Page 1 July 2021

Utilization Management Policy Name: Attention Deficit Hyperactive Disorder (ADHD) - Net Results

Restricted Product(s): restriction is on branded products unless otherwise noted. Quantity restrictions apply to brand and generic forms.

• Adderall® • Aptensio XR® • Metadate CD® • Adhansia XR™ • Azstarys™ • Methylin® • Amphetamine ER suspension 1.25 • Cotempla XR ODT™ • MydayisTM mg/mL (authorized generic Adzenys • Concerta® • Dexedrine®/ Dexedrine XR® ERTM suspension) • Daytrana® • Relexxii™ • amphetamine/ dextroamphetamine • DyanavelTM XR • Ritalin®/ Ritalin LA/ Ritalin SR ER (generic Adderall XR®1) • Focalin®/ Focalin XR® • Strattera® • Adzenys XR-ODTTM • Intuniv® • Zenzedi® • Adzenys ERTM suspension • Kapvay®

FDA Approved Use: • The treatment of attention deficit hyperactivity disorder (ADHD) Criteria for Approval of generic Adderall XR: 1. The patient 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 patient 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 products that require Medical Necessity PA, refer to the Medical Necessity PA UM Criteria.

Duration of Approval: 365 days (1 year)

Criteria for Approval of Restricted Brand Name Products:

1. The request is for Qelbree; AND

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a. The patient has experienced a therapeutic failure or inadequate response to ONE of the following non-stimulant ADHD products: atomoxetine (generic Straterra), guanfacine ER (generic Intuniv); OR i. The patient has a documented intolerance, hypersensitivity, or FDA labeled contraindication to ALL of the following non- stimulant ADHD products: atomoxetine (generic Straterra), guanfacine ER (generic Intuniv); AND b. The patient has experienced a therapeutic failure or inadequate response to ONE unrestricted generic stimulant ADHD product; OR i. The patient has a documented intolerance, hypersensitivity, or FDA labeled contraindication to ALL unrestricted generic stimulant ADHD products; OR 2. The requested product is a Brand medication with an unrestricted generic equivalent: a. The patient had a sub-therapeutic or intolerant response (therapeutic failure) to an inactive ingredient of the generic product, but not present in the Brand; OR i. The patient has a documented intolerance to an inactive ingredient of the generic product that are not found in the brand product; AND b. The patient has experienced a therapeutic failure or inadequate response to ONE other unrestricted ADHD product; OR i. The patient had a documented intolerance, hypersensitivity, or FDA labeled contraindication to all unrestricted ADHD products; OR 3. All other requests: a. The patient has experienced a therapeutic failure or inadequate response to TWO, unrestricted, ADHD products; OR b. The patient had a documented intolerance, hypersensitivity, or FDA labeled contraindication to all unrestricted ADHD products; AND 4. For products that require Medical Necessity PA, refer to the Medical Necessity PA UM Criteria.

Duration of Approval: 365 days (1 year)

Quantity Limitations: quantity limitations apply to brand and associated generic products. Medication Quantity per Day Max Daily Dose/Maximum Dose Studied (unless specified) 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 Adderall XR (amphetamine/ dextroamphetamine extended release) 10mg 1 studied; no adequate evidence that doses Adderall XR (amphetamine/ dextroamphetamine extended release) 15mg 1 greater than 20mg/day conferred additional Adderall XR (amphetamine/ dextroamphetamine extended release) 20mg 1 benefit 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

Adhansia XR (methylphenidate extended release) 25mg 1 Per FDA label: Dosages above 85 mg daily in Adhansia XR (methylphenidate extended release) 35mg 1 adults and 70 mg and above daily in pediatric Adhansia XR (methylphenidate extended release) 45mg 1 patients are associated with disproportionate Adhansia XR (methylphenidate extended release) 55mg 1 increases in the incidence of certain adverse Adhansia XR (methylphenidate extended release) 70mg 1 reactions. 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 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

Azstarys (serdexmethylphenidate/dexmethylphenidate) 26.1mg / 5.2mg 1 ADHD: Doses greater than 52.3 mg/10.4 mg Azstarys (serdexmethylphenidate/dexmethylphenidate) 39.2mg / 7.8mg 1 once daily have not been studied or Azstarys (serdexmethylphenidate/dexmethylphenidate) 52.3mg / 10.4mg 1 recommended

Concerta (methylphenidate extended release) 18mg/ and non-equivalent 1 Pediatric (6-12yoa): Doses greater than 54mg methylphenidate extended release Concerta generic per day have not been studied and are not Concerta (methylphenidate extended release) 27mg/ and non-equivalent 1 recommended methylphenidate extended release Concerta generic Concerta (methylphenidate extended release) 36mg/ and non-equivalent 2 Pediatric (13-17yoa): Doses greater than methylphenidate extended release Concerta generic 72mg per day have not been studied and are Concerta (methylphenidate extended release) 54mg/ and non-equivalent 1 not recommended methylphenidate extended release Concerta generic 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

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 be necessary to exceed a total of 40 mg per Dexedrine (dextroamphetamine extended release) 10mg 4 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

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

Jornay PM (methylphenidate extended release) 20 mg 1 Per the FDA label, daily dosage above Jornay PM (methylphenidate extended release) 40 mg 1 100mg/day is not recommended. 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 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 Solution (methylphenidate) 5mg/5mL 15 mL Methylin Solution (methylphenidate) 10mg/5mL 30 mL

Adults: Doses above 50 mg daily have shown Mydayis 12.5 mg extened-release capsule 1 no additional clinically meaningful benefit (mixed salts of a single-entity amphetamine product) Mydayis 25 mg extened-release capsule 1

(mixed salts of a single-entity amphetamine product) Pediatric (13-17): Doses higher than 25 mg Mydayis 37.5 mg extened-release capsule 1 have not been evaluated in clinical trials in (mixed salts of a single-entity amphetamine product) pediatric patients Mydayis 50 mg extened-release capsule 1 (mixed salts of a single-entity amphetamine product)

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.

Relexxii (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

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.

Strattera (atomoxetine) 10mg 2 Children and adolescents: Doses of 0.5 to Strattera (atomoxetine) 18mg 2 1.8mg/kg/day were studied; 1.8mg/kg/day Strattera (atomoxetine) 25mg 2 dose did not provide any additional benefit Strattera (atomoxetine) 40mg 2 over that observed with the 1.2mg/kg/day Strattera (atomoxetine) 60mg 2 dose. 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

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: 365 days (1 year)

*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:

July 2021: Criteria update: Added Azstarys to the policy. July 2021: Criteria change: Removal of Jornay PM from restriction. Duration of approval decreased to 365 days. April 2021: Criteria update: Added Qelbree to restricted products. Requests for brand meds with an unrestricted generic equivalent required to t/f the associated generic product. January 2021: Criteria update: Added Brand Concerta to restricted products. October 2020: Criteria update: Removed authorized generic methylphenidate ER 24 HR capsule due to true generic coming on the market.

October 2020: Criteria change: Removed methylphenidate ER (generic Concerta) from restricted products. May 2020: Criteria update: Added Methylphenidate ER capsule (authorized generic Aptensio XR) to the policy. Feb 2020: Criteria update: Procentra removed from restricted section due to MSC Y status – only QL Jan 2020: Criteria update: Removed unrestricted/suggested alternatives. Added Amphetamine ER suspension 1.25 mg/mL (authorized generic Adzenys ERTM suspension) to the policy. Jul 2019: Criteria update: Adhansia XR added to the policy. Jul 2019: Criteria change: Increased requirement to a trial of two alternatives for approval. May 2019: Criteria update: Jornay PM added to the policy. Mar 2019: Relexxii (methylphenidate ER 72mg) added to the policy. Feb 2019: Corrected Vyvanse on restricted drug section. Jul 2018: Removed methylphenidate er 72mg from ST restriction due to generic status. Apr 2018: Net Results removed from standard policy; Quillichew and Quillivant no longer have prerequisites. 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; 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

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• 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.

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