2021 Prior Authorization List Part B Appendix a (PDF)
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
BAFF-Neutralizing Interaction of Belimumab Related to Its Therapeutic Efficacy for Treating Systemic Lupus Erythematosus
ARTICLE DOI: 10.1038/s41467-018-03620-2 OPEN BAFF-neutralizing interaction of belimumab related to its therapeutic efficacy for treating systemic lupus erythematosus Woori Shin1, Hyun Tae Lee1, Heejin Lim1, Sang Hyung Lee1, Ji Young Son1, Jee Un Lee1, Ki-Young Yoo1, Seong Eon Ryu2, Jaejun Rhie1, Ju Yeon Lee1 & Yong-Seok Heo1 1234567890():,; BAFF, a member of the TNF superfamily, has been recognized as a good target for auto- immune diseases. Belimumab, an anti-BAFF monoclonal antibody, was approved by the FDA for use in treating systemic lupus erythematosus. However, the molecular basis of BAFF neutralization by belimumab remains unclear. Here our crystal structure of the BAFF–belimumab Fab complex shows the precise epitope and the BAFF-neutralizing mechanism of belimumab, and demonstrates that the therapeutic activity of belimumab involves not only antagonizing the BAFF–receptor interaction, but also disrupting the for- mation of the more active BAFF 60-mer to favor the induction of the less active BAFF trimer through interaction with the flap region of BAFF. In addition, the belimumab HCDR3 loop mimics the DxL(V/L) motif of BAFF receptors, thereby binding to BAFF in a similar manner as endogenous BAFF receptors. Our data thus provides insights for the design of new drugs targeting BAFF for the treatment of autoimmune diseases. 1 Department of Chemistry, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Republic of Korea. 2 Department of Bio Engineering, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea. These authors contributed equally: Woori Shin, Hyun Tae Lee, Heejin Lim, Sang Hyung Lee. -
Ocrevus (Ocrelizumab) Policy Number: C11250-A
Prior Authorization Criteria Ocrevus (ocrelizumab) Policy Number: C11250-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DUE BY OR BEFORE 8/1/2017 2/17/2021 4/26/2022 LAST P&T J CODE TYPE OF CRITERIA APPROVAL/VERSION J2350-injection,ocrelizumab, Q2 2021 RxPA 1mg 20200428C11250-A PRODUCTS AFFECTED: Ocrevus (ocrelizumab) DRUG CLASS: Multiple Sclerosis Agents - Monoclonal Antibodies ROUTE OF ADMINISTRATION: Intravenous PLACE OF SERVICE: Specialty Pharmacy or Buy and Bill The recommendation is that medications in this policy will be for pharmacy benefit coverage and the IV infusion products administered in a place of service that is a non-hospital facility-based location (i.e., home infusion provider, provider’s office, free-standing ambulatory infusion center) AVAILABLE DOSAGE FORMS: Ocrevus SOLN 300MG/10ML FDA-APPROVED USES: Indicated for the treatment of: • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease, in adults • Primary progressive MS, in adults COMPENDIAL APPROVED OFF-LABELED USES: None COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Multiple Sclerosis REQUIRED MEDICAL INFORMATION: A. RELAPSING FORMS OF MULTIPLE SCLEROSIS: 1. Documentation of a definitive diagnosis of a relapsing form of multiple sclerosis as defined by the McDonald criteria (see Appendix), including: Relapsing- remitting multiple sclerosis [RRMS], secondary-progressive multiple sclerosis [SPMS] with relapses, and progressive- relapsing multiple sclerosis [PRMS] or First clinical episode with MRI features consistent with multiple sclerosis Molina Healthcare, Inc. confidential and proprietary © 2021 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission from Molina Healthcare. -
Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution. -
Xolair/Omalizumab
Therapeutic/Humanized Antibodies ELISA Kits ‘Humanized antibodies” are ‘Animal Antibodies’ that have been modified by recombinant DNA-technology to reduce the overall content of the animal- portion of immunoglobulin so as to increase acceptance by humans or minimize ‘rejection’. By analogy, if the hands of a mouse is actually responsible for grabbing things then ‘humanized-mouse’ will only contain the ‘mouse hands’ and the rest of the body will be human. Since the size of the IgGs is similar in mouse and human, the size of the native mouse IgG and the ‘humanized IgG’ does not significantly change. Antigen recognition property of an antibody actually resides in small portion of the IgG molecule called the ‘antigen binding site or Fab’. Therefore, humanized antibodies contain the minimal portion from the Fab or the epitopes necessary for antigen binding. The process of "humanization of antibodies" is usually applied to animal (mouse) derived monoclonal antibodies for therapeutic use in humans (for example, antibodies developed as anti-cancer drugs). Xolair (Anti-IgE) is an example of humanized IgG. The portion of the mouse IgG that remains in the ‘humanized IgG’ may be recognized as foreign by humans and may result into the generation of “Human Anti-Drug Antibodies (HADA). The presence of anti-Drug antibody (e.g., Human Anti-Rituximab IgG) that may limit the long-term usage the humanized antibody (Rituximab). Not all monoclonal antibodies designed for human therapeutic use need be humanized since many therapies are short-term. The International Nonproprietary Names of humanized antibodies end in “-zumab”, as in “omalizumab”. Humanized antibodies are distinct from chimeric or fusion antibodies. -
Chemokine Receptors in Allergic Diseases Laure Castan, A
Chemokine receptors in allergic diseases Laure Castan, A. Magnan, Grégory Bouchaud To cite this version: Laure Castan, A. Magnan, Grégory Bouchaud. Chemokine receptors in allergic diseases. Allergy, Wiley, 2017, 72 (5), pp.682-690. 10.1111/all.13089. hal-01602523 HAL Id: hal-01602523 https://hal.archives-ouvertes.fr/hal-01602523 Submitted on 11 Jul 2018 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Distributed under a Creative Commons Attribution - ShareAlike| 4.0 International License Allergy REVIEW ARTICLE Chemokine receptors in allergic diseases L. Castan1,2,3,4, A. Magnan2,3,5 & G. Bouchaud1 1INRA, UR1268 BIA; 2INSERM, UMR1087, lnstitut du thorax; 3CNRS, UMR6291; 4Universite de Nantes; 5CHU de Nantes, Service de Pneumologie, Institut du thorax, Nantes, France To cite this article: Castan L, Magnan A, Bouchaud G. Chemokine receptors in allergic diseases. Allergy 2017; 72: 682–690. Keywords Abstract asthma; atopic dermatitis; chemokine; Under homeostatic conditions, as well as in various diseases, leukocyte migration chemokine receptor; food allergy. is a crucial issue for the immune system that is mainly organized through the acti- Correspondence vation of bone marrow-derived cells in various tissues. Immune cell trafficking is Gregory Bouchaud, INRA, UR1268 BIA, rue orchestrated by a family of small proteins called chemokines. -
September 11, 2018 DUR Minutes
Maine Department of Health and Human Services PAUL R. LEPAGE MaineCare Services BETHANY L. HAMM GOVERNOR Pharmacy Unit ACTING COMMISSIONER 11 State House Station Augusta, Maine 04333-0011 TO: Maine Drug Utilization Review Board DATE: 9/14/2018 RE: Maine DUR Board Meeting minutes from September 11, 2018 ATTENDANCE PRESENT ABSENT EXCUSED Linda Glass, MD X Lisa Wendler, Pharm. D., Clinical Pharmacy Specialist, X Maine Medical CTR Mike Antoniello, MD X Kathleen Polonchek, MD X Kenneth McCall, PharmD X Steve Diaz, MD X Erin Ackley, PharmD. X Corinn Martineau, PharmD. X Non –Voting Mike Ouellette, R.Ph., Change Healthcare X Jeffery Barkin, MD, Change Healthcare X Christopher Pezzullo, State Health Officer DHHS, DO X Jill Kingsbury, MaineCare Pharmacy Director X Guests of the Board: Ed Bosshart, PharmD, Jeff Caulfield, Lead Epidemiologist for Viral Infections from CDC: Discussed HCV treatment. CALL TO ORDER: 5:30PM Jill Kingsbury called the meeting to order at 5:30 PM. PUBLIC COMMENTS Robert Mead from Pfizer: Highlighted the attributes of Retacrit. Jane Guo from Otsuka: Highlighted the attributes of Jynarque. OLD BUSINESS DUR MINUTES The June DUR meeting minutes were accepted as written. MAINECARE UPDATE No update at this time. NEW BUSINESS INTRODUCTION: USE OF CHRONIC TRIPTANS The use of triptans has become standard of care for the treatment of acute migraine headaches, given their effectiveness, safety and tolerability. However, like many medications used to treat migraine, overuse renders them less effective. Additionally, rebound headaches from triptan overuse is common. For patients who experience frequent headaches, or whose headaches are long lasting or chronic, use of headache prophylactic medications are recommended by several medical associations, including the American Headache Society and the American Academy of Neurology. -
Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models. -
Exploring the Association Between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: a Vigibase Study
Drug Safety https://doi.org/10.1007/s40264-018-00789-9 ORIGINAL RESEARCH ARTICLE Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study Lotte A. Minnema1,2 · Thijs J. Giezen2,3 · Patrick C. Souverein1 · Toine C. G. Egberts1,4 · Hubert G. M. Leufkens1 · Helga Gardarsdottir1,4,5 © The Author(s) 2019 Abstract Introduction Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse efects in patients, includ- ing depression and suicidal ideation and behavior. Objective The aim of this study was to quantify and characterize spontaneously reported adverse drug reactions (ADRs) of depression and suicidal ideation and behavior related to mAb users, and to explore a possible association with their mecha- nism of action. Methods We included mAb ADRs that were reported in VigiBase, and identifed those related to depression and suicidal ideation and behavior. Reporting odds ratios (RORs) were estimated for each mAb (bevacizumab as the reference) and according to their infuence on the immune system (not directly targeting [reference], stimulating, or suppressing). Those suppressing the immune system were further divided into their intended indication (auto-immune diseases, cancer). Results Overall, 2,924,319 ADRs for 44 mAbs were included; 9455 ADRs were related to depression and 1770 were related to suicidal ideation and behavior. The association was strongest for natalizumab and belimumab, both for depression (ROR 5.7, 95% confdence interval [CI] 5.0–6.4; and ROR 5.1, 95% CI 4.2–6.2) and suicidal ideation and behavior (ROR 12.0, 95% CI 7.9–18.3; and ROR 20.2, 95% CI 12.4–33.0). -
Biologic Armamentarium in Psoriasis
Vol 9, Issue 1, 2016 ISSN - 0974-2441 Review Article BIOLOGIC ARMAMENTARIUM IN PSORIASIS GANESH PAI1*, NITHIN SASHIDHARAN2 1Medical Director, Derma-Care ‘The Trade Centre’, Mangalore - 575 003, Karnataka, India. 2Consultant Clinical Pharmacologist, Derma-Care ‘The Trade Centre’, Mangalore - 575 003, Karnataka, India. Email: [email protected] Received: 14 July 2015, Revised and Accepted: 24 August 2015 ABSTRACT Psoriasis is an autoimmune disease and further classed as a chronic inflammatory skin condition serving as a global burden. A moderate to severe psoriasis can be treated with conventional therapies. Less efficacy, poor patient compliance, and toxicity issues were the major problems associated with conventional therapies. The introduction of biologic therapy has a great impression on psoriatic treatment duration and enhanced quality of life in psoriasis patients. The new biologic therapies are tailor-made medications with the goal of more specific and effective treatment; less toxicity. The biologic therapy is aimed to target antigen presentation and co-stimulation, T-cell activation, and leukocyte adhesion; and pro-inflammatory cascade. They act as effective and safer substitute to traditional therapy. Secukinumab, certolizumab, itolizumab, golimumab, ustekinumab, adalimumab, infliximab etanercept, alefacept, etc. are the approved biologic with the global market. This review briefs about psoriasis pathogenesis, traditional treatments, and biologic therapies potential. Keywords: Psoriasis, Biologic, Non-biologic treatment. INTRODUCTION migration, potentiation of Th1 type of response, angiogenesis, and epidermal hyperplasia [7]. Psoriasis is an autoimmune disease and further classed as a chronic inflammatory skin condition with prevalence ranging 1-3% in the TNF- is plays vital role in the pathogenesis of psoriasis. It acts by world [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) -
Cutaneous Adverse Effects of Biologic Medications
REVIEW CME MOC Selena R. Pasadyn, BA Daniel Knabel, MD Anthony P. Fernandez, MD, PhD Christine B. Warren, MD, MS Cleveland Clinic Lerner College Department of Pathology Co-Medical Director of Continuing Medical Education; Department of Dermatology, Cleveland Clinic; of Medicine of Case Western and Department of Dermatology, W.D. Steck Chair of Clinical Dermatology; Director of Clinical Assistant Professor, Cleveland Clinic Reserve University, Cleveland, OH Cleveland Clinic Medical and Inpatient Dermatology; Departments of Lerner College of Medicine of Case Western Dermatology and Pathology, Cleveland Clinic; Assistant Reserve University, Cleveland, OH Clinical Professor, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH Cutaneous adverse effects of biologic medications ABSTRACT iologic therapy encompasses an expo- B nentially expanding arena of medicine. Biologic therapies have become widely used but often As the name implies, biologic therapies are de- cause cutaneous adverse effects. The authors discuss the rived from living organisms and consist largely cutaneous adverse effects of tumor necrosis factor (TNF) of proteins, sugars, and nucleic acids. A clas- alpha inhibitors, epidermal growth factor receptor (EGFR) sic example of an early biologic medication is inhibitors, small-molecule tyrosine kinase inhibitors insulin. These therapies have revolutionized (TKIs), and cell surface-targeted monoclonal antibodies, medicine and offer targeted therapy for an including how to manage these reactions -
Curriculum Vitae: Daniel J
CURRICULUM VITAE: DANIEL J. WALLACE, M.D., F.A.C.P., M.A.C.R. Up to date as of January 1, 2019 Personal: Address: 8750 Wilshire Blvd, Suite 350 Beverly Hills, CA 90211 Phone: (310) 652-0010 FAX: (310) 360-6219 E mail: [email protected] Education: University of Southern California, 2/67-6/70, BA Medicine, 1971. University of Southern California, 9/70-6/74, M.D, 1974. Postgraduate Training: 7/74-6/75 Medical Intern, Rhode Island (Brown University) Hospital, Providence, RI. 7/75-6/77 Medical Resident, Cedars-Sinai Medical Center, Los Angeles, CA. 7/77-6/79 Rheumatology Fellow, UCLA School of Medicine, Los Angeles, CA. Medical Boards and Licensure: Diplomate, National Board of Medical Examiners, 1975. Board Certified, American Board of Internal Medicine, 1978. Board Certified, Rheumatology subspecialty, 1982. California License: #G-30533. Present Appointments: Medical Director, Wallace Rheumatic Study Center Attune Health Affiliate, Beverly Hills, CA 90211 Attending Physician, Cedars-Sinai Medical Center, Los Angeles, 1979- Clinical Professor of Medicine, David Geffen School of Medicine at UCLA, 1995- Professor of Medicine, Cedars-Sinai Medical Center, 2012- Expert Reviewer, Medical Board of California, 2007- Associate Director, Rheumatology Fellowship Program, Cedars-Sinai Medical Center, 2010- Board of Governors, Cedars-Sinai Medical Center, 2016- Member, Medical Policy Committee, United Rheumatology, 2017- Honorary Appointments: Fellow, American College of Physicians (FACP) Fellow, American College of Rheumatology (FACR)