Clinical Insights: May 12, 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

    RetevmoTM (selpercatinib) Capsules – New Drug Approval – May 8, 2020 – The U.S. Food and Drug Administration approved RetevmoTM (selpercatinib) capsules to treat three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers – in patients whose tumors have an alteration (mutation or fusion) in a specific gene (RET or “rearranged during transfection”). RetevmoTM is the first therapy approved specifically for cancer patients with the RET gene alterations. <Read More>

    TabrectaTM (capmatinib) Tablets – New Drug Approval – May 6, 2020 – The U.S. Food and Drug Administration approved TabrectaTM (capmatinib) for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. TabrectaTM is the first FDA-approved therapy to treat NSCLC with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping). <Read More> 

    ElyxybTM (celecoxib) Oral Solution – New Drug Approval – May 6, 2020 – Dr. Reddy’s Laboratories Ltd. announced approval of ElyxybTM (celecoxib oral solution 25 mg/mL) by the U.S. Food and Drug Administration. ElyxybTM (previously known as DFN-15) is indicated for the acute treatment of migraine with or without aura in adults. ElyxybTM is the latest product emerging from Dr. Reddy’s portfolio of successful acute migraine treatments. The company is working to commercialize this product through partners. <Read More>

    Fensolvi® (leuprolide acetate) – New Drug Approval – May 4, 2020 – Tolmar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for FENSOLVI® (leuprolide acetate) for injectable suspension for the treatment of pediatric patients two years of age and older with central precocious puberty (CPP). CPP is a rare disease defined as the onset of puberty before age eight in girls and before age nine in boys. <Read More>

    New Formulation Approval

    No new update

    New Indication Approval

    Farxiga® (dapagliflozin) Tablets – New Indication Approval – May 5, 2020 – The U.S. Food and Drug Administration approved Farxiga® (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. Heart failure occurs when the heart does not pump enough blood to support the body’s needs, and this type of heart failure happens when the heart’s main pumping chamber, the left ventricle, is weakened. <Read More>

    New Drug Shortage

    May 08, 2020

    May 06, 2020

    May 05, 2020

    New Drug Recall and Safety Alerts

    Lactated Ringer’s Injection, USP by ICU Medical Inc. – New Drug Recall – May 8, 2020 – ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer’s Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint. <Read More>

    New Generic Approval and Launch

    No new update.

    Clinical and Pharmacy News

    New CMS Rule Could Raise Out-Of-Pocket Drug Costs – May 11, 2020 – CMS announced a new rule to go into effect in July that will likely raise out-of-pocket drug costs for many consumers, according to STAT. Under the rule, CMS will allow insurers and employers to exclude certain copay assistance programs from counting toward deductibles and out-of-pocket maximums. The rule applies even for expensive brand-name drugs with no generic alternatives. <Read More>

    IDSA PPE Recommendations: A Practical Approach to Protect HCWs – May 11, 2020 – One of the pressing needs of the COVID-19 pandemic is personal protective equipment (PPE) for health care workers (HCWs) on the front lines. Many hospitals throughout the United States have been reporting shortages and developing strategies to stretch these precious resources. Among these strategies are extending the use of disposable PPE or reusing it. The Infectious Diseases Society of America released recommendations about using PPE for infection prevention among HCWs caring for patients with suspected or confirmed COVID-19, addressing settings with various resource levels, including those with and without sufficient PPE supplies. <Read More> 

    Eosinophilic Esophagitis Management Clinical Practice Guidelines (AGA/JTF, 2020) – May 11, 2020 – The American Gastroenterological Association (AGA) Institute and the Joint Task Force on Practice Parameters (JTF) from the American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma & Immunology issued clinical practice recommendations on the management of eosinophilic esophagitis. <Read More> 

    NICE Releases COVID-19 Rapid Guideline On Acute Kidney Injury In Hospital – May 11, 2020 – National Institute for Health and Care Excellence has released rapid Covid 19 guidelines on acute kidney injury in hospital. The purpose of this guideline is to help healthcare professionals prevent, detect and manage acute kidney injury in adults in hospital with known or suspected COVID-19. This is important to improve outcomes and reduce the need for renal replacement therapy. <Read More>

    Two-Thirds of Hospital Pharmacies Have Reduced Staff During COVID-19 Pandemic, ASHP Survey Finds – May 11, 2020 – Two-thirds of hospital pharmacies have reduced staff during the COVID-19 pandemic, according to a survey conducted by the American Society of Health-System Pharmacists. The survey was conducted between April 21 and April 24 and included 258 respondents from hospitals of various sizes. Two-thirds of the respondents said their hospital has reduced pharmacy staff during the pandemic. Of those facilities, the most common methods of reducing staff were by cutting hours (79 percent), not filling vacant positions (49 percent), furloughing workers (31 percent) or making a temporary reduction in the number of positions (31 percent). <Read More>

    Most Critically Ill COVID-19 Patients Survive with Respiratory Failure Treatment Strategy, Research Finds – May 10, 2020 – The majority of critically ill COVID-19 patients survive under current treatment guidelines for respiratory failure, clinicians at two Harvard teaching hospitals found. The team of doctors — led by Massachusetts General Hospital pulmonologist and Harvard Medical School professor Charles C. Hardin — announced the findings in a press release Wednesday after publishing their research in the peer-reviewed American Journal of Respiratory and Critical Care Medicine. <Read More> 

    New Recommendations for Pediatric Psoriasis Care – May 9, 2020 – Although one-third of diagnosed cases of psoriasis are pediatric, clinical guidelines addressing the unique physiology, treatments, and patient-parent-provider interactions experienced by pediatric patients with psoriasis have not previously existed. To fill this void, the American Academy of Dermatology (AAD) and the National Psoriasis Foundation (NPF) co-developed a guideline for the management and treatment of psoriasis in pediatric patients, published in the Journal of the American Academy of Dermatology. <Read More> 

    More than 240 Health Care Associations Sign Letter Pushing for Pharmacy DIR Reform – May 8, 2020 – Over 240 patient advocates and health care associations pushed Congress on immediate action to reform pharmacy direct and indirect remuneration (DIR) clawback and performance measure fees, according to a letter sent to Congressional leaders. The letter urged DIR fee reform in order to make prescription drugs more affordable for patients and prevent pharmacies from closing, which would limit access to vulnerable populations. <Read More> 

    Updated Guidelines For Treatment For Diverticulitis Released By ASCRS – May 8, 2020 – American Society of Colon and Rectal Surgeons (ASCRS) has released updated guidance on medical and surgical treatment of left-sided colonic diverticulitis. The guidelines have been published in the Diseases of the Colon & Rectum. The updated guidance has been developed by a panel of the ASCRS Clinical Practice Guidelines Committee, and the new recommendations were posted on the DC&R website. <Read More>

    Hospitals Reporting Short Supplies of Neuromuscular Blockers – May 8, 2020 – A new survey by the American Society of Health-System Pharmacists (ASHP) indicates that critical care drug shortages are improving, but neuromuscular blockers are frequently in short supply at many hospitals. The survey—round 4 of a biweekly assessment of pharmacy resources—collected answers from 258 ASHP members at hospitals of various sizes from around the country. The survey was conducted April 21 to April 24, 2020. <Read More>

    The Unusual Symptoms of COVID-19 – May 7, 2020 – In late April, the US Centers for Disease Control and Prevention updated its list of COVID-19 symptoms. The CDC initially listed fever, cough, and shortness of breath as the defining clinical aspects of COVID-19, but the agency now recognizes that repeated shaking with chills, muscle pain, headache, sore throat, and a loss of taste or smell may accompany an infection. <Read More>

    International Society of Hypertension Releases Global Practice Guidelines – May 7, 2020 – The International Society of Hypertension (ISH) has released the ISH 2020 Global Hypertension Practice Guidelines to help reduce the burden of this significant health threat affecting people from every country and socio-economic group. Developed by a panel of leading hypertension specialists from across the globe, the ISH Guidelines outline the best approaches to the management of hypertension and provide simple, clear recommendations for health professionals and those affected by hypertension. <Read More>

     AMP Publishes Evidence-Based Recommendations to Standardize Clinical Genotyping Tests for Warfarin Response – May 6, 2020 – The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, today published consensus, evidence-based recommendations to aid in the design, validation and interpretation of clinical genotyping tests for the prediction of warfarin response. <Read More>

    Novel Agent Shows Benefit in Anemia Disorder – May 6, 2020 – An investigational monoclonal antibody called sutimlimab was found to be effective in controlling cold agglutinin disease (CAD) in a pivotal phase 3 trial. The novel treatment binds to complement component 1 (C1), preventing the hemolytic anemia that characterizes CAD, an autoimmune disorder. “Based on these results, we believe sutimlimab could become the first approved treatment for this challenging disease,” reported Alexander RÖth, MD, from the Department of Hematology at the University of Duisburg-Essen, in Essen, Germany. <Read More>

    Steering Clear Of Trouble From Hospital to Home – May 6, 2020 – Transitioning a patient from the hospital to the home setting on parenteral nutrition (PN) can introduce a number of potential hazards. But several steps, from ensuring a safe home PN setup to identifying the appropriate PN formulation, can go a long way in protecting patients during this crucial handoff, according to a presentation at the ASPEN20 Virtual Conference. <Read More>

    340B in the News

     340B Health Renews Calls for CMS to Scrap Controversial Hospital Survey – May 11, 2020 – Advocacy group 340B Health is renewing calls for the Trump administration to scrap a controversial survey that requires hospitals to provide cost data. The group sent a letter to the Centers for Medicare & Medicaid Services (CMS) last week calling for a retraction, because safety-net hospitals that rely on the program are fighting the COVID-19 pandemic and the survey takes a lot of time to fill out. <Read More>

    CMS Proceeds With Controversial 340B Acquisition Cost Survey During COVID-19 Pandemic – Due May 15, 2020 – April 30, 2020 – Hospitals that purchase certain covered outpatient drugs at 340B pricing received notice late last week that they must quickly compile and submit their net acquisition costs for 340B-purchased drugs to their Medicare Administrative Contractors (MAC) in just over two weeks, with submissions due by May 15, 2020. CMS’s Hospital Survey for Specified Covered Outpatient Drugs (SCODs) excludes critical access hospitals. This comes at a time when 340B safety-net hospital resources are under tremendous pressure given the current COVID-19 pandemic. <Read More>