Subject: ADHD Agents Limit Policy 682-H 12-2022

Drug

AMPHETAMINES

ADZENYS (ALL PRODUCTS)  (amphetamine)

DYANAVEL (ALL PRODUCTS)  (amphetamine)

EVEKEO (ALL PRODUCTS)  (amphetamine)

AMPHETAMINE-DEXTROAMPHETAMINES

ADDERALL (ALL PRODUCTS)  (amphetamine-dextroamphetamine)

MYDAYIS (ALL PRODUCTS)  (amphetamine-dextroamphetamine)

DEXMETHYLPHENIDATES

AZSTARYS (ALL PRODUCTS)  (serdexmethylphenidate / dexmethylphenidate)

FOCALIN (ALL PRODUCTS)  (exmethylphenidate)

DEXTROAMPHETAMINES

DEXEDRINE (ALL PRODUCTS)  (dextroamphetamine)

dextroamphetamine (ALL PRODUCTS)

PROCENTRA (ALL PRODUCTS)  (dextroamphetamine)

XELSTRYM (ALL PRODUCTS)  (dextroamphetamine)

ZENZEDI (ALL PRODUCTS)  (dextroamphetamine)

LISDEXAMFETAMINES

VYVANSE (ALL PRODUCTS)  (lisdexamfetamine)

METHAMPHETAMINES

DESOXYN (ALL PRODUCTS)  (methamphetamine)

METHYLPHENIDATES

ADHANSIA (ALL PRODUCTS)  (methylphenidate)

APTENSIO (ALL PRODUCTS)  (methylphenidate)

CONCERTA (ALL PRODUCTS)  (methylphenidate)

COTEMPLA (ALL PRODUCTS)  (methylphenidate)

DAYTRANA (ALL PRODUCTS)  (methylphenidate)

JORNAY (ALL PRODUCTS)  (methylphenidate)

METHYLIN (ALL PRODUCTS)  (methylphenidate)

methylphenidate (ALL PRODUCTS)

QUILLICHEW (ALL PRODUCTS)  (methylphenidate)

QUILLIVANT (ALL PRODUCTS)  (methylphenidate)

RELEXXII (ALL PRODUCTS)  (methylphenidate)

RITALIN (ALL PRODUCTS)  (methylphenidate)

SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITORS

QELBREE (ALL PRODUCTS)  (viloxazine)

STRATTERA (ALL PRODUCTS)  (atomoxetine)

Policy:

FDA-approved Indications
Adderall
Adderall is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Adderall XR, Daytrana, Focalin, Focalin XR, QuilliChew ER, Quillivant XR, Strattera
These products are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Adhansia XR, Adzenys ER, Adzenys XR-ODT, Azstarys, Dyanavel XR, Jornay PM
These products are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. 

Aptensio XR
Aptensio XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
Limitations of Use
Pediatric patients younger than 6 years of age experienced higher plasma exposure than patients 6 years and older at the same dose and high rates of adverse reactions, most notably weight loss.

Concerta
Concerta is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.

Cotempla XR-ODT
Cotempla XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Desoxyn
Attention Deficit Disorder with Hyperactivity: Desoxyn tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

Dexedrine Spansule
Dexedrine is indicated in:
Narcolepsy
Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome.

Dextroamphetamine Tablets, ProCentra, Zenzedi
These products are indicated for:
Narcolepsy
Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

Evekeo
Evekeo is indicated for:
Narcolepsy
Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.
Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines should be weighed against possible risks inherent in use of the drug.

Evekeo ODT
Evekeo ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Methylin Oral Solution, Methylphenidate, Methylphenidate Extended-Release, Ritalin/Ritalin SR
These products are indicated for the treatment of:
Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults. 
Narcolepsy

Methylphenidate CD Capsules
Methylphenidate hydrochloride extended release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.

Methylphenidate Chewable Tablets
Attention Deficit Disorders
Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.
Narcolepsy

Methylphenidate Osmotic Extended-Release, Relexxii
These products are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older.

Mydayis
Mydayis is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older.
Limitations of Use
Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite.

Qelbree
Qelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.

Ritalin LA
Ritalin LA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age.

Vyvanse
Vyvanse is indicated for the treatment of:
    •    Attention Deficit Hyperactivity Disorder (ADHD) in adults and
         pediatric patients 6 years and older
    •    Moderate to Severe Binge-Eating Disorder (BED) in adults
Limitations of Use
Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older.
Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

Xelstrym
Xelstrym is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Limitations of Use
Pediatric patients younger than 6 years of age experienced more long-term weight loss than patients 6 years and older.

 

LIMIT CRITERIA   Limits do not accumulate together, patient is allowed the   maximum limit for each drug and strength
Drug	Maximum Dose/24 hours   (ADHD only)1-40	1 Month Limit*	3 Month Limit*
Adderall (amphetamine-   dextroamphetamine)   5 mg, 7.5 mg, 10 mg, 12.5 mg	40 mg	90 tabs/25 days	270 tabs/75 days
Adderall (amphetamine-   dextroamphetamine)   15 mg, 20 mg		60 tabs/25 days	180 tabs/75 days
Adderall (amphetamine-   dextroamphetamine) 30 mg		30 tabs/25 days	90 tabs/75 days
Adderall XR (amphetamine-   dextroamphetamine extended-   release) 5 mg, 10 mg	30 mg	90 caps/25 days	270 caps/75 days
Adderall XR (amphetamine-   dextroamphetamine extended-   release)   15 mg, 20 mg, 25 mg, 30 mg		30 caps/25 days	90 caps/75 days
Adhansia XR 25 mg, 35 mg, 45 mg	100 mg	60 caps/25 days	180 caps/75 days
Adhansia XR 55 mg, 70 mg, 85 mg		30 caps/25 days	90 caps/75 days
Adzenys ER oral suspension   1.25 mg/mL	18.8 mg	450 mL/   25 days	1,350 mL/75 days
Adzenys XR-ODT 3.1 mg,   6.3 mg, 9.4 mg	18.8 mg	60 tabs/25 days	180 tabs/75 days
Adzenys XR-ODT 12.5 mg,   15.7 mg. 18.8 mg		30 tabs/   25 days	90 tabs/75 days
Aptensio XR (methylphenidate   extended-release) 10 mg, 15 mg,   20 mg, 30 mg	60 mg	60 caps/25 days	180 caps/75 days
Aptensio XR (methylphenidate   extended-release) 40 mg, 50 mg,   60 mg		30 caps/25 days	90 caps/75 days
Azstarys 26.1 mg/5.2 mg, 39.2   mg/7.8 mg, 52.3 mg/10.4 mg	52.3 mg/10.4 mg	30 caps/25 days	90 caps/75 days
Concerta (methylphenidate   osmotic extended-release) 18 mg,   27 mg, 36 mg	72 mg	60 tabs/25 days	180 tabs/75 days
Concerta (methylphenidate osmotic   extended-release) 54 mg		30 tabs/   25 days	90 tabs/75 days
Cotempla XR-ODT 8.6 mg,   17.3 mg, 25.9 mg	51.8 mg	60 tabs/25 days	180 tabs/75 days
Daytrana (methylphenidate   transdermal) Patch 10 mg, 15 mg,   20 mg, 30 mg	30 mg	30 patches/   25 days	90 patches/   75 days
Desoxyn (methamphetamine) 5 mg	25 mg	150 tabs/   25 days	450 tabs/75 days
Dexedrine Spansule   (dextroamphetamine sustained-   release) 5 mg, 10 mg	40 mg	120 caps/   25 days	360 caps/75 days
Dexedrine Spansule   (dextroamphetamine sustained-   release) 15 mg		60 caps/25 days	180 caps/75 days
Dextroamphetamine 5 mg, 10 mg	40 mg	120 tabs/   25 days	360 tabs/75 days
Dyanavel XR oral suspension   2.5 mg/mL	20 mg	240 mL/   25 days	720 mL/75 days
Dyanavel XR tablets 5 mg, 10 mg		60 tabs/25 days	180 tabs/75 days
Dyanavel XR tablets 15 mg, 20 mg		30 tabs/25 days	90 tabs/75 days
Evekeo (amphetamine)   5 mg, 10 mg	40 mg	120 tabs/   25 days	360 tabs/75 days
Evekeo ODT 5 mg, 10 mg	40 mg	120 tabs/   25 days	360 tabs/75 days
Evekeo ODT 15 mg, 20 mg		60 tabs/25 days	180 tabs/75 days
Focalin (dexmethylphenidate)   2.5 mg, 5 mg	20 mg	120 tabs/   25 days	360 tabs/75 days
Focalin (dexmethylphenidate)   10 mg		60 tabs/25 days	180 tabs/75 days
Focalin XR (dexmethylphenidate   extended-release) 5 mg, 10 mg,   15 mg, 20 mg	40 mg	60 caps/25 days	180 caps/75 days
Focalin XR (dexmethylphenidate   extended-release) 25 mg, 30 mg,   35 mg, 40 mg		30 caps/25 days	90 caps/75 days
Jornay PM 20 mg, 40 mg	100 mg	60 caps/25 days	180 caps/75 days
Jornay PM 60 mg, 80 mg, 100 mg		30 caps/25 days	90 caps/75 days
Methylin (methylphenidate)   oral solution 5 mg/5 mL	60 mg	1,800 mL/   25 days	5,400 mL/75 days
Methylin (methylphenidate)   oral solution 10 mg/5 mL		900 mL/25 days	2,700 mL/75 days
Methylphenidate chewable tablets   2.5 mg, 5 mg, 10 mg	60 mg	180 tabs/   25 days	540 tabs/75 days
Methylphenidate extended-release   10 mg, 20 mg	60 mg	90 tabs/25 days	270 tabs/75 days
Methylphenidate extended-release   (CD) 10 mg, 20 mg, 30 mg	60 mg	60 caps/25 days	180 caps/75 days
Methylphenidate extended-release   (CD) 40 mg, 50 mg, 60 mg		30 caps/25 days	90 caps/75 days
Methylphenidate Osmotic   Extended-Release   45 mg, 63 mg, 72 mg	72 mg	30 tabs/25 days	90 tabs/75 days
Mydayis 12.5 mg, 25 mg	50 mg	60 caps/25 days	180 caps/75 days
Mydayis 37.5 mg, 50 mg		30 caps/25 days	90 caps/75 days
ProCentra (dextroamphetamine)   oral solution 5 mg/5 mL	40 mg	1,200 mL/   25 days	3,600 mL/75 days
Qelbree 100 mg, 150 mg, 200 mg	600 mg	90 caps/25 days	270 caps/75 days
QuilliChew ER 20 mg, 30 mg	60 mg	60 tabs/25 day	180 tabs/75 days
QuilliChew ER 40 mg		30 tabs/25 days	90 tabs/75 days
Quillivant XR oral suspension   25 mg/5 mL (5 mg/mL)	60 mg	360 mL/   25 days	1,080 mL/75 days
Relexxii 18 mg, 27 mg, 36 mg	72 mg	60 tabs/25 days	180 tabs/75 days
Relexxii 45 mg, 54 mg, 63 mg,   72 mg		30 tabs/25 days	90 tabs/75 days
Ritalin (methylphenidate)   5 mg, 10 mg	60 mg	180 tabs/   25 days	540 tabs/75 days
Ritalin (methylphenidate) 20 mg		90 tabs/   25 days	270 tabs/75 days
Ritalin LA (methylphenidate   extended-release (LA))   10 mg, 20 mg, 30 mg	60 mg	60 caps/25 days	180 caps/75 days
Ritalin LA (methylphenidate   extended-release (LA)) 40 mg,   60 mg		30 caps/25 days	90 caps/75 days
Strattera (atomoxetine)   10 mg, 18 mg, 25 mg	100 mg	120 caps/   25 days	360 caps/75 days
Strattera (atomoxetine)   40 mg		60 caps/25 days	180 caps/75 days
Strattera (atomoxetine) 60 mg,   80 mg, 100 mg		30 caps/25 days	90 caps/75 days
Vyvanse 10 mg, 20 mg, 30 mg	70 mg	60 units/25 days	180 units/75 days
Vyvanse 40 mg, 50 mg,   60 mg, 70 mg		30 units/25 days	90 units/75 days
Xelstrym 4.5 mg, 9 mg,   13.5 mg, 18 mg	18 mg	30 transdermal   systems/25 days	90 transdermal   systems/75 days
Zenzedi (dextroamphetamine)   2.5 mg, 5 mg, 7.5 mg, 10 mg	40 mg	120 tabs/   25 days	360 tabs/75 days
Zenzedi (dextroamphetamine)   15 mg, 20 mg		60 tabs/25 days	180 tabs/75 days
Zenzedi (dextroamphetamine)   30 mg		30 tabs/25 days	90 tabs/75 days
*The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow   time for refill processing.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Adderall [package insert]. Parsippany, NJ: Teva Pharmaceuticals; February 2022.
2. Adderall XR [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; February 2022.
3. Adhansia XR [package insert]. Stamford, CT: Adlon Therapeutics L.P.; June 2021.
4. Adzenys ER [package insert]. Grand Prairie, TX: Neos Therapeutics Brands, LLC.; September 2017.
5. Adzenys XR-ODT [package insert]. Grand Prairie, TX: Neos Therapeutics Brands, LLC.; February 2022.
6. Aptensio XR [package insert]. Coventry, RI: Rhodes Pharmaceuticals L.P.; June 2021.
7. Azstarys [package insert]. Grand Rapids, MI: Corium, Inc.; June 2021.
8. Concerta [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; April 2022.
9. Cotempla XR-ODT [package insert]. Grand Prairie, TX: Neos Therapeutics Brands, LLC.; June 2021.
10. Daytrana [package insert]. Miami, FL: Noven Therapeutics, LLC; June 2021.
11. Desoxyn [package insert]. Flowood, MS: Key Therapeutics, LLC.; July
12. Dexedrine Spansule [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; January 2022.
13. Dextroamphetamine sulfate [package insert]. Monmouth Junction, NJ: Tris Pharma, Inc.; August 2022.
14. Dyanavel XR [package insert]. Monmouth Junction, NJ: NextWave Pharmaceuticals, Inc.; May 2022.
15. Evekeo [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; January 2022.
16. Evekeo ODT [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; September 2022.
17. Focalin [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2021.
18. Focalin XR [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2021.
19. Jornay PM [package insert]. Morrisville, NC: Ironshore Pharmaceuticals Inc.; June 2021.
20. Methylphenidate Hydrochloride (CD) [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; May 2022.
21. Methylin Solution [package insert]. Florham Park, NJ: Shionogi Inc.; July 2021.
22. Methylphenidate Hydrochloride Chewable Tablets [package insert]. Lawrenceville, GA: XLCare Pharmaceuticals, Inc.; August 2021.
23. Methylphenidate IR Tablet [package insert]. Somerset, NJ: Solco Healthcare US, LLC; May 2022.
24. Methylphenidate ER Tablet [package insert]. Newtown, PA: KVK-Tech, Inc.; April 2021.
25. Methylphenidate Osmotic Extended Release [package insert]. Alpharetta, GA: Trigen Laboratories, LLC; June 2022.
26. Mydayis [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; August 2020.
27. ProCentra [package insert]. Newport, KY: Independence Pharmaceuticals, LLC; December 2021.
28. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; April 2022.
29. QuilliChew ER [package insert]. Monmouth Junction, NJ: NextWave Pharmaceuticals, Inc.; June 2021.
30. Quillivant XR [package insert]. Monmouth Junction, NJ: NextWave Pharmaceuticals, Inc.; June 2021.
31. Relexxii [package insert]. Alpharetta, GA: Vertical Pharmaceuticals, LLC; June 2022.
32. Ritalin/Ritalin SR [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2021.
33. Ritalin LA [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2021.
34. Strattera [package insert]. Indianapolis, IN: Lilly USA, LLC; January 2022.
35. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; October
36. Xelstrym [package insert]. Miami, FL: Noven Therapeutics, Inc.; March 2022.
37. Zenzedi [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; January 2022.
38. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed September 29, 2022.
39. Lexicomp Online, Lexi-Drugs Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed September 29, 2022.
40. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed September 29, 2022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 23, 2023