CurrentCignaPolicy N/A

Adzynma (recombinant ADAMTS13) prior authorization

This document is Cigna's prior authorization form and coverage criteria capture for Adzynma (recombinant ADAMTS13) used to treat congenital thrombotic thrombocytopenic purpura and other indications; it governs prior authorization submission requirements for providers and affects patients whose payor is Cigna.

Policy Summary

PayerCigna

PolicyAdzynma (recombinant ADAMTS13) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed prior authorization form with medication dose, frequency, duration, J-code and attach documentation of baseline ADAMTS13 activity, antibody status, and genetic testing as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

40 IU/kgprophylaxis max weekly

135 IU/kgon-demand max weekly

<10%diagnostic threshold

Coverage Criteria for Adzynma (recombinant ADAMTS13)

Authorization criteria

Covered when ALL of the following are met:

Prerequisites: 1) Medication is prescribed for congenital thrombotic thrombocytopenic purpura or other indicated diagnosis; 2) Medication is prescribed by or in consultation with a hematologist; 3) Documentation of baseline ADAMTS13 activity <10% (prior to any ADYNZMA or plasma-based therapy) is provided; 4) Documentation that the patient does NOT have anti-ADAMTS13 autoantibodies is provided when requested; 5) If applicable, documentation of a pathogenic ADAMTS13 gene variant/mutation (typically homozygous or compound heterozygous) is provided; 6) Intended dosing matches the specified limits for routine prophylaxis and/or on-demand therapy.ADAMTS13 activity <10%

All required documentation (chart notes, lab results, diagnostic test results, claims records, prescription receipts, etc.) must be attached; failure to attach may result in denial.

Dosing criteria

Dosing constraints (must be met as applicable):

Dosing options:

Policy Summary

PayerCigna

PolicyAdzynma (recombinant ADAMTS13) 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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Provider Requirements and Actions

Prior Authorization

Prior authorization required — complete form with dosing, J‑Code, and diagnosis

Submit a prior authorization using the completed form and include the medication name, specific dose, frequency, duration, the J‑Code to be billed, and the ICD‑10 diagnosis code; attach all required supporting documentation referenced on the form.

Provide Dose, Frequency of therapy, and Duration of therapy as listed on the form (Medication Requested fields).
Enter the J‑Code and ICD10 diagnosis code in the form fields.
Attach documentation of ADAMTS13 activity, antibody status, and genetic testing as applicable.

Billing Rule

Medication acquisition — document sourcing (Accredo and other channels)

Indicate on the form where the medication will be obtained and, if using Accredo, note that Accredo is Cigna's nationally preferred specialty pharmacy and orders can be placed via e‑prescribe, fax, or verbal channels listed on the form.

Select one: Accredo Specialty Pharmacy; Prescriber's office stock (bill on medical claim); Retail pharmacy; Home Health/Home Infusion vendor; or Other (specify).
If using Accredo, orders may be placed via E‑prescribe (NCPDP 4436920), Fax 888.302.1028, or Verbal 866.759.1557.

Documentation Required

Required supporting documentation — attach chart notes, labs, test results, claims or prescriptions

Attach patient‑specific supporting documentation to the prior authorization to verify baseline ADAMTS13 activity, antibody status, and genetic testing when applicable; acceptable documents include chart notes, laboratory and diagnostic test results, claims records, and prescription receipts.

All documentation must include patient‑specific identifying information.
Documentation may include chart notes, laboratory results, medical test results, claims records, and prescription receipts.

Denial Risk

Denial risk — missing baseline ADAMTS13 activity <10% documentation

Requests may be denied if medical documentation confirming baseline ADAMTS13 activity <10% (prior to any Adzynma or plasma‑based therapy) is not attached to the authorization.

The form explicitly states: "PLEASE NOTE: Medical documentation specific to your response must be attached to this case or your request may be denied."
Baseline ADAMTS13 activity must be documented as less than 10% (less than 10 IU/dL) prior to therapy.

Denial Risk

Denial risk — missing anti‑ADAMTS13 antibody or ADAMTS13 gene variant documentation

Requests may be denied if documentation confirming absence of anti‑ADAMTS13 autoantibodies or documentation of a pathogenic ADAMTS13 gene variant/mutation (when indicated) is not provided with the request.

For antibody status: the form asks if documentation is being provided that the patient does NOT have anti‑ADAMTS13 autoantibodies and warns that documentation must be attached or the request may be denied.
For genetic testing: the form asks if documentation is being provided that the patient has a pathogenic ADAMTS13 gene variant/mutation and warns that documentation must be attached or the request may be denied.

OpenPayer

Adzynma (recombinant ADAMTS13) prior authorization

Coverage Criteria for Adzynma (recombinant ADAMTS13)

Coding and Diagnostic Codes

Provider Requirements and Actions

Background

Definitions and Thresholds