Sanofi CareConnectPSS: Personalized Support Services for Your Eligible Patients
Whether your patient is newly diagnosed with Gaucher disease type 1 (GD1) or switching treatment, a member of the Sanofi CareConnectPSS team can be there to help ensure personalized support for their rare disease.
- Participation in CareConnectPSS is free, voluntary, and confidential
- CareConnectPSS is designed to support each eligible patient’s unique journey and help them overcome challenges related to living with a rare disease
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Starting Treatment
CareConnectPSS can help make it easier by assisting with insurance verification and helping your eligible patient understand their coverage. CareConnectPSS can also help them manage out-of-pocket costs and unforeseen financial challenges, and can provide answers to disease- and treatment-specific questions.
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Insurance Changes
CareConnectPSS can also assist with insurance matters related to changes in employment, marital, or dependency status, or if your eligible patient now qualifies for Medicare, Medicaid, or other insurance options. CareConnectPSS can help ensure a smooth transition from old insurance to new.
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Resource Connections
Through CareConnectPSS, your eligible patient can access a range of programs and other support offerings to address their individual needs.
For more information, visit CareConnectPSS.com or call
1-800-745-4447, Option 3
Whether in person, by phone, or via electronic communication, any information your eligible patients provide will be strictly confidential. CareConnectPSS will always keep your patients informed of our intentions and interactions. Our priority is to make sure they have the support and resources needed to best manage their medical condition.
CareConnectPSS Co-pay Assistance Program
- This program helps eligible US patients who are prescribed one of Sanofi's treatments pay for qualifying, out-of-pocket, drug-related expenses, including co-pays, coinsurance, and deductibles.
- To be eligible, your patients must:
- Be a resident of the United States
- Have commercial insurance
- Be prescribed one of Sanofi's treatments*
- Have prescription drug coverage for their Sanofi treatment
- 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). The program is also not valid where prohibited by law.
- Patients can 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 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, 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, whether public or private. Sanofi reserves the right to make eligibility decisions, set program maximums, and rescind, revoke, or amend this program at any time without notice. Savings provided by the Co-Pay Program may vary depending on patients’ out-of-pocket costs. Program details provided upon registration.
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Have a question about Gaucher disease type 1 or Cerdelga?
Sanofi representatives may provide you with more information
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Curious about the Cerdelga mechanism of action?
See how Cerdelga works to reduce GL-1 production1
Indication and Usage
CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
Limitations of Use:
- Patients who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect.
- A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers).
Important Safety Information
CONTRAINDICATIONS
CERDELGA is contraindicated in the following patients based on CYP2D6 metabolizer status due to the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac intervals:
- Extensive Metabolizers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, EMs with moderate or severe hepatic impairment, or EMs with mild hepatic impairment and taking a strong or moderate CYP2D6 inhibitor.
- Intermediate Metabolizers (IMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, IMs taking a strong CYP3A inhibitor, or IMs with any degree of hepatic impairment.
- Poor Metabolizers (PMs) taking a strong CYP3A inhibitor, or PMs with any degree of hepatic impairment.
WARNINGS AND PRECAUTIONS
CERDELGA is predicted to cause increases in ECG intervals (PR, QTc, and QRS) at substantially elevated plasma concentrations and may increase risk of cardiac arrhythmias. Use of CERDELGA is contraindicated, to be avoided, or requires dosage adjustment in patients taking CYP2D6 or CYP3A inhibitors, depending on CYP2D6 metabolizer status, type of inhibitor, or degree of hepatic impairment. Avoid use of CERDELGA in patients with pre-existing cardiac disease, long QT syndrome, or in combination with Class IA or Class III antiarrhythmic medications.
ADVERSE REACTIONS
The most common adverse reactions (≥10%) to CERDELGA include: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain.
DRUG INTERACTIONS
Coadministration of CERDELGA with CYP2D6 or CYP3A inhibitors may increase eliglustat concentrations, which may increase the risk of cardiac arrhythmias from prolongations of the PR, QTc, and/or QRS cardiac interval. Use of CERDELGA is contraindicated, to be avoided, or may require dosage adjustment depending on the concomitant drug and CYP2D6 metabolizer status. See section 7 of the full Prescribing Information for more details and other potentially significant drug interactions.
USE IN SPECIFIC POPULATIONS
Available data on the use of CERDELGA in pregnant women is not sufficient to assess drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CERDELGA and any potential adverse effects on the breastfed child from CERDELGA or from the underlying maternal condition.
Use of CERDELGA in patients with renal impairment is based on the patient’s CYP2D6 metabolizer status. Avoid use of CERDELGA in EMs with end-stage renal disease (ESRD), and IMs and PMs with any degree of renal impairment.
Use of CERDELGA is contraindicated or may require dosage adjustment in patients with hepatic impairment based on CYP2D6 metabolizer status, concomitant use of CYP2D6 or CYP3A inhibitors, and degree of hepatic impairment.
Please see accompanying full Prescribing Information.
Reference: 1. Scott LJ. Eliglustat: a review in Gaucher disease type 1. Drugs. 2015;75(14):1669-1678.
Indication and Usage
CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
Limitations of Use:
- Patients who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect.
- A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers).
Important Safety Information
CONTRAINDICATIONS
CERDELGA is contraindicated in the following patients based on CYP2D6 metabolizer status due to the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac intervals:
- Extensive Metabolizers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, EMs with moderate or severe hepatic impairment, or EMs with mild hepatic impairment and taking a strong or moderate CYP2D6 inhibitor.
- Intermediate Metabolizers (IMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, IMs taking a strong CYP3A inhibitor, or IMs with any degree of hepatic impairment.
- Poor Metabolizers (PMs) taking a strong CYP3A inhibitor, or PMs with any degree of hepatic impairment.
WARNINGS AND PRECAUTIONS
CERDELGA is predicted to cause increases in ECG intervals (PR, QTc, and QRS) at substantially elevated plasma concentrations and may increase risk of cardiac arrhythmias. Use of CERDELGA is contraindicated, to be avoided, or requires dosage adjustment in patients taking CYP2D6 or CYP3A inhibitors, depending on CYP2D6 metabolizer status, type of inhibitor, or degree of hepatic impairment. Avoid use of CERDELGA in patients with pre-existing cardiac disease, long QT syndrome, or in combination with Class IA or Class III antiarrhythmic medications.
ADVERSE REACTIONS
The most common adverse reactions (≥10%) to CERDELGA include: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain.
DRUG INTERACTIONS
Coadministration of CERDELGA with CYP2D6 or CYP3A inhibitors may increase eliglustat concentrations, which may increase the risk of cardiac arrhythmias from prolongations of the PR, QTc, and/or QRS cardiac interval. Use of CERDELGA is contraindicated, to be avoided, or may require dosage adjustment depending on the concomitant drug and CYP2D6 metabolizer status. See section 7 of the full Prescribing Information for more details and other potentially significant drug interactions.
USE IN SPECIFIC POPULATIONS
Available data on the use of CERDELGA in pregnant women is not sufficient to assess drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CERDELGA and any potential adverse effects on the breastfed child from CERDELGA or from the underlying maternal condition.
Use of CERDELGA in patients with renal impairment is based on the patient’s CYP2D6 metabolizer status. Avoid use of CERDELGA in EMs with end-stage renal disease (ESRD), and IMs and PMs with any degree of renal impairment.
Use of CERDELGA is contraindicated or may require dosage adjustment in patients with hepatic impairment based on CYP2D6 metabolizer status, concomitant use of CYP2D6 or CYP3A inhibitors, and degree of hepatic impairment.
Please see accompanying full Prescribing Information.
Reference: 1. Scott LJ. Eliglustat: a review in Gaucher disease type 1. Drugs. 2015;75(14):1669-1678.