Enhanced Annual Drug List Dispensing Limits
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic) -
Pulmonary Delivery of Biological Drugs
pharmaceutics Review Pulmonary Delivery of Biological Drugs Wanling Liang 1,*, Harry W. Pan 1 , Driton Vllasaliu 2 and Jenny K. W. Lam 1 1 Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 21 Sassoon Road, Pokfulam, Hong Kong, China; [email protected] (H.W.P.); [email protected] (J.K.W.L.) 2 School of Cancer and Pharmaceutical Sciences, King’s College London, 150 Stamford Street, London SE1 9NH, UK; [email protected] * Correspondence: [email protected]; Tel.: +852-3917-9024 Received: 15 September 2020; Accepted: 20 October 2020; Published: 26 October 2020 Abstract: In the last decade, biological drugs have rapidly proliferated and have now become an important therapeutic modality. This is because of their high potency, high specificity and desirable safety profile. The majority of biological drugs are peptide- and protein-based therapeutics with poor oral bioavailability. They are normally administered by parenteral injection (with a very few exceptions). Pulmonary delivery is an attractive non-invasive alternative route of administration for local and systemic delivery of biologics with immense potential to treat various diseases, including diabetes, cystic fibrosis, respiratory viral infection and asthma, etc. The massive surface area and extensive vascularisation in the lungs enable rapid absorption and fast onset of action. Despite the benefits of pulmonary delivery, development of inhalable biological drug is a challenging task. There are various anatomical, physiological and immunological barriers that affect the therapeutic efficacy of inhaled formulations. This review assesses the characteristics of biological drugs and the barriers to pulmonary drug delivery. -
Immunfarmakológia Immunfarmakológia
Gergely: Immunfarmakológia Immunfarmakológia Prof Gergely Péter Az immunpatológiai betegségek döntő többsége gyulladásos, és ennek következtében általában szövetpusztulással járó betegség, melyben – jelenleg – a terápia alapvetően a gyulladás csökkentésére és/vagy megszűntetésére irányul. Vannak kizárólag gyulladásgátló gyógyszereink és vannak olyanok, amelyek az immunreakció(k) bénításával (=immunszuppresszió révén) vagy emellett vezetnek a gyulladás mérsékléséhez. Mind szerkezetileg, mind hatástanilag igen sokféle csoportba oszthatók, az alábbi felosztás elsősorban didaktikus célokat szolgál. 1. Nem-szteroid gyulladásgátlók (‘nonsteroidal antiinflammatory drugs’ NSAID) 2. Kortikoszteroidok 3. Allergia-elleni szerek (antiallergikumok) 4. Sejtoszlás-gátlók (citosztatikumok) 5. Nem citosztatikus hatású immunszuppresszív szerek 6. Egyéb gyulladásgátlók és immunmoduláns szerek 7. Biológiai terápia 1. Nem-szteroid gyulladásgátlók (NSAID) Ezeket a vegyületeket, melyek őse a szalicilsav (jelenleg, mint acetilszalicilsav ‘aszpirin’ használatos), igen kiterjedten alkalmazzák a reumatológiában, az onkológiában és az orvostudomány szinte minden ágában, ahol fájdalom- és lázcsillapításra van szükség. Egyes felmérések szerint a betegek egy ötöde szed valamilyen NSAID készítményt. Szerkezetük alapján a készítményeket több csoportba sorolhatjuk: szalicilátok (pl. acetilszalicilsav) pyrazolidinek (pl. fenilbutazon) ecetsav származékok (pl. indometacin) fenoxiecetsav származékok (pl. diclofenac, aceclofenac)) oxicamok (pl. piroxicam, meloxicam) propionsav -
(12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub
US 20170172932A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub. Date: Jun. 22, 2017 (54) EARLY CANCER DETECTION AND A 6LX 39/395 (2006.01) ENHANCED IMMUNOTHERAPY A61R 4I/00 (2006.01) (52) U.S. Cl. (71) Applicant: Gholam A. Peyman, Sun City, AZ CPC .......... A61K 9/50 (2013.01); A61K 39/39558 (US) (2013.01); A61K 4I/0052 (2013.01); A61 K 48/00 (2013.01); A61K 35/17 (2013.01); A61 K (72) Inventor: sham A. Peyman, Sun City, AZ 35/15 (2013.01); A61K 2035/124 (2013.01) (21) Appl. No.: 15/143,981 (57) ABSTRACT (22) Filed: May 2, 2016 A method of therapy for a tumor or other pathology by administering a combination of thermotherapy and immu Related U.S. Application Data notherapy optionally combined with gene delivery. The combination therapy beneficially treats the tumor and pre (63) Continuation-in-part of application No. 14/976,321, vents tumor recurrence, either locally or at a different site, by filed on Dec. 21, 2015. boosting the patient’s immune response both at the time or original therapy and/or for later therapy. With respect to Publication Classification gene delivery, the inventive method may be used in cancer (51) Int. Cl. therapy, but is not limited to such use; it will be appreciated A 6LX 9/50 (2006.01) that the inventive method may be used for gene delivery in A6 IK 35/5 (2006.01) general. The controlled and precise application of thermal A6 IK 4.8/00 (2006.01) energy enhances gene transfer to any cell, whether the cell A 6LX 35/7 (2006.01) is a neoplastic cell, a pre-neoplastic cell, or a normal cell. -
CDER List of Licensed Biological Products With
Center for Drug Evaluation and Research List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date DATE OF FIRST REFERENCE PRODUCT DATE OF LICENSURE LICENSURE EXCLUSIVITY EXPIRY DATE INTERCHANGEABLE (I)/ BLA STN PRODUCT (PROPER) NAME PROPRIETARY NAME (mo/day/yr) (mo/day/yr) (mo/day/yr) BIOSIMILAR (B) WITHDRAWN 125118 abatacept Orencia 12/23/05 NA NA 103575 abciximab ReoPro 12/22/94 NA NA Yes 125274 abobotulinumtoxinA Dysport 04/29/09 125057 adalimumab Humira 12/31/02 NA NA 761071 adalimumab-adaz Hyrimoz 10/30/18 B 761058 adalimumab-adbm Cyltezo 08/25/17 B 761118 adalimumab-afzb Abrilada 11/15/19 B 761024 adalimumab-atto Amjevita 09/23/16 B 761059 adalimumab-bwwd Hadlima 07/23/19 B 125427 ado-trastuzumab emtansine Kadcyla 02/22/13 125387 aflibercept Eylea 11/18/11 103979 agalsidase beta Fabrazyme 04/24/03 NA NA 125431 albiglutide Tanzeum 04/15/14 017835 albumin chromated CR-51 serum Chromalbin 02/23/76 103293 aldesleukin Proleukin 05/05/92 NA NA 103948 alemtuzumab Campath, Lemtrada 05/07/01 NA NA 125141 alglucosidase alfa Myozyme 04/28/06 NA NA 125291 alglucosidase alfa Lumizyme 05/24/10 125559 alirocumab Praluent 07/24/15 103172 alteplase, cathflo activase Activase 11/13/87 NA NA 103950 anakinra Kineret 11/14/01 NA NA 020304 aprotinin Trasylol 12/29/93 125513 asfotase alfa Strensiq 10/23/15 101063 asparaginase Elspar 01/10/78 NA NA 125359 asparaginase erwinia chrysanthemi Erwinaze 11/18/11 761034 atezolizumab Tecentriq 05/18/16 761049 avelumab Bavencio 03/23/17 -
P&T Summary 2Q2019
BLUE SHIELD OF CALIFORNIA SECOND QUARTER 2019 FORMULARY AND MEDICATION POLICY UPDATES EFFECTIVE AUGUST 1, 2019 for Large Group, Small Group, and Individual & Family Plans The Blue Shield of California (BSC) Pharmacy and Therapeutics (P&T) Committee, consisting of network physicians and pharmacists, regularly evaluates drugs for formulary inclusion and medication policy coverage criteria. The second quarter 2019 P&T Committee decisions on formulary changes and medication policy changes, which apply to Commercial members with an outpatient drug benefit, are summarized below: PHARMACY BENEFIT FORMULARY UPDATE: Please refer to the appropriate drug formulary posted on our website for the following information: • Quantity limits, if applicable, for specific drugs • Formulary status of newly available strengths of existing drugs. Note: The formulary status of newly available strengths of existing drugs will have the same formulary status as the existing strengths unless otherwise noted. • Non-formulary and non-preferred generic drugs that do not require prior authorization or step therapy • Brand-name medications that are now non-formulary or non-preferred because these medications have newly available generic equivalents covered on the formulary Formularies are available at blueshieldca.com/pharmacy. Select the appropriate drug formulary – “Standard Drug Formulary” or “Plus Drug Formulary”. Summary of changes to the Medicare formularies are available at blueshieldca.com/pharmacy. Select “Medicare Drug Formulary”, then select the appropriate -
A Abacavir Abacavirum Abakaviiri Abagovomab Abagovomabum
A abacavir abacavirum abakaviiri abagovomab abagovomabum abagovomabi abamectin abamectinum abamektiini abametapir abametapirum abametapiiri abanoquil abanoquilum abanokiili abaperidone abaperidonum abaperidoni abarelix abarelixum abareliksi abatacept abataceptum abatasepti abciximab abciximabum absiksimabi abecarnil abecarnilum abekarniili abediterol abediterolum abediteroli abetimus abetimusum abetimuusi abexinostat abexinostatum abeksinostaatti abicipar pegol abiciparum pegolum abisipaaripegoli abiraterone abirateronum abirateroni abitesartan abitesartanum abitesartaani ablukast ablukastum ablukasti abrilumab abrilumabum abrilumabi abrineurin abrineurinum abrineuriini abunidazol abunidazolum abunidatsoli acadesine acadesinum akadesiini acamprosate acamprosatum akamprosaatti acarbose acarbosum akarboosi acebrochol acebrocholum asebrokoli aceburic acid acidum aceburicum asebuurihappo acebutolol acebutololum asebutololi acecainide acecainidum asekainidi acecarbromal acecarbromalum asekarbromaali aceclidine aceclidinum aseklidiini aceclofenac aceclofenacum aseklofenaakki acedapsone acedapsonum asedapsoni acediasulfone sodium acediasulfonum natricum asediasulfoninatrium acefluranol acefluranolum asefluranoli acefurtiamine acefurtiaminum asefurtiamiini acefylline clofibrol acefyllinum clofibrolum asefylliiniklofibroli acefylline piperazine acefyllinum piperazinum asefylliinipiperatsiini aceglatone aceglatonum aseglatoni aceglutamide aceglutamidum aseglutamidi acemannan acemannanum asemannaani acemetacin acemetacinum asemetasiini aceneuramic -
Guidelines on the Use of Therapeutic Apheresis In
DOI: 10.1002/jca.21705 Guidelines on the Use of Therapeutic Apheresis in Clinical Practice – Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Eighth Special Issue Anand Padmanabhan1 | Laura Connelly-Smith2 | Nicole Aqui3 | Rasheed A. Balogun4 | Reinhard Klingel5 | Erin Meyer6 | Huy P. Pham7 | Jennifer Schneiderman8 | Volker Witt9 | Yanyun Wu10 | Nicole D. Zantek11 | Nancy M. Dunbar12 | Guest Editor: Joseph Schwartz13 1Medical Sciences Institute & Blood Research Institute, Versiti & Department of Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin 2Department of Medicine, Seattle Cancer Care Alliance & University of Washington, Seattle, Washington 3Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 4Department of Medicine, University of Virginia, Charlottesville, Virginia 5Apheresis Research Institute, Cologne, Germany & First Department of Internal Medicine, University of Mainz, Mainz, Germany 6Department of Hematology/Oncology/BMT/Pathology, Nationwide Children’s Hospital, Columbus, Ohio 7Department of Pathology, Keck School of Medicine of the University of Southern California, Los Angeles, California 8Department of Pediatric Hematology/Oncology/Neuro-oncology/Stem Cell Transplant, Ann & Robert H. Lurie Children’s Hospital of Chicago, Northwestern University, Chicago, Illinois 9Department for Pediatrics, St. Anna Kinderspital, Medical University of Vienna, Vienna, Austria 10Bloodworks NW & Department -
MEDICAL BENEFIT MANAGEMENT PROGRAM SPECIALTY PRIOR AUTHORIZATION DRUG LIST Effective March 1, 2021
MEDICAL BENEFIT MANAGEMENT PROGRAM SPECIALTY PRIOR AUTHORIZATION DRUG LIST Effective March 1, 2021 Register at https://www.express-path.com. If you have questions, please call (877) 787-8705. DRUG NAME GENERIC DESCRIPTION THERAPY CLASS REIMBURSEMENT CODE Cablivi caplacizumab Blood Cell Deficiency C9047 Beovu brolucizumab-dbll Ophthalmic Conditions J0179 Adakveo crizanlizumab-tmca Miscellaneous Conditions C9053 (eff 4/1/20), J0791 (eff 7/1/20) Vyepti eptinezumab-jjmr Miscellaneous Conditions C9063 (eff 7/1/20), J3032 (eff 10/1/20) Durysta Bimatoprost Ophthalmic Conditions C9399, J3490, J7351 (eff 10/1/20) Asceniv immune globulin Immune Deficiency C9399, J3590, J1599 (eff 1/1/21) Reblozyl luspatercept-aamt Blood Cell Deficiency C9399, J3590, J0896 (eff 7/1/20) Viltepso viltolarsen Muscular Dystrophies C9399, J3590, C9071 (eff 1/1/21) Brineura cerliponase alfa Enzyme Deficiencies J0567 Eylea aflibercept Ophthalmic Conditions J0178 Beovu brolucizumab-dbll Ophthalmic Conditions J0179 Fabrazyme agalsidase beta Enzyme Deficiencies J0180 Lemtrada alemtuzumab Multiple Sclerosis J0202 Lumizyme alglucosidase alfa Enzyme Deficiencies J0221 Onpattro patisiran Amyloidosis J0222 Prolastin-C alpha1-proteinase inhibitor Alpha 1 Deficiency J0256 Nulojix belatacept Transplant J0485 Crysvita burosumab-twza Endocrine Disorders J0584 Botox onabotulinumtoxinA Neuromuscular Conditions J0585 Dysport abobotulinumtoxinA Neuromuscular Conditions J0586 Myobloc rimabotulinumtoxinB Neuromuscular Conditions J0587 Xeomin incobotulinumtoxinA Neuromuscular Conditions J0588 -
Perioperative Medication Management - Adult/Pediatric - Inpatient/Ambulatory Clinical Practice Guideline
Effective 6/11/2020. Contact [email protected] for previous versions. Perioperative Medication Management - Adult/Pediatric - Inpatient/Ambulatory Clinical Practice Guideline Note: Active Table of Contents – Click to follow link INTRODUCTION........................................................................................................................... 3 SCOPE....................................................................................................................................... 3 DEFINITIONS .............................................................................................................................. 3 RECOMMENDATIONS ................................................................................................................... 4 METHODOLOGY .........................................................................................................................28 COLLATERAL TOOLS & RESOURCES..................................................................................................31 APPENDIX A: PERIOPERATIVE MEDICATION MANAGEMENT .................................................................32 APPENDIX B: TREATMENT ALGORITHM FOR THE TIMING OF ELECTIVE NONCARDIAC SURGERY IN PATIENTS WITH CORONARY STENTS .....................................................................................................................58 APPENDIX C: METHYLENE BLUE AND SEROTONIN SYNDROME ...............................................................59 APPENDIX D: AMINOLEVULINIC ACID AND PHOTOTOXICITY -
CDER List of Licensed Biological Products With
Center for Drug Evaluation and Research List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date DATE OF FIRST REFERENCE PRODUCT DATE OF LICENSURE LICENSURE EXCLUSIVITY EXPIRY DATE INTERCHANGEABLE (I)/ BLA STN PRODUCT (PROPER) NAME PROPRIETARY NAME (mo/day/yr) (mo/day/yr) (mo/day/yr) BIOSIMILAR (B) WITHDRAWN 125118 abatacept Orencia 12/23/05 NA NA 103575 abciximab ReoPro 12/22/94 NA NA 125274 abobotulinumtoxinA Dysport 04/29/09 125057 adalimumab Humira 12/31/02 NA NA 761071 adalimumab-adaz Hyrimoz 10/30/18 B 761058 adalimumab-adbm Cyltezo 08/25/17 B 761024 adalimumab-atto Amjevita 09/23/16 B 125427 ado-trastuzumab emtansine Kadcyla 02/22/13 125387 aflibercept Eylea 11/18/11 103979 agalsidase beta Fabrazyme 04/24/03 NA NA 125431 albiglutide Tanzeum 04/15/14 103293 aldesleukin Proleukin 05/05/92 NA NA 103948 alemtuzumab Campath, Lemtrada 05/07/01 NA NA 125141 alglucosidase alfa Myozyme 04/28/06 NA NA 125291 alglucosidase alfa Lumizyme 05/24/10 125559 alirocumab Praluent 07/24/15 103172 alteplase, cathflo activase Activase 11/13/87 NA NA 103950 anakinra Kineret 11/14/01 NA NA 125513 asfotase alfa Strensiq 10/23/15 101063 asparaginase Elspar 01/10/78 NA NA 125359 asparaginase erwinia chrysanthemi Erwinaze 11/18/11 761034 atezolizumab Tecentriq 05/18/16 761049 avelumab Bavencio 03/23/17 103764 basiliximab Simulect 05/12/98 NA NA 103691 becaplermin Regranex 12/16/97 NA NA 125288 belatacept Nulojix 06/15/11 125370 belimumab Benlysta 03/09/11 761043 belimumab Benlysta -
(INN) for Biological and Biotechnological Substances
WHO/EMP/RHT/TSN/2019.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2019 WHO/EMP/RHT/TSN/2019.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2019 International Nonproprietary Names (INN) Programme Technologies Standards and Norms (TSN) Regulation of Medicines and other Health Technologies (RHT) Essential Medicines and Health Products (EMP) International Nonproprietary Names (INN) for biological and biotechnological substances (a review) FORMER DOCUMENT NUMBER: INN Working Document 05.179 © World Health Organization 2019 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.