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Real-World Evidence

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CABLIVI® (caplacizumab-yhdp) impacts PEX, hospital, and ICU stays: Improving aTTP/iTTP resource utilization1,2

Lower HRU was associated with CABLIVI in combination with plasma exchange and immunosuppressive therapy use in a clinical setting2

The safety and efficacy of CABLIVI* was established in a phase 3 clinical study HERCULES, with a primary endpoint of time to platelet count response.

HERCULES

*In combination with PEX and immunosuppressive therapy.

In the HERCULES study, lower HRU was associated with early CABLIVI use vs placebo2-4

 

 

Mean days
in ICU (95% CI)

Mean days
in hospital (95% CI)

Mean days
receiving PEX (95% CI)

Mean volume
of PEX (95% CI)

CABLIVI + PEX + IS

3.4
$9,188

9.9
$17,822

5.8
$26,663

21.3 L

Placebo + PEX + IS

9.7
$26,211

14.4
$27,603

9.4
$43,212

35.9 L

HRU Cost Differential

6.3
$17,024

4.5
$9,780

3.6
$16,549

14.6 L

These data were collected prospectively. Descriptive statistics were run but were not tested for significance. The clinical significance of these data is unknown.

To monetize the HRU outlines above, the 2019/20/21 MedPAR file (100% sample) was used to obtain Medicare payments and charges for aTTP/iTTP cases with Medicare FFS coverage. The Medicare payment amount reflects the base DRG and outlier payments. A standard cost to charge ratio was applied to generate an estimated cost (ie, the cost to the hospital to deliver care) for ICU and non-ICU days—the latter factoring in patients who spend a portion of their time in the general ward and those who spend their entire stay in the general ward. The cost of PEX is based on Heatwole et al. Mean days in the ICU, cost per day: $2,702; mean days in the hospital, cost per day: $1,795–$2,193; mean days receiving PEX, cost per day: $4,597.

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ISTH Guidelines recommendations

aTTP/iTTP=acquired/immune-mediated thrombotic thrombocytopenic purpura; CI=confidence interval; DRG=diagnosis-related group; FFS=fee for service; ICU=intensive care unit; IS=immunosuppressive therapy; ISTH=International Society on Thrombosis and Haemostasis; PEX=plasma exchange.

INDICATION

CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: 
CABLIVI is contraindicated in patients with previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients. Hypersensitivity reactions have included urticaria.

WARNINGS AND PRECAUTIONS:
Hemorrhage:

  • CABLIVI increases the risk of bleeding. In clinical studies, severe bleeding adverse reactions of epistaxis, gingival bleeding, upper gastrointestinal hemorrhage, and metrorrhagia were each reported in 1% of subjects. Overall, bleeding events occurred in approximately 58% of patients on CABLIVI versus 43% of patients on placebo.
  • In the postmarketing setting cases of life-threatening and fatal bleeding were reported in patients receiving CABLIVI.
  • The risk of bleeding is increased in patients with underlying coagulopathies (e.g. hemophilia, other coagulation factor deficiencies). It is also increased with concomitant use of CABLIVI with drugs affecting hemostasis and coagulation.
  • Avoid concomitant use of CABLIVI with antiplatelet agents, thrombolytic drugs, heparin or anticoagulants. If clinically significant bleeding occurs, interrupt use of CABLIVI. Von Willebrand factor concentrate may be administered to rapidly correct hemostasis. If CABLIVI is restarted, monitor closely for signs of bleeding.
  • Withhold CABLIVI for 7 days prior to elective surgery, dental procedures or other invasive interventions. If emergency surgery is needed, the use of von Willebrand factor concentrate may be considered to correct hemostasis. After the risk of surgical bleeding has resolved, and CABLIVI is resumed, monitor closely for signs of bleeding.

ADVERSE REACTIONS:
In adults, the most common adverse reactions (>15% of patients) are epistaxis, headache, and gingival bleeding. In pediatric patients, the most frequently reported adverse reactions are epistaxis and tachycardia.

DRUG INTERACTIONS:
Concomitant use of CABLIVI with any anticoagulant or antiplatelet agent may increase the risk of bleeding. Avoid concomitant use when possible. Assess and monitor closely for bleeding with concomitant use.

PREGNANCY:
There are no available data on CABLIVI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage.

  • Fetal/neonatal adverse reactions: CABLIVI may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding.
  • Maternal adverse reactions: All patients receiving CABLIVI, including pregnant women, are at risk for bleeding. Pregnant women receiving CABLIVI should be carefully monitored for evidence of excessive bleeding.

Please see full Prescribing Information.
Instructions For Use
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INDICATION

IMPORTANT SAFETY INFORMATION

References: 1. CABLIVI. Prescribing information. Sanofi. 2. Scully M, Cataland SR, Peyvandi F, et al; HERCULES Investigators. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346 and suppl/protocol. doi:10.1056/NEJMoa1806311 3. Estimated 2019/2020/2021 MedPAR file. 4. Heatwole C, Johnson N, Holloway R, Noyes K. Plasma exchange versus intravenous immunoglobulin for myasthenia gravis crisis: an acute hospital cost comparison study. J Clin Neuromuscul Dis. 2011;13(2):85-94. doi: 10.1097/CND.0b013e31822c34dd

CABLIVI and Sanofi are registered trademarks of Sanofi or an affiliate. MAT-US-2513557-v1.0-01/2026 Last Updated: January 2026.

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