Subject: Cablivi 2871-A SGM P2023

Drug

CABLIVI  (caplacizumab-yhdp)

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and
          compendial uses are considered a covered benefit provided that
          all the approval criteria are met and the member has no
          exclusions to the prescribed therapy.

          FDA-Approved Indications
          Cablivi is indicated for the treatment of adult patients with
          acquired thrombotic thrombocytopenic purpura (aTTP), in
          combination with plasma exchange and immunosuppressive
          therapy.

          All other indications are considered experimental/investigational
          and not medically necessary.


    II.  DOCUMENTATION
          Submission of the following information is necessary to initiate
          the prior authorization review:
          For continuation of therapy: medical record documentation of
          signs of persistent underlying aTTP


  III.  CRITERIA FOR INITIAL APPROVAL

          Acquired thrombotic thrombocytopenic purpura (aTTP)
          Authorization of 30 days may be granted for treatment of
          acquired thrombotic thrombocytopenic purpura (aTTP), after the
          plasma exchange period in the inpatient setting, when all of the
          following criteria are met:
          A.  The member received the requested medication with plasma
               exchange.
          B.  The requested medication will be given in combination with
               immunosuppressive therapy.
          C.  The member will not receive the requested medication
               beyond 30 days from the cessation of plasma exchange
               unless the member has documented persistent aTTP.
          D.  The member has not experienced more than 2 recurrences of
               aTTP while on the requested medication. (A recurrence is
               when the member needs to reinitiate plasma exchange. A
               28-day extension of therapy does not count as a recurrence.)

 
   IV.  CONTINUATION OF THERAPY

          Authorization of 28 days may be granted for continuation of
          therapy for aTTP when all of the following criteria are met:
          A.  The request for continuation of therapy is for extension of
               therapy after the initial course of the requested medication
               (initial course: treatment with the requested medication
               during and 30 days after plasma exchange).
          B.  The member has either of the following documented signs of
               persistent underlying aTTP:
               1.  ADAMTS13 activity level less than 10% or
               2.  All of the following:
                    a.  Microangiopathic hemolytic anemia (MAHA)
                         documented by the presence of schistocytes on
                         peripheral smear
                    b.  Thrombocytopenia (platelet count below normal per
                         laboratory reference range), and
                    c.  Elevated lactate dehydrogenase (LDH) level (LDH level
                         above normal per laboratory reference range)
          C.  The requested medication will be given in combination with
               immunosuppressive therapy.
          D.  The member has not received a prior 28-day extension of
               therapy after the initial course of the requested medication
               for this course of treatment.
          E.  The member has not experienced more than 2 recurrences of
               aTTP while on the requested medication. (A recurrence is
               when the member needs to reinitiate plasma exchange. A
               28-day extension of therapy does not count as a recurrence.)

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Cablivi [package insert]. Cambridge, MA: Genzyme Corporation; April 2023.
2. Scully M, Cataland SR, Peyvandi F; et al. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346.
3. Sadler JE. Pathophysiology of thrombotic thrombocytopenic purpura. 2017;130(10):1181-1188.
4. Scully M, Cataland S, Coppo P, et al. Consensus on the standardization of terminology in thrombotic thrombocytopenic purpura and related thrombotic microantiopathies. J Thromb Haemost. 2017; 15(2):312-322.
5. Scully M, Hunt BJ, Benjamin S, et al. Guidelines on the diagnosis and management of thrombotic thrombocytopenic purpura and other thrombotic microangiopathies. Br J Haematol. 2012;158(3)323-335.
6. Westwood JP, Thomas M, Alwan F, et al. Rituximab prophylaxis to prevent thrombotic thrombocytopenic purpura relapse: outcome and evaluation of dosing regimens. Blood Adv. 2017; 1(15):1159-1166.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 31, 2023