Sanofi Genzyme is committed to ensuring all patients with aTTP 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.
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. Like other drugs, CABLIVI is expected to be bundled into inpatient payment rates (ie, MS-DRGs) when used in the hospital setting. 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.
Connective Tissue Disorders With MCC
Connective Tissue Disorders With CC
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.
The specifics of coverage may vary by payer. Please refer to the individual patient’s plan to determine any applicable coverage requirements.
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.
CMS has approved CABLIVI’s application for an NTAP for FY2021, effective February 6, 2019. The maximum NTAP for CABLIVI is $33,215 for FY2021. Specifically, if the cost of CABLIVI exceeds the full DRG payment (including payments for IME and DSH, but excluding outlier payments), Medicare will make an add-on payment equal to the lesser of: 65% of the cost of CABLIVI or 65% of the amount by which the costs of the case exceed the standard DRG payment.16,17
The specifics of coverage may vary by payer and can be specific to the patient’s unique plan. Please reference the individual patient’s plan to determine any applicable coverage requirements.
There is no specific ICD-10-CM code for aTTP. Providers should always review payer-specific materials and use their own clinical judgment when submitting claims for use of CABLIVI. However, there are 3 ICD-10-PCS codes that describe the specific procedure of injecting CABLIVI in the hospital inpatient setting to ensure that NTAP is considered.
Introduction of Caplacizumab Into Subcutaneous Tissue, Percutaneous Approach, New Technology Group 5
Introduction of Caplacizumab Into Peripheral Vein, Percutaneous Approach, New Technology Group 5
Introduction of Caplacizumab Into Central Vein, Percutaneous Approach, New Technology Group 5
Find more information regarding coverage and other reimbursement considerations.
aTTP=acquired thrombotic thrombocytopenia purpura; CC=complication or comorbidity; CMS=Centers for Medicare and Medicaid Services; DRG=Diagnosis Related Group; DSH=disproportionate share hospital; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification; ICD-10-PCS=International Classification of Diseases, Tenth Revision, Procedure Coding System; IME=indirect medical education; MCC=major complication or comorbidity; MS-DRG=Medicare Severity Diagnosis Related Group.
†Thrombotic microangiopathy has the inclusion note of thrombotic thrombocytopenic purpura, which would describe aTTP.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
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:
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
CONCOMITANT USE OF ANTICOAGULANTS:
Concomitant use of CABLIVI with any anticoagulant may increase the risk of bleeding. Assess and monitor closely for bleeding with concomitant use.
There are no available data on CABLIVI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage.
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.
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References: 1. CABLIVI [package insert]. Cambridge, MA: Genzyme Corporation; 2019. 2. Scully M, Cataland SR, Peyvandi F, et al; for the HERCULES Investigators. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346. 3. Zheng XL, Vesely SK, Cataland SR, et al. ISTH guidelines for the diagnosis of thrombotic thrombocytopenic purpura. J Thromb Haemost. 2020;18(10):2486-2495. doi:10.1111/jth.15006. 4. Grall M, Azoulay E, Galicier L, et al. Thrombotic thrombocytopenic purpura misdiagnosed as autoimmune cytopenia: causes of diagnostic errors and consequence on outcome. Experience of the French thrombotic microangiopathies reference centre. Am J Hematol. 2017;92(4):381-387. 5. Scully M, Hunt BJ, Benjamin S, et al. On behalf of British Committee for Standards in Haematology. Guidelines on the diagnosis and management of thrombotic thrombocytopenic purpura and other thrombotic microangiopathies. Br J Haematol. 2012;158(3):323-335. 6. Goel R, King KE, Takemoto CM, et al. Prognostic risk-stratified score for predicting mortality in hospitalized patients with thrombotic thrombocytopenic purpura: national representative data from 2007 to 2012. Transfusion. 2016;56(6):1451-1458. 7. Peyvandi F, Scully M, Kremer Hovinga JA, et al. Caplacizumab reduces the frequency of major thromboembolic events, exacerbations and death in patients with acquired thrombotic thrombocytopenic purpura. J Thromb Haemost. 2017;15(7):1448-1452. 8. Joly BS, Coppo P, Veyradier A. Thrombotic thrombocytopenic purpura. Blood. 2017;129(21):2836-2846. 9. Kremer Hovinga JA, Coppo P, Lämmle B, et al. Thrombotic thrombocytopenic purpura. Nat Rev Dis Primers. 2017;3:17020. doi:10.1038/nrdp.2017.20. 10. Holz J-B. The TITAN trial—assessing the efficacy and safety of an anti-von Willebrand factor Nanobody in patients with acquired thrombotic thrombocytopenic purpura. Transfus Apher Sci. 2012;46(3):343-346. 11. Supplement to: Scully M, Cataland SR, Peyvandi F, et al; for the HERCULES Investigators. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346. 12. Protocol for: Scully M, Cataland SR, Peyvandi F, et al; for the HERCULES Investigators. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346. 13. Zheng XL, Vesely SK, Cataland SR, et al. ISTH guidelines for treatment of thrombotic thrombocytopenic purpura. J Thromb Haemost. 2020;18(10):2496-2502. doi: 10.1111/jth.15010. 14. CABLIVI [instructions for use]. Cambridge, MA: Genzyme Corporation; 2019. 15. Centers for Medicare & Medicaid Services. Draft ICD-10-CM/PCS MS-DRGv28 Definitions Manual: MDC 8 Diseases & Disorders of the Musculoskeletal System & Connective Tissue Disorders. https://www.cms.gov/icd10manual/fullcode_cms/P0209.html. Accessed July 25, 2019. 16. Centers for Medicare & Medicaid Services. Department of Health and Human Services. 42 CFR Parts 405, 412, 413, 417, 476, 480, 484, and 495. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals Fed Regist. September 18, 2020;85(182):58432-59107. 17. Brodie S. Regulatory insight: Reviewing ICD-10-PCS Section X. ACDIS. Acdis.org website. https://acdis.org/resources/regulatory-insight-reviewing-icd-10-pcs-section-x. Accessed December 9, 2020.18. Centers for Medicare & Medicaid Services. 2019 ICD-10-CM. https://www.cms.gov/Medicare/Coding/ICD10/2019-ICD-10-CM.html. Updated June 20, 2019. Accessed July 23, 2019. 19. Centers for Medicare & Medicaid Services. 2020 ICD-10-PCS. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-PCS.html. Accessed July 25, 2019.