CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Adzynma (ADAMTS13, recombinant-krhn) drug policy

Defines indications, inclusion and exclusion criteria, coding, and utilization management/approval authority for Adzynma (ADAMTS13, recombinant-krhn) requests processed by the UM department. Applies to medication requests for adult and pediatric members where Adzynma is being considered.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdzynma (ADAMTS13, recombinant-krhn) drug policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 12, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation of confirmed congenital TTP diagnosis, prior authorization history and continuity, absence of disease progression for continuation requests, and dosing that does not exceed 40 IU/kg; supporting evidence must align with FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1HCPCS code listed

40 IU/kgsingle-dose maximum (exclusion if exceeded)

2committee review dates listed (2023, 2024)

Policy Snapshot

Adzynma (recombinant ADAMTS13) is an enzyme replacement therapy FDA-approved for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP). The policy permits Adzynma for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric members with a confirmed diagnosis of cTTP, consistent with FDA labeling and prescribing information.

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The policy scope defines coverage decisions to align with FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidance, or adequate peer‑reviewed literature. Use of Adzynma for off‑label cancer‑related indications is considered investigational when evidence is insufficient as defined by the policy (for example, inadequate representation of patient/condition characteristics, inadequate representation of concomitant oncologic regimens, lack of clinically meaningful outcomes per ASCO thresholds, weak experimental design, or reliance on case reports/meeting abstracts).