ph-91114
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Cablivi Quantity Limit Program Summary

Policy Number: PH-91114

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

Cablivi Quantity Limit

TARGET AGENT(S)

Cablivi® (caplacizumab-yhdp)

Brand (generic)

GPI

Multisource Code

Quantity Limit

Cablivi (caplacizumab-yhdp)

 

11 mg single dose vial

85151020806420

M, N, O, or Y

58 vials/365 days

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Quantities above the program quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

  1. BOTH of the following
  1. The patient had at least one occurrence of acquired thrombotic thrombocytopenic purpura (aTTP) during the current course of therapy

AND

  1. The patient has NOT had more than 2 occurrences of aTTP while using the requested agent during the current course of therapy

OR

  1. The patient had a relapse/recurrence of aTTP after completion of a course of therapy and requires an additional course of therapy

Length of Approval:

For patients having occurrence(s) of aTTP on current course of therapy: approve number of vials requested up to 58 vials/365 days

Relapse of aTTP: approve 58 vials/365 days

FDA APPROVED INDICATIONS AND DOSAGE1

Agent(s)

Indication(s)

Dosage

Cablivi®

(caplacizumab-yhdp)

Injection for intravenous or subcutaneous use

 ● Treatment of adult patients with acquired thrombotic thrombocytopenia purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy

 aTTP:

Cablivi should be administered upon initiation of plasma exchange therapy

First day of treatment:

11 mg bolus intravenous injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after plasma exchange on day 1

Subsequent days of treatment during daily plasma exchange:

11 mg subcutaneous injection once daily following plasma exchange

Treatment after plasma exchange period:

11 mg subcutaneous injection once daily continuing for 30 days following the last daily plasma exchange. If after initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days

CLINICAL RATIONALE2

Acquired thrombotic thrombocytopenic purpura (aTTP) is a blood disorder characterized by thrombocytopenia, small areas of bleeding under the skin (purpura), low red blood cell count, and hemolytic anemia. Complications may include neurological problems, fever, abnormal kidney function, abdominal pain, and heart problems. aTTP usually begins in adulthood but can affect children. An episode of TTP usually occurs suddenly and lasts for days or weeks but may continue to months. Relapses can occur in up to 60 % of people who have aTTP. aTTP is caused when a person’s body mistakenly makes antibodies that block the activity of ADAMTS13 enzyme. The ADAMTS13 enzyme normally helps control the activity of certain blood clotting factors. Treatment includes plasma exchange and in some cases, may also include corticosteroid therapy or rituximab.

Efficacy

The efficacy of Cablivi for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy was established in a pivotal multicenter, randomized, double-blind, placebo- controlled trial (HERCULES) (NCT02553317). 72 patients were randomized to receive Cablivi and 73 patients received placebo. Patients in both groups received plasma exchange and immunosuppressive therapy. The efficacy of Cablivi in patients with aTTP was established based on time to platelet count response (platelet count ≥ 150,000/μL followed by cessation of daily plasma exchange within 5 days). Time to platelet count response was shorter among patients treated with Cablivi compared to placebo. Treatment with Cablivi resulted in a lower number of patients with TTP-related death, recurrence of TTP, or at least one treatment-emergent major thromboembolic event (a composite endpoint) during the treatment period.1

During the treatment period and 28-day follow-up, treatment with caplacizumab was associated with a significantly shorter time to platelet normalization, compared with placebo: 2.69 days (95% CI 1.89-2.83] versus 2.88 days (95% CI 2.68-3.56; p=0.01). The authors also reported that caplacizumab-treated patients were 1.55 times more likely than placebo-treated patients to have a normalization of the platelet count at any time point (p=0.01).3

Caplacizumab significantly outperformed standard-of-care alone in other secondary outcomes, including:3

  • composite of TTP-related death, TTP recurrence, or a thromboembolic event: 12% vs. 49% (p<0.001)
  • recurrence of TTP at any time: 12% vs. 38% (p<0.001)

Disease exacerbation, defined as recurrence of TTP within 30 days after daily plasma exchange, occurred in 31 patients (28 in the placebo group and 3 in the caplacizumab group). Of these, 28 had an unresolved autoimmune disease that may have been the underlying culprit, the researchers noted.3

Health-care resource use also appeared lower in the caplacizumab group: In the placebo group, patients required an average of 9.4 days of plasma-exchange therapy, compared with 5.8 days in the caplacizumab group. This represented a 38-percent shorter duration of treatment and a 41-percent lower volume of plasma exchanged (p values not reported). Duration of hospitalization and intensive care unit stays were reduced, as well.3

Safety1

Cablivi contains no boxed warnings and is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or any of its excipients.

Cablivi should be discontinued if the patient experiences more than 2 recurrences of aTTP, while on Cablivi.

REFERENCES

  1. Cablivi Prescribing Information. Genzyme Corporation. February 2019.
  2. U.S. Department of Health & Human Services. National Institutes of Health. Thrombotic Thrombocytopenic Purpura, Acquired. https://rarediseases.info.nih.gov/diseases/4607/thrombotic-thrombocytopenic-purpura-acquired. Accessed December 2019.
  3. ASH Clinical News. Bleeding disorders. Literature Scan. News. https://www.ashclinicalnews.org/news/caplacizumab-improves-platelet-normalization-time-reduces-mortality-acquired-ttp/. Accessed December 2019.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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