CurrentBlue Cross Blue Shield - IowaPolicy 05.05.03

Skyclarys (omaveloxolone) — Friedreich's ataxia: coverage criteria

This policy governs prior authorization, coverage criteria, and quantity limits for Skyclarys (omaveloxolone) for treatment of Friedreich's ataxia in Wellmark/Blue Cross and Blue Shield members and applies to prescribers and payers adjudicating benefits.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySkyclarys (omaveloxolone) — Friedreich's ataxia: coverage criteria

Policy CodePolicy 05.05.03

Change TypeNo material changes

Effective DateJul 14, 2023

Next Review Date

Key ActionSubmit prior authorization with documentation of FXN gene mutation, clinical manifestations, baseline mFARS score, age ≥16, and ambulatory status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥16minimum age for coverage

12 moauthorization duration

3/dayquantity limit

mFARS<80baseline severity

Coverage Criteria for Skyclarys (omaveloxolone)

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Initial Therapy

Covered when ALL of the following are met:

Initial approval criteria: Member has a confirmed diagnosis of Friedreich's ataxia documented by detection of a mutation of the FXN gene.

Initial approval criteria: Member demonstrates clinical manifestations of disease (examples: muscle weakness, decline in coordination, frequent falling).

Initial approval criteria: Member is 16 years of age or older.>= 16 years

Initial approval criteria: Patient is ambulatory.

Initial approval criteria: Baseline modified Friedreich's Ataxia Rating Scale (mFARS) score is < 80.< 80

Authorization may be granted for 12 months.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation authorization criteria: Member has experienced a positive clinical response to therapy (examples: slowed disease progression; improvement in or stabilization of speech or swallowing; improved or stabilized upper or lower limb coordination; improved upright stability).clinical improvement or stabilization required

Wellmark may request clinical records to confirm response; authorization may be granted for 12 months.

Use of Skyclarys is considered not medically necessary for members who do not meet the policy's required elements, including: lack of diagnostic confirmation by detection of an FXN gene mutation; absence of documented clinical manifestations of Friedreich's ataxia (for example, muscle weakness, decline in coordination, or frequent falling); being younger than 16 years of age; not being ambulatory; or having a baseline mFARS score ≥ 80 (coverage requires baseline mFARS < 80).

Coding and Quantity Limits

Procedures and billing codesmixed

N/A	No specific CPT/HCPCS/ICD codes listed

Quantity limit — Skyclarys 50 mg capsules

ProductSkyclarys (omaveloxolone) 50 mg capsules

Quantity limit3 capsules per day

RationaleLimit aligns with policy-specified daily maximum for Skyclarys 50 mg formulation

Age — minimum age for coverage

Minimum age16 years

FDA indication age rangeAdults and adolescents aged 16 years and older (FDA-approved)

Documentation requirementAge must be documented in medical record or chart notes submitted with prior authorization

Baseline mFARS — baseline score requirement for coverage

Baseline mFARS requirementModified Friedreich's Ataxia Rating Scale (mFARS) score < 80

TimingBaseline score required at time of initial authorization request

Use for eligibilitymFARS used to determine baseline disease severity for coverage determinations

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation of FXN gene mutation, clinical manifestations of Friedreich's ataxia, baseline mFARS score, age (≥ 16 years), ambulatory status, and other required items listed below.

FXN gene mutation test result
Chart notes documenting clinical manifestations (e.g., muscle weakness, decline in coordination, frequent falls)
Baseline modified Friedreich's Ataxia Rating Scale (mFARS) score (< 80)
Proof member is ≥ 16 years of age
Documentation that patient is ambulatory
Prescriber specialty or consultation note

Step Therapy

No step therapy requirements are specified in this policy.

Documentation Required

Required Initial Documentation

Initial prior authorization requests must include chart notes or medical records documenting clinical manifestations of Friedreich's ataxia and supporting evidence. Documentation should include FXN gene mutation test results, baseline mFARS score, age, ambulatory status, and prescriber specialty or consultation.

Chart notes or medical records documenting clinical signs/symptoms
FXN gene mutation testing/analysis
Baseline mFARS score documentation
Age verification (≥ 16 years)
Documentation of ambulatory status
Prescriber specialty or consultation note

Denial Risk

Denial Triggers / Not Medically Necessary Conditions

Requests will be considered not medically necessary when the patient does not meet the stated criteria for therapy. Examples that trigger denial include lack of confirmed FXN gene mutation, absence of documented clinical manifestations, baseline mFARS score ≥ 80, patient age < 16 years, non-ambulatory status, or therapy prescribed without required specialist involvement or documentation of positive clinical response for continuation.

No documented FXN gene mutation
No medical record evidence of clinical manifestations
Baseline mFARS score ≥ 80
Patient age < 16 years
Patient is non-ambulatory
Prescriber not a neurologist or specialist and no consultation note
Lack of documentation of positive clinical response for continuation requests

Background

Friedreich's ataxia is a hereditary neurodegenerative disorder characterized by progressive ataxia and related neurologic dysfunction. The policy requires a confirmed diagnosis by detection of a mutation of the FXN gene and documentation of clinical manifestations such as muscle weakness, decline in coordination, and frequent falling. Skyclarys (omaveloxolone) is indicated for treatment of Friedreich's ataxia in eligible patients aged 16 years or older, with authorization decisions tied to baseline disease severity and ambulatory status; initial approvals may be granted for 12 months when all criteria are met.

Definitions

Friedreich's ataxia — definition and diagnostic confirmation

DefinitionFriedreich's ataxia is a hereditary neurodegenerative condition characterized by clinical manifestations such as muscle weakness, decline in coordination, and frequent falling.

Diagnostic confirmationDiagnosis must be confirmed by detection of a mutation of the FXN gene (testing/analysis confirming FXN gene mutation).

Clinical evidenceMedical record or chart notes must document clinical manifestations of disease (e.g., muscle weakness, decline in coordination, frequent falling).

mFARS — modified Friedreich's Ataxia Rating Scale

mFARS definitionModified Friedreich's Ataxia Rating Scale (mFARS)

Coverage thresholdBaseline mFARS score must be < 80 for initial authorization

Role in policymFARS score is used to assess baseline disease severity and determine eligibility for Skyclarys treatment