P&T Summary 2Q2021
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Application Withdrawal Assessment Report for Luveniq
Committee for Medicinal Products for Human Use (CHMP) Assessment report Luveniq voclosporin Procedure No.: EMEA/H/C/002069//0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 5 1.1. Submission of the dossier.................................................................................... 5 1.2. Steps taken for the assessment of the product ....................................................... 6 2. Scientific discussion ................................................................................ 7 2.1. Introduction ...................................................................................................... 7 2.2. Quality aspects .................................................................................................. 8 2.2.1. Introduction ................................................................................................... 8 2.2.2. Active Substance............................................................................................. 8 2.2.3. Finished Medicinal Product ............................................................................. -
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) -
Benlysta® (Belimumab)
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2021 P 1227-6 Program Prior Authorization/Notification Medication Benlysta® (belimumab)* *This program applies to the subcutaneous formulation of belimumab P&T Approval Date 9/2017, 9/2018, 9/2019, 9/2020, 2/2021, 7/2021 Effective Date 10/1/2021; Oxford only: 10/1/2021 1. Background: Benlysta® is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy and adult patients with active lupus nephritis who are receiving standard therapy. Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics. Use of Benlysta is not recommended in these situations. 2. Coverage Criteria: A. Systemic Lupus Erythematosus 1. Initial Authorization a. Benlysta will be approved based on all of the following criteria: (1) Diagnosis of systemic lupus erythematosus -AND- (2) Laboratory testing has documented the presence of autoantibodies [e.g., ANA, Anti-dsDNA, Anti-Sm, Anti-Ro/SSA, Anti-La/SSB] -AND- (3) Patient is currently receiving standard immunosuppressive therapy [e.g., hydroxychloroquine, chloroquine, prednisone, azathioprine, methotrexate] -AND- (4) Patient does not have severe active central nervous system lupus -AND- (5) Patient is not receiving Benlysta in combination with either of the following: (a) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Kineret (anakinra)] © 2021 UnitedHealthcare Services, Inc. 1 (b) Lupkynis (voclosporin) Authorization will be issued for 12 months. -
January 2021 Update
PUBLISHED JULY 08, 2021 OCTOBER/DECEMBER 2020; JANUARY 2021 UPDATE CHANGES TO THE HIGHMARK DRUG FORMULARIES Following is the update to the Highmark Drug Formularies and pharmaceutical management procedures for January 2021. The formularies and pharmaceutical management procedures are updated on a bimonthly basis, and the following changes reflect the decisions made in October, December, and January by our Pharmacy and Therapeutics Committee. These updates are effective on the dates noted throughout this document. Please reference the guide below to navigate this communication: Section I. Highmark Commercial and Healthcare Reform Formularies A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Healthcare Reform Formulary B. Changes to the Highmark Healthcare Reform Essential Formulary C. Changes to the Highmark Core Formulary D. Changes to the Highmark National Select Formulary E. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Formulary Program 4. Quantity Level Limit (QLL) Programs As an added convenience, you can also search our drug formularies and view utilization management policies on the Provider Resource Center (accessible via NaviNet® or our website). Click the Pharmacy Program/Formularies link from the menu on the left. Highmark Blue Cross Blue Shield Delaware is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides secure, web-based portal between providers and health insurance companies. IMPORTANT DRUG SAFETY UPDATES 03/31/2021 – Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease. -
Study Protocol
CLINICAL STUDY PROTOCOL Study Title: An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder Protocol Number: RVT-901-3003 Compound Name and/or Vibegron Number: Indication Treatment of Overactive Bladder Sponsor: Urovant Sciences GmbH Viaduktstrasse 8 4051 Basel Switzerland Development Phase: 3 Regulatory Identifier(s): IND# 106,410 EudraCT# 2017-003293-14 Current Version and Version 3.0; 15 NOV 2018 Effective Date: Previous Version(s) and Version 2.1; 12 FEB 2018 Effective Date(s): Version 2.0; 30 JAN 2018 Version 1.2; 01 NOV 2017 Version 1.1; 05 OCT 2017 Version 1.0; 29 SEP 2017 Study Director: , , Clinical Development Confidentiality Statement The information contained in this document, particularly unpublished data, is the property or under control of Urovant Sciences GmbH, and is provided to you in confidence as an investigator, potential investigator or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The information is only to be used by you in connection with authorized clinical studies of the investigational drug described in the protocol. You will not disclose any of the information to others without written authorization from Urovant Sciences GmbH. except to the extent necessary to obtain informed consent from those persons to whom the drug may be administered. Confidential Page | 1 NCT Number: NCT03492281 This NCT number has been applied to the document for purposes of posting on clinicaltrials.gov Clinical Study Protocol RVT-901-3003 Urovant Sciences GmbH Effective: 15 NOV 2018 SUMMARY OF CHANGES Version Location Description of Change 3.0 Global Minor typographical/formatting errors were corrected. -
Psychiatric History and Overactive Bladder Symptom Severity in Ambulatory Urogynecological Patients
Journal of Clinical Medicine Article Psychiatric History and Overactive Bladder Symptom Severity in Ambulatory Urogynecological Patients Artur Rogowski 1,2,* , Maria Krowicka-Wasyl 2, Ewa Chotkowska 2, Tomasz Kluz 3, Andrzej Wróbel 4 , Dominika Berent 5 , Paweł Mierzejewski 6, Halina Sienkiewicz-Jarosz 7, Adam Wichniak 8, Marcin Wojnar 9 , Jerzy Samochowiec 10 , Katarzyna Kilis-Pstrusinska 11 and Przemyslaw Bienkowski 9 1 Faculty of Medicine, Collegium Medicum, Cardinal Stefan Wyszynski University in Warsaw, 01-938 Warsaw, Poland 2 Department of Obstetrics and Gynecology, Mother and Child Institute, 01-211 Warsaw, Poland; [email protected] (M.K.-W.); [email protected] (E.C.) 3 Department of Gynecology and Obstetrics, Institute of Medical Sciences, Medical College of Rzeszow University, 35-310 Rzeszów, Poland; [email protected] 4 Second Department of Gynecology, Medical University of Lublin, Jaczewskiego 8, 20-954 Lublin, Poland; [email protected] 5 Regional Psychiatric Hospital Drewnica, 05-091 Zabki, Poland; [email protected] 6 Departments of Pharmacology, Institute of Psychiatry and Neurology, 02-957 Warsaw, Poland; [email protected] 7 Department of Neurology I, Institute of Psychiatry and Neurology, 02-957 Warsaw, Poland; [email protected] 8 Department of Psychiatry III, Institute of Psychiatry and Neurology, 02-957 Warsaw, Poland; Citation: Rogowski, A.; [email protected] 9 Krowicka-Wasyl, M.; Chotkowska, E.; Department of Psychiatry, Medical University of Warsaw, 02-091 Warsaw, Poland; Kluz, T.; Wróbel, A.; Berent, D.; [email protected] (M.W.); [email protected] (P.B.) 10 Mierzejewski, P.; Sienkiewicz-Jarosz, Department of Psychiatry, Pomeranian Medical University, 70-111 Szczecin, Poland; [email protected] 11 Department of Pediatric Nephrology, Wroclaw Medical University, 02-091 Wroclaw, Poland; H.; Wichniak, A.; Wojnar, M.; et al. -
Prior Authorization Lupkynis™ (Voclosporin Capsules)
Cigna National Formulary Coverage Policy Prior Authorization Lupkynis™ (voclosporin capsules) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 79744 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. -
Lupkynis (Voclosporin Capsules) Annual Review Date: 02/18/2021
Policy: Lupkynis (voclosporin capsules) Annual Review Date: 02/18/2021 Last Revised Date: 02/18/2021 OVERVIEW Lupkynis, a calcineurin inhibitor immunosuppressant, is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adults with active lupus nephritis.1 Safety and efficacy have not been established in combination with cyclophosphamide and is not recommended. The recommended starting dose is 23.7 mg twice daily taken on an empty stomach, used in combination with mycophenolate mofetil and corticosteroids. Dose modifications are required based on estimated glomerular filtration rate (eGFR). Lupkynis is not recommended if baseline eGFR is ≤ 45 mL/min/1.73 m2 unless the benefit exceeds the risk. If therapeutic benefit is not apparent by Week 24, consider discontinuation of Lupkynis. POLICY STATEMENT This policy involves the use of Lupkynis. Prior authorization is recommended for pharmacy benefit coverage of Lupkynis. Approval is recommended for those who meet the conditions of coverage in the Criteria and Initial/Extended Approval for the diagnosis provided. Conditions Not Recommended for Approval are listed following the recommended authorization criteria. Requests for uses not listed in this policy will be reviewed for evidence of efficacy and for medical necessity on a case-by-case basis. Because of the specialized skills required for evaluation and diagnosis of patients treated with Lupkynis as well as the monitoring required for adverse events and long-term efficacy, initial approval requires Lupkynis be prescribed by or in consultation with a physician who specializes in the condition being treated. All approvals for initial therapy are provided for the initial approval duration noted below; if reauthorization is allowed, a response to therapy is required for continuation of therapy unless otherwise noted below. -
Gemtesa® (Vibegron) – New Drug Approval
Gemtesa® (vibegron) – New drug approval • On December 23, 2020, Urovant Sciences announced the FDA approval of Gemtesa (vibegron), for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. • OAB is a common condition that occurs when the bladder muscle contracts involuntarily. Over 30 million Americans are estimated to suffer from bothersome symptoms of OAB. • Gemtesa is a selective human beta-3 adrenergic receptor agonist. Activation of the beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling. • The efficacy of Gemtesa was established in a 12-week, double-blind, randomized, placebo- controlled, and active-controlled study in 1,515 patients with OAB (urge urinary incontinence, urgency, and urinary frequency). The co-primary endpoints were change from baseline in average daily number of micturitions and average daily number of urge urinary incontinence (UUI) episodes at week 12. — The change from baseline at week 12 in the average daily number of micturitions was -1.8 and -1.3 for Gemtesa and placebo, respectively (difference of -0.5, 95% CI: -0.8, -0.2; p < 0.001). — The change from baseline at week 12 in the average daily number of UUI episodes was -2.0 and -1.4 for Gemtesa and placebo, respectively (difference of -0.6, 95% CI: -0.9, -0.3; p < 0.0001). • A warning and precaution for Gemtesa is urinary retention. • The most common adverse reactions (2%) with Gemtesa use were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. • The recommended dose of Gemtesa is one 75 mg tablet orally, once daily with or without food. -
New Century Health Policy Changes April 2021
Policy # Drug(s) Type of Change Brief Description of Policy Change new Pepaxto (melphalan flufenamide) n/a n/a new Fotivda (tivozanib) n/a n/a new Cosela (trilaciclib) n/a n/a Add inclusion criteria: NSCLC UM ONC_1089 Libtayo (cemiplimab‐rwlc) Negative change 2.Libtayo (cemiplimab) may be used as montherapy in members with locally advanced, recurrent/metastatic NSCLC, with PD‐L1 ≥ 50%, negative for actionable molecular markers (ALK, EGFR, or ROS‐1) Add inclusion criteria: a.As a part of primary/de�ni�ve/cura�ve‐intent concurrent chemo radia�on (Erbitux + Radia�on) as a single agent for members with a UM ONC_1133 Erbitux (Cetuximab) Positive change contraindication and/or intolerance to cisplatin use OR B.Head and Neck Cancers ‐ For recurrent/metasta�c disease as a single agent, or in combination with chemotherapy. Add inclusion criteria: UM ONC_1133 Erbitux (Cetuximab) Negative change NOTE: Erbitux (cetuximab) + Braftovi (encorafenib) is NCH preferred L1 pathway for second‐line or subsequent therapy in the metastatic setting, for BRAFV600E positive colorectal cancer.. Add inclusion criteria: B.HER‐2 Posi�ve Breast Cancer i.Note #1: For adjuvant (post‐opera�ve) use in members who did not receive neoadjuvant therapy/received neoadjuvant therapy and did not have any residual disease in the breast and/or axillary lymph nodes, Perjeta (pertuzumab) use is restricted to node positive stage II and III disease only. ii.Note #2: Perjeta (pertuzumab) use in the neoadjuvant (pre‐opera�ve) se�ng requires radiographic (e.g., breast MRI, CT) and/or pathologic confirmation of ipsilateral (same side) axillary nodal involvement. -
Changes to the Drug Formularies
Published September 2, 2021 The formularies and pharmaceutical management procedures are updated on a bimonthly basis, and the following changes reflect the decisions made in April 2021 by our Pharmacy and Therapeutics Committee. These updates are effective on the dates noted throughout this document. Please reference the guide below to navigate this communication: Section I. Highmark Commercial and Healthcare Reform Formularies A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Healthcare Reform Formulary B. Changes to the Highmark Progressive Healthcare Reform Formulary C. Changes to the Highmark Healthcare Reform Essential Formulary D. Changes to the Highmark Core Formulary E. Changes to the Highmark National Select Formulary F. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Formulary Program 4. Quantity Level Limit (QLL) Programs Section II. Highmark Medicare Part D Formularies A. Changes to the Highmark Medicare Part D 5-Tier Incentive Formulary B. Changes to the Highmark Medicare Part D 5-Tier Closed Formulary C. Additions to the Specialty Tier D. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Quantity Level Limit (QLL) Program As an added convenience, you can also search our drug formularies and view utilization management policies on the Provider Resource Center (accessible via NaviNet® or our website). Click the Pharmacy Program/Formularies link from the menu on the left. Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides a secure, web-based portal between providers and health insurance companies. -
Immunfarmakológia Immunfarmakológia
Gergely: Immunfarmakológia Immunfarmakológia Prof Gergely Péter Az immunpatológiai betegségek döntő többsége gyulladásos, és ennek következtében általában szövetpusztulással járó betegség, melyben – jelenleg – a terápia alapvetően a gyulladás csökkentésére és/vagy megszűntetésére irányul. Vannak kizárólag gyulladásgátló gyógyszereink és vannak olyanok, amelyek az immunreakció(k) bénításával (=immunszuppresszió révén) vagy emellett vezetnek a gyulladás mérsékléséhez. Mind szerkezetileg, mind hatástanilag igen sokféle csoportba oszthatók, az alábbi felosztás elsősorban didaktikus célokat szolgál. 1. Nem-szteroid gyulladásgátlók (‘nonsteroidal antiinflammatory drugs’ NSAID) 2. Kortikoszteroidok 3. Allergia-elleni szerek (antiallergikumok) 4. Sejtoszlás-gátlók (citosztatikumok) 5. Nem citosztatikus hatású immunszuppresszív szerek 6. Egyéb gyulladásgátlók és immunmoduláns szerek 7. Biológiai terápia 1. Nem-szteroid gyulladásgátlók (NSAID) Ezeket a vegyületeket, melyek őse a szalicilsav (jelenleg, mint acetilszalicilsav ‘aszpirin’ használatos), igen kiterjedten alkalmazzák a reumatológiában, az onkológiában és az orvostudomány szinte minden ágában, ahol fájdalom- és lázcsillapításra van szükség. Egyes felmérések szerint a betegek egy ötöde szed valamilyen NSAID készítményt. Szerkezetük alapján a készítményeket több csoportba sorolhatjuk: szalicilátok (pl. acetilszalicilsav) pyrazolidinek (pl. fenilbutazon) ecetsav származékok (pl. indometacin) fenoxiecetsav származékok (pl. diclofenac, aceclofenac)) oxicamok (pl. piroxicam, meloxicam) propionsav