Currentmedical mutual - ohioPolicy N/A

Cablivi (caplacizumab-yhdp) coverage

Defines prior authorization, coverage criteria, dosing, and documentation requirements for Cablivi (caplacizumab-yhdp) for treatment of acquired thrombotic thrombocytopenic purpura (aTTP) for Medical Mutual - Ohio.

Policy Summary

Payermedical mutual - ohio

PolicyCablivi (caplacizumab-yhdp) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 21, 2019

Next Review DateN/A

Key ActionObtain prior authorization when billing Cablivi using HCPCS code J3590 and ensure prescription or consultation by a hematologist with concurrent plasma exchange and immunosuppressive therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60maximum duration (days)

≥12minimum age

J3590required HCPCS

2max recurrences

Coverage Criteria for Cablivi (caplacizumab-yhdp)

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.

FDA-Approved aTTP criteria: A) Patient is ≥ 12 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: systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, mycophenolate mofetil, hydroxychloroquine, bortezomib); AND D) If patient previously received Cablivi, they have not had more than two recurrences of acquired thrombotic thrombocytopenic purpura while on Cablivi; AND E) Cablivi is prescribed by, or in consultation with, a hematologist.

One course = daily dosing up to 60 days after last plasma exchange; therapy should be discontinued after >2 recurrences on therapy.

Provider Requirements and Administrative Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cablivi when billed using HCPCS code J3590. Requests meeting policy criteria may be authorized by a nurse reviewer; requests that do not meet criteria will be forwarded to a physician reviewer for determination.

HCPCS: J3590 (Unclassified biologics)
Claims with J3590 may pend with Remark Code M3M or M4M

Note

Specialist Involvement and Combination Therapy Requirement

Initial approval requires that Cablivi be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., a hematologist). Initial therapy must be administered in combination with plasma exchange as described in the policy and follow the dosing and duration criteria. One course consists of Cablivi given in conjunction with plasma exchange and continued for up to 60 days (one dose per day) following the last plasma exchange session.

Prescriber: specialist (hematologist) or consultation with specialist required
Therapy must be used in combination with plasma exchange
One course = treatment with plasma exchange + up to 60 days of Cablivi (one dose/day)

Documentation Required

Documentation Required Upon Request

The Company may request additional documentation to support its coverage determination. Providers must make available patient records, test results, and/or credentials of the provider ordering or performing the service upon request. Failure to provide requested documentation may affect the determination of medical necessity and reimbursement.

Documentation may include patient medical records, diagnostic test results, and provider credentials
Additional documentation must be provided upon request to support medical necessity

Denial Risk

The Company may deny reimbursement when the drug or services were not medically necessary, investigational or experimental, not within the member's benefit scope, or when billing practices are inappropriate or excessive. Participating providers may be required to write off charges denied as not medically necessary.

Denial reasons: not medically necessary, investigational/experimental, outside scope of benefits, inappropriate/excessive billing patterns
Liability: providers may be required to write off denied charges

Background

Cablivi (caplacizumab‑yhdp) is a von Willebrand factor–directed antibody fragment indicated for treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults and pediatric patients aged 12 years and older; it is used in combination with plasma exchange and immunosuppressive therapy. The authorized treatment course allows administration up to 60 days following the last plasma exchange, with monitoring for bleeding risk advised.

Definitions

aTTP

DefinitionAcquired thrombotic thrombocytopenic purpura (aTTP) is the indication for which Cablivi is approved; therapy is given in combination with plasma exchange and immunosuppressive therapy.

Indicated ageAdults and pediatric patients ≥ 12 years of age.

Therapy contextUsed in combination with plasma exchange (PEX) and immunosuppressive therapy.

Drug classvon Willebrand factor (vWF)-directed antibody fragment (caplacizumab - Cablivi).

Primary clinical useTreatment of aTTP to reduce microvascular thrombosis related to vWF-mediated platelet adhesion.