ModifiedCentenePolicy CP.PMN.113

Safinamide (Xadago) for Parkinson's disease

This policy governs prior authorization and coverage criteria for safinamide (Xadago) as adjunctive treatment to levodopa/carbidopa for members with Parkinson's disease experiencing 'off' episodes, affecting commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicySafinamide (Xadago) for Parkinson's disease

Policy CodePolicy CP.PMN.113

Change TypeMultiple material revisions (approval duration, step therapy, concurrent therapy requirement)

Effective DateJul 1, 2017

Next Review Date

Key ActionSubmit prior authorization demonstrating diagnosis of PD, age ≥18, 'off' time on levodopa/carbidopa, trial/failure of two adjunct agents, and plan to use safinamide with levodopa/carbidopa.

SourceLink

POLICY UPDATE CHANGES

Initial approval duration revised from 6 months to 12 months.

Removed 'idiopathic' as a Parkinson's disease qualifier from the diagnostic criterion.

Step therapy bypass for Illinois HIM per IL HB 5395: step requirements do not apply for Illinois HIM requests as of 1/1/2026.

Requirement for concurrent treatment with carbidopa/levodopa explicitly stated in initial and continued therapy criteria.

Corrected reference for 'off' time definition to Appendix D.

100 mg/dayMaximum daily safinamide dose authorized

12 monthsApproval duration for initial and continued therapy

≥18Minimum age for coverage

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial PD criteria: 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 (MAO-B inhibitor e.g., rasagiline; COMT inhibitor e.g., entacapone or tolcapone; dopamine agonist e.g., ropinirole or pramipexole), unless contraindicated or clinically significant adverse effects; 5) Prescribed in combination with levodopa/carbidopa; 6) Dose does not exceed both: a) 100 mg per day and b) 1 tablet per day; Approval duration: 12 months.

Continuation Therapy

Covered when ALL of the following are met

Continued PD criteria: 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) Prescribed in combination with carbidopa/levodopa; 4) If request is for a dose increase, new dose does not exceed both: a) 100 mg per day and b) 1 tablet per day; Approval duration: 12 months.

Other Indications

For uses not specifically listed

Other diagnoses/indications: 1) If the drug has undergone a label change within the last 6 months not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business as listed in the policy (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as appropriate); 2) If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Requests for uses of safinamide that are not FDA-approved and not specifically addressed in this policy will not be authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies. Prior authorization is required for covered indications and the provider must demonstrate that the member meets all applicable approval criteria (see Initial and Continued Therapy sections), including concurrent treatment with levodopa/carbidopa and adherence to dose limits (maximum 100 mg/day; 1 tablet/day).

For members covered under state Medicaid programs, any conflicting state Medicaid coverage provisions take precedence over this clinical policy. Coverage decisions remain subject to the member’s evidence of coverage and applicable state and federal requirements; providers should follow the Medicaid program’s rules when they differ from this policy.

When a request is for an indication that is not FDA‑approved, the request will be evaluated against the applicable off‑label use policy for the member’s line of business (see CP.CPA.09 for Commercial, HIM.PA.154 for marketplace/HIM, and CP.PMN.53 for Medicaid). If the off‑label evidence submitted does not meet the criteria in those referenced policies, the request will be considered not medically necessary and may be denied. Providers must include supporting clinical documentation (e.g., office notes, labs, prior therapy history) to establish that the requested off‑label use is appropriate per the referenced off‑label policies.

Coding

Codes referencedmixed

N/A	No explicit CPT/HCPCS/ICD-10 codes listed in this policy excerpt

inv-08: Maximum daily dose

Maximum daily dose100 mg/day

Dose frequency limit1 tablet per day

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

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must document diagnosis, age, evidence of 'off' time on levodopa/carbidopa, trial/failure of two adjunct agents from different classes (MAO‑B inhibitor, COMT inhibitor, dopamine agonist) unless contraindicated or intolerant, and that safinamide (Xadago) will be used concomitantly with levodopa/carbidopa. Approval duration for Commercial members is 12 months.

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

Documentation Required

Required Documentation

Provide supporting clinical documentation with the prior authorization request. Examples include office chart notes, medication history showing trials of required adjunct agents, documentation of 'off' time (see Appendix D), and relevant lab or imaging results when applicable. Lack of sufficient documentation may result in denial.

Background

Safinamide is a selective MAO‑B inhibitor approved as adjunctive therapy to levodopa/carbidopa for adults with Parkinson’s disease who experience motor fluctuations or "off" episodes. It is supplied as oral tablets (commonly 50 mg and 100 mg strengths) and is typically started at 50 mg once daily with the option to increase to 100 mg once daily if additional benefit is needed; the policy authorizes a maximum daily dose of 100 mg. Indications for coverage under this policy require that safinamide be used in combination with carbidopa/levodopa and that the member has documented "off" time despite levodopa/carbidopa therapy.

Definitions

inv-18: 'Off' time/episodes

DefinitionReturn of Parkinson’s disease motor symptoms (bradykinesia, rest tremor, or rigidity) when the L-dopa treatment effect wears off after each dosing interval; motor fluctuations between ‘on’ and ‘off’ time.

ContextOccurs while on levodopa/carbidopa therapy and is the indication for adjunctive safinamide per policy.

ContrastDistinct from dyskinesia, which typically results from excessive L-dopa exposure rather than wearing-off effects.

inv-19: Clinical policy definition

PurposeA clinical policy provides guidance on medical necessity to assist in coverage decisions and benefit administration; it is not a treatment recommendation or a contract.

BasisDeveloped by experienced clinicians using peer-reviewed literature, guidelines, regulatory status, and professional input to reflect standards of medical practice.