CurrentCignaPolicy IP0161

Hematology - Cablivi (caplacizumab-yhdp) coverage criteria

Defines Cigna's coverage criteria and prior authorization expectations for Cablivi when used to treat acquired thrombotic thrombocytopenic purpura (aTTP) in adults, including dosing limits and prescribing requirements.

Policy Summary

PayerCigna

PolicyHematology - Cablivi (caplacizumab-yhdp) coverage criteria

Policy CodePolicy IP0161

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and ensure the medication is prescribed by or in consultation with a hematologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60 daysmaximum treatment period following last plasma exchange

11 mgstandard daily dose (SC) after day 1

C9047HCPCS code for caplacizumab-yhdp, 1 mg

≥18minimum patient age for coverage

IP0161Coverage Policy Number

Coverage Criteria for Cablivi (caplacizumab-yhdp)

Policy Summary

PayerCigna

PolicyHematology - Cablivi (caplacizumab-yhdp) coverage criteria

Policy CodePolicy IP0161

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and ensure the medication is prescribed by or in consultation with a hematologist.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial/Single Course Coverage Criteria

Approve for one course of treatment (up to 60 days following the last plasma exchange session) if ALL of the following are met:

FDA-approved indication for aTTP: A) Patient ≥ 18 years of age; AND B) Cablivi was initiated in the inpatient setting, in combination with plasma exchange therapy; AND C) Patient is currently receiving at least one immunosuppressive therapy (examples include systemic corticosteroids, rituximab or a rituximab product, cyclosporine, cyclophosphamide, mycophenolate mofetil, hydroxychloroquine, bortezomib); AND D) If the patient has previously received Cablivi, he/she has not had more than two recurrences of acquired thrombotic thrombocytopenic purpura while on Cablivi; AND E) The medication is prescribed by or in consultation with a hematologist.

Approvals provided for the duration noted (months counted as 30 days). Treatment is given during plasma exchange and continued for up to 30 days after the last plasma exchange; may be extended up to 28 days for persistent disease; do not exceed 60 doses following the last plasma exchange.

Cablivi for any other use is considered not medically necessary.

Use of Cablivi for indications other than acquired thrombotic thrombocytopenic purpura is not medically necessary.

Provider Actions, Prior Authorization & Prescribing Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for Cablivi; approvals are provided for the duration noted (months counted as 30 days). Prescriber must be a hematologist or have consulted with one.

Approvals are provided for the duration noted; when authorized in months, 1 month = 30 days.

Step Therapy

Required concurrent therapies

Approval expects Cablivi to be initiated in the inpatient setting and used in combination with plasma exchange and concurrent immunosuppressive therapy.

Cablivi must have been initiated in the inpatient setting in combination with plasma exchange therapy.
Patient must be currently receiving at least one immunosuppressive therapy (examples: systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, mycophenolate mofetil, hydroxychloroquine, bortezomib).

Documentation Required

Prescriber and authorization requirement

Prior authorization is recommended and approval requires the medication to be prescribed by or in consultation with a hematologist (or a physician who has consulted with or specializes in the condition).

Prescriber must be a hematologist or have consulted with a hematologist.

Denial Risk

Claims and coding denial risk

Claims submitted without covered diagnosis or procedure codes will be denied; reimbursement is only provided if the service is submitted in accordance with the relevant criteria and covered codes.

Use the most appropriate codes as of the effective date of submission; services billed without covered code(s) under the applicable Coverage Policy will be denied.

Background

Thrombotic thrombocytopenic purpura (TTP) is a rare, potentially fatal disorder caused by severe ADAMTS13 deficiency. The acquired form (aTTP or iTTP) is immune-mediated and results from autoantibodies that inhibit ADAMTS13, leading to accumulation of ultra-large von Willebrand factor multimers and microvascular platelet aggregation. Cablivi (caplacizumab-yhdp) is a von Willebrand factor–directed nanobody indicated for aTTP in adults and is used in combination with plasma exchange and immunosuppressive therapy.

Definitions

acquired thrombotic thrombocytopenic purpura (aTTP, iTTP) — definition and brief explanation

TermAcquired thrombotic thrombocytopenic purpura (aTTP, iTTP)

DefinitionAn immune-mediated form of TTP caused by autoantibodies that inhibit plasma ADAMTS13 activity, leading to accumulation of ultra-large von Willebrand factor (vWF) multimers and microvascular platelet aggregation.

PathophysiologyReduced ADAMTS13 activity allows ultra-large vWF multimers to bind platelets, causing excessive platelet clumping in the microvasculature and risking multi-organ failure and death.

Differential—hereditary vs acquiredHereditary (congenital) TTP is due to ADAMTS13 mutations; acquired (immune-mediated) TTP is due to autoantibodies against ADAMTS13.

Relevant therapy mechanismCablivi (caplacizumab-yhdp) is a vWF-directed nanobody that inhibits the interaction between ultra-large vWF multimers and platelets, preventing vWF‑mediated platelet adhesion and consumption.

OpenPayer

Hematology - Cablivi (caplacizumab-yhdp) coverage criteria

Coverage Criteria for Cablivi (caplacizumab-yhdp)

Coding and Billing

Provider Actions, Prior Authorization & Prescribing Requirements

Background

Definitions