Drugs That Require Prior Authorization

Total Page:16

File Type:pdf, Size:1020Kb

Drugs That Require Prior Authorization 2017 Drugs Requiring Prior Authorization List 12/1/17 Edition Status Definition PA required Prior Authorization is required. Please submit a Pharmacy Prior Authorization Request Form. Non-Preferred Use another agent similar to requested agent. Specific indication might be required also. Step Therapy An adequate trial of another preferred agent(s) is required before approval. Specialty Requires Prior Authorization. Refer to Specialty Pharmacy Medication Policies on CareSource.com Note: A drug is available generically if its listing includes both a generic and a brand name. Drug Status Special Instructions 8-Mop 10 mg Capsule PA required Required Diagnosis= Cutaneous T-Cell Lymphoma (CTCL) OR Psoriasis With A 30 Day Trial Of Calcipotriene Abelcet 5 mg/mL Vial Medical Benefit Bill Through Medical Benefit ABSORICA 10 mg CAPSULE Non-Preferred Requires trials of 30 days total of each group below either at the same time, separately, or overlapping Topicals: benzoyl peroxide 5% or 10%; benzoyl peroxide 4% or 8% liquid (Panoxyl), erythromycin/benzoyl (Benzamycin), sulfacetamide (Klaron), clindamycin topical (Cleocin T), erythromycin topical, tretinoin cream or gel or adapalene 0.1% gel or cream [or previously approved for a similar non-preferrerd topical agent] AND Orals: minocycline, doxycycline, tetracycline, or erythromycin ABSORICA 20 mg CAPSULE Non-Preferred Requires trials of 30 days total of each group below either at the same time, separately, or overlapping Topicals: benzoyl peroxide 5% or 10%; benzoyl peroxide 4% or 8% liquid (Panoxyl), erythromycin/benzoyl (Benzamycin), sulfacetamide (Klaron), clindamycin topical (Cleocin T), erythromycin topical, tretinoin cream or gel or adapalene 0.1% gel or cream [or previously approved for a similar non-preferrerd topical agent] AND Orals: minocycline, doxycycline, tetracycline, or erythromycin ABSORICA 30 mg CAPSULE Non-Preferred Requires trials of 30 days total of each group below either at the same time, separately, or overlapping Topicals: benzoyl peroxide 5% or 10%; benzoyl peroxide 4% or 8% liquid (Panoxyl), erythromycin/benzoyl (Benzamycin), sulfacetamide (Klaron), clindamycin topical (Cleocin T), erythromycin topical, tretinoin cream or gel or adapalene 0.1% gel or cream [or previously approved for a similar non-preferrerd topical agent] AND Orals: minocycline, doxycycline, tetracycline, or erythromycin 1 Drug Status Special Instructions ABSORICA 40 mg CAPSULE Non-Preferred Requires trials of 30 days total of each group below either at the same time, separately, or overlapping Topicals: benzoyl peroxide 5% or 10%; benzoyl peroxide 4% or 8% liquid (Panoxyl), erythromycin/benzoyl (Benzamycin), sulfacetamide (Klaron), clindamycin topical (Cleocin T), erythromycin topical, tretinoin cream or gel or adapalene 0.1% gel or cream [or previously approved for a similar non-preferrerd topical agent] AND Orals: minocycline, doxycycline, tetracycline, or erythromycin ABSTRAL 100 mcg TABLET PA required Required diagnosis = breakthrough pain in adults with cancer who are receiving and are tolerant to opioid therapy SUBLINGAL ABSTRAL 200 mcg TABLET PA required Required diagnosis = breakthrough pain in adults with cancer who are receiving and are tolerant to opioid therapy SUBLINGAL ABSTRAL 300 mcg TABLET PA required Required diagnosis = breakthrough pain in adults with cancer who are receiving and are tolerant to opioid therapy SUBLINGAL ABSTRAL 400 mcg TABLET PA required Required diagnosis = breakthrough pain in adults with cancer who are receiving and are tolerant to opioid therapy SUBLINGAL ABSTRAL 600 mcg TABLET PA required Required diagnosis = breakthrough pain in adults with cancer who are receiving and are tolerant to opioid therapy SUBLINGAL ABSTRAL 800 mcg TABLET PA required Required diagnosis = breakthrough pain in adults with cancer who are receiving and are tolerant to opioid therapy SUBLINGAL ACANYA GEL PUMP 2.5%-1.2% Non-Preferred Formulary Agents: BENZOYL PEROXIDE 2.5% GEL AND CLINDAMYCIN, CLINDAMAX (CLEOCIN-T) 1% GEL separately used together Acebutolol 200 mg Capsule Non-Preferred Formulary Agent(s): Any Formulary Beta-Blockers (Atenolol, Bisoprolol, Carvedilol, Labetalol, Metoprolol Succinate Or Tartrate, Nadolol, Propranolol) Acebutolol 400 mg Capsule Non-Preferred Formulary Agent(s): Any Formulary Beta-Blockers (Atenolol, Bisoprolol, Carvedilol, Labetalol, Metoprolol Succinate Or Tartrate, Nadolol, Propranolol) ACETAMINOPHEN- Non-Preferred Formulary Agents: Butalbital-Acetaminophen 50-325MG tablet (Phrenilin, Marten tabs), Butalbital-Acetaminophen- ISOMETHEPTENE-CAFFEINE Caffeine (Esgic-Plus) 50-500-40MG tablet, Butalbital-Aceteminophen-Caffeine (Fioricet) 50-325-40MG tablet (PRODRIN) TAB 325-65-20 MG ACETAMINOPHEN- Non-Preferred Formulary Agents: Butalbital-Acetaminophen 50-325MG tablet (Phrenilin, Marten tabs), Butalbital-Acetaminophen- ISOMETHEPTENE-CAFFEINE Caffeine (Esgic-Plus) 50-500-40MG tablet, Butalbital-Aceteminophen-Caffeine (Fioricet) 50-325-40MG tablet (PRODRIN) TAB 500-130-20 MG ACCU-CHEK TEST STRIPS/METER Non-Preferred Formulary Agents: FreeStyle or Precision products ACETAMINOPHEN-CAFFEINE- Non-Preferred Formulary Agent: Butalbital-Aceteminophen-Caffeine-Codeine (FIORICET-COD) 30-50-325-40 capsule DIHYDROCODEINE (PANLOR/PANLOR SS) 712.8-60-32 mg TABLET ACETYLCYSTEINE 10% Solution Non-Preferred Required Diagnosis: acetaminophen overdose OR *as mucolytic for diagnoses such as: chronic emphysema, chronic asthmatic bronchitis, emphyseam with bronchits, pneumonia, bronchitis, pulmonary complications of cystic fibrosis 2 Drug Status Special Instructions ACETYLCYSTEINE 20% Solution Non-Preferred Required Diagnosis: acetaminophen overdose OR *as mucolytic for diagnoses such as: chronic emphysema, chronic asthmatic bronchitis, emphyseam with bronchits, pneumonia, bronchitis, pulmonary complications of cystic fibrosis ACID JELLY Non-Preferred Formulary Agents: ALIGN, FLORAJEN, FLORA-Q, RESTORA, RISAQUAD, REZYST, or DIFF-STAT (oral probiotics) ACIPHEX 10 mg SPRINKLE CAPS Non-Preferred Formulary Agent: RABEPRAZOLE (ACIPHEX EC) 20 MG TABLET ACIPHEX 5 mg SPRINKLE CAPS Non-Preferred Formulary Agent: RABEPRAZOLE (ACIPHEX EC) 20 MG TABLET ACITRETIN (SORIATANE) 10 mg Non-Preferred Formulary Agent: calcipotriene (Dovonex) or previous approval of Enbrel, Humira, or Stelara CAPSULE ACITRETIN (SORIATANE) 17.5 mg Non-Preferred Formulary Agent: calcipotriene (Dovonex) or previous approval of Enbrel, Humira, or Stelara CAPSULE ACITRETIN (SORIATANE) 25 mg Non-Preferred Formulary Agent: calcipotriene (Dovonex) or previous approval of Enbrel, Humira, or Stelara CAPSULE ACLARO, ACLARO PD 4% Excluded benefit EMULSION ACTEMRA 200/10 mL Medical Benefit Please see the state specific Pharmacy Policy Statement titled Actemra by clicking your state under Pharmacy Policies at https://www.caresource.com/providers/policies/ ACTEMRA 400/20 mL Medical Benefit Please see the state specific Pharmacy Policy Statement titled Actemra by clicking your state under Pharmacy Policies at https://www.caresource.com/providers/policies/ ACTEMRA 162 mg/0.9 mL Medical Benefit Please see the state specific Pharmacy Policy Statement titled Actemra by clicking your state under Pharmacy Policies at https://www.caresource.com/providers/policies/ ACTEMRA 80 mg/4 mL Medical Benefit Please see the state specific Pharmacy Policy Statement titled Actemra by clicking your state under Pharmacy Policies at https://www.caresource.com/providers/policies/ ACTHAR HP Specialty Specialty; follow policy on CareSource.com. Acticlate 75 mg Tablet Non-Preferred Formulary Agent(s): Doxycycline Hyclate Capsule (50 mg Or 100 mg), Doxycycline Hyclate Tablet (20 mg Or 100 mg), Doxycycline Monohydrate Capsule (50 mg Or 100mg) Or Doxycycline Monohydrate (Adoxa) 75 mg Tablet Acticlate 150 mg Tablet Non-Preferred Formulary Agent(s): Doxycycline Hyclate Capsule (50 mg Or 100 mg), Doxycycline Hyclate Tablet (20 mg Or 100 mg), Doxycycline Monohydrate Capsule (50 mg Or 100mg) Or Doxycycline Monohydrate (Adoxa) 75 mg Tablet ACTIMMUNE 2 MILLION UNIT VIAL PA required Required diagnosis = chronic granulomatous disease or malignant osteoporosis Active OB Non-Preferred Formulary Agent(s): Any Formulary Prenatal Vitamin ACTONEL 150 mg TABLET Non-Preferred Formulary Agent: alendronate ACTONEL 30 mg TABLET Non-Preferred Formulary Agent: alendronate ACTONEL 35 mg TABLET Non-Preferred Formulary Agent: alendronate ACTONEL 5 mg TABLET Non-Preferred Formulary Agent: alendronate 3 Drug Status Special Instructions ACTONEL WITH CALCIUM TABLET Non-Preferred Formulary Agent: alendronate then Actonel and OTC calcium 500 mg tablet 35 mg/500 mg ACTOPLUS MET XR 15-1,000MG Step Therapy Formulary agents: Metformin IR or ER (Glucophage or Glucophage ER) TABLET ACTOPLUS MET XR 30-1,000MG Step Therapy Formulary agents: Metformin IR or ER (Glucophage or Glucophage ER) TABLET ACUVAIL 0.45% OPHTH SOLUTION Non-Preferred Formulary Agent: ketorolac (ACULAR) 0.5% EYE DROPS ACYCLOVIR (ZOVIRAX) 5% Step Therapy Required Diagnosis= Acute Outbreak Of Genital Herpes Simplex OR Cold Sores/Oral Herpes Simplex OINTMENT With A Trial Of Abreva Aczone 5% Gel Non-Preferred Formulary Agent(s): Adapalene 0.1% Gel Or Cream, Benzoyl Peroxide 5% Or 10%, Benzoyl Peroxide 4% Or 8% Liquid (Panoxyl), Clindamycin Topical (Cleocin T), Erythromycin Topical, Erythromycin/Benzoyl (Benzamycin), Sulfacetamide (Klaron), Or Tretinoin Cream Or Gel Aczone 7.5% Gel With Pump Non-Preferred Formulary Agent(s): Adapalene 0.1% Gel Or Cream, Benzoyl Peroxide 5% Or 10%, Benzoyl Peroxide 4% Or 8% Liquid (Panoxyl),
Recommended publications
  • Diagnosis and Treatment of Tinea Versicolor Ronald Savin, MD New Haven, Connecticut
    ■ CLINICAL REVIEW Diagnosis and Treatment of Tinea Versicolor Ronald Savin, MD New Haven, Connecticut Tinea versicolor (pityriasis versicolor) is a common imidazole, has been used for years both orally and top­ superficial fungal infection of the stratum corneum. ically with great success, although it has not been Caused by the fungus Malassezia furfur, this chronical­ approved by the Food and Drug Administration for the ly recurring disease is most prevalent in the tropics but indication of tinea versicolor. Newer derivatives, such is also common in temperate climates. Treatments are as fluconazole and itraconazole, have recently been available and cure rates are high, although recurrences introduced. Side effects associated with these triazoles are common. Traditional topical agents such as seleni­ tend to be minor and low in incidence. Except for keto­ um sulfide are effective, but recurrence following treat­ conazole, oral antifungals carry a low risk of hepato- ment with these agents is likely and often rapid. toxicity. Currently, therapeutic interest is focused on synthetic Key Words: Tinea versicolor; pityriasis versicolor; anti­ “-azole” antifungal drugs, which interfere with the sterol fungal agents. metabolism of the infectious agent. Ketoconazole, an (J Fam Pract 1996; 43:127-132) ormal skin flora includes two morpho­ than formerly thought. In one study, children under logically discrete lipophilic yeasts: a age 14 represented nearly 5% of confirmed cases spherical form, Pityrosporum orbicu- of the disease.3 In many of these cases, the face lare, and an ovoid form, Pityrosporum was involved, a rare manifestation of the disease in ovale. Whether these are separate enti­ adults.1 The condition is most prevalent in tropical tiesN or different morphologic forms in the cell and semitropical areas, where up to 40% of some cycle of the same organism remains unclear.: In the populations are affected.
    [Show full text]
  • 4 Supplementary File
    Supplemental Material for High-throughput screening discovers anti-fibrotic properties of Haloperidol by hindering myofibroblast activation Michael Rehman1, Simone Vodret1, Luca Braga2, Corrado Guarnaccia3, Fulvio Celsi4, Giulia Rossetti5, Valentina Martinelli2, Tiziana Battini1, Carlin Long2, Kristina Vukusic1, Tea Kocijan1, Chiara Collesi2,6, Nadja Ring1, Natasa Skoko3, Mauro Giacca2,6, Giannino Del Sal7,8, Marco Confalonieri6, Marcello Raspa9, Alessandro Marcello10, Michael P. Myers11, Sergio Crovella3, Paolo Carloni5, Serena Zacchigna1,6 1Cardiovascular Biology, 2Molecular Medicine, 3Biotechnology Development, 10Molecular Virology, and 11Protein Networks Laboratories, International Centre for Genetic Engineering and Biotechnology (ICGEB), Padriciano, 34149, Trieste, Italy 4Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Trieste, Italy 5Computational Biomedicine Section, Institute of Advanced Simulation IAS-5 and Institute of Neuroscience and Medicine INM-9, Forschungszentrum Jülich GmbH, 52425, Jülich, Germany 6Department of Medical, Surgical and Health Sciences, University of Trieste, 34149 Trieste, Italy 7National Laboratory CIB, Area Science Park Padriciano, Trieste, 34149, Italy 8Department of Life Sciences, University of Trieste, Trieste, 34127, Italy 9Consiglio Nazionale delle Ricerche (IBCN), CNR-Campus International Development (EMMA- INFRAFRONTIER-IMPC), Rome, Italy This PDF file includes: Supplementary Methods Supplementary References Supplementary Figures with legends 1 – 18 Supplementary Tables with legends 1 – 5 Supplementary Movie legends 1, 2 Supplementary Methods Cell culture Primary murine fibroblasts were isolated from skin, lung, kidney and hearts of adult CD1, C57BL/6 or aSMA-RFP/COLL-EGFP mice (1) by mechanical and enzymatic tissue digestion. Briefly, tissue was chopped in small chunks that were digested using a mixture of enzymes (Miltenyi Biotec, 130- 098-305) for 1 hour at 37°C with mechanical dissociation followed by filtration through a 70 µm cell strainer and centrifugation.
    [Show full text]
  • Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
    TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object.
    [Show full text]
  • Therapeutic Class Overview Antifungals, Topical
    Therapeutic Class Overview Antifungals, Topical INTRODUCTION The topical antifungals are available in multiple dosage forms and are indicated for a number of fungal infections and related conditions. In general, these agents are Food and Drug Administration (FDA)-approved for the treatment of cutaneous candidiasis, onychomycosis, seborrheic dermatitis, tinea corporis, tinea cruris, tinea pedis, and tinea versicolor (Clinical Pharmacology 2018). The antifungals may be further classified into the following categories based upon their chemical structures: allylamines (naftifine, terbinafine [only available over the counter (OTC)]), azoles (clotrimazole, econazole, efinaconazole, ketoconazole, luliconazole, miconazole, oxiconazole, sertaconazole, sulconazole), benzylamines (butenafine), hydroxypyridones (ciclopirox), oxaborole (tavaborole), polyenes (nystatin), thiocarbamates (tolnaftate [no FDA-approved formulations]), and miscellaneous (undecylenic acid [no FDA-approved formulations]) (Micromedex 2018). The topical antifungals are available as single entity and/or combination products. Two combination products, nystatin/triamcinolone and Lotrisone (clotrimazole/betamethasone), contain an antifungal and a corticosteroid preparation. The corticosteroid helps to decrease inflammation and indirectly hasten healing time. The other combination product, Vusion (miconazole/zinc oxide/white petrolatum), contains an antifungal and zinc oxide. Zinc oxide acts as a skin protectant and mild astringent with weak antiseptic properties and helps to
    [Show full text]
  • Therapeutic Drug Class
    BUREAU FOR MEDICAL SERVICES WEST VIRGINIA MEDICAID EFFECTIVE PREFERRED DRUG LIST WITH PRIOR AUTHORIZATION CRITERIA 07/01/13 This is not an all-inclusive list of available covered drugs and includes only managed categories. Refer to cover page for complete list of rules governing this PDL. Version 2013.3c Prior authorization for a non-preferred agent in any category will be given only if there has been a trial of the preferred brand/generic equivalent or preferred formulation of the active ingredient, at a therapeutic dose, that resulted in a partial response with a documented intolerance. Prior authorization of a non-preferred isomer, pro-drug, or metabolite will be considered with a trial of a preferred parent drug of the same chemical entity, at a therapeutic dose, that resulted in a partial response with documented intolerance or a previous trial and therapy failure, at a therapeutic dose, with a preferred drug of a different chemical entity indicated to treat the submitted diagnosis. (The required trial may be overridden when documented evidence is provided that the use of these preferred agent(s) would be medically contraindicated.) Unless otherwise specified, the listing of a particular brand or generic name includes all legend forms of that drug. OTC drugs are not covered unless specified. PA criteria for non-preferred agents apply in addition to general Drug Utilization Review policy that is in effect for the entire pharmacy program, including, but not limited to, appropriate dosing, duplication of therapy, etc. The use of pharmaceutical samples will not be considered when evaluating the members’ medical condition or prior prescription history for drugs that require prior authorization.
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2006/0140990 A1 Bortz Et Al
    US 2006O140990A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0140990 A1 Bortz et al. (43) Pub. Date: Jun. 29, 2006 (54) COMPOSITION FOR TOPICAL TREATMENT (60) Provisional application No. 60/507,138, filed on Oct. OF MIXED VAGINAL INFECTIONS 1, 2003. Provisional application No. 60/504,017, filed on Sep. 19, 2003. (75) Inventors: Jonathan Bortz, Saint Louis, MO (US); R. Saul Levinson, Chesterfield, Publication Classification MO (US); Mitchell Kirschner, St. (51) Int. Cl. Louis, MO (US); Robert C. Cuca, A61K 3 1/7034 (2006.01) Glen Carbon, IL (US) A6IR 9/00 (2006.01) Correspondence Address: (52) U.S. Cl. .............................................. 424/400: 514/35 HARNESS, DICKEY, & PIERCE, P.L.C (57) ABSTRACT 7700 BONHOMME, STE 400 ST. LOUIS, MO 63105 (US) A pharmaceutical composition comprises (a) an antibacterial agent in an antibacterially effective amount, illustratively (73) Assignee: Drug Tech Corporation, Wilmington, comprising clindamycin or a pharmaceutically acceptable salt or ester thereof, and (b) an antifungal agent in an DE (US) antifungally effective amount, illustratively comprising (21) Appl. No.: 11/326,979 butoconazole or a pharmaceutically acceptable salt or ester thereof. The composition is adapted for application in a unit (22) Filed: Jan. 5, 2006 dose amount to a Vulvovaginal Surface and has at least one nonlipoidal internal phase and at least one lipoidal external Related U.S. Application Data phase that is bioadhesive to the vulvovaginal surface. The composition is useful for administration to a Vulvovaginal (63) Continuation-in-part of application No. 10/944,416, Surface to treat a mixed bacterial vaginosis and Vulvovaginal filed on Sep.
    [Show full text]
  • Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
    MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01
    [Show full text]
  • Oxistat® (Oxiconazole) Prior Authorization Request Form DO NOT COPY for FUTURE USE
    OptumRx has partnered with CoverMyMeds to receive prior authorization requests, saving you time and often delivering real-time determinations. Visit go.covermymeds.com/OptumRx to begin using this free service Oxistat® (oxiconazole) Prior Authorization Request Form DO NOT COPY FOR FUTURE USE. FORMS ARE UPDATED FREQUENTLY AND MAY HAVE BARCODES. This form may be faxed to 844-403-1029. Member Information (required) Provider Information (required) Member Name: Provider Name: Insurance ID#: NPI#: Specialty: Date of Birth: Office Phone: Street Address: Office Fax: City: State: ZIP: Office Street Address: Phone: City: State: ZIP: Medication Information (required) Medication Name: Strength: Dosage Form: Directions for Use: Clinical Information (required) 1. Does the patient have a diagnosis of tinea infection (i.e., tinea pedis, cruris, corporis or versicolor)? ❑ Yes ❑ No 2. Has the patient experienced an inadequate treatment response, intolerance or contraindication to any of ❑ Yes ❑ No the following generic creams: terbinafine 1%, clotrimazole 1%, ketoconazole 2% or miconazole 1% or 2%? 3. Does the requested quantity exceed 120 units (grams or milliliters)? ❑ Yes ❑ No Information on this form is accurate as of this date. Prescriber’s Signature: Date: Are there any other comments, diagnoses, symptoms, medications tried or failed, and/or any other information the physician feels is important to this review? ________________________________________________________________________________________________________________ ________________________________________________________________________________________________________________
    [Show full text]
  • Oxistat Oxistat
    PRESCRIBING INFORMATION OXISTAT® (oxiconazole nitrate cream) Cream, 1%* OXISTAT® (oxiconazole nitrate lotion) Lotion, 1%* *Potency expressed as oxiconazole FOR TOPICAL DERMATOLOGIC USE ONLY— NOT FOR OPHTHALMIC OR INTRAVAGINAL USE DESCRIPTION OXISTAT Cream and Lotion formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4- dichlorobenzyl)oxime], mononitrate. The compound has the empirical formula C18H13ON3Cl4•HNO3, a molecular weight of 492.15, and the following structural formula: Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. CLINICAL PHARMACOLOGY Pharmacokinetics: The penetration of oxiconazole nitrate into different layers of the skin was assessed using an in vitro permeation technique with human skin. Five hours after application of 2.5 mg/cm2 of oxiconazole nitrate cream onto human skin, the concentration of oxiconazole nitrate was demonstrated to be 16.2 µmol in the epidermis, 3.64 µmol in the upper corium, and 1.29 µmol in the deeper corium.
    [Show full text]
  • Topical Antifungals Used for Treatment of Seborrheic Dermatitis
    Journal of Bacteriology & Mycology: Open Access Review Article Open Access Topical antifungals used for treatment of seborrheic dermatitis Abstract Volume 4 Issue 1 - 2017 Seborrheic dermatitis is a common inflammatory condition mainly affecting scalp, Sundeep Chowdhry, Shikha Gupta, Paschal face and other seborrheic sites, characterized by a chronic relapsing course. The mainstay of treatment includes topical therapy comprising antifungals (ketoconazole, D’souza Department of Dermatology, ESI PGIMSR, India ciclopirox olamine) and anti-inflammatory agents along with providing symptomatic relief from itching. Oral antifungals and retinoids are indicated only in the severe, Correspondence: Sundeep Chowdhry, Senior Specialist and recalcitrant cases. The objective of this review is to discuss various topical antifungals Assistant Professor, Department of Dermatology, ESI PGIMSR, available for use in seborrheic dermatitis of scalp, face and flexural areas, discuss their Basaidarapur, New Delhi, India, Tel 919910084482, efficacy and safety profiles from relevant studies available in the literature along with Email [email protected] upcoming novel delivery methods to enhance the efficacy of these drugs. Received: October 28, 2016 | Published: January 06, 2017 Keywords: seborrheic dermatitis, antifungal agents, ketoconazole, ciclopirox Introduction Discussion Seborrheic dermatitis (SD) is a common, chronic inflammatory Treatment considerations disease that affects around 1-3% of the general population in many countries including the U.S., 3-5% of patients consisting of young Treatment for SD should aim for not just achieving remission of adults. The incidence of the disease has two peaks: one in newborn lesions but also to eliminate itching and burning sensation and prevent 6 infants up to three months of age, and the other in adults of around recurrence of the disease.
    [Show full text]
  • Application Number
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205175Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 205-175 Priority or Standard Standard Submit Date(s) December 22, 2012 Received Date(s) December 24, 2012 PDUFA Goal Date October 24, 2013 Division / Office DDDP/ODE III Reviewer Name(s) Amy S. Woitach, D.O. Review Completion Date September 20, 2013 Established Name Econazole Nitrate Foam, 1% (Proposed) Trade Name Ecoza Therapeutic Class Antifungal Applicant Amderma Pharmaceuticals Formulation(s) Topical Foam Dosing Regimen Once daily for 4 weeks Indication(s) Interdigital tinea pedis Intended Population(s) Ages 12 years and older Template Version: March 6, 2009 Reference ID: 3376891 Clinical Review Amy S. Woitach, D.O. NDA 205-175 Econazole Nitrate Foam (Ecoza) 1% Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT......................................... 7 1.1 Recommendation on Regulatory Action ............................................................. 7 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ... 8 1.4 Recommendations for Postmarket Requirements and Commitments ................ 8 2 INTRODUCTION AND REGULATORY BACKGROUND ........................................ 9 2.1 Product Information .......................................................................................... 10 2.2 Tables of Currently Available Treatments for Tinea Pedis................................ 11 2.3 Availability of Proposed Active Ingredient in the United States
    [Show full text]
  • Common Study Protocol for Observational Database Studies WP5 – Analytic Database Studies
    Arrhythmogenic potential of drugs FP7-HEALTH-241679 http://www.aritmo-project.org/ Common Study Protocol for Observational Database Studies WP5 – Analytic Database Studies V 1.3 Draft Lead beneficiary: EMC Date: 03/01/2010 Nature: Report Dissemination level: D5.2 Report on Common Study Protocol for Observational Database Studies WP5: Conduct of Additional Observational Security: Studies. Author(s): Gianluca Trifiro’ (EMC), Giampiero Version: v1.1– 2/85 Mazzaglia (F-SIMG) Draft TABLE OF CONTENTS DOCUMENT INFOOMATION AND HISTORY ...........................................................................4 DEFINITIONS .................................................... ERRORE. IL SEGNALIBRO NON È DEFINITO. ABBREVIATIONS ......................................................................................................................6 1. BACKGROUND .................................................................................................................7 2. STUDY OBJECTIVES................................ ERRORE. IL SEGNALIBRO NON È DEFINITO. 3. METHODS ..........................................................................................................................8 3.1.STUDY DESIGN ....................................................................................................................8 3.2.DATA SOURCES ..................................................................................................................9 3.2.1. IPCI Database .....................................................................................................9
    [Show full text]