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Evaluation of the Efficacy and Safety of Tavaborole Topical Solution, 5%, In
Journal of Dermatological Treatment ISSN: 0954-6634 (Print) 1471-1753 (Online) Journal homepage: http://www.tandfonline.com/loi/ijdt20 Evaluation of the efficacy and safety of tavaborole topical solution, 5%, in the treatment of onychomycosis of the toenail in adults: a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies Aditya K. Gupta, Steve Hall, Lee T. Zane, Shari R. Lipner & Phoebe Rich To cite this article: Aditya K. Gupta, Steve Hall, Lee T. Zane, Shari R. Lipner & Phoebe Rich (2017): Evaluation of the efficacy and safety of tavaborole topical solution, 5%, in the treatment of onychomycosis of the toenail in adults: a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies, Journal of Dermatological Treatment, DOI: 10.1080/09546634.2017.1329510 To link to this article: http://dx.doi.org/10.1080/09546634.2017.1329510 Accepted author version posted online: 18 May 2017. Published online: 30 May 2017. Submit your article to this journal Article views: 41 View related articles View Crossmark data Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ijdt20 Download by: [Oregon Health & Science University Library] Date: 27 September 2017, At: 13:42 JOURNAL OF DERMATOLOGICAL TREATMENT, 2017 https://doi.org/10.1080/09546634.2017.1329510 ORIGINAL ARTICLE Evaluation of the efficacy and safety of tavaborole topical solution, 5%, in the treatment of onychomycosis of the toenail in adults: a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies Aditya K. -
HMSA ASO Topical Antifungals Jublia (Efinaconazole) Kerydin (Tavaborole
PA Request Criteria HMSA ASO Topical Antifungals This fax machine is located in a secure location as required by HIPAA regulations. Fax complete signed and dated forms to CVS/Caremark at 855-762-5207. Please contact CVS/Caremark at 855-240-0543 with questions regarding the prior authorization process. When conditions are met, we will authorize the coverage of Topical Antifungals. Patient Information Patient Name: Patient Phone: - - Patient ID: Patient Group No: Patient DOB: / / Prescribing Physician Physician Name: Physician - - Phone: Physician Fax: - - Physician Address: City, State, Zip: Drug Name (select from list of drugs shown) Jublia (efinaconazole) Kerydin (tavaborole) Oxiconazole Cream Oxistat Cream (oxiconazole) Quantity: ____________ Frequency: __________________ Strength: __________________ Route of Administration: _______________________ Expected Length of Therapy: _____________________ Diagnosis: ICD Code: __________________________________ Comments: _____________________________________________________ ______________________________________________________________________ ______________________________________________________________________ Please check the appropriate answer for each applicable question. 1. Is this a request for oxiconazole cream (Oxistat)? Y N 2. Is the requested drug being prescribed for any of the following: A) tinea corporis, B) tinea Y N cruris, C) tinea pedis, D) tinea versicolor? 3. Is the drug being prescribed for onychomycosis of the toenail(s) due to Trichophyton Y N rubrum and Trichophyton mentagrophytes? 4. Has the diagnosis been confirmed with a fungal diagnostic test (e.g., KOH preparation, Y N fungal culture, or nail biopsy)? I attest that the medication requested is medically necessary for this patient. I further attest that the information provided is accurate and true, and that the documentation supporting this information is available for review if requested by the claims processor, the health plan sponsor, or, if applicable a state or federal regulatory agency. -
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 -
Common Derm Conditions and Treatments
4/10/17 Classes of Dermatologic Medications What is that?! Common Dermatologic Conditions and ● Topical Immune Suppressants ● Immune Suppressants How to Treat Them ● Vitamin D Derivatives ● Antibiotics, Antivirals, Antiparasitic Matthew Fox, MD ● Retinoids ● Antimalarials Assistant Professor, Division of Dermatology ● Biologic Agents Dell Medical School, University of Texas at Austin Director of Dermatologic Surgery, Seton Healthcare Family ● Chemotherapeutic agents Learning Objectives Approach to Dermatologic Conditions • Know the clinical subtypes of acne *Know the mechanism and recommended dosing of topical retinoids, oral antibiotics and oral retinoids in the management of acne Acne • Understand the clinical presentation cutaneous dermatophyte infection Infectious diseases of the Skin *Know the classes and recommended dosing of antifungal treatments • Recognize the clinical manifestations of dermatitis Eczema *Know the relative potencies, side effects and indications of topical steroids Psoriasis • Describe the classic clinical findings for psoriasis *Know the mechanism of action and side effects of systemic antipsoriatic medications Sun Damage / Actinic Keratoses • Know the pertinent history and physical exam findings associated with a diagnosis of skin cancer, including the ABCDEs of melanoma Fundamentals Words to the wise… • All medications have side effects If you advise the patients of side effects ahead of time, you are informing the • Always consider drug interactions, patient. including with food and supplements If you did not tell the patient about a known • Always consider pregnancy and lactation side effect until after they experience status that side effect, it is an excuse 1 4/10/17 Reference: Approach to Dermatologic Conditions • Wolverton SE, ed. Acne Comprehensive Infectious diseases of the Skin Dermatologic Drug Eczema nd Therapy, 2 Ed. -
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 -
Federal Register/Vol. 83, No. 31/Wednesday, February 14, 2018
Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices 6563 Wireless Telecommunications Bureau Signed: DEPARTMENT OF HEALTH AND and Wireline Competition Bureau (the Dayna C. Brown, HUMAN SERVICES Bureaus) may implement, and (3) certify Secretary and Clerk of the Commission. Centers for Disease Control and its challenge. The USAC system will [FR Doc. 2018–03166 Filed 2–12–18; 4:15 pm] validate a challenger’s evidence using Prevention BILLING CODE 6715–01–P an automated challenge validation [CDC–2018–0004; NIOSH–233–B] process. Once all valid challenges have been identified, a challenged party that NIOSH List of Antineoplastic and Other chooses to respond to any valid FEDERAL RESERVE SYSTEM Hazardous Drugs in Healthcare challenge(s) may submit additional data Settings: Proposed Additions to the via the online USAC portal during the Change in Bank Control Notices; NIOSH Hazardous Drug List 2018 established response window. A Acquisitions of Shares of a Bank or AGENCY: Centers for Disease Control and challenged party may submit technical Bank Holding Company information that is probative regarding Prevention, HHS. ACTION: Notice of draft document the validity of a challenger’s speed tests, The notificants listed below have available for public comment. including speed test data and other applied under the Change in Bank device-specific data collected from Control Act (12 U.S.C. 1817(j)) and transmitter monitoring software or, SUMMARY: The National Institute for § 225.41 of the Board’s Regulation Y (12 alternatively, may submit its own speed Occupational Safety and Health test data that conforms to the same CFR 225.41) to acquire shares of a bank (NIOSH) of the Centers for Disease standards and requirements specified by or bank holding company. -
Therapeutic Class Overview Onychomycosis Agents
Therapeutic Class Overview Onychomycosis Agents Therapeutic Class • Overview/Summary: This review will focus on the antifungal agents Food and Drug Administration (FDA)-approved for the treatment of onychomycosis.1-9 Onychomycosis is a progressive infection of the nail bed which may extend into the matrix or plate, leading to destruction, deformity, thickening and discoloration. Of note, these agents are only indicated when specific types of fungus have caused the infection, and are listed in Table 1. Additionally, ciclopirox is only FDA-approved for mild to moderate onychomycosis without lunula involvement.1 The mechanisms by which these agents exhibit their antifungal effects are varied. For ciclopirox (Penlac®) the exact mechanism is unknown. It is believed to block fungal transmembrane transport, causing intracellular depletion of essential substrates and/or ions and to interfere with ribonucleic acid (RNA) and deoxyribonucleic acid (DNA).1 The azole antifungals, efinaconazole (Jublia®) and itraconazole tablets (Onmel®) and capsules (Sporanox®) works via inhibition of fungal lanosterol 14-alpha-demethylase, an enzyme necessary for the biosynthesis of ergosterol. By decreasing ergosterol concentrations, the fungal cell membrane permeability is increased, which results in leakage of cellular contents.2,5,6 Griseofulvin microsize (Grifulvin V®) and ultramicrosize (GRIS-PEG®) disrupts the mitotic spindle, arresting metaphase of cell division. Griseofulvin may also produce defective DNA that is unable to replicate. The ultramicrosize tablets are absorbed from the gastrointestinal tract at approximately one and one-half times that of microsize griseofulvin, which allows for a lower dose of griseofulvin to be administered.3,4 Tavaborole (Kerydin®), is an oxaborole antifungal that interferes with protein biosynthesis by inhibiting leucyl-transfer ribonucleic acid (tRNA) synthase (LeuRS), which prevents translation of tRNA by LeuRS.7 The final agent used for the treatment of onychomycosis, terbinafine hydrochloride (Lamisil®), is an allylamine antifungal. -
204427Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204427Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number 204,427 Priority or Standard Standard Submit Date July 29, 2013 Received Date July 29, 2013 PDUFA Goal Date July 29, 2014 Division / Office DDDP Reviewer Name Milena Lolic, M.D., M.S. Review Completion Date March 11, 2014 Established Name Tavaborole solution 5% Trade Name Kerydin Therapeutic Class Oxaborole antifungal Applicant Anacor Pharmaceuticals Inc. Formulation Solution Dosing Regimen Daily for 48 weeks Indication Onychomycosis Intended Population Adults Template Version: March 6, 2009 Reference ID: 3477657 Clinical Review Milena Lolic, MD, MS NDA 204,427 Kerydin (tavaborole) Topical Solution, 5% Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT......................................... 7 1.1 Recommendation on Regulatory Action ............................................................. 7 1.2 Risk Benefit Assessment.................................................................................... 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 ............................................................................................ 9 2.2 Currently Available Treatments for Proposed Indication................................... 10 2.3 Availability -
Clinical Protocol
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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 -
(Jublia), Tavaborole (Kerydin) Reference Number: CP.CPA.54 Effective Date: 11.16.16 Last Review Date: 11.17 Revision Log Line of Business: Medicaid – Medi-Cal
Clinical Policy: Efinaconazole (Jublia), Tavaborole (Kerydin) Reference Number: CP.CPA.54 Effective Date: 11.16.16 Last Review Date: 11.17 Revision Log Line of Business: Medicaid – Medi-Cal See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are onychomycosis antifungal agents requiring prior authorization: Efinaconazole (Jublia®), Tavaborole (Kerydin™) FDA approved indication Jublia, Kerydin are indicated: • For the treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Centene Corporation® that Jublia, and Kerydin are medically necessary when the following criteria are met: I. Initial Approval Criteria A. Onychomycosis (must meet all): 1. Diagnosis of onychomycosis of the toenails; 2. Failure of maximally tolerated doses of terbinafine tablets unless contraindicated or clinically significant adverse effects are experienced. Approval duration: 48 weeks B. Other diagnoses/indications 1. Refer to CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). II. Continued Therapy A. Onychomycosis (must meet all): 1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; 2. Documentation of positive response to therapy. Approval duration: 48 weeks B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or Page 1 of 4 CLINICAL POLICY Efinaconazole, Tavaborole 2. -
204427Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204427Orig1s000 MICROBIOLOGY / VIROLOGY REVIEW(S) Division of Anti-Infective Products Clinical Microbiology Review Dermatology and Dental Consult NDA#: 204,427 Page 1 of 58 Tavaborole Original Anchor Pharmaceuticals, Inc. Date Review Completed: 3-4-14 NDA type: 505 (b)(1) Date Company Submitted: 7-26-13 Date Received by CDER: 7-29-13 Date Assigned: 8-7-13 NAME AND ADDRESS OF APPLICANT: Anacor Pharmaceuticals, Inc. 1 020 East Meadow Circle Palo Alto, CA 94303 Contact Person: Carmen R. Rodriguez, M.Sc. VP, Regulatory Affairs and Quality DRUG PRODUCT NAMES: Proprietary Name: Kerydin Established Name/Code Name(s): Tavaborole Topical Solution, 5%/AN2690 Molecular Weight: 151.9 Daltons Chemical Name: 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole Molecular Formula: C7H6BFO2 Structure: DRUG CATEGORY Antifungal (topical) PROPOSED INDICATION Treatment of onychomycosis (b) (4) PROPOSED DOSAGE FORM, STRENGTH AND ROUTE OF ADMINISTRATION: Dosage Form: Solution Route of Administration: Topical Dosage: Once daily Strength: 5% Duration of Treatment: 48 weeks Reference ID: 3466044 Division of Anti-Infective Products Clinical Microbiology Review Dermatology and Dental Consult NDA#: 204,427 Page 2 of 58 Tavaborole Original Anchor Pharmaceuticals, Inc. Date Review Completed: 3-4-14 DISPENSED: Prescription Product RELATED DOCUMENTS: Not Applicable REMARKS This is a New Drug Application for Tavaborole Topical Solution, 5%, which is being submitted under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act and under the provisions of Title 21CFR§314.50. This application proposes the use of Tavaborole Topical Solution, 5% for the treatment of patients with onychomycosis (b) (4) A consult request was received on 7-29-13 by the Division of Anti-infective Products (DAIP) from the Division of Dermatology and Dental Products (DDDP), with a desired completion date of March 7, 2014.