CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 2304-3

Skyclarys (omaveloxolone) prior authorization and medical necessity

Defines prior authorization and medical necessity criteria for Skyclarys (omaveloxolone) for treatment of Friedreich's ataxia in adults and adolescents (≥16 years) for Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySkyclarys (omaveloxolone) prior authorization and medical necessity

Policy CodePolicy 2025 P 2304-3

Change TypeNo material changes

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of Friedreich's ataxia, confirmed FXN gene mutation, and prescription by or consultation with an approved specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization period

≥16age indication

3specialist prescribers

2023-2025P&T review

Coverage and Authorization Criteria

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inv-01: Initial Authorization

Covered when ALL of the following are met

Initial Authorization: Member has a diagnosis of Friedreich's ataxia; confirmed presence of a mutation in the frataxin (FXN) gene; and medication is prescribed by, or in consultation with, a neurologist, neurogeneticist, or physical medicine and rehabilitation physician (physiatrist).

Authorization issued for 12 months.

inv-02: Reauthorization

Covered when ALL of the following are met

Reauthorization: Documentation of positive clinical response to Skyclarys therapy; and medication is prescribed by, or in consultation with, a neurologist, neurogeneticist, or physical medicine and rehabilitation physician (physiatrist).

Authorization issued for 12 months.

State and federal mandates and member-specific benefit plan terms may further affect coverage determinations for Skyclarys (omaveloxolone). In addition, automated approval or re‑approval processes that rely on prior claim/medication history, diagnosis codes, and claim logic may be used by the payer, and supply limits may apply.

Initial Therapy Requirements

inv-11: Initial Therapy

Covered when ALL of the following are met

Initial Therapy: Diagnosis of Friedreich's ataxia; confirmed FXN gene mutation; prescribed by or in consultation with a neurologist, neurogeneticist, or physical medicine and rehabilitation physician (physiatrist).

Authorization issued for 12 months.

Continuation / Reauthorization Requirements

inv-12: Continuation Therapy

Reauthorization / continuation therapy requirements

Continuation: Documentation of positive clinical response to Skyclarys therapy and continued prescribing by or in consultation with a neurologist, neurogeneticist, or physical medicine and rehabilitation physician (physiatrist).

Authorization issued for 12 months.

Provider Requirements and Administrative Actions

Prior Authorization

Initial Authorization Requirements

Initial authorization requires documented diagnosis of Friedreich's ataxia, genetic confirmation of a pathogenic mutation in the frataxin (FXN) gene, and that the medication is prescribed by or in consultation with an appropriate specialist. Authorization is issued for 12 months.

Diagnosis: Friedreich's ataxia
Genetic confirmation: mutation in the frataxin (FXN) gene
Prescriber specialty: Neurologist; Neurogeneticist; Physical Medicine and Rehabilitation physician (physiatrist)
Authorization duration: 12 months

Prior Authorization

Reauthorization Requirements

Reauthorization requires documented positive clinical response to Skyclarys and continued prescribing or consultation by an appropriate specialist. Authorization is issued for 12 months.

Documentation of positive clinical response to therapy
Prescriber specialty: Neurologist; Neurogeneticist; Physical Medicine and Rehabilitation physician (physiatrist)
Authorization duration: 12 months
State mandates, federal requirements, and member benefit plan may affect coverage

Billing Rule

Automated Processes and Supply Limits

Automated approval and re-approval processes may be used based on prior claim or medication history, diagnosis codes (ICD-10), and/or claim logic. Supply limits may apply.

Automated processes: approvals may be granted using prior claim/medication history and claim logic
Supply limits: quantity or duration limits may be enforced

Documentation Required

Required Documentation

Required documentation must be submitted to support both initial authorization and reauthorization and should include diagnosis, genetic confirmation, and documentation of prescriber specialty or consultation as applicable.

Clinical documentation: medical records supporting diagnosis of Friedreich's ataxia
Genetic test report: documentation of FXN gene mutation
Prescribing information: note indicating prescribing provider specialty or consultation details
For reauthorization: documentation of positive clinical response

Denial Risk

Triggers for Denial

Coverage will be denied if required criteria or documentation are missing. Common triggers for denial include absence of the required diagnosis, lack of documented FXN genetic confirmation, or prescribing by a provider who is not a listed specialty or lacks documented consultation with one.

Missing diagnosis of Friedreich's ataxia
No documented FXN gene mutation confirmation
Prescribing provider is not a Neurologist, Neurogeneticist, or Physiatrist and no documented specialist consultation

Step Therapy / Automated Approval Rules

Step	Requirement
1	Automated approval or re‑approval may be used based on prior claim/medication history and diagnosis codes (ICD‑10); use of automated processes varies by program and/or therapeutic class. Supply limits may apply.

Quantity and Supply Limits

inv-14: Skyclarys (omaveloxolone) — may be subject to supply limits

Supply limitsMay be subject to supply limits; supply limits may be in place and automated approval/re‑approval processes can be used.

Automated approvalsInitial and reauthorization approvals may be granted based on prior claim/medication history, diagnosis codes (ICD‑10), and claim logic via automated processes.

Program variabilityUse of automated approval and re‑approval processes varies by program and therapeutic class.

Background and Indication

Skyclarys (omaveloxolone) is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. Coverage under this policy is linked to molecular confirmation of disease — specifically a confirmed mutation in the frataxin (FXN) gene — and requires that the medication be prescribed by, or in consultation with, an appropriate specialist (neurologist, neurogeneticist, or physiatrist). Authorization durations for both initial and continuation therapy are set at 12 months.

For operational purposes, providers should document the diagnosis, FXN gene mutation confirmation, and specialist involvement when requesting prior authorization. Note that payer programs may use automated rules based on prior claims and diagnosis codes to approve or reauthorize therapy, and that supply limits may be enforced under plan or program rules.

Key Definitions

inv-10: Friedreich's ataxia — defined and requirement for confirmed FXN mutation noted

DefinitionFriedreich's ataxia: a genetic neurodegenerative disorder for which Skyclarys is indicated; policy requires confirmed mutation in the frataxin (FXN) gene.

Molecular confirmationCoverage requires confirmed presence of a mutation in the frataxin (FXN) gene.

Age indicationIndicated for adults and adolescents aged ≥16 years.

Specialist involvementMedication must be prescribed by, or in consultation with, a neurologist, neurogeneticist, or physical medicine and rehabilitation physician (physiatrist).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySkyclarys (omaveloxolone) prior authorization and medical necessity

Policy CodePolicy 2025 P 2304-3

Change TypeNo material changes

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of Friedreich's ataxia, confirmed FXN gene mutation, and prescription by or consultation with an approved specialist.

SourceLink

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