Utilization Management Policy Name: Attention Deficit Hyperactive Disorder (ADHD) Restricted Product(s): restriction is on branded products unless otherwise noted. Quantity restrictions apply to brand and generic forms. Quantity limits apply. Adderall amphetamine/ dextroamphetamine ER (generic Adderall XR 1 ) Adzenys XR-ODT TM Adzenys ER TM suspension Aptensio XR methylphenidate ER (generic Concerta ) Cotempla XR ODT Daytrana Dyanavel TM XR Focalin / Focalin XR Intuniv Kapvay Metadate CD Methylin Methylphenidate chews (generic Methylin Chews) Methylphenidate ER Osmotic Release 72mg Mydayis TM Procentra Quillichew TM Quillivant XR Dexedrine / Dexedrine XR Ritalin / Ritalin LA/ Ritalin SR Strattera *Vyvanse Zenzedi *Vyvanse is restricted on Essential formularies. Unrestricted/Suggested Alternative(s): generic formulations of ADHD medications unless otherwise noted. Quantity limits apply. Amphetamine/dextroamphetamine (generic Adderall) Adderall XR (brand name) Concerta (brand name) Dexmethylphenidate/dexmethylphenidate ER (generic Focalin/Focalin ER Guanfacine SR (generic Intuniv) Clonidine SR (generic Kapvay) Methylphenidate (generic of Methylin) Dextroamphetamine (generic Procentra) Dextroamphetamine/dextroamphetamine SR (generic Dexedrine/Dexedrine XR) Methylphenidate/ methylphenidate SR (generic Ritalin/Ritalin LA) Atomoxetine (generic Strattera) **Vyvanse **Vyvanse is unrestricted on Enhanced and Net Results formularies. Page 1
FDA Approved Use: The treatment of attention deficit hyperactivity disorder (ADHD) Rationale: Adderall XR and Concerta are considered preferred brands due to the high cost of their associated generics. Blue Cross NC is able to provide the brand name product at a better overall price for patients. As a whole, this class of medication is now available in generic forms. This means that the best options for the first trial of an ADHD medication is a generic or one of the preferred brands. Quantity limits have been added to ensure optimal/safe doses for patients. Criteria Summary: Generic Adderall XR/Concerta: Clinical contraindication to the brand name product; quantity limits apply. Other Brand name Products: Trial and failure of a generic; quantity limits apply. Criteria for Approval of generic Adderall XR/Concerta: 1. The member had a sub-therapeutic or intolerant response (therapeutic failure) to an inactive ingredient of the brand name product, but not present in the generic OR 2. The member has a documented intolerance to an inactive ingredient of the brand name product that are not found in the generic product; OR 3. The prescriber provides a written, clinical, explanation for the medical necessity of the generic product over the brand name product. 4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies (outlined below)* Duration of Approval: 365 days Criteria for Approval of Restricted Brand Name Products: 1. The patient has experienced a therapeutic failure or inadequate response to one, unrestricted, ADHD agent; OR 2. The patient had a documented intolerance, hypersensitivity, or FDA labeled contraindication to all the unrestricted ADHD products; AND 3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies (outlined below)* Duration of Approval: 1095 days (3 years) Page 2
Criteria for Non-formulary medications Not otherwise addressed 1. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies (outlined below)* Quantity Limitations: quantity limitations apply to brand and associated generic products. Medication Quantity per Day (unless specified) Max Daily Dose/Maximum Dose Studied Per FDA Label Adderall (amphetamine/ dextroamphetamine) 5mg 3 ADHD (Pediatric and Adults): Not to exceed Adderall (amphetamine/ dextroamphetamine) 7.5mg 3 40mg/day except only in rare cases Adderall (amphetamine/ dextroamphetamine) 10mg 3 Adderall (amphetamine/ dextroamphetamine) 12.5mg 3 Narcolepsy: 60mg/day in divided doses Adderall (amphetamine/ dextroamphetamine) 15mg 2 Adderall (amphetamine/ dextroamphetamine) 20mg 3 Adderall (amphetamine/ dextroamphetamine) 30mg 2 Adderall XR (amphetamine/ dextroamphetamine extended release) 5mg 1 Pediatric (6-17 yoa): 10mg to 40mg per day studied; no adequate evidence that doses greater than 20mg/day conferred additional benefit Adderall XR (amphetamine/ dextroamphetamine extended release) 10mg 1 Adderall XR (amphetamine/ dextroamphetamine extended release) 15mg 1 Adderall XR (amphetamine/ dextroamphetamine extended release) 20mg 1 Adderall XR (amphetamine/ dextroamphetamine extended release) 25mg 1 Adderall XR (amphetamine/ dextroamphetamine extended release) 30mg 1 Adults: 20mg to 60mg per day studied; no adequate evidence that doses greater than 20mg/day conferred additional benefit Adzenys ER (amphetamine ER suspension) 1.25mg/mL 15.1mL Pediatric (6-12 yoa): 18.8 mg once daily Pediatric (13-17 yoa): 12.5 mg once daily Adults: 18.8 mg once daily Page 3
Adzenys XR-ODT (amphetamine ER dispersible) 3.1mg 1 Pediatric (6-12 yoa): 18.8 mg once daily Adzenys XR-ODT (amphetamine ER dispersible) 6.3mg 1 Adzenys XR-ODT (amphetamine ER dispersible) 9.4 mg 1 Pediatric (13-17 yoa): 12.5 mg once daily Adzenys XR-ODT (amphetamine ER dispersible) 12.5mg 1 Adzenys XR-ODT (amphetamine ER dispersible) 15.7mg 1 Adults: 18.8 mg once daily Adzenys XR-ODT (amphetamine ER dispersible) 18.8mg 1 Aptensio XR (methylphenidate extended release) 10mg 1 ADHD (Pediatric and Adults): Doses greater Aptensio XR (methylphenidate extended release) 15mg 1 than 60mg per day have not been studied and Aptensio XR (methylphenidate extended release) 20mg 1 are not recommended Aptensio XR (methylphenidate extended release) 30mg 1 Aptensio XR (methylphenidate extended release) 40mg 1 Aptensio XR (methylphenidate extended release) 50mg 1 Aptensio XR (methylphenidate extended release) 60mg 1 Concerta (methylphenidate extended release) 18mg/ and non-equivalent methylphenidate extended release Concerta generic Concerta (methylphenidate extended release) 27mg/ and non-equivalent methylphenidate extended release Concerta generic Concerta (methylphenidate extended release) 36mg/ and non-equivalent methylphenidate extended release Concerta generic Concerta (methylphenidate extended release) 54mg/ and non-equivalent methylphenidate extended release Concerta generic 1 Pediatric (6-12yoa): Doses greater than 54mg per day have not been studied and are not 1 recommended 2 1 Pediatric (13-17yoa): Doses greater than 72mg per day have not been studied and are not recommended Adults (18-65yoa): Doses greater than 72mg per day have not been studied and are not recommended Cotempla XR-ODT (methylphenidate ER ODT) 8.6mg 1 Daily doses above 51.8 mg have not been Cotempla XR-ODT (methylphenidate ER ODT) 17.3mg 2 studied and are not recommended. Cotempla XR-ODT (methylphenidate ER ODT) 25.9mg 2 Page 4
Daytrana (methylphenidate transdermal patch) 10mg/9hr 1 Doses greater than 30mg/9hr were not studied Daytrana (methylphenidate transdermal patch) 15mg/9hr 1 Daytrana (methylphenidate transdermal patch) 20mg/9hr 1 Daytrana (methylphenidate transdermal patch) 30mg/9hr 1 Dextroamphetamine (DextroStat) 5mg 2 Narcolepsy: 5-60mg/day in divided doses Dextroamphetamine (DextroStat) 10mg 6 ADHD: 40mg/day Dexedrine (dextroamphetamine extended release) 5mg 3 ADHD: Per FDA label, only in rare cases will it Dexedrine (dextroamphetamine extended release) 10mg 4 be necessary to exceed a total of 40 mg per day. Dexedrine (dextroamphetamine extended release) 15mg 4 Dyanavel XR (amphetamine extended release) 2.5mg per 1mL 8 ml ADHD: Per FDA label, daily doses above 20mg are not recommended. Focalin (dexmethylphenidate) 2.5mg 3 Per FDA label, the maximum recommended Focalin (dexmethylphenidate) 5mg 3 dose is 20mg/day (10mg twice daily). Focalin (dexmethylphenidate) 10mg 2 Focalin XR (dexmethylphenidate extended release) 5mg 1 Per FDA label, doses above 30mg/day in Focalin XR (dexmethylphenidate extended release) 10mg 1 pediatrics and 40mg/day in adults have not Focalin XR (dexmethylphenidate extended release) 15mg 1 been studied and are not recommended. Focalin XR (dexmethylphenidate extended release) 20mg 1 Focalin XR (dexmethylphenidate extended release) 25mg 1 Focalin XR (dexmethylphenidate extended release) 30mg 1 Focalin XR (dexmethylphenidate extended release) 35mg 1 Focalin XR (dexmethylphenidate extended release) 40mg 1 Page 5
Intuniv (guanfacine extended release) 1mg 1 Per the FDA label, doses above 4mg/day Intuniv (guanfacine extended release) 2mg 1 have not been systematically studied in Intuniv (guanfacine extended release) 3mg 1 controlled clinical studies. Intuniv (guanfacine extended release) 4mg 1 Kapvay (clonidine extended release) 0.1mg 4 0.2mg given twice daily Metadate CD (methylphenidate extended release) 10mg 1 Per FDA label, daily dosage above 60mg is Metadate CD (methylphenidate extended release) 20mg 1 not recommended. Metadate CD (methylphenidate extended release) 30mg 1 Metadate CD (methylphenidate extended release) 40mg 1 Metadate CD (methylphenidate extended release) 50mg 1 Metadate CD (methylphenidate extended release) 60mg 1 Metadate ER (methylphenidate extended release) 10mg 3 Children 6yo: Per FDA label, daily dosage Metadate ER (methylphenidate extended release) 20mg 3 above 60mg/day is not recommended Methylin Chew Tabs (methylphenidate) 2.5mg 3 Children 6yo: Per FDA label, daily dosage Methylin Chew Tabs (methylphenidate) 5mg 3 above 60mg/day is not recommended. Methylin Chew Tabs (methylphenidate) 10mg 6 Methylin Chew Solution (methylphenidate) 5mg/5mL 15 ml Methylin Chew Solution (methylphenidate) 10mg/5mL 30 ml Methylphenidate ER Osmotic Release 72mg 1 Pediatric (13-17yoa): Doses greater than 72mg per day have not been studied and are not recommended Adults (18-65yoa): Doses greater than 72mg per day have not been studied and are not recommended Page 6
Mydayis 12.5 mg extened-release capsule (mixed salts of a single-entity amphetamine product) Mydayis 25 mg extened-release capsule (mixed salts of a single-entity amphetamine product) Mydayis 37.5 mg extened-release capsule (mixed salts of a single-entity amphetamine product) Mydayis 50 mg extened-release capsule (mixed salts of a single-entity amphetamine product) 1 Adults: Doses above 50 mg daily have shown no additional clinically meaningful benefit 1 Pediatric (13-17): Doses higher than 25 mg 1 have not been evaluated in clinical trials in pediatric patients 1 Procentra (dextroamphetamine) 5mg/5mL 60 ml ADHD: Per FDA label, only in rare cases will it be necessary to exceed a total of 40mg/day. Quillichew ER (methylphenidate extended release) 20mg 1 Per the FDA label, daily dosage above 60 mg Quillichew ER (methylphenidate extended release) 30mg 2 is not recommended. Quillichew ER (methylphenidate extended release) 40mg 1 Quillivant XR (methylphenidate extended release) 25 mg/5 ml 60 mg or 12 ml ADHD: Per FDA label, dosage >60mg/day is not recommended. Doses up to 60mg/day were studied in clinical trials. Ritalin (methylphenidate) 5mg 3 Children 6yo: Per FDA label, daily doses Ritalin (methylphenidate) 10mg 3 above 60mg/day is not recommended. Ritalin (methylphenidate) 20mg 3 Ritalin LA (methylphenidate extended release) 10mg 1 Per FDA label: daily dosage above 60mg is Ritalin LA (methylphenidate extended release) 20mg 1 not recommended. Ritalin LA (methylphenidate extended release) 30mg 2 Ritalin LA (methylphenidate extended release) 40mg 1 Ritalin LA (methylphenidate extended release) 60mg 1 Ritalin SR (methylphenidate extended release) 20mg 3 Children 6yo: Per FDA label, daily doses above 60mg/day is not recommended. Page 7
Strattera (atomoxetine) 10mg 2 Children and adolescents: Doses of 0.5 to 1.8mg/kg/day were studied; 1.8mg/kg/day dose did not provide any additional benefit over that observed with the 1.2mg/kg/day dose. Strattera (atomoxetine) 18mg 2 Strattera (atomoxetine) 25mg 2 Strattera (atomoxetine) 40mg 2 Strattera (atomoxetine) 60mg 2 Strattera (atomoxetine) 80mg 1 Strattera (atomoxetine) 100mg 1 Adults: Doses of 60 to 120mg/day were studied; mean final dose was approximately 95mg/day. Vyvanse (lisdexamphetamine) capsule or chew 10mg 1 Per the FDA label, doses >70mg/day were not Vyvanse (lisdexamphetamine) capsule or chew 20mg 1 studied in clinical trials. Only once daily doses Vyvanse (lisdexamphetamine) capsule or chew 30mg 1 were studied. Vyvanse (lisdexamphetamine) capsule or chew 40mg 1 Vyvanse (lisdexamphetamine) capsule or chew 50mg 1 Vyvanse (lisdexamphetamine) capsule or chew 60mg 1 Vyvanse (lisdexamphetamine) capsule 70mg 1 Zenzedi (dextroamphetamine) 2.5mg 3 ADHD: Per FDA label, only in rare cases will it Zenzedi (dextroamphetamine) 5mg 2 be necessary to exceed a total of 40mg/day. Zenzedi (dextroamphetamine) 7.5mg 8 Zenzedi (dextroamphetamine) 10mg 6 Zenzedi (dextroamphetamine) 15mg 2 Zenzedi (dextroamphetamine) 20mg 3 Zenzedi (dextroamphetamine) 30mg 2 Page 8
Quantity Limit Exception Criteria: 1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer s product insert; OR 4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). Duration of Approval: 1095 days (3 years) *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: August 2015; Last updated; December 2017. Jan 2018: Added new to market drug Methylphenidate ER Osmotic Release 72mg and Adzenys ER suspension to criteria Dec 2017: Extended authorization lengths to 3 years for step and quantity approvals Aug 2017: Added new to market drug, Cotempla XR ODT. Jul 2017: Added new to market drug, Mydayis. Jun 2017: Reformatting, no change to criteria; atomoxetine added as an unrestricted product in alignment with its release. May 2017: Methylphenidate hcl chews added to restriction due to sole manufacturer in the market. Page 9
Apr 2017: Restrictions placed on select brand name products; Stand alone criteria for methylphenidate and amphetamine/dextroamphetamine ER consolidated into one criteria. Jan 2017: Reviewed for ASO Net Results and Essential Formularies; Non-formulary verbiage added. Mar 2016: Added new to market drug, Adzenys XR-ODT Feb 2016: Added new to market medications, Dynavel XR and Quillichew ER to the policy. Aug 2015: Revision - Evekeo and Desoxyn removed from the ADHD QL criteria and added to their own program with ADHD QL and Short Term Weight Loss PA Non-Discrimination and Accessibility Notice Discrimination is Against the Law Blue Cross and Blue Shield of North Carolina ( BCBSNC ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. BCBSNC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. BCBSNC: 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 1-888-206-4697, TTY and TDD, call 1-800-442-7028. If you believe that BCBSNC 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: Page 10
BCBSNC, PO Box 2291, Durham, NC 27702, Attention: Civil Rights Coordinator- Privacy, Ethics & Corporate Policy Office, Telephone 919-765-1663, Fax 919-287-5613, TTY 1-888-291-1783 civilrightscoordinator@bcbsnc.com You can file a grievance in person or by mail, fax, or email. 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 https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, 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. 20201 1-800-368-1019, 800-537- 7697 (TDD). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. This Notice and/or attachments may have important information about your application or coverage through BCBSNC. 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 1-888-206-4697. ATTENTION: If you speak another language, language assistance services, free of charge, are available to you. Call 1-888-206-4697 (TTY: 1-800-442-7028). ATENCIÓN: Si habla español, tiene a su disposición servicios gratuitos de asistencia lingüística. Llame al 1-888-206-4697 (TTY: 1-800-442-7028). 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 1-888-206-4697 (TTY:1-800-442-7028) CHÚ Ý: Nếu bạn nói Tiếng Việt, có các dịch vụ hỗ trợ ngôn ngữ miễn phí dành cho bạn. Gọi số 1-888-206-4697 (TTY: 1-800-442-7028). 주의 : 한국어를사용하시는경우, 언어지원서비스를무료로이용하실수있습니다. 1-888-206-4697 (TTY: 1-800-442-7028) 번으로전화해주십시오. ATTENTION : Si vous parlez français, des services d'aide linguistique vous sont proposés gratuitement. Appelez le 1-888-206-4697 (ATS : 1-800-442-7028). Page 11
LUS CEEV: Yog tias koj hais lus Hmoob, cov kev pab txog lus, muaj kev pab dawb rau koj. Hu rau 1-888-206-4697 (TTY: 1-800-442-7028). ملحوظة: إذا كنت تتحدث اللغة العربية فإن خدمات المساعدة اللغوية تتوافر لك بالمجان. اتصل برقم 1-888-206-4697. المبرقة الكاتبة: 1-800-442-7028. ВНИМАНИЕ: Если вы говорите на русском языке, то вам доступны бесплатные услуги перевода. Звоните 1-888-206-4697 (телетайп: 1-800-442-7028). PAUNAWA: Kung nagsasalita ka ng Tagalog, maaari kang gumamit ng mga serbisyo ng tulong sa wika nang walang bayad. Tumawag sa 1-888-206-4697 (TTY: 1-800-442-7028). 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 1-888-206-4697 (TTY: 1-800-442-7028). 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 1-888-206-4697 (TTY: 1-800-442-7028) ACHTUNG: Wenn Sie Deutsch sprechen, stehen Ihnen kostenlos sprachliche Hilfsdienstleistungen zur Verfügung. Rufnummer: 1-888-206-4697 (TTY: 1-800-442-7028). 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 1-888-206-4697 (TTY: 1-800-442-7028) 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 1-888-206-4697 (TTY: 1-800-442-7028). 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 1-888-206-4697(TTY: 1-800-442-7028) まで お電話にてご連絡ください Page 12