Page 1. Utilization Management Policy Name: Topical Antibiotics Restricted Product(s): brand name topical acne products

Transcription

1 Utilization Management Policy Name: Topical Antibiotics Restricted Product(s): brand name topical acne products Unrestricted/Suggested Alternative(s): Aczone (dapsone) Acanya (clindamycin/benzoyl peroxide) Aktipak (benzoyl peroxide-erythromycin) Azelex (azelaic acid) Benzaclin (clindamycin/benzoyl peroxide) Benzamycin (erythromycin/benzoyl peroxide) Cleocin-T (clindamycin) Clindagel (clindamycin) Duac (clindamycin/benzoyl peroxide) Erygel (erythromycin) Evoclin (clindamycin) Finacea (azelaic acid) Klaron (sulfacetamide sodium) Metrocream (metronidazole) Metrogel (metronidazole) Metrolotion (metronidazole) Noritate (metronidazole) Onexton TM (clindmycin/benzoyl peroxide) erythromycin gel (generic Erygel) clindamycin phosphate gel (generic Cleocin-t) clindamycin phosphate-benzoyl peroxide gel (Benzaclin) clindamycin phosph-benzoyl peroxide (refrig) (Duac) benzoyl peroxide-erythromycin gel (Benzamycin) sulfacetamide sodium lotion 10% (acne) (Klaron) metronidazole cream 0.75% (Metrocream) metronidazole gel 0.75% metronidazole lotion 0.75% (Metrolotion) FDA Approved Use: for the topical treatment of acne vulgaris Rationale: Other products, such erythromycin gel (generic Erygel ) and clindamycin phosphate gel (generic Cleocin-t ), treat the same condition at a substantially lower cost to members with equal results. Page 1

2 Criteria Summary: Trial of effect and lower cost product Criteria for Approval of Restricted Product(s): 1. The patient has had a trial and failure of two generic topical antibiotics; OR 2. The patient has a clinical contraindication/ intolerance to those generic topical antibiotics that they have not tried; AND 3. For formularies that exclude (non-formulary) the requested medication, approval may be warranted when the criteria above is met (Nonformulary Exception Criteria outlined below)* Duration of Approval: 365 days *Non-formulary Exception Criteria Non-Formulary Exception criteria applies on formularies which exclude requested product(s). Satisfactory completion of criteria points (above) may satisfy some, or all, portions of the Non-Formulary Exception Criteria. This criteria is summarized as: a) Request must be for an FDA approved indication; AND b) Patient must have a trial and failure of up to TWO formulary medications or a clinical contraindication/intolerance to those medications not tried. References: all information referenced is from FDA package insert unless otherwise noted below. Policy Implementation/Update Information: originated: January 2016; last updated:. Jul 2017: reformatted criteria; new to market Aktipak added to criteria; brand Akne-Mycin removed as it is no longer on market Jan 2017: reviewed for Essential Formulary. Removal of Non-FDA approved products. Jan 2016: original utilization management criteria issued. Non-Discrimination and Accessibility Notice Discrimination is Against the Law Blue Cross and Blue Shield of North Carolina ( Blue Cross NC ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Page 2

3 Blue Cross NC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. Blue Cross NC: Provides free aids and services to people with disabilities to communicate effectively with us, such as: - Qualified interpreters - Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: - Qualified interpreters - Information written in other languages If you need these services, contact Customer Service , TTY and TDD, call If you believe that Blue Cross NC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Blue Cross NC, PO Box 2291, Durham, NC 27702, Attention: Civil Rights Coordinator- Privacy, Ethics & Corporate Policy Office, Telephone , Fax , TTY civilrightscoordinator@bcbsnc.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, Civil Rights Coordinator - Privacy, Ethics & Corporate Policy Office is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD). Complaint forms are available at This Notice and/or attachments may have important information about your application or coverage through Blue Cross NC. Look for key dates. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call Customer Service Page 3

4 ATTENTION: If you speak another language, language assistance services, free of charge, are available to you. Call ATENCIÓN: Si habla español, tiene a su disposición servicios gratuitos de asistencia lingüística. Llame al 注意 : 如果您講廣東話或普通話, 您可以免費獲得語言援助服務 請致電 (TTY: ) CHÚ Ý: Nếu bạn nói Tiếng Việt, có các dịch vụ hỗ trợ ngôn ngữ miễn phí dành cho bạn. Gọi số 주의 : 한국어를사용하시는경우, 언어지원서비스를무료로이용하실수있습니다 (TTY: ) 번으로전화해주십시오. ATTENTION : Si vous parlez français, des services d'aide linguistique vous sont proposés gratuitement. Appelez le (ATS : ). LUS CEEV: Yog tias koj hais lus Hmoob, cov kev pab txog lus, muaj kev pab dawb rau koj. Hu rau ملحوظة: إذا كنت تتحدث اللغة العربية فإن خدمات المساعدة اللغوية تتوافر لك بالمجان. اتصل برقم المبرقة الكاتبة: ВНИМАНИЕ: Если вы говорите на русском языке, то вам доступны бесплатные услуги перевода. Звоните (телетайп: ). PAUNAWA: Kung nagsasalita ka ng Tagalog, maaari kang gumamit ng mga serbisyo ng tulong sa wika nang walang bayad. Tumawag sa (TTY: ). સ ચન : જ તમ ગ જર ત બ લત હ, ત નન:સ લ ક ભ ષ સહ ય સ વ ઓ તમ ર મ ટ ઉપલબ ધ છ. ફ ન કર ច ណ ប រស នបរ ប កអ នកន យ យជ ភ ស ខ ម រ បសវ កម ជ ន យខ នកភ ស ម ននតល ជ នសប ម រ ប កអ នកប យម នគ តថ ល ស ម ទ ន ក ទ នងត ម រយ បលម (TTY: ) ACHTUNG: Wenn Sie Deutsch sprechen, stehen Ihnen kostenlos sprachliche Hilfsdienstleistungen zur Verfügung. Rufnummer: (TTY: ). Page 4

5 ध य न द : यदद आप द न द ब लत त आपक दलए म फ त म भ ष स यत स व ए उपलब ध (TTY: ) पर क ल कर ໂປດຊາບ: ຖ າວ າ ທ ານເວ າພາສາ ລາວ, ການບ ລການຊ ວຍເຫອດ ານພາສາ, ໂດຍບ ເສ ຽຄ າ, ແມ ນມ ພ ອມໃຫ ທ ານ. ໂທຣ 注意事項 : 日本語を話される場合 無料の言語支援をご利用いただけます (TTY: ) まで お電話にてご連絡ください Page 5