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BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross

and Blue Shield Plans. BCBSNC is an independent licensee of the Blue Cross and Blue Shield Association. All other marks are the property of their respective ow ners.

July 2019

Utilization Management Policy Name: Attention Deficit Hyperactive Disorder (ADHD) - Enhanced & Essential

Restricted Product(s):

• Adderall®

• Adhansia XR™

• amphetamine/ dextroamphetamine ER (generic Adderall XR®1)

• Adzenys XR-ODTTM

• Adzenys ERTM suspension

• Aptensio XR®

• methylphenidate ER (generic Concerta®)

• Methylphenidate ER 10 mg capsule & tablet

• Cotempla XR ODT™

• Daytrana®

• Dexedrine®/ Dexedrine XR®

• DyanavelTM XR

• Focalin®/ Focalin XR®

• Intuniv®

• Jornay PMTM

• Kapvay®

• Metadate CD®

• Methylin®

• MydayisTM

• Procentra®

• QuillichewTM

• Quillivant XR®

• RelexxiilTM

• Ritalin®/ Ritalin LA/ Ritalin SR

• Strattera®

• Zenzedi®

Unrestricted/Suggested Alternative(s): generic formulations of

ADHD medications unless otherwise noted. Quantity limits apply.

Preferred Brands

• Adderall XR (brand name)

• Concerta (brand name)

• Vyvanse

Preferred Generics

• Amphetamine/dextroamphetamine (generic Adderall)

• Dexmethylphenidate/dexmethylphenidate ER (generic

Focalin/Focalin ER)

• Guanfacine SR (generic Intuniv)

• Clonidine SR (generic Kapvay)

• Methylphenidate (generic of Methylin)

• Methylphenidate chews (generic Methylin Chews)

• Dextroamphetamine (generic Procentra)

• Dextroamphetamine/dextroamphetamine SR (generic

Dexedrine/Dexedrine XR)

• Methylphenidate/ methylphenidate SR (generic Ritalin/Ritalin

LA)

• Atomoxetine (generic Strattera)



July 2019

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; AND 4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies (outlined below)*

Duration of Approval: 365 days (1 year)

Criteria for Approval of Restricted Brand Name Products:

1. The patient has experienced a therapeutic failure or inadequate response to TWO, unrestricted, ADHD products; OR 2. The patient had a documented intolerance, hypersensitivity, or FDA labeled contraindication to all the unrestricted ADHD prod ucts; 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)



July 2019

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

40mg/day except only in rare cases Narcolepsy: 60mg/day in divided doses

Adderall (amphetamine/ dextroamphetamine) 7.5mg 3 Adderall (amphetamine/ dextroamphetamine) 10mg 3 Adderall (amphetamine/ dextroamphetamine) 12.5mg 3

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 Adults: 20mg to 60mg 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

Adhansia XR (methylphenidate extended release) 25mg 1 Per FDA label: Dosages above 85 mg daily in

adults and 70 mg and above daily in pediatric patients are associated with disproportionate increases in the incidence of certain adverse reactions.

Adhansia XR (methylphenidate extended release) 35mg 1 Adhansia XR (methylphenidate extended release) 45mg 1 Adhansia XR (methylphenidate extended release) 55mg 1

Adhansia XR (methylphenidate extended release) 70mg 1



July 2019

Adhansia XR (methylphenidate extended release) 85mg 1

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

Adzenys XR-ODT (amphetamine ER dispersible) 3.1mg 1 Pediatric (6-12 yoa): 18.8 mg once daily

Pediatric (13-17 yoa): 12.5 mg once daily Adults: 18.8 mg once daily

Adzenys XR-ODT (amphetamine ER dispersible) 6.3mg 1 Adzenys XR-ODT (amphetamine ER dispersible) 9.4 mg 1

Adzenys XR-ODT (amphetamine ER dispersible) 12.5mg 1 Adzenys XR-ODT (amphetamine ER dispersible) 15.7mg 1 Adzenys XR-ODT (amphetamine ER dispersible) 18.8mg 1

Aptensio XR (methylphenidate extended release) 10mg 1 ADHD (Pediatric and Adults): Doses greater

than 60mg per day have not been studied and are not recommended

Aptensio XR (methylphenidate extended release) 15mg 1 Aptensio XR (methylphenidate extended release) 20mg 1



Concerta (methylphenidate extended release) 18mg/ 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 recommended Pediatric (13-17yoa): Doses greater than 72mg per day have not been studied and are not recommended


1


2


1



July 2019

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 studied and are not recommended. Cotempla XR-ODT (methylphenidate ER ODT) 17.3mg 2

Cotempla XR-ODT (methylphenidate ER ODT) 25.9mg 2

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 ADHD: 40mg/day Dextroamphetamine (DextroStat) 10mg 6

Dexedrine (dextroamphetamine extended release) 5mg 3 ADHD: Per FDA label, only in rare cases will it

be necessary to exceed a total of 40 mg per day.

Dexedrine (dextroamphetamine extended release) 10mg 4

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

dose is 20mg/day (10mg twice daily). Focalin (dexmethylphenidate) 5mg 3

Focalin (dexmethylphenidate) 10mg 2

Focalin XR (dexmethylphenidate extended release) 5mg 1 Focalin XR (dexmethylphenidate extended release) 10mg 1



July 2019

Focalin XR (dexmethylphenidate extended release) 15mg 1 Per FDA label, doses above 30mg/day in pediatrics and 40mg/day in adults have not 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

Intuniv (guanfacine extended release) 1mg 1 Per the FDA label, doses above 4mg/day

have not been systematically studied in controlled clinical studies.

Intuniv (guanfacine extended release) 2mg 1 Intuniv (guanfacine extended release) 3mg 1

Intuniv (guanfacine extended release) 4mg 1

Jornay PM (methylphenidate extended release) 20 mg 1 Per the FDA label, daily dosage above 100mg/day is not recommended. Jornay PM (methylphenidate extended release) 40 mg 1

Jornay PM (methylphenidate extended release) 60 mg 1

Jornay PM (methylphenidate extended release) 80 mg 1 Jornay PM (methylphenidate extended release) 100 mg 1

Kapvay (clonidine extended release) 0.1mg 4 Recommended dose is 0.2mg given twice

daily

Metadate CD (methylphenidate extended release) 10mg 1 Per FDA label, daily dosage above 60mg is not recommended.

Metadate CD (methylphenidate extended release) 20mg 1

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 above 60mg/day is not recommended Metadate ER (methylphenidate extended release) 20mg 3



July 2019

Methylin Chew Tabs (methylphenidate) 2.5mg 3 Children ≥6yo: Per FDA label, daily dosage above 60mg/day is not recommended. Methylin Chew Tabs (methylphenidate) 5mg 3

Methylin Chew Tabs (methylphenidate) 10mg 6

Methylin Solution (methylphenidate) 5mg/5mL 15 mL Methylin Solution (methylphenidate) 10mg/5mL 30 mL

Mydayis 12.5 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 Pediatric (13-17): Doses higher than 25 mg have not been evaluated in clinical trials in pediatric patients

Mydayis 25 mg extened-release capsule (mixed salts of a single-entity amphetamine product)

1

Mydayis 37.5 mg extened-release capsule (mixed salts of a single-entity amphetamine product)

1

Mydayis 50 mg extened-release capsule (mixed salts of a single-entity amphetamine product)

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 is not recommended. Quillichew ER (methylphenidate extended release) 30mg 2

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.

Relexxii (methylphenidate ER Osmotic Release) 72mg 1 Pediatric (13-17yoa): Doses greater than

72mg per day have not been studied and are not recommended



July 2019

Adults (18-65yoa): Doses greater than 72mg per day have not been studied and are not recommended

Ritalin (methylphenidate) 5mg 3 Children ≥6yo: Per FDA label, daily doses above 60mg/day is not recommended. Ritalin (methylphenidate) 10mg 3

Ritalin (methylphenidate) 20mg 3

Ritalin LA (methylphenidate extended release) 10mg 1 Per FDA label: daily dosage above 60mg is not recommended. Ritalin LA (methylphenidate extended release) 20mg 1

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.

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. Adults: Doses of 60 to 120mg/day were studied; mean final dose was approximately 95mg/day.

Strattera (atomoxetine) 18mg 2

Strattera (atomoxetine) 25mg 2 Strattera (atomoxetine) 40mg 2

Strattera (atomoxetine) 60mg 2 Strattera (atomoxetine) 80mg 1 Strattera (atomoxetine) 100mg 1

Vyvanse (lisdexamphetamine) capsule or chew 10mg 1 Per the FDA label, doses >70mg/day were not

studied in clinical trials. Only once daily doses were studied.

Vyvanse (lisdexamphetamine) capsule or chew 20mg 1 Vyvanse (lisdexamphetamine) capsule or chew 30mg 1

Vyvanse (lisdexamphetamine) capsule or chew 40mg 1 Vyvanse (lisdexamphetamine) capsule or chew 50mg 1



July 2019

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 be necessary to exceed a total of 40mg/day. Zenzedi (dextroamphetamine) 5mg 2

Zenzedi (dextroamphetamine) 7.5mg 8

Zenzedi (dextroamphetamine) 10mg 6 Zenzedi (dextroamphetamine) 15mg 2

Zenzedi (dextroamphetamine) 20mg 3 Zenzedi (dextroamphetamine) 30mg 2

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



July 2019

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; Jul 2019

Jul 2019: Criteria update: Adhansia XR added to the policy. Jul 2019: Criteria Change: Increased requirement to a trial of two alternatives for approval. Added methylphenidate ER 10mg to restriction. May 2019: Criteria update: Jornay PM added to the policy. Jan 2019: Vyvanse restriction removed for the Enhanced and Essential formularies Jul 2018: Methylphenidate ER Osmotic Release 72mg is no longer restricted due to generic status (MSC Y) Apr 2018: Net Results removed from policy. 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. Apr 2017: Restrictions placed on select brand name products; Standalone 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



July 2019

• Blue Cross and Blue Shield of North Carolina (“BCBSNC”) complies with applicable Federal civil rights laws and does not discr iminate 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:

➢ 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 [email protected]

• 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.

mailto:[email protected]

http://www.hhs.gov/ocr/office/file/index.html



July 2019

• 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: 한국어를 사용하시는 경우, 언어 지원 서비스를 무료로 이용하실 수 있습니다.

1-888-206-4697 (TTY: 1- 800-442-7028)번으로 전화해 주십시오.

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).

خدمات المساعدة اللغوية تتوافر لك بالمجان. اتصل برقمملحوظة: إذا كنت تتحدث اللغة العربية، فإن

.1-800-442-7028. المبرقة الكاتبة: 4697-206-888-1

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).

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).

tel:1-888-206-4697

tel:1-800-442-7028



July 2019

સુચના: જો તમે ગજુરાતી બોલતા હો, તો નન:સુલ્કુ ભાષા સહાય સેવાઓ તમારા માટે ઉપલબ્ધ છે. ફોન કરો 1-888-206-4697 (TTY: 1-800-442-7028).

ចំណំ៖ ប្រសិនបរើបោកអ្នកនយិាយជាភាសាខ្មែរ បសវាកម្ែជនំយួខ្ននកភាសាមាននតល់ជនូសប្មារប់ោកអ្នកបោយម្ិនគតិថ្លៃ។ សូម្ទំនាក់ទំនងតាម្រយៈបលម៖ 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).

ध्यान दें: यदद आप दिन्दी बोलते िैं तो आपके दलए मुफ्त में भाषा सिायता सेवाएं उपलब्ध िैं। 1-888-206-4697 (TTY: 1-800-442-7028) पर कॉल करें। ໂປດຊາບ: ຖ້າວ່າ ທ່ານເວ ້ າພາສາ ລາວ, ການບໍ ລິ ການຊ່ວຍເຫ ຼື ອດ້ານພາສາ, ໂດຍບໍ່ ເສັຽຄ່າ, ແມ່ນມີ ພ້ອມໃຫ້ທ່ານ. 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。

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