CurrentAvMedPolicy N/A

Cablivi (caplacizumab-yhdp) prior authorization

Defines AvMed pharmacy prior authorization and step-edit requirements for Cablivi (caplacizumab) for treatment of acquired thrombotic thrombocytopenic purpura (aTTP), including initial and reauthorization criteria and documentation expectations for prescribers and specialty pharmacy.

Policy Summary

PayerAvMed

PolicyCablivi (caplacizumab-yhdp) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide documentation including ADAMTS13 <10%, PLASMIC score 6–7, evidence of plasma exchange dates, and hematology involvement; first dose must be given inpatient.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

58 daysmax total duration post plasma exchange

12 yrsminimum age

<10%ADAMTS13 threshold

6-7PLASMIC score

Coverage Criteria for Cablivi (caplacizumab)

Initial Authorization

Policy Summary

PayerAvMed

PolicyCablivi (caplacizumab-yhdp) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

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Initial authorization criteria: Member has a diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) confirmed with a PLASMIC score of 6 to 7; documentation of ADAMTS13 activity < 10%; first dose of Cablivi is administered in an inpatient setting by a healthcare provider; date of initiation of plasma exchange and date of initiation of Cablivi provided; prescribed by or in consultation with a hematologist; member is 12 years of age or older; prescribed in combination with plasma exchange therapy and immunosuppressive therapy (e.g., glucocorticoids, rituximab) with date immunosuppressive therapy was started documented; dosing does not exceed loading dose 22 mg on day 1 followed by maintenance 11 mg daily for 30 days after last daily plasma exchange; for a request for a new treatment cycle, member has experienced no more than two recurrences of aTTP while taking Cablivi.

All documentation supporting each checked item must be provided.

Reauthorization / Treatment Extension

Reauthorization up to a total of 58 days post plasma exchange when ALL of the following are met

Reauthorization criteria: Member previously received medication for the covered indication or previously met initial approval criteria; for a request for a new treatment cycle, member has experienced no more than two recurrences of aTTP while taking Cablivi; request is for treatment extension due to recurrence of aTTP; member continues to experience signs of persistent underlying disease after completing 30 days of treatment beyond the last plasma exchange; extension of treatment will not exceed 28 days; suppressed ADAMTS13 activity (<10%); evidence of microangiopathic hemolytic anemia (presence of schistocytes on peripheral smear); thrombocytopenia (platelets <100,000); >2x elevated lactate dehydrogenase; elevated reticulocyte count (>120 x10^9/L); dates of initiation and last plasma exchange provided; total duration will not exceed 58 days post plasma exchange.Total duration <=58 days post plasma exchange

Provider must submit documentation (labs, diagnostics, chart notes) for all listed items.

Non‑FDA approved indications for Cablivi are not addressed in this policy and will not be authorized unless the prescriber submits sufficient documentation of efficacy and safety in accordance with the plans off‑label use policy (ERX.PA.01) or applicable evidence of coverage documents. Requests seeking use beyond the scope of FDA‑approved indications or beyond the policy's stated limits (including approval beyond a total of 58 days of therapy post plasma exchange) will not be authorized.

Cablivi should be discontinued if the patient experiences more than two recurrences of aTTP while receiving Cablivi. A recurrence is defined as a new decrease in platelet count while on Cablivi that necessitates reinitiation of plasma exchange after platelet normalization (≥150,000/µL). For requests to initiate a new treatment cycle, documentation must show the member has had no more than two recurrences while taking Cablivi; continuation beyond these recurrence limits will not be approved.

Initial Therapy Requirements

Initial therapy

Initial therapy — covered when ALL of the following are met

Initial therapy: Initiation approved for aTTP with PLASMIC score 6-7 and ADAMTS13 activity <10%; first dose administered inpatient by a healthcare provider; therapy prescribed in combination with plasma exchange and immunosuppressive therapy; patient age ≥12 years; dosing: loading dose 22 mg on day 1 then maintenance 11 mg daily for 30 days after last daily plasma exchange; prescribed by or in consultation with a hematologist; dates of plasma exchange and Cablivi initiation documented.

All items must be documented.

Continuation / Reauthorization Criteria

Continuation therapy

Continuation therapy — reauthorization and extension rules (ALL conditions required)

Continuation therapy: Member may receive up to a total of 58 days of Cablivi after completion of plasma exchange; treatment extensions for recurrence are limited to a maximum of 28 days beyond the 30-day post-exchange course and only if suppressed ADAMTS13 (<10%) and objective evidence of ongoing MAHA and thrombocytopenia are documented (schistocytes on smear, platelets <100,000), plus >2x elevated LDH and elevated reticulocyte count (>120 x10^9/L); no more than two recurrences while on Cablivi are allowed; dates of initiation and last plasma exchange must be provided.<=58 days total

Documentation required for all listed findings (labs, diagnostics, chart notes).

Key Clinical Thresholds and Coding Values

inv-05: ADAMTS13 activity — required lab threshold for approval

Required ADAMTS13 activityADAMTS13 activity less than 10%

Use for approvalDocumented suppressed ADAMTS13 activity (<10%) required for reauthorization or treatment extension

Supporting instructionAll checked criteria must be supported by lab results, diagnostics, and chart notes

inv-06: PLASMIC score high-risk — required PLASMIC score for initial authorization

Required PLASMIC scorePLASMIC score 6 to 7 (High Risk)

PurposeEstimate likelihood of severe ADAMTS13 deficiency to identify candidates for Cablivi initiation

DocumentationPLASMIC score must be provided and supported by clinical/lab documentation

inv-07: Platelet count threshold for MAHA/thrombocytopenia — platelet count criterion

Platelet count thresholdThrombocytopenia defined as platelets < 100,000/µL

Severe thrombocytopenia examplePLASMIC score criterion includes platelet count <30,000/µL as part of scoring (see PLASMIC components)

Recurrence signalNew decrease in platelet count while on Cablivi that necessitates reinitiation of plasma exchange after prior normalization

Provider Requirements, Documentation, and Risks

Prior Authorization

Prior Authorization and Initial Dosing Setting

Prior authorization is required. The first dose must be administered in an inpatient setting; samples do not satisfy prior authorization requirements.

PA required prior to outpatient dispensing
First dose must be given inpatient by a healthcare provider
Samples do not meet PA requirements

Billing Rule

Specialty Pharmacy / Samples

Medication must be dispensed via the designated specialty pharmacy. Manufacturer or clinic samples cannot be used to meet specialty pharmacy or prior authorization requirements.

Specialty pharmacy distribution required: Proprium Rx
Samples do not meet step-edit / preauthorization criteria

Documentation Required

Required Documentation

Complete documentation is required to support the request. Include prescriber and member identifiers, dosing schedule, diagnosis and ICD code, patient weight (if applicable), plasma exchange dates, and supporting clinical notes and lab results.

Prescriber name, signature, NPI, office contact, phone and fax
Member name, AvMed ID, date of birth
Dosing schedule, length of therapy, dates of Cablivi® initiation and plasma exchange
Diagnosis and ICD code, PLASMIC score if applicable, ADAMTS13 activity
Weight and date weight obtained (if applicable)
Chart notes documenting concomitant plasma exchange and immunosuppressive therapy

Denial Risk

Incomplete Documentation

Incomplete, incorrect, or missing forms, labs, or signatures may delay review or result in denial of the request.

Authorization may be delayed or denied if the request form is not fully completed or legible
Preprinted signature stamps are not valid — prescribing physician must sign and print name
Missing lab values (e.g., ADAMTS13 activity) or missing dates (plasma exchange, Cablivi® start) jeopardize approval

Denial Risk

Duration Limit Exceeded

Requests for treatment beyond the overall policy duration will not be authorized. Approval is limited to up to 58 days total post plasma exchange (initial authorization plus any extension).

Initial authorization: up to 30 days post plasma exchange
Reauthorization/extension: up to an additional 28 days, not to exceed 58 days total post plasma exchange
Approvals beyond 58 days post plasma exchange will be denied

Site of Care Requirements

Note

Site of care: first dose inpatient, subsequent outpatient via specialty pharmacy

The first dose of Cablivi must be administered during the inpatient encounter; subsequent doses are provided in the outpatient setting via the specialty pharmacy.

First dose: inpatient by a healthcare provider.
Subsequent outpatient dosing: dispensed through specialty pharmacy (Proprium Rx).

Billing Rule

Specialty pharmacy provision required; samples do not meet step-edit/PA

The medication must be provided by the specialty pharmacy listed (Proprium Rx). Use of samples does not satisfy the step-edit or preauthorization requirement.

Specialty pharmacy provision is mandatory for fulfillment of the PA/step-edit.

Definitions

inv-14: Recurrence — definition for recurrence while on Cablivi requiring plasma exchange reinitiation

Definition of recurrenceA new decrease in platelet count while receiving Cablivi that necessitates reinitiation of plasma exchange after platelet normalization (≥150,000/µL)

Action requiredReinitiate plasma exchange when recurrence occurs while on Cablivi

Treatment limit contextNo more than two recurrences while on Cablivi allowed for continued therapy per policy

inv-15: Refractory disease — definition for refractory TTP (lack of expected platelet response)

Definition of refractory diseaseTTP that does not respond to initial treatment with plasma exchange (PEX) and glucocorticoids (e.g., lack of doubling of platelet count within four days or occurrence of new neurologic symptoms not attributable to bleeding or infection)

Clinical indicatorsLack of expected platelet response within four days or new neurologic signs despite treatment

Implication for therapyConsidered failure of initial therapy when criteria met; documentation required for treatment decisions

Background

Cablivi (caplacizumab) is an anti‑von Willebrand factor agent indicated for acquired thrombotic thrombocytopenic purpura (aTTP). It is used in combination with plasma exchange and immunosuppressive therapy (for example, glucocorticoids or rituximab) to address microangiopathic hemolytic anemia and thrombocytopenia. Prior authorization is required; the first dose must be administered in an inpatient setting by a healthcare provider, and treatment is guided by objective criteria including a PLASMIC score and documented ADAMTS13 activity < 10%.