Prior Authorization of Radicava (edaravone) - Pharmacy Services
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This bulletin establishes prior authorization requirements and clinical review criteria for prescriptions of Radicava (edaravone) for Pennsylvania Medical Assistance fee-for-service providers and enrolled pharmacies; managed care providers should contact their MCOs.
No material clinical or coverage changes in this revision.
Coverage Criteria for Radicava (edaravone)
Initial Therapy
Covered when ALL of the following are met for initial authorization:
From Section B items 1-3
From Section B item 4 a-h
From Section B item 5
Continuation / Renewal Therapy
Covered for renewals when ALL of the following are met:
From renewals Section items 1-2 and 4
From renewals Section 3a
From renewals Section 3b-d
From renewals Section 5
Dependence on invasive mechanical ventilation by tracheostomy or endotracheal intubation and receipt of enteral tube feedings are exclusionary for initial authorization of Radicava (edaravone). These clinical factors indicate a level of respiratory or nutritional support that is outside the population defined for initial eligibility in the Section B ALS-specific criteria. Documented ventilatory dependence or ongoing tube feeding should be included in the prior authorization record and will render the request ineligible under the initial-therapy criteria.
If a prior authorization request does not meet the Section B clinical review guidelines, the case will be escalated to a physician reviewer. The physician reviewer may approve the request when, in their professional judgment, the services are medically necessary to meet the beneficiary’s medical needs. Conversely, if the physician reviewer determines the services are not medically necessary, the request may be denied. This process ensures consistent application of the criteria while preserving reviewer discretion for exceptional clinical circumstances.
Key Clinical Thresholds and Coding
Provider Requirements and Authorization Process
Prior authorization required
All prescriptions for Radicava (edaravone) must be prior authorized; requests are evaluated against the clinical review guidelines in Section B to determine medical necessity.
Concomitant riluzole required unless contraindicated
Radicava is expected to be prescribed in combination with riluzole; use without riluzole is only acceptable if there is a documented contraindication or intolerance to riluzole.
Documentation required for medical necessity
Submit documentation that supports medical necessity, including diagnosis, prescriber specialty, and baseline clinical data outlined in the clinical review guidelines.
- Diagnosis that is FDA‑approved or a medically accepted indication (e.g., ALS).
- Prescribed by or in consultation with a neurologist or appropriate specialist.
- Baseline evaluation including an ALSFRS‑R score or other standardized assessment.
- Disease duration (must be less than 2 years for initial ALS authorization).
- Baseline forced vital capacity (FVC ≥ 80%).
- Status regarding mechanical invasive ventilation and tube feedings.
- Documentation of concomitant riluzole use OR documented contraindication/intolerance to riluzole, or baseline transaminases >5x ULN.
- If quantity exceeds limits, justification per Quantity Limits Chapter.
Noncompliant requests referred and at risk for denial
Requests that do not meet the Section B clinical review guidelines will be referred to a physician reviewer and may be denied if the reviewer determines the services are not medically necessary.
Background
Radicava (edaravone) is an FDA-approved treatment for amyotrophic lateral sclerosis (ALS). The Department’s Drug Utilization Review (DUR) Board recommended that prescriptions for Radicava require prior authorization to ensure appropriate patient selection and alignment with the populations studied in clinical trials and the FDA label. Prior authorization allows review personnel to confirm required baseline assessments (for example, a baseline ALSFRS-R or other standardized tool), disease duration, respiratory function (FVC), and absence of contraindications before approval.
Definitions
Initial Authorization (ALS)
Initial Authorization (ALS)
Initial prior authorization requirements specific to ALS:
From SECTION I B.4.a
From SECTION I B.4.b
From SECTION I B.4.c
From SECTION I B.4.d (exclusionary for initial eligibility)
From SECTION I B.4.e (exclusionary for initial eligibility)
From SECTION I B.4.f-g-h
From SECTION I B.5
Renewal and Continuation Criteria
Renewals
Renewal criteria for beneficiaries previously approved for Radicava:
From renewals Section 1-2 and 4
From renewals Section 3a
From renewals Section 3b-d
From renewals Section 5
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | Radicava (edaravone) must be prescribed in combination with riluzole unless the beneficiary has a documented contraindication or intolerance to riluzole (or has baseline serum transaminases >5× ULN). |
Quantity Limits and Review
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