ModifiedmhnPolicy CP.PMN.113

Safinamide (Xadago) — adjunctive therapy for Parkinson's disease

Policy governing medical necessity criteria and authorization requirements for safinamide (Xadago) as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing 'off' episodes; applies to members under the payer's Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicySafinamide (Xadago) — adjunctive therapy for Parkinson's disease

Policy CodePolicy CP.PMN.113

Change TypeApproval duration and concurrent therapy requirement revised

Effective DateJul 1, 2017

Next Review Date

Key ActionSubmit prior authorization showing PD diagnosis, age ≥18, 'off' time on levodopa/carbidopa, failure of two adjunct agents from different classes, and documentation of concurrent levodopa/carbidopa therapy.

SourceLink

POLICY UPDATE CHANGES

Initial approval duration revised from 6 months to 12 months and continued therapy approval aligned to initial therapy; requirement for concurrent treatment with carbidopa/levodopa clarified.

Step therapy bypass for Illinois HIM requests as of 1/1/2026 per IL HB 5395.

requirement for concurrent treatment with carbidopa/levodopa

Commercial approval duration revised to 12 months

12 monthsApproval duration

100 mg/dayMaximum daily dose

≥18 yrsMinimum age

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2Failed adjuncts required

Commercial, HIM, MedicaidLines of business

Coverage Criteria for Safinamide (Xadago)

inv-01: Initial Therapy — Parkinson's Disease

Covered when ALL of the following are met:

Initial Approval - Parkinson's Disease: 1. Diagnosis of Parkinson's disease; 2. Age >= 18 years; 3. Member is experiencing 'off' time on levodopa/carbidopa therapy (see Appendix D); 4. Failure of two adjunct drugs prescribed in combination with levodopa/carbidopa, each from different classes (examples: MAO-B inhibitor — rasagiline; COMT inhibitor — entacapone or tolcapone; Dopamine agonist — ropinirole/pramipexole), unless clinically significant adverse effects or contraindications; 5. Prescribed in combination with levodopa/carbidopa; 6. Dose does not exceed both: a) 100 mg per day; and b) 1 tablet per day.dose <= 100 mg/day; tablets <=1/day

Approval duration: 12 months

inv-02: Continuation Therapy — Parkinson's Disease

Covered when ALL of the following are met:

Continued Therapy - Parkinson's Disease: 1. Member meets one of the following: a) currently receiving medication via the 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. Prescribed in combination with carbidopa/levodopa; 4. If request is for a dose increase, the new dose does not exceed both: a) 100 mg per day; and b) 1 tablet per day.dose <= 100 mg/day; tablets <=1/day

Approval duration: 12 months

inv-03: Commercial Authorization Conditions — Coverage requires specific treatment conditions and approval duration as indicated by the policy summary

Coverage requires the following specific treatment conditions and authorizations:

Commercial Safinamide Authorization Conditions: 1. Member must be receiving safinamide concurrently with carbidopa/levodopa (concurrent treatment requirement). 2. Authorization/approval duration for commercial members is up to 12 months.

Concurrent therapy requirement and commercial approval duration as specified in the policy summary.

Non‑FDA approved indications that are not specifically addressed by this clinical policy are not authorized for coverage unless the provider submits sufficient documentation demonstrating the indication’s efficacy and safety in accordance with applicable off‑label use policies or evidence of coverage documents.

When state Medicaid coverage provisions conflict with the terms of this clinical policy, state Medicaid coverage provisions take precedence. Providers should refer to the applicable state Medicaid manual for specific coverage requirements.

Use of safinamide for non‑FDA approved indications without appropriate supporting documentation per the referenced off‑label use policies or evidence of coverage is considered not authorized and may be denied.

Coding and Dosing Information

No explicit CPT/HCPCS/ICD codes listedmixed

No codes listed

inv-08: Maximum daily dose — 100 mg/day

Maximum daily dose100 mg/day

Typical titrationStart 50 mg once daily; increase to 100 mg once daily after 2 weeks if needed

Dose limit contextAdjunctive to levodopa/carbidopa for PD with 'off' episodes

inv-09: Tablet limit — 1 tablet per day

Tablet limit1 tablet per day

Dose relationshipTablet limit corresponds with maximum dose of 100 mg/day

Applies to

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial approval. Requests must document diagnosis of Parkinson's disease, age ≥ 18 years, evidence of 'off' time on carbidopa/levodopa therapy, and that the member meets the policy's step therapy and concurrent therapy requirements.

Prior authorization required for initial approval demonstrating PD diagnosis, age ≥18, and 'off' time on levodopa/carbidopa.

Prior Authorization

Approval Duration and Concurrent Therapy Requirement

Commercial approvals are issued for 12 months. Approval requires that the member be prescribed safinamide in combination with carbidopa/levodopa (concurrent therapy requirement).

Approval duration: 12 months
Concurrent treatment with carbidopa/levodopa required for approval.

Background on Safinamide (Xadago)

Safinamide is a selective MAO‑B inhibitor indicated as adjunctive treatment to levodopa/carbidopa for patients with Parkinson’s disease who experience "off" episodes. "Off" episodes represent a return of motor symptoms (for example, bradykinesia, tremor, or rigidity) when the effect of levodopa diminishes; typical dosing begins at 50 mg once daily and may be increased to a maximum of 100 mg/day (usually one tablet per day) as tolerated.

Key Definitions

inv-19: Off time/episodes — 'Off' time: return of PD symptoms when L-dopa effect wears off after each dosing

Definition'Off' time: return of PD symptoms (bradykinesia, rest tremor or rigidity) when the L-dopa treatment effect wears off after each dosing interval.

Clinical featuresSymptoms include bradykinesia, tremor, and rigidity

Contrast'Off' time is distinct from dyskinesia, which typically results from too much L-dopa

inv-20: Health Plan — definition of 'Health Plan' that adopted this clinical policy

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates.

ScopeApplies to plans that adopt this clinical policy and operate under Centene Management Company, LLC or its affiliates

Policy Summary

Payermhn

PolicySafinamide (Xadago) — adjunctive therapy for Parkinson's disease

Policy CodePolicy CP.PMN.113

Change TypeApproval duration and concurrent therapy requirement revised

Effective DateJul 1, 2017

Next Review Date

SourceLink

On This Page

Adjunctive therapy with levodopa/carbidopa for Parkinson's disease

Denial Risk

Denial Risk for Insufficient Documentation or Non‑Covered Indications

Failure to provide sufficient clinical documentation demonstrating that the member meets all approval criteria, or requests for non‑FDA approved indications not supported per the plan's off‑label use policies, may result in denial of the request.

Requests for non‑FDA indications require additional supporting documentation per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53).
Insufficient documentation of required criteria (diagnosis, 'off' time, prior adjunct therapy, concurrent levodopa/carbidopa) risks denial.

Documentation Required

Required Clinical Documentation

Provider must submit documentation such as office chart notes, medication history, lab results, or other clinical information supporting that the member meets all approval criteria (diagnosis, age, 'off' time, prior adjunct therapy trials, and concurrent levodopa/carbidopa use).

Include chart notes documenting 'off' time (see Appendix D) while on levodopa/carbidopa.
Document prior trials of two adjunct agents from different classes or evidence of contraindication/intolerance.
Document current concurrent use of carbidopa/levodopa.

Documentation Required

Provider Documentation and Compliance

Providers must follow plan documentation and coverage terms. Coverage decisions are subject to the Health Plan's benefit terms, state and federal law, and plan‑level administrative policies and procedures.

Coverage is subject to applicable evidence of coverage/certificate/policy contract terms and to state and federal requirements.
The Health Plan may change, amend, or withdraw this policy; providers remain responsible for obtaining prior authorization and complying with current requirements.

Step Therapy

Step Therapy Requirements

Step therapy requires failure of two adjunct drugs from different classes (MAO‑B inhibitor, COMT inhibitor, dopamine agonist) when used in combination with levodopa/carbidopa, unless clinically significant adverse effects are experienced or all are contraindicated. Illinois HIM requests are exempt from these step therapy requirements per IL HB 5395 as of 1/1/2026.

Required failures: two agents from different classes (e.g., rasagiline; entacapone or tolcapone; ropinirole/pramipexole).
Step therapy bypass: IL HIM per IL HB 5395 (effective 1/1/2026).
Note: Prior authorization may be required for the listed adjunct agents.

Prior Authorization

Concurrent Therapy Note

Concurrent treatment with carbidopa/levodopa must be documented at the time of request. Failure to document concurrent levodopa/carbidopa therapy may result in denial.

Document current carbidopa/levodopa therapy.
Lack of documentation of concurrent therapy is a basis for denial.

UseGuides medical necessity determinations but does not constitute a contract or guarantee of payment