CurrentCignaPolicy V060125

Lamzede (velmanase) prior authorization for alpha-mannosidosis

Form and clinical criteria governing prior authorization requests for Lamzede (velmanase) for treatment of alpha-mannosidosis for Cigna members; applies to providers requesting coverage and specialty pharmacy dispensing.

Policy Summary

PayerCigna

PolicyLamzede (velmanase) prior authorization for alpha-mannosidosis

Policy CodePolicy V060125

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation including genetic test results or alpha-mannosidase activity and completed administrative fields.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

855-840-1678fax

800-882-4462urgent phone

Accredopreferred pharmacy

Policy Overview

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Lamzede (velmanase) before services are rendered. Providers should submit a complete prior authorization request using the plan's form or via www.covermymeds.com or SureScripts in the EHR. For urgent requests, contact the plan by phone as directed on the payer website.

Standard prior authorization processing times apply per plan policy.
If therapy is ongoing and previously authorized, indicate continuation of therapy on the request form.

Documentation Required

Documentation Required for Authorization

Documentation-dependent authorization: Approval is contingent on receipt of required supportive clinical documentation. Requests lacking the items below may be delayed or denied.

Indicate whether this is a new start or continuation of therapy.
Provide ICD-10 diagnosis; indicate alpha-mannosidosis if applicable.

Policy Summary

PayerCigna

PolicyLamzede (velmanase) prior authorization for alpha-mannosidosis

Policy CodePolicy V060125

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation including genetic test results or alpha-mannosidase activity and completed administrative fields.

SourceLink

On This Page

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Documentation Required

Supportive Documentation (must be attached)

Required Supportive Documentation: This medication requires attachment of supporting clinical information. Submit chart notes, lab/test results, and genetic testing reports as applicable to demonstrate medical necessity.

Evidence of alpha-mannosidase activity < 10% of normal in blood leukocytes, if applicable.
Genetic testing confirming biallelic pathogenic variants in MAN2B1.
Clinical documentation of non-CNS disease manifestations (for example, progressive motor function disturbances, physical disability, hearing/speech impairment, skeletal abnormalities, immune deficiency) when relevant.
Medication history including dates of prior use, source (samples, out-of-pocket), and current weight, dose, frequency, and duration of therapy.

Coverage Criteria

Initial therapy coverage criteria

Covered when ALL of the following are met

Diagnosis and testing: Diagnosis of alpha-mannosidosis supported by alpha-mannosidase activity <10% in blood leukocytes and/or presence of biallelic pathogenic MAN2B1 variants on genetic testingalpha-mannosidase activity <10%

Supportive documentation (lab and genetic test reports) must be attached

Clinical manifestations: Presence of non-central nervous system disease manifestations (for example: progressive motor function disturbances, physical disability, hearing and speech impairment, skeletal abnormalities, or immune deficiency)

Document clinical features in chart notes and attach supporting documentation

Prescriber specialty: Medication prescribed by or in consultation with a geneticist, endocrinologist, metabolic disease subspecialist, or physician who specializes in lysosomal storage disorders

Indicate consulting specialist on the form and attach consultation notes as applicable

Administrative completion: Required administrative fields (asterisked items) on the prior authorization form are completed and supportive documentation is provided

Completed patient and provider information fields marked with an asterisk are required to process the request; missing items may delay or prevent review

The prior authorization form does not list explicit categorical exclusions; however, approval is contingent on sufficient diagnostic and administrative documentation. In practice, lack of diagnostic confirmation (eg, failure to document alpha‑mannosidase activity < 10% of normal or absence of confirmatory genetic testing) or omission of required supportive materials and asterisked administrative fields is implied to preclude approval and may delay or prevent review. Providers must attach the requested chart notes, labs/tests, and test reports to avoid an implied exclusion for insufficient documentation.

Use of Lamzede without the specified biochemical or genetic confirmation is considered unsupported for coverage. The form requires either documented alpha‑mannosidase activity < 10% of normal in blood leukocytes and/or evidence of biallelic pathogenic MAN2B1 variants on genetic testing, and states that supportive documentation must be attached. Requests lacking these confirmations will not meet the clinical criteria for coverage.

Diagnostic Definitions

Confirmed biochemical diagnosis

DefinitionConfirmed biochemical diagnosis: alpha‑mannosidase activity less than 10% of normal in blood leukocytes as supportive laboratory confirmation.

Required documentationForm requires that supportive documentation (laboratory reports demonstrating <10% activity) be attached to the request.

Role in coverage criteriaBiochemical confirmation (<10% activity) is a primary element of the initial therapy coverage criteria for Lamzede.

Genetic confirmation

Genetic confirmationPresence of biallelic pathogenic variants in MAN2B1 as confirmed by genetic testing.

Form questionThe form asks: 'Does the patient have biallelic pathogenic variants in Mannosidase Alpha Class 2B Member 1 (MAN2B1) as confirmed by genetic testing?' and requires attachment of genetic test results.

Equivalence to biochemical testGenetic confirmation (biallelic MAN2B1 pathogenic variants) serves as an alternative or complementary diagnostic confirmation to alpha‑mannosidase activity <10%.

Initial Therapy Requirements

Initial therapy requirements

Initial authorization requires diagnostic confirmation and specialist involvement

Diagnostic confirmation: Alpha-mannosidase activity <10% in blood leukocytes and/or biallelic pathogenic MAN2B1 variants on genetic testingalpha-mannosidase activity <10%

Attach laboratory and genetic test reports to the request

Specialist involvement: Prescribed by or in consultation with a geneticist, endocrinologist, metabolic disease subspecialist, or physician specializing in lysosomal storage disorders

Indicate the prescribing or consulting specialist on the form and attach consultation documentation as appropriate

Provider Submission Requirements

Documentation Required

Provide completed asterisked patient and provider information

Complete all patient and provider fields marked with an asterisk on the form; these required administrative items must be provided for the request to be processed.

Required physician identifiers (DEA, NPI or TIN)
Patient name, Cigna ID, date of birth, and address
Office contact, phone, and fax as indicated on the form

Documentation Required

Attach required supportive documentation

Attach supportive documentation with the request, including genetic testing results, alpha-mannosidase activity reports, relevant chart notes, and lab/test results as indicated on the form.

Genetic testing confirming biallelic pathogenic MAN2B1 variants (if applicable)
Laboratory report showing alpha-mannosidase activity (<10% of normal if positive)
Chart notes documenting non-CNS disease manifestations and clinical history
Any other relevant labs/tests referenced on the form

Denial Risk

Authorization is documentation-dependent — missing materials may cause denial

Authorization decisions depend on receipt of the required documentation; failure to attach genetic test reports, alpha-mannosidase activity results, chart notes, or other supportive labs/tests may result in denial or non-authorization.

Billing Rule

Document infusion site and justify alternate settings when needed

Per some Cigna plans, infusions must occur in the lowest cost, medically appropriate setting; indicate facility details on the form and document medical necessity if an alternate setting is required.

Provide facility name, state, tax ID, and address on the form
If not eligible for lowest-cost setting, include medical necessity rationale to justify alternate site

Site of Care and Specialty Pharmacy

Step Therapy

Select the lowest-cost medically appropriate infusion setting; Accredo preferred

Arrange infusion in the lowest cost, medically appropriate setting when possible; Cigna’s nationally preferred specialty pharmacy (Accredo) is identified for obtaining the medication.

Settings to consider: infusion center, home infusion, or physician's office
Specialty pharmacy: Accredo is Cigna’s nationally preferred specialty pharmacy

Step	Action	Provider note
1	Consider redirection of infusion to an alternate, lower‑cost medically appropriate setting (e.g., alternate infusion site, physician's office, or home) with assistance from a Specialty Care Options Case Manager.	Form asks whether the patient is a candidate for redirection; if 'Yes', provide medical necessity rationale and indicate if candidate for home infusion or if physician has an in‑office infusion site.
2	Specialty Care Options Case Manager may assist in coordinating redirection and arranging home or alternate site infusion when clinically appropriate.	Document clinical justification for redirection on the prior authorization form to support site‑of‑care change and potential cost‑effective placement per plan requirements.
3	If redirection is not appropriate, document medical necessity rationale for retaining the current infusion setting.	Provide facility/physician dispensing and administering details (facility name, state, tax ID, address) as requested on the form to facilitate review.

OpenPayer

Lamzede (velmanase) prior authorization for alpha-mannosidosis

Policy Overview

Coverage Criteria

Diagnosis and Testing Codes

Diagnostic Definitions

Initial Therapy Requirements

Continuation / Renewal Criteria

Provider Submission Requirements

Site of Care and Specialty Pharmacy