CurrentCignaPolicy N/A

Kanuma (sebelipase alfa) prior authorization

Cigna's prior authorization form and criteria for coverage of Kanuma (sebelipase alfa) for treatment of lysosomal acid lipase deficiency; affects prescribing providers and specialty pharmacies dispensing this therapy.

Policy Summary

PayerCigna

PolicyKanuma (sebelipase alfa) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and attach supportive documentation (genetic test results, chart notes, lab/test results); indicate ICD-10, dose, frequency, duration, weight, and whether request is new or continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

855-840-1678fax to submit form

800-882-4462urgent requests phone

Accredopreferred specialty pharmacy

Coverage Criteria for Kanuma (sebelipase alfa)

Initial coverage criteria

Covered when ALL of the following are met

Diagnosis documented

Diagnostic confirmation: Either deficiency of LAL activity in leukocytes, fibroblasts, or liver tissue OR genetic testing demonstrating biallelic pathogenic or likely pathogenic LAL gene variants
Form requests selection and supportive documentation

Prescriber qualifications: Drug is prescribed by, or in consultation with, a geneticist, endocrinologist, metabolic disorder subspecialist, or physician specializing in lysosomal storage disorders

Form contains clinician specialty question

Documentation provided: Supportive documentation (genetic test results, chart notes, lab/test results) attached to request

Policy Summary

PayerCigna

PolicyKanuma (sebelipase alfa) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Form explicitly states these are required

Continuation therapy criteria

Covered when ALL of the following are met for continued established therapy

Therapy status: Request indicates continued established therapy and start date

Form asks if continued and start date

Clinical response: Documentation that patient is having a beneficial clinical response to therapy

Form requires supportive documentation and asks Yes/No if beneficial response

Requests that do not include diagnostic confirmation (neither an enzyme assay demonstrating deficient lysosomal acid lipase activity nor genetic testing showing biallelic pathogenic or likely pathogenic LAL gene variants) or that lack required supportive documentation (genetic test results, chart notes, lab/test results, etc.) may be excluded from coverage or denied. The prior authorization form requires selection of the diagnostic method and attachment of supporting documentation to establish medical necessity for Kanuma.

Use of Kanuma (sebelipase alfa) without documentation of lysosomal acid lipase (LAL) deficiency by either an enzyme assay (deficient LAL activity in leukocytes, fibroblasts, or liver tissue) or by genetic testing demonstrating biallelic pathogenic or likely pathogenic LAL gene variants is not supported by this form and may be considered not medically necessary.

Initial Therapy Requirements

Initial therapy

Initial therapy requirements

Diagnosis confirmation: Diagnosis of LAL deficiency with documentation by enzyme assay or genetic testing

Form requires selection of diagnostic method and supportive documentation

Prescriber specialty: Prescribed by or in consultation with appropriate specialist (geneticist, endocrinologist, metabolic disorder specialist, or lysosomal storage disorder specialist)

Form asks about prescriber specialty

Continuation Therapy Requirements

Continuation therapy

Requirements for continued therapy

Beneficial response: If continued established therapy is requested, provider must document beneficial clinical response

Form asks to indicate Yes/No and attach supporting documentation

Coding and Patient Data

Requested drugmixed

Kanuma

Kanuma (sebelipase alfa) medication requested — form lists medication name rather than billing codes

Patient weight

Required patient weightProvider must supply patient's current weight in lb or kg on the form

PurposeWeight is required to determine dose and administration details (dose/frequency fields present on form)

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kanuma (sebelipase alfa). Include ICD-10 diagnosis code(s), dose, frequency, duration, patient weight, and indicate whether the request is a new start or continuation of therapy. For continued therapy requests, document the start date and whether the patient is having a beneficial clinical response.

Include: ICD-10, dose, frequency, duration, weight, new vs continuation
If continuation, provide start date and evidence of clinical benefit

Documentation Required

Required Documentation and Form Completion

Attach all required supportive clinical documentation with the request. This includes genetic test results or documentation of lysosomal acid lipase activity deficiency (in leukocytes, fibroblasts, or liver tissue), genetic reports showing biallelic pathogenic/likely pathogenic LAL gene variants when applicable, pertinent chart notes, lab/test results, and documentation of any prior or concurrent therapies.

Genetic test results or LAL activity assay results
If genetic testing used, documentation of biallelic pathogenic/likely pathogenic variants
Chart notes, labs, disease stage, prior therapy, performance status

Denial Risk

Missing Supportive Documentation May Delay or Deny Request

Requests missing required supportive documentation (genetic reports, LAL activity results, chart notes, labs, or completed patient/provider fields on the form) may be denied or deferred. Ensure all asterisked patient and provider fields on the form are completed and that the prescriber attestation and signature/date are included.

Incomplete forms or missing genetic/LAL assay documentation may lead to denial or deferral
Complete all required patient/provider fields and prescriber signature/date

Note

Site-of-Care Consideration

Indicate site-of-care for administration on the form (home, physician office, hospital outpatient, or other). Per some Cigna plans, infusion must occur in the least intensive, medically appropriate setting; consider re-direction to an alternate setting (e.g., home or physician office) with assistance from a Specialty Care Options Case Manager when appropriate.

Select site-of-care on the form: Home, Physician's Office, Hospital Outpatient, or Other
Infusion should occur in the least intensive medically appropriate setting; consider re-direction

Site-of-Care and Infusion Setting

Note

Specify administration site and consider candidacy for redirection

Indicate on the form where the drug will be administered; per some Cigna plans, infusion must occur in the least intensive, medically appropriate setting and the form asks whether the patient is a candidate for home infusion or redirection to an alternate setting.

Select administration site: Patient's Home, Physician's Office, Hospital Outpatient, or Other
Answer whether patient is a candidate for re-direction to an alternate setting and provide medical necessity rationale if not

Background on Kanuma

Kanuma (sebelipase alfa) is indicated for treatment of Lysosomal Acid Lipase (LAL) deficiency. Diagnosis commonly requires demonstration of deficient LAL activity in leukocytes, fibroblasts, or liver tissue, or identification of biallelic pathogenic or likely pathogenic variants in the LAL gene. The prior authorization request must include documentation of the diagnosis method and attach supportive documentation (genetic test results, chart notes, laboratory/test results) to be considered for coverage.

Definitions and Diagnostic Criteria

Lysosomal Acid Lipase Deficiency diagnostic criteria

Diagnostic demonstrationDeficiency of lysosomal acid lipase activity demonstrated in leukocytes, fibroblasts, or liver tissue

Genetic confirmationGenetic testing showing biallelic pathogenic or likely pathogenic LAL gene variants

Form requirementForm asks to indicate which diagnostic method was used and to provide supportive documentation/genetic report

Step Therapy Considerations

Step	Requirement
1	Consider redirection to the least intensive medically appropriate setting for infusion when applicable; assistance from the Specialty Care Options Case Manager may be used to arrange alternate sites (e.g., home, physician's office, alternate infusion site).