Sanofi Promise: A Warranty Program for CABLIVI | CABLIVI reimbursement
Sanofi is committed to individuals living with acquired thrombotic thrombocytopenic purpura (aTTP/iTTP)
and the healthcare professionals who support them.
As part of this commitment, the cost of CABLIVI will be refunded in the hospital setting for up to six (6) inpatient doses for patients who fail to reach initial clinical response to CABLIVI or up to twelve (12) inpatient doses for patients who exacerbate while on CABLIVI treatment, as defined by the program terms. Additional Eligibility Requirements, Terms and Conditions apply. CABLIVI must be administered according to the FDA-approved label (Prescribing Information). Refund amount will be up to the wholesale acquisition cost (WAC) or actual acquisition cost, whichever is less.
The first evidence-based guidelines for aTTP/iTTP recommend CABLIVI,* the first and only FDA-approved therapy for adults in combination with PEX and immunosuppressive therapy, for acute aTTP/iTTP events—initial and relapsing.
*A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. Assumes timely access to ADAMTS13 testing and clinical diagnosis based on high likelihood of aTTP/iTTP. In de novo patients where no reasonable access to ADAMTS13 activity testing is available, the Guidelines do not recommend CABLIVI; however, treatment of a patient previously diagnosed with aTTP/iTTP could be safely undertaken on clinical grounds without the need for a confirmatory ADAMTS13 test.33
If a patient is non-responsive to CABLIVI treatment within the inpatient setting, your institution may be eligible for a refund
CABLIVI must be administered in the 50 United States, District of Columbia, or Puerto Rico and prescribed according to its FDA-approved label (Prescribing Information). CABLIVI treatment must be discontinued at the discretion of the healthcare provider for one of the following reasons:
Additional Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions below.
FILING A CLAIM
To file a claim, you must fully complete and sign the Warranty Claim Form, Hospital Declarations and Authorizations Form, and Physician Attestation Form available below within 90 days following the patient becoming a non-responder to CABLIVI.
You can submit the forms by:
MAIL: AIG Claims, Inc., PO Box 845, Stevens Point, WI 54481-0047
Call 1-800-295-4010 Monday-Friday, 7 am to 7 pm CT for any questions or to learn more about the Sanofi Promise Warranty Program for CABLIVI.
Please review the full Terms and Conditions carefully before initiating the reimbursement process.
To successfully file a claim, the following 3 forms must be completed and submitted:
Sanofi (referred to as “us”, “we” and similar terms) is proud to offer the Sanofi Promise Warranty Program for CABLIVI (the “Program”) to each institution that purchases CABLIVI (referred to as “you”, “your” and similar terms) and who meets the Eligibility Requirements and follows the Benefit Request Process described below (the “Terms”). You should carefully review these Terms. Coverage is subject to certain terms, conditions, and limitations, including limitations on the amount of coverage.
Overview of Program
For institutions who meet the Eligibility Requirements, the cost of CABLIVI will be refunded for up to six (6) inpatient doses for patients who fail to reach initial clinical response to CABLIVI or up to twelve (12) inpatient doses for patients who exacerbate while on CABLIVI treatment. Refund amount will be up to wholesale acquisition cost (WAC) or actual acquisition cost, whichever is less.
Medication Eligible for the Program
In order for you to be eligible to use the Program, you must satisfy all of the criteria listed below:
Benefit Request Process:
In order to be eligible for a refund under this Program, you must satisfy the requirements above and submit the information below (the “Claims Information”), within ninety (90) days following the patient becoming a non-responder to CABLIVI.
Additional Terms and Conditions
LIMITATION OF LIABILITY
IN NO EVENT, UNDER ANY CAUSE OF ACTION OF THEORY OF LIABILITY, SHALL SANOFI, ITS DISTRIBUTORS OR SUPPLIERS BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES, OF ANY NATURE WHATSOEVER, ARISING OUT OF OR IN CONNECTION WITH THE PROGRAM, EVEN IF SANOFI HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
NOTWITHSTANDING ANY DAMAGES THAT YOU MIGHT INCUR FOR ANY REASON WHATSOEVER INCLUDING, WITHOUT LIMITATION, ALL DAMAGES REFERENCED HEREIN AND ALL DIRECT OR GENERAL DAMAGES IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, THE ENTIRE AGGREGATE LIABILITY OF SANOFI AND ANY OF ITS DISTRIBUTORS AND/OR SUPPLIERS SHALL BE LIMITED TO THE MAXIMUM AMOUNT SET FORTH ABOVE FOR THE PRODUCT THAT IS SUBJECT TO THE PROGRAM. SOME STATES AND/OR JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU. THE LIMITATIONS OF LIABILITY SET FORTH ABOVE SHALL APPLY TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAW.
ARBITRATION: Read the following arbitration provision (“Provision”) carefully. It limits certain of your rights, including your right to obtain relief or damages through court action.
To begin Arbitration, either you or we must make a written demand to the other party for arbitration for the applicable claim (“Claim”). The Arbitration will take place before a single arbitrator. It will be administered in keeping with the Expedited Procedures of the Commercial Arbitration Rules (“Rules”) of the American Arbitration Association (“AAA”) in effect when the Claim is filed. You may get a copy of these AAA’s Rules by visiting www.adr.org. The filing fees to begin and carry out arbitration will be shared equally between you and us. This does not prohibit the arbitrator from giving the winning party their fees and expenses of the arbitration. Unless you and we agree, the arbitration will take place in the county and state where you live. The Federal Arbitration Act, 9 U.S.C. Ch. 1, et seq., will govern and not any state law on arbitration. YOU AGREE AND UNDERSTAND THAT this arbitration provision means that you give up your right to go to court on any Claim covered by this provision. You also agree that any arbitration proceeding will only consider your Claim. Claims by, or on behalf of, other individuals will not be arbitrated in any proceeding that is considering your Claims. THE DEGREE TO WHICH ARBITRATION CAN BE USED AS A DISPUTE RESOLUTION PROCESS FOR CONSUMER CLAIMS VARIES FROM STATE TO STATE, SO THIS ARBITRATION PROVISION MAY NOT APPLY TO YOU, DEPENDING ON YOUR STATE OF RESIDENCE. In the event this Arbitration provision is not approved by the appropriate state regulatory agency, and/or is stricken, severed, or otherwise deemed unenforceable by a court of competent jurisdiction, you and us specifically agree to waive and forever give up the right to a trial by jury. Instead, in the event any litigation arises between you and us, any such lawsuit will be tried before a judge, and a jury will not be impaneled or struck.
Sanofi is committed to ensuring all patients with 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.
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.
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.
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.
Introduction of Caplacizumab Into Subcutaneous Tissue, Percutaneous Approach, New Technology Group 5 Introduction of Other Therapeutic Substance into Subcutaneous Tissue, Percutaneous Approach
Introduction of Caplacizumab Into Peripheral Vein, Percutaneous Approach, New Technology Group 5 Introduction of Other Therapeutic Substance into Peripheral Vein, Percutaneous Approach
Introduction of Caplacizumab Into Central Vein, Percutaneous Approach, New Technology Group 5 Introduction of Other Therapeutic Substance into Central Vein, Percutaneous Approach
Find more information regarding coverage and other reimbursement considerations.
aTTP=acquired thrombotic thrombocytopenic purpura; DRG=diagnosis related group; DSH=disproportionate share hospital; FDA=Food and Drug Administration; 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; iTTP=immune-mediated thrombotic thrombocytopenic purpura; MCC=major complication or comorbidity; MS-DRG=Medicare Severity Diagnosis Related Group; PEX=plasma exchange.
INFORMATION AND INDICATIONS
IMPORTANT SAFETY INFORMATION
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 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.
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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Low levels of ADAMTS-13 with high anti-ADAMTS-13 antibodies during remission of immune-mediated thrombotic thrombocytopenic purpura highly predict for disease relapse: a multi-institutional study. Am J Hematol. 2020;95(8):953-959. doi:10.1002/ajh.25845. 11. Knoebl P, Cataland S, Peyvandi F, et al. Efficacy and safety of open-label caplacizumab in patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study. J Thromb Haemost. 2020;18(2):479-484. doi:10.1111/jth.14679. 12. Sayani FA, Abrams CS. How I treat refractory thrombotic thrombocytopenic purpura. Blood. 2017;130(14):1684. doi:10.1182/blood-2017-08-803171. 13. Kremer Hovinga JA, Coppo P, Lämmle B, Moake JL, Miyata T, Vanhoorelbeke K. Thrombotic thrombocytopenic purpura. Nat Rev Dis Primers. 2017;3:17020. doi:10.1038/nrdp.2017.20. 14. 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. 15. Azoulay E, Bauer PR, Mariotte E, et al; Nine-i Investigators. Expert statement on the ICU management of patients with thrombotic thrombocytopenic purpura. Intensive Care Med. 2019;45(11):1518-1539. doi:10.1007/s00134-019-05736-5. 16. Kremer Hovinga JA, Vesely SK, Terrell DR, Lämmle B, George JN. Survival and relapse in patients with thrombotic thrombocytopenic purpura. Blood. 2010;115(8):1500-1511. doi:10.1182/blood-2009-09-243790. 17. Upreti H, Kasmani J, Dane K, et al. Reduced ADAMTS13 activity during TTP remission is associated with stroke in TTP survivors. Blood. 2019;134(13):1037-1045. doi:10.1182/blood.2019001056. 18. Cuker A, Cataland SR, Coppo P, et al. Redefining outcomes in immune TTP: an international working group consensus report. 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Laurence J, Haller H, Mannucci PM, Nangaku M, Praga M, de Cordoba SR. Atypical hemolytic uremic syndrome (aHUS): essential aspects of an accurate diagnosis. Clin Adv Hematol Oncol. 2016;14 Suppl 11(11):2-15. 26. 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. doi:10.1056/NEJMoa1806311. 27. 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. doi:10.1056/NEJMoa1806311. 28. CABLIVI [instructions for use]. Cambridge, MA: Genzyme Corporation. 29. 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 30. Centers for Medicare & Medicaid Services. ICD-10-CM/PCS MS-DRGv37 Definitions Manual: MDC 8 Diseases & Disorders of the Musculoskeletal System & Connective Tissue Disorders. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0213.html. Updated September 12, 2019. Accessed January 9, 2023. 31. Centers for Medicare & Medicaid Services. 2023 ICD-10-CM. https://www.cms.gov/files/zip/2023-code-tables-tabular-and-index.zip. Updated July 27, 2022. Accessed January 9, 2023. 32. Centers for Medicare & Medicaid Services. 2023 ICD-10-PCS. https://www.cms.gov/files/zip/2023-icd-10-pcs-code-tables-and-index.zip. Accessed January 9, 2023.