CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cablivi (caplacizumab-yhdp) — Coverage Criteria

Defines coverage, clinical criteria, exclusions, and authorization process for Cablivi (caplacizumab-yhdp) for members of Neighborhood Health Plan of Rhode Island; applies to providers submitting medication requests for this drug.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCablivi (caplacizumab-yhdp) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJul 26, 2024

Next Review DateJul 10, 2024

Key ActionSubmit prior authorization with clinical documentation showing aTTP diagnosis and concurrent use with plasma exchange and immunosuppressive therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 daysmaximum treatment duration

11 mgsingle dose max

aTTPprimary indication

Jul 26, 2024effective

Coverage Criteria for Cablivi (caplacizumab-yhdp)

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Initial and Continuation Therapy

Covered when ALL of the following are met

Continuation request exempt criteria: For continuation requests: (1) the requested medication was used within the last year; AND (2) the member has not experienced disease progression and/or intolerance to the requested medication; AND (3) additional medication(s) are not being added to the continuation request.

From continuation requests inclusion criteria (policy).

Initial/ongoing therapy for aTTP: Member has acquired thrombotic thrombocytopenic purpura (aTTP) and Cablivi (caplacizumab-yhdp) is being used in combination with plasma exchange and immunosuppressive therapy (examples: systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, vincristine).

From aTTP inclusion criteria (policy).

Coverage exclusions for Cablivi (caplacizumab-yhdp) include situations where the member’s platelet count is within normal limits or the member is not at risk of bleeding. Requests will also be excluded when dosing exceeds the policy’s single-dose limit of 11 mg, or when treatment would continue beyond 30 days after the last plasma exchange (except where an additional extension is permitted as described in the policy). These exclusion criteria are applied when clinical documentation does not support the need for continued therapy or the requested dosing/duration exceeds established thresholds.

Investigational or off‑label uses of Cablivi that are not supported by accepted evidence are considered not approvable. The policy requires supporting evidence from FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature; evidence is considered insufficient when it relies on abstracts only, isolated case reports, or other sources that do not adequately represent the patient population, regimen, or clinically meaningful outcomes. Requests lacking this level of evidence may be denied as not medically necessary.

Coding and Quantity Limits

Maximum treatment duration beyond last plasma exchange

Maximum treatment duration beyond last plasma exchange30 days (may be extended an additional 28 days if ADAMTS13 activity remains suppressed, allowing a total of two treatment courses)

Extension conditionExtension permitted only when ADAMTS13 activity levels remain suppressed after the last plasma exchange

Total possible durationUp to 58 days total when extension applied (30 days + additional 28 days)

Single dose limit

Single dose maximum11 mg per single dose

Policy exclusionDosing that exceeds the 11 mg single-dose limit is listed as an exclusion and may be denied

Quantity limits moduleCablivi quantity limit set to 11 mg per dose per policy coding section

Cablivi (caplacizumab-yhdp) — quantity limit summary

Product and active ingredientCablivi (caplacizumab-yhdp)

Quantity limit (per single dose)11 mg

Policy placementListed under Quantity Limits in the drug policy module

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Clinical documentation must show the indication for Cablivi (caplacizumab-yhdp), evidence of concurrent use with plasma exchange and immunosuppressive therapy for aTTP, and any relevant prior treatment history. Include provider notes, treatment dates, laboratory data (e.g., ADAMTS13 activity), and plan for duration of therapy.

Include dates of plasma exchange and start/stop dates for Cablivi
Provide ADAMTS13 activity levels when available
Document prior therapies and response/intolerance

Note

Combination Therapy Requirement for aTTP

Cablivi must be used in combination with plasma exchange and immunosuppressive therapy for treatment of acquired thrombotic thrombocytopenic purpura (aTTP). Examples of acceptable immunosuppressive therapies include systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, or vincristine. Immunosuppressive therapy may be tapered or discontinued at the treating provider's discretion.

Concurrent plasma exchange is required
Concurrent immunosuppressive therapy (examples listed) required

Documentation Required

Supporting Documentation Required

Supporting documentation must be provided with the request. Acceptable sources include FDA‑approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards. Provide copies or citations of relevant guidance or literature and any patient‑specific evidence that supports the requested use.

FDA labeling or prescribing information
CMS‑approved compendia or NCCN/ASCO guidelines
Peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Denial Risk

Triggers for Denial

Triggers for denial include requests where dosing exceeds the single‑dose limit of 11 mg, treatment duration exceeds the maximum extension limits, lack of concurrent plasma exchange and immunosuppressive therapy for aTTP, or use for investigational/off‑label indications without sufficient supporting evidence. Continuation requests not meeting continuation criteria or lacking evidence of prior benefit may also be denied.

Single dose > 11 mg
Treatment beyond 30 days after last plasma exchange without documented suppressed ADAMTS13 activity justification (extensions only up to additional 28 days in select cases)
Use without concurrent plasma exchange and immunosuppressive therapy for aTTP
Off‑label or investigational use without CMS‑recognized compendia or acceptable peer‑reviewed evidence
Continuation requests lacking prior use within 1 year, evidence of no progression/intolerance, or adding new medications

Initial Therapy

Initial therapy coverage for aTTP requires:

Initial therapy criteria: Cablivi (caplacizumab-yhdp) is being used for a member with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy (examples include systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, or vincristine).

Per aTTP inclusion criteria; immunosuppressive therapy may be tapered or discontinued at provider discretion.

Continuation Therapy

Continuation requests for previously used medications may be approved if all of the following are met:

Continuation criteria: Requested medication was used within the last year; the member has not experienced disease progression and/or intolerance to the requested medication; and no additional medication(s) are being added to the continuation request.

Continuation request exemption from policy.

Step Therapy / Usage Constraints

Requirement	Examples
Must be used in combination with plasma exchange and immunosuppressive therapy for treatment of acquired thrombotic thrombocytopenic purpura (aTTP).	Systemic corticosteroids; rituximab; cyclosporine; cyclophosphamide; vincristine (immunosuppressive therapy may be tapered or discontinued at the treating provider's discretion).

Site of Care

Note

No explicit site-of-care restrictions; follow FDA labeling

No explicit site-of-care restrictions are specified in the policy; providers should follow the FDA package insert for medication management and site-specific administration guidance.

Refer to the FDA labeling/package insert for details on administration, monitoring, and site‑of‑care considerations.

Definitions

aTTP — definition and brief description

DefinitionAcquired thrombotic thrombocytopenic purpura (aTTP) is a disorder treated with plasma exchange, immunosuppression, and caplacizumab as described in clinical trials such as HERCULES

Typical managementTreatment strategy includes plasma exchange plus immunosuppressive therapy (examples: systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, vincristine)

Role of CabliviCablivi (caplacizumab-yhdp) is used in combination with plasma exchange and immunosuppression for aTTP to reduce platelet aggregation mediated by von Willebrand factor

Background

Cablivi (caplacizumab‑yhdp) is an anti‑von Willebrand factor nanobody indicated for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). In clinical practice and per this policy, it is used in conjunction with therapeutic plasma exchange and immunosuppressive therapy to reduce microvascular thrombosis and associated complications; coverage decisions reference the FDA prescribing information and major clinical evidence supporting use in aTTP.