Amyotrophic Lateral Sclerosis (ALS) — Pharmacy Management Drug Policy
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Defines pharmacy coverage, prior authorization and recertification requirements for FDA-approved and related ALS drugs (riluzole oral suspension, edaravone formulations, others noted) for Univera Healthcare members across listed product lines.
No material clinical or coverage changes in this revision.
Coverage Criteria for ALS Therapies
Tiglutik (riluzole oral suspension) — Initial
Covered when ALL of the following are met
Temporary FDA authorization (effective January 2024) permitting importation of Teglutik to mitigate Tiglutik shortage.
Radicava / generic edaravone — Initial and Recertification
Covered when ALL of the following are met
Recommended dosing and quantity limits for Radicava (IV and oral suspension) are specified in policy; ORS quantity limits: 50 mL — 1 per 28 days; 70 mL — 1 per 365 days.
General drug approval and recertification
Covered when ALL of the following are met
Required for continued approval.
Recertification reviews may require trial of preferred agents unless contraindicated; coverage/utilization management is contract dependent.
Requests for Radicava (intravenous edaravone) and generic edaravone are limited to FDA‑approved indications for amyotrophic lateral sclerosis (ALS). Per policy, Radicava and generic edaravone will not be covered for any other non‑FDA approved indication.
This policy does not apply to Medicare Part D and D‑SNP pharmacy benefits; consult the member's specific benefit for Part D coverage. Additionally, physician‑administered drugs may be excluded from coverage under Medicaid Managed Care/HARP if the drug manufacturer does not participate in the Medicaid Drug Rebate Program (MDRP). Providers should review contract/benefit language because utilization management and coverage are contract dependent.
Continued coverage for edaravone (Radicava or generic) requires documentation at recertification. The provider must attest that the patient continues to benefit from therapy and that the patient is not dependent on invasive ventilation or tracheostomy, unless the tracheostomy is in place solely for the prevention of aspiration. Dependence on invasive ventilation or tracheostomy for respiratory support is inconsistent with recertification requirements and may preclude continued coverage.
Billing and procedure codes listed in this policy may not be covered in every situation; eligibility for reimbursement is determined by the member's contract and benefits. Items and codes designated Experimental/Investigational (E/I) or Not Medically Necessary/Appropriate (NMN) per the policy's code key are not covered as indicated. Providers should review the policy guidelines and applicable code key when submitting claims.
Coding
| J1301 | Radicava and edaravone injection, J-code (if assigned) |
Provider Actions, Prior Authorization, and Documentation
Prior authorization: neurologist attestation and 6‑month approvals
Prior authorization is required for listed ALS drugs. The prescriber (or consulting) neurologist/ALS specialist must attest to the ALS diagnosis and eligibility per the drug-specific criteria. Initial and recertification approvals are for 6 months unless otherwise stated in individual drug criteria.
- Prescriber or consulting neurologist/ALS specialist attestation of diagnosis and eligibility is required.
- Initial and recertification requests will be for 6 months at a time (unless individual drug criteria state otherwise).
Prior authorization requirement and utilization management notes
Prior authorization is required per this policy for covered ALS drugs; some products (including medical-administered formulations) require PA before criteria are added. Utilization management and PA requirements may be contract dependent.
- Refer to contract/benefit language for exclusions and PA applicability.
- This policy applies to drugs included on a formulary; non-formulary products should follow Non-Formulary Medication Exception Review procedures.
Recertification may require trial of cost‑effective alternatives
At recertification, the plan may require the member to have trialed more cost‑effective alternatives (e.g., generics or other guideline-supported options) as they become available; recertification may reflect the current preferred formulary.
- Recertification reviews may result in requirement to try generics or other guideline-supported treatment options when available.
- Ongoing use must reflect the current policy's preferred formulary.
Preferred drug trial / step therapy exceptions — documentation required
Trials of preferred drugs may be required as part of coverage criteria. Exceptions to step therapy are permitted if the provider documents that the preferred drug is contraindicated, previously failed, expected to be ineffective, would pose risk to adherence, or if the patient is clinically stable on the requested therapy.
- Provider must document rationale and supporting evidence for exceptions (e.g., contraindication, prior failure, likely ineffectiveness, risk to adherence, or patient stability).
- Supportive documentation of previous drug use must be submitted when required and not present in claims history.
Recertification requires documentation of ongoing benefit
Recertification requests must include documentation demonstrating the drug provides ongoing benefit, such as progress notes, imaging, laboratory findings, or other objective or subjective measures.
- Documentation must show improvement or stability in disease state or condition.
- Dose and frequency must align with FDA label or recognized compendia.
Required clinical documentation for initial and recertification requests
Clinical documentation must be submitted for each initial and recertification request unless otherwise specified; acceptable supporting documentation includes progress notes, diagnostic testing, lab results, genetic/biomarker results, imaging, and documentation of previous treatments.
- Submit progress notes documenting previous treatments/treatment history.
- Include diagnostic testing, laboratory or genetic testing results, imaging, and other objective/subjective measures as applicable.
Denial risk: non‑FDA indications and invasive ventilation/tracheostomy dependence
Requests for Radicava or generic edaravone will be denied if intended for any non‑FDA approved indication. Requests will also be denied if the patient is dependent on invasive ventilation or a tracheostomy, unless the tracheostomy is for prevention of aspiration only.
- Radicava and generic edaravone are not covered for non‑FDA approved indications.
- Continuation is contingent on attestation that the patient is not dependent on invasive ventilation or tracheostomy (unless trach is for aspiration prevention).
Contract-dependent exclusions — verify contract/benefit language
Coverage and utilization management are contract dependent; drugs referenced in this policy may be excluded by specific contract or benefit language—failure to follow contract/benefit provisions can result in denial.
- Refer to specific contract/benefit language for exclusions of injectable or other medications.
- This policy does not apply to Medicare Part D and D‑SNP pharmacy benefits.
Background
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease affecting both upper and lower motor neurons, leading to progressive muscle weakness and eventual respiratory compromise. Diagnosis is clinical and may use established criteria such as the revised El Escorial/Awaji or Gold Coast criteria; evaluations can include electromyography and genetic testing. Management is multidisciplinary and may include FDA‑approved disease‑modifying therapies (for example, riluzole formulations and edaravone) alongside supportive care. The clinical course is variable but frequently leads to respiratory failure over several years.
Definitions and Diagnostic Criteria
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