Sanofi is committed to ensuring all patients with acquired/immune-mediated thrombotic thrombocytopenic purpura (aTTP/iTTP) have access to treatment with CABLIVI. The information below will help guide you in obtaining coverage for your patients.
*This information is subject to change, and providers should consult relevant references for the description of each code to determine its appropriateness. Use of the information below does not guarantee that the payer will provide coverage for CABLIVI and is not intended to be a substitute for, or an influence on, the independent medical judgment of the prescriber.
Coverage
The codes discussed below are provided for informational purposes only, are subject to change, and should not be construed as legal advice. The codes listed herein may not apply to all patients or to all health plans. Conversely, additional codes not listed may apply to some patients.
For patients covered by Medicare, drug costs for doses administered in the hospital are typically included in the MS-DRG payment and are covered under Medicare Part A. After inpatient discharge, most patients will self-administer CABLIVI at home; these drug costs are expected to be covered under the Medicare Part D (pharmacy) benefit.
The 3 MS-DRGs that represent the greatest number of potential patients who may be eligible for treatment involving CABLIVI are shown in the table below.
| Potential MS-DRGs1 | |
| 545 | Connective Tissue Disorders With MCC |
| 546 | Connective Tissue Disorders With CC |
| 547 | Connective Tissue Disorders Without CC/MCC |
This may not be reflective of all MS-DRG codes that may be used for CABLIVI. The DRG code is determined by the payer based on the primary diagnosis.
Other reimbursement considerations
The specifics of coverage may vary by payer. Please refer to the individual patient’s plan to determine any applicable coverage requirements.
Diagnosis and procedure codes
There is no specific ICD-10-CM code for aTTP/iTTP. Providers should always review payer-specific materials and use their own clinical judgment when submitting claims for use of CABLIVI.
| ICD-10-CM Code2 | |
| M31.1 | Thrombotic Microangiopathy† |
| ICD-10-PCS Code3 | |
| XW013W5 –or– 3E013GC |
Introduction of Caplacizumab Into Subcutaneous Tissue, Percutaneous Approach, New Technology Group 5 Introduction of Other Therapeutic Substance into Subcutaneous Tissue, Percutaneous Approach |
| XW033W5 –or– 3E033GC |
Introduction of Caplacizumab Into Peripheral Vein, Percutaneous Approach, New Technology Group 5 Introduction of Other Therapeutic Substance into Peripheral Vein, Percutaneous Approach |
| XW043W5 –or– 3E043GC |
Introduction of Caplacizumab Into Central Vein, Percutaneous Approach, New Technology Group 5 Introduction of Other Therapeutic Substance into Central Vein, Percutaneous Approach |
†Thrombotic microangiopathy has the inclusion note of thrombotic thrombocytopenic purpura, which would describe aTTP/iTTP.
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CC=complication or comorbidity; DRG=diagnosis related group; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification; ICD-10-PCS=International Classification of Diseases, Tenth Revision, Procedure Coding System; MCC=major complication or comorbidity; MS-DRG=Medicare Severity Diagnosis Related Group.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
IMPORTANT SAFETY INFORMATION AND INDICATIONS
IMPORTANT SAFETY INFORMATION AND INDICATIONS
CONTRAINDICATIONS:
CABLIVI is contraindicated in patients with a 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 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:
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
CONCOMITANT USE OF ANTICOAGULANTS OR ANTIPLATELET AGENTS:
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.
INDICATIONS:
CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Please see full Prescribing Information.
Instructions For Use
Sharps Medical Waste Disposal (PDF)
Learn more about Sanofi’s commitment to fighting counterfeit drugs.
References: 1. Centers for Medicare & Medicaid Services. ICD-10-CM/PCS MS-DRG v37.0 Definitions Manual. Updated September 12, 2019. Accessed April 14, 2023. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0213.html 2. Centers for Medicare & Medicaid Services. 2023 ICD-10-CM. Updated July 27, 2022. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-code-tables-tabular-and-index.zip 3. Centers for Medicare & Medicaid Services. 2023 ICD-10-PCS. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-icd-10-pcs-code-tables-and-index.zip
IMPORTANT SAFETY INFORMATION AND INDICATIONS
CONTRAINDICATIONS:
CABLIVI is contraindicated in patients with a 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 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:
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
CONCOMITANT USE OF ANTICOAGULANTS OR ANTIPLATELET AGENTS:
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.
INDICATIONS:
CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Please see full Prescribing Information.
Instructions For Use
Sharps Medical Waste Disposal (PDF)
Learn more about Sanofi’s commitment to fighting counterfeit drugs.
References: 1. Centers for Medicare & Medicaid Services. ICD-10-CM/PCS MS-DRG v37.0 Definitions Manual. Updated September 12, 2019. Accessed April 14, 2023. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0213.html 2. Centers for Medicare & Medicaid Services. 2023 ICD-10-CM. Updated July 27, 2022. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-code-tables-tabular-and-index.zip 3. Centers for Medicare & Medicaid Services. 2023 ICD-10-PCS. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-icd-10-pcs-code-tables-and-index.zip
IMPORTANT SAFETY INFORMATION AND INDICATIONS
IMPORTANT SAFETY INFORMATION AND INDICATIONS
CONTRAINDICATIONS:
CABLIVI is contraindicated in patients with a 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 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:
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
CONCOMITANT USE OF ANTICOAGULANTS OR ANTIPLATELET AGENTS:
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.
INDICATIONS:
CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Please see full Prescribing Information.
Instructions For Use
Sharps Medical Waste Disposal (PDF)
Learn more about Sanofi’s commitment to fighting counterfeit drugs.
References: 1. Centers for Medicare & Medicaid Services. ICD-10-CM/PCS MS-DRG v37.0 Definitions Manual. Updated September 12, 2019. Accessed April 14, 2023. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0213.html 2. Centers for Medicare & Medicaid Services. 2023 ICD-10-CM. Updated July 27, 2022. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-code-tables-tabular-and-index.zip 3. Centers for Medicare & Medicaid Services. 2023 ICD-10-PCS. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-icd-10-pcs-code-tables-and-index.zip
IMPORTANT SAFETY INFORMATION AND INDICATIONS
CONTRAINDICATIONS:
CABLIVI is contraindicated in patients with a 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 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:
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
CONCOMITANT USE OF ANTICOAGULANTS OR ANTIPLATELET AGENTS:
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.
INDICATIONS:
CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Please see full Prescribing Information.
Instructions For Use
Sharps Medical Waste Disposal (PDF)
Learn more about Sanofi’s commitment to fighting counterfeit drugs.
References: 1. Centers for Medicare & Medicaid Services. ICD-10-CM/PCS MS-DRG v37.0 Definitions Manual. Updated September 12, 2019. Accessed April 14, 2023. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0213.html 2. Centers for Medicare & Medicaid Services. 2023 ICD-10-CM. Updated July 27, 2022. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-code-tables-tabular-and-index.zip 3. Centers for Medicare & Medicaid Services. 2023 ICD-10-PCS. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-icd-10-pcs-code-tables-and-index.zip
IMPORTANT SAFETY INFORMATION AND INDICATIONS
IMPORTANT SAFETY INFORMATION AND INDICATIONS
CONTRAINDICATIONS:
CABLIVI is contraindicated in patients with a 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 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:
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
CONCOMITANT USE OF ANTICOAGULANTS OR ANTIPLATELET AGENTS:
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.
INDICATIONS:
CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Please see full Prescribing Information.
Instructions For Use
Sharps Medical Waste Disposal (PDF)
Learn more about Sanofi’s commitment to fighting counterfeit drugs.
References: 1. Centers for Medicare & Medicaid Services. ICD-10-CM/PCS MS-DRG v37.0 Definitions Manual. Updated September 12, 2019. Accessed April 14, 2023. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0213.html 2. Centers for Medicare & Medicaid Services. 2023 ICD-10-CM. Updated July 27, 2022. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-code-tables-tabular-and-index.zip 3. Centers for Medicare & Medicaid Services. 2023 ICD-10-PCS. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-icd-10-pcs-code-tables-and-index.zip
IMPORTANT SAFETY INFORMATION AND INDICATIONS
CONTRAINDICATIONS:
CABLIVI is contraindicated in patients with a 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 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:
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
CONCOMITANT USE OF ANTICOAGULANTS OR ANTIPLATELET AGENTS:
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.
INDICATIONS:
CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Please see full Prescribing Information.
Instructions For Use
Sharps Medical Waste Disposal (PDF)
Learn more about Sanofi’s commitment to fighting counterfeit drugs.
References: 1. Centers for Medicare & Medicaid Services. ICD-10-CM/PCS MS-DRG v37.0 Definitions Manual. Updated September 12, 2019. Accessed April 14, 2023. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0213.html 2. Centers for Medicare & Medicaid Services. 2023 ICD-10-CM. Updated July 27, 2022. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-code-tables-tabular-and-index.zip 3. Centers for Medicare & Medicaid Services. 2023 ICD-10-PCS. Accessed April 12, 2023. https://www.cms.gov/files/zip/2023-icd-10-pcs-code-tables-and-index.zip