Therapeutic Class Overview Immunomodulators
Total Page：16
File Type：pdf, Size：1020Kb
Load more
Recommended publications
-
Old and New Challenges in Uveitis Associated with Behçet's Disease
Journal of Clinical Medicine Review Old and New Challenges in Uveitis Associated with Behçet’s Disease Julie Gueudry 1,* , Mathilde Leclercq 2, David Saadoun 3,4,5 and Bahram Bodaghi 6 1 Department of Ophthalmology, Hôpital Charles Nicolle, F-76000 Rouen, France 2 Department of Internal Medicine, Hôpital Charles Nicolle, F-76000 Rouen, France; [email protected] 3 Department of Internal Medicine and Clinical Immunology, AP-HP, Centre National de Références Maladies Autoimmunes et Systémiques Rares et Maladies Autoinflammatoires Rares, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] 4 Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMR S 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005 Paris, France 5 Biotherapy (CIC-BTi), Hôpital Pitié-Salpêtrière, AP-HP, F-75651 Paris, France 6 Department of Ophthalmology, IHU FOReSIGHT, Sorbonne-AP-HP, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] * Correspondence: [email protected]; Tel.: +33-2-32-88-80-57 Abstract: Behçet’s disease (BD) is a systemic vasculitis disease of unknown origin occurring in young people, which can be venous, arterial or both, classically occlusive. Ocular involvement is particularly frequent and severe; vascular occlusion secondary to retinal vasculitis may lead to rapid and severe loss of vision. Biologics have transformed the management of intraocular inflammation. However, the diagnosis of BD is still a major challenge. In the absence of a reliable biological marker, diagnosis is based on clinical diagnostic criteria and may be delayed after the appearance of the onset sign. However, therapeutic management of BD needs to be introduced early in order to control inflammation, to preserve visual function and to limit irreversible structural damage. -
Fig. L COMPOSITIONS and METHODS to INHIBIT STEM CELL and PROGENITOR CELL BINDING to LYMPHOID TISSUE and for REGENERATING GERMINAL CENTERS in LYMPHATIC TISSUES
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date Χ 23 February 2012 (23.02.2012) WO 2U12/U24519ft ft A2 (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, A61K 31/00 (2006.01) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, PCT/US201 1/048297 KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (22) International Filing Date: ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, 18 August 201 1 (18.08.201 1) NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (25) Filing Language: English TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (26) Publication Language: English ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/374,943 18 August 2010 (18.08.2010) US kind of regional protection available): ARIPO (BW, GH, 61/441,485 10 February 201 1 (10.02.201 1) US GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, 61/449,372 4 March 201 1 (04.03.201 1) US ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, (72) Inventor; and EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, ΓΓ, LT, LU, (71) Applicant : DEISHER, Theresa [US/US]; 1420 Fifth LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, Avenue, Seattle, WA 98101 (US). -
Targeted Review List Kaiser HMO, Multi-Choice, PPO, Senior Advantage Effective 1/01/2020
Kaiser Permanente Georgia Region Provider Targeted Review List Kaiser HMO, Multi-Choice, PPO, Senior Advantage Effective 1/01/2020 The Affiliated Community Physician is responsible for verification of member eligibility and benefit coverage by logging on to KP Online-Affiliate or calling Member Services at 404-261- 2590. Failure to obtain authorization prior to providing the services listed below will result in a denial of payment. A medical necessity review decision will be issued to your office and to the member upon completion of the review process. Receipt of complete clinical information with the initial request will expedite the process. Authorization for approval of services based on medical necessity is never a guarantee of payment which must also meet the criteria of member eligibility and benefit availability. The Kaiser Permanente Quality Resource Management Department requires authorization of all post stabilization care including observation and inpatient admissions. Please call our Emergency Care Management hub at 404-365-4254 for authorization. For emergency authorization of home health or durable medical services after regular business hours, contact 404-365-0966 or 800-611-1811 to speak with the QRM case manager on call. Hours of Operation: Quality Resource Management Department Monday through Friday 8:00 am – 5:00 pm 404-364-7320/800-221-2412 Member Services Department Monday through Friday 7:00 am – 7:00 pm 404-261-2590 Emergency Care Management Hub Available 24/7 404-365-4254 Medical necessity review is required for the following services/conditions: HMO members require QRM review and approval for reimbursement of any non- contracted, out of network (office based, outpatient, inpatient) services. -
Review Anti-Cytokine Biologic Treatment Beyond Anti-TNF in Behçet's Disease
Review Anti-cytokine biologic treatment beyond anti-TNF in Behçet’s disease A. Arida, P.P. Sfikakis First Department of Propedeutic Internal ABSTRACT and thrombotic complications (1-3). Medicine Laikon Hospital, Athens, Unmet therapeutic needs in Behçet’s Treatment varies according to type and University Medical School, Greece. disease have drawn recent attention to severity of disease manifestations. Cor- Aikaterini Arida, MD biological agents targeting cytokines ticosteroids, interferon-alpha and con- Petros P. Sfikakis, MD other than TNF. The anti-IL-17 anti- ventional immunosuppressive drugs, Please address correspondence to: body secukinumab and the anti-IL-2 such as azathioprine, cyclosporine-A, Petros P. Sfikakis, MD, receptor antibody daclizumab were not cyclophosphamide and methotrexate, First Department of Propedeutic superior to placebo for ocular Behçet’s and Internal Medicine, are used either alone or in combination Laikon Hospital, in randomised controlled trials, com- for vital organ involvement. During the Athens University Medical School, prising 118 and 17 patients, respec- last decade there has been increased use Ag Thoma, 17, tively. The anti-IL-1 agents anakinra of anti-TNF monoclonal antibodies in GR-11527 Athens, Greece. and canakinumab and the anti-IL-6 patients with BD who were refractory E-mail: [email protected] agent tocilizumab were given to iso- to conventional treatment or developed Received on June 7, 2014; accepted in lated refractory disease patients, who life-threatening complications (4, 5). revised form on September 17, 2014. were either anti-TNF naïve (n=9) or Anti-TNF treatment has been shown to Clin Exp Rheumatol 2014; 32 (Suppl. 84): experienced (n=18). -
Challenges and Approaches for the Development of Safer Immunomodulatory Biologics
REVIEWS Challenges and approaches for the development of safer immunomodulatory biologics Jean G. Sathish1*, Swaminathan Sethu1*, Marie-Christine Bielsky2, Lolke de Haan3, Neil S. French1, Karthik Govindappa1, James Green4, Christopher E. M. Griffiths5, Stephen Holgate6, David Jones2, Ian Kimber7, Jonathan Moggs8, Dean J. Naisbitt1, Munir Pirmohamed1, Gabriele Reichmann9, Jennifer Sims10, Meena Subramanyam11, Marque D. Todd12, Jan Willem Van Der Laan13, Richard J. Weaver14 and B. Kevin Park1 Abstract | Immunomodulatory biologics, which render their therapeutic effects by modulating or harnessing immune responses, have proven their therapeutic utility in several complex conditions including cancer and autoimmune diseases. However, unwanted adverse reactions — including serious infections, malignancy, cytokine release syndrome, anaphylaxis and hypersensitivity as well as immunogenicity — pose a challenge to the development of new (and safer) immunomodulatory biologics. In this article, we assess the safety issues associated with immunomodulatory biologics and discuss the current approaches for predicting and mitigating adverse reactions associated with their use. We also outline how these approaches can inform the development of safer immunomodulatory biologics. Immunomodulatory Biologics currently represent more than 30% of licensed The high specificity of the interactions of immu- biologics pharmaceutical products and have expanded the thera- nomodulatory biologics with their relevant immune Biotechnology-derived peutic options available -
Ilaris Canakinumab for Systemic Juvenile Idiopathic Arthritis SJIA
Subject: Ilaris (canakinumab) for Systemic Juvenile Original Effective Date: 4/24/2015 Idiopathic Arthritis (SJIA) Policy Number: MCP-246 Revision Date(s): Review Date(s): 12/15/2016; 6/22/2017 DISCLAIMER This Medical Policy is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this Molina medical coverage policy (MCP) document and provide the directive for all Medicare members. SUMMARY This policy addresses the coverage of Ilaris (canakinumab) for the treatment of Systemic Juvenile Idiopathic Arthritis (SJIA) when appropriate criteria are met. -
WHO EML Application Tocilizumab
WHO EML Application Tocilizumab Condition Juvenile Idiopathic Arthritis 1 Summary statement of the proposal for inclusion. The application proposes the inclusion of Tocilizumab on the complementary list of the EML/EMLc/both for the treatment of Systemic Onset Juvenile Idiopathic Arthritis (SOJIA). The rationale for the complementary list is that the use of this drug requires specialised care. The proposed listing on both the EML and EMLc reflects the fact that JIA affects children through adolescence and into adulthood. This rationale is consistent with the listing for the anti-TNF biologics currently listed for JIA. Juvenile Idiopathic Arthritis (JIA) is the most common chronic rheumatic disease of childhood, affecting approximately one per 1000 children (1, 2). JIA is characterised by joint inflammation of more than 6 weeks’ duration, with onset before age sixteen years and where no other cause is found (2). JIA is an autoimmune, non-infective, inflammatory joint disease, the cause of which remains poorly understood with both genetic and environmental contributions (3). It is a distinct entity from rheumatoid arthritis, differing in clinical presentations, prognosis, disease outcomes and treatment approaches. The age of onset in JIA is typically young, with a peak incidence between 1-3 years of age, although the disease persists into adulthood in approximately 50% of cases (4). Even in patients in whom the inflammatory disease resolves, joint or extra-articular damage – with associated disability – are common and if not treated then can result in irreversible sequelae and impact on quality of life (5). Current treatment approaches for children with JIA aim for normal physical and psychosocial functioning, and with access to modern treatments, good outcomes are a realistic and achievable goal for many children with this condition (6) . -
Specialty Guideline Management
Reference number 1800-A SPECIALTY GUIDELINE MANAGEMENT ARCALYST (rilonacept) POLICY I. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. FDA-Approved Indications Treatment of Cryopyrin Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 years of age and older. All other indications are considered experimental/investigational and not medically necessary. II. CRITERIA FOR INITIAL APPROVAL Cryopyrin-associated periodic syndrome (CAPS) Authorization of 12 months may be granted for treatment of CAPS when all of the following criteria are met: A. Member has a diagnosis of familial cold auto-inflammatory syndrome (FCAS) with classic signs and symptoms (i.e., recurrent, intermittent fever and rash that were often exacerbated by exposure to generalized cool ambient temperature) or Muckle-Wells syndrome (MWS) with classic signs and symptoms (i.e., chronic fever and rash of waxing and waning intensity, sometimes exacerbated by exposure to generalized cool ambient temperature). B. Member has functional impairment limiting the activities of daily living. III. CONTINUATION OF THERAPY Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for an indication outlined in Section II and who achieve or maintain positive -
Inflammatory Conditions – Kevzara™ (Sarilumab for Subcutaneous Injection)
Cigna National Formulary Coverage Policy Prior Authorization Inflammatory Conditions – Kevzara® (sarilumab for subcutaneous injection) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 59231 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 3 Revision History ................................................... 3 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. -
Prior Authorization Policy
PRIOR AUTHORIZATION POLICY POLICY: Inflammatory Conditions – Arcalyst® (rilonacept for subcutaneous injection Regeneron Pharmaceuticals) DATE REVIEWED: 11/06/2019; selected revision 04/01/2020 OVERVIEW Arcalyst is an interleukin-1 (IL-1) blocker indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children aged 12 years and older.1 Arcalyst, also known is a recombinant dimeric fusion protein that blocks IL-1β signaling and to a lesser extent also binds IL-1α and IL-1 receptor antagonist (IL-1ra). In adults ≥ 18 years of age, Arcalyst is initiated with a loading dose of 320 mg delivered as two subcutaneous (SC) injections of 160 mg on the same day at two separate sites. Dosing is continued with 160 mg once weekly as a single injection. In adolescents aged 12 to 17 years, therapy is initiated with a loading dose of 4.4 mg/kg, up to a maximum of 320 mg, delivered as one or two SC injections with a maximum single-injection volume of 2 mL. If the initial dose is two injections, then patients should be given Arcalyst on the same day at two separate sites. In adolescents, dosing is continued with 2.2 mg/kg, up to a maximum of 160 mg, once weekly as a single injection. Disease Overview CAPS is a rare inherited inflammatory disease associated with overproduction of IL-1. CAPS encompasses three rare genetic syndromes. FCAS, MWS, and neonatal onset multisystem inflammatory disorder (NOMID) or chronic infantile neurological cutaneous and articular syndrome (CINCA) are thought to be one condition along a spectrum of disease severity.2-3 FCAS is the mildest phenotype and NOMID is the most severe. -
761037Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761037Orig1s000 OTHER REVIEW(S) --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- CHRISTINE H FORD 05/19/2017 Reference ID: 4100987 Continuation of Question 4 Additional data or analysis required for a previously submitted or expected study/clinical trial (provide explanation) Meta-analysis or pooled analysis of previous studies/clinical trials Immunogenicity as a marker of safety Other (provide explanation) Agreed upon: Quality study without a safety endpoint (e.g., manufacturing, stability) Pharmacoepidemiologic study not related to safe drug use (e.g., natural history of disease, background rates of adverse events) Clinical trials primarily designed to further define efficacy (e.g., in another condition, different disease severity, or subgroup) that are NOT required under Subpart H/E Dose-response study or clinical trial performed for effectiveness Nonclinical study, not safety-related (specify) Other 5. Is the PMR/PMC clear, feasible, and appropriate? Does the study/clinical trial meet criteria for PMRs or PMCs? Are the objectives clear from the description of the PMR/PMC? Has the applicant adequately justified the choice -
Cytokine & CAM Antagonists
Cytokine & CAM Antagonists Medical policy no. 66.27.00-3 Effective Date: October 1, 2019 Note: New-to-market drugs included in this class based on the Apple Health Preferred Drug List are non-preferred and subject to this prior authorization (PA) criteria. Non-preferred agents in this class require an inadequate response or documented intolerance due to severe adverse reaction or contraindication to at least TWO preferred agents. If there is only one preferred agent in the class documentation of inadequate response to ONE preferred agent is needed. If a drug within this policy receives a new indication approved by the Food and Drug Administration (FDA), medical necessity for the new indication will be determined on a case-by-case basis following FDA labeling. To see the list of the current Apple Health Preferred Drug List (AHPDL), please visit: https://www.hca.wa.gov/assets/billers-and- providers/apple-health-preferred-drug-list.xlsx Background: Cytokines and cell-adhesion molecule (CAM) are chemical mediators involved in inflammatory processes throughout the body. Medications included in this policy are used to treat a group of diseases that may be caused or worsened by an overactive immune system such as rheumatoid arthritis, psoriasis, and ulcerative colitis. Administration is different for each medication, and may be administered subcutaneously (SC), intravenously (IV), or orally. Medical necessity Drug Medical Necessity adalimumab (HUMIRA) Cytokine and CAM antagonists may be considered medically necessary etanercept (ENBREL) when