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 Gaucher Registry (sponsored by Sanofi Genzyme) is the world’s largest cooperative observational study on Gaucher disease. The International Collaborative Gaucher Group (ICGG) established the registry in 1991 as a longitudinal database tracking outcomes of routine clinical practice.
Data from the Gaucher Registry provides insight into Gaucher disease. Publications based on this 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 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 Genzyme’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 Genzyme’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 CareConnectPSS Co-Pay Program is available only in the United States and cannot be combined with any other rebate/coupon, free trial, or similar offer. Co-Pay benefits are not transferable. This program assists patients with their out-of-pocket drug costs for their prescribed Sanofi Genzyme treatment only and does not cover or provide support for the cost of MD office visits/evaluations, nursing services/observation periods, blood work, x-rays or other testing, premedications/other medications, Epipens, transportation or other related services. No claim for reimbursement of any out-of-pocket expense covered by the CareConnectPSS Co-Pay Program may be submitted to any third-party payer, where public or private. Sanofi Genzyme reserves the right to make eligibility decisions, set program maximums, and rescind, revoke, or amend this program without notice.
The Cerezyme Support Program has been designed by Sanofi Genzyme 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 Genzyme’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 our 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 Genzyme Charitable Access Program.
To learn more about the Sanofi Genzyme Charitable Access Program or to request an application form, call 1-800-745-4447, Option 3
Disclaimer: The Sanofi Genzyme 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 Genzyme Case Manager for updated billing codes.
In addition to the reimbursement expertise provided by our Sanofi Genzyme Case Managers, Sanofi Genzyme 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 type I Gaucher disease. Refer to the Statement of Medical Necessity sample (Appendix B). This information may need to be submitted with the claim; for specific requirements check with the payer or contact your Sanofi Genzyme 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 Genzyme Case Managers can assist in obtaining written authorization for Cerezyme treatment.
For more information, contact Sanofi Genzyme Support Services at 1-800-745-4447, Option 3
Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:
Approximately 15% of patients have developed IgG antibodies to Cerezyme during the first year of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity, and these patients have a higher risk of hypersensitivity. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.
Hypersensitivity has also been observed in patients without detectable IgG antibodies. Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of all patients, and anaphylactoid reactions in less than 1%. Treatment with Cerezyme should be approached with caution in patients who have exhibited hypersensitivity symptoms such as pruritus, flushing, urticarial, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension. Pre-treatment with antihistamines and/or corticosteroids and a reduced rate of infusion may allow continued treatment in most patients.
In less than 1% of patients, pulmonary hypertension and pneumonia have been observed during treatment with Cerezyme. These are known complications of Gaucher disease regardless of treatment. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.
Approximately 13.8% of patients have experienced adverse events related to treatment with Cerezyme. Some of these are injection site reactions such as discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. Additional adverse reactions that have been reported include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Transient peripheral edema has also been reported for this therapeutic class of drug.
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Genzyme Medical Information at 1-800-745-4447, Option 2.
Please see Full Prescribing Information (PDF).