Apokyn prior authorization (neurologist, levodopa trials, generic trial required for brand)

Prescribe Apokyn only when a neurologist documents PD with 'off' episodes, current oral carbidopa/levodopa, attempts to increase levodopa dose/frequency, and trials of two other 'off' episode treatments from two different classes; brand Apokyn requests must include documentation of serious side effects or failure with generic apomorphine injection. Quantity limit: 30 mL/30 days (exceptions up to 60 mL/30 days when clinically justified).

• Prescriber must be a neurologist.
• Document diagnosis of Parkinson's disease with inadequately controlled 'off' episodes.
• Record current oral carbidopa/levodopa and attempts to increase dose and dosing frequency.
• Document trials of two other 'off' episode treatments from two different classes (COMT inhibitor, oral dopamine agonist, MAO-B inhibitor).
• For brand Apokyn, submit documentation of generic apomorphine injection serious side effects or drug failure.
• Quantity limit 30 mL/30 days; up to 60 mL/30 days may be considered when clinically justified.

Gocovri prior authorization (neurologist; generic amantadine trial/failures applicable)

Submit Gocovri requests from a neurologist and document either dyskinesia on levodopa with prior trial/failure of generic amantadine ≥200 mg/day, or PD with wearing off plus current levodopa, levodopa dose/frequency increase attempts, and failures of two specified agents; include the 60 capsules/30 days quantity limit.

• Prescriber must be a neurologist.
• Path A (dyskinesia): document levodopa-based therapy and generic amantadine serious side effects or drug failure at ≥200 mg/day.
• Path B (wearing off): document current carbidopa/levodopa, attempts to increase levodopa dose/frequency, and failures of two agents (pramipexole, ropinirole, entacapone, tolcapone, selegiline, or rasagiline).
• Quantity limit: 60 capsules/30 days.

Inbrija prior authorization (neurologist, carbidopa ≥100 mg, prior levodopa adjustments)

Request Inbrija only from a neurologist with documented PD wearing off, current oral carbidopa/levodopa including at least 100 mg carbidopa, attempts to increase levodopa dose/frequency, and failures of two specified agents; apply the 120 capsules/30 days limit (up to 300 when justified).

• Prescriber must be a neurologist.
• Document diagnosis of PD with 'wearing off' and current oral carbidopa/levodopa with ≥100 mg carbidopa.
• Document attempted increases in levodopa dose and dosing frequency.
• Document serious side effects or drug failure with TWO of: pramipexole, ropinirole, entacapone, tolcapone, selegiline, rasagiline.
• Quantity limit: 120 inhalation capsules/30 days; up to 300/30 days may be considered when clinically justified.

Mirapex ER prior authorization (age, prior IR pramipexole trial, quantity limits)

For Mirapex ER, document patient is ≥18 years with PD and a prior trial and failure of immediate‑release pramipexole; ensure quantity limits are followed per strength.

• Patient age ≥18 years.
• Document diagnosis of Parkinson's disease.
• Provide evidence of trial and failure of immediate‑release pramipexole.
• Adhere to quantity limits by strength (30 tablets/30 days for most strengths; 60 tablets/30 days for 2.25 mg).

Neupro prior authorization (indication, prior oral agent trials; swallow exception)

Submit Neupro requests documenting an FDA‑approved indication (Parkinson disease or moderate‑severe RLS) and prior serious side effects or failure with both oral pramipexole and ropinirole (waived if inability to swallow); limit to 1 patch/day.

• Confirm FDA‑approved diagnosis of Parkinson disease or moderate‑severe restless legs syndrome.
• Document serious side effects or drug failure with oral pramipexole AND ropinirole (or documentation of inability to swallow to waive this requirement).
• Quantity limit: 1 patch per day.

Nourianz prior authorization (neurologist, levodopa regimen, prior agent failures)

For Nourianz, submit a neurologist‑initiated request documenting PD with wearing off, current carbidopa/levodopa regimen, attempts to increase levodopa dose/frequency, and failures of two specified agents; apply the 30 tablets/30 days limit.

• Prescriber must be a neurologist.
• Document PD with 'wearing off' and current oral carbidopa/levodopa regimen.
• Document attempted levodopa dose/frequency increases.
• Document serious side effects or drug failure with TWO of: pramipexole, ropinirole, entacapone, tolcapone, selegiline, rasagiline.
• Quantity limit: 30 tablets per 30 days.

Nuplazid prior authorization (PDP diagnosis; specialty prescriber; indication restriction)

Prescribe Nuplazid only for documented Parkinson's disease psychosis (PDP) and ensure the prescriber is a neurologist, psychiatrist, psychiatric nurse practitioner, or geriatrician; note Nuplazid is not approved for other indications and has a 30 tablets/30 days limit.

• Document diagnosis: Parkinson's disease psychosis (PDP).
• Prescribing clinician must be neurologist, psychiatrist, psychiatric nurse practitioner, or geriatrician.
• Nuplazid will not be approved for non‑FDA indications (e.g., dementia‑related psychosis).
• Quantity limit: 30 tablets/capsules per 30 days.
• Consider hepatic and renal impairment cautions per policy (not recommended with CrCL < 30 mL/min).

Onapgo prior authorization (neurologist attestation, ≥3 hours off, prior class trials, combination exclusion)

For Onapgo, submit a neurologist attestation that the patient has advanced PD, is ≥18, responsive to levodopa, has inadequately controlled 'off' periods despite levodopa/carbidopa dose/frequency increases and trials of two other 'off' episode classes, and attest to ≥3 hours 'off' time/day; do not combine Onapgo with Apokyn, Vyalev, or Duopa. Quantity limit: 600 mL/30 days; approvals for 12 months with continuation based on response.

• Prescriber must be a neurologist and attest to ≥3 hours of 'off' time per day.
• Document advanced Parkinson's disease and age ≥18 years.
• Document current oral carbidopa/levodopa and responsiveness to levodopa.
• Document attempted increases in levodopa/carbidopa dose/frequency and trials of TWO other 'off' episode classes (COMT inhibitors, oral dopamine agonists, MAO‑B inhibitors).
• Onapgo is not authorized in combination with Apokyn, Vyalev, or Duopa.
• Quantity limit: 600 mL per 30 days; approval period: 12 months with continued approval based on positive response/disease stability.

Prior authorization required (prescriber, diagnosis, trials, dosing/quantity per agent)

Prior authorization is required for the listed PD agents and must include the specific prescriber specialty, diagnosis, documented prior trials/failures, and adherence to dosing and quantity limits per individual drug criteria.

• Include prescriber specialty and clinical diagnosis as specified for each agent.
• Provide documentation of required prior medication trials, dose/frequency adjustments, and reasons for discontinuation where applicable.
• Ensure requested dosing and quantities comply with the individual product limits in the policy.

Vyalev coding for PA (HCPCS J7356 effective 7/1/2025)

Use HCPCS code J7356 for Vyalev medical‑benefit billing and prior authorization tracking beginning 7/1/2025.

• HCPCS J7356 = Vyalev (effective 7/1/2025).
• Use this code when submitting medical‑benefit claims or PA requests for Vyalev.

Prior authorization and formulary requirements (submit prior trials, formulary justification, MDRP confirmation)

When policy criteria apply, submit prior authorization with evidence of required prior drug trials, clinical justification if bypassing formulary alternatives, and confirmation of manufacturer participation in the Medicaid Drug Rebate Program for physician‑administered products when applicable.

• Provide supportive documentation of previous drug use if the preferred agent is not found in claims history.
• If requesting a physician‑administered drug under Medicaid Managed Care/HARP, confirm the manufacturer participates in the Medicaid Drug Rebate Program.

Required prior trials across classes (document trials and failure/intolerance of alternates)

Document prior trials of alternate classes or listed agents and reasons for discontinuation (lack of efficacy, diminished effect, or adverse event) as most agents require documented failure of specified alternatives before approval.

• Record the specific agents tried and clear rationale for discontinuation (e.g., lack of efficacy or adverse event).
• Include evidence of trials across classes such as COMT inhibitors, oral dopamine agonists, and MAO‑B inhibitors when required by the product criteria.

Step therapy / trial requirements (two‑class trials and off‑time attestations)

Follow step therapy requirements: many agents require documented trials of two other medication classes or specific agents (e.g., Onapgo and Vyalev require trials of TWO classes for 'off' episodes); include prescriber attestations of off‑time where required.

• Document trials of TWO other treatments from TWO different classes for 'off' episodes when required.
• For Vyalev, prescriber must attest to ≥2.5 hours of 'off' time per day; for Onapgo, attest to ≥3 hours per day.
• Ensure trials include the classes listed (COMT inhibitors, oral dopamine agonists, MAO‑B inhibitors) or other specified agents.

Step therapy implicit: trial of same‑class drug or AB‑rated generic required prior to brand coverage

Unless an exception is documented, require a trial of an AB‑rated generic or another drug in the same pharmacologic class before approving the requested brand‑name product.

• For brand‑name drugs with an AB‑rated generic, include documentation of a trial of the AB‑rated generic unless an exception is justified and documented.
• Apokyn brand requests require documentation of generic apomorphine failure/serious side effects per policy.

Onapgo and Vyalev prescriber attestation (minimum off‑time required)

Prescriber must attest that the patient experiences the minimum required 'off' time to support Onapgo (≥3 hours/day) and Vyalev (≥2.5 hours/day) authorizations as specified in each product's criteria.

• Onapgo: prescriber attestation of ≥3 hours of 'off' time per day is required.
• Vyalev: prescriber attestation of ≥2.5 hours of 'off' time per day is required.

Diagnosis, current therapy, and prior trial documentation (include levodopa details and prior failures)

Include documentation of PD diagnosis, current levodopa/carbidopa therapy when required, and prior medication trials or failures/serious side effects for each request.

• Document the clinical diagnosis of Parkinson's disease and subtype when relevant (e.g., PDP for Nuplazid).
• Provide medication history showing current levodopa/carbidopa regimen and any dose/frequency adjustments attempted.
• Include documentation of trials and reasons for failure for prior therapies specified by the product criteria.

Required clinical documentation (submit progress notes, tests, and measures for initial and recertification)

Submit clinical documentation for every initial and recertification request unless otherwise specified; supportive records include progress notes, diagnostic tests, labs/imaging, and objective or subjective measures of benefit.

• Clinical documentation must be submitted for each request (initial and recertification) unless otherwise specified.
• Acceptable supporting documentation: progress notes, diagnostic testing, lab results, imaging, and measures demonstrating benefit or stability.

Recertification documentation (evidence of ongoing benefit required)

For recertification, provide documentation that the drug is providing ongoing benefit (improvement or stability) consistent with the policy's recertification expectations.

• At recertification, document objective or subjective improvement or disease stability attributable to the requested drug.
• Continued approval may require trial of more cost‑effective alternatives as they become available.

Documentation must support prior therapy trials and reasons for discontinuation

Ensure documentation records prior therapy trials and the clinical reason for discontinuation (lack of efficacy, diminished effect, or adverse event) or a rationale why the required drug is not in the patient's best interest.

• Specify the prior agent(s), duration of trial, and precise reason for discontinuation (e.g., inefficacy, adverse effect).
• If bypassing a required trial, include clinical rationale such as adherence barriers or comorbidity concerns.

Documentation to support that the individual is stable on the requested drug (medical profile required)

Provide evidence that the individual is clinically stable on the requested drug (medical profile, disease state, comorbidities) when seeking continuation of therapy.

• Include age, disease state, comorbidities, and rationale supporting clinical stability on the requested medication.
• Stability documentation supports continuation decisions per standard medical practice.

For brand‑name drugs with an AB‑rated generic, document trial of AB‑rated generic or justified exception

For brand‑name drugs with an AB‑rated generic, document a trial of the AB‑rated generic before brand coverage unless a documented exception justifies bypassing the generic trial.

• Document the AB‑rated generic trial and outcome, or provide a documented clinical exception to support brand request.
• Apokyn brand requests specifically require generic apomorphine trial documentation for approval.

Vyalev concurrent therapy exclusion (not authorized with Duopa unless transitioning)

Vyalev will be denied if requested for patients currently receiving Duopa unless documentation shows the patient is being transitioned from Duopa to Vyalev.

• Do not approve Vyalev for concomitant use with Duopa unless the request documents transition from Duopa to Vyalev.
• Include transition plan details when applicable.

Denial risk: brand Apokyn without generic trial documentation

Requests for brand‑name Apokyn without documentation of serious side effects or drug failure with generic apomorphine injection will be denied.

• Submit documentation of generic apomorphine injection failure or serious side effects for brand Apokyn requests.
• Absence of such documentation risks denial of the brand request.

Denial risk: Nuplazid restricted to PDP only (non‑FDA uses not approved)

Nuplazid will not be approved for any non‑FDA approved indication, including dementia‑related psychosis; ensure indication is Parkinson's disease psychosis (PDP) before authorization.

• Indication must be Parkinson's disease psychosis (PDP).
• Requests for dementia‑related psychosis or other non‑PDP indications will be denied.

Onapgo combination exclusion (not authorized with Apokyn, Vyalev, or Duopa)

Onapgo will not be authorized in combination with Apokyn, Vyalev, or Duopa; do not submit requests proposing concomitant use with these products.

• Onapgo cannot be used concomitantly with Apokyn, Vyalev, or Duopa.
• Requests proposing combinations with these agents will be denied.

Onapgo exclusion (duplicate emphasis: prohibited combinations)

Do not request Onapgo concurrently with Apokyn, Vyalev, or Duopa; such combination requests will not be authorized per policy.

• Combination use with Apokyn, Vyalev, or Duopa is prohibited.
• Ensure therapy plans avoid these combinations to prevent denial.

Denial risk: missing prior trial documentation

Failure to document required prior trials or a same‑class drug trial with reasons for discontinuation (lack of efficacy, diminished effect, adverse event) may result in denial of the request.

• Document required prior trials and clear reasons for discontinuation.
• Lack of documentation of prior trials or discontinuation reasons increases denial risk.

Denial risk: physician‑administered drug exclusion for non‑MDRP manufacturers (Medicaid)

Requests for physician‑administered drugs manufactured by companies not participating in the Medicaid Drug Rebate Program will not be covered under Medicaid Managed Care/HARP; verify manufacturer MDRP participation for Medicaid claims.

• Confirm manufacturer participation in the Medicaid Drug Rebate Program for physician‑administered products under Medicaid Managed Care/HARP.
• Nonparticipating manufacturers' products are not covered for these lines of business and may be denied.