CurrentmhnPolicy CP.PMN.113

Clinical Policy: Safinamide (Xadago)

Coverage criteria for safinamide (Xadago) as adjunctive treatment to levodopa/carbidopa for patients with Parkinson's disease experiencing 'off' episodes; applies to Commercial, HIM, and Medicaid lines of business affiliated with Centene.

Policy Summary

Payermhn

PolicyClinical Policy: Safinamide (Xadago)

Policy CodePolicy CP.PMN.113

Change TypeClarified continued therapy durationremoved monotherapy limitation

Effective Date07.01.17

Next Review Date

Key ActionSubmit prior authorization showing diagnosis of idiopathic Parkinson's disease, age ≥18, 'off' time on levodopa/carbidopa, failure of two adjunct agents from different classes, and dose ≤100 mg/day.

SourceLink

POLICY UPDATE CHANGES

Revised continued therapy approval duration for Commercial from length of benefit to 12 months or duration of request, whichever is less.

Monotherapy limitation of use removed per FDA label update.

References to HIM.PHAR.21 revised to HIM.PA.154; references reviewed and updated.

Continued therapy approval duration for Commercial was changed from length of benefit to 12 months or duration of request, whichever is less.

Monotherapy limitation of use removed per FDA label update (noted in 1Q 2021 annual review).

100 mg/daymaximum daily dose

6 monthsinitial approval duration

12 monthscontinued therapy approval duration

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≥18minimum patient age

12 monthsCommercial continued therapy

Coverage Criteria

Initial Therapy (Parkinson's Disease)

Covered when ALL of the following are met:

Parkinson's Disease initial approval: 1. Diagnosis of idiopathic Parkinson's disease; 2. Age ≥ 18 years; 3. Member is experiencing 'off' time on levodopa/carbidopa therapy; 4. Failure of two of the following adjunct drugs prescribed in combination with levodopa/carbidopa, each from different classes, unless clinically significant adverse effects are experienced or all are contraindicated: (a) MAO-B inhibitor: rasagiline; (b) COMT inhibitor: entacapone, tolcapone; (c) Dopamine agonist: ropinirole/ropinirole ER, pramipexole/pramipexole ER; 5. Prescribed in combination with levodopa/carbidopa; 6. Dose does not exceed both: (a) 100 mg per day; (b) 1 tablet per day.

Approval duration: 6 months

Continuation Therapy (Parkinson's Disease)

Covered when ALL of the following are met:

Parkinson's Disease continued therapy: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed both: (a) 100 mg per day; (b) 1 tablet per day.

Approval duration: HIM/Medicaid - 12 months; Commercial - 12 months or duration of request, whichever is less

Non‑FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety provided in accordance with the applicable off‑label use policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid, or as otherwise supported by evidence of coverage documents.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules and requirements.

Coding & Dosing

Maximum daily dose

Maximum daily dose100 mg/day

Typical dosing regimenStart 50 mg PO QD; increase to 100 mg PO QD after 2 weeks if needed

Tablet limitDo not exceed 1 tablet per day

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document diagnosis of idiopathic Parkinson's disease, age ≥ 18 years, and that the member is experiencing 'off' time on levodopa/carbidopa therapy. Requests for initial approval must show the drug is prescribed in combination with levodopa/carbidopa and that the requested safinamide dose does not exceed 100 mg per day and 1 tablet per day. Approval duration for initial therapy: 6 months.

Required documentation: office chart notes, lab results, or other clinical information supporting all approval criteria.
Initial approval duration: 6 months.

Prior Authorization

Prior Authorization for Continued Therapy

For continued therapy (renewal) requests, the adjunctive indication must remain unchanged (safinamide used with levodopa/carbidopa for 'off' time). Continued therapy approvals for Commercial members are limited to 12 months or the duration of the request, whichever is less. Providers must submit documentation demonstrating ongoing benefit and that the member continues to meet the applicable criteria.

Continued therapy approval duration (Commercial): 12 months or duration of request, whichever is less.

Background

Safinamide is a monoamine oxidase type B (MAO‑B) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa for patients with Parkinson’s disease who are experiencing "off" episodes. "Off" episodes describe motor fluctuations when the effect of levodopa wears off and symptoms such as bradykinesia, tremor, or rigidity return. Safinamide is intended to be used in combination with levodopa/carbidopa to reduce these motor fluctuations in eligible patients.

Definitions

MAO-B

DefinitionMonoamine oxidase type B (MAO-B) enzyme

Drug classSafinamide (Xadago) is an MAO-B inhibitor

Indication contextUsed as adjunctive treatment to levodopa/carbidopa for PD patients experiencing 'off' episodes

Off time/episodes

DefinitionReturn of Parkinson disease symptoms (bradykinesia, rest tremor, or rigidity) when L-dopa effect wears off after each dosing interval

Relation to motor fluctuationsPart of motor fluctuations alternating with 'on' time when L-dopa suppresses symptoms

Revision History

11.16.21annual_review

1Q 2022 annual review: revised continued therapy approval duration for Commercial from length of benefit to 12 months or duration of request, whichever is less; references reviewed and updated.

10.03.22template_update

Template changes applied to other diagnoses/indications and the continued therapy section; references reviewed and updated.

11.15.22annual_review

1Q 2023 annual review: no significant clinical changes; references reviewed and updated.

Policy Summary

Payermhn

PolicyClinical Policy: Safinamide (Xadago)

Policy CodePolicy CP.PMN.113

Change TypeClarified continued therapy durationremoved monotherapy limitation

Effective Date07.01.17

Next Review Date

SourceLink

On This Page

Documentation must show continued clinical benefit and maintenance of initial approval criteria.

Step Therapy

Step Therapy Requirement

Step therapy is required prior to approval for initial therapy. Providers must document failure of two adjunct drugs (each used with levodopa/carbidopa) from different classes unless there are contraindications or clinically significant adverse effects.

Required failures (two agents from different classes): MAO-B inhibitor (e.g., rasagiline); COMT inhibitor (e.g., entacapone, tolcapone); dopamine agonist (e.g., ropinirole, pramipexole).
Prior authorization may also be required for the listed comparator agents.

Note

Step Therapy / Template Notes

Template and annual review notes: no substantive changes to the adjunctive indication. Template edits were applied to other diagnoses/indications and the continued therapy section during routine updates; continued therapy approval duration for Commercial was revised to 12 months or duration of request, whichever is less.

Template changes applied to other diagnoses/indications and continued therapy section.
No change to the adjunctive indication itself.

Denial Risk

Non‑Covered Indications / Off‑Label Use Risk

Requests for indications not covered by FDA approval and not addressed in this policy (non‑FDA approved/off‑label uses) require sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies. Lack of such documentation or evidence of coverage may result in denial.

Non‑FDA approved indications require evidence per off‑label use policies for the member's product line.
If state or plan evidence of coverage documents address the indication, those documents apply.

Documentation Required

Policy and Coverage Documents / Required Documentation

Providers must follow all plan coverage documents and applicable state and federal requirements. This clinical policy is a guide to medical necessity and does not guarantee coverage or payment. Submit supporting documentation (office notes, labs, etc.) with prior authorization requests. For Medicaid members, state Medicaid provisions take precedence when they conflict with this policy.

This policy does not replace benefit contract terms — coverage decisions are subject to the member's evidence of coverage/certificate/policy.
Documentation required: office chart notes, lab results, or other clinical information to support that all criteria are met.

Contrast with dyskinesia

'Off' episodes result from too little L-dopa, whereas dyskinesia typically results from too much L-dopa

Monotherapy limitation of use

Prior restriction statusMonotherapy limitation of use was removed per FDA label update

Date noted in reviewsRemoval documented in 1Q 2021 annual review (Date = 10.20.20; P&T Approval Date = 02.21)

Current implicationSafinamide may be used without the previous monotherapy restriction per updated labeling

10.13.23annual_review

1Q 2024 annual review: no significant clinical changes; references reviewed and updated.

11.13.24annual_reviewLatest

1Q 2025 annual review: no significant clinical changes; references reviewed and updated.