DOCSLIB.ORG

2021 Aetna Premier Plan

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

Plan for your best health 2020 Aetna Pharmacy Drug Guide Aetna Premier Plan Aetna.com Health benefits and health insurance plans are offered, administered and/or underwritten by Aetna Health Inc., Aetna Health Insurance Company of New York, Aetna HealthAssurance Pennsylvania Inc., Aetna Health Insurance Company and/or Aetna Life Insurance Company (Aetna). In Florida, by Aetna Health Inc. and/or Aetna Life Insurance Company. In Utah and Wyoming by Aetna Health of Utah Inc. and Aetna Life Insurance Company. In Maryland, by Aetna Health Inc., 151 Farmington Avenue, Hartford, CT 06156. Each insurer has sole financial responsibility for its own products. 2021 Pharmacy Drug Guide – Premier Table of Contents INFORMATIONAL SECTION..................................................................................................................4 ANALGESICS - DRUGS TO TREAT PAIN AND INFLAMMATION.................................................15 ANTI - INFECTIVES................................................................................................................................ 27 ANTI-INFECTIVES - DRUGS TO TREAT INFECTIONS....................................................................27 ANTINEOPLASTIC AGENTS - DRUGS TO TREAT CANCER.......................................................... 42 ANTINEOPLASTICS AND ADJUNCTIVE THERAPIES..................................................................... 54 CARDIOVASCULAR - DRUGS TO TREAT HEART AND CIRCULATION CONDITIONS...........54 CENTRAL NERVOUS SYSTEM - DRUGS TO TREAT NERVOUS SYSTEM DISORDERS............72 ENDOCRINE AND METABOLIC - DRUGS TO TREAT DIABETES AND REGULATE HORMONES........................................................................................................................................... 107 GASTROINTESTINAL - DRUGS TO TREAT STOMACH AND INTESTINAL DISORDERS.......141 GENITOURINARY - DRUGS TO TREAT GENITAL AND URINARY TRACT CONDITIONS...150 HEMATOLOGIC - DRUGS TO TREAT BLOOD DISORDERS......................................................... 154 IMMUNOLOGIC AGENTS - DRUGS TO TREAT DISORDERS OF THE IMMUNE SYSTEM.....163 MEDICAL DEVICES.............................................................................................................................. 174 NUTRITIONAL/SUPPLEMENTS - VITAMINS AND SUPPLEMENTS............................................199 OPHTHALMIC - DRUGS TO TREAT EYE CONDITIONS................................................................207 OTHER.....................................................................................................................................................213 RESPIRATORY - DRUGS TO TREAT BREATHING DISORDERS................................................. 214 TOPICAL - DRUGS TO TREAT EAR AND SKIN CONDITIONS.....................................................226 TOC-3 How to use this guide Your guide includes a list of commonly used drugs covered on your pharmacy plan. The amount you pay depends on the drug your doctor prescribes. It’s either a flat fee or a percentage of the prescription’s price after you meet your deductible, if applicable. Preferred generic drugs cost less. Preferred brand drugs will have a higher cost. Your plan includes You’re covered for all types of medicine — some more expensive, and some less. • Brand and generic drugs that are hand-picked for their quality and effectiveness • Generic: the lowest cost • A specialty pharmacy that fills specialty prescriptions • Preferred brand: a slightly higher cost (ones that are injected, infused or taken by mouth) — • Non-preferred brand: a higher cost and provides services that include personal • Preferred Specialty: lower cost for specialty drugs support, helpful resources and training, and free secure home delivery • Non-preferred Specialty: higher cost for non-preferred specialty drugs • A home delivery pharmacy that delivers maintenance drugs to your home or wherever Your pharmacy plan may not have all the coverage levels you choose (for drugs that are taken regularly to listed above so check your plan documents to see how treat conditions like diabetes or asthma) much you will pay. What you can expect to pay For your exact coverage and cost, and to learn more about your plan With your pharmacy plan, the amount you pay depends on the drug your doctor prescribes. It’s either a flat fee or Visit the website that’s on your member ID card. a percentage of the drug’s/medicine’s price. Then log in to your account, where you can: Each drug is grouped as a generic, a brand or a • Find out the coverage* and estimate of cost for specialty drug. The preferred drugs within these specific drugs groups will generally save you money compared • View your deductibles and plan limits to a non-preferred drug. Typically, generic drugs • Order medications are less expensive than brands. • Check your pharmacy order status Specialty prescription drugs typically include higher-cost • Get a member ID card drugs that require special handling, special storage or • View your claims, Explanation of Benefits and more. monitoring. These types of drugs may include, but are not limited to, drugs that are injected, infused, inhaled or taken by mouth. * Check your plan documents for coverage information. Your plan may not cover certain drugs such as infertility, erectile dysfunction, weight loss and smoking cessation. 1 Have more questions about your CVS Caremark Mail Service Pharmacy™ pharmacy benefits? You can have maintenance drugs sent right to your home We’re here to help. There are several ways you can or anywhere else you choose by CVS Caremark Mail learn more about your benefits: Service Pharmacy. These are drugs that are taken regularly for chronic conditions like diabetes or asthma. • Check your Plan Design and Benefits Summary in Depending on your plan, you can get up to a 90-day your enrollment kit. supply of medicine for less cost. It’s fast and convenient, • Call the toll-free number on your member ID card. and standard shipping is always free. • Review our pharmacy frequently asked questions (FAQs) and answers. Just visit the website that’s on Get started right away your member ID card to search for the “Pharmacy FAQ.” You can submit your order using one of these options: Specialty Pharmacy Network 1. Online — Visit your secure member website and An in-network specialty pharmacy can fill your sign in to your account. There you can add or prescriptions for specialty drugs. These are the types remove your prescriptions. of drugs that may be injected, infused or taken by mouth. 2. Phone — Call us toll-free, 24/7 at 1-888-792-3862. They often need special storage and handling. And they If you need the help of a telephone device for the need to be delivered quickly. A nurse or pharmacist may hard of hearing, call 1-877-833-2779. monitor you during your treatment, if needed. With this type of pharmacy, you can get 3. Mail — Get a new prescription from your doctor. Then this medicine sent right to your home. mail it to us with a completed order form. You can find the form on your secure member website. The mailing address is on the form. How to get started with a specialty pharmacy Ordering your prescriptions through our specialty Your doctor can submit your order using one of pharmacy is easy. And we typically offer a 30-day these options: medicine supply. 1. Online — They can submit your prescriptions using • To transfer your prescription, just call us toll-free the e-prescribe services on our provider website. at 1-866-353-1892. 2. Fax — They can fax your prescription to • For a new prescription, your doctor can send it to 1-877-270-3317. Make sure they include your member us in one of four ways: ID number, date of birth and mailing address on the 1. Electronically: Through e-prescribe fax cover sheet. Only a doctor may fax a prescription. 2. Fax: 1-800-323-2445 3. Phone: 1-800-237-2767 If you mail in your own prescription, please send it with a completed Patient Profile Form. To find this form, just visit the website that’s on your member ID card, to search for the “Patient Profile Form.” 2 Frequently asked questions How can I save on prescriptions? What is step therapy? Here are some tips to pay less out of pocket for your Some drugs require step therapy. This means that prescription drugs: you must try one or more prerequisite drug(s) before a step therapy drug is covered. • Ask your doctor to consider prescribing drugs that are on the Pharmacy Drug Guide (formulary). The prerequisite drugs have U.S. Food and Drug • Ask your doctor to consider prescribing generic Administration (FDA) approval and may cost less. They drugs instead of brand-name drugs. treat the same condition as the step therapy drug. • Our home delivery pharmacy may save you money. If you don’t try the appropriate prerequisite drug first, you For more information, visit the website on your may need to pay full cost for the step-therapy drug. member ID card and log in to your account. What are quantity limits? What are generic drugs? Quantity limits help your doctor and pharmacist make Generic drugs are proven to be just as safe and effective sure that you use your drug correctly and safely. We use as brand-name drugs. They contain the same active medical guidelines and FDA-approved recommendations ingredients in the same amounts as the brand-name from drug makers to set these coverage limits. The drugs and work the same way. So they have the same quantity limit program includes: risks and benefits as brand-name drugs. However, they • Dose efficiency edits — Limits
Recommended publications
  • NG198 Evidence Review E1

    NG198 Evidence Review E1

    1 2 Research recommendations for review question: For people with mild to 3 moderate acne vulgaris what are the most effective treatment options? 4 Research question - physical modalities 5 What is the effectiveness of physical modalities (such as light devices) in the treatment of 6 acne vulgaris or persistent acne vulgaris-related scarring? 7 Why this is important 8 Physical treatments for acne are popular with people because they have the benefit of 9 treating a local area without systemic effects. They can be used in people with co-morbidities 10 or side effects where other treatments are unsuitable. They are currently available in the 11 private sector but there is no standardisation of treatment modalities or duration. Many 12 different physical therapies have been described for acne including: 13 • Comedone extraction 14 • Phototherapy – including UVB, intense pulsed light, blue and red light 15 • Photochemical therapy (e.g. photodynamic therapy) 16 • Laser 17 • Photopneumatic therapy (e.g. intense pulsed light + vacuum) 18 • Photothermal therapy (eg gold nanoparticles +light or laser) 19 Physical treatments are also used for acne scarring. These include: 20 • Punch excision 21 • CO2 laser 22 • Dermabrasion 23 • Radiofrequency (e.g. fractional microneedling, bipolar) 24 Further research is required to determine the most effective physical treatments for acne and 25 acne scarring. This could open the way to wider availability in the NHS. 26 Table 26: Research recommendation rationale Research question What is the effectiveness of physical modalities (such as light devices) in the treatment of acne vulgaris or persistent acne vulgaris-related scarring? Why is this needed Importance to ‘patients’ or the Physical treatments for acne are popular with people because population they have the benefit of treating a local area without systemic effects.
  • June 2021 Therapeutic Research Center (TRC) Is the Leading Advisory Service on Drug Therapy and Medication Management

    June 2021 Therapeutic Research Center (TRC) Is the Leading Advisory Service on Drug Therapy and Medication Management

    June 2021 Therapeutic Research Center (TRC) is the leading advisory service on drug therapy and medication management. Every month over 400,000 prescribers, pharmacists, and pharmacy technicians rely on our unbiased, evidence-based clinical recommendations to help them improve medication use, prevent medication errors, and improve patient care and outcomes. We also have one of the most extensive CE/CME course offerings in the industry. Our accredited continuing education and continuing medical education courses are trusted and relied on by hundreds of thousands of pharmacists, technicians, and prescribers every month. Therapeutic Research Center does not receive commercial support and does not accept any advertising. It is completely independent and is supported entirely by subscriptions. Credit is reported to CPE Monitor, AAFP, and CE Broker as appropriate. Accreditation Information: Therapeutic Research Center is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing education for physicians. Pharmacist’s Letter / Therapeutic Research Center is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Therapeutic Research Center / Prescriber’s Letter is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number:080517. Select Therapeutic Research Center courses are also acceptable for American Academy of Family Physicians (AAFP) Prescribed credit, American Osteopathic Association (AOA) credit, and American College of Emergency Physicians (ACEP) Category I Credit. Please refer to the detailed accreditation statements available online for each course. Get started at TherapeuticResearchCenter.com. Log in to access your course list or purchase a course or subscription. For additional assistance, please call 209-472-2240 and we’ll be happy to help you.
  • Acne Class Update

    Acne Class Update

    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-2596 Drug Class Update with New Drug Evaluation: Acne Drugs Date of Review: June 2020 Date of Last Review: November 2018 Dates of Literature Search: 08/03/2018 - 12/26/2019 Generic Name: Trifarotene Brand Name (Manufacturer): Aklief® (Galderma Laboratories, LP) Dossier Received: no Current Status of PDL Class: See Appendix 1. Purpose for Class Update: The acne class has had one new approval, trifarotene cream, and several new product formulations since it was last reviewed in 2018. The purpose of this update is to evaluate new comparative evidence for trifarotene cream for the treatment of acne vulgaris and any new data on comparative efficacy or harms in the acne class since the previous update. Acne conglobata, acne fulminans, and severe cystic acne are covered conditions under the Oregon Health Plan (OHP). Research Questions: 1. What is the comparative efficacy and effectiveness of treatments for severe acne (topical agents of adapalene, adapalene/benzoyl peroxide, tretinoin, tazarotene, benzoyl peroxide, salicylic acid, dapsone, azelaic acid, clindamycin, erythromycin, minocycline, sulfacetamide, trifarotene; oral systemic antibiotics of doxycycline, minocycline, tetracycline, azithromycin, erythromycin, clindamycin, trimethoprim, and sulfamethoxazole/trimethoprim; hormonal agents of oral contraceptives and spironolactone; and oral isotretinoin)? 2. What are the comparative harms of treatments for severe acne? 3. Are there subpopulations of patients in which a particular treatment for severe acne would be more effective or associated with less harm? Conclusions: There are no new high-quality clinical practice guidelines which have evaluated comparative efficacy and safety of treatments for acne vulgaris.
  • January 2021 Update

    January 2021 Update

    PUBLISHED JULY 08, 2021 OCTOBER/DECEMBER 2020; JANUARY 2021 UPDATE CHANGES TO THE HIGHMARK DRUG FORMULARIES Following is the update to the Highmark Drug Formularies and pharmaceutical management procedures for January 2021. The formularies and pharmaceutical management procedures are updated on a bimonthly basis, and the following changes reflect the decisions made in October, December, and January by our Pharmacy and Therapeutics Committee. These updates are effective on the dates noted throughout this document. Please reference the guide below to navigate this communication: Section I. Highmark Commercial and Healthcare Reform Formularies A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Healthcare Reform Formulary B. Changes to the Highmark Healthcare Reform Essential Formulary C. Changes to the Highmark Core Formulary D. Changes to the Highmark National Select Formulary E. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Formulary Program 4. Quantity Level Limit (QLL) Programs As an added convenience, you can also search our drug formularies and view utilization management policies on the Provider Resource Center (accessible via NaviNet® or our website). Click the Pharmacy Program/Formularies link from the menu on the left. Highmark Blue Cross Blue Shield Delaware is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides secure, web-based portal between providers and health insurance companies. IMPORTANT DRUG SAFETY UPDATES 03/31/2021 – Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease.
  • Acne Vulgaris

    Acne Vulgaris

    CLINICAL REVIEW What’s New in the Management of Acne Vulgaris Leon H. Kircik, MD A better understanding of acne pathophysiology and the PRACTICE POINTS role of inflammation has, however, yielded a better under- • Sarecycline is the first new antibiotic approved for standing of how existing therapies treat the disease and acne in several years. have led to more comprehensive treatment strategies that • Tazarotene foam 0.1% was relaunched to the market. are multitargeted. Nonetheless, topical and oral antibiotics The foam formulation attempts to impart moisturizing remain mainstays of acne therapy, along with topical reti- effects to offset potential irritation. noids and benzoyl peroxide. Current guidelines of care for • Topical minocycline for acne optimizes the therapeutic acne emphasize strategies that reduce dependence on anti- effects while reducing systemic effects. biotics and minimizecopy the risk for resistance.4 The therapeutic • Clascoterone and cannabidiol currently are under landscape might at last be shifting, with new chemical enti- investigation for acne treatment. ties for acne and several novel formulations in development. Sarecycline: A Novel Tetracycline Tetracyclinenot antibiotics have been used to manage acne Drug development continues to focus on the challenge of treat- since the 1950s, but their method of action in the disease ing acne effectively and safely. Inflammation is a backdrop to has not been fully elucidated.5 In addition to antibiotic the commonly cited elements of the pathophysiology of acne: effects, tetracyclines have been shown to confer anti- Propionibacterium acnes proliferation, increased sebum Dopro- inflammatory properties and other biologic effects.6,7 duction with an increase in circulating androgens, and faulty keratinization.
  • Study Protocol

    Study Protocol

    CLINICAL STUDY PROTOCOL Study Title: An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder Protocol Number: RVT-901-3003 Compound Name and/or Vibegron Number: Indication Treatment of Overactive Bladder Sponsor: Urovant Sciences GmbH Viaduktstrasse 8 4051 Basel Switzerland Development Phase: 3 Regulatory Identifier(s): IND# 106,410 EudraCT# 2017-003293-14 Current Version and Version 3.0; 15 NOV 2018 Effective Date: Previous Version(s) and Version 2.1; 12 FEB 2018 Effective Date(s): Version 2.0; 30 JAN 2018 Version 1.2; 01 NOV 2017 Version 1.1; 05 OCT 2017 Version 1.0; 29 SEP 2017 Study Director: , , Clinical Development Confidentiality Statement The information contained in this document, particularly unpublished data, is the property or under control of Urovant Sciences GmbH, and is provided to you in confidence as an investigator, potential investigator or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The information is only to be used by you in connection with authorized clinical studies of the investigational drug described in the protocol. You will not disclose any of the information to others without written authorization from Urovant Sciences GmbH. except to the extent necessary to obtain informed consent from those persons to whom the drug may be administered. Confidential Page | 1 NCT Number: NCT03492281 This NCT number has been applied to the document for purposes of posting on clinicaltrials.gov Clinical Study Protocol RVT-901-3003 Urovant Sciences GmbH Effective: 15 NOV 2018 SUMMARY OF CHANGES Version Location Description of Change 3.0 Global Minor typographical/formatting errors were corrected.
  • DRUG and MEDICAL DEVICE HIGHLIGHTS Helping You Maintain and Improve Your Health 2019

    DRUG and MEDICAL DEVICE HIGHLIGHTS Helping You Maintain and Improve Your Health 2019

    DRUG AND MEDICAL DEVICE HIGHLIGHTS Helping you maintain and improve your health 2019 DRUG AND MEDICAL DEVICE HIGHLIGHTS 2019 Helping you maintain and improve your health Learn about the new drugs and medical devices that Health Canada approved for sale in Canada, the information we published about potential safety issues, and our other accomplishments in 2019. Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of all of Canada’s people and to making this country’s population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system. Également disponible en français sous le titre : Préserver et améliorer votre santé : Faits saillants sur les médicaments et les instruments médicaux 2019 To obtain additional information, please contact: Health Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613-957-2991 Toll free: 1-866-225-0709 Fax: 613-941-5366 TTY: 1-800-465-7735 E-mail: [email protected] © Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2020 Publication date: May 2020 This publication may be reproduced for personal or internal use only without permission provided the source is fully acknowledged. Cat.: H161-11E-PDF ISSN: 2562-9816 Pub.: 190484 CONTENTS WELCOME TO OUR 2019 HIGHLIGHTS REPORT ..........................................................................................1 MESSAGE FROM THE CHIEF MEDICAL
  • Psychiatric History and Overactive Bladder Symptom Severity in Ambulatory Urogynecological Patients

    Psychiatric History and Overactive Bladder Symptom Severity in Ambulatory Urogynecological Patients

    Journal of Clinical Medicine Article Psychiatric History and Overactive Bladder Symptom Severity in Ambulatory Urogynecological Patients Artur Rogowski 1,2,* , Maria Krowicka-Wasyl 2, Ewa Chotkowska 2, Tomasz Kluz 3, Andrzej Wróbel 4 , Dominika Berent 5 , Paweł Mierzejewski 6, Halina Sienkiewicz-Jarosz 7, Adam Wichniak 8, Marcin Wojnar 9 , Jerzy Samochowiec 10 , Katarzyna Kilis-Pstrusinska 11 and Przemyslaw Bienkowski 9 1 Faculty of Medicine, Collegium Medicum, Cardinal Stefan Wyszynski University in Warsaw, 01-938 Warsaw, Poland 2 Department of Obstetrics and Gynecology, Mother and Child Institute, 01-211 Warsaw, Poland; [email protected] (M.K.-W.); [email protected] (E.C.) 3 Department of Gynecology and Obstetrics, Institute of Medical Sciences, Medical College of Rzeszow University, 35-310 Rzeszów, Poland; [email protected] 4 Second Department of Gynecology, Medical University of Lublin, Jaczewskiego 8, 20-954 Lublin, Poland; [email protected] 5 Regional Psychiatric Hospital Drewnica, 05-091 Zabki, Poland; [email protected] 6 Departments of Pharmacology, Institute of Psychiatry and Neurology, 02-957 Warsaw, Poland; [email protected] 7 Department of Neurology I, Institute of Psychiatry and Neurology, 02-957 Warsaw, Poland; [email protected] 8 Department of Psychiatry III, Institute of Psychiatry and Neurology, 02-957 Warsaw, Poland; Citation: Rogowski, A.; [email protected] 9 Krowicka-Wasyl, M.; Chotkowska, E.; Department of Psychiatry, Medical University of Warsaw, 02-091 Warsaw, Poland; Kluz, T.; Wróbel, A.; Berent, D.; [email protected] (M.W.); [email protected] (P.B.) 10 Mierzejewski, P.; Sienkiewicz-Jarosz, Department of Psychiatry, Pomeranian Medical University, 70-111 Szczecin, Poland; [email protected] 11 Department of Pediatric Nephrology, Wroclaw Medical University, 02-091 Wroclaw, Poland; H.; Wichniak, A.; Wojnar, M.; et al.
  • 19F Henry Ford Health System Publication List – May 2021 This

    19F Henry Ford Health System Publication List – May 2021 This

    19f Henry Ford Health System Publication List – May 2021 This bibliography aims to recognize the scholarly activity and provide ease of access to journal articles, meeting abstracts, book chapters, books and other works published by Henry Ford Health System personnel. Searches were conducted in PubMed, Embase, and Web of Science during the month, and then imported into EndNote for formatting. There are 144 unique citations listed this month, with 8 articles and 5 conference abstracts on COVID-19. Articles are listed first, followed by conference abstracts, books and book chapters, and a bibliography of publications on COVID-19. Because of various limitations, this does not represent an exhaustive list of all published works by Henry Ford Health System authors. Click the “Full Text” link to view the articles to which Sladen Library provides access. If the full- text of the article is not available, you may request it through ILLiad by clicking on “Request Article,” or calling us at (313) 916-2550. If you would like to be added to the monthly email distribution list to automatically receive a PDF of this bibliography, or you have any questions or comments, please contact [email protected]. If your published work has been missed, please use this form to notify us for inclusion on next month’s list. All articles and abstracts listed here are deposited into Scholarly Commons, the HFHS institutional repository. Jump to: Articles Administration Neurology Allergy and Immunology Neurosurgery Anesthesiology Obstetrics, Gynecology and Women’s Behavioral
  • 2020 Research Annual Report Table of Contents

    2020 Research Annual Report Table of Contents

    2020 RESEARCH ANNUAL REPORT TABLE OF CONTENTS PART I – INTERNAL MEDICINE DEPARTMENT ALLERGY AND IMMUNOLOGY ...................................................................................... 1 CARDIOLOGY/CARDIOVASCULAR RESEARCH…………………………………………..2 ENDOCRINOLOGY AND METABOLISM ........................................................................ 3 GASTROENTEROLOGY ................................................................................................ 5 HYPERTENSION AND VASCULAR RESEARCH……………………………………….…...6 PULMONARY……………………………………………………………………………………10 SLEEP MEDICINE………………………………………………………………………………10 GENERAL INTERNAL MEDICINE…………………………………………………….………12 HEMATOLOGY/ONCOLOGY………………………………………………………………….12 PART II – ALL OTHER CLINICAL DEPARTMENTS DERMATOLOGY ......................................................................................................... .14 EMERGENCY MEDICINE……………………………………………………………………..17 NEUROLOGY…………………………………………………………………………………...19 NEUROSURGERY……………………………………………………………………………… ORTHOPAEDICS/BONE & JOINT…………………………………………………………….31 OTOLARYNGOLOGY………………………………………………………………………… .36 PATHOLOGY ................................................................................................................ .36 PEDIATRICS…………………………………………………………………………………….37 PSYCHIATRY/BEHAVORIAL HEALTH………………………………………………………38 RADIATION ONCOLOGY ............................................................................................. 39 UROLOGY………………………………………………………………………………………40 WOMEN’S HEALTH……………………………………………………………………………42 i PART III POPULATION
  • Gemtesa® (Vibegron) – New Drug Approval

    Gemtesa® (Vibegron) – New Drug Approval

    Gemtesa® (vibegron) – New drug approval • On December 23, 2020, Urovant Sciences announced the FDA approval of Gemtesa (vibegron), for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. • OAB is a common condition that occurs when the bladder muscle contracts involuntarily. Over 30 million Americans are estimated to suffer from bothersome symptoms of OAB. • Gemtesa is a selective human beta-3 adrenergic receptor agonist. Activation of the beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling. • The efficacy of Gemtesa was established in a 12-week, double-blind, randomized, placebo- controlled, and active-controlled study in 1,515 patients with OAB (urge urinary incontinence, urgency, and urinary frequency). The co-primary endpoints were change from baseline in average daily number of micturitions and average daily number of urge urinary incontinence (UUI) episodes at week 12. — The change from baseline at week 12 in the average daily number of micturitions was -1.8 and -1.3 for Gemtesa and placebo, respectively (difference of -0.5, 95% CI: -0.8, -0.2; p < 0.001). — The change from baseline at week 12 in the average daily number of UUI episodes was -2.0 and -1.4 for Gemtesa and placebo, respectively (difference of -0.6, 95% CI: -0.9, -0.3; p < 0.0001). • A warning and precaution for Gemtesa is urinary retention. • The most common adverse reactions (2%) with Gemtesa use were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. • The recommended dose of Gemtesa is one 75 mg tablet orally, once daily with or without food.
  • A20-73 Trifarotene (Acne Vulgaris) – Benefit Assessment According to §35A Social Code Book V1

    A20-73 Trifarotene (Acne Vulgaris) – Benefit Assessment According to §35A Social Code Book V1

    IQWiG Reports – Commission No. A20-73 Trifarotene (acne vulgaris) – Benefit assessment according to §35a Social Code Book V1 Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Trifaroten (Acne vulgaris) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 November 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract of dossier assessment A20-73 Version 1.0 Trifarotene (acne vulgaris) 12 November 2020 Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Trifarotene (acne vulgaris) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 13 August 2020 Internal Commission No. A20-73 Address of publisher Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Im Mediapark 8 50670 Köln Germany Phone: +49 221 35685-0 Fax: +49 221 35685-1 E-mail: [email protected] Internet: www.iqwig.de Institute for Quality and Efficiency in Health Care (IQWiG) - i - Extract of dossier assessment A20-73 Version 1.0 Trifarotene (acne vulgaris) 12 November 2020 Medical and scientific advice . Prof. Dr. med. Dr. rer. nat. Enno Schmidt, University Hospital Schleswig-Holstein, Lübeck, Germany IQWiG thanks the medical and scientific advisor for his contribution to the dossier assessment. However, the advisor was not involved in the actual preparation of the dossier assessment. The responsibility for the contents of the dossier assessment lies solely with IQWiG. IQWiG employees involved in the dossier assessment . Anke Penno . Katharina Biester . Moritz Felsch .