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Prior Authorization Requirements for Select Drugs

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Pharmacy Policy Bulletin Title: Prior Authorization Requirements for Select Drugs Policy #: Rx.01.202 Application of pharmacy policy is determined by benefits and contracts. Benefits may vary based on product line, group, or contract. Some medications may be subject to precertification, age, quantity, or formulary restrictions (ie limits on non- preferred drugs). Individual member benefits must be verified. This pharmacy policy document describes the status of pharmaceutical information and/or technology at the time the document was developed. Since that time, new information relating to drug efficacy, interactions, contraindications, dosage, administration routes, safety, or FDA approval may have changed. This Pharmacy Policy will be regularly updated as scientific and medical literature becomes available. This information may include new FDA-approved indications, withdrawals, or other FDA alerts. This type of information is relevant not only when considering whether this policy should be updated, but also when applying it to current requests for coverage. Members are advised to use participating pharmacies in order to receive the highest level of benefits. Intent: The intent of this policy is to communicate the medical necessity criteria for selected drugs with generic and/or therapeutic alternatives as provided under the member's prescription drug benefit. Description: The Prior Authorization Requirements for Select Drugs is designed to expedite and automate access to certain medications that require prior authorization (PA) by using information available in the member's prescription drug benefit claim history. If the prerequisite drug(s) is (are) in the claim history, the requested medication will be available at the point of sale without having their prescriber submit a PA request. If there is no history of the prerequisite drug(s) in a member's claim history, a PA request will be required per the standard process. Definitions: A. Target: the medication to which the prior authorization is applied B. Prerequisite: the alternative medication(s) that must be used prior to approving the target medication Policy: A medication with an alternative or alternatives will be approved when ALL of the following are met: 1. FDA or compendia approved indication; and 2. Request is not for an excluded benefit (ie cosmetic); and 3. ONE of the following: a. Inadequate response or inability to tolerate the alternative(s) listed; OR b. The medication is requested for the treatment of stage IV, advanced metastatic cancer or a severe adverse health condition experienced as a result of stage IV, advanced metastatic cancer Target Prerequisite(s) Category Mitigare ®, Colcrys®, Gloperba® colchicine tablets Anti-gout Febuxostat (Uloric®) generic allopurinol Anti-gout Daytrana®, amphetamine ER 1.25mg/ml suspension [Adzenys® ER], Adzenys XR- 2 generic ADHD stimulants (e.g. ADHD ODT®, Dyanavel XR®, Mydayis®, methylphenidate, amphetamines, etc) Cotempla®, Evekeo ODT Concerta® Dexedrine® spansule Desoxyn® generic equivalent of requested brand ADHD Metadate CD® Ritalin LA® Focalin XR® Adderall®, Kapvay®, Intuniv®, Strattera® Quillichew®, Quillivant®, Methylphenidate ER [Aptensio®], Jornay PM®, Adhansia Generic methylphenidate ADHD XR® Atacand [HCT]®, Avapro [Avalide]®, Cozaar [Hyzaar]®, Diovan [HCT] ®, 3 generic angiotensin receptor blockers or Micardis [HCT]®, Exforge [HCT]®, combinations (e.g. losartan, olmesartan, Angiotensin II receptor antagonists Twynsta®, Benicar [HCT]®, Azor®, valsartan, etc) Tribenzor®, Edarbi®, Edarbyclor®, Tekturna [HCT]®, Byvalson® 3 generic angiotensin-converting enzyme Vasotec®, Zestril®, Prinivil® ACE-Inhibitors (ACE) inhibitors (e.g. lisinopril, enalapril) Lamictal® generic lamotrigine anticonvulsants Keppra ® generic levetiracetam anticonvulsants generic levetiracetam OR continuation of Briviact® anticonvulsants therapy with Briviact® Wellbutrin XL®, Prozac®, Lexapro®, 3 generic antidepressants (e.g. citalopram, Antidepressants Zoloft®, Effexor XR®, Aplenzin® venlafaxine, bupropion, sertraline, etc) Topamax® [sprinkle] topiramate Anticonvulsants generic topiramate IR OR continuation of Trokendi XR®, topiramate ER [Qudexy therapy with Trokendi XR®, topiramate ER Anticonvulsants XR®] [Qudexy XR®] Three generic anticonvulsants OR Xcopri® Anticonvulsants continuation of therapy with Xcopri® Fetzima®, Pristiq®, Khedezla®, Viibryd® 3 generic antidepressants (e.g. citalopram, venlafaxine, bupropion, sertraline, etc) OR Antidepressants continuous therapy with requested agent for a minimum of 2 weeks 2 generic antidepressants (e.g. citalopram, venlafaxine, bupropion, sertraline, etc) OR Trintellix® Antidepressants continuous therapy with requested agent for a minimum of 2 weeks Cymbalta®, Drizalma® Duloxetine Antidepressants Fortamet® 2 generic metformin products Anti-diabetics HIV therapy and ONE of the following: Mytesi® Antidiarrheal loperimide or diphenoxylate/ atropine 2 generic antipsychotic agents (e.g. Abilify®, Abilify Mycite®, Saphris®, aripirazole, paliperidone, quetiapine, Vraylar®, Fanapt®, Latuda®, Invega®, antipsychotics risperidone, etc) OR continuation of Rexulti®, Caplyta™, Secuado® therapy with requested medication Valtrex® generic valacyclovir Antivirals 3 generic benzodiazepines (e.g. Ativan®, Valium®, Xanax®, Klonopin® lorazepam, diazepam, alprazolam, Benzodiazepine clonazepam, etc) Inderal LA®, Tenormin®, Tenoretic®, 3 generic beta blockers (e.g. propranolol, Beta blockers Kapspargo™ atenolol, metoprolol, etc) Penicillamine [Cuprimine®], Depen® Chelating agents Trientine/Clovique [Syprine®] ONE of the following: Trulicity®, Byetta®, Adlyxin® Bydureon®, Victoza®, Rybelsus® or Anti-diabetics Ozempic® Xultrophy Soliqua Anti-diabetics Symlin® Insulin within 180 days Anti-diabetics Non-preferred diabetic testing supplies (test One Touch® Anti-diabetics strips and meters) Nesina®, Oseni®, Kazano®, Tradjenta®, Januvia® or Janumet® AND Onglyza® or Anti-diabetics Jentadueto® Kombiglyze® One of the following: Jardiance®, Qtern®, Steglatro™, Steglujan™, Synjardy® [XR], Glyxambi® or Trijardy® Anti-diabetics Segluromet™, Invokana®, Invokamet® [XR] XR AND One of the following: Farxiga® or Xigduo® XR Humulin®, Humalog® (insulin lispro), One of the following: Novolin® or Anti-diabetics Apidra®, Admelog®, Lyumjev®, Fiasp® Novolog® Basaglar®, Levemir®, Tresiba®, Semglee® One of the following: Lantus®, Toujeo®, Anti-diabetics Bravelle®, Follistim® Gonal-F Fertility 3 generic HMG CoA reductase inhibitors Lipitor®, Crestor®, Livalo®, Vytorin® (e.g. simvastatin, atorvastatin, Zypitamag®, Ezallor® rosuvastatin, pravastatin, etc) HMG Co A reductase inhibitors Lovaza® Omega-3-acid ethyl esters Cholesterol lowering agents Zetia® generic ezetimibe Cholesterol lowering agents 2 generic antihypertensives in different Vecamyl® Hypertension classes One antidiarrheal medication (e.g. Viberzi® loperamide) AND one antispasmodic (e.g. IBS dicyclomine, etc) Lactulose solution and ONE of the Amitiza® IBS following: Linzess® or Symproic® Both of the following: lactulose solution Trulance ®, Zelnorm® IBS and Linzess® Motegrity® Linzess® IBS 2 of the following: Avonex®, Betaseron®, glatiramer (Copaxone®, Glatopa®), Tecfidera®, Plegridy®, Vumerity®, Extavia®, Rebif [Rebidose] ®, Mavenclad® MS Bafiertam®, dimethyl fumarate, Kesimpta® OR continuation of therapy with the requested agent Dimethyl fumarate AND one of the Tecfidera® MS following: Vumerity® or Bafiertam® Conzip®, Qdolo® 2 generic tramadol products Narcotic analgesic Anaprox DS®, Naprelan CR®, Naprosyn®, EC-Naprosyn®, Celebrex®, Arthrotec®, Daypro®, Mobic®, Zipsor®, Fenoprofen, 3 generic prescription strength NSAIDS Fenortho™, Nalfon®, Qmiiz™ ODT, (e.g. ibuprofen, naproxen, diclofenac, NSAIDs Relafen [DS®], indomethacin [Tivorbex®], celecoxib, meloxicam, etc) Meloxicam [Vivlodex®], diclofenac [Zorvolex®], Ketoprofen 25mg caps Butalbital/APAP 25/325mg tablet [Allzital®], Butalbital/APAP 50/325mg tabs Non-Narcotic Analgesic Butalbital/APAP 50/300mg tabs/caps Butalbital/APAP/Caffeine 50/325mg/40mg Vanatol S®, Vanatol LQ® Non-Narcotic Analgesic tabs OR caps Zioptan®, Vyzulta™, ONE of the following generics: latanoprost, Rescula®, Xelpros®, Rocklatan®, Travatan Ophthalmic prostaglandins bimatoprost, travoprost AND Lumigan® Z® Both of the following: Prolensa® and one Bromsite®, Ilevro®, Nevanac® Ophthalmic NSAIDs generic (diclofenac, flurbiprofen, ketorolac) Cequa™ Restasis® Misc. ophthalmic agents Both of the following: Myrbetriq® AND 2 Toviaz® generic alternatives (e.g. solifenacin, Overactive bladder agents oxybutynin, tolterodine, etc) Vesicare® Generic equivalent of requested brand Overactive bladder agents Xadago® generic rasagiline and selegiline Parkinson's disease Rytary® generic carbidopa/ levodopa Parkinson's disease Ongentys® Generic entacapone Parkinson’s disease Durlaza® aspirin Platelet inhibitors ProAir Digihaler®, Proventil®, Albuterol ProAir® Pulmonary [Ventolin®], Xopenex® Two of the following: Arnuity Ellipta®, Alvesco®, Asmanex®, Qvar®, Armonair® Flovent Diskus/ HFA®, Pulmicort Pulmonary Flexhaler® ONE of the following: Breo Ellipta®, Dulera®, AirDuo® Pulmonary Symbicort® or Advair® Diskus/HFA Utibron Neohaler®, Bevespi Aerosphere®, ONE of the following: Anoro Ellipta®, Pulmonary Duaklir® Stiolto Respimat® Tudorza® Lonhala Magnair®, Seebri®, ONE of the following: Spiriva® or Incruse® Pulmonary Yupelri™ Ellipta Both of the following: Creon® and Pancreaze®, Pertzye®, Viokace® Pancreatic enzymes Zenpep® Finacea®, Zilxi® Soolantra® Rosacea Rhofade® Mirvaso® Rosacea Noritate®
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    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 212895Orig1s000 NON-CLINICAL REVIEW(S) DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH PHARMACOLOGY/TOXICOLOGY NDA/BLA REVIEW AND EVALUATION Application number: 212895 Supporting document/s: 1 Applicant’s letter date: 2/28/2019 CDER stamp date: 2/28/2019 Product: Levoamlodipine Maleate Indication: Hypertension disorder, systemic arterial Applicant: CSPC Ouyi Pharmaceutical Co., LTD Review Division: Cardiovascular and Renal Products Reviewer: Philip Gatti, Ph.D. Supervisor/Team Leader: Xuan Chi, M.D., Ph.D. Division Director: Norman Stockbridge, M.D., Ph.D. Project Manager: Sabry Soukehal Template Version: September 1, 2010 Disclaimer Except as specifically identified, all data and information discussed below and necessary for approval of [NDA number] are owned by [name of applicant] or are data for which [name of applicant] has obtained a written right of reference. Any information or data necessary for approval of [NDA number] that [name of applicant] does not own or have a written right to reference constitutes one of the following: (1) published literature, or (2) a prior FDA finding of safety or effectiveness for a listed drug, as reflected in the drug’s approved labeling. Any data or information described or referenced below from reviews or publicly available summaries of a previously approved application is for descriptive purposes only and is not relied upon for approval of [NDA number]. 1 Reference ID: 4459491 NDA # 212895 Reviewer: Philip Gatti TABLE OF CONTENTS 1 EXECUTIVE SUMMARY ......................................................................................... 3 1.1 INTRODUCTION .................................................................................................... 3 1.2 BRIEF DISCUSSION OF NONCLINICAL FINDINGS .....................................................
  • Calcium Channel Ca2+ Channels; Ca Channels

    Calcium Channel Ca2+ Channels; Ca Channels

    Calcium Channel Ca2+ channels; Ca channels Calcium channel is an ion channel which displays selective permeability to calcium ions. It is sometimes synonymous as voltage-dependent calcium channel, although there are also ligand-gated calcium channels. Voltage-gated calcium (CaV) channels catalyse rapid, highly selective influx of Ca2+ into cells despite a 70-fold higher extracellular concentration of Na+. Some calcium channel blockers have the added benefit of slowing your heart rate, which can further reduce blood pressure, relieve chest pain (angina) and control an irregular heartbeat. www.MedChemExpress.com 1 Calcium Channel Inhibitors, Antagonists, Activators, Agonists & Modulators (+)-Kavain (2R/S)-6-PNG Cat. No.: HY-B1671 (6-Prenylnaringenin) Cat. No.: HY-115681 (+)-Kavain, a main kavalactone extracted from Piper (2R/S)-6-PNG (6-Prenylnaringenin) is a Cav3.2 2+ methysticum, has anticonvulsive properties, (T-type) Ca channel blocker (IC50=991 nM). attenuating vascular smooth muscle contraction (2R/S)-6-PNG suppresses neuropathic allodynia in through interactions with voltage-dependent Na+ mouse pain models. and Ca2+ channels. Purity: 99.98% Purity: ≥99.0% Clinical Data: Launched Clinical Data: Phase 1 Size: 10 mM × 1 mL, 5 mg, 10 mg Size: 5 mg (R)-(+)-Bay-K-8644 (R)-Lercanidipine D3 hydrochloride Cat. No.: HY-15125 Cat. No.: HY-B0612DS (R)-(+)-Bay-K-8644 is a calcium channel (R)-lercanidipine D3 (hydrochloride) is a inhibitor. (R)-(+)-Bay-K-8644 inhibits Ba2+ deuterium labeled (R)-Lercanidipine hydrochloride. currents (IBa) (IC50=975 nM). (R)-Lercanidipine D3 (hydrochloride), the R-enantiomer of Lercanidipine, is a calcium channel blocker. Purity: 99.69% Purity: >98% Clinical Data: No Development Reported Clinical Data: No Development Reported Size: 10 mM × 1 mL, 5 mg, 10 mg, 25 mg, 50 mg, 100 mg Size: 1 mg, 5 mg (R)-Lercanidipine hydrochloride (Rac)-MEM 1003 Cat.