthering the understanding, diagnosis, treatment, and prevention of blood disorders, announced the publication of the ASH 2020 Guidelines for Sickle Cell Disease Management of Acute and Chronic Pain, the new installment of the Society’s evidence-based practice guidelines on the disease. <Read More> 

    Evaluation and Management of Rheumatic Diseases: A Case-Based Review – June 19, 2020 – Over the past 2 decades, new discoveries regarding the immunology of rheumatic diseases have led to the rapid development of targeted therapies for various conditions spanning the rheumatological spectrum. In December 2019, HCP Live® hosted an educational seminar series evaluating current strategies in the management of rheumatic diseases, specifically psoriatic arthritis (PsA), rheumatoid arthritis (RA), and nonradiographic axial spondyloarthritis (nr-AxSpA)…This article provides a summary of key insights from the discussion, including updates in treatment guidelines as well as key data for select agents and challenges to care. <Read More>

    Insight into Dexamethasone’s Benefits in Severe COVID-19 – June 19, 2020 – In a press release, researchers from a large, randomized controlled trial for COVID-19 treatments announced that they’d seen an improvement in survival at 28 days after entry into the trial for the sickest patients who received the drug dexamethasone. In ventilated patients in particular, giving the steroid reduced deaths by one-third in the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial. <Read More> 

    ESMO Guidance On Management of Colorectal Cancer During COVID-19 Outbreak – June 19, 2020 – The European Society of Medical Oncology (ESMO) has issued adapted guidance on the management and treatment of colorectal cancer (CRC) in the COVID-19 era. The guidelines have been released to maintain the highest levels of care to all patients, ensure the safety of patients and healthcare workers and save as many lives as possible. The guidelines have been published in the journal ESMO Open. <Read More> 

    Mobile Pharmacies—Driving Down Rural Cancer Care Disparities – June 19, 2020 – People living in rural communities are often located far away from the major cancer centers that offer a full spectrum of treatments, including clinical trials. This distance barrier makes cancer patients vulnerable to disparities in care. Delivering cancer care to patients in or near the rural communities in which they reside reduces barriers and improves access…However, in order to improve efficiency and benefit for patients, this strategy must be continuously evolving. A recent step in the evolution of this model of care has resulted in the development and implementation of a mobile, USP 800 compliant, compounding pharmaceutical vehicle… a “mobile pharmacy.” <Read More> 

    Older Adults Struggle to Get Pfizer’s $225,000-a-Year Heart Drug – June 18, 2020 – Pfizer Inc.’s new $225,000-a-year heart drug is being labeled by researchers critical of the cost as “the most expensive cardiac medication in history.” When the company initially priced the drug, called tafamidis, critics warned the high cost would present a prohibitive financial barrier to some patients. A new analysis that hones in on 50 people prescribed the medication offers data suggesting that may be true for many patients. <Read More> 

    SCPC Urges CDC to Exempt Long-Term Care Patients from Opioid Guidelines – June 18, 2020 – The Senior Care Pharmacy Coalition (SCPC) announced that it submitted a letter to the Centers for Disease Control and Prevention (CDC) urging the agency to consider the unique needs of patients in long-term care (LTC) facilities when crafting the next modification of the CDC’s Opioid Guidelines. In a letter addressed to Director Dr. Robert Redfield, SCPC asked the CDC to include a specific statement in the Opioid Guidelines to clarify that any recommended opioid limits do not apply to patients in long-term care facilities, including skilled nursing facilities, nursing facilities, and assisted living facilities. <Read More> 

    Genetic Testing Recommended for All Men With Metastatic Prostate Cancer – June 18, 2020 – Genetic testing is recommended for all men with metastatic prostate cancer (PCa) or who have a family history indicative of hereditary PCa, according to a new consensus guideline. <Read More>

    Court Rules Trump Can’t Require Drugmakers to Disclose Prices in TV Ads – June 18, 2020 – In a major legal setback for President Donald Trump on a high-profile consumer issue, a federal appeals court has ruled that his administration lacks the legal authority to force drug companies to disclose prices in their TV ads. <Read More>

    IG Report Recommends Fresh Look at FEHB Prescription Drug Costs – June 18, 2020 – An inspector general report has recommended that OPM reexamine prescription drug costs in the Federal Employees Health Benefits program, saying that the agency “may not be obtaining the most cost effective pharmacy benefit arrangements”—in other words, that the program, and ultimately both the government and enrollees, may be paying too much. <Read More>

    The Impact of Coronavirus on Pharmacy Students Beginning APPE Rotations – June 18, 2020 – As student pharmacists adapting to the opportunities and challenges of beginning Advanced Pharmacy Practice Experience (APPE) rotations in the midst of the coronavirus 2019 (COVID-19) pandemic, we are eager to share our thoughts with the Pharmacy Times® community. We never could have imagined that we would be experiencing our long-anticipated P4 rotations during the worst pandemic our country has seen in a century. <Read More> 

    CMS Proposes Rule to Base Prescription Drug Payments on Patient Outcomes – June 17, 2020 – The Centers for Medicare & Medicaid Services (CMS) released a proposed rule that ties payment for prescription drugs on patient outcomes. According to a press release, CMS’s proposal aims to loosen regulations on developing value-based purchasing (VBP) arrangements, encourage innovation, and empower “states, private payers, and manufacturers to pay for prescription drugs based on clinical outcomes.” <Read More> 

    ‘You Ruined My Life’: Patients Blame CDC for Poor Pain Care – June 17, 2020 – Over 5,000 people have left comments in the Federal Register sharing their experiences and concerns about the quality of pain care in the United States. Tuesday was the final day for people to make public comments, which the Centers for Disease Control and Prevention will consider as it updates and possibly expands its controversial opioid prescribing guideline. <Read More>

    COVID-19 Pandemic: OSHA Issues Guidance for Retail Pharmacy Workers – June 17, 2020 – To help protect retail pharmacy workers from exposure to COVID-19, OSHA has issued a safety alert. The alert features a series of tips for employers, including:

    • Install clear, plastic barriers between workers and customers at order and pickup counters.
    • Supply workers with gloves and eye and face protection, as needed. Allow workers to wear a cloth facial covering or surgical mask over their nose and mouth.
    • Provide an area for workers to wash their hands.
    • Clean and disinfect frequently touched surfaces such as checkout and customer service counters.
    • Consult OSHA’s health care worker and employer guidance for workers who may need additional protections, including those providing clinical services to patients.
    • Encourage workers to stay home when sick.

    <Read More> 

    COVID-19 Slowing, but Shortages Still Seen in Ventilator Drugs – June 17, 2020 – One would think that the reduction in the number of people requiring mechanical ventilation for COVID-19 would ameliorate the shortages in medications used during ventilation. Unfortunately, it has not done so. Almost every drug class used for mechanical ventilation—sedatives, analgesics, paralytics and vasopressors—is still in short supply, according to the FDA. <Read More> 

    American Pharmacists Association (APhA) and APhA Foundation Join National Organizations to Promote Pharmacists-Patient Care – June 17, 2020 – The American Pharmacists Association (APhA) and APhA Foundation joined 20 other organizations comprised of patients, healthcare providers, public health, payers and purchasers, in support of the National Forum for Heart Disease & Stroke Prevention’s Value & Access Initiative by signing a Joint Policy Statement, including recommendations that will expand access to care options for patients nationwide, especially in underserved or otherwise vulnerable populations. <Read More>

    The Wholesaler and the Health System: A Powerful COVID-19 Partnership – June 17, 2020 – Stockpiling of key drugs used in critical care, early crisis management meetings and rapid clinical interventions helped the University of Chicago Medicine (UCM) health system avoid potentially deadly delays in getting its COVID-19 patients into care during the height of the pandemic. <Read More>

    SVS Releases New Clinical Practice Guidelines on Visceral Artery Aneurysms – June 17, 2020 – The Society for Vascular Surgery (SVS) has released new clinical practice guidelines on the appropriate care and treatment of aneurysms of the visceral arteries.  These SVS evidence-based practice guidelines offer recommendations to inform the diagnosis, treatment options, screening and follow-up of visceral aneurysms. Evidence-based size thresholds for repair of aneurysms of the renal arteries, splenic artery, coeliac artery, and hepatic artery, among others are included. Open surgical and endovascular repair strategies are described as well as specific circumstances in which aneurysms may be considered for repair at a smaller size such as in women of childbearing age. False aneurysms are also discussed. <Read More> 

    Hidden in Plain Sight — Reconsidering the Use of Race Correction in Clinical Algorithms – June 17, 2020 – Physicians still lack consensus on the meaning of race. When the Journal took up the topic in 2003 with a debate about the role of race in medicine, one side argued that racial and ethnic categories reflected underlying population genetics and could be clinically useful. Others held that any small benefit was outweighed by potential harms that arose from the long, rotten history of racism in medicine. Weighing the two sides, the accompanying Perspective article concluded that though the concept of race was “fraught with sensitivities and fueled by past abuses and the potential for future abuses,” race-based medicine still had potential: “it seems unwise to abandon the practice of recording race when we have barely begun to understand the architecture of the human genome.” <Read More> 

    Depression Linked to Increased Risk of Cardiovascular Disease – June 17, 2020 – Depression has been linked to an increased risk of cardiovascular disease, according to a new study out of Simon Fraser University published in JAMA Psychiatry. The study found that individuals with 4 or more depressive symptoms had a 20% increase in cardiovascular events and death. According to the press release, 1 in 5 Canadians will experience mental health problems in their lifetime and 8% will experience a major depressive event. <Read More> 

    AI Makes Inroads Into Oncology Practice – June 17, 2020 – Oncology practices large and small are starting to tap into the power of data analytics and artificial intelligence (AI) to help identify patients at risk of relapse or adverse effects (AEs) and to assist in making clinical decisions on care. Informatic tools are now using predictive analytics and evidenced-based mechanisms, and these are being combined with electronic health records (EHRs) to bring the power of big data to daily practice. <Read More>

    The Benefits of Capping Medicare Part D Out-of-Pocket Costs Will Vary Substantially Depending on the Drugs That Beneficiaries Use – June 17, 2020 – Although delayed as a result of the COVID-19 public health emergency, there are persistent and ongoing efforts to reform the Medicare Part D benefit. Since its June 2016 Report to Congress, the Medicare Payment Advisory Commission (MedPAC) continues to recommend changes to the Part D benefit design, including eliminating the coverage gap and creating a maximum out-of-pocket (MOOP) cap on beneficiary cost-sharing that will be financed by a combination of plan, manufacturer and Medicare individual reinsurance payments as well as through greater flexibility for plans to manage formularies. <Read More> 

    Drug-Spending Trends of the Three Largest Pharmacy Benefit Managers – June 17, 2020 – Drug Channels released its 2019 report on drug spending of the nation’s three largest pharmacy benefit managers, CVS Health, Express Scripts and Prime Therapeutics. The three PBMs accounted for about 60 percent of pro forma U.S. retail mail, long-term care and specialty equivalent prescription claims in 2019…This is the third consecutive year that spending growth in nonspecialty drugs declined by mid-single digits, according to pharmacy news site Drug Channels. The decline can be attributed to deeper commercial rebates on brand-name drugs, deflation in generics and a small increase in generic dispensing rates. <Read More> 

    American Headache Society Updated Guideline On Use of Neuroimaging for Migraine – June 16, 2020 – Most experts agree that neuroimaging should be used sparingly and with caution when diagnosing and treating migraine. Yet, when to use and when not to use neuroimaging has long been a vexed issue…To cut through this lack of clarify, the American Headache Society (AHS) recently released an updated, evidence-based guideline for neuroimaging in patients with migraine. The guidelines were published in the Society’s Headache journal in December 2019 based on a review and analysis of decades worth of research. <Read More> 

    FDA Approves First-Ever Prescription Video Game – June 16, 2020 – A new video game is just what the doctor ordered, at least for some kids. For the first time, the Food and Drug Administration has approved a prescription video game. Now, physicians may prescribe Akili Interactive’s EndeavorRx, formerly known as Project EVO, to children between the ages of 8 and 12 who struggle with ADHD. <Read More> 

    ASIPP Releases Guidelines for Facet Joint Interventions – June 16, 2020 – The American Society of Interventional Pain Physicians (ASIPP) has published comprehensive, evidence-based guidelines for performing diagnostic and therapeutic facet joint interventions for the management of chronic spinal pain. The guidelines were published in the journal Pain Physician. <Read More> 

    Immunization Administration During Coronavirus Disease Pandemic – June 16, 2020 – Since the beginning of the COVID-19 pandemic, a number of measures were implemented to decrease the spread of the disease, including stay-at-home and shelter-in-place orders, use of face coverings in public places, and amplified hand hygiene recommendations…In order to address some of these concerns, the Centers for Disease Control and Prevention (CDC) has provided guidance for administration of pediatric and adult immunizations. <Read More> 

    Metformin Access Not Impeded by Recall, Experts Say – June 16, 2020 – Despite the recall of several different manufacturers’ formulations of extended-release (ER) metformin because of higher than acceptable levels of a potentially cancer-causing chemical, experts say patients and providers should experience no significant disruptions in access to therapy, and they urge patients not to switch or discontinue their medication without consulting their doctor. <Read More> 

    Variations in The Specialty Pharmacy Hub Model – June 16, 2020 – Specialty pharmacy hubs have become increasingly popular in recent years, offering a wide variety of services to pharmaceutical manufacturers. Although many hubs offer similar services, no 2 specialty pharmacy hubs and no 2 hub programs are entirely alike…In many cases, these services are offered as a “menu” for pharmaceutical manufacturers that may only need a subset of services from the list. Primary aspects of a program that define which services will be used include hub type (hub lite vs full service), hub necessity (mandatory vs non-mandatory), hub size (large/transactional vs small/dedicated), network composition, and therapeutic area/methods of administration. <Read More> 

    Get Familiar With the FDA Drug Recall Process – June 16, 2020 – On average, 4500 drugs and medical devices are pulled from shelves across the United States each year, because of product recalls. Drugs can be recalled, because of a variety of reasons, including issues involving drug contamination, safety, changes in potency, or mislabeling. Although recalls aim to protect the public from potentially harmful products, for some of these drugs, more than 100 million prescriptions have been issued prior to being withdrawn from the market. As the world of health care continues to see an increasing trend in the number of both OTC and prescription drug recalls, it is imperative that pharmacists familiarize themselves with the FDA recall process. <Read More> 

    Walmart to Boost Pharmacy Business with CareZone’s Tech Acquisition – June 16, 2020 – CNBC reported that Walmart has acquired prescription management technology from CareZone to boost its pharmacy space. Founded in 2020, CareZone has developed applications that help people manage their medicines. The company helps its members figure out what’s covered under their health plan and arranges for home delivery. The company has approximately 3.5 million members. <Read More> 

    GSK Arthritis Treatment Voltaren® Approved for Over-the-Counter Sale – June 16, 2020 – GlaxoSmithKline’s Voltaren® Arthritis Pain Gel, which was formerly a prescription drug, can now be purchased over-the-counter, the company announced. The treatment has been available as a doctor-prescribed treatment for more than 10 years. The FDA approved Voltaren® for over-the-counter sale in February and it has just now hit stores as an OTC product. It’s the first OTC prescription-strength, non-steroidal anti-inflammatory topical gel for arthritis pain available in the U.S., according to GlaxoSmithKline. <Read More> 

    FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic – June 16, 2020 – The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labeled as homeopathic. <Read More>

    340B in the News

    Preparing For The Next COVID-19 Crisis: A Strategy To Save Safety-Net Hospitals June 22, 2020 – In the past several months, the COVID-19 pandemic has taken a tremendous human toll measured in hospitalizations and deaths, and a global financial toll measured in millions of businesses closed and rising unemployment. In the US, the devastation is particularly acute in low-income communities and among people of color. Safety-net hospitals serving these communities are suffering, too. Many are initiating layoffs and could shut their doors permanently…These facilities could be identified based on definitions of “safety-net hospital” that incorporate data on hospitals’ bad debt or uncompensated care; such data are publicly available in the annual cost reports that Medicare-certified hospitals submit to the Centers for Medicare and Medicaid Services (CMS). In addition, the allocation formula should reflect national data on emergency services use and eligibility for the 340B program. <Read More>