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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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

amphetamine extended-release oral suspension Adzenys ER PA  
amphetamine extended-release oral suspension Dyanavel XR PA  
amphetamine extended-release orally disintegrating tablet Adzenys XR-ODT PA  
amphetamine salts extended-release-Adderall XR Adderall XR BP PD PA   - < 3 years and PA > 60 units/month
amphetamine salts extended-release-Mydayis Mydayis PA  
lisdexamfetamine Vyvanse PD PA   - < 3 years and PA > 60 units/month

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 > 60 units/month (all agents combined). Concurrent therapy with a short- or intermediate-acting agent and a long-acting agent will also require PA for quantities > 90 units/month (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:

  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Narcolepsy

Approved medications for ADHD according to age:

  • six years old: all cerebral stimulants, atomoxetine
  • < six years old: short- and intermediate-acting mixed amphetamine salts and dextroamphetamine, atomoxetine
  • three years old: short-acting dextroamphetamine/amphetamine

Approved medications for narcolepsy:

  • Short- or intermediate-acting mixed amphetamine salts, dextroamphetamine, and methylphenidate
  • modafinil

Precautionary use in:

  • advanced arteriosclerosis, symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma, motor tics, Tourette syndrome, and seizure disorders
  • psychologically agitated states, history of drug abuse
  • MAO inhibitor use within 14 days

At least 80% of children will respond to one of the stimulants. The American Academy of Pediatrics recommends a trial of at least two different stimulants (unless contraindicated) before therapy is considered unsuccessful.

 

 Cerebral Stimulants and Miscellaneous Agents – Long-Acting Methylphenidate Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

dexmethylphenidate extended-release Focalin XR BP PD PA   - < 3 years and PA > 60 units/month
methylphenidate extended-release 72 mg tablet PA  
methylphenidate extended-release chewable tablet Quillichew ER PA  
methylphenidate extended-release oral suspension Quillivant XR PA  
methylphenidate extended-release orally disintegrating tablet Cotempla XR-ODT PA  
methylphenidate extended-release-Aptensio XR Aptensio XR PA  
methylphenidate extended-release-Concerta Concerta BP PA   - < 3 years and PA > 60 units/month
methylphenidate extended-release-Metadate CD Metadate CD PA  
methylphenidate transdermal Daytrana PA  
methylphenidate-Ritalin LA Ritalin LA PA  

 Cerebral Stimulants and Miscellaneous Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

atomoxetine Strattera # PA   - < 6 years
clonidine extended-release tablet PA  
guanfacine extended-release Intuniv # PA   - < 3 years

 Cerebral Stimulants and Miscellaneous Agents – Short-and Intermediate-Acting Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

amphetamine salts Adderall # PA   - < 3 years and PA > 90 units/month
amphetamine sulfate PA  
dexmethylphenidate Focalin # PA   - < 3 years and PA > 90 units/month
dextroamphetamine 2.5 mg, 7.5 mg, 15 mg, 20 mg, 30 mg tablet PA  
dextroamphetamine 5 mg, 10 mg tablet PA   - < 3 years and PA > 90 units/month
dextroamphetamine 5 mg, 10 mg, 15 mg capsule Dexedrine # PA   - < 3 years and PA > 90 units/month
dextroamphetamine solution PA   - < 3 years and PA > 900 mL/month
methamphetamine Desoxyn PA  
methylphenidate chewable tablet PA   - < 3 years and PA > 90 units/month
methylphenidate oral solution Methylin oral solution # PA   - < 3 years and PA > 900 mL/month
methylphenidate powder PA  
methylphenidate sustained-release tablet PA   - < 3 years and PA > 90 units/month
methylphenidate-Ritalin Ritalin # PA   - < 3 years and PA > 90 units/month
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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.
 
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Narcolepsy

Note: The above list may not include all FDA-approved indications

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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.
  • 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 requested medication (see below).

 

All requests for cerebral stimulants at quantities above established quantity limits (per month)

  • 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).

  
Adzenys ER, Adzenys XR-ODT, Dyanavel XR, Mydayis

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • for Mydayis, member must be ≥ 13 years old; and
    • clinical rationale for use of the requested agent instead of Adderall XR; and
    • clinical rationale for use of the requested agent instead of Vyvanse.

  

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 generically available immediate-release amphetamine product; or 
      • clinical rationale for use of the requested agent over generically available immediate-release amphetamine products.

 

  • 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 generically available immediate-release amphetamine product; or
      • clinical rationale for use of the requested agent over generically available immediate-release amphetamine products.

 

Aptensio XR, Cotempla XR-ODT, Daytrana, methylphenidate extended-release (generic Metadate CD, Ritalin LA), Quillichew ER, Quillivant XR

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • clinical rationale for use of the requested agent instead of Focalin XR; and
    • one of the following:
      • clinical rationale for use of the requested agent instead of Concerta; or
      • clinical rationale for requested formulation over solid oral formulations.

 

clonidine extended-release tablet

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • trial and outcome (inadequate response or adverse reaction) to immediate-release clonidine; and
    • one of the following:
      • inadequate response (defined as ≥ seven days of therapy) to one methylphenidate product and one amphetamine product; or 
      • adverse reaction to one stimulant which would be expected of either class; or
      • contraindication to stimulants; and
    • member must be ≥ six years old; and
    • requested quanity is ≤ 120 units/30 days.

  

 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 over dextroamphetamine 5 mg and 10 mg tablets.

 

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 options.

 

methylphenidate extended-release 72 mg tablet

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • clinical rationale for use of the requested agent instead of two Concerta 36 mg tablets; and
    • clinical rationale for use of the requested agent instead of Focalin XR.

   

methylphenidate powder

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why other commercially available formulations cannot be used.

 

In addition to individual drug PA criteria where applicable, some behavioral health medications are subject to additional polypharmacy and age limit restrictions.

  

Behavioral Health Medication Polypharmacy (pharmacy claims for any combination of four or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, hypnotic agents, and mood stabilizers] within a 45-day period) for members < 18 years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • For regimens including ≤ 2 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.

 

  • For regimens including ≥ 3 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 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)  and documentation 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) and documentation 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.

SmartPA: Claims will usually process at the pharmacy without a PA request if the member is < 18 years of age, has a history of MassHealth medical claims for seizure, and has a history of paid MassHealth pharmacy claims for four or less behavioral health medications within the past 60 days and one mood stabilizer agent is identified as being used for seizure only.

  

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 old

  • 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.

 

Cerebral Stimulant for members < three years old

  • 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 stimulant(s) and corresponding diagnoses; and
      • clinical rationale for use of cerebral stimulant in member < three years old.

 

atomoxetine for members < six years old

  • 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 old, prescriber is a specialist (e.g. psychiatrist) or consult is provided.

 

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

90 units/month

dexmethylphenidate (Focalin)

Tablet: 2.5, 5, 10 mg

90 units/month

dextroamphetamine

Tablet: 2.5, 5, 7.5, 10, 15, 20, 30 mg

90 units/month

dextroamphetamine (Dexedrine)

Capsule: 5, 10, 15 mg

90 units/month

dextroamphetamine oral solution

Solution: 5 mg/5 mL

900 mL/month

methamphetamine (Desoxyn)

Tablet: 5 mg

N/A

methylphenidate chewable tablet

Chewable Tablet: 2.5, 5, 10 mg

90 units/month

methylphenidate sustained-release tablet

Tablet: 10, 20 mg

90 units/month

methylphenidate (Ritalin)

Tablet: 5, 10, 20 mg

90 units/month

methylphenidate oral solution (Methylin)

Solution: 5 mg/5 mL, 10 mg/5 mL

900 mL/month

mixed amphetamine salts (Adderall)

Tablet: 5, 7.5, 10, 12.5, 15, 20, 30 mg

90 units/month

Long-Acting Agents

amphetamine (Adzenys XR-ODT)

Tablet: 3.1, 6.3, 9.4, 12.5, 15.7, 18.8 mg

30 units/month

amphetamine (Adzenys ER)

Suspension: 1.25 mg/mL

N/A

amphetamine (Dyanavel XR)

Suspension: 2.5 mg/mL

N/A

dexmethylphenidate (Focalin XR)

Capsule: 5,10, 15, 20, 25, 30, 35, 40 mg

60 units/month

lisdexamfetamine (Vyvanse)

Capsule: 10, 20, 30, 40, 50, 60, 70 mg

Chewable Tablet: 10, 20, 30, 40, 50, 60 mg

60 units/month

methylphenidate (Aptensio XR)

Capsule: 10, 15, 20, 30, 40, 50, 60 mg

30 units/month

methylphenidate (Concerta)

Tablet: 18, 27, 36, 54 mg

60 units/month

methylphenidate

Tablet: 72 mg

30 units/month

methylphenidate (Cotempla XR-ODT)

Tablet: 8.6, 17.3, 25.9 mg

30 units/month

methylphenidate (Metadate CD)

Capsule: 10, 20, 30, 40, 50, 60 mg

60 units/month

methylphenidate (Quillichew ER)

Tablet: 20, 30, 40 mg

60 units/month

methylphenidate (Quillivant XR)

Suspension: 25 mg/5 mL

N/A

methylphenidate (Ritalin LA)

Capsule: 10, 20, 30, 40, 60 mg

60 units/month

methylphenidate transdermal (Daytrana)

Patch: 10, 15, 20, 30 mg

30 units/month

mixed amphetamine salts (Adderall XR)

Capsule: 5, 10, 15, 20, 25, 30 mg

60 units/month

mixed amphetamine salts (Mydayis)

Capsule: 12.5, 25, 37.5, 50 mg

30 units/month

 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: 08/2019


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Last updated 11/18/19