CurrentCignaPolicy N/A

Prior authorization form for Mepsevii (vestronidase alfa-vjbk)

A Cigna prior authorization request form used to request coverage for the enzyme replacement therapy Mepsevii for patients with Mucopolysaccharidosis Type VII (Sly syndrome). Intended for prescribers/office staff to document clinical information and submit supportive documentation for review.

Policy Summary

PayerCigna

PolicyPrior authorization form for Mepsevii (vestronidase alfa-vjbk)

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionAttach laboratory or molecular genetic test results documenting beta-glucuronidase deficiency or biallelic pathogenic/likely pathogenic GUS variants when submitting the prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5standard response time for prescription drug coverage requests

855-840-1678fax number to submit completed form

800-882-4462phone number for urgent requests

Clinical documentation required for Mepsevii prior authorization

Coverage consideration requires documentation that the patient has Mucopolysaccharidosis Type VII (Sly syndrome) confirmed by one of the following tests and other provider qualifications:

Policy Summary

PayerCigna

PolicyPrior authorization form for Mepsevii (vestronidase alfa-vjbk)

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionAttach laboratory or molecular genetic test results documenting beta-glucuronidase deficiency or biallelic pathogenic/likely pathogenic GUS variants when submitting the prior authorization.

SourceLink

On This Page

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ALL of the following

Diagnosis of Mucopolysaccharidosis Type VII (Sly syndrome).
ICD-10 code(s) to be provided on form (ICD10 field present).
Diagnostic confirmation (one of)
- Laboratory test demonstrating deficiency of beta-glucuronidase activity in leukocytes, fibroblasts, or serum.
  Attach laboratory test results.
- Molecular genetic test demonstrating biallelic pathogenic or likely pathogenic glucuronidase (GUS) gene variants.
  Attach genetic report.
Medication request includes supportive documentation (genetic test results, chart notes, lab/test results, etc).
Form explicitly states supportive documentation must be attached.
Prescribing physician is a specialist or in consultation with a specialist.
Prescriber should be a geneticist, endocrinologist, metabolic disorder sub-specialist, or physician who specializes in lysosomal storage disorders; form asks whether prescribed by or in consultation with such specialist.

Administration and logistic information required

Information about drug acquisition, administration site and therapy intent must be provided:

ALL of the following

Indicate whether request is a new start or continuation of therapy and provide start date if continuation.
Form contains 'new start of therapy' and 'continuation of therapy' checkboxes.
Provide dose, frequency of therapy, and patient weight.
Form requests dose, frequency, and current weight in lb/kg.
Specify where medication will be obtained (Accredo specialty pharmacy, hospital outpatient, retail, other, home health/home infusion, physician's office stock).
Accredo listed as Cigna's nationally preferred specialty pharmacy.
Specify where drug will be administered (home, physician's office, hospital outpatient, other).
Form notes some Cigna plans require infusion in least intensive medically appropriate setting and asks if patient is candidate for re-direction to alternate setting.
Provide facility/dispensing provider details if applicable (facility name, state, tax ID, address).

What providers must do

Prior Authorization

Attach supportive diagnostic documentation

Providers must attach laboratory or molecular genetic test results that document either a deficiency of beta-glucuronidase activity (in leukocytes, fibroblasts, or serum) or molecular genetic testing showing biallelic pathogenic or likely pathogenic glucuronidase (GUS) gene variants when submitting the prior authorization.

Prior Authorization

Specialist prescribing or consultation

The medication should be prescribed by, or in consultation with, a geneticist, endocrinologist, metabolic disorder sub-specialist, or a physician who specializes in lysosomal storage disorders; indicate on the form whether the prescriber meets one of these specialist criteria.

Documentation Required

Administration and acquisition details

Document where the medication will be obtained and where it will be administered, whether the request is a new start or a continuation of therapy, the dosing and frequency, and the patient's current weight to support the prior authorization request.

Indicate new start or continuation and provide start date if continuation (chunk 2).
Provide dose, frequency, and current weight in lb/kg (chunk 2).
Specify where medication will be obtained (Accredo, hospital outpatient, retail, home infusion, physician's office stock, or other) (chunk 3).
Specify administration site (home, physician's office, hospital outpatient, other) and facility/dispensing provider details if applicable (chunk 5; chunk 4).

Denial Risk

Incomplete asterisked fields may prevent response by fax

Failure to complete all asterisked patient and physician identifier fields on the form will prevent Cigna from responding via fax with the outcome of the review and could delay processing of the request.

Clinical and administrative background

Mepsevii (vestronidase alfa-vjbk) is an enzyme replacement therapy indicated for Mucopolysaccharidosis Type VII (Sly syndrome). This prior authorization form operationalizes Cigna's review process by requiring documentation that establishes the diagnosis and the medical necessity of therapy, and by collecting logistical details about acquisition and administration.

To confirm diagnosis, the form requires supportive clinical documentation such as a laboratory assay demonstrating deficiency of beta-glucuronidase activity in leukocytes, fibroblasts, or serum, or a molecular genetic report demonstrating biallelic pathogenic or likely pathogenic GUS gene variants. The form explicitly states that these genetic test results, chart notes, and lab/test results must be attached with the request.

The request must also indicate whether the prescription is a new start or a continuation of therapy, provide dosing, frequency, and the patient’s current weight, and document where the medication will be obtained (for example, Accredo Specialty Pharmacy, hospital outpatient, retail, home infusion, or physician's office stock) and where it will be administered (home, physician's office, hospital outpatient, or other).

Prescribing clinicians should be a geneticist, endocrinologist, metabolic disorder sub-specialist, or a physician who specializes in lysosomal storage disorders, or the request should document consultation with such a specialist. Providers must also supply facility/dispensing details when applicable and complete all required identifying fields to avoid delays in processing or inability to receive a faxed response.

OpenPayer

Prior authorization form for Mepsevii (vestronidase alfa-vjbk)

Clinical documentation required for Mepsevii prior authorization

Requested/Reference Codes

What providers must do

Clinical and administrative background

Defined terms

Submission and response information