CurrentmhnPolicy CP.PMN.89

GOCOVRI (PDF)

Defines medical necessity criteria, initial and continued authorization, dosing limits, exclusions, and therapeutic alternatives for extended-release amantadine (Gocovri) for dyskinesia and 'off' episodes in Parkinson's disease across Commercial, HIM, and Medicaid lines.

Policy Summary

Payermhn

PolicyGOCOVRI (PDF)

Policy CodePolicy CP.PMN.89

Change TypeRevised (1Q 2026)

Effective DateOct 10, 2017

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria and note Illinois HIM requests bypass step therapy as of 2026-01-01 per IL HB 5395.

SourceLink

POLICY UPDATE CHANGES

Removed Osmolex ER from policy due to discontinuation; for PD with 'off' episodes, moved failure of immediate-release amantadine within the overall failure of two PD adjunct drugs; added step therapy bypass for IL HIM per IL HB 5395; aligned continued therapy requirement for concurrent carbidopa/levodopa; revised commercial approval durations to 12 months; references updated.

Changed commercial approval duration to 12 months (from length of benefit) earlier in 2021/2022 updates.

2Covered Indications

12Approval duration (months)

≥18Minimum age

≤274Max daily dose (mg)

Coverage Summary

Coverage stance: covered_with_criteria for Gocovri (amantadine ER) when used for treatment of dyskinesia in PD patients on levodopa-based therapy and as adjunctive treatment for 'off' episodes when the policy's medical necessity criteria are met. Scope applies to Commercial, HIM, and Medicaid lines of business. Contraindication relevant to coverage: end-stage renal disease. Product strengths available: 68.5 mg and 137 mg ER capsules.

Key thresholds & quick facts

Maximum daily dose≤ 274 mg/day

Maximum capsules per day≤ 2 capsules/day

Minimum age≥ 18 years

Approval duration12 months

Product strengths68.5 mg and 137 mg ER capsules

Initial Therapy — Dyskinesia in Parkinson's Disease

I. Initial Approval Criteria - A. Dyskinesia in Patients with Parkinson's Disease

must meet all

ALL of the following

Diagnosis of dyskinesia in patients with Parkinson's disease (PD)
Age ≥ 18 years
Member is receiving levodopa-based therapy
Member must use immediate-release amantadine, unless contraindicated or clinically significant adverse effects are experienced
Step therapy requirement does not apply for Illinois HIM requests as of 1/1/2026 per IL HB 5395
Dose limits

Initial Therapy — Parkinson's Disease with 'Off' Episodes

I. Initial Approval Criteria - B. Parkinson's Disease With 'Off' Episodes

must meet all

ALL of the following

Diagnosis of Parkinson's disease (PD)
Age ≥ 18 years
Member is experiencing 'off' time on levodopa/carbidopa therapy (see Appendix D)
Adjunct drug options (must fail two, from different classes)
- MAO-B inhibitor: rasagiline

Initial Therapy — Other Indications

I. Initial Approval Criteria - C. Other diagnoses/indications

must meet one of following

ANY of the following

If drug recently (within last 6 months) underwent a label change not yet reflected in this policy, follow formulary/no-coverage or non-formulary policies as applicable (CP.CPA.190; HIM.PA.33; CP.PMN.255; HIM.PA.103; CP.PMN.16)
If requested use is not listed under section III and criterion 1 does not apply, refer to off-label use policy for relevant line of business (CP.CPA.09; HIM.PA.154; CP.PMN.53)

Continuation Therapy

II. Continued Therapy - A. All Indications in Section I

must meet all

ALL of the following

ANY of the following
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy (e.g., reductions in OFF time, improvement in dyskinesia symptoms)
Member continues to receive concurrent treatment with carbidopa/levodopa

Not Authorized / Exclusions

III. Diagnoses/Indications NOT authorized

Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09; HIM.PA.154; CP.PMN.53) or evidence of coverage documents

Provider Actions / Prior Authorization

Prior Authorization

Documentation required for approval

Provider must submit documentation (office notes, labs, or other clinical information) supporting that the member has met all approval criteria.

Step Therapy

Step therapy requirement

For dyskinesia: member must use immediate-release amantadine prior to Gocovri unless contraindicated or clinically significant adverse effects occur. For Parkinson's disease with 'off' episodes: failure of two adjunct drugs prescribed with levodopa/carbidopa, from different classes (options include a MAO-B inhibitor [rasagiline], a COMT inhibitor [entacapone/tolcapone], a dopamine agonist [ropinirole/pramipexole], or immediate‑release amantadine) is required. Note: prior authorization may be required for the listed adjunct agents.

Applicable Codes & Product Availability

Product availability (strengths)NDC|mixed

68.5 mg	Extended-release capsule strength
137 mg	Extended-release capsule strength

Product strengths listed are the available Gocovri extended-release capsule strengths: 68.5 mg and 137 mg. For billing and coverage decisions, note the policy contraindication: end-stage renal disease.

Clinical Evidence & References

Evidence sources cited in the policy include the FDA Prescribing Information (Gocovri Prescribing Information, Adamas Pharma; July 2025) and an evidence/guideline review: Mov Disord. 2025;40(5):776-794 (update on treatments for PD motor fluctuations).

Background

Background: Gocovri (amantadine ER) is an extended-release formulation indicated for treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy and as adjunctive treatment to levodopa/carbidopa for patients experiencing 'off' episodes. Available as extended-release capsules in 68.5 mg and 137 mg strengths. Contraindication: end-stage renal disease.

Definitions

Off time/episodesReturn of PD symptoms (bradykinesia, rest tremor, or rigidity) when L-dopa effect wears off after each dosing interval.

DyskinesiaInvoluntary movements typically resulting from too much levodopa.

Revision History

2026-02-26materialLatest

1Q 2026 annual review: removed Osmolex ER from policy due to discontinuation; for PD with 'off' episodes, moved failure of immediate-release amantadine within the overall requirement to fail two PD adjunct drugs from different classes; added step therapy bypass for Illinois HIM per IL HB 5395 (step therapy requirements do not apply for Illinois HIM requests as of 1/1/2026); aligned continued therapy requirement for concurrent carbidopa/levodopa; revised commercial approval durations to 12 months; references reviewed and updated.

2021-10-18administrative

Administrative change to approval duration: changed commercial approval duration to 12 months (from length of benefit or duration of request, whichever is less) during 1Q 2022 updates.