Takhzyro (lanadelumab-flyo)
|
|
- Belinda Lamb
- 5 years ago
- Views:
Transcription
1 Takhzyro (lanadelumab-flyo) Policy Number: Last Review: 1/2019 Origination: 1/2019 Next Review: 1/2020 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Takhzyro (lanadelumab) when it is determined to be medically necessary because the criteria shown below are met. When Policy Topic is covered Takhzyro (lanadelumab) may be considered medically necessary when all of the following criteria are met: FDA-Approved Indications 1. Hereditary Angioedema (HAE) Due to C1 Inhibitor (C1-INH) Deficiency [Type I or Type II] Prophylaxis, Initial Therapy. Approve Takhzyro for 1 year if the patient meets the following criteria (A and B): A) The patient has HAE type I or type II as confirmed by the following diagnostic criteria (i and ii): i. The patient has low levels of functional C1-INH protein (< 50% of normal) at baseline, as defined by the laboratory reference values [documentation required]; AND ii. The patient has lower than normal serum C4 levels at baseline, as defined by the laboratory reference values [documentation required]; AND B) The medication is prescribed by or in consultation with an allergist/immunologist or a physician that specializes in the treatment of HAE or related disorders. Takhzyro is FDA-approved for routine prophylaxis of attacks of HAE in patients 12 years of age and older. 1 The WAO/EAACI guidelines and an international consensus algorithm note that HAE diagnosis can be confirmed by measuring functional C1-INH protein levels (usually < 50% of normal in patients with HAE), C4 levels, and C1-INH antigenic levels. 2-3,8 Patients with HAE type I have low C4 and C1- INH antigenic protein levels, along with low levels of functional C1-INH protein. 2 Patients with HAE type
2 II have low C4 and functional C1-INH protein level, with a normal or elevated C1- INH antigenic protein level. C1-INH replacement therapies are appropriate for both HAE type I and type II. Patients with the third type of HAE, previously referred to as HAE type III, have normal C4 and C1-INH antigenic protein levels. 2. Hereditary Angioedema (HAE) Due to C1 Inhibitor (C1-INH) Deficiency [Type I or Type II] Patients Currently Receiving Takhzyro Prophylactic Therapy. Approve Takhzyro for 1 year if the patient meets all of the following criteria (A, B, and C): A) The patient is currently receiving Takhzyro for HAE type I or type II prophylaxis [documentation required to confirm HAE type I or type II diagnosis]; AND B) According to the prescribing physician, the patient has had a favorable clinical response (e.g., decrease in number of HAE acute attack frequency, decrease in HAE attack severity, decrease in duration of HAE attacks) since initiating Takhzyro prophylactic therapy compared with baseline (i.e., prior to initiating prophylactic therapy); AND C) The medication is prescribed by or in consultation with an allergist/immunologist or a physician that specializes in the treatment of HAE or related disorders. Drug must be sourced from an approved specialty pharmacy provider. When Policy Topic is not covered Takhzyro (lanadelumab) is considered not medically necessary when the above criteria is not met and investigational for all other uses, including: 1. Concomitant Use with Other HAE Prophylactic Therapies (e.g., Cinryze, Haegarda ). Takhzyro has not been studied in combination with other prophylactic therapies for HAE, and combination therapy for long-term prophylactic use is not recommended. Patients may use other medications, including Cinryze, for on-demand treatment of acute HAE attacks, and for short-term (procedural) prophylaxis. 2. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available. Considerations Takhzyro (lanadelumab) requires prior authorization through the Clinical Pharmacy Department. This Blue Cross and Blue Shield of Kansas City policy statement was developed using available resources such as, but not limited to: Food and Drug Administration (FDA) approvals, Facts and Comparisons, National specialty guidelines, local medical policies of other health plans, Medicare (CMS), local providers.
3 Description of Procedure or Service Takhzyro is a human monoclonal antibody inhibitor of plasma kallikrein indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older. 1 HAE is characterized by recurrent episodes of non-pruritic, non-pitting, subcutaneous or submucosal edema associated with pain syndrome, nausea, vomiting, diarrhea, and/or life-threatening airway swelling. 2 A consensus document published by an international expert panel on HAE diagnosis and treatment notes there are two categories of HAE: HAE due to C1 esterase inhibitor (C1-INH) deficiency and HAE with normal C1-INH. HAE due to C1-INH deficiency has two subtypes: type I HAE characterized by low C1-INH antigen and function; and type II HAE with normal C1-INH antigen but low C1-INH function. 3 A third type, previously called type III HAE but now referred to as HAE with normal C1-INH, occurs in patients with normal C1-INH function; the exact cause has not been determined. There is a wide variation in the frequency and severity of attacks for all types of HAE. Clinical experience suggests that minor trauma and/or stress, among other triggers, may precipitate attacks. Untreated attacks typically last over 48 to 96 hours. There are no randomized or controlled clinical trial data available with any therapy for use in HAE with normal C1-INH. 4,5 Until data from randomized controlled studies become available, no firm recommendations regarding the treatment of HAE with normal C1-INH can be made. Guidelines The World Allergy Organization (WAO) and European Academy of Allergy and Clinical Immunology (EAACI) revised and updated guidelines (2017) for the management of HAE in patients throughout the world. 3 Long-term prophylaxis should be considered in patients based on the severity of the disease, frequency of attacks, the patient s quality of life, availability of resources, and the failure to achieve adequate control by appropriate on-demand therapy. As these factors can vary over time, all patients should be evaluated for long-term prophylaxis at every visit, at least annually. C1-INH concentrate is first-line for long-term prophylaxis. The use of androgens for long-term prophylaxis may be considered as second-line but should be considered critically due to potential for adverse events. A practice parameter update from a Joint Task Force (2013) has similar recommendations. 6 Treatment with low-to-moderate doses of anabolic androgens are noted to provide effective and relatively safe long-term HAE prophylaxis for many patients. Treatment with antifibrinolytic agents are noted as being generally less effective than androgens, and treatment with plasma-derived C1-INH replacement therapies are considered effective and safe for long-term prophylaxis. Plasma-derived C1-INH replacement therapies are the preferred agents for longterm prophylaxis during pregnancy.
4 The US Hereditary Angioedema Association Medical Advisory Board published recommendations (2013) for the management of HAE due to C1-INH deficiency. 7 As per the Advisory Board, there are no rigid criteria to meet for long-term prophylaxis; the decision should reflect the needs of the individual patient by taking into consideration attack frequency, severity, other comorbid conditions, access to emergency medical services, patient experience, and preference. The recommendations note that although anabolic androgens have been used for prophylaxis for a long time, they have dose-related adverse events which may be significant. Anabolic androgens should not be used in patients < 16 years of age and in pregnant or breastfeeding women. They should also be discontinued if the patient is not tolerating the adverse events. The Advisory Board s position is that anabolic androgens should not be used in patients who have a preference for alternative therapy and that patients should not be required to fail anabolic androgen therapy as a prerequisite to receiving prophylactic C1-INH therapy. Plasma-derived C1-INH therapy has been proven to be effective and safe for longterm prophylactic therapy; however, repeated intravenous administration can result in loss of readily accessible veins. Although indwelling ports have been used, the Medical Advisory Board discourages the use of indwelling ports, unless it is medically necessary, due to the risk of thrombosis and infection. Other agents that are used off-label for prophylactic therapy are anabolic androgens such as oxandrolone and methyltestosterone and antifibrinolytics such as aminocaproic acid and tranexamic acid. The guidelines have not been updated to include Takhzyro for prophylaxis of HAE attacks. Rationale Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Takhzyro (lanadelumab) while maintaining optimal therapeutic outcomes. References 1. Takhzyro for subcutaneous injection [prescribing information]. Lexington, MA: Shire; August Bowen T, Cicardi M, Farkas H, et al international consensus algorithm for the diagnosis, therapy and management of hereditary angioedema. Ann Allergy Asthma Immunol. 2010;6: Mauer M, Magerl M, Ansotegui I, et al. The international WAO/EAACI guideline for the management of hereditary angioedema the 2017 revision and update. Allergy. 2018;73(8): Available at: Accessed on September 4, Zuraw BL, Bork K, Binkley KE, et al. Hereditary angioedema with normal C1 inhibitor function: consensus of an international expert panel. Allergy Asthma Proc. 2012;33:S145-S156.
5 5. Magerl M, Germenis AE, Maas C, et al. Hereditary angioedema with normal C1 inhibitor. Update on evaluation and treatment. Immunol Allergy Clin N Am. 2017;37: Zuraw BL, Bernstein JA, Lang DM. A focused parameter update: Hereditary angioedema, acquired C1 inhibitor deficiency, and angiotensin-converting enzyme inhibitor-associated angioedema. J Allergy Clin Immunol. 2013;131(6): e Zuraw BL, Banerji A, Bernstein JA, et al. US Hereditary Angioedema Association Medical Advisory Board 2013 recommendations for the management of hereditary angioedema due to C1 inhibitor deficiency. J Allergy Clin Immunol: In Practice. 2013;1: Available at: Recommendations.pdf. Accessed on July 26, Wagenaar-Bos IGA, Drouet C, Aygoren-Pursun E, et al. Functional C1-inhibitor diagnostics in hereditary angioedema: assay evaluation and recommendations. J Immunol. Methods. 2008;338: Billing Coding/Physician Documentation Information N/A Pharmacy benefit; specialty pharmacy sourcing Additional Policy Key Words N/A Policy Implementation/Update Information 01/2019 New policy titled Takhzyro (lanadelumab) State and Federal mandates and health plan contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The medical policies contained herein are for informational purposes. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents Blue KC and are solely responsible for diagnosis, treatment and medical advice. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, photocopying, or otherwise, without permission from Blue KC.
Medical Policy An independent licensee of the Blue Cross Blue Shield Association
Hereditary Angioedema Page 1 of 17 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Hereditary Angioedema (Berinert, Cinryze, Firazyr, Haegarda, Kalbitor, Ruconest,
More information2018 Blue Cross and Blue Shield of Louisiana
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationInfluenza Therapies. Considerations Prescription influenza therapies require prior authorization through pharmacy services.
Influenza Therapies Policy Number: 5.01.515 Last Review: 10/2017 Origination: 10/2002 Next Review: 10/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for influenza
More informationIngrezza (valbenazine)
Ingrezza (valbenazine) Policy Number: 5.01.635 Last Review: 7/2018 Origination: 07/2017 Next Review: 7/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Ingrezza
More informationVosevi (sofosbuvir/velpatasvir/voxilaprevir)
Vosevi (sofosbuvir/velpatasvir/voxilaprevir) Policy Number: 5.01.646 Last Review: 10/2017 Origination: 10/2017 Next Review: 11/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide
More informationHAE disease fact sheet
[Insert organization logo and the hae day :-) logo] HAE disease fact sheet Hereditary Angioedema (HAE) is a rare, potentially life threatening inherited disorder with symptoms of severe, painful, and recurring
More informationAddyi (flibanserin) When Policy Topic is covered Coverage of Addyi is recommended in those who meet the following criteria:
Addyi (flibanserin) Policy Number: 5.01.605 Last Review: 10/2018 Origination: 10/2015 Next Review: 10/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Addyi when
More informationAntigen Leukocyte Antibody Test
Antigen Leukocyte Antibody Test Policy Number: 2.01.93 Last Review: 4/2014 Origination: 4/2014 Next Review: 4/2015 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage for
More informationFacet Arthroplasty. Policy Number: Last Review: 9/2018 Origination: 9/2009 Next Review: 3/2019
Facet Arthroplasty Policy Number: 7.01.120 Last Review: 9/2018 Origination: 9/2009 Next Review: 3/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage for total facet
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Neprilysin Inhibitor (Entresto ) Page 1 of 6 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Neprilysin Inhibitor (Entresto ) Prime Therapeutics will review Prior
More informationThe Journal of Angioedemasit amet
Hereditary Angioedema with Normal C1 Inhibitor Response to Progesterone Therapy: A Case Report and Review of the Literature. James Kuhlen MD 1,2, Ami Mehra MD 3, and Michelle Conroy MD 1, 2 1 Massachusetts
More informationC1 Esterase Inhibitor (Cinryze )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationAvastin (bevacizumab)
Avastin (bevacizumab) Policy Number: 5.02.502 Last Review: 04/2018 Origination: 03/2017 Next Review: 04/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Avastin
More informationIntracellular Micronutrient Analysis
Intracellular Micronutrient Analysis Policy Number: 2.04.73 Last Review: 1/2019 Origination: 1/2013 Next Review: 1/2020 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage
More informationHetlioz (tasimelteon)
Hetlioz (tasimelteon) Policy Number: 5.01.687 Last Review: 01/2019 Origination: 01/2019 Next Review: 01/2020 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Hetlioz
More informationPolicy. not covered Sipuleucel-T. Considerations Sipuleucel-T. Description Sipuleucel-T. be medically. Sipuleucel-T. covered Q2043.
Cellular Immunotherapy forr Prostate Cancer Policy Number: 8.01.53 Origination: 11/2010 Last Review: 11/2014 Next Review: 11/2015 Policy BCBSKC will provide coverage for cellular immunotherapy for prostate
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Xermelo (telotristat) Page 1 of 5 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Xermelo (telotristat) Prime Therapeutics will review Prior Authorization requests
More informationSubject: Ruconest (C1 esterase inhibitor [recombinant]) Original Effective Date: 1/13/15. Policy Number: MCP-233 Revision Date(s): 12/13/17
Subject: Ruconest (C1 esterase inhibitor [recombinant]) Original Effective Date: 1/13/15 Policy Number: MCP-233 Revision Date(s): 12/13/17 Review Date: 12/15/2016 DISCLAIMER This Medical Policy is intended
More informationAntigen Leukocyte Antibody Test
Antigen Leukocyte Antibody Test Policy Number: 2.01.93 Last Review: 4/2018 Origination: 4/2014 Next Review: 4/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage for
More informationElectrical Stimulation for Scoliosis
Electrical Stimulation for Scoliosis Policy Number: 1.01.509 Last Review: 8/2017 Origination: 8/2008 Next Review: 8/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Xermelo (telotristat) Page 1 of 5 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Xermelo (telotristat) Prime Therapeutics will review Prior Authorization requests
More informationBiofeedback as a Treatment of Headache
Biofeedback as a Treatment of Headache Policy Number: 2.01.29 Last Review: 7/2018 Origination: 7/2008 Next Review: 7/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) may provide coverage
More informationBioimpedance Devices for Detection and Management of Lymphedema
Bioimpedance Devices for Detection and Management of Lymphedema Policy Number: 2.01.82 Last Review: 5/2017 Origination: 1/2011 Next Review: 5/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue
More informationProphylaxis for Hereditary Angioedema with Lanadelumab and C1 Inhibitors: Effectiveness and Value
Prophylaxis for Hereditary Angioedema with Lanadelumab and C1 Inhibitors: Effectiveness and Value Revised Background and Scope May 10, 2018 Background Hereditary angioedema (HAE) is a rare genetic disorder
More informationPoteligeo (mogamulizmuab-kpkc)
Poteligeo (mogamulizmuab-kpkc) Policy Number: 5.02.556 Last Review: 1/2019 Origination: 1/2019 Next Review: 1/2020 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Poteligeo
More informationTopical Immunomodulator Step Therapy Program
Topical Immunomodulator Step Therapy Program Policy Number: 5.01.557 Last Review: 8/2017 Origination: 7/2013 Next Review: 8/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) BCBSKC will provide
More informationTHE CURRENT STATE OF MANAGEMENT OF HAE IN EUROPE
THE CURRENT STATE OF MANAGEMENT OF HAE IN EUROPE The Current State of Management of HAE in Europe Four years ago, HAEi (the international umbrella organization for the world s HAE patient groups) published
More informationSurgical Treatment of Bilateral Gynecomastia
Surgical Treatment of Bilateral Gynecomastia Policy Number: 7.01.13 Last Review: 4/2018 Origination: 4/2006 Next Review: 4/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Afrezza Page 1 of 7 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Afrezza (human insulin) Prime Therapeutics will review Prior Authorization requests Prior Authorization
More informationPeripheral Subcutaneous Field Stimulation
Peripheral Subcutaneous Field Stimulation Policy Number: 7.01.139 Last Review: 9/2014 Origination: 7/2013 Next Review: 1/2015 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Page 1 of 5 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Prime Therapeutics will review Prior Authorization requests Prior Authorization Form: https://www.bcbsks.com/customerservice/forms/pdf/priorauth-6514ks-ingr.pdf
More informationTimed Therapeutic Procedures
Timed Therapeutic Procedures Policy Number: 10.01.526 Last Review: 4/2014 Origination: 4/2009 Next Review: 4/2015 Policy Documentation to support the reporting of timed procedure codes is required. The
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Topical Doxepin Page 1 of 5 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Topical Doxepin Prime Therapeutics will review Prior Authorization requests Prior Authorization
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Oral Anticoagulants Page 1 of 7 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Oral Anticoagulant - Bevyxxa (betrixaban), Eliquis (apixaban), Pradaxa (dabigatran),
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Ocaliva (obeticholic acid) Page 1 of 6 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Ocaliva (obeticholic acid) Prime Therapeutics will review Prior Authorization
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
CGRP Page 1 of 8 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: CGRP (calcitonin gene-related peptide) Prime Therapeutics will review Prior Authorization requests
More informationUloric Step Therapy Program
Uloric Step Therapy Program Policy Number: 5.01.584 Last Review: 7/2017 Origination: 7/2014 Next Review: 7/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for brand
More informationBioimpedance Devices for Detection and Management of Lymphedema
Bioimpedance Devices for Detection and Management of Lymphedema Policy Number: 2.01.82 Last Review: 5/2018 Origination: 1/2011 Next Review: 5/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Topical Doxepin Page 1 of 6 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Topical Doxepin (For Individuals Who Purchased BlueCare/KS Solutions/EPO Products) Prime
More informationDrug Infusion Site of Care Policy
Drug Infusion Site of Care Policy Policy Number: 5.02.538 Last Review: 6/1/2018 Origination: 7/1/2017 Next Review: 6/1/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will NOT provide coverage
More informationNutrient/Nutritional Panel Testing
Nutrient/Nutritional Panel Testing Policy Number: 2.04.136 Last Review: 10/2017 Origination: 10/2015 Next Review: 10/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage
More informationChenodal (chenodiol)
Chenodal (chenodiol) Policy Number: 5.01.549 Last Review: 04/2018 Origination: 06/2013 Next Review: 04/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Chenodal
More informationLifting the Veil on a Potentially Fatal Disease. May 28, Grand Hyatt New York New York, NY. Educational partner, RMEI, LLC
ANGIOEDEMA: Lifting the Veil on a Potentially Fatal Disease May 28, 2014 Grand Hyatt New York New York, NY Educational partner, RMEI, LLC Session 2: Rare Cases in Angioedema: Lifting the Veil onn a Potentially
More informationTranstympanic Micropressure Applications as a Treatment of Meniere s Disease
Transtympanic Micropressure Applications as a Treatment of Meniere s Disease Policy Number: 1.01.23 Last Review: 8/2014 Origination: 2/2006 Next Review: 8/2015 Policy Blue Cross and Blue Shield of Kansas
More informationANGIOEDEMA WHAT YOU NEED TO KNOW
ANGIOEDEMA WHAT YOU NEED TO KNOW K I MBERLY HULL DO No relevant disclosures OBJECTIVES Review the etiologies of angioedema without urticaria Discuss the diagnostic approach to angioedema Discuss acute
More informationDynamic Spinal Visualization and Vertebral Motion Analysis
Dynamic Spinal Visualization and Vertebral Motion Analysis Policy Number: 6.01.46 Last Review: 2/2019 Origination: 2/2006 Next Review: 2/2020 Policy Blue Cross and Blue Shield of Kansas City (Blue KC)
More informationDATE: 24 April 2015 CONTEXT AND POLICY ISSUES
TITLE: C1 Esterase Inhibitor for Prophylaxis against Hereditary Angioedema Attacks: A Review of the Clinical Effectiveness, Cost-Effectiveness, and Guidelines DATE: 24 April 2015 CONTEXT AND POLICY ISSUES
More informationVertebral Axial Decompression
Vertebral Axial Decompression Policy Number: 8.03.09 Last Review: 11/2017 Origination: 11/2005 Next Review: 11/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage
More informationPiper Jaffray 30 th Annual Healthcare Conference. November 27, 2018
Piper Jaffray 30 th Annual Healthcare Conference Jon Stonehouse Chief Executive Officer Dr. William Sheridan Chief Medical Officer November 27, 2018 Forward Looking Statements BioCryst s presentation may
More informationIntraoperative Fluorescence Imaging Systems
Intraoperative Fluorescence Imaging Systems Policy Number: 10.01.530 Last Review: 01/2018 Origination: 01/2015 Next Review: 01/2019 Policy Intraoperative fluorescence imaging (SPY Imaging) to evaluate
More informationThiazolidinedione Step Therapy Program
Thiazolidinedione Step Therapy Program Policy Number: 5.01.580 Last Review: 7/2018 Origination: 07/2014 Next Review: 7/2019 LoB: ACA Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide
More informationTreatment regimens. Single IV infusion of pdc1 INH at a dose of 10 or 20 U/kg, or placebo, for a single abdominal or facial attack (not laryngeal)
Annex 1 Letters supporting the application (separate document) Annex 2 Pivotal clinical trials (and extension studies) evaluating for treatment of acute HAE attacks Reference Study type Patients Treatment
More informationPeripheral Subcutaneous Field Stimulation
Peripheral Subcutaneous Field Stimulation Policy Number: 7.01.139 Last Review: 3/2018 Origination: 7/2013 Next Review: 9/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide
More informationCorporate Medical Policy
Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: belimumab_benlysta 6/2011 2/2018 2/2019 3/2018 Description of Procedure or Service Belimumab (Benlysta) is
More informationWhen is prophylaxis for hereditary angioedema necessary?
Review When is prophylaxis for hereditary angioedema necessary? Timothy Craig, DO*; Marc Riedl, MD ; Mark S. Dykewicz, MD ; Richard G. Gower, MD ; James Baker, MD ; Frank J. Edelman, MD ; David Hurewitz,
More informationAngioedema. Disclosures. Question #1. Objectives. Question #3. Question #2 12/28/2015. Differentiate the various angioedema subtypes
None Disclosures Jason Knuffman, M.D. Allergy and Clinical Immunology Quincy Medical Group Unity Point Health System Quincy, IL Objectives Question #1 Differentiate the various angioedema subtypes Identify
More information:: Non histamine-induced angioedema
:: Non histamine-induced angioedema This document is a translation of the French recommendations drafted by Dr. Laurence Bouillet, reviewed and published by Orphanet in 2009. - - Some of the procedures
More informationPracticalities of a reduced volume formulation of a C1 INH concentrate for the treatment of hereditary angioedema: real life experience
Dempster Allergy Asthma Clin Immunol (2018) 14:44 https://doi.org/10.1186/s13223-018-0267-4 Allergy, Asthma & Clinical Immunology RESEARCH Open Access Practicalities of a reduced volume formulation of
More informationCorporate Medical Policy Investigational (Experimental) Services
Corporate Medical Policy Investigational (Experimental) Services File Name: Origination: investigational_(experimental)_services 1/1996 Description of Procedure or Service BCBSNC defines the terms "investigational"
More informationProphylaxis for Hereditary Angioedema with Lanadelumab and C1 Inhibitors: Effectiveness and Value
Prophylaxis for Hereditary Angioedema with Lanadelumab and C1 Inhibitors: Effectiveness and Value Final Evidence Report November 15, 2018 Prepared for Institute for Clinical and Economic Review, 2018 ICER
More informationUpdate on laboratory tests for the diagnosis and differentiation of hereditary angioedema and acquired angioedema
Update on laboratory tests for the diagnosis and differentiation of hereditary angioedema and acquired angioedema Ashley Frazer-Abel, Ph.D., 1 and Patricia C. Giclas, Ph.D. 2 ABSTRACT The importance of
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Cystic Fibrosis Transmembrane Page 1 of 11 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Prime Therapeutics
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Natpara (parathyroid hormone) Page 1 of 8 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Natpara (parathyroid hormone) Prime Therapeutics will review Prior Authorization
More informationVertebral Axial Decompression
Vertebral Axial Decompression Policy Number: 8.03.09 Last Review: 11/2018 Origination: 11/2005 Next Review: 11/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage
More informationPradaxa (dabigatran)
Pradaxa (dabigatran) Policy Number: 5.01.574 Last Review: 7/2018 Origination: 6/2014 Next Review: 7/2019 LoB: ACA Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Pradaxa
More information* Autoantibody positive (i.e. antinuclear antibody or ANA titre 1:80 or anti-double stranded (ds) DNA antibody 30 IU/mL)
Benlysta (belimumab) Policy Number: 5.02.509 Last Review: 05/2018 Origination: 06/2011 Next Review: 05/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Benlysta
More informationPeripheral Subcutaneous Field Stimulation
Peripheral Subcutaneous Field Stimulation Policy Number: 7.01.139 Last Review: 9/2018 Origination: 7/2013 Next Review: 3/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide
More informationHereditary angioedema (HAE) is a rare genetic disorder
Perioperative management for patients with hereditary angioedema Anesu H. Williams, D.H.Sc., M.P.A., 1 and Timothy J. Craig, D.O. 2 ABSTRACT Hereditary angioedema (HAE) is a rare autosomal dominant disease
More informationXarelto (rivaroxaban)
Xarelto (rivaroxaban) Policy Number: 5.01.575 Last Review: 7/2018 Origination: 6/2014 Next Review: 7/2019 LoB: ACA Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Xarelto
More informationMedical Policy An Independent Licensee of the Blue Cross and Blue Shield Association
Ampyra (dalfampridine) Page 1 of 9 Medical Policy An Independent Licensee of the Blue Cross and Blue Shield Association Title: Ampyra (dalfampridine) Prime Therapeutics will review Prior Authorization
More informationand will be denied as not medically necessary** if not met. This criterion only applies to the initial
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationOptimizing Screening and Management of the Patient with Hereditary Angioedema: A Primer for Primary Care Practice
Optimizing Screening and Management of the Patient with Hereditary Angioedema: A Primer for Primary Care Practice Learning Objectives After participating in this educational activity, participants should
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Urea Cycle Disorders Page 1 of 7 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Urea Cycle Disorders Prime Therapeutics will review Prior Authorization requests
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Aimovig) Reference Number: CP.PHAR.128 Effective Date: 07.10.18 Last Review Date: 08.18 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this policy
More informationSurgical Interruption of Pelvic Nerve Pathways for Primary and Secondary Dysmenorrhea
Surgical Interruption of Pelvic Nerve Pathways for Primary and Secondary Dysmenorrhea Policy Number: 4.01.17 Last Review: 11/2013 Origination: 11/2007 Next Review: 11/2014 Policy Blue Cross and Blue Shield
More informationPromacta (eltrombopag)
Promacta (eltrombopag) Policy Number: 5.01.542 Last Review: 5/2018 Origination: 6/2013 Next Review: 5/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Promacta
More information2017 Blue Cross and Blue Shield of Louisiana
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationAnesthesia Processing Guidelines
Anesthesia Processing Guidelines Policy Number: 10.01.511 Last Review: 5/2018 Origination: 10/1988 Next Review: 5/2019 Policy The following guidelines are utilized in processing anesthesia claims: 1) Anesthesia
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
New to Market Drugs Page 1 of 5 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: New to Market Drugs: Including (cannabidiol) Prime Therapeutics will review Prior
More informationCorporate Medical Policy Septoplasty
Corporate Medical Policy Septoplasty File Name: Origination: Last CAP Review: Next CAP Review: Last Review: septoplasty 4/1999 8/2018 8/2019 8/2018 Description of Procedure or Service There are many potential
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Substrate Reduction Therapy Page 1 of 7 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Substrate Reduction Therapy! Prime Therapeutics will review Prior Authorization
More informationHereditary angioedema: Validation of the end point time to onset of relief by correlation with symptom intensity DO NOT COPY
Hereditary angioedema: Validation of the end point time to onset of relief by correlation with symptom intensity Jonathan A. Bernstein, M.D., 1 Bruce Ritchie, M.D., 2 Robyn J. Levy, M.D., 3 Richard L.
More informationIndication. Important Safety Information
When symptoms of a hereditary angioedema (HAE) attack appear Reach for FIRAZYR first Self-administer FIRAZYR (icatibant injection) upon recognition of an HAE attack after you have been trained by a healthcare
More informationCorporate Medical Policy Cellular Immunotherapy for Prostate Cancer
Corporate Medical Policy Cellular Immunotherapy for Prostate Cancer File Name: Origination: Last CAP Review: Next CAP Review: Last Review: cellular_immunotherapy_for_prostate_cancers 6/2010 8/2017 8/2018
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Tagrisso) Reference Number: CP.PHAR.294 Effective Date: 12.01.16 Last Review Date: 08.18 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this
More informationTavalisse (fostamatinib disodium hexahydrate)
Tavalisse (fostamatinib disodium hexahydrate) Policy Number: 5.01.661 Last Review: 07/2018 Origination: 07/2018 Next Review: 07/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Oral Immunotherapy Agents Page 1 of 13 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Oral Immunotherapy Agents Prime Therapeutics will review Prior Authorization
More informationOcaliva (obeticholic acid tablets)
Ocaliva (obeticholic acid tablets) Policy Number: 5.01.619 Last Review: 11/2018 Origination: 11/2016 Next Review: 11/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky (Oralair) Reference Number: CP.PMN.85 Effective Date: 11.16.16 Last Review Date: 08.18 Line of Business: Commercial, Medicaid
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Cystic Fibrosis Transmembrane Page 1 of 13 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Prime Therapeutics
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Ragwitek) Reference Number: CP.PMN.83 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial, Medicaid See Important Reminder at the end of this policy for important
More informationHereditary angioedema (HAE) is a rare but potentially
Severity of Hereditary Angioedema, Prevalence, and Diagnostic Considerations Jonathan A. Bernstein, MD Hereditary angioedema (HAE) is a rare but potentially life-threatening disease affecting approximately
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Nerlynx) Reference Number: CP.PHAR.365 Effective Date: 09.05.17 Last Review Date: 11.18 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this policy
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Strensiq (asfotase alfa) Page 1 of 5 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Strensiq (asfotase alfa) Prime Therapeutics will review Prior Authorization
More informationTymlos (abaloparatide)
Tymlos (abaloparatide) Policy Number: 5.01.638 Last Review: 11/2018 Origination: 10/2017 Next Review: 11/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Tymlos
More informationThe Journal of Angioedemasit amet
Successful Prophylaxis of Hereditary Angioedema with Human C1 Inhibitor Concentrate: A Collection of Case Reports Isabelle Boccon-Gibod, MD 1,2,* ; Bernard Floccard, MD 2,3 ; Yann Ollivier, MD 2,4 ; Aurélie
More informationSelf-administration of C1-inhibitor concentrate in patients with hereditary or acquired angioedema caused by C1-inhibitor deficiency
Self-administration of C1-inhibitor concentrate in patients with hereditary or acquired angioedema caused by C1-inhibitor deficiency Marcel Levi, MD, a Goda Choi, MD, a Charles Picavet, MA, b and C. Erik
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Krystexxa) Reference Number: CP.PHAR.115 Effective Date: 06.01.13 Last Review Date: 02.19 Line of Business: Commercial, Medicaid Coding Implications Revision Log See Important Reminder
More informationExondys 51 (eteplirsen) injection Policy Number: Last Review: 10/2018 Origination: 10/2016 Next Review: 10/2019
Exondys 51 (eteplirsen) injection Policy Number: 5.01.618 Last Review: 10/2018 Origination: 10/2016 Next Review: 10/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage
More information