Table 31: Cerebral Stimulants and Miscellaneous Agents
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Central Nervous System (CNS)
Medication Class/Individual Agents: Cerebral Stimulant
I. Prior-Authorization Requirements
Cerebral Stimulants and Miscellaneous Agents – Long-Acting Amphetamine Agents |
Clinical Notes |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
Concurrent therapy with long-acting agents will require PA for quantities > two units/day (all agents combined). Concurrent therapy with a short- or intermediate-acting agent and a long-acting agent will also require PA for quantities > three units/day (all agents combined). Cerebral stimulant solutions will require PA for quantities > 40 mL/day (all agents combined). Individual drug quantity limits may also apply (see reference table below for individual drug quantity limits and dose consolidation options). FDA-approved indications:
Approved medications for ADHD according to age:
Approved medications for narcolepsy:
Precautionary use in:
The American Academy of Pediatrics (AAP) suggests evidence is particularly strong for stimulant medications for elementary and school-aged children and adolescents. Adjunctive therapies (guanfacine extended-release and clonidine extended-release 0.1 mg tablet) may be considered if stimulant therapy is not fully effective or limited by side effects. Atomoxetine has also demonstrated efficacy in reducing core symptoms among school-aged children and adolescents (AAP, 2019). |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cerebral Stimulants and Miscellaneous Agents – Long-Acting Methylphenidate Agents |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cerebral Stimulants and Miscellaneous Agents – Not Otherwise Classified |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cerebral Stimulants and Miscellaneous Agents – Short-and Intermediate-Acting Agents |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
# | This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent. |
BP | Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent. |
A90 | Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply. |
II. Therapeutic Uses
FDA-approved, for example:
- Attention Deficit Hyperactivity Disorder (ADHD)
- Narcolepsy
- Binge-eating disorder (lisdexamfetamine)
Non-FDA-approved, for example:
- Autism spectrum disorder
- Binge-eating disorder (all other cerebral stimulant agents)
- Depressive condition (as adjunctive treatment)
- Excessive sleepiness or fatigue associated with a chronic medical condition such as: cancer-related fatigue, multiple sclerosis, Parkinson's disease
- Sleep disorder (hypersomnia, obstructive sleep apnea, shift work disorder)
- Traumatic brain injury
Note: The above lists may not include all FDA-approved and non-FDA approved indications.
III. Evaluation Criteria for Approval
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
- All PA requests must include clinical diagnosis, drug name, dose, and frequency for all stimulants prescribed.
- Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
- A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
- For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
- Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
All requests for cerebral stimulants at quantities above established quantity limits (per day)
- Documentation of the following is required:
- individual drug PA criteria must be met first where applicable; and
- medical necessity for an increased dosage that results in requiring quantities that exceed the determined limits (see reference table below for individual drug quantity limits and dose consolidation options)
All requests for cerebral stimulant in members ≥ 21 years of age (new to therapy)
- Documentation of the following is required:
- individual drug PA criteria must be met first where applicable; and
- individual drug quantity limits must be met first where applicable; and
- clinically appropriate diagnosis including:
- ADHD; or
- autism spectrum disorder; or
- binge eating disorder; or
- depressive condition (as adjunctive treatment); or
- excessive sleepiness or fatigue associated with a chronic medical condition such as: cancer-related fatigue, multiple sclerosis, Parkinson's disease; or
- narcolepsy; or
- sleep disorder (hypersomnia, obstructive sleep apnea, shift work disorder); or
- traumatic brain injury.
Please note, three-month provisional approval may be allowed for members who were stabilized on the requested medication during a recent hospitalization.
SmartPA: Claims for amphetamine salts, amphetamine salts ER, Daytrana, dextroamphetamine (5 mg and 10 mg tablet, 5 mg, 10 mg, and 15 mg capsule, or solution), dexmethylphenidate, dexmethylphenidate ER, lisdexamfetamine capsule, methylphenidate (Ritalin), methylphenidate ER (Concerta), methylphenidate oral solution, methylphenidate SR, methylphenidate chewable tablet within quantity limits will usually process at the pharmacy without a PA request if the member is ≥ 21 years of age and has a history of a paid MassHealth pharmacy claims for a CNS stimulant within the last 90 days, or if the member is ≥ 21 years of age and has an appropriate diagnosis in history.†
Adzenys XR-ODT, amphetamine extended-release 1.25 mg/mL oral suspension, amphetamine salts extended-release (generic Mydayis), Dyanavel XR, lisdexamfetamine chewable tablet, Xelstrym
- Documentation of all of the following is required:
- appropriate diagnosis; and
- for amphetamine salts extended-release (generic Mydayis), member is ≥ 13 years of age; and
- clinical rationale for use of the requested agent instead of amphetamine salts extended-release (generic Adderall XR); and
- clinical rationale for use of the requested agent instead of lisdexamfetamine capsule; and
- for Dyanavel XR suspension, one of the following:
- requested quantity is ≤8 mL (20 mg)/day; or
- clinical rationale for exceeding the FDA approved maximum dose.
amphetamine sulfate
- Documentation of the following is required for diagnosis of ADHD:
- appropriate diagnosis; and
- one of the following:
- inadequate response (defined as ≥ seven days of therapy) or adverse reaction to one amphetamine immediate-release product available without PA; or
- clinical rationale for use of the requested agent instead of amphetamine immediate-release products available without PA.
- Documentation of the following is required for diagnosis of narcolepsy:
- appropriate diagnosis; and
- medical records documenting the results of the sleep study used to confirm narcolepsy [polysomnogram (PSG) or Multiple Sleep Latency Test (MSLT)]; and
- one of the following:
- inadequate response (defined as ≥ seven days of therapy) or adverse reaction to one amphetamine immediate-release product available without PA; or
- clinical rationale for use of the requested agent instead of amphetamine immediate-release products available without PA.
Azstarys, Cotempla XR-ODT, Jornay PM, methylphenidate extended-release (generic Aptensio XR, Ritalin LA), methylphenidate extended-release CD, Quillichew ER, Quillivant XR
- Documentation of the following is required:
- appropriate diagnosis; and
- clinical rationale for use of the requested agent instead of dexmethylphenidate extended-release; and
- clinical rationale for use of the requested agent instead of methylphenidate transdermal; and
- one of the following:
- medical necessity for requested formulation instead of solid oral formulations as noted by one of the following:
- member utilizes tube feeding (G-tube/J-tube); or
- member has a swallowing disorder or condition affecting ability to swallow; or
- member is < 13 years of age; or
- clinical rationale for use of the requested agent instead of methylphenidate extended-release (generic Concerta); and
- medical necessity for requested formulation instead of solid oral formulations as noted by one of the following:
- for Quillivant XR, one of the following:
- requested quantity is ≤ 12 mL (60 mg)/day; or
- clinical rationale for exceeding the FDA approved maximum dose.
Please note, six-month provisional approval may be allowed for members who are stabilized on the requested medication and there is severe risk of harm.
clonidine extended-release 0.1 mg tablet exceeding quantity limits
- Documentation of the following is required:
- individual drug PA criteria must be met first where applicable; and
- medical necessity for an increased dosage that results in requiring quantities that exceed the determined limits
dextroamphetamine 2.5 mg, 7.5 mg, 15 mg, 20 mg, 30 mg tablet
- Documentation of the following is required:
- appropriate diagnosis; and
- medical necessity for requested strength instead of dextroamphetamine 5 mg and 10 mg tablets available without PA.
Evekeo ODT
- Documentation of the following is required:
- appropriate diagnosis; and
- medical necessity for requested formulation instead of solid oral formulations as noted by one of the following:
- member utilizes tube feeding (G-tube/J-tube); or
- member has a swallowing disorder or condition affecting ability to swallow; or
- member is < 13 years of age.
methamphetamine
- Documentation of the following is required:
- diagnosis of ADHD; and
- medical records documenting an inadequate response (defined as ≥ seven days of therapy) or adverse reaction to all other stimulant and non-stimulant medications.
methylphenidate extended-release 72 mg tablet and Relexxii
- Documentation of the following is required:
- appropriate diagnosis; and
- for the 45 mg, 63 mg and 72 mg tablets, clinical rationale for use of the requested agent instead of all of the following:
- two methylphenidate extended-release (generic Concerta) tablets to achieve the requested dose (i.e., 27 mg and 18 mg, 27 mg and 36 mg, or 36 mg and 36 mg); and
- dexmethylphenidate extended-release; and
- methylphenidate transdermal; and
- for the 18 mg, 27 mg, 36 mg, and 54 mg tablets clinical rationale for use of the requested agent instead of all of the following:
- dexmethylphenidate extended-release; and
- methylphenidate extended-release tablets (generic Concerta); and
- methylphenidate transdermal.
Qelbree
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ six years of age; and
- inadequate response (defined as ≥ seven days of therapy), adverse reaction, or contraindication to atomoxetine; and
- appropriate dosing; and
- one of the following:
- for members < 18 years of age, one of the following:
- for 100 mg capsule, requested quantity is ≤ one unit/day; or
- for 150 mg and 200 mg capsule, requested quantity is ≤ two units/day; or
- for members ≥ 18 years of age, one of the following:
- for 100 mg capsule, requested quantity is ≤ one unit/day; or
- for 150 mg and 200 mg capsule, requested quantity is ≤ three units/day.
- for members < 18 years of age, one of the following:
In addition to individual drug PA criteria where applicable, some behavioral health medications are subject to additional polypharmacy and age limit restrictions. Please note, one-month provisional approval may be allowed for members who are stabilized on the requested medication to avoid risk of destabilization.
Behavioral Health Medication Polypharmacy (pharmacy claims for any combination of four or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, armodafinil, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, donepezil, hypnotic agents, memantine, modafinil, mood stabilizers (agents considered to be used only for seizure diagnoses are not included), naltrexone, and viloxazine] within a 45-day period) for members < 18 years of age
- For all requests, individual drug PA criteria must be met first where applicable.
- For regimens including ≤ two mood stabilizers (also includes regimens that do not include a mood stabilizer), documentation of the following is required:
- one of the following:
- member had a recent psychiatric hospitalization (within the last three months); or
- member has a history of severe risk of harm to self or others; or
- all of the following:
- appropriate diagnoses; and
- treatment plan including names of current behavioral health medications and corresponding diagnoses; and
- prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.
- one of the following:
- For regimens including ≥ three mood stabilizers, documentation of the following is required:
- one of the following:
- member had a recent psychiatric hospitalization (within the last three months); or
- member has a history of severe risk of harm to self or others; or
- all of the following:
- appropriate diagnoses; and
- treatment plan including names of current behavioral health medications and corresponding diagnoses; and
- prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
- one of the following:
- member has a seizure diagnosis only; or
- member has an appropriate psychiatric diagnosis, with or without seizure diagnosis, and one of the following:
- cross-titration/taper of mood stabilizer therapy; or
- inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate; or
- member has a diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis, and that other clinically appropriate therapies have been tried and failed; therefore, multiple mood stabilizers are needed; or
- member has psychiatric and comorbid diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis, and that other clinically relevant therapies have been tried and failed; therefore, multiple mood stabilizers are needed, and one of the following:
- cross-titration/taper of mood stabilizer therapy; or
- inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate.
- one of the following:
Cerebral Stimulant Polypharmacy (overlapping pharmacy claims for 2 or more cerebral stimulants [immediate-release and extended-release formulations of the same chemical entity are not included in this restriction and are counted as one cerebral stimulant agent] for at least 60 days within a 90-day period) for members < 18 years of age
- For all requests, individual drug PA criteria must be met first where applicable.
- Documentation of the following is required:
- one of the following:
- member had a recent psychiatric hospitalization (within the last three months); or
- member has a history of severe risk of harm to self or others; or
- all of the following:
- appropriate diagnosis; and
- treatment plan including names of current cerebral stimulants and corresponding diagnoses; and
- inadequate response (defined as > seven days of therapy), adverse reaction, or contraindication to monotherapy trial with a methylphenidate product; and
- inadequate response (defined as > seven days of therapy), adverse reaction, or contraindication to monotherapy trial with an amphetamine product; and
- clinical rationale for cerebral stimulant polypharmacy.
- one of the following:
Alpha2 Agonist or Cerebral Stimulant for members < three years of age
- For all requests, individual drug PA criteria must be met first where applicable.
- Documentation of the following is required:
- one of the following:
- member had a recent psychiatric hospitalization (within the last three months); or
- member has a history of severe risk of harm to self or others; or
- for an alpha2 agonist and member has a cardiovascular diagnosis only; or
- all of the following:
- appropriate diagnosis; and
- treatment plan including names of current alpha2 agonist(s) and cerebral stimulant(s) and corresponding diagnoses; and
- clinical rationale for use of alpha2 agonist or cerebral stimulant in member < three years of age.
- one of the following:
atomoxetine or viloxazine for members < six years of age
- Documentation of the following is required:
- one of the following:
- member had a recent psychiatric hospitalization (within the last three months); or
- member has a history of severe risk of harm to self or others; or
- all of the following:
- appropriate diagnosis; and
- treatment plan including names of current behavioral health medications and corresponding diagnoses; and
- if member is < three years of age, prescriber is a specialist (e.g. psychiatrist) or consult is provided.
- one of the following:
Reference Table:
Please note in addition to individual drug quantity limits, concurrent therapy quantity limits may also apply.
Drug Name |
Availability |
Individual Drug Quantity Limits |
Short- and Intermediate-Acting Agents |
||
amphetamine sulfate |
Tablet: 5, 10 mg |
Three units/day |
amphetamine sulfate (Evekeo ODT) |
Tablet: 5, 10, 15, 20 mg |
Three units/day |
dexmethylphenidate (Focalin) |
Tablet: 2.5, 5, 10 mg |
Three units/day |
dextroamphetamine |
Tablet: 2.5, 5, 7.5, 10, 15, 20, 30 mg |
Three units/day |
dextroamphetamine (Dexedrine Spansule) |
Capsule: 5, 10, 15 mg |
Three units/day |
dextroamphetamine oral solution |
Solution: 5 mg/5 mL |
40 mL/day |
methamphetamine (Desoxyn) |
Tablet: 5 mg |
N/A |
methylphenidate chewable tablet |
Chewable Tablet: 2.5, 5, 10 mg |
Three units/day |
methylphenidate sustained-release tablet |
Tablet: 10, 20 mg |
Three units/day |
methylphenidate (Ritalin) |
Tablet: 5, 10, 20 mg |
Three units/day |
methylphenidate oral solution (Methylin) |
Solution: 5 mg/5 mL, 10 mg/5 mL |
30 mL/day |
mixed amphetamine salts (Adderall) |
Tablet: 5, 7.5, 10, 12.5, 15, 20, 30 mg |
Three units/day |
Long-Acting Agents |
||
amphetamine (Adzenys XR-ODT) |
Tablet: 3.1, 6.3, 9.4, 12.5, 15.7, 18.8 mg |
One unit/day |
amphetamine (Dyanavel XR) |
Suspension: 2.5 mg/mL |
8 mL/day |
amphetamine (Dyanavel XR) |
Tablet: 5, 10, 15, 20 mg |
One unit/day |
dexmethylphenidate (Focalin XR) |
Capsule: 5,10, 15, 20, 25, 30, 35, 40 mg |
Two units/day |
dextroamphetamine (Xelstrym) |
Patch: 4.5, 9, 13.5, 18 mg |
One unit/day |
lisdexamfetamine (Vyvanse) |
Capsule: 10, 20, 30, 40, 50, 60, 70 mg Chewable Tablet: 10, 20, 30, 40, 50, 60 mg |
Two units/day |
methylphenidate (Aptensio XR) |
Capsule: 10, 15, 20, 30, 40, 50, 60 mg |
One unit/day |
methylphenidate (Concerta) |
Tablet: 18, 27, 36, 54 mg |
Two units/day |
methylphenidate |
Tablet: 72 mg |
One unit/day |
methylphenidate, CD |
Capsule: 10, 20, 30, 40, 50, 60 mg |
Two units/day |
methylphenidate (Jornay PM) |
Capsule: 20, 40, 60, 80, 100 mg |
One unit/day |
methylphenidate (Cotempla XR-ODT) |
Tablet: 8.6, 17.3, 25.9 mg |
One unit/day |
methylphenidate (Quillichew ER) |
Tablet: 20, 30, 40 mg |
Two units/day |
methylphenidate (Quillivant XR) |
Suspension: 25 mg/5 mL |
12 mL/day |
methylphenidate (Relexxii) |
Tablet: 45, 63 mg |
One unit/day |
methylphenidate (Ritalin LA) |
Capsule: 10, 20, 30, 40, 60 mg |
Two units/day |
methylphenidate transdermal (Daytrana) |
Patch: 10, 15, 20, 30 mg |
One unit/day |
mixed amphetamine salts (Adderall XR) |
Capsule: 5, 10, 15, 20, 25, 30 mg |
Two units/day |
mixed amphetamine salts (Mydayis) |
Capsule: 12.5, 25, 37.5, 50 mg |
One unit/day |
serdexmethylphenidate/dexmethylphenidate (Azstarys) |
Capsule: 26.1/5.2, 39.2/7.8, 52.3/10.4 mg |
One unit/day |
† Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.
Original Effective Date: 04/2006
Last Revised Date: 03/2024
Clinical Criteria Main Page | Back to top | Previous | Next
Last updated 08/12/24