FDA-approved, for example:

• Management of opioid withdrawal symptoms
• Opioid dependence

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

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.
• 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.

Brixadi

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member has been initiated on treatment with a single dose of a transmucosal buprenorphine product or is already being treated with buprenorphine; and
  • clinical rationale for use of Brixadi instead of Sublocade documented as one of the following:
    • inadequate response or adverse reaction to Sublocade that cannot be expected or managed as part of buprenorphine therapy; or
    • medical necessity for weekly dosing; or
    • documented low belly fat inhibiting proper Sublocade administration; or
    • documented low body fat with BMI below 8.5 and attestation that Sublocade administration would cause harm to the patient.

buprenorphine tablet ≤ 24 mg/day

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • clinical rationale for prescribing buprenorphine instead of buprenorphine/naloxone documented as one of the following:
    • medical records documenting naloxone allergy; or
    • current pregnancy (request must include anticipated date of delivery); or
    • member is breastfeeding; or
    • prescriber documents desire to avoid buprenorphine/naloxone due to moderate-to-severe hepatic impairment (i.e., Child-Pugh B to C).

buprenorphine tablet > 24 mg/day to ≤ 32 mg/day

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • clinical rationale for prescribing buprenorphine instead of buprenorphine/naloxone documented as one of the following:
    • medical records documenting naloxone allergy; or
    • current pregnancy (request must include anticipated date of delivery); or
    • member is breastfeeding; or
    • prescriber documents desire to avoid buprenorphine/naloxone due to moderate-to-severe hepatic impairment (i.e., Child-Pugh B to C); and
  • one of the following:
    • this is the lowest effective dose for the member; or
    • complete treatment plan.

buprenorphine tablet > 32 mg/day

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • clinical rationale for prescribing buprenorphine instead of buprenorphine/naloxone documented as one of the following:
    • medical records documenting naloxone allergy; or
    • current pregnancy (request must include anticipated date of delivery); or
    • member is breastfeeding; or
    • prescriber documents desire to avoid buprenorphine/naloxone due to moderate-to-severe hepatic impairment (i.e., Child-Pugh B to C); and
  • medical necessity for dosing greater than 32 mg/day as noted by CYP3A4 genotyping confirming member is a rapid CYP3A4 metabolizer.

buprenorphine/naloxone film and buprenorphine/naloxone tablet > 24 mg/day to ≤ 32 mg/day for > 90 days

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • this is the lowest effective dose for the member; or
    • complete treatment plan.

buprenorphine/naloxone film and buprenorphine/naloxone tablet > 32 mg/day

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical necessity for dosing greater than 32 mg/day as noted by CYP3A4 genotyping confirming member is a rapid CYP3A4 metabolizer.

Lifems Naloxone

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • clinical rationale to establish medical necessity of the convenience kit formulation, as it pertains to the caregiver; and
  • requested quantity is ≤ 2 kits/year.

lofexidine

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication to oral clonidine; and
  • requested dose is ≤ 0.72 mg four times daily; and
  • requested duration is ≤ 14 days.

Opvee

• Documentation of all of the following is required:
  • indication is opioid overdose prevention/reversal; and
  • medical necessity for the use of a long-acting formulation for overdose reversal; and
  • requested quantity is ≤ two inhalers/year.

Zubsolv ≤ 17.2 mg/4.3 mg/day

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical records documenting an adverse reaction to buprenorphine/naloxone film that is allergic in nature, or cannot be expected or managed during the course of buprenorphine therapy.

Zubsolv > 17.2 mg/4.3 mg/day to ≤ 22.8 mg/5.8 mg/day

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical records documenting an adverse reaction to buprenorphine/naloxone film that is allergic in nature, or cannot be expected or managed during the course of buprenorphine therapy; and
  • one of the following:
    • this is the lowest effective dose for the member; or
    • complete treatment plan.

Zubsolv > 22.8 mg/5.8 mg/day

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical records documenting an adverse reaction to buprenorphine/naloxone film that is allergic in nature, or cannot be expected or managed during the course of buprenorphine therapy; and
  • medical necessity for dosing greater than 22.8/5.8 mg/day as noted by CYP3A4 genotyping confirming member is a rapid CYP3A4 metabolizer.

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, meprobamate, modafinil, mood stabilizers (agents considered to be used only for seizure diagnoses are not included), naltrexone, prazosin, and viloxazine] within a 45-day period if one of the following is included: an antipsychotic, a benzodiazepine, divalproex/valproate, lithium, or a tricyclic antidepressant; or, pharmacy claims for any combination of five or more behavioral health medications [as defined  above] 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, child adolescent psychiatrist [including psychiatric nurse practitioners], neurologist, pediatric neurologist, developmental and behavioral pediatrics) or consult is provided; and
    • if member has been on the requested polypharmacy regimen for the past 12 months with no adjustments (i.e., dose decrease, attempted discontinuation), at least one of the following:
      • previous efforts to reduce/simplify the regimen in the past 24 months resulted in symptom exacerbation; or
      • family/caregiver does not support the regimen change at this time due to risk of exacerbation; or
      • other significant barrier for therapy discontinuation.

• For regimens including ≥ two 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, child adolescent psychiatrist [including psychiatric nurse practitioners], neurologist, pediatric neurologist, developmental and behavioral pediatrics) or consult is provided; and
    • if member has been on the requested polypharmacy regimen for the past 12 months with no adjustments (i.e., dose decrease, attempted discontinuation), at least one of the following:
      • previous efforts to reduce/simplify the regimen in the past 24 months resulted in symptom exacerbation; or
      • family/caregiver does not support the regimen change at this time due to risk of exacerbation; or
      • other significant barrier for therapy discontinuation; 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.

naltrexone for members < six 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 behavioral health medications and corresponding diagnoses; and
    • prescriber is a specialist (e.g. psychiatrist, child adolescent psychiatrist [including psychiatric nurse practitioners], neurologist, pediatric neurologist, developmental and behavioral pediatrics) or consult is provided; and
    • if member has been on the requested agent for the past 12 months with no adjustments (i.e., dose decrease, attempted discontinuation), at least one of the following:
      • previous efforts to reduce/simplify the regimen in the past 24 months resulted in symptom exacerbation; or
      • family/caregiver does not support the regimen change at this time due to risk of exacerbation; or
      • other significant barrier for therapy discontinuation. 

^†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.

Please see the following link to find out more information regarding buprenorphine/naloxone tablets and buprenorphine/naloxone film: https://www.mass.gov/lists/masshealth-pharmacy-publications-and-notices-for-prescribers-and-other-providers-0.