CurrentCignaPolicy v051525

Cablivi (caplacizumab) prior authorization for aTTP

Prior authorization requirements and clinical information collection for Cablivi (caplacizumab) when prescribed for acquired (autoimmune) thrombotic thrombocytopenic purpura (aTTP) for Cigna members. Affects prescribers, administering facilities, and pharmacy/benefit managers submitting coverage requests.

Policy Summary

PayerCigna

PolicyCablivi (caplacizumab) prior authorization for aTTP

Policy CodePolicy v051525

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form with required identifiers, diagnosis, dosing (11 mg), administration details, and documentation of plasma exchange and concurrent immunosuppressive therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

11 mgstandard dose per injection referenced

60+dose threshold referenced after last plasma exchange

2recurrence count threshold referenced for prior Cablivi recipients

Coverage and Review Considerations

Authorization review considerations

Coverage evaluation will consider the following items collected on the prior authorization form

Essential documentation and clinical facts: Completed prior authorization form with all required patient and provider identifiers and prescriber signature; documented diagnosis (aTTP) and ICD-10 code as provided on the form; medication requested (Cablivi 11 mg) with dose, quantity, frequency, and duration; administration site/facility and whether administration is in the least intensive medically appropriate setting

Include facility/dispensing details and attestations as requested on the form

Initiation and dosing details: Whether Cablivi was initiated inpatient; whether initiation was given in combination with plasma exchange; for new starts, confirmation that day 1 dosing included an 11 mg IV bolus prior to plasma exchange followed by an 11 mg subcutaneous dose after plasma exchange; whether requested dosing is 11 mg subcutaneous up to once daily

Providers must document administration pattern for initial plasma-exchange-associated dosing

Policy Summary

PayerCigna

PolicyCablivi (caplacizumab) prior authorization for aTTP

Policy CodePolicy v051525

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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Required Provider Actions and Documentation

Documentation Required

Documentation completeness and clinical initiation details

Prior authorization is required for Cablivi (caplacizumab). Complete documentation is necessary for timely review; incomplete items may prevent a response. Be sure to include whether Cablivi was initiated inpatient, whether it was started with plasma exchange, prior Cablivi exposure and recurrence history, and whether the request is for the standard dosing (11 mg subcutaneous up to once daily).

Submit a completed prior authorization form with all asterisked (*) items (physician and patient identifiers).
Indicate if Cablivi was initiated in an inpatient setting to treat acquired (autoimmune) TTP (aTTP).
Document whether Cablivi was initiated in combination with plasma exchange and, if initiated on day 1, confirm two-dose administration (11 mg IV bolus prior to plasma exchange and 11 mg SC after completion).
If previously received Cablivi, document number of recurrences of aTTP while on therapy (specifically whether >2 recurrences occurred).
State whether the patient has received >60 doses of Cablivi following the last plasma exchange session.
If requesting continuation, provide dates and details of prior doses, response, and rationale for ongoing therapy.
Provide clinical rationale, relevant history, and prior treatments tried (drug names, dates, durations, outcomes, intolerances/adverse reactions).

Prior Authorization

Concurrent therapy and alternatives

Concurrent therapies and reasonable alternatives must be documented. Indicate current immunosuppressive therapy status and use of plasma exchange. If plasma exchange is not used, provide medical rationale. Document whether the prescriber is a hematologist or consulted with one.

Is the patient currently receiving at least one immunosuppressive therapy? (Specify agent(s), start date, and response.)
Was Cablivi initiated in combination with plasma exchange therapy? If not, explain medical reasons plasma exchange was not used or is contraindicated.
Clarify setting of initiation (inpatient vs outpatient) and whether therapy was given in consultation with a hematologist.
If applicable, describe alternatives considered (e.g., plasma exchange alone, immunosuppressive regimens) and why they are unsuitable or ineffective for this patient.

Background

Cablivi (caplacizumab) is requested on the form to treat acquired (autoimmune) thrombotic thrombocytopenic purpura (aTTP). The form documents whether this is a new start or prior exposure, asks if initial dosing on day 1 included the recommended 11 mg intravenous bolus before plasma exchange and an 11 mg subcutaneous dose after plasma exchange, and confirms whether ongoing dosing is 11 mg subcutaneous up to once daily. The form also asks whether the patient has received over 60 doses following the last plasma exchange and whether the patient experienced more than two (2) recurrences of aTTP while on Cablivi. Providers must include clinical rationale, prior therapies, and attest to the accuracy of the information when submitting the form.

Definitions and Key Terms

caplacizumab (Cablivi) — dosing and form capture

Caplacizumab (Cablivi) dosing — initiation with plasma exchangeOn day 1 when initiated with plasma exchange: 11 mg IV bolus prior to plasma exchange followed by 11 mg subcutaneous after completion of plasma exchange

Usual maintenance dosing11 mg via subcutaneous injection up to once daily (form asks: 'Is the requested dosing 11 mg via subcutaneous injection up to once daily?')

Medication line on formMedication requested entry lists: Cablivi 11mg powder for injection

Indication captured on formForm collects diagnosis: acquired (autoimmune) thrombotic thrombocytopenic purpura (aTTP)

aTTP (acquired thrombotic thrombocytopenic purpura)

Definition of aTTPAcquired (autoimmune) thrombotic thrombocytopenic purpura — the diagnosis option listed on the prior authorization form for Cablivi

Form requirement to specify diagnosisForm asks the provider to select 'acquired (autoimmune) thrombotic thrombocytopenic purpura (aTTP)' or 'other (please specify)'

Clinical context for Cablivi useCablivi (caplacizumab) is used to treat aTTP; the form collects whether therapy was initiated inpatient and whether initiation included plasma exchange

OpenPayer

Cablivi (caplacizumab) prior authorization for aTTP

Coverage and Review Considerations

Diagnosis and Coding Details

Required Provider Actions and Documentation

Background

Definitions and Key Terms