Blue Rx Value Plus Formulary
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
AHFS Pharmacologic-Therapeutic Classification System
AHFS Pharmacologic-Therapeutic Classification System Abacavir 48:24 - Mucolytic Agents - 382638 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Acitretin 84:92 - Skin and Mucous Membrane Agents, Abaloparatide 68:24.08 - Parathyroid Agents - 317036 Aclidinium Abatacept 12:08.08 - Antimuscarinics/Antispasmodics - 313022 92:36 - Disease-modifying Antirheumatic Drugs - Acrivastine 92:20 - Immunomodulatory Agents - 306003 4:08 - Second Generation Antihistamines - 394040 Abciximab 48:04.08 - Second Generation Antihistamines - 394040 20:12.18 - Platelet-aggregation Inhibitors - 395014 Acyclovir Abemaciclib 8:18.32 - Nucleosides and Nucleotides - 381045 10:00 - Antineoplastic Agents - 317058 84:04.06 - Antivirals - 381036 Abiraterone Adalimumab; -adaz 10:00 - Antineoplastic Agents - 311027 92:36 - Disease-modifying Antirheumatic Drugs - AbobotulinumtoxinA 56:92 - GI Drugs, Miscellaneous - 302046 92:20 - Immunomodulatory Agents - 302046 92:92 - Other Miscellaneous Therapeutic Agents - 12:20.92 - Skeletal Muscle Relaxants, Miscellaneous - Adapalene 84:92 - Skin and Mucous Membrane Agents, Acalabrutinib 10:00 - Antineoplastic Agents - 317059 Adefovir Acamprosate 8:18.32 - Nucleosides and Nucleotides - 302036 28:92 - Central Nervous System Agents, Adenosine 24:04.04.24 - Class IV Antiarrhythmics - 304010 Acarbose Adenovirus Vaccine Live Oral 68:20.02 - alpha-Glucosidase Inhibitors - 396015 80:12 - Vaccines - 315016 Acebutolol Ado-Trastuzumab 24:24 - beta-Adrenergic Blocking Agents - 387003 10:00 - Antineoplastic Agents - 313041 12:16.08.08 - Selective -
Pharmacokinetics, Pharmacodynamics and Drug
pharmaceutics Review Pharmacokinetics, Pharmacodynamics and Drug–Drug Interactions of New Anti-Migraine Drugs—Lasmiditan, Gepants, and Calcitonin-Gene-Related Peptide (CGRP) Receptor Monoclonal Antibodies Danuta Szkutnik-Fiedler Department of Clinical Pharmacy and Biopharmacy, Pozna´nUniversity of Medical Sciences, Sw.´ Marii Magdaleny 14 St., 61-861 Pozna´n,Poland; [email protected] Received: 28 October 2020; Accepted: 30 November 2020; Published: 3 December 2020 Abstract: In the last few years, there have been significant advances in migraine management and prevention. Lasmiditan, ubrogepant, rimegepant and monoclonal antibodies (erenumab, fremanezumab, galcanezumab, and eptinezumab) are new drugs that were launched on the US pharmaceutical market; some of them also in Europe. This publication reviews the available worldwide references on the safety of these anti-migraine drugs with a focus on the possible drug–drug (DDI) or drug–food interactions. As is known, bioavailability of a drug and, hence, its pharmacological efficacy depend on its pharmacokinetics and pharmacodynamics, which may be altered by drug interactions. This paper discusses the interactions of gepants and lasmiditan with, i.a., serotonergic drugs, CYP3A4 inhibitors, and inducers or breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) inhibitors. In the case of monoclonal antibodies, the issue of pharmacodynamic interactions related to the modulation of the immune system functions was addressed. It also focuses on the effect of monoclonal antibodies on expression of class Fc gamma receptors (FcγR). Keywords: migraine; lasmiditan; gepants; monoclonal antibodies; drug–drug interactions 1. Introduction Migraine is a chronic neurological disorder characterized by a repetitive, usually unilateral, pulsating headache with attacks typically lasting from 4 to 72 h. -
210913Orig1s000 CLINICAL PHARMACOLOGY REVIEW(S)
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210913Orig1s000 CLINICAL PHARMACOLOGY REVIEW(S) Office of Clinical Pharmacology Review NDA Number 212489 Link to EDR \\cdsesub1\evsprod\nda212489 Submission Date 04/26/2019 Submission Type 505(b)(1) NME NDA (Standard Review) Brand Name ONGENTYS Generic Name opicapone Dosage Form/Strength and Capsules: 25 mg and 50 mg Dosing Regimen 50 mg administered orally once daily at bedtime Route of Administration Oral Proposed Indication Adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s Disease experiencing “OFF” episodes Applicant Neurocrine Biosciences, Inc. (NBI) Associated IND IND (b) (4) OCP Review Team Mariam Ahmed, Ph.D. Atul Bhattaram, Ph.D. Sreedharan Sabarinath, Ph.D. OCP Final Signatory Mehul Mehta, Ph.D. 1 Reference ID: 4585182 Table of Contents 1. EXECUTIVE SUMMARY .............................................................................................................................................................. 4 1.1 Recommendations ..................................................................................................................................................... 4 1.2 Post-Marketing Requirements and Commitments ......................................................................................... 6 2. SUMMARY OF CLINICAL PHARMACOLOGY ASSESSMENT ............................................................................................. 6 2.1 Pharmacology and Clinical Pharmacokinetics .................................................................................................. -
Changes to the Highmark Drug Formularies
AUGUST 2020 JULY/AUGUST 2020 UPDATE CHANGES TO THE HIGHMARK DRUG FORMULARIES Following is the update to the Highmark Drug Formularies and pharmaceutical management procedures for July/August 2020. The formularies and pharmaceutical management procedures are updated on a bimonthly basis, and the following changes reflect the decisions made in June 2020 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 Formulary and 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. -
List of Union Reference Dates A
Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov. -
Pharmacy Prior Authorization Grid ALTCS, and Pharmacy
Please Note: Refer to the other PA grids for applicable covered services that require PA. PA Grids: Medical, Behavioral Health, Pharmacy Prior Authorization Grid ALTCS, and Pharmacy. (Effective Date of Service 1/1/2021) Injectables that require Prior Authorization All chemotherapeutic drugs must be used for FDA-approved indications and/or in accordance with NCCN guidelines *Indicates prior authorization required if billed charges are greater than $400 PA Required HMO 13 HCPCS Short Description (BUCA- Code SNP) 90378 Respiratory Syncytial Virus Immune Globulin Yes C9036 Patisiran Yes C9047 Caplacizumab-yhdp Yes C9061 Teprotumumab-trbw Yes C9063 Eptinezumab-jjmr Yes C9131 Factor VIII antihemophilic factor pegylated-auci Yes C9132 Prothrombin Complex Concentrate (Human), Kcentra Yes C9133 Factor IX (Antihemophilic Factor, Recombinant), Rixibus Yes C9399 Mipomersen (Kynamro) Yes J0129 Abatacept Yes J0135 Adalimumab Yes J0178 Aflibercept Yes J0179 Brolucizumab-dbll, 1 mg Yes J0180 Agalsidase Beta Yes J0205 Alglucerase Yes J0215 Alefacept Yes J0220 Alglucosidase Alfa (Myozyme) Yes J0221 Alglucosidase Alfa (Lumizyme) Yes J0222 Patisiran, 0.1 mg Yes J0223 Givosiran 0.5 mg Yes J0256 Alpha 1-Proteinase Inhibitor Yes J0257 Alpha 1-Proteinase Inhibitor (Glassia) Yes J0275 Alprostadil Urethral Suppository Yes J0490 Belimumab Yes J0517 Benralizumab Yes J0567 Cerliponase alfa Yes J0570 Buprenorphine implant Yes J0584 Burosumab-twza 1 mg Yes J0585 Onabotulinumtoxina (Botox) Yes J0586 Abobotulinumtoxina (Dysport) Yes J0587 Rimabotulinumtoxinb (Myobloc) -
Oxford Policy Update Bulletin: April 2020
Oxford April 2020 policy update bulletin Medical & Administrative Policy Updates Take Note POLICY IMPLEMENTATION DELAYED Implementation of the changes associated with the following Clinical Policies, previously announced for an effective date on or after Apr. 1, 2020, has been delayed as noted below: Policy Title Status Effective Date Genitourinary Pathogen Nucleic Acid Detection Panel Testing New May 1, 2020 Jun. 1, 2020 Outpatient Surgical Procedures - Site of Service Revised Apr. 6, 2020 TBD Tysabri® (Natalizumab) New Apr. 1, 2020 Jul. 1, 2020 Access a policy listed below for complete details on the latest updates. A comprehensive summary of changes is provided at the bottom of every policy document for your reference. To view a detailed version of this bulletin, click here. Policy Title Status Effective Date CLINICAL POLICY Abnormal Uterine Bleeding and Uterine Fibroids Revised Jun. 1, 2020 Actemra® (Tocilizumab) Injection for Intravenous Infusion Revised May 1, 2020 Adakveo® (Crizanlizumab-Tmca) Updated Apr. 1, 2020 Adakveo® (Crizanlizumab-Tmca) Revised Jul. 1, 2020 Cell-Free Fetal DNA Testing Revised Jun. 1, 2020 Cimzia® (Certolizumab Pegol) New Jul. 1, 2020 Collagen Crosslinks and Biochemical Markers of Bone Turnover Revised May 1, 2020 Drug Coverage Criteria – New and Therapeutic Equivalent Medications Revised May 1, 2020 Drug Coverage Guidelines Revised Apr. 1, 2020 Adakveo (Crizanlizumab-Tmca) Givlaari (Givosiran) Ziextenzo (Pegfilgrastim-Bmez) Drug Coverage Guidelines Revised May 1, 2020 Adlyxin (Lixisenatide) Arnuity -
Regulatory News
WHO Drug Information Vol. 28, No. 4, 2014 Regulatory news Ebola curative – transfusions of whole blood or blood plasma from recovered patients Update on treatments and vaccines have been scheduled to be conducted in Liberia, in line with WHO technical The Ebola crisis has prompted an guidelines (4). unprecedented cooperation between regulators In September the European Medicines to support WHO and to advise on possible Agency (EMA) established an expert pathways for the development, evaluation and group to review available information approval of medicines to fight Ebola. Progress on Ebola experimental treatments – towards provision of treatments and vaccines is excluding convalescent therapies – and summarized below. invited developers to submit their data (5). In August 2014, a WHO-convened panel Vaccines had agreed unanimously that is ethically On 29–30 September, 70 experts acceptable to use of experimental attended a WHO-convened consultation medicines and vaccines under the on Ebola vaccines. They took stock of the exceptional circumstances of the Ebola many ongoing efforts to rapidly evaluate epidemic (1). In early September, WHO the safety and efficacy of Ebola vaccines convened a consultation on potential for deployment as soon as possible to Ebola therapies and vaccines (2). The critical frontline workers and ultimately to importance of supportive care and populations at risk in mass vaccination community response was stressed in this campaigns. Two candidate vaccines have and subsequent discussions. clinical-grade vials available for safety trials. (6) Treatments In October, WHO convened industry In September, more than 200 experts leaders and key partners to discuss trials from around the world met at WHO and production of Ebola vaccine (7). -
Health Plan Insights
Health Plan Insights January 2020 Updates from December 2019 800.361.4542 | envisionrx.com Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any form or medium, without EnvisionRxOptions’ prior written consent. Recent FDA Approvals New Medications TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE Avsola Amgen Inc. Injection, Biosimilar to Remicade. For the treatment December 6, 2019 (infliximab-axxq) 100 mg/20 mL of/reducing the signs and symptoms of: Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis in combination with methotrexate, psoriatic arthritis, and plaque psoriasis. Vyondys 53 Sarepta Intravenous Solution, For the treatment of Duchenne muscular December 12, (golodirsen) Therapeutics, Inc. 50 mg/mL dystrophy (DMD) in patients who have a 2019 confirmed mutation of the DMD gene that is amenable to exon 53 skipping. Padcev Astellas Injection, For the treatment of adult patients with locally December 18, (enfortumab 20 mg/vial and 30 advanced or metastatic urothelial cancer who 2019 vedotin-ejfv) mg/vial have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. Conjupri CSPC Ouyi Tablets, For use alone or in combination with other (levamlodipine) Pharmaceutical 1.25 mg, 2.5 mg, and antihypertensive agents for the treatment of December 19, Co., Ltd. 5 mg hypertension, to lower blood pressure. 2019 Caplyta Intra-Cellular Capsules, For the treatment of schizophrenia in adults. December 20, (lumateperone) Therapies, Inc. -
Alder Biopharmaceuticals, Inc. (Exact Name of Registrant As Specified in Its Charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36431 Alder BioPharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 90-0134860 (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) 11804 North Creek Parkway South Bothell, WA 98011 (Address of principal executive offices including zip code) Registrant’s telephone number, including area code: (425) 205-2900 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. -
VYEPTI™ (EPTINEZUMAB) Policy Number: CSLA2020D0090A Effective Date: TBD
Proprietary Information of United Healthcare: The information contained in this document is proprietary and the sole property of United HealthCare Services, Inc. Unauthorized copying, use and distribution of this information are strictly prohibited. Copyright 2020 United HealthCare Services, Inc. UnitedHealthcare® Community Plan Medical Benefit Drug Policy VYEPTI™ (EPTINEZUMAB) Policy Number: CSLA2020D0090A Effective Date: TBD Table of Contents Page Commercial Policy APPLICATION ...................................................... 1 Vyepti™ (Eptinezumab) COVERAGE RATIONALE ........................................ 1 APPLICABLE CODES ............................................. 2 BACKGROUND ................................................... 43 CLINICAL EVIDENCE ............................................ 4 U.S. FOOD AND DRUG ADMINISTRATION ............ 54 CENTERS FOR MEDICARE AND MEDICAID SERVICES 54 REFERENCES ....................................................... 5 POLICY HISTORY/REVISION INFORMATION ...... 65 INSTRUCTIONS FOR USE .................................... 65 APPLICATION This Medical Benefit Drug Policy only applies to state of Louisiana. COVERAGE RATIONALE Vyepti has been added to the Review at Launch program. Please reference the Medical Benefit Drug Policy titled Review at Launch for New to Market Medications for additional details. Chronic Migraine Vyepti is proven and medically necessary for the preventive treatment of chronic migraines when all of the following criteria are met: For initial therapy, all of the -
The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances
WHO/PSM/QSM/2006.3 The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances 2006 Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines Medicines Policy and Standards The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.