109 Form

Gene Therapies for Metachromatic Leukodystrophy
Prior Authorization Request Form for Lenmeldy (atidarsagene autotemcel) #109

Medical Policy #106 Gene Therapies for Metachromatic Leukodystrophy

CLINICAL DOCUMENTATION ▪ Clinical documentation that supports the medical necessity criteria for Lenmeldy (atidarsagene autotemcel) must be submitted.
▪ If the patient does not meet all the criteria listed below, please submit a letter of medical necessity with a request for Clinical Exception (Individual Consideration) explaining why an exception is justified.

Requesting Prior Authorization Using Authorization Manager Providers will need to use Authorization Manager to submit initial authorization requests for services. Authorization Manager, available 24/7, is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter. For commercial members, the requests must meet medical policy guidelines.

To ensure the request is processed accurately and quickly: • Enter the facility’s NPI or provider ID for where services are being performed. • Enter the appropriate surgeon’s NPI or provider ID as the servicing provider, not the billing group.

Authorization Manager Resources • Refer to our Authorization Manager page for tips, guides, and video demonstrations.

Complete Prior Authorization Request Form for Lenmeldy (atidarsagene autotemcel (109) using Authorization Manager.

For out of network providers: Requests should still be faxed to 888-973-0726.

Patient Information Patient Name:

Today’s Date: BCBSMA ID#:

Date of Treatment: Date of Birth:

Place of Service: Outpatient  Inpatient 

Distributor:

Physician Information Facility Information Name:

Name:
Address:

Address: Phone #:

Phone #: Fax#:

Fax#: NPI#:

NPI#:

Please check off if the patient has the following diagnosis:

• 2 -

  Duchenne muscular dystrophy (DMD) 

  Please check off that the patient meets ALL the following criteria:

  1. Confirmed diagnosis of metachromatic leukodystrophy (MLD) by gene sequencing and/or deletion/duplication assessment identifies biallelic ARSA pathogenic or likely pathogenic variants. 
  2. If a proband individual, has all of the following: a. ARSA enzyme activity in leukocytes below reference values b. Urinary sulfatide levels above reference values.

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  3. Confirmed diagnosis of one of the following subtypes of MLD (see Policy Guidelines): a. Pre-symptomatic late infantile b. Pre-symptomatic early juvenile c. Early symptomatic early juvenile.

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  4. Meet the institutional requirements for a stem cell transplant procedure where the individual is expected to receive gene therapy. The requirements may include: a. Adequate performance status score (e.g., Karnofsky performance status, Lansky performance status) b. Absence of advanced liver disease c. Adequate estimate glomerular filtration rate (eGFR) d. Adequate diffusing capacity of the lungs for carbon monoxide (DLCO) e. Adequate ventricular ejection fraction (LVEF) f. Absence of clinically significant active infection(s).

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  5. Have not received a previous allogenic hematopoietic stem cell transplant or gene therapy.

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  HCPCS Codes Code Description J3590 Unclassified biologics J3490 Unclassified drugs C9399 Unclassified drugs or biologicals

  Providers should enter the relevant diagnosis code(s) below: Code Description

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  Providers should enter other relevant code(s) below: Code Description

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