Cablivi - NC Standard

• Cablivi® (caplacizumab-yhdp)

• For the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy.

Initial Coverage Criteria:

1. The patient is 18 years of age or older; AND

2. The patient has been diagnosed with acquired thrombotic thrombocytopenic purpura (aTTP); AND

3. The patient will be treated with intravenous injection of Cablivi at least 15 minutes prior to plasma exchange followed by a subcutaneous dose of Cablivi the day following plasma exchange; AND

4. The patient will be treated with a subcutaneous injection once daily for 30 days following plasma exchange; AND

5. Cablivi will be discontinued if the patient experiences more than 2 recurrences of aTTP while on treatment; AND

6. The patient does not have sepsis, infection with E. coli 0157, atypical hemolytic uremic syndrome, disseminated intravascular coagulation or congenital thrombotic thrombocytopenic purpura; AND

7. Cablivi will be used in combination with immunosuppressive therapy (e.g., systemic corticosteroids, cyclosporine, hydroxychloroquine); AND

8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 30 days 

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND

2. The patient has completed the initial treatment course however there are persistent signs of underlying disease as marked by a suppressed ADAMTS13 activity level, as determined at 7 day intervals for a maximum of 28 days (medical record documentation required); AND

3. The patient has not completed a continuation trial of Cablivi in the past; AND

4. The patient does not have sepsis, infection with E.coli 0157, atypical hemolytic uremic syndrome, disseminated intravascular coagulation or congenital thrombotic thrombocytopenic purpura. 

Duration of Approval: 28 days

 quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND

2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND

3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR

4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

all information referenced is from FDA package insert unless otherwise noted below. 

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually. 

September 2023: Criteria update: Criteria reviewed and formatting changes.  Expanded immunosuppressive therapy examples to be used in combination with Cablivi.

October 2021: Criteria update: Annual criteria review. Cablivi to be used in combination with immunosuppressive therapy. 

August 2019: Original utilization management criteria issued.