Centene Amantadine ER Coverage & Prior Auth

Coverage Criteria for Amantadine ER

Initial Therapy - Dyskinesia

Covered when ALL of the following are met:

Dyskinesia in PD initial approval: 1. Diagnosis of dyskinesia in patients with Parkinson's disease; 2. Age >= 18 years; 3. Member is receiving levodopa-based therapy; 4. Member must use immediate-release amantadine unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed one of the following: a) Gocovri 274 mg per day (2 capsules per day); or b) Osmolex ER 322 mg per day (2 tablets per day).age >= 18; dose limits: Gocovri 274 mg/day or Osmolex ER 322 mg/day

Dose phrasing and capsule/tablet counts are from product-specific dosing in policy.

Initial Therapy - PD 'Off' Episodes

Covered when ALL of the following are met:

PD with off episodes initial approval: 1. Diagnosis of Parkinson's disease; 2. Request is for Gocovri; 3. Age > 18 years; 4. Member is experiencing 'off' time on levodopa/carbidopa therapy; 5. Failure of two adjunct drugs prescribed in combination with levodopa/carbidopa, each from different classes unless contraindicated or clinically significant adverse effects are experienced (examples: MAO-B inhibitor such as rasagiline; COMT inhibitor such as entacapone; dopamine agonist such as ropinirole or pramipexole); 6. Member must use immediate-release amantadine unless contraindicated or clinically significant adverse effects are experienced; 7. Dose does not exceed 274 mg per day (Gocovri: 2 capsules per day).age > 18; prior failure of 2 adjunct agents from different classes; dose limit 274 mg/day

Prior authorization may be required for listed adjunct agents; step therapy requirement simplified per policy updates.

Initial Therapy - Drug-Induced Extrapyramidal Reactions

Covered when ALL of the following are met:

Drug-induced extrapyramidal reactions initial approval: 1. Diagnosis of a drug-induced extrapyramidal reaction; 2. Request is for Osmolex ER; 3. Age >= 18 years; 4. Member must use immediate-release amantadine unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 322 mg per day (Osmolex ER: 2 tablets per day).age >= 18; dose limit 322 mg/day

Applies specifically to Osmolex ER as the requested product.

Continued Therapy

Covered when ALL of the following are met:

Continued therapy: 1. Member meets one of the following: a) currently receiving medication via Centene benefit; or b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; or member has previously met initial approval criteria; 2. Member is responding positively to therapy (e.g., reductions in OFF time, improvement in dyskinesia); 3. If request is for a dose increase, new dose does not exceed the applicable maximum: Gocovri 274 mg per day; Osmolex ER 322 mg per day.response to therapy required; dose limits apply

Continuity of care considerations depend on state/product addenda; see full policy for details.

Recorded policy criteria updates

Policy edits and additions recorded in annual reviews (details of exact criteria located elsewhere in the full policy).

Prior authorization and indication edits: Criteria were added for Gocovri for the FDA-approved indication of Parkinson's 'off' episodes and age requirements per Gocovri and Osmolex labeling; language regarding prior trial of immediate-release amantadine was simplified in template updates.

Refer to full policy history for dated annual review details and P&T notes.

Requests for therapy with amantadine extended-release formulations for indications that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (for example, CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents. Prior authorization is required and the provider must include supporting clinical documentation to justify use for non‑labeled indications.

Use of amantadine extended‑release formulations is contraindicated in members with end‑stage renal disease. Prescriptions for members with this condition may be denied on the basis of this explicit contraindication; providers should document renal function and consider alternative therapies when applicable.

Within the cited policy excerpts, the only explicit limitation identified is the contraindication for end‑stage renal disease. No additional explicit 'not medically necessary' statements are present in these sections; other non‑FDA indications are handled per the off‑label coverage policies referenced in this document.

Dosing and Coding Information

No codes in excerptmixed

No codes listed

Gocovri — starting dose and titration

Initiation137 mg orally at bedtime (QHS) for 1 week

TitrationAfter 1 week, increase to 274 mg orally at bedtime (two 137 mg capsules)

Maximum daily dose274 mg/day (Gocovri)

Osmolex ER — starting dose and titration

Initiation129 mg orally each morning (QAM)

TitrationIncrease dose in weekly intervals per prescribing information

Maximum daily dose

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Gocovri and Osmolex ER. Provider must submit documentation (such as office chart notes, lab results, medication history, and other clinical information) demonstrating that the member meets the indication-specific approval criteria described in this policy. Approval may be denied if required documentation is insufficient or the indication is not a covered indication.

PA required for Gocovri (amantadine) and Osmolex ER (amantadine) for all covered indications
Documentation to support PA: office notes, labs, medication history, prior therapy trials, and other relevant clinical records
Denial possible if documentation is missing or the indication is not covered

Prior Authorization

Prior Authorization for Gocovri/Osmolex ER

Requests for Gocovri (approved for dyskinesia in Parkinson's disease and for PD 'off' episodes) and Osmolex ER (approved for drug-induced extrapyramidal reactions and dyskinesia per labeling) require prior authorization. For Gocovri specifically, ensure age requirements, concomitant levodopa-based therapy, and any required adjunct therapy trials (for the PD off indication) are documented. Annual review updates have added Gocovri criteria for PD 'off' episodes and age requirements per product labeling; prior authorization duration may be 12 months or the duration of the request per plan rules.

Definitions and Clinical Terms

Definition — Dyskinesia

ContextTypically related to excessive levodopa effect rather than insufficient dopamine

Targeted indicationFDA-approved indication for amantadine ER formulations (Gocovri; Osmolex ER) for dyskinesia in PD

Definition — 'Off' episodes

Clinical featuresMay include bradykinesia, rest tremor, rigidity

RelevanceGocovri is indicated as adjunctive treatment to levodopa/carbidopa for PD patients experiencing "off" episodes

Definition — Motor fluctuations

Background

Amantadine extended‑release formulations (Gocovri and Osmolex ER) are oral agents classified as NMDA receptor antagonists and are indicated to manage levodopa‑related motor complications. Gocovri is FDA‑approved for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa‑based therapy and is also indicated as adjunctive treatment for PD 'off' episodes. Osmolex ER is indicated for dyskinesia and for drug‑induced extrapyramidal reactions in adults. Recommended dosing differs by product: Gocovri initiation is typically 137 mg PO QHS for 1 week, then 274 mg PO QHS (maximum 274 mg/day), while Osmolex ER may start at 129 mg PO QAM with weekly increases to a maximum of 322 mg/day. Prescribing information for each product should be used to support dosing and safety documentation.

Revision History and Policy Updates

2021-02-13annual_review

1Q 2021 annual review: added HIM line of business; added criteria for Gocovri for the newly FDA‑approved indication of Parkinson 'off' episodes; added age requirements per labeling; simplified prior trial language for immediate‑release amantadine; references updated.

2021-10-18annual_review

1Q 2022 annual review (listed with 10.18.21 date): no significant clinical changes; commercial approval duration revised to 12 months or duration of request; Appendix D revised; references updated.

2022-11-14annual_review

OpenPayer

Amantadine ER (Gocovri; Osmolex ER)

Coverage Criteria for Amantadine ER

Dosing and Coding Information

Provider Actions and Prior Authorization Requirements

Definitions and Clinical Terms

Background

Revision History and Policy Updates