Clinical Policy: Amantadine ER (Gocovri)
Customize your policy alerts
Sign up for meridian Policy MDN.CP.PMN.89 alerts
Get alerted when Policy MDN.CP.PMN.89 changes without checking for updates manually.
Monitor payer policy activity
Defines medical necessity, prior authorization, and coverage criteria for Gocovri (amantadine ER) for dyskinesia and 'off' episodes in Parkinson's disease for Meridian lines of business.
Removed Osmolex ER from policy due to discontinuation.
For PD with 'off' episodes, moved the failure of immediate‑release amantadine within the overall failure of two PD adjunct drugs.
For continued therapy, aligned initial therapy requirement for concurrent treatment with carbidopa/levodopa.
Coverage Criteria for Gocovri (amantadine ER)
inv-03: Continuation Therapy
Continued therapy covered when ALL of the following are met
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the plan's off‑label use policy (see CP.PMN.53 for Medicaid) or other applicable evidence‑of‑coverage documentation.
Osmolex ER has been removed from this policy due to product discontinuation and is no longer listed as a therapeutic option or comparator in the policy materials.
Use of amantadine ER (Gocovri) for non‑FDA‑approved indications without sufficient documentation of efficacy and safety per the off‑label use policy is not authorized and will be considered not covered absent supporting evidence.
Dosing and Coding Highlights
Provider Requirements and Prior Authorization
Prior authorization required — document all initial criteria
Prior authorization is required. The provider must demonstrate the member meets all initial approval criteria including diagnosis of dyskinesia or PD as applicable, age ≥ 18 years, concurrent carbidopa/levodopa–based therapy, trial of immediate‑release amantadine unless contraindicated or clinically significant adverse effects, and that the prescribed dose does not exceed 274 mg/day.
- Demonstrate diagnosis and age requirement
- Confirm concurrent carbidopa/levodopa therapy
- Document IR amantadine trial or contraindication
- Verify dose ≤ 274 mg/day
Prior authorization considers dosing/titration and prior therapy
Prior authorization decisions will consider the recommended titration schedule and maintenance dose: start 137 mg PO QHS for 1 week then increase to 274 mg PO QHS; prior therapy failures as specified in the policy will also be evaluated.
- Week 1: 137 mg PO QHS
- After week 1: increase to 274 mg PO QHS (maintenance)
Step therapy — document failure of two adjunct drug classes
For Parkinson disease with 'off' episodes, coverage requires documented failure of two adjunct drugs prescribed with levodopa/carbidopa, each from different classes (MAO‑B inhibitor, COMT inhibitor, dopamine agonist), unless clinically significant adverse effects or contraindications exist.
- MAO‑B inhibitor: selegiline
- COMT inhibitor: entacapone
- Dopamine agonists: ropinirole or pramipexole
Expect prior trials/failures including IR amantadine
The policy expects prior trials/failures of Parkinson adjunctive medications before approval; immediate‑release amantadine must be used unless contraindicated or causes clinically significant adverse effects.
- IR amantadine trial required unless contraindicated or intolerant
- Prior adjunctive therapy failures should be documented
Required documentation — include clinical notes and med history
Submit supporting clinical documentation with the prior authorization request — examples include office chart notes, laboratory results, or other clinical information that show the member meets all approval criteria.
- Office chart notes documenting diagnosis, symptoms, and response
- Records of prior medication trials, adverse effects, or contraindications
- Medication history confirming concurrent carbidopa/levodopa use
Policy revision — prior treatment history and IR amantadine clarified
Policy revisions clarify expectations about prior treatment history: failure of two PD adjunct drugs (from different classes) and the positioning/requirement of immediate‑release amantadine within that failure sequence are relevant to approval decisions.
- Failure sequencing and IR amantadine placement updated in 1Q2026 review
- Concurrent carbidopa/levodopa use emphasized for continued therapy
Denial risk — insufficient documentation or off‑label use
Requests may be denied if documentation does not show the member met all approval criteria, or if the request is for a non‑FDA indication without sufficient off‑label documentation per the off‑label use policy.
- Lack of clinical records verifying prior trials/failures or concurrent levodopa/carbidopa
- Insufficient evidence for non‑FDA indications per CP.PMN.53
Operational impact — formulary/product and criteria changes
Operational changes such as removal of Osmolex ER from the formulary and updates to adjunct‑failure ordering or concurrent therapy requirements may lead to denials if submitted documentation does not reflect the revised criteria.
- Osmolex ER removed due to discontinuation (1Q2026 review)
- Ensure documentation matches current adjunct‑failure and concurrent therapy requirements
Background
Amantadine extended‑release (Gocovri) is an extended‑release formulation of amantadine and a weak uncompetitive N‑methyl‑D‑aspartate (NMDA) receptor antagonist indicated to reduce dyskinesia in patients with Parkinson disease who are receiving levodopa‑based therapy and for adjunctive treatment of "off" episodes. Dyskinesia commonly results from excessive dopaminergic effect of levodopa, while "off" episodes represent a return of Parkinson disease motor symptoms when the effect of levodopa wanes. Gocovri is supplied in extended‑release capsule strengths and is dosed using a nightly titration schedule to a maximum maintenance dose of 274 mg/day.
Definitions
Policy Revision History
Removed Osmolex ER from the policy due to discontinuation; moved the placement of immediate‑release amantadine within the failure sequence for PD with 'off' episodes; and aligned continued therapy requirement to specify concurrent carbidopa/levodopa use; references reviewed and updated.
Template changes applied to diagnoses/indications and continued therapy section; references reviewed and updated.
Policy originally created (initial document date recorded).
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.