CurrentCignaPolicy N/A

Parkinson's Disease - Amantadine Extended-Release Products Prior Authorization with Step Therapy

Defines prior authorization, step therapy, and documentation requirements for coverage of extended-release amantadine products (Gocovri, Osmolex ER) for Parkinson's disease and drug-induced extrapyramidal reactions for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyParkinson's Disease - Amantadine Extended-Release Products Prior Authorization with Step Therapy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateMar 25, 2025

Key ActionObtain prior authorization and document trial of immediate-release amantadine (or justify intolerance) and specialist consultation for approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2extended-release products named

3 monthsinitial approval duration

1 yearcontinuation approval duration

requireddocumentation required

neurologistspecialist prescribing

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Coverage Criteria for Amantadine Extended‑Release Products

Gocovri (amantadine ER) — FDA‑Approved Indication (Parkinson's Disease)

Covered when ONE of the following is met

Gocovri approval options

Initial Therapy (A): i. Patient meets ONE of the following (a or b): a) Patient is experiencing dyskinesia; OR b) Patient is experiencing 'off' episodes (examples include muscle stiffness, slow movements, or difficulty starting movements); ii. Patient is currently receiving levodopa-based therapy (e.g., carbidopa/levodopa); iii. Patient has tried immediate-release amantadine (capsules, tablets, or oral solution) and meets ONE of the following (a or b): a) Patient derived benefit from immediate-release amantadine but had intolerable adverse events, as determined by the prescriber [documentation required]; OR b) Patient could not achieve a high enough dosage to gain adequate benefit, as determined by the prescriber [documentation required]; iv. Medication is prescribed by or in consultation with a neurologist
Initial approval duration 3 months
Continuation Therapy (B): i. Patient is currently receiving levodopa-based therapy (e.g., carbidopa/levodopa); ii. Patient has tried immediate-release amantadine (capsules, tablets, or oral solution) and meets ONE of the following (a or b): a) Patient derived benefit from immediate-release amantadine but had intolerable adverse events, as determined by the prescriber [documentation required]; OR b) Patient could not achieve a high enough dosage to gain adequate benefit, as determined by the prescriber [documentation required]; iii. Patient has had a response to therapy (e.g., decrease in dyskinesia, decrease in 'off' episodes), as determined by the prescriber; iv. Medication is prescribed by or in consultation with a neurologist
Continuation approval duration 1 year

Osmolex ER (amantadine ER) — FDA‑Approved Indications (Drug‑Induced Extrapyramidal Reactions; Parkinson's Disease)

Covered when ONE of the following is met

Osmolex ER approval options for extrapyramidal reactions

Initial Therapy for drug-induced extrapyramidal reactions (A): i. Patient has tried immediate-release amantadine (capsules, tablets, or oral solution) and meets ONE of the following (a or b): a) Patient derived benefit from immediate-release amantadine but had intolerable adverse events, as determined by the prescriber [documentation required]; OR b) Patient could not achieve a high enough dosage to gain adequate benefit, as determined by the prescriber [documentation required]; ii. Medication is prescribed by or in consultation with a neurologist
Initial approval duration 3 months
Continuation Therapy for drug-induced extrapyramidal reactions (B): i. Patient has tried immediate-release amantadine (capsules, tablets, or oral solution) and meets ONE of the following (a or b): a) Patient derived benefit from immediate-release amantadine but had intolerable adverse events, as determined by the prescriber [documentation required]; OR b) Patient could not achieve a high enough dosage to gain adequate benefit, as determined by the prescriber [documentation required]; ii. Patient has had a response to therapy (e.g., decrease in extrapyramidal reactions), as determined by the prescriber; iii. Medication is prescribed by or in consultation with a neurologist

Osmolex ER approval options for Parkinson's Disease

Covered when ONE of the following is met

Osmolex ER PD options

Initial Therapy for Parkinson's Disease (A): i. Patient has tried immediate-release amantadine (capsules, tablets, or oral solution) and meets ONE of the following (a or b): a) Patient derived benefit from immediate-release amantadine but had intolerable adverse events, as determined by the prescriber [documentation required]; OR b) Patient could not achieve a high enough dosage to gain adequate benefit, as determined by the prescriber [documentation required]; ii. Medication is prescribed by or in consultation with a neurologist
Initial approval duration 3 months
Continuation Therapy for Parkinson's Disease (B): i. Patient has tried immediate-release amantadine (capsules, tablets, or oral solution) and meets ONE of the following (a or b): a) Patient derived benefit from immediate-release amantadine but had intolerable adverse events, as determined by the prescriber [documentation required]; OR b) Patient could not achieve a high enough dosage to gain adequate benefit, as determined by the prescriber [documentation required]; ii. Patient has had a response to therapy (e.g., decrease in dyskinesia), as determined by the prescriber; iii. Medication is prescribed by or in consultation with a neurologist
Continuation approval duration 1 year

Gocovri® (amantadine extended‑release) and Osmolex® ER (amantadine extended‑release) are considered not medically necessary for uses other than the specific indications listed in this policy. The policy’s coverage criteria define the covered indications and required documentation; these criteria will be updated as new published data become available.

Use of Gocovri or Osmolex ER for any indication not specified in this policy is considered not medically necessary.

Referenced Product and Coding

Referenced Prescribing InformationNDC

Gocovri PI (Adamas) - July 2025	Gocovri® extended-release capsules prescribing information
Osmolex ER PI (Vertical) - July 2025	Osmolex® ER extended-release tablets prescribing information
Amantadine capsules PI (Alembic) - June 2025	Amantadine capsules prescribing information
Amantadine tablets PI (Teva) - June 2025	Amantadine tablets prescribing information
Amantadine oral solution PI (Akorn) - July 2022	Amantadine oral solution prescribing information

Provider Requirements, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for amantadine extended-release products. Typical approval durations: initial approvals for new starts are for 3 months; approvals for patients currently receiving an amantadine extended-release product are for 1 year. Approvals are provided for the duration noted and when expressed in months, 1 month = 30 days. Amantadine extended-release products must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization required for Gocovri and Osmolex ER
Initial therapy approvals: 3 months
Continuation (currently receiving product): 1 year
1 month = 30 days

Step Therapy

Step Therapy — Immediate‑Release Amantadine Trial Required

A trial of immediate‑release amantadine (capsules, tablets, or oral solution) is required prior to approval of amantadine extended‑release products unless the prescriber documents intolerance, contraindication, or inadequate dosing/response. Documentation should specify the formulation tried, dosing, duration, and clinical response or adverse events that justify bypassing step therapy.

Product Definitions

inv-12: Gocovri — key-value summary of product

IndicationExtended-release amantadine (Gocovri) is indicated for dyskinesia in patients receiving levodopa-based therapy and for 'off' episodes as adjunctive treatment to levodopa/carbidopa in Parkinson's disease.

FormulationExtended-release capsules (amantadine ER).

Typical use / coverage specificsPrior authorization required. Initial approvals: 3 months for new starts if patient has trialed immediate‑release amantadine (with documented benefit but intolerable adverse events, or inability to achieve adequate dose) and prescription is by or in consultation with a neurologist. Continuation approvals: 1 year if already receiving Gocovri with documented response and neurologist involvement.

Related immediate‑release productsImmediate‑release amantadine available as capsules, tablets, and oral solution; a prior trial or documented justification is required before extended‑release approval.

inv-13: Osmolex ER — key-value summary of product

Background

Amantadine extended‑release formulations (marketed as Gocovri and Osmolex ER) are oral, extended‑release amantadine products used in clinical practice for Parkinson’s disease–related motor complications (including dyskinesia and ‘off’ episodes) and, for Osmolex ER, for drug‑induced extrapyramidal reactions. Immediate‑release amantadine formulations are also available and are referenced in the policy’s step‑therapy and prior‑authorization requirements.