CurrentAspirus ArisePolicy Utilization Review Policy 327

Hematology - Adzynma Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing, and documentation requirements for Adzynma for treatment of congenital thrombotic thrombocytopenic purpura for Aspirus Medicare Plans.

Policy Summary

PayerAspirus Arise

PolicyHematology - Adzynma Utilization Management Medical Policy

Policy CodePolicy Utilization Review Policy 327

Change TypeNo material changes

Effective Date3/15/2024

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation demonstrating baseline ADAMTS13 activity <10%, absence of anti‑ADAMTS13 antibodies, and pathogenic ADAMTS13 gene variant; approvals are for 1 year when criteria and dosing are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

<10%Required baseline ADAMTS13

40 IU/kgMax prophylaxis dose

135 IU/kgMax on-demand weekly

1 yearInitial approval duration

All Aspirus MedicarePlans governed

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Coverage and Authorization Criteria

Initial approval — Congenital Thrombotic Thrombocytopenic Purpura

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

FDA-Approved Indication — diagnostic and prescriber criteria: A) Baseline ADAMTS13 activity <10% (<10 IU/dL); AND B) No anti-ADAMTS13 autoantibodies as determined by diagnostic test; AND C) Presence of a pathogenic variant or mutation in the ADAMTS13 gene (usually homozygous or compound heterozygous); AND D) Medication prescribed by or in consultation with a hematologist.see children nodes

Documentation for each element is required; baseline refers to pre-treatment values.

Approved dosing

Dosing. Approve the following dosing regimens (A and/or B):

Dosing options: A) Routine prophylaxis: up to 40 IU/kg IV once weekly; OR B) On-demand therapy: up to 135 IU/kg IV per week as needed for acute events (on-demand given daily until 2 days after resolution but total weekly dose not to exceed 135 IU/kg).40 IU/kg weekly; 135 IU/kg weekly max

On-demand therapy described as daily dosing until 2 days after event resolves; total weekly dose limit applies.

Coverage of Adzynma is limited to the circumstances explicitly listed in the Recommended Authorization Criteria. Requests for use outside those criteria are not recommended for approval. The criteria will be revised as new published data become available, and providers should anticipate updates that may change covered indications or requirements.

Provider Requirements, Documentation, and Exceptions

Prior Authorization

Prior Authorization Required

Prior authorization is recommended. Approval is granted for 1 year when all specified diagnostic and prescribing criteria are met and dosing conforms to the documented regimens. Requests for doses outside the documented dosing will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Adzynma must be prescribed by or in consultation with a physician who specializes in the condition being treated (hematologist for congenital TTP). Automation: None.

Approve for 1 year when ALL FDA‑approved indication criteria are met (ADAMTS13 activity < 10%; no anti‑ADAMTS13 autoantibodies; pathogenic/likely pathogenic ADAMTS13 gene variant; prescribed by/with hematologist).
Dosing approvals: routine prophylaxis up to 40 IU/kg IV once weekly; on‑demand therapy up to 135 IU/kg IV per week (total weekly dose not to exceed 135 IU/kg).
Requests for doses outside documented dosing considered case‑by‑case by clinician.

Step Therapy

Dose Exceptions / Step Therapy

No automated step therapy is specified. Requests that propose a different step or sequencing of therapies than described in this policy will be reviewed individually.

Documentation Required

Required Documentation

Documentation is required as noted in the criteria. Acceptable documentation may include chart notes, laboratory data, diagnostic test results, and genetic test results demonstrating baseline ADAMTS13 activity, absence of anti‑ADAMTS13 autoantibodies, and presence of a pathogenic ADAMTS13 gene variant. Documentation must support the diagnosis and baseline measurements prior to therapy.

Baseline ADAMTS13 activity (< 10%) [documentation required].
Diagnostic test showing absence of anti‑ADAMTS13 autoantibodies [documentation required].
Genetic testing showing pathogenic ADAMTS13 variant [documentation required].
Evidence the medication is prescribed by or in consultation with a hematologist.

Denial Risk

Denial Trigger

Requests that do not meet the Recommended Authorization Criteria, or for indications or circumstances not listed in the criteria, are not recommended for approval. Criteria may be updated as new published data become available.

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.
Denial likely if documentation does not demonstrate baseline ADAMTS13 < 10%, absence of anti‑ADAMTS13 autoantibodies, or pathogenic ADAMTS13 gene variant, or if prescribing does not involve a hematologist.

Policy Summary

PayerAspirus Arise

PolicyHematology - Adzynma Utilization Management Medical Policy

Policy CodePolicy Utilization Review Policy 327

Change TypeNo material changes

Effective Date3/15/2024

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Hematology - Adzynma Utilization Management Medical Policy

Coverage and Authorization Criteria

Diagnostic Thresholds and Coding

Provider Requirements, Documentation, and Exceptions

Clinical Background

Key Definitions