CurrentMass General Brigham Health PlanPolicy N/A

Cablivi (caplicizumab-yhdp) — Coverage Criteria for acquired thrombotic thrombocytopenic purpura (aTTP)

Defines medical benefit coverage criteria, authorization, and reauthorization limits for Cablivi (caplicizumab-yhdp) when used to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP) for members of MassHealth.

Policy Summary

PayerMass General Brigham Health Plan (MassHealth)

PolicyCablivi (caplicizumab-yhdp) — Coverage Criteria for aTTP

Policy CodePolicy N/A

Change TypeMaterial revision — reauthorization wording updated

Effective DateMay 12, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of aTTP diagnosis, patient age >18, planned combination with immunosuppressive therapy, and requested quantity ≤1 unit/day after initial bolus.

SourceLink

POLICY UPDATE CHANGES

Reauthorization verbiage was updated to state 'up to a max of 28 days' following FDA label.

30 daysinitial approval duration

28 daysreauthorization limit per period

≤1 unit/daymax daily qty

Adultsage requirement

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inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Authorization for Cablivi: 1. Diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP).

Initial Authorization for Cablivi: 2. Medication will be given in combination with immunosuppressive therapy (e.g., corticosteroids, rituximab).

Initial Authorization for Cablivi: 3. Member is > 18 years of age (policy covers adults only).

Initial Authorization for Cablivi: 4. Requested quantity is ≤ 1 unit/day after initial bolus injection.≤ 1 unit/day

Authorization may be reviewed case-by-case for members new to the plan.

inv-02: Continuation Therapy

Reauthorization possible when ALL of the following are met

Reauthorization for Cablivi: Prescriber documents that the member has signs of persistent underlying disease such as suppressed ADAMTS13 activity levels following the initial 30 days of treatment.Reauthorization limited to up to 28 days per authorization

Initial approvals limited to 30 days; reauthorizations may only approve up to a max of 28 additional days.

Use of manufacturer-provided samples or medications obtained through a manufacturer's patient assistance program should be documented. When therapy was received as samples or through a patient assistance program and documentation is not provided, those doses may be excluded from authorization review and are not considered when assessing coverage under this policy.

This policy applies only to adult members. Use of Cablivi for patients who are ≤ 18 years of age is not covered under these criteria; the member must be >18 years to meet the age requirement for authorization.

Coding and Quantity Limits

No explicit codes listed in policymixed

No codes listed

inv-06: Maximum daily quantity after initial bolus — ≤ 1 unit/day

Maximum daily quantity after initial bolusRequested quantity must be ≤ 1 unit/day following the initial bolus injection.

Initial authorization contextThis threshold is part of initial authorization criteria for Cablivi; documentation must show diagnosis of aTTP and combination with immunosuppressive therapy.

Applies to adults onlyMember must be > 18 years of age for this threshold to be applicable.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization may be reviewed on a case-by-case basis for members who are new to the plan and are currently receiving treatment with the requested medication (excluding products obtained as samples or via manufacturer patient assistance programs).

Contact medical benefit: Phone: 833-895-2611; Fax: 888-656-6671 (or 844-403-1029 for pharmacy)

Step Therapy

No step therapy requirements specified for this medication within the medical benefit.

Documentation Required

Required Documentation

Clinical documentation must support the diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) and show that the requested medication will be given in combination with immunosuppressive therapy (e.g., corticosteroids, rituximab) or plasma exchange as indicated. For reauthorizations, prescriber documentation must show signs of persistent underlying disease such as suppressed ADAMTS13 activity levels after the initial 30 days of treatment. Include member age and dosing/quantity justification (requested quantity ≤ 1 unit/day after initial bolus).

Diagnosis: acquired thrombotic thrombocytopenic purpura (aTTP)
Treatment plan: concurrent immunosuppressive therapy or plasma exchange when indicated
Laboratory: ADAMTS13 activity levels for continuation requests
Dosing: requested quantity ≤ 1 unit/day after initial bolus
Age: member > 18 years

Denial Risk

Denial Triggers

Authorization may be denied if the member does not meet all required criteria — for example, member is < 18 years of age, insufficient documentation of aTTP diagnosis, lack of evidence of planned combination therapy (immunosuppression or plasma exchange), requested quantity exceeds limits, or missing documentation for continuation (e.g., no suppressed ADAMTS13 activity after 30 days).

Not an adult (≤ 18 years)
Insufficient clinical documentation supporting aTTP diagnosis
No documentation of combination therapy with immunosuppression or plasma exchange
Requested quantity > 1 unit/day after initial bolus
For reauthorization: absence of evidence of persistent disease (no ADAMTS13 data)

Definitions

inv-12: aTTP definition — acquired thrombotic thrombocytopenic purpura description and key pathophysiology

DefinitionAcquired thrombotic thrombocytopenic purpura (aTTP) — a microangiopathic disorder treated in adults with severe ADAMTS13 deficiency and thrombocytopenia; Cablivi is indicated for adult patients with aTTP in combination with plasma exchange and immunosuppressive therapy.

Key pathophysiologyaTTP is characterized by severe deficiency of the metalloprotease ADAMTS13 leading to accumulation of ultra-large von Willebrand factor multimers, platelet aggregation, and microvascular thrombosis.

Clinical implicationManagement typically includes plasma exchange and immunosuppression; caplacizumab (Cablivi) reduces platelet–vWF interactions and is used adjunctively.