Important Safety Information: 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... View more

Support and Resources

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

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.

  • All patients with a confirmed diagnosis of Gaucher disease are eligible for inclusion
  • By enrolling patients in the registry, participating physicians will receive patient-specific reports to monitor disease status

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.

Reporting. Collaborating. Advancing. Help to improve the quality of care for patients with Gaucher disease. Visit the Gaucher Registry to learn more.
CareConnectPSS

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.

Our range of support to help patients manage living with a rare disease
  • Programs and other offerings on a range of disease, treatment, and support topics
  • Dedicated CareConnectPSS Case Managers and Patient Education Liaisons
  • Disease-specific information, including genetic education and other resources
  • Care coordination for moves, vacations, and more
  • Assistance with understanding new or changing insurance, as well as resources to help with out-of-pocket costs

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.

CareConnectPSS Co-Pay Assistance Program

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 open to individuals who:
  • Have commercial insurance
  • Have prescription drug coverage
  • Are prescribed one of Sanofi Genzyme’s treatments*
  • Are residents of the United States

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.

Cerezyme Support Program

The Cerezyme Support Program has been designed by Sanofi Genzyme to help educate and support patients taking Cerezyme. The program covers topics such as:

Establishing a treatment routine, including tips to help take Cerezyme as prescribed
• Establishing a treatment routine, including tips for managing your Cerezyme infusion schedule
Good communication between patients and their health care team
• Fostering good communication between patients and their health care team
Access to resources for patients questions
• Facilitating access to resources when patients have questions

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.

Sanofi Genzyme Charitable Access Program

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.

The Sanofi Genzyme Charitable Access Program has been established in the United States through the Sanofi Genzyme Charitable Foundation, Inc. The program is committed to providing Cerezyme to individuals who:
  • Medically need Cerezyme and
  • Are uninsured or have inadequate insurance coverage for Cerezyme

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.

To be considered for the program, patients will be asked to provide the following:

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.

Please note that the Sanofi Genzyme Charitable Access Program is considered a temporary program. Patients and their families are expected to continue exploring alternative resources with the assistance of a CareConnectPSS Case Manager. These may include:
  • Private insurance
  • Government programs

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.

Billing and reimbursement

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
CPT-4 96365
96366
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)
Revenue 260
261
258
636
General IV therapy service
Infusion pump
IV solutions
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

Have questions about Cerezyme?

Your local representative can help provide answers

Request a rep
Learn more about patient support

Sign up to request more information

Visit CareConnectPSS
Indication & Usage

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:

  • anemia
  • thrombocytopenia
  • bone disease
  • hepatomegaly or splenomegaly
Important Safety Information

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).