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1 Table S1 Therapeutic biologic product approvals, classes and innovation categories: Approval year Trade name Active Ingredient(s) Drug class Innovation category Approval date 16 Intron-A Interferon Alfa-2b interferon alpha 04-Jun Roferon-A Interferon alfa-2a interferon alpha 04-Jun Orthoclone OKT3 Muromonab-CD3 17 Activase Alteplase 19 Epogen Epoetin alfa Anti-CD3 Monoclonal Antibody 19-Jun-86 activators (TPA) 13-Nov- 87 agent (ESA) -Jun Alferon N Injection 19 Eminase Anistreplase 1990 Actimune 1991 Neupogen Filgrastim Interferon alfa-n3 (Human Leukocyte Derived) interferon alpha 10-Oct-89 activators (TPA) 27-Nov- 89 Interferon gamma- 1b interferon gamma 20-Dec-90 Granulocyte colonystimulating factor (G- CSF) 20-Feb Leukine Sargramostim 1991 BOTOX Botulinum Toxin Type A Granulocyte-macrophage colony stimulating factor (GM-CSF) 05-Mar- 91 inhibitor 09-Dec Proleukin Aldesleukin lymphocyte growth factor 1992 OncoScint Satumomab Pendetide 1993 Betaseron Interferon beta-1b 1993 Pulmozyme Dornase alfa 1994 Oncaspar Pegaspargase 05-May- 92 (MAbs) 29-Dec-92 interferon beta 23-Jul-93 deoxyribonuclease 1 (rhdnase) enzyme 30-Dec-93 asparagine-specific enzyme -Feb-94
2 1994 Cerezyme Imiglucerase 1994 ReoPro Abciximab 1995 Eprex Epoetin alfa glucocerebroside-specific enzyme 23-May- 94 glycoprotein IIb/IIIa inhibitor 22-Dec-94 agent (ESA) 29-Sep May Avonex Interferon beta-1a interferon beta Humalog Lispro Insulin insulin analog 14-Jun CEA-Scan Arcitumomab 1996 Myoscint Imciromab Pentetate 1996 Verluma Nofetumomab 1996 ProstaScint Capromab Pendetide 1996 Retavase Reteplase 1997 Infergen 1997 Neumega Oprelvekin 1997 Rituxan Rituximab 1997 Zenapax Daclizumab (MAbs) 28-Jun-96 (MAbs) 03-Jul-96 (MAbs) 20-Aug- 96 (MAbs) 28-Oct-96 activators (TPA) 30-Oct-96 Interferon alfacon- 1 interferon alpha 06-Oct-97 megakaryocyte growth factor CD20-directed cytolytic monoclonal antibody 25-Nov Nov- 97 interleukin-2 (IL-2) receptor antagonist 10-Dec Regranex Becaplermin human platelet-derived growth factor 16-Dec Refludan Lepirudin direct thrombin inhibitor 06-Mar- 19 Simulect Basiliximab 19 Synagis Palivizumab 19 Remicade Infliximab 19 Herceptin Trastuzumab interleukin-2 (IL-2) receptor antagonist 12-May- RSV anti-f protein monoclonal (mab) 19-Jun- (TNF) blocker 24-Aug- HER2/neu receptor antagonist 25-Sep-
3 19 Enbrel Etanercept (TNF) blocker 19 Thyrogen Thyrotropin Alfa tests for thyroid function 02-Nov- 30-Nov Ontak Denileukin diftitox CD25-directed cytotoxin 05-Feb-99 Interferon alfa-n1 25-Mar Wellferon (Lymphoblastoid) interferon alpha Lantus Insulin Glargine insulin analog 20-Apr Mylotarg 2000 TNKase Tenecteplase 2000 NovoLog 2000 Myobloc 20 Peg-Intron Gemtuzumab Ozogamicin CD33-directed cytotoxin 17-May- 00 activators (TPA) 02-Jun-00 Insulin Aspart Recombinant insulin analog 07-Jun-00 Botulinum Toxin Type B 20 Campath Alemtuzumab inhibitor 08-Dec-00 Peginterferon alfa- 2b interferon alpha 19-Jan- CD52-directed cytolytic antibody 20 Natrecor Nesiritide natriuretic peptide 20 Aranesp Darbepoetin alfa 20 Kineret Anakinra 20 Xigris Drotrecogin alfa (Activated) 2002 Neulasta Pegfilgrastim 07-May- 10-Aug- agent (ESA) 17-Sep- interleukin-1 (IL-1) receptor antagonist recombinant activated protein C 14-Nov- 21-Nov- Granulocyte colonystimulating factor (G- CSF) 31-Jan Zevalin Ibritumomab tiuxetan 2002 Rebif Interferon beta-1a CD20-directed radiotherapeutic antibody 19-Feb-02 interferon beta 07-Mar Elitek Rasburicase uric acid specific enzyme 12-Jul Pegasys 2002 Humira Adalimumab Peginterferon alfa- 2a interferon alpha 16-Oct-02 (TNF) blocker 31-Dec-02
4 2003 Amevive Alefacept 2003 Somavert Pegvisomant CD2-directed LFA-3/Fc fusion protein 30-Jan-03 growth hormone receptor antagonist 25-Mar Fabrazyme agalsidase beta neutral glycosphingolipidspecific enzyme 24-Apr Aldurazyme Laronidase MPS I 30-Apr Xolair Omalizumab anti-ige antibody 20-Jun Bexxar Tositumomab and Iodine I 131 Tositumomab 2003 Raptiva Efalizumab 2004 Erbitux Cetuximab CD20-directed radiotherapeutic antibody 27-Jun-03 CDa-directed humanized IgG1 antibody 27-Oct-03 epidermal growth factor receptor (EGFR) antagonist 12-Feb Avastin Bevacizumab vascular endothelial growth factor (VEGF) directed antibody 26-Feb Apidra Insulin Glulisine insulin analog 16-Apr NeutroSpec Technetium (99m Tc) fanolesomab 2004 Tysabri Natalizumab 2004 Kepivance Palifermin (MAbs) 02-Jul-04 integrin receptor antagonist 23-Nov- 04 mucocutaneous epithelial cell growth factor 15-Dec Naglazyme Galsulfase MPS VI 31-May Levemir Insulin Detemir insulin analog 16-Jun Increlex 2005 Hylenex Recombinant Mecasermin [rdna Origin] insulin-like growth factor- 1 (IGF-1) 30-Aug- 05 Hyaluronidase Human hyaluronidase 02-Dec-05
5 2005 Iplex Mecasermin Rinfabate [rdna Origin] 2005 Orencia Abatacept insulin-like growth factor- 1 (IGF-1) 12-Dec-05 human CTLA-4 and Fc- IgG1 recombinant fusion protein 23-Dec Myozyme Alglucosidase alfa 2006 Lucentis Ranibizumab 2006 Elaprase Idursulfase glycogen-specific enzyme 28-Apr-06 ophthalmic VEGF inhibitor 30-Jun-06 Hunter syndrome 24-Jul Vectibix Panitumumab epidermal growth factor receptor (EGFR) antagonist 27-Sep Soliris Eculizumab complement inhibitor 16-Mar Pegzerepoetin alfa Mircera 2008 Arcalyst Rilonacept 2008 Cimzia Certolizumab pegol 2008 Nplate Romiplostim 2009 Simponi Golimumab 2009 Dysport Abobotulinumtoxin A 2009 Ilaris Canakinumab 2009 Stelara Ustekinumab 2009 Arzerra Ofatumumab agent (ESA) 14-Nov- 07 interleukin-1 (IL-1) receptor antagonist 27-Feb-08 (TNF) blocker 22-Apr-08 thrombopoiesis stimulating agent 22-Aug- 08 (TNF) blocker 24-Apr-09 inhibitor 29-Apr-09 interleukin-1 (IL-1) receptor antagonist 17-Jun-09 interleukin-12 and -23 antagonist 25-Sep-09 CD20-directed cytolytic monoclonal antibody 26-Oct Kalbitor Ecallantide plasma kallikrein inhibitor -Dec Actemra Tocilizumab 20 Xiaflex interleukin-6 (IL-6) receptor inhibitor 08-Jan-10 Clostridial collagenase collagenase 02-Feb-10
6 20 Vpriv Velaglucerase Alfa glucocerebroside-specific enzyme 26-Feb Lumizyme Alglucosidase alfa (2000L) 20 Prolia Denosumab 20 Xeomin Incobotulinumtoxin A 20 Krystexxa Pegloticase glycogen-specific enzyme 24-May- 10 RANK ligand (RANKL) inhibitor -Jun-10 inhibitor 30-Jul-10 PEGylated uric acid specific enzyme 14-Sep Benlysta Belimumab 20 Yervoy Ipilimumab 20 Nulojix Belatacept 20 Adcetris Brentuximab vedotin 20 Eylea Aflibercept 20 Erwinaze Erwinia L- asparaginase B-lymphocyte stimulator (BLyS)-specific inhibitor cytotoxic T-lymphocyte antigen 4 (CTLA-4)- blocking antibody 09-Mar- 25-Mar- selective T-cell costimulation blocker 15-Jun- CD30-directed antibodydrug conjugate ophthalmic VEGF inhibitor asparagine-specific enzyme 19-Aug- 18-Nov- 18-Nov- 22 Voraxaze Glucarpidase carboxypeptidase enzyme First in class 17-Jan Elelyso Taliglucerase Alfa 22 Perjeta Pertuzumab 22 Zaltrap Ziv-aflibercept 22 Neutroval tbo-filgrastim 22 Jetrea Ocriplasmin glucocerebroside-specific enzyme -May- 12 HER2/neu receptor antagonist 08-Jun-12 vascular endothelial growth factor (VEGF) directed antibody Granulocyte colonystimulating factor (G- CSF) 03-Aug Aug- 12 proteolytic enzyme - truncated human serine protease plasmin 17-Oct-12
7 22 Raxibacumab Raxibacumab 22 Gattex Teduglutide 23 Kadcyla ado-trastuzumab emtansine 23 Gazyva Obinutuzumab 24 Vimzim Elosulfase alfa 24 Myalept Metreleptin Bacillus anthracis protective antigen inhibitor 14-Dec-12 glucagon-like peptide-2 (GLP-2) analog 21-Dec-12 HER2 Antibody drug conjugate 22-Feb-13 CD20-directed cytolytic monoclonal antibody -Nov- 13 Morquio A syndrome 14-Feb-14 leptin analog 24-Feb Tanzeum Albiglutide glucagon-like peptide-1 (GLP-1) receptor agonist 15-Apr Cyramza Ramucirumab 24 Sylvant Siltuximab 24 Entyvio Vedolizumab 24 Plegridy Peginterferon beta- 1a 24 Keytruda Pembrolizumab vascular endothelial growth factor (VEGFR2) directed antibody 21-Apr-14 interleukin-6 (IL-6) receptor inhibitor - Castleman's Disease 23-Apr-14 integrin receptor antagonist interferon beta 20-May Aug- 14 anti-programmed death-1 (PD-1) monoclonal antibody 04-Sep Trulicity Dulaglutide glucagon-like peptide-1 (GLP-1) receptor agonist 18-Sep Blincyto Blinatumomab 24 Opdivo Nivolumab Bispecific CD19-directed CD3 T-cell engager 03-Dec-14 anti-programmed death-1 (PD-1) monoclonal antibody 22-Dec-14
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Serving Hoosier Healthwise, Healthy Indiana Plan and Hoosier Care Connect Medical Policies and Clinical Utilization Management Guidelines Attached is a list of the Guidelines and/or Medical Policies the
Medical Policies and Clinical Utilization Management Guidelines update
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How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study
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Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.18 Subject: Orencia Page: 1 of 8 Last Review Date: March 16, 2018 Orencia Description Orencia (abatacept)
Clinical Utilization Management Guidelines update
Medicaid Managed Care The Clinical Utilization Management (UM) Guidelines on this list represent the Clinical UM Guidelines adopted by the Medical Operations Committee for the Government Business Division.
Percent Brand Name Generic Name Strength How Supplied NDC from AWP/SWP Adcetris. Amprya dalfampridine 10 mg 60 count bottle
Department of General Services Procurement Division Contract # 01-14- 65-57 Pharmaceutical Acquisitions Section Exhibit G-1 April 30, 2015 Walgreens Specialty Pharmacy LLC, Products Pricing Crescent Healthcare,
Pharmacy Management Drug Policy
SUBJECT: POLICY NUMBER: PHARMACY-63 EFFECTIVE DATE: 12/04 LAST REVIEW DATE: 1/29/2018 If the member s subscriber contract excludes coverage for a specific service or prescription drug, it is not covered
Medical Policies and Clinical Utilization Management Guidelines
Medicaid Managed Care Medical Policies and Clinical Utilization Management Guidelines Attached is a list of the Clinical UM Guidelines and/or Medical Policies the health plan has adopted. The full list
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Regulatory Status FDA-approved indications: Entyvio is an α4β7integrin receptor antagonist indicated for: (1)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.12 Subject: Entyvio Page: 1 of 7 Last Review Date: September 20, 2018 Entyvio Description Entyvio
8/15/2017. Hematopoiesis, Growth Factors, and Immunology. Hematopoiesis. Origin of Blood Cells. Objectives
Objectives Hematopoiesis, Growth Factors, and Immunology Juanita Madison, MN, RN, AOCN, AOCNS Oncology Clinical Nurse Specialist Swedish Cancer Institute September, 2017 Describe the hematopoietic system
Drug Name Generic Name J-Code Unclassified Drugs in excess of $10,000
Unclassified Drugs in excess of $10,000 J3490 Unclassified Biologics in excess of $10,000 J3590 Revenue Codes in excess of $10,000 R250 - R259 ABRAXANE paclitaxel protein-bound J9264 & J9267 ACTEMRA tocilizumab
Medical Policy An independent licensee of the Blue Cross Blue Shield Association
Otezla (apremilast) Page 1 of 7 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Otezla (apremilast) Prime Therapeutics will review Prior Authorization requests Prior
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Abstral fentanyl citrate oral tablet Controlled Dangerous substance Actemra tocilizumab Monoclonal antibody Acthar corticotropin Hormone Actimmune interferon gamma 1b Interferon Actiq fentanyl citrate
High Risk Medications
Department Policy Code: D: MM-5705 Entity: Fairview Health Services Department: Home Infusion Manual: Policies & Procedures Category: Medication Management Subject: High Risk Medications Purpose: To provide