FDA-approved, for example:

• bipolar disorder
• fibromyalgia
• migraine prophylaxis
• neuropathic pain associated with diabetic peripheral neuropathy
• postherpetic neuralgia
• seizure disorder(s) including Dravet syndrome, treatment-resistant epilepsy associated with tuberous sclerosis complex (TSC), infantile spasms, Lennox-Gastaut syndrome (LGS), partial seizures, and primary generalized tonic-clonic seizures

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

• All PA requests must include clinical diagnosis, drug name, dose, and frequency. 
• 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).

Afinitor Disperz and everolimus 2.5 mg, 5 mg, 7.5 mg, 10 mg

• Documentation of the following is required: 
  • diagnosis of treatment-resistant epilepsy associated with tuberous sclerosis complex (TSC); and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • an inadequate response to combination therapy with at least two anticonvulsants or contraindication to all other anticonvulsants; and
  • requested agent will be used as adjunctive therapy with at least one anticonvulsant agent; and
  • requested quantity is ≤ 30 units/30 days.

Aptiom

• Documentation of the following is required: 
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ four years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • an inadequate response or adverse reaction to any two anticonvulsants.

SmartPA: Claims for Aptiom will usually process at the pharmacy without a PA request if the member is ≥ four years of age, has a history of MassHealth medical claims for epilepsy/seizures, the prescriber is a neurologist, and the member has a history of paid MassHealth pharmacy claims for any two anticonvulsants. Claims for Aptiom will also usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent and if the member has a history of MassHealth medical claims for epilepsy/seizures.^†

Briviact

• Documentation of the following is required:
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ four years of age; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • an inadequate response or adverse reaction to any two anticonvulsants; and
  • if the request is for the tablet formulation, requested quantity is ≤ two tablets/day.

SmartPA: Claims for Briviact (within the quantity limit of two tablets/day for the tablet formulation) will usually process at the pharmacy without a PA request if the member is ≥ four years of age, has a history of MassHealth medical claims for epilepsy/seizures, the prescriber is a neurologist, and if the member has a history of paid MassHealth pharmacy claims for any two anticonvulsants. Claims for Briviact (within the quantity limit of two tablets/day for the tablet formulation) will also usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent and if the member has a history of MassHealth medical claims for epilepsy/seizures.^†

clobazam suspension, tablet, and Sympazan

• Documentation of the following is required:
  • diagnosis of Lennox-Gastaut Syndrome, epilepsy, or a seizure disorder; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • member is ≥ two years of age; and
  • for requests for Sympazan, medical necessity for this branded film formulation instead of clobazam tablets and suspension; and
  • one of the following:
    • for the diagnosis of Lennox-Gastaut Syndrome, an inadequate response, adverse reaction, or contraindication to two of the following anticonvulsants: divalproex/valproic acid, felbamate, lamotrigine, or topiramate; or
    • for the diagnosis of epilepsy or a seizure disorder, an inadequate response or adverse reaction to any two anticonvulsants.

Diacomit

• Documentation of the following is required:
  • diagnosis of Dravet syndrome; and
  • member is ≥ two years of age; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • requested medication will be used in combination with clobazam; and
  • an inadequate response or adverse reaction to one of the following anticonvulsants, or a contraindication to all of the following anticonvulsants: clonazepam, divalproex/valproic acid, ethosuximide, levetiracetam, phenobarbital, topiramate, and zonisamide.

Epidiolex

• Documentation of the following is required for the diagnosis of Dravet syndrome:
  • medical records supporting the diagnosis of Dravet syndrome; and
  • member is ≥ two years of age; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • an inadequate response or adverse reaction to two of the following anticonvulsants, or a contraindication to all of the following anticonvulsants: clobazam, clonazepam, divalproex/valproic acid, ethosuximide, levetiracetam, phenobarbital, stiripentol, topiramate, and zonisamide.
• Documentation of the following is required for the diagnosis of Lennox-Gastaut syndrome:
  • medical records supporting the diagnosis of Lennox-Gastaut syndrome; and
  • member is ≥ two years of age; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • an inadequate response or adverse reaction to two of the following anticonvulsants, or a contraindication to all of the following anticonvulsants: clobazam, divalproex/valproic acid, felbamate, lamotrigine, and topiramate.
• Documentation of the following is required for the diagnosis of seizures associated with tuberous scleroris complex (TSC)
  • member is ≥ two years of age; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy.

Equetro

• Documentation of the following is required for the diagnosis of bipolar disorder:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a psychiatrist or consult notes from a psychiatry office are provided; and
  • medical necessity for this branded extended-release formulation instead of carbamazepine extended-release capsules.
• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • one of the following:
    • member has been stabilized on carbamazepine (any form); or
    • an inadequate response or adverse reaction to any two anticonvulsants; and
  • medical necessity for this branded extended-release formulation instead of carbamazepine extended-release capsules.
• Documentation of the following is required for the diagnosis of pain associated with trigeminal neuralgia:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • medical necessity for this branded extended-release formulation instead of carbamazepine extended-release capsules.

SmartPA: Claims for Equetro will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent and if the member has a history of MassHealth medical claims for epilepsy/seizures or bipolar disorder.^†

Fintepla

• Documentation of the following is required:
  • diagnosis of Dravet syndrome; and
  • member is ≥ two years of age; and
  • prescriber is a neurologist or consult notes from neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • an inadequate response or adverse reaction to two of the following anticonvulsants, or a contraindication to all of the following anticonvulsants: clobazam, clonazepam, divalproex/valproic acid, ethosuximide, levetiracetam, phenobarbital, stiripentol, topiramate, and zonisamide; and
  • one of the following:
    • if not used in combination with stiripentol, requested dose does not exceed 11.9 mL/day (26 mg/day); or
    • if used in combination with stiripentol, requested dose does not exceed 7.8 mL/day (17 mg/day).

Fycompa

• Documentation of the following is required: 
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ four years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • an inadequate response or adverse reaction to any two anticonvulsants.

SmartPA: Claims for Fycompa will usually process at the pharmacy without a PA request if the member is ≥ four years of age, has a history of MassHealth medical claims for epilepsy/seizures, the prescriber is a neurologist, and the member has a history of paid MassHealth pharmacy claims for any two anticonvulsants. Claims for Fycompa will also usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent and if the member has a history of MassHealth medical claims for epilepsy/seizures.^†

Lamictal XR starter kit and lamotrigine extended-release

• Documentation of the following is required for the diagnosis of bipolar disorder:
  • appropriate diagnosis; and
  • prescriber is a psychiatrist or consult notes from a psychiatry office are provided; and
  • medical necessity for the extended-release formulation instead of the immediate-release formulation. 
• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical necessity for the extended-release formulation instead of the immediate-release formulation.

lamotrigine tablet starter kit

• Documentation of the following is required for the diagnosis of bipolar disorder:
  • appropriate diagnosis; and
  • prescriber is a psychiatrist or consult notes from a psychiatry office are provided.
• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided.

lamotrigine ODT and lamotrigine ODT starter kit 

• Documentation of the following is required for the diagnosis of bipolar disorder:
  • appropriate diagnosis; and
  • prescriber is a psychiatrist or consult notes from a psychiatry office are provided; and
  • medical condition in which the member is not able to swallow pills; and
  • an inadequate response or adverse reaction to lamotrigine dispersible tablets. 
• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical condition in which the member is not able to swallow pills; and
  • an inadequate response or adverse reaction to lamotrigine dispersible tablets.

lamotrigine powder

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

Oxtellar XR

• Documentation of the following is required:
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ six years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • medical necessity for this branded extended-release formulation instead of oxcarbazepine tablets and suspension; and
  • one of the following:
    • member has been stabilized on oxcarbazepine (any form); or
    • an inadequate response or adverse reaction to any two anticonvulsants.

pregabalin

• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • an inadequate response or adverse reaction to any two anticonvulsants.
• Documentation of the following is required for the diagnosis of diabetic peripheral neuropathy or postherpetic neuralgia:
  • appropriate diagnosis; and
  • an inadequate response (defined as at least four weeks of therapy) or adverse reaction to one of the following or contraindication to all of the following:
    • tricyclic antidepressant; or
    • duloxetine; or
    • lidocaine patch; or
    • venlafaxine; and
  • an inadequate response (defined as two weeks of therapy with a minimum dose of 1,200 mg/day), adverse reaction, or contraindication to gabapentin.
• Documentation of the following is required for the diagnosis of fibromyalgia:
  • appropriate diagnosis; and
  • an inadequate response (defined as at least four weeks of therapy) or adverse reaction to one of the following or contraindication to all of the following:
    • tricyclic antidepressants; or 
    • cyclobenzaprine; or 
    • SSRI; or
    • SNRI; and
  • an inadequate response (defined as two weeks of therapy with a minimum dose of 1,200 mg/day), adverse reaction, or contraindication to gabapentin.

rufinamide

• Documentation of the following is required:
  • diagnosis of Lennox-Gastaut Syndrome, epilepsy, or a seizure disorder; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • one of the following:
    • for the diagnosis of Lennox-Gastaut Syndrome, member will be using the requested agent as adjunctive therapy and an inadequate response, adverse reaction, or contraindication to two of the following anticonvulsants: divalproex/valproic acid, felbamate, lamotrigine, or topiramate; or
    • for the diagnosis of epilepsy or a seizure disorder, an inadequate response or adverse reaction to any two anticonvulsants.

SmartPA: Claims for rufinamide will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for epilepsy/seizures, the prescriber is a neurologist, and the member has a history of paid MassHealth pharmacy claims for any two anticonvulsants. Claims for rufinamide will also usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent and if the member has a history of MassHealth medical claims for epilepsy/seizures.^†  

Spritam

• Documentation of the following is required:  
  • diagnosis of myoclonic seizures, epilepsy, or a seizure disorder; and
  • medical necessity for this oral tablet for suspension formulation instead of levetiracetam solution; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • one of the following:
    • diagnosis of myoclonic seizures and member is ≥ 12 years of age; or
    • diagnosis of epilepsy or a seizure disorder and all of the following:
      • member is ≥ four years of age; and
      • one of the following:
        • member has been stabilized on levetiracetam (any form); or
        • an inadequate response or adverse reaction to any two anticonvulsants.   

tiagabine

• Documentation of the following is required:  
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ 12 years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member will be using the requested agent as adjunctive therapy; and
  • an inadequate response or adverse reaction to any two anticonvulsants.   

topiramate extended-release capsule (generic Qudexy XR)

• Documentation of the following is required for the diagnosis of Lennox-Gastaut Syndrome, epilepsy, or a seizure disorder:  
  • appropriate diagnosis; and
  • member is ≥ two years of age; and
  • medical necessity for this extended-release formulation instead of topiramate tablets; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • one of the following:
    • for the diagnosis of Lennox-Gastaut Syndrome, member will be using the requested agent as adjunctive therapy and one of the following:
      • member has been stabilized on topiramate (any form); or
      • an inadequate response, adverse reaction, or contraindication to two of the following anticonvulsants: divalproex/valproic acid, felbamate, lamotrigine, or topiramate; or
    • for the diagnosis of epilepsy or a seizure disorder, one of the following:
      • member has been stabilized on topiramate (any form); or
      • an inadequate response or adverse reaction to any two anticonvulsants.

• Documentation of the following is required for the diagnosis of migraine prophylaxis:
  • appropriate diagnosis; and
  • member is ≥ 12 years of age; and
  • medical necessity for this extended-release formulation instead of topiramate tablets; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • an inadequate response or adverse reaction to topiramate tablets; and
  • an inadequate response or adverse reaction to one of the following or contraindication to all of the following prophylactic treatments:
    • beta-blocker; or
    • calcium channel blocker; or
    • divalproex or valproic acid; or
    • tricyclic antidepressant.

SmartPA: Claims for topiramate extended-release capsule (generic Qudexy XR) will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent and if the member has a history of MassHealth medical claims for epilepsy/seizures.†

topiramate powder

• Documentation of the following is required: 
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • clinical rationale why other commercially available alternatives cannot be used.

Trokendi XR

• Documentation of the following is required for the diagnosis of Lennox-Gastaut Syndrome, epilepsy, or a seizure disorder:  
  • appropriate diagnosis; and
  • member is ≥ six years of age; and
  • medical necessity for this extended-release formulation instead of topiramate tablets; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • one of the following:
    • for the diagnosis of Lennox-Gastaut Syndrome, member will be using the requested agent as adjunctive therapy and one of the following:
      • member has been stabilized on topiramate (any form); or
      • an inadequate response, adverse reaction, or contraindication to two of the following anticonvulsants: divalproex/valproic acid, felbamate, lamotrigine, or topiramate; or
    • for the diagnosis of epilepsy or a seizure disorder, one of the following:
      • member has been stabilized on topiramate (any form); or
      • an inadequate response or adverse reaction to any two anticonvulsants.

• Documentation of the following is required for the diagnosis of migraine prophylaxis:
  • appropriate diagnosis; and
  • member is ≥ 12 years of age; and
  • medical necessity for this extended-release formulation instead of topiramate tablets; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • an inadequate response or adverse reaction to topiramate tablets; and
  • an inadequate response or adverse reaction to one of the following or contraindication to all of the following prophylactic treatments:
    • beta-blocker; or
    • calcium channel blocker; or
    • divalproex or valproic acid; or
    • tricyclic antidepressant.

SmartPA: Claims for Trokendi XR will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent and if the member has a history of MassHealth medical claims for epilepsy/seizures.†

vigabatrin

• Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member is ≥ ten years of age; and
  • member will be using the requested agent as adjunctive therapy; and
  • an inadequate response or adverse reaction to any two anticonvulsants. 
• Documentation of the following is required for the diagnosis of infantile spasms:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • member is < two years of age. 

Vimpat solution and tablet

• Documentation of the following is required:
  • diagnosis of epilepsy or a seizure disorder; and
  • member is ≥ four years of age; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • an inadequate response or adverse reaction to any two anticonvulsants.

Mood Stabilizer Polypharmacy (overlapping pharmacy claims for three or more mood stabilizers 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 for members with seizure diagnosis only:
  • appropriate diagnosis (seizure) without comorbid condition.

• Documentation of the following is required for members with psychiatric diagnoses:
  • 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 psychiatric diagnoses; and
    • treatment plan including names of current mood stabilizers and corresponding diagnoses; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; 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.

• Documentation of the following is required for members with a diagnoses in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain):
  • 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 in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain); and
    • treatment plan including names of current mood stabilizers and corresponding diagnoses; and
    • documentation that other clinically appropriate therapies have been tried and failed; therefore, multiple mood stabilizers are needed.

• Documentation of the following is required for members with a psychiatric diagnosis and comorbid diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain):
  • 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:
    • psychiatric diagnosis and diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain); and
    • treatment plan including names of current mood stabilizers and corresponding diagnoses; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; 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 three or less mood stabilizers for at least 60 days of therapy out of the last 90 days and one mood stabilizer agent is identified as being used for seizure only.^†

Mood Stabilizer for members < six years old (agents considered to be used only for seizure diagnoses are not included)

• 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
    • member has a seizure diagnosis only; or
  • all of the following:
    • appropriate diagnosis; and
    • treatment plan including names of current behavioral health medications and corresponding indications; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.

SmartPA: Claims for mood stabilizers or benzodiazepines will usually process at the pharmacy without a PA request if the member is < six years of age, has a history of MassHealth medical claims for seizure, and does not have a history of MassHealth medical claims for psychiatric diagnoses and/or other diagnoses in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain).^†