CurrentMass General Brigham Health PlanPolicy N/A

Adjunctive Parkinson's disease medications: Inbrija, Xadago, Nourianz prior authorization and quantity limits

This policy governs prior authorization, continuation, and quantity limits for Inbrija (levodopa inhalation), Xadago (safinamide), and Nourianz (istradefylline) for members of the Mass General Brigham Health Plan; it affects prescribers and pharmacists requesting coverage under the pharmacy benefit and specialty channels.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdjunctive Parkinson's disease medications: Inbrija, Xadago, Nourianz prior authorization and quantity limits

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of Parkinson disease with 'off' episodes, concurrent carbidopa/levodopa use, and prior therapy failures as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial approval

12 monthsreauthorization

300 / 30dInbrija qty

30 / 30dNourianz qty

18+

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Coverage Criteria for Inbrija, Xadago, and Nourianz

Inbrija and Xadago initial coverage criteria

Authorization may be granted for members new to the plan who are currently receiving treatment with Inbrija or Xadago (excluding products obtained as samples or via manufacturer's patient assistance programs), OR when the following criteria are met and documentation is provided:

ANY of the following

New-to-plan continuation
- Member is currently receiving treatment with Inbrija or Xadago
  Product must not have been obtained as samples or via manufacturer's patient assistance programs
New prescription / coverage initiation
- Member has a diagnosis of Parkinson disease experiencing "off" episodes
- Member is > 18 years of age
- Member is concurrently taking carbidopa/levodopa
- Member is experiencing "off" symptoms with carbidopa/levodopa therapy
- Prior treatment failure
  - Member has had an inadequate response or adverse reaction to selegiline and rasagiline
  - For Inbrija only: Member has had an inadequate response or adverse reaction to selegiline, rasagiline, and Xadago

Nourianz initial coverage criteria

Authorization may be granted for members new to the plan who are currently receiving treatment with Nourianz (excluding products obtained as samples or via manufacturer's patient assistance programs), OR when the following criteria are met and documentation is provided:

ANY of the following

New-to-plan continuation
- Member is currently receiving treatment with Nourianz
  Product must not have been obtained as samples or via manufacturer's patient assistance programs
New prescription / coverage initiation
- Member has a diagnosis of Parkinson disease experiencing "off" episodes
- Member is concurrently taking carbidopa/levodopa

Continuation/Reauthorization

Reauthorization (continuation of therapy) requires documentation that the member is benefiting from therapy. Authorization may be renewed when ALL of the following are met:

ALL of the following

Physician documentation of improvement in the member's condition since initiating therapy
Must demonstrate ongoing clinical benefit (e.g., reduced frequency/severity of "off" episodes, improved motor function)
Member remains on concomitant carbidopa/levodopa therapy when applicable
Member is adherent to the prescribed regimen
Pharmacy refill history or clinician documentation may be used
Requested quantity and dosing are within policy limits and consistent with approved labeling
Excessive quantities or off-label dosing require additional justification

Products obtained as samples or provided through a manufacturer's patient assistance program are not eligible for authorization and do not establish prior use for the purposes of this policy.

Provider Requirements, Step Therapy, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Inbrija, Xadago, and Nourianz. Authorization may be granted for members new to the plan who are currently receiving treatment with the specified product, provided the product was not obtained as samples or through the manufacturer's patient assistance program (PAP).

Applies to Inbrija, Xadago, and Nourianz
New-to-plan approvals allowed if member currently receiving therapy and product NOT obtained as samples or via PAP

Step Therapy

Step Therapy Requirements

Step therapy: members must have had an inadequate response or intolerance to required prior therapies before authorization for Inbrija, Xadago, or Nourianz will be approved. For Inbrija and Xadago: documentation of inadequate response or adverse reaction to both selegiline and rasagiline is required. Additionally for Inbrija, the member must have had an inadequate response or adverse reaction to Xadago. For Nourianz: the member must have had inadequate response or intolerance to at least two of the following classes/agents — dopamine agonist (e.g., pramipexole, ropinirole), COMT inhibitor (e.g., entacapone, tolcapone), and MAO-B inhibitor (e.g., selegiline, rasagiline) — unless the member has a contraindication to all available generic agents.

Definitions

Definition — Off episodes

TermOff episodes

DefinitionPeriods of reduced motor benefit from carbidopa/levodopa therapy when Parkinson symptoms re-emerge

Clinical contextOccurs in patients receiving levodopa formulations (e.g., inhaled levodopa/Inbrija) and may be treated adjunctively with agents such as MAO‑B inhibitors (Xadago) or adenosine A2A antagonists (Nourianz)

Background

Parkinson disease motor symptoms result from a deficiency of striatal dopamine. Levodopa crosses the blood–brain barrier and is converted to dopamine in the CNS; oral carbidopa/levodopa remains the foundational therapy. In this policy context, Inbrija is an inhaled levodopa formulation used to treat intermittent "off" episodes, while Xadago (an MAO‑B inhibitor) and Nourianz (an adenosine A2A receptor antagonist) are adjunctive agents used with carbidopa/levodopa to manage "off" periods.

Quantity Limits and Coding Notes

Quantity limits apply as described in the coverage details: Inbrija — 300 capsules per 30 days, and Nourianz — 30 tablets per 30 days. Providers should ensure prescriptions and claims do not exceed these limits and include required documentation of concurrent carbidopa/levodopa use and clinical indication when requesting overrides or prior authorization.

Revision History

2018-09-24review

Policy reviewed.

2019-06-19update

Inbrija added to the policy.

2019-09-18review

Policy reviewed.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdjunctive Parkinson's disease medications: Inbrija, Xadago, Nourianz prior authorization and quantity limits

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of Parkinson disease with 'off' episodes, concurrent carbidopa/levodopa use, and prior therapy failures as required.

SourceLink

On This Page

Member is > 18 years of age

Member is experiencing "off" symptoms with carbidopa/levodopa therapy

Adjunctive therapy or prior intolerance

Member has inadequate response or intolerance to at least two of the following classes: dopamine agonists (e.g., pramipexole, ropinirole), COMT inhibitors (e.g., entacapone, tolcapone), MAO-B inhibitors (e.g., selegiline, rasagiline)
Member has contraindication to all available generic agents to treat Parkinson's disease

Inbrija & Xadago: failure/intolerance to selegiline AND rasagiline required
Inbrija only: failure/intolerance to selegiline, rasagiline AND Xadago required
Nourianz: inadequate response/intolerance to ≥2 of {dopamine agonist, COMT inhibitor, MAO-B inhibitor} OR contraindication to all available generic agents

Documentation Required

Documentation Requirements

Required documentation must be provided with the authorization request. This includes: diagnosis of Parkinson disease with documented "off" episodes, member age (>18 years), confirmation the member is concurrently taking carbidopa/levodopa, description of "off" symptoms on carbidopa/levodopa therapy, and clear evidence of prior trials and outcomes (inadequate response or intolerance) with the specific prior agents required by step therapy.

Diagnosis: Parkinson disease with documented "off" episodes
Age: member > 18 years
Concomitant therapy: currently taking carbidopa/levodopa
Clinical status: description of "off" symptoms while on carbidopa/levodopa
Prior therapy evidence: dates, agents, and outcomes showing inadequate response or adverse reaction/intolerance to required agents
For continuation/reauthorization: physician documentation of clinical improvement

Denial Risk

Denial Triggers

Denial risk: authorization may be denied for members new to the plan if documentation of prior therapy trials is missing or if the product was obtained as samples or via manufacturer PAP. Providers should ensure prior-treatment documentation is complete and that the medication was not sourced from samples or PAP before submitting a request.

Risk of denial when prior trial documentation is absent or incomplete
Risk of denial if medication was obtained as samples or through manufacturer's patient assistance programs

2020-07-22review

Policy reviewed at P&T meeting and Nourianz added to criteria.

2020-09-16review

Policy reviewed and updated at September P&T meeting; quantity limit added for Nourianz effective 2020-12-01.

2020-12-01effective_date

Policy effective date (Inbrija, Xadago, Nourianz) established.

2022-11-16reviewLatest

Reviewed for November P&T; separated MassHealth versus Commercial/Exchange lines and no clinical policy changes noted.