FDA-approved, for example:

• Drug-induced extrapyramidal symptoms (Gocovri, Osmolex ER)
• Parkinson’s disease
• Parkinson's disease psychosis (Nuplazid)

Non-FDA-approved, for example:

• Restless leg syndrome (pramipexole extended-release)

Note: The above lists may not include all FDA-approved and non-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.

carbidopa/levodopa orally disintegrating tablet

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is unable to swallow pills or use a conventional formulation; and
  • member is not currently receiving other oral formulations.

Duopa

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member has a PEG tube; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to carbidopa/levodopa immediate-release tablet formulation; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to carbidopa/levodopa extended-release tablet formulation.

Gocovri

• Documentation of the following is required for a diagnosis of Parkinson's disease:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to three or contraindication to all of the following: carbidopa/levodopa, dopamine agonist, monoamine oxidase-type B (MAO B) inhibitor, anticholinergic agent; and
  • for the 68.5 mg capsule, member has moderate or severe renal impairment; and
  • one of the following:
    • for 68.5 mg capsule, requested quantity is ≤ one unit/day; or
    • for 137 mg capsule, requested quantity is ≤ f two units/day; and
  • medical necessity for use of amantadine extended-release instead of amantadine immediate-release (capsules, tablets, oral solution); and
  • medical necessity for use of amantadine extended-release capsules instead of amantadine extended-release tablets.

• Documentation of the following is required for a diagnosis of Parkinson's disease with dyskinesia while on levodopa-based therapy:
  • appropriate diagnosis; and
  • member is experiencing dyskinesia while on levodopa-based therapy; and
  • member is concurrently taking carbidopa/levodopa; and
  • for the 68.5 mg capsule, member has moderate or severe renal impairment; and
  • one of the following:
    • for 68.5 mg capsule, requested quantity is ≤ one unit/day; or
    • for 137 mg capsule, requested quantity is ≤ two units/day; and
  • medical necessity for use of amantadine extended-release instead of amantadine immediate-release (capsules, tablets, oral solution); and
  • medical necessity for use of amantadine extended-release capsules instead of amantadine extended-release tablets.

• Documentation of the following is required for a diagnosis of Parkinson's disease with "off" episodes while on carbidopa/levodopa therapy:
  • appropriate diagnosis; and
  • member is experiencing “off” symptoms with carbidopa/levodopa therapy despite maximizing dose; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to carbidopa/levodopa in combination with all of the following: dopamine agonist, catechol-o-methyl transferase (COMT) inhibitor, MAO B inhibitor; and
  • for the 68.5 mg capsule, member has moderate or severe renal impairment; and
  • one of the following:
    • for 68.5 mg capsule, requested quantity is ≤ one unit/day; or
    • for 137 mg capsule, requested quantity is ≤  two units/day; and
  • medical necessity for use of amantadine extended-release instead of amantadine immediate-release (capsules, tablets, oral solution); and
  • medical necessity for use of amantadine extended-release capsules instead of amantadine extended-release tablets.

• Documentation of the following is required for a diagnosis of drug-induced extrapyramidal symptoms:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to one or contraindication to all anticholinergic agents; and
  • for the 68.5 mg capsule, member has moderate or severe renal impairment; and
  • one of the following:
    • for 68.5 mg capsule, requested quantity is ≤ one unit/day; or
    • for 137 mg capsule, requested quantity is ≤ two units/day; and
  • medical necessity for use of amantadine extended-release instead of amantadine immediate-release (capsules, tablets, oral solution); and
  • medical necessity for use of amantadine extended-release capsules instead of amantadine extended-release tablets.

Inbrija and Kynmobi

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is experiencing “off” symptoms with carbidopa/levodopa therapy despite maximizing dose; and
  • medical records documenting an inadequate response or adverse reaction to carbidopa/levodopa immediate-release used as needed for “off” symptoms; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to carbidopa/levodopa in combination with all of the following: dopamine agonist, COMT inhibitor, MAO B inhibitor; and
  • one of the following:
    • for Inbrija, requested dose is 84 mg (two 42 mg capsules) up to five times per day as needed for “off” symptoms; or
    • for Kynmobi, requested quantity is ≤ five units/day.

Neupro > one unit/day and rasagiline > one unit/day

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is concurrently taking carbidopa/levodopa; and
  • medical records documenting titration to doses exceeding the quantity limit.

Nourianz

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is experiencing “off” symptoms with carbidopa/levodopa therapy despite maximizing dose; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to carbidopa/levodopa in combination with all of the following: dopamine agonist, COMT inhibitor, MAO B inhibitor; and
  • requested quantity is ≤ one unit/day.

Ongentys and tolcapone 

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is concurrently taking carbidopa/levodopa; and
  • for Ongentys, an inadequate response, adverse reaction, or contraindication to entacapone.
  • for tolcapone, an inadequate response, adverse reaction, or contraindication to both of the following: entacapone, Ongentys.

SmartPA: Claims for Ongentys will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for Parkinson’s disease, a history of paid MassHealth pharmacy claims for a carbidopa/levodopa product for at least 90 days within the last 120 days, and a history of paid MassHealth pharmacy claims for entacapone.†

SmartPA: Claims for tolcapone will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for Parkinson’s disease, a history of paid MassHealth pharmacy claims for a carbidopa/levodopa product for at least 90 days within the last 120 days, and a history of paid MassHealth pharmacy claims for entacapone and Ongentys.†

Osmolex ER

• Documentation of the following is required for a diagnosis of Parkinson's disease:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to three or contraindication to all of the following: carbidopa/levodopa, dopamine agonist, MAO B inhibitor, anticholinergic agent; and
  • one of the following:
    • for Osmolex ER tablet, requested quantity is ≤ one unit/day; or
    • for Osmolex ER tablet dose pack, requested quantity is ≤ two units/day; and
  • medical necessity for use of amantadine extended-release instead of amantadine immediate-release (capsules, tablets, oral solution).

• Documentation of the following is required for a diagnosis of Parkinson's disease with dyskinesia while on levodopa-based therapy:
  • appropriate diagnosis; and
  • member is experiencing dyskinesia while on levodopa-based therapy; and
  • member is concurrently taking carbidopa/levodopa; and
  • one of the following:
    • for Osmolex ER tablet, requested quantity is ≤ one unit/day; or
    • for Osmolex ER tablet dose pack, requested quantity is ≤ two units/day; and
  • medical necessity for use of amantadine extended-release instead of amantadine immediate-release.

• Documentation of the following is required for a diagnosis of Parkinson's disease with "off" episodes while on carbidopa/levodopa therapy:
  • appropriate diagnosis; and
  • member is experiencing “off” symptoms with carbidopa/levodopa therapy despite maximizing dose; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to carbidopa/levodopa in combination with all of the following: dopamine agonist, COMT inhibitor, and MAO B inhibitor; and
  • one of the following:
    • for Osmolex ER tablet, requested quantity is ≤ one unit/day; or
    • for Osmolex ER tablet dose pack,requested quantity is ≤ two units/day; and
  • medical necessity for use of amantadine extended-release instead of amantadine immediate-release.

• Documentation of the following is required for a diagnosis of drug-induced extrapyramidal symptoms:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to one or contraindication to all anticholinergic agents; and
  • medical necessity for use of amantadine extended-release instead of amantadine immediate-release (capsules, tablets, oral solution); and
  • one of the following:
    • for Osmolex ER tablet, requested quantity is ≤ one unit/day; or
    • for Osmolex ER tablet dose pack, requested quantity is ≤ two units/day.

pramipexole extended-release

• Documentation of the following is required for the diagnosis of Parkinson’s disease:
  • appropriate diagnosis; and
  • medical records documenting an adverse reaction or inadequate response to both of the following: pramipexole immediate-release, ropinirole extended-release.

• Documentation of the following is required for the diagnosis of Restless leg syndrome:
  • appropriate diagnosis; and
  • medical records documenting inadequate response with the immediate-release formulation; and
  • inadequate response or adverse reaction one other non-ergot dopamine agonist; and 
  • medical necessity for use instead of ropinirole ER.

Rytary

• Documentation of the following is required:
  • appropriate diagnosis; and
  • medical records documenting an inadequate response or adverse reaction to the carbidopa/levodopa immediate-release tablet formulation; and
  • medical necessity for use instead of carbidopa/levodopa extended-release tablet.

Xadago

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is concurrently taking carbidopa/levodopa; and
  • member is experiencing “off” symptoms with carbidopa/levodopa therapy; and
  • medical records documenting an inadequate response or adverse reaction to selegiline and rasagiline; and
  • requested quantity is ≤ one unit/day.

Zelapar

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is concurrently taking carbidopa/levodopa; and
  • member is unable to swallow pills or use a conventional formulation; and
  • member is not currently receiving other oral solid formulation; and
  • requested quantity is ≤ two units/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.