CurrentAvMedPolicy N/A

Prior authorization and step-therapy criteria for antiparkinson agents (pharmacy/specialty drugs)

Defines prior authorization and step-therapy requirements for listed antiparkinson medications (oral, transdermal, inhaled) for AvMed members; intended for prescribers and pharmacy/clinical operations submitting PA requests.

Policy Summary

PayerAvMed

PolicyPrior authorization and step-therapy criteria for antiparkinson agents (pharmacy/specialty drugs)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed, signed PA form with supporting documentation (chart notes, labs, pharmacy claims) and ensure the prescriber is a neurologist or consulted with one when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~15drugs listed on PA form

6initial authorization duration (months)

12re-authorization duration (months)

1specialty pharmacy named

Prior Authorization Criteria for Antiparkinson Agents

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General initial authorization (applies to all listed antiparkinson agents unless drug-specific criteria override)

All of the following must be met for approval:

ALL of the following

Member must be 18 years of age or older
Medication must be prescribed by, or in consultation with, a neurologist
Member must have a confirmed diagnosis of Parkinson's disease in an individual who is having intermittent OFF episodes while on continuous carbidopa/levodopa therapy
Must submit chart notes
Provider has made adjustments to member's carbidopa/levodopa dose to manage symptoms without success
Member is receiving concurrent therapy with carbidopa/levodopa within the past 30 days AND the requested medication will be used in combination with continuous carbidopa/levodopa treatment
Member is currently not taking and has not recently (within 2 weeks) taken a nonselective MAO inhibitor (e.g., phenelzine, tranylcypromine, isocarboxazid)

Carbidopa-levodopa ER capsules (Rytary ABA), Crexont, Rytary

All of the following must be met for approval:

ALL of the following

Member must meet the general initial authorization criteria
required trials
- Documentation of trial and failure of BOTH: combination therapy of carbidopa/levodopa IR with carbidopa/levodopa extended-release
- AND trial/failure of one of:
  - Dopamine agonist: ropinirole or ropinirole ER, pramipexole or pramipexole ER
  - Monoamine oxidase B inhibitor: rasagiline

Inbrija (levodopa inhalation) and Nourianz (istradefylline)

All of the following must be met for approval:

ALL of the following

Member must meet the general initial authorization criteria
ALL of the following
- ANY of the following
  - Monoamine oxidase B inhibitors: rasagiline
  - Dopamine agonists: ropinirole or ropinirole ER, pramipexole or pramipexole ER
  - COMT inhibitors: generic entacapone, Ongentys (opicapone) (requires PA), tolcapone (requires PA)

Lodosyn (carbidopa tablets)

All of the following must be met for approval:

ALL of the following

Member is currently receiving carbidopa/levodopa therapy and Lodosyn is being used in combination to reduce levodopa-associated side effects (e.g., nausea) and to enhance effectiveness

Neupro (rotigotine transdermal)

All of the following must be met for approval (diagnosis-dependent):

ALL of the following

indications
- Parkinson's disease
- Moderate to severe restless legs syndrome
For Parkinson's disease: ONE of
- Oral dopamine agonist failure pathway
  - Member must meet all general initial criteria
  - Documentation of trial and failure or intolerance to BOTH pramipexole immediate release and ropinirole extended-release

Ongentys (opicapone)

All of the following must be met for approval:

ALL of the following

Documentation of trial and failure of a COMT inhibitor: generic entacapone
Member does NOT have a history of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms

Tolcapone (Tasmar)

All of the following must be met for approval:

ALL of the following

ALL of the following
- Documentation of trial and failure of ALL of the following: COMT inhibitors: generic entacapone and Ongentys (opicapone)
- Dopamine agonists: ropinirole or ropinirole ER, pramipexole or pramipexole ER
- Monoamine oxidase B inhibitors: rasagiline
Provider attests to monitoring for liver failure/hepatic dysfunction and will discontinue tolcapone if ALT/AST levels exceed 2 times the upper limit of normal

Xadago (safinamide)

All of the following must be met for approval:

ALL of the following

ALL of the following
- Documentation of trial and failure or intolerance to BOTH of the following monoamine oxidase inhibitors: selegiline and rasagiline
Member does NOT have severe hepatic impairment (Child-Pugh C)

What Providers Must Do

Prior Authorization

Submit signed PA form with documentation

Prescribing physician must sign and clearly print name on the completed PA request (preprinted stamps not valid); include office phone and fax numbers and the prescriber's NPI. All documentation supporting checked criteria — including lab results, diagnostics, and chart notes — must be provided with the form or the request may be denied.

Prescriber signature and printed name required (no preprinted stamps).
Include office phone, fax, and NPI on the form.
Attach all supporting documentation (labs, diagnostics, chart notes) or risk denial.

Documentation Required

Document prior therapy trials and failures

Provide chart notes or pharmacy-paid claim records that verify trials and failures exactly as required by the drug-specific step pathways (for example: entacapone COMT trial, dopamine agonists such as ropinirole or pramipexole, and MAO-B inhibitors such as rasagiline). These records must be submitted to support each checked line on the form.

Chart notes or pharmacy paid claims must document trial and failure per the stated step requirements.
Examples: entacapone (COMT), ropinirole/pramipexole (dopamine agonists), rasagiline (MAO-B).

Documentation Required

Liver monitoring for tolcapone

For tolcapone requests the provider must attest that they will monitor for hepatic dysfunction and discontinue tolcapone if transaminases (ALT/AST) exceed twice the upper limit of normal (2x ULN); supporting liver test results should be provided.

Provider attestation to monitor liver function is required.
Tolcapone must be discontinued if ALT/AST > 2x ULN.

Prior Authorization

Neurologist involvement required

Initial approvals require that the medication be prescribed by, or in consultation with, a neurologist; chart notes documenting neurologist involvement should be submitted with the PA.

Medication must be prescribed by or in consultation with a neurologist for initial authorization.
Submit chart notes to verify neurologist involvement.

Denial Risk

Contraindication exclusions

Requests may be denied if exclusionary contraindications apply; verify and document absence of these before submitting the PA.

Recent use (within 2 weeks) of nonselective MAOIs (e.g., phenelzine, tranylcypromine, isocarboxazid).
History of asthma, COPD, or other chronic underlying lung disease for Inbrija.
History of pheochromocytoma, paraganglioma, or other catecholamine‑secreting neoplasms for Ongentys.
Severe hepatic impairment (Child‑Pugh C) for Xadago.

Dosing Maximums and Quantity Limits

Dose limits and utilization thresholds

Inbrija dosing limitMaximum 84 mg per dose, up to 5 times daily (max 420 mg/day); quantity limit: 10 capsules/day; contraindicated in members with a history of asthma, COPD, or other chronic underlying lung disease.

Crexont (carbidopa-levodopa ER) maximumMaximum carbidopa 525 mg / levodopa 2.1 g per day (in up to 4 divided doses); quantity limit: 6 capsules/day.

Rytary maximumQuantity limit: 10 capsules per day (all strengths).

Neupro maximums by indicationEarly PD: max 6 mg/24 hr; Advanced PD: max 8 mg/24 hr; RLS: max 3 mg/24 hr; quantity limit: 30 patches/30 days (all strengths).

Lodosyn quantity limitMaximum quantity limit: 8 tablets per day.

Ongentys dosing50 mg once daily; maximum quantity limit: 1 capsule per day.

Nourianz dosing20 mg once daily, may increase to 40 mg once daily based on response and tolerability; maximum quantity limit: 1 tablet per day.

Tolcapone monitoringProvider must monitor for hepatic dysfunction and discontinue tolcapone if ALT/AST levels exceed 2 times the upper limit of normal.

Clinical and Administrative Background

This prior authorization form governs use of adjunct and alternative antiparkinson agents primarily for management of OFF episodes in Parkinson’s disease and for restless legs syndrome (Neupro). Providers must document a confirmed diagnosis and submit chart notes supporting intermittent OFF episodes while the member is on continuous carbidopa/levodopa therapy; the medication is intended to be used in combination with ongoing carbidopa/levodopa treatment (concurrent therapy within the past 30 days).

The policy enforces step therapy requirements: trials of generic or other formulary agents are required before approval of specialty or branded products. Examples include required trials of combination carbidopa/levodopa IR plus extended-release formulations and trials of alternative classes such as dopamine agonists (pramipexole, ropinirole), MAO-B inhibitors (rasagiline), and COMT inhibitors (generic entacapone) prior to coverage of many listed agents. Prescribers must be neurologists or consult with a neurologist for initial approval and must submit the completed, signed PA form and supporting documentation (chart notes or pharmacy claims) to avoid denial.

OpenPayer

Prior authorization and step-therapy criteria for antiparkinson agents (pharmacy/specialty drugs)

Prior Authorization Criteria for Antiparkinson Agents

Drugs Listed on PA Form (NDC/drug grouping)

What Providers Must Do

Dosing Maximums and Quantity Limits

Clinical and Administrative Background

Defined Terms

Policy Revision Notes

carbidopa-levodopa ER	Rytary ABA / Rytary / Crexont (carbidopa-levodopa ER capsules)
istradefylline	Nourianz
opicapone	Ongentys
levodopa inhalation powder	Inbrija
tolcapone	Tasmar
carbidopa	Lodosyn
rotigotine transdermal	Neupro
safinamide	Xadago
entacapone	generic COMT inhibitor (listed as step therapy option)
rasagiline	MAO-B inhibitor (listed as step therapy option)