Amyotrophic lateral sclerosis (ALS) agents prior authorization
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Defines prior authorization criteria for select ALS medications for Georgia Medicaid Fee-For-Service members, including eligibility, required trial/failure steps, exceptions process, and authorization length.
No material clinical or coverage changes in this revision.
Coverage Criteria for ALS Agents
Exservan and Tiglutik - Initial Coverage
Covered when ALL of the following are met:
Applies to Exservan and Tiglutik.
Radicava ORS - Initial Coverage
Covered when ALL of the following are met:
Logical OR used for two alternative pathways to approval.
Relyvrio - Initial Coverage
Covered when ALL of the following are met:
Requires prior failure/intolerance to both riluzole and edaravone products.
Exceptions to the conditions of coverage may be requested and are considered through the prior authorization process. To initiate an exceptions review, contact OptumRx at 1-866-525-5827 and provide clinical rationale and supporting documentation demonstrating why the standard coverage criteria cannot be met for the member.
Named Products and Codes
| Riluzole tablet (generic) | Riluzole tablet generic |
| Exservan | Exservan (riluzole oral film) -- Non-Preferred |
| Radicava ORS | Radicava ORS (edaravone oral suspension) |
| Relyvrio | Relyvrio (sodium phenylbutyrate/taurursodiol) |
| Tiglutik | Tiglutik (riluzole oral suspension) |
Provider Actions, Documentation, and Authorization
Prior authorization required; 1-year approvals
Prior authorization is required for Exservan, Tiglutik, Radicava ORS, and Relyvrio and is approvable when the specific drug-level criteria are met; authorizations are issued for a 1‑year period.
Step therapy requirements for edaravone and combination therapy
Follow the policy's step therapy pathways: Radicava ORS requires prior inadequate response, allergy, contraindication, drug–drug interaction, or intolerable side effect to riluzole tablets (Rilutek), or — if the member is unable to swallow solids — the same failure/intolerance with riluzole oral film or suspension (Exservan, Tiglutik). Relyvrio requires prior inadequate responses, allergies, contraindications, drug–drug interactions, or intolerable side effects to both riluzole (Rilutek, Exservan, Tiglutik) and edaravone products (Radicava, Radicava ORS).
- Radicava ORS: failure/intolerance to riluzole tablets OR (unable to swallow solids AND failure/intolerance to riluzole oral film/suspension).
- Relyvrio: failure/intolerance to riluzole products AND edaravone products.
Required clinical documentation to support PA
Submit clinical documentation that verifies the member has a diagnosis of amyotrophic lateral sclerosis (ALS), is 18 years of age or older, and — where applicable — documents prior inadequate response, allergy, contraindication, drug–drug interaction, or intolerable side effect to the specified prior agent(s) or inability to swallow solid oral formulations.
- ALS diagnosis documentation.
- Member age (≥ 18 years).
- Documentation of prior inadequate response, allergy, contraindication, drug–drug interaction, or intolerable side effect to required prior agents when step therapy applies.
- Documentation of inability to swallow solid oral dosage formulations when approval pathway relies on that criterion.
Denial risk for missing trials or criteria
Requests that do not document the required prior trial(s), member age (≥18), ALS diagnosis, or required intolerance/allergy/contraindication/drug–drug interaction or inability to swallow solids may be denied.
- Missing documentation of prior inadequate response or intolerance to riluzole or edaravone when required.
- Missing proof of ALS diagnosis or member age ≥18.
- Missing documentation of inability to swallow solid oral formulations when that pathway is used.
Background
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease affecting motor neurons. Disease-modifying agents covered under this policy include riluzole formulations (tablet, oral film, oral suspension), edaravone formulations (intravenous and oral suspension), and combination therapy (sodium phenylbutyrate/taurursodiol). Coverage and prior authorization requirements vary by product and depend on the member having a documented diagnosis of ALS, being 18 years of age or older, and meeting drug-specific prior trial or formulation criteria (for example, inability to swallow solids or prior inadequate response/intolerance to specified agents).
Definitions
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