CurrentBlue Cross Blue Shield - MassachusettsPolicy N/A

Lenmeldy (atidarsagene autotemcel) — Coverage and Prior Authorization Criteria

Coverage and prior authorization requirements for Lenmeldy (atidarsagene autotemcel) for treatment of metachromatic leukodystrophy (MLD) and instructions for providers on documentation and authorization submission.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyLenmeldy (atidarsagene autotemcel) — Coverage and Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit initial authorization requests via Authorization Manager and include required clinical documentation confirming MLD and transplant-readiness evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3required diagnostic evidence items listed

5pre-transplant adequacy checks enumerated

3billing codes provided

Auth Managerprior authorization method

Coverage Criteria for Lenmeldy (atidarsagene autotemcel)

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Initial therapy eligibility

Covered when ALL of the following are met

Diagnostic confirmation: Confirmed diagnosis of metachromatic leukodystrophy (MLD) by gene sequencing and/or deletion/duplication assessment identifying biallelic ARSA pathogenic or likely pathogenic variants

Proband-specific requirements: If a proband individual, must have ARSA enzyme activity in leukocytes below reference values AND urinary sulfatide levels above reference values

Document laboratory reference ranges and results

Subtype eligibility: Confirmed diagnosis of one of the following subtypes: pre-symptomatic late infantile; pre-symptomatic early juvenile; early symptomatic early juvenile

See Policy Guidelines for subtype definitions

Transplant/institutional readiness: Meet institutional requirements for a stem cell transplant procedure where the individual is expected to receive gene therapy, which may include adequate performance status (e.g., Karnofsky/Lansky), absence of advanced liver disease, adequate eGFR, adequate DLCO, adequate LVEF, and absence of clinically significant active infection(s)

Specific threshold values not listed in document

Prior therapies: Have not received a previous allogeneic hematopoietic stem cell transplant or prior gene therapy

Individuals who have previously received an allogeneic hematopoietic stem cell transplant or prior gene therapy are excluded from coverage for Lenmeldy (atidarsagene autotemcel). This exclusion mirrors the policy requirement that candidates for treatment must not have previously undergone these therapies.

If a patient does not meet all listed diagnostic, subtype, or transplant-readiness criteria, the treatment request may be considered not medically necessary unless an approved Clinical Exception is granted. Providers should submit a letter of medical necessity requesting an exception and include the required clinical documentation described in the policy to support why an exception is justified.

Required documentation includes confirmation of MLD (biallelic ARSA pathogenic or likely pathogenic variants by gene sequencing and/or deletion/duplication assessment), proband-specific laboratory evidence when applicable (ARSA leukocyte enzyme activity below reference and urinary sulfatide above reference), subtype classification, and evidence of institutional transplant readiness (e.g., performance status, absence of advanced liver disease, adequate eGFR, DLCO, LVEF, and absence of clinically significant active infection).

Provider Submission, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization: Initial authorization requests must be submitted via Authorization Manager (available 24/7). Authorization Manager is the preferred and quickest method to review requirements, request authorizations, submit clinical documentation, check case status, and view/print decision letters. For out-of-network providers, requests may be faxed to 888-973-0726.

Enter the appropriate surgeon's NPI or provider ID as the servicing provider (not the billing group).
Enter the facility's NPI or provider ID for the place where services will be performed.

Documentation Required

Required Clinical Documentation

Submit documentation supporting medical necessity for Lenmeldy (atidarsagene autotemcel). If the patient does not meet all listed criteria, submit a Letter of Medical Necessity requesting a Clinical Exception (Individual Consideration) explaining why an exception is justified. Clinical documentation must include genetic confirmation and relevant laboratory and clinical assessments.

Genetic testing demonstrating biallelic pathogenic or likely pathogenic ARSA variants (gene sequencing and/or deletion/duplication assessment).
If a proband, ARSA enzyme activity in leukocytes below reference values and urinary sulfatide levels above reference values.
Documentation of MLD subtype classification (pre-symptomatic late infantile; pre-symptomatic early juvenile; early symptomatic early juvenile).
Institutional requirements for stem cell transplant candidacy (performance status such as Karnofsky or Lansky, absence of advanced liver disease, acceptable eGFR, acceptable DLCO, adequate LVEF, absence of clinically significant active infection).

Note

Administrative Patient and Facility Information

Administrative patient and facility information must be provided with the authorization request to allow accurate processing and scheduling.

Patient name, BCBSMA member ID, date of birth, and today's date.
Date of planned treatment and place of service (Outpatient or Inpatient).
Distributor (if applicable).
Facility name, address, phone, fax, and NPI.
For commercial members, ensure all requests meet medical policy guidelines and include the appropriate servicing provider and facility identifiers.

Denial Risk

Prior Treatments Exclusion

Prior treatments exclusion: The patient must not have received a prior allogeneic hematopoietic stem cell transplant (HSCT) or prior gene therapy. Failure to document absence of prior allogeneic HSCT or gene therapy may result in denial.

Diagnostic Definitions and Requirements

Confirmed diagnosis of MLD — genetic criteria

Genetic testing standardIdentification of biallelic ARSA pathogenic or likely pathogenic variants by gene sequencing and/or deletion/duplication assessment

Scope of variantsPathogenic or likely pathogenic variants in both ARSA alleles (biallelic) required for confirmation

Accepted methodsSequence analysis and deletion/duplication assessment as documented in clinical testing

Proband diagnostic criteria — laboratory confirmation

Enzyme activity thresholdARSA enzyme activity in leukocytes below laboratory reference values

Sulfatide thresholdUrinary sulfatide levels above laboratory reference values

Proband documentationIf proband, both abnormal ARSA enzyme activity and elevated urinary sulfatide must be documented with reference ranges