CurrentAetnaPolicy N/A

Skysona (elivaldogene autotemcel) Precertification Request — Coverage Criteria and Provider Requirements

Precertification request form and requirements for Skysona (elivaldogene autotemcel) for Aetna members; used by providers to request start or continuation of therapy and to document required clinical information for coverage review.

Policy Summary

PayerAetna

PolicySkysona (elivaldogene autotemcel) Precertification Request — Coverage Criteria and Provider Requirements

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete Aetna precertification form and submit required clinical documentation (diagnosis of CALD, ABCD1 genetic results, VLCFA, MRI with Loes score, neurologic function score, and HSCT eligibility) via phone or fax for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1-2 pagesform length

multipleexplicit clinical items

designated centeradministration site

Coverage Criteria for Skysona (elivaldogene autotemcel)

Precertification clinical criteria

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Patient and diagnosis: Patient has a diagnosis of cerebral adrenoleukodystrophy (CALD) and is male

Form includes checkboxes for diagnosis of CALD and male sex

Expertise: Prescriber is or is consulting with a clinician who specializes in the treatment of adrenoleukodystrophy (ALD)

Specialist consultation checkbox on form

Genetic and biochemical confirmation: Genetic testing documents a pathogenic or likely pathogenic variant in ABCD1 (and full deletions of ABCD1 transgene are identified/assessed)

Form queries pathogenic/likely pathogenic ABCD1 variants and full ABCD1 deletions; VLCFA biochemical testing is also requested

VLCFA: Elevated very long chain fatty acids (VLCFA) per the laboratory reference range, if available

Form asks whether VLCFA values are elevated per lab reference

Radiographic criteria: Central radiographic review of brain MRI demonstrates early active CNS disease with Loes score between 0.5 and 9 (inclusive) on the 34‑point scale and gadolinium enhancement of demyelinating lesionsLoes 0.5-9

Form requests central MRI review, Loes score, and gadolinium enhancement status

Neurologic function: Neurologic Function Score (NFS) less than or equal to 1<=1

NFS checkbox on form

HSCT consideration: Patient is eligible for hematopoietic stem cell transplant (HSCT) but unable to find a matched sibling donor

Form queries HSCT eligibility and lack of matched sibling donor; used in clinical assessment

Treatment center: Administration will be provided at an Aetna designated gene therapy treatment center (or the designated center is identified)

Form asks whether administration will be provided at an Aetna designated gene therapy treatment center

Prior therapies: No prior receipt of the requested drug or any other gene therapy and documentation of prior allogeneic HSCT status

Form queries prior gene therapy receipt and prior allo‑HSCT as part of suitability assessment

Provider Actions and Precertification Requirements

Prior Authorization

Precertification required

Prior authorization is required. Submit an Aetna precertification request by phone or fax and complete the form indicating whether this is a start of treatment (include start date) or a continuation of therapy (include date of last treatment) for Skysona (elivaldogene autotemcel).

Use Aetna Precertification Notification contact methods shown on the form (phone/fax).
Check the appropriate box for Start of treatment or Continuation of therapy and provide the corresponding date.

Step Therapy

Document HSCT eligibility and donor status

The precertification form specifically asks whether the patient is eligible for hematopoietic stem cell transplant (HSCT) but unable to find a matched sibling donor; include this information on the form as it is used in clinical assessment.

Answer the HSCT eligibility question and indicate inability to find a matched sibling donor if applicable.

Documentation Required

Required documentation for precertification

Complete and submit the precertification form with all required patient, insurance, prescriber, dispensing/administration, product, and clinical information: patient demographics and contact information, Aetna member and other insurance IDs, prescriber credentials and specialty, place of administration/dispensing provider and CPT administration code(s), product name/dose/frequency, primary and secondary ICD codes, and all clinical items queried on the form (diagnosis of CALD, sex, specialist consultation, genetic testing/ABCD1 results, VLCFA results, central MRI review with Loes score and gadolinium enhancement, Neurologic Function Score, HSCT history/eligibility, prior gene therapy/allo‑HSCT, and designated gene therapy treatment center).

Include prescriber identifiers: state license number, NPI, DEA, and specialty.
Provide MRI central review results including Loes score (0.5–9) and gadolinium enhancement status.
Specify whether administration will occur at an Aetna designated gene therapy treatment center and name the center if yes.

Denial Risk

Incomplete information may delay or lead to denial

Incomplete or missing information may delay review or result in denial; the plan may request additional information or clarification to evaluate the request.

Ensure all fields are completed and legible; signature and date required on the acknowledgement section.
Respond promptly to any plan requests for additional information.

Note

Prescriber qualifications and specialty consultation

The prescriber must be an M.D. or D.O., or an advanced practice provider (N.P. or P.A.); the requested medication must be prescribed by or in consultation with a prescriber who specializes in the treatment of adrenoleukodystrophy (ALD).

Check the prescriber type on the form (M.D., D.O., N.P., P.A.) and indicate specialty (e.g., Neurologist).
If prescribed in consultation, document the specialist involved.

Definitions and Clinical Terms

CALD (definition and form query)

DefinitionCerebral adrenoleukodystrophy (CALD) is the diagnosis explicitly queried on the precertification form for Skysona

Form itemForm asks whether the patient has a diagnosis of CALD (Yes/No checkbox)

Exclusion queryForm asks whether CALD is secondary to head trauma (explicit checkbox)

Loes score (definition and form requirement)

DefinitionLoes score — a 34-point MRI-based scale to assess extent of cerebral demyelination

Form requirementForm requests central radiographic review of brain MRI demonstrating early active CNS disease with Loes score reported

Associated MRI itemForm also asks whether MRI demonstrates gadolinium enhancement of demyelinating lesions

VLCFA (definition and form query)

VLCFA meaningVery long chain fatty acids (VLCFA)

Form itemForm asks whether patient has elevated VLCFA values per the reference range of the laboratory performing the test (Yes/No checkbox)

Role in assessmentVLCFA biochemical testing is requested as part of the required clinical documentation for precertification

Eligibility Requirements

Eligibility for coverage consideration requires completion of the precertification form documenting that ALL required items are present: confirmation of a diagnosis of Cerebral adrenoleukodystrophy (CALD), patient sex (male), that the prescriber is or is consulting with an ALD specialist, genetic testing results for ABCD1 (pathogenic or likely pathogenic variant and absence of full ABCD1 transgene deletion where applicable), VLCFA results per the performing laboratory's reference range, central radiographic review demonstrating early active CNS disease with a Loes score between 0.5 and 9 (inclusive) and gadolinium enhancement, a Neurologic Function Score (NFS) ≤ 1, documentation of HSCT eligibility status (including whether a matched sibling donor is unavailable), and identification of the administering gene therapy treatment center. Prior receipt of gene therapy or prior allo-HSCT must also be reported on the form.