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® 
• Adderall XR® 
• Adhansia XR™ 
• Amphetamine ER suspension 1.25 mg/mL (branded generic Adzenys ERTM suspension) 
• Adzenys XR-ODTTM 
• Adzenys ERTM suspension 
• Aptensio XR® 
• Azstarys™ 
• Cotempla XR ODT™ 
• Concerta® 
• Daytrana® 
• Dexedrine® / Dexedrine XR® 
• DyanavelTM XR 
• Focalin® / Focalin XR® 
• Intuniv® 
• Kapvay® 
• Metadate CD® 
• Methylin® 
• Methylphenidate ER OSM 72mg (authorized generic Relexxii) 
• MydayisTM 
• Qelbree™ 
• Relexxii™ 
• Ritalin® / Ritalin LA/ Ritalin SR 
• Strattera® 
• Zenzedi®

FDA Approved Use

The treatment of attention deficit hyperactivity disorder (ADHD)

Criteria for Approval of Restricted Brand Name Products

1. The request is for Qelbree; AND 
   1. 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 
      1. The patient has a documented intolerance, hypersensitivity, or FDA labeled contraindication to ALL of the following nonstimulant ADHD products: atomoxetine (generic Straterra), guanfacine ER (generic Intuniv); AND 
   2. The patient has experienced a therapeutic failure or inadequate response to ONE unrestricted generic stimulant ADHD product; OR 
      1. 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: 
   1. 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
      1. The patient has a documented intolerance to an inactive ingredient of the generic product that are not found in the brand product; AND 
   2. The patient has experienced a therapeutic failure or inadequate response to ONE other unrestricted ADHD product; OR 
      1. The patient had a documented intolerance, hypersensitivity, or FDA labeled contraindication to all unrestricted ADHD products; OR 
3. All other requests: 
   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 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 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)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

July 2022: Criteria update: Added Dyanavel XR chewable tablets to policy.
July 2022: Criteria update: Updated Zenzedi 7.5mg and 15mg quantity limit to 3 per day. Increased Qelbree 200mg quantity limit to 3 tabs per day.
Jan 2022: Criteria update: Removed generic Adderall XR from restriction. Added brand Adderall XR to policy. Notation of restriction on AG Relexxi added.
October 2021: Criteria update: Adzenys ER suspension updated to a branded generic product.
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