Pharmacy Prior Authorization Criteria

Cablivi (caplacizumab-yhdp)

For diagnosis of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Prior Authorization

Length of Approval: 3 Months [A]
For diagnosis of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

AND

First dose was/will be administered by a healthcare provider as a bolus intravenous injection

AND

Used in combination with immunosuppressive therapy (e.g., rituximab, glucocorticoids) [3]

AND

AND

2024-03-05, 2022-01-06, 2021-09-27, 2021-05-20, 2021-01-28

Cablivi Prescribing Information. Cambridge, MA. Genzyme Corporation. April 2023
Understanding TTP. https://www.understandingttp.com/patient/ttp-treatment/#overview-of-treatment. Accessed January 28, 2021.
FDA News Release: FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder. U.S. Food and Drug Administration; February 6, 2019. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630851.htm. Accessed January 28, 2021.

Three month approval duration, based on package insert stating longest therapy in trial was 77 days.
Per package insert, after the plasma exchange period can use injection once daily for 30 days beyond the last plasma exchange and after the initial treatment course, if signs of persistent underlying disease are present treatment can be extended for a maximum of 28 days, totaling 58 days of therapy after last plasma exchange.

2024-03-05: 2024 Annual Review - no changes to criteria
2022-01-06: 2022 Annual Review - No changes to criteria, updated background information
2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
2021-01-28: Annual review - no updates to clinical criteria