DOCSLIB.ORG

May2013 CPG Updates

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

New Drugs May 2013 (Original New Drug Applications: FDA) Generic Name Trade Name Indication(s) CPG Action/Date January 2013 Icosapent Ethyl Vascepa Cardiovascular Agents: 5/20/13 Antihyperlipidemic Agents. CTP holder may Indicated as an adjunct prescribe. to diet to reduce triglyceride levels in adult patients with severe (500mg/dL or more) Formulary Pg. 12 hypertriglyceridemia. Linaclotide Linzess Gastrointestinal Agents: 5/20/13 Linaclotide. Indicated for the CTP holder may treatment of chronic prescribe. idiopathic constipation in adults and for the treatment of irritable bowel syndrome with Formulary Pg. 21 constipation in adults. Teriflunomide Aubagio Biologic/ Immunologic 5/20/13 Agents: Immunologic Agents: Physician Initiated/ Immunomodulators. Physician Consult Indicated for the treatment of patients with relapsing forms of Formulary Pg. 24 multiple sclerosis. February 2013 Vitamin A Palmitate Aquasol Nutrients & Nutritional 5/20/13 Injection Agents: Vitamins. Indicated for the CTP holder may treatment of vitamin A prescribe. Formulary Pg. 5 deficiency. Perampanel Fycompa Central Nervous System 5/20/13 Agents: Anticonvulsants: Adjuvant Physician Initiated/ Anticonvulsants. Physician Consult Indicated as an adjunctive therapy for the treatment of partial- onset seizures with or without secondarily Formulary Pg. 19 generalized seizures in 1 CPG Updates May 2013 patients with epilepsy who are 12 years and older. Regorafenib Stivarga Antineoplastic Agents: 5/20/13 Kinase Inhibitors. Indicated for the CTP holder May treatment of patients NOT prescribe. with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an antivascular endothelial growth factor (VEGF) therapy, and, if KRAS wild type, an antiepidermal growth factor receptor (EGFR) Formulary Pg. 29 therapy. Omacetaxine Synribo Antineoplastic Agents: 5/20/13 Mepesuccinate Protein Synthesis Injection Inhibitor. CTP holder May Indicated for the NOT prescribe. treatment of adults with chronic or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to 2 or more tyrosine kinase Formulary Pg. 29 inhibitors. March 2013 Tofacitinib Citrate Xeljanz Biologic Immunologic 5/20/13 Oral Agents: Antirheumatic Agents. Physician Initiated/ Indicated for the Physician Consult treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate as monotherapy or in combination with methotrexate or other nonbiologic disease Formulary Pg. 24 modifying antirheumatic 2 CPG Updates May 2013 drugs. Triamcinolone Trivaris Ophthalmic Agents: 5/20/13 Acetonide – Corticosteroids. Intravitreal Injection Indicated for the CTP holder May treatment of sympathetic NOT prescribe. ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive Formulary Pg. 26 to topical corticosteroids. Ocriplasmin Jetrea Ophthalmic Agents: 5/20/13 Ophthalmic Proteolytic Enzymes. CTP holder May Indicated for the NOT prescribe. treatment of symptomatic Formulary Pg. 26 vitreomacular adhesion. Sulfacetamide Sulster Ophthalmic Agents: 5/20/13 Sodium - Ophthalmic Ophthalmic Antibiotics. Indicated for the CTP holder may treatment of prescribe. conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide Formulary Pg. 26 therapy of trachoma. Vincristine Sulfate Marqibo Antineoplastic Agents: 5/20/13 Liposome Antimitotic Agents. Indicated for the CTP holder May treatment of adult NOT prescribe. patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following 2 or more anti- Formulary Pg. 27 leukemia therapies. April 2013 Apixaban Eliquis Hematological Agents: 5/20/13 Anticoagulants. Indicated to reduce the Physician Initiated/ risk of stroke and Physician Consult systemic embolism in Formulary Pg. 7 patients with nonvalvular 3 CPG Updates May 2013 atrial fibrillation. Pasireotide Signifor Endocrine & Metabolic 5/20/13 Diaspartate Injection Agents: Somatostatin Analogs. CTP holder may Indicated for the prescribe. treatment of adult patients with Cushing disease for whom pituitary surgery is not an option or has not Formulary Pg. 9 been curative Lomitapide Juxtapid Cardiovascular Agents: 5/20/13 Antihyperlipidemic Agents. CTP holder may Indicated as an adjunct prescribe. to a low fat diet and other lipid-lowering treatments, including low-density lipoprotein apheresis where available, to reduce low- density lipoprotein cholesterol, total cholesterol, apolipoprotein, and non- high-density lipoprotein cholesterol in patients with homozygous Formulary Pg. 12 familiar hypercholesterolemia. Mometasone Furoate Propel Respiratory Agents: 5/20/13 Miscellaneous Respiratory Agents. CTP holder May Indicated to maintain NOT prescribe. patency following Formulary Pg. 14 ethmoid sinus surgery. Teduglutide Gattex Gastrointestinal Agents: 5/20/13 Glucagon-Like Peptide-2 Analogs. CTP holder may Indicated for the prescribe. treatment of adult patients with short bowel syndrome who are dependent on parenteral Formulary Pg. 21 support. Crofelemer Fulyzaq Gastrointestinal Agents: 5/20/13 Antidiarrheals. Indicated for CTP holder may symptomatic relief of prescribe. 4 CPG Updates May 2013 Formulary Pg. 21 noninfectious diarrhea in patients with HIV/AIDS on antiretroviral therapy. Unoprostone Rescula Ophthalmic Agents: 5/20/3 Isopropyl Ophthalmic Agents for Glaucoma. Indicated for lowering Physician Initiated/ intraocular pressure in Physician Consult patients with open-angle glaucoma or ocular Formulary Pg. 26 hypertension. Cysteamine Cystaran Ophthalmic Agents: 5/20/3 Hydrochloride Cystine-Depleting Ophthalmic Agents. Physician Initiated/ Indicated for the Physician Consult treatment of corneal cysteine crystal accumulations in Formulary Pg. 26 patients with cystinosis. Ponatinib Iclusig Antineoplastic Agents: 5/20/13 Kinase Inhibitors. Indicated for the CTP holder May treatment of adult NOT prescribe. patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy and for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia that is resistant or intolerant to prior tyrosine kinase Formulary Pg. 29 inhibitors. Cabozantinib Cometriq Antineoplastic Agents: 5/20/13 Kinase Inhibitors. Indicated for the CTP holder May treatment of patients NOT prescribe. with progressive metastatic medullary Formulary Pg. 29 thyroid cancer. 5 CPG Updates May 2013 New Drugs Indications/ Warnings May 2013 (New Drug Indications/ Black Box Warnings: FDA Generic Name Trade Name Indication(s) CPG Action/Date January 2013 Pregabalin Oral Lyrica Central Nervous System Current: CTP holder Agents: Anticonvulsants. may prescribe. New indication for the management of 5/20/13 neuropathic pain No Changes associated with spinal Formulary Pg. 19 cord injury. February 2013 Levofloxacin Oral and Levaquin Anti-Infectives, Current: CTP holder Injection Systemic: may prescribe. Fluoroquinolones. New indication for 5/20/13 treatment of plague, No changes including pneumonic and septicemic plague, due to Yersinia pestis and prophylaxis of plague in adults and pediatric patients 6 months and Formulary Pg. 22 older. Emtricitabine/ Truvada Anti-Infectives, Current: Physician Tenofovir Disoproxil Systemic: Antiretroviral Initiated/ Physician Fumarate Agents: Nucleoside Consult Analog Reverse Transcriptase Inhibitor 5/20/13 Combinations. No Change New indication for pre- exposure prophylaxis to reduce sexually acquired HIV-1 in adults at high Formulary Pg. 24 risk. Ranibizumab Lucentis Ophthalmic Agents: Current: CTP holder Selective Vascular May NOT prescribe. Endothelial Growth Factor Antagonist. 5/20/13 New indication for the No Change treatment of patients with diabetic macular Formulary Pg. 26 edema. Aflibercept Eylea Ophthalmic Agents: Current: CTP holder Selective Vascular May NOT prescribe. Endothelial Growth Factor Antagonists. 5/20/13 New indication for the No Change treatment of neovascular (wet) age-related 6 CPG Updates May 2013 macular degeneration. Formulary Pg. 26 Cetuximab Erbitux Antineoplastic Agents: Current: CTP holder Monoclonal Antibodies. May NOT prescribe. New indication for treatment of K-Ras 5/20/13 mutation-negative (wild- No Change type), epidermal growth factor receptor expressing metastatic Formulary Pg. 29 colorectal cancer. March 2013 Tapentadol Nucynta ER Central Nervous System Current: CTP holder Agents: Schedule II may prescribe for analgesics. initial therapy or in New indication for the an institutional management of setting per neuropathic pain institutional associated with diabetic standards. peripheral neuropathy in Physician Initiated/ adults when a Physician Consult continuous, around-the- for CTPs holder clock opioid analgesic is initiating therapy needed for an extended with a schedule II period of time. medication for more Formulary Pg. 16 than a 7-day supply. 5/20/13 No Change Calcipotriene/ Taclonex Dermatologic Agents: Current: CTP holder Betamethasone Antipsoriatic Agents. may prescribe. Dipropionate New indication for the topical treatment of 5/20/13 plaque psoriasis of the No Change scalp and body in patients 18 years and Formulary Pg. 25 older. Pazopanib Votrient Antineoplastic Agents: Current: CTP holder Kinase Inhibitors.
Recommended publications
  • List of Covered Drugs

    List of Covered Drugs

    List of Covered Drugs Effective July 1, 2016 INTRODUCTION We are pleased to provide the 2011 Gold Coast Health Plan List of Covered Drugs as a useful reference and informational tool. The GCHP List of Covered Drugs can assist practitioners in selecting clinically appropriate and cost effective products for their patients. The information contained in the GCHP List of Covered Drugs is provided solely for the convenience of medical providers. We do not warrant or assure accuracy of such information nor is it intended to be comprehensive in nature. This List of Covered Drugs is not intended to be a substitute for the knowledge, expertise, skill and judgment of the medical provider in his or her choice of prescription drugs. All the information in this List of Covered Drugs is provided as a reference for drug therapy selection. Specific drug selection for an individual patient rests solely with the prescriber. We assume no responsibility for the actions or omissions of any medical provider based upon reliance, in whole or in part, on the information contained herein. The medical provider should consult the drug manufacturer's product literature or standard references for more detailed information. National guidelines can be found on the National Guideline Clearinghouse site at http://www.guideline.gov PREFACE The GCHP List of Covered Drugs is organized by sections. Each section is divided by therapeutic drug class primarily defined by mechanism of action. Unless exceptions are noted, generally all applicable dosage forms and strengths of the drug cited are included in the GCHP List of Covered Drugs. Generics should be considered the first line of prescribing.
  • List of Approved Ndas for Biological Products That Were Deemed to Be Blas on March 23, 2020

    List of Approved Ndas for Biological Products That Were Deemed to Be Blas on March 23, 2020

    List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 On March 23, 2020, an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) was deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (see section 7002(e)(4)(A) of the Biologics Price Competition and Innovation Act of 2009). To enhance transparency and facilitate planning for the March 23, 2020, transition date, FDA compiled a preliminary list of approved applications for biological products under the FD&C Act that were listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and that would be affected by this transition provision. FDA posted this list on the FDA website in December 2018, and periodically updated this list before the March 23, 2020, transition date. The September 2019 update to this preliminary list added certain administratively closed applications related to approved applications for biological products that were on the December 2018 version of this list. The January 2020 update to the preliminary list reflected a change to the definition of “biological product” made by the Further Consolidated Appropriations Act, 2020, which was enacted on December 20, 2019. Section 605 of this Act further amended the definition of a “biological product” in section 351(i) of the PHS Act to remove the parenthetical “(except any chemically synthesized polypeptide)” from the statutory category of “protein.” FDA has provided below a list of each approved application for a biological product under the FD&C Act that was deemed to be a license (i.e., an approved biologics license application (BLA)) for the biological product on March 23, 2020.
  • Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease

    Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease

    UnitedHealthcare® Commercial Medical Benefit Drug Policy Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease Policy Number: 2021D0048K Effective Date: April 1, 2021 Instructions for Use Table of Contents Page Related Commercial Policy Coverage Rationale ....................................................................... 1 • Provider Administered Drugs – Site of Care Applicable Codes .......................................................................... 3 Background.................................................................................... 3 Community Plan Policy Benefit Considerations .................................................................. 3 • Intravenous Enzyme Replacement Therapy (ERT) Clinical Evidence ........................................................................... 4 for Gaucher Disease U.S. Food and Drug Administration ............................................. 6 Centers for Medicare and Medicaid Services ............................. 6 References ..................................................................................... 7 Policy History/Revision Information ............................................. 8 Instructions for Use ....................................................................... 8 Coverage Rationale See Benefit Considerations This policy refers to the following drug products, all of which are intravenous enzyme replacement therapies used in the treatment of Gaucher disease: Cerezyme® (imiglucerase) Elelyso® (taliglucerase) VPRIV® (velaglucerase)
  • DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1

    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)
  • AHFS Pharmacologic-Therapeutic Classification System

    AHFS Pharmacologic-Therapeutic Classification System

    AHFS Pharmacologic-Therapeutic Classification System Abacavir 48:24 - Mucolytic Agents - 382638 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Acitretin 84:92 - Skin and Mucous Membrane Agents, Abaloparatide 68:24.08 - Parathyroid Agents - 317036 Aclidinium Abatacept 12:08.08 - Antimuscarinics/Antispasmodics - 313022 92:36 - Disease-modifying Antirheumatic Drugs - Acrivastine 92:20 - Immunomodulatory Agents - 306003 4:08 - Second Generation Antihistamines - 394040 Abciximab 48:04.08 - Second Generation Antihistamines - 394040 20:12.18 - Platelet-aggregation Inhibitors - 395014 Acyclovir Abemaciclib 8:18.32 - Nucleosides and Nucleotides - 381045 10:00 - Antineoplastic Agents - 317058 84:04.06 - Antivirals - 381036 Abiraterone Adalimumab; -adaz 10:00 - Antineoplastic Agents - 311027 92:36 - Disease-modifying Antirheumatic Drugs - AbobotulinumtoxinA 56:92 - GI Drugs, Miscellaneous - 302046 92:20 - Immunomodulatory Agents - 302046 92:92 - Other Miscellaneous Therapeutic Agents - 12:20.92 - Skeletal Muscle Relaxants, Miscellaneous - Adapalene 84:92 - Skin and Mucous Membrane Agents, Acalabrutinib 10:00 - Antineoplastic Agents - 317059 Adefovir Acamprosate 8:18.32 - Nucleosides and Nucleotides - 302036 28:92 - Central Nervous System Agents, Adenosine 24:04.04.24 - Class IV Antiarrhythmics - 304010 Acarbose Adenovirus Vaccine Live Oral 68:20.02 - alpha-Glucosidase Inhibitors - 396015 80:12 - Vaccines - 315016 Acebutolol Ado-Trastuzumab 24:24 - beta-Adrenergic Blocking Agents - 387003 10:00 - Antineoplastic Agents - 313041 12:16.08.08 - Selective
  • Ten Years of the Hunter Outcome Survey (HOS): Insights, Achievements, and Lessons Learned from a Global Patient Registry Joseph Muenzer1, Simon A

    Ten Years of the Hunter Outcome Survey (HOS): Insights, Achievements, and Lessons Learned from a Global Patient Registry Joseph Muenzer1, Simon A

    Muenzer et al. Orphanet Journal of Rare Diseases (2017) 12:82 DOI 10.1186/s13023-017-0635-z REVIEW Open Access Ten years of the Hunter Outcome Survey (HOS): insights, achievements, and lessons learned from a global patient registry Joseph Muenzer1, Simon A. Jones2, Anna Tylki-Szymańska3, Paul Harmatz4, Nancy J. Mendelsohn5,6, Nathalie Guffon7, Roberto Giugliani8, Barbara K. Burton9, Maurizio Scarpa10,11, Michael Beck12, Yvonne Jangelind13, Elizabeth Hernberg-Stahl14, Maria Paabøl Larsen15,17, Tom Pulles16,18 and David A. H. Whiteman15* Abstract Mucopolysaccharidosis type II (MPS II; Hunter syndrome; OMIM 309900) is a rare lysosomal storage disease with progressive multisystem manifestations caused by deficient activity of the enzyme iduronate-2-sulfatase. Disease- specific treatment is available in the form of enzyme replacement therapy with intravenous idursulfase (Elaprase®, Shire). Since 2005, the Hunter Outcome Survey (HOS) has collected real-world, long-term data on the safety and effectiveness of this therapy, as well as the natural history of MPS II. Individuals with a confirmed diagnosis of MPS II who are untreated or who are receiving/have received treatment with idursulfase or bone marrow transplant can be enrolled in HOS. A broad range of disease- and treatment-related information is captured in the registry and, over the past decade, data from more than 1000 patients from 124 clinics in 29 countries have been collected. Evidence generated from HOS has helped to improve our understanding of disease progression in both treated and untreated patients and has extended findings from the formal clinical trials of idursulfase. As a long-term, global, observational registry, various challenges relating to data collection, entry, and analysis have been encountered.
  • WO 2017/173059 Al 5 October 2017 (05.10.2017) P O P C T

    WO 2017/173059 Al 5 October 2017 (05.10.2017) P O P C T

    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization I International Bureau (10) International Publication Number (43) International Publication Date WO 2017/173059 Al 5 October 2017 (05.10.2017) P O P C T (51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, C12N 9/26 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, (21) International Application Number: KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, PCT/US20 17/024981 MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, (22) International Filing Date: NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, 30 March 2017 (30.03.2017) RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, (25) Filing Language: English ZA, ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 62/3 15,400 30 March 2016 (30.03.2016) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/457,584 10 February 2017 (10.02.2017) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 15/473,994 30 March 2017 (30.03.2017) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (71) Applicant: AMICUS THERAPEUTICS, INC.
  • Publications in Scientific Journals (Peer Reviewed) 1

    Publications in Scientific Journals (Peer Reviewed) 1

    Last Updated July 2020 Publications in Scientific Journals (Peer Reviewed) 1. Eisengart JB, King KE, Shapiro EG, Whitley CB, Muenzer J. The nature and impact of neurobehavioral symptoms in neuronopathic Hunter syndrome. Mol Genet Metab Rep. 2019 Dec 20;22:100549. PMID: 32055445 2. Viskochil D, Clarke LA, Bay L, Keenan H, Muenzer J, Guffon N. Growth patterns for untreated individuals with MPS I: Report from the international MPS I registry. Am J Med Genet A. 2019 Dec;179(12):2425-2432. PMID: 31639289 3. Clarke LA, Giugliani R, Guffon N, Jones SA, Keenan HA, Munoz-Rojas MV, Okuyama T, Viskochil D, Whitley CB, Wijburg FA, Muenzer J. Genotype-phenotype relationships in mucopolysaccharidosis type I (MPS I): Insights from the International MPS I Registry. Clin Genet. 2019 Clin Genet. 2019 Oct;96(4):281-289. PMID: 31194252 4. Taylor JL, Clinard K, Powell CM, Rehder C, Young SP, Bali D, Beckloff SE, Gehtland LM, Kemper AR, Lee S, Millington D, Patel HS, Shone SM, Woodell C, Zimmerman SJ, Bailey DB Jr, Muenzer J. The North Carolina Experience with Mucopolysaccharidosis Type I Newborn Screening. J Pediatr. 2019 Aug;211:193-200. PMID: 31133280 5. Akyol MU, Alden TD, Amartino H, Ashworth J, Belani K, Berger KI, Borgo A, Braunlin E, Eto Y, Gold JI, Jester A, Jones SA, Karsli C, Mackenzie W, Marinho DR, McFadyen A, McGill J, Mitchell JJ, Muenzer J, Okuyama T, Orchard PJ, Stevens B, Thomas S, Walker R, Wynn R, Giugliani R, Harmatz P, Hendriksz C, Scarpa M; MPS Consensus Programme Steering Committee; MPS Consensus Programme Co-Chairs.
  • Enzyme Replacement Therapy Srx-0019 Policy Type ☒ Medical ☐ Administrative ☐ Payment

    Enzyme Replacement Therapy Srx-0019 Policy Type ☒ Medical ☐ Administrative ☐ Payment

    MEDICAL POLICY STATEMENT Original Effective Date Next Annual Review Date Last Review / Revision Date 06/15/2011 03/15/2017 10/04/2016 Policy Name Policy Number Enzyme Replacement Therapy SRx-0019 Policy Type ☒ Medical ☐ Administrative ☐ Payment Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination.
  • BCBSVT Specialty Drug List Effective 2021.07.01.Xlsx

    BCBSVT Specialty Drug List Effective 2021.07.01.Xlsx

    Effective Date: 07/01/2021 SPECIALTY DRUG LIST Revised Date: 05/07/2021 DOSAGE EXCLUDED ON NATIONAL DRUG CLASS DRUG NAME GENERIC NAME FORM PERFORMANCE FORMULARY ANEMIA ARANESP SOLN DARBEPOETIN ALFA SOLN INJ ANEMIA ARANESP SOSY DARBEPOETIN ALFA SOLN PREFILLED SYRINGE ANEMIA EPOGEN SOLN EPOETIN ALFA INJ X ANEMIA PROCRIT SOLN EPOETIN ALFA INJ X ANEMIA REBLOZYL SOLR LUSPATERCEPT-AAMT FOR SUBCUTANEOUS INJ ANEMIA RETACRIT SOLN EPOETIN ALFA-EPBX INJ ANTI-GOUT AGENT KRYSTEXXA SOLN PEGLOTICASE INJ (FOR IV INFUSION) ANTI-INFECTIVE PREVYMIS SOLN LETERMOVIR IV SOLN ANTI-INFECTIVE PREVYMIS TABS LETERMOVIR TAB ASTHMA CINQAIR SOLN RESLIZUMAB IV INFUSION SOLN ASTHMA FASENRA SOSY BENRALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE ASTHMA FASENRA PEN SOAJ BENRALIZUMAB SUBCUTANEOUS SOLN AUTO-INJECTOR ASTHMA NUCALA SOAJ MEPOLIZUMAB SUBCUTANEOUS SOLUTION AUTO-INJECTOR ASTHMA NUCALA SOLR MEPOLIZUMAB FOR INJ ASTHMA NUCALA SOSY MEPOLIZUMAB SUBCUTANEOUS SOLUTION PREF SYRINGE ASTHMA XOLAIR SOLR OMALIZUMAB FOR INJ ASTHMA XOLAIR SOSY OMALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE CARDIOVASCULAR VYNDAMAX CAPS TAFAMIDIS CAP CARDIOVASCULAR VYNDAQEL CAPS TAFAMIDIS MEGLUMINE (CARDIAC) CAP CENTRAL NERVOUS SYSTEM AGENTS AUSTEDO TABS DEUTETRABENAZINE TAB CENTRAL NERVOUS SYSTEM AGENTS ENSPRYNG SOSY SATRALIZUMAB-MWGE SUBCUTANEOUS SOLN PREF SYRINGE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ CAPS TASIMELTEON CAPSULE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ LQ SUSP TASIMELTEON ORAL SUSP CHEMOTHERAPY PROTECTANT AMIFOSTINE SOLR AMIFOSTINE CRYSTALLINE FOR INJ CHEMOTHERAPY PROTECTANT ELITEK
  • Horizon Therapeutics Public Annual Report 2020

    Horizon Therapeutics Public Annual Report 2020

    Horizon Therapeutics Public Annual Report 2020 Form 10-K (NASDAQ:HZNP) Published: February 26th, 2020 PDF generated by stocklight.com octb inte UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-35238 HORIZON THERAPEUTICS PUBLIC LIMITED COMPANY (Exact name of Registrant as specified in its charter) Ireland Not Applicable (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) Connaught House, 1st Floor 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland Not Applicable (Address of principal executive offices) (Zip Code) 011 353 1 772 2100 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol Name of Each Exchange on Which Registered Ordinary shares, nominal value $0.0001 per share HZNP The Nasdaq Global Select Market Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐. Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒. Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
  • Medical Policy Statement

    Medical Policy Statement

    MEDICAL POLICY STATEMENT Effective Next Annual Last Review / Date Review Date Revision Date 06/15/2011 06/15/2012 06/15/2011 Author Shelley Jones RN, CCM, Wendy Null RPh CSMG Medical Policy Statements are derived from literature based and supported clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services are those health care services or supplies which are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative and are not provided mainly for the convenience of the member or provider. A. SUBJECT Alglucerase (Ceredase) Infusion B. BACKGROUND Alglucerase (Ceredase) is a modified form of the enzyme, ß-glucocerebrosidase (ß-D- glucosyl-N-acylsphingosine glucohydrolase). Alglucerase (Ceredase) catalyzes the hydrolysis of the glycolipid, glucocerebroside, to glucose and ceramide as part of the normal degradation pathway for membrane lipids. Glucocerebroside is primarily derived from hematologic cell turnover. Gaucher disease is characterized by a functional deficiency in ß-glucocerebrosidase enzymatic activity and the resultant accumulation of lipid glucocerebroside in tissue macrophages, which become engorged and are termed Gaucher cells. The patient selection criteria outlined was derived from the FDA-approved prescribing information for alglucerase (Ceredase), the studies that were presented to the FDA in support of the pre-market approval application, and studies in the peer-reviewed published medical literature.