CurrentMass General Brigham Health PlanPolicy N/A

Cablivi (caplacizumab-yhdp) — Prior Authorization and Quantity Limits for acquired TTP

Policy governs prior authorization, coverage criteria, and quantity limits for Cablivi for adult members with acquired TTP under Mass General Brigham Health Plan (MassHealth/Commercial/Exchange). Affects prescribers and pharmacy/medical benefit adjudication.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCablivi (caplacizumab-yhdp) — Prior Authorization and Quantity Limits for acquired TTP

Policy CodePolicy N/A

Change TypeReauthorization clarification & quantity limit added

Effective DateMay 12, 2025

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals limited to 30 days and reauthorizations limited to up to 28 days.

SourceLink

POLICY UPDATE CHANGES

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

Added quantity limit to criteria and simplified reauthorization criteria in prior reviews.

Initial approvals are limited to 30 days and reauthorizations limited to up to 28 days.

30Initial approval length

28Max reauth length

AdultsAge restriction

PEx + immuno

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Required combo therapy

Coverage Criteria for Cablivi (caplacizumab-yhdp)

Initial Approval Criteria

Covered when ALL of the following are met

Initial therapy criteria: Member has a diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP).

Documentation required to support diagnosis.

Initial therapy criteria: The requested medication will be given in combination with immunosuppressive therapy (e.g., corticosteroids, rituximab).

Documentation required to show planned concomitant immunosuppressive therapy.

Initial therapy criteria: Member is \u2265 18 years of age (adult).

Age must be documented in medical record or membership data.

Initial therapy criteria: Requested quantity is < 1 unit/day after initial bolus injection.< 1 unit/day after initial bolus injection

Quantity limits apply per policy; document dosing schedule.

Reauthorization Criteria

Covered for reauthorization when ALL of the following are met

Reauthorization criteria: Prescriber documents signs of persistent underlying disease such as suppressed ADAMTS13 activity levels following the initial 30 days of treatment.Reauthorization limited to a maximum of 28 days per authorization

Reauthorizations may be approved for up to 28 days; initial approvals are limited to 30 days.

Use of Cablivi (caplacizumab) for indications other than acquired thrombotic thrombocytopenic purpura (aTTP) is not supported by the coverage criteria in this policy. Authorization is granted only when all required criteria for aTTP treatment are documented and met.

Requests that do not meet policy criteria will be considered not medically necessary. Common triggers where criteria are not met include: patients younger than 18 years, use of Cablivi without concurrent immunosuppressive therapy (for example corticosteroids or rituximab), and requests for a dosing quantity of ≥ 1 unit/day after the initial bolus.

Coding and Quantity Limits

No codes listedmixed

No codes listed

Quantity limit / dosing frequency

Dosing frequencyRequested quantity must be < 1 unit/day after initial bolus injection

Initial approval durationInitial approvals are limited to 30 days of therapy

Reauthorization duration limitReauthorizations may be approved for up to 28 days per authorization

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are limited to 30 days; reauthorizations may be approved for up to 28 days each. Authorization may be reviewed case-by-case for members new to the plan who are currently receiving the medication (excluding samples or manufacturer patient assistance programs).

Initial approval: 30 days
Reauthorization: up to 28 days per authorization
Case-by-case review for members new to the plan who are currently receiving treatment (excludes samples and manufacturer patient assistance programs)

Step Therapy

Step Therapy Status

Step therapy is not applicable for this medication.

Step Therapy: N/A

Background

Cablivi (caplacizumab) is indicated for treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) when used in combination with plasma exchange and immunosuppressive therapy. Coverage under this policy requires documentation that the member has a diagnosis of aTTP and that the medication will be administered alongside immunosuppression; the initial authorization framework also includes limits on patient age (adult only) and dosing frequency.

Definitions

aTTP (definition)

DefinitionAcquired thrombotic thrombocytopenic purpura (aTTP) — the indicated diagnosis for Cablivi therapy

Treatment contextCablivi is indicated for adult patients with aTTP in combination with plasma exchange and immunosuppressive therapy

Age restrictionAdults only (member is ≥ 18 years of age)

Suppressed ADAMTS13 activity (definition)

Laboratory evidence for reauthorizationPrescriber must document signs of persistent underlying disease such as suppressed ADAMTS13 activity levels following the initial 30 days of treatment

TimingAssessment of suppressed ADAMTS13 activity is required after the initial 30-day approval period

Policy Summary

PayerMass General Brigham Health Plan

PolicyCablivi (caplacizumab-yhdp) — Prior Authorization and Quantity Limits for acquired TTP

Policy CodePolicy N/A

Change TypeReauthorization clarification & quantity limit added

Effective DateMay 12, 2025

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals limited to 30 days and reauthorizations limited to up to 28 days.

SourceLink

On This Page

Documentation Required

Required Documentation

Prescriber must supply documentation to support medical necessity. Include diagnostic confirmation and evidence of appropriate use in combination with other therapies when applicable.

Diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP)
Documentation that the medication will be given in combination with immunosuppressive therapy (e.g., corticosteroids, rituximab) and used with plasma exchange when clinically indicated
Laboratory evidence if applicable (e.g., suppressed ADAMTS13 activity levels)
For reauthorization: prescriber documentation of persistent signs of underlying disease (such as suppressed ADAMTS13 activity) following the initial 30 days of treatment

Denial Risk

Triggers for Denial / How to Avoid

Requests may be denied if required criteria or documentation are missing or the clinical situation does not match the policy. Avoid these common denial triggers by providing complete, clear documentation.

Diagnosis is not aTTP
Medication is not being used in combination with required immunosuppressive therapy or plasma exchange when indicated
Member is under 18 years of age
Requested quantity exceeds <1 unit/day after initial bolus or otherwise exceeds policy quantity limits
Incomplete supporting documentation (missing diagnosis, labs, or treatment plan)

Documentation roleSuppressed ADAMTS13 activity is used to justify reauthorization for additional therapy (limited to up to 28 days)