Managing a genetic disease is a lifetime commitment. From diagnosis
to treatment, our dedicated team of professionals is available to
provide disease education and help address your patients’ needs,
including assistance with health insurance issues, all free of charge.
The ICGG Gaucher Registry (sponsored by Sanofi) is the world’s largest cooperative observational study on Gaucher disease. The ICGG established the Gaucher Registry in 1991 as a longitudinal database tracking outcomes of routine clinical practice.
Data from the ICGG Gaucher Registry provide insight into Gaucher disease. Publications based on these data have helped increase understanding of Gaucher disease, its natural history, diagnosis, treatment, and management as well as bone disease, pediatric presentation, and genotypes. The ICGG Gaucher Registry maintains its integrity by a commitment to patient privacy and confidentiality, as well as a commitment to the quality of data.
CareConnectPSS, personalized support services for patients, represents Sanofi’s more than 35-year commitment to supporting the rare disease community. CareConnectPSS is designed to support each patient’s unique journey.
For more information visit us at CareConnectPSS.com
Access to these and other services is voluntary, and your patients are not obligated to begin treatment if they contact us. You and your patients make all treatment-related decisions, and most importantly the privacy and security of their personal information are always protected.
The CareConnectPSS Co-Pay Program* helps eligible, US patients who are prescribed one of Sanofi’s treatments pay for eligible, out-of-pocket, drug-related expenses, including copays, coinsurance, and deductibles.
The program is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), or other federal or state programs (including any state prescription drug assistance programs).
Patients can download the enrollment form or call 1-800-745-4447, Option 3 to learn more about the program and application process.
The Cerezyme Support Program has been designed by Sanofi to help educate and support patients taking Cerezyme. The program covers topics such as:
This program also provides optional email updates and text messages with tips, stories, and messages related to their treatment.
Encourage your patients to join! Call us at 1-800-745-4447, Option 3.
This program was established in the US to provide Sanofi’s therapies to eligible individuals who do not have health insurance or have inadequate coverage for treatment. It is considered a temporary solution until long-term coverage can be secured.
Qualified individuals with Gaucher disease type 1 whose physicians have recommended treatment with Cerezyme may be eligible for the Charitable Access Program. If a patient is ineligible for the program, their CareConnectPSS Case Manager will work with the patient and their health care providers to explore alternative coverage options.
A CareConnectPSS Case Manager will coordinate with you and your patient to obtain the necessary documentation, including a signed waiver, and keep you updated on the status of your patient’s application. Applications are reviewed on a monthly basis and are kept confidential by the Sanofi Charitable Access Program.
To learn more about the Sanofi Charitable Access Program or to request an application form, call 1‑800‑745‑4447, Option 3
Disclaimer: The Sanofi Charitable Access Program may be discontinued at any time at the discretion of the Charitable Access Program Committee.
To bill for Cerezyme therapy, you must use the appropriate codes. The billing procedures may vary according to the site of service or third-party payer guidelines. Please reference this site or call a Sanofi Case Manager for updated billing codes.
In addition to the reimbursement expertise provided by our Sanofi Case Managers, Sanofi also offers a Guide to Cerezyme Billing and Reimbursement to help you through the process.
Cerezyme billing codes
|ICD-10-CM||E75.22||Lipidosis (Gaucher Disease)|
|NDC||58468-4663-1||400 unit vial|
|HCPCS||J1786||Cerezyme® - injection, imiglucerase, 10 units|
|Intravenous infusion therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
Each additional hour (List separately in addition to primary procedure code, 96365)
|General IV therapy service
Drugs and biologicals requiring a HCPCS code
The unique J-code assigned to Cerezyme, significantly streamlines the reimbursement process. Cerezyme is eligible for reimbursement by commercial payers and Medicare. However, specific policies vary across insurers and from plan to plan.
Providers are responsible for the selection of appropriate codes. Information in the table above provides a general framework for understanding possible coding alternatives. It should not be used as a substitute for a healthcare professional’s own judgment. Any specific guidance or direction regarding claims submission offered by the payer supersedes the information below.
Since third party payers evaluate treatment based on medical necessity, expected outcome, and cost, they generally require documentation of diagnosis and clinical symptoms of Gaucher disease type 1. Refer to the Statement of Medical Necessity sample. This information may need to be submitted with the claim; for specific requirements check with the payer or contact your Sanofi Case Manager.
To help avoid potential problems obtaining reimbursement, the treating physician should request written confirmation of coverage from the third party payer prior to initiation of enzyme replacement therapy. Sanofi Case Managers can assist in obtaining written authorization for Cerezyme treatment.
For more information, contact Sanofi Support Services at 1-800-745-4447, Option 3
Cerezyme® (imiglucerase) for injection is indicated for treatment of adults and pediatric patients 2 years of age and older with Type 1 Gaucher disease that results in one or more of the following conditions:
Warnings and Precautions:
Hypersensitivity and Infusion-Associated Reactions: Hypersensitivity reactions, some of which are serious and include anaphylaxis have been reported. Hypersensitivity and other infusion-associated reactions have been reported during or shortly after infusion and include pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, cough, cyanosis, tachycardia, and hypotension. Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions. Not all patients with symptoms of hypersensitivity have detectable IgG antibody. Consider periodic monitoring during the first year of treatment for IgG antibody formation.
If a severe hypersensitivity reaction occurs, discontinue Cerezyme treatment and initiate appropriate medical treatment. Consider the risks and benefits of readministering Cerezyme to individual patients following a severe reaction. If Cerezyme is readministered, consider reducing the rate of infusion, pretreat with antihistamines and/or corticosteroids, and monitor patients for new signs and symptoms of a severe hypersensitivity reaction.
Adverse reactions reported in adults include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting.
Adverse reactions reported in pediatric patients 2 years of age and older are similar to adults.
Approximately 15% of patients treated and tested to date have developed IgG antibody to Cerezyme during the first year of therapy. Patients who developed IgG antibody did so largely within 6 months of treatment and rarely developed antibodies to Cerezyme after 12 months of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity. Patients with antibody to Cerezyme have higher risk of hypersensitivity reaction.
Please see Full Prescribing Information (PDF).
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Medical Information at 1-800-745-4447, Option 2.