IpsenCares logo

This site is intended for U.S. residents only

Go to Healthcare Professional Site

This website is intended for U.S. residents only

Patient support for eligible and enrolled patients prescribed Bylvay

Once the provider has prescribed Bylvay, the IPSEN CARES® Patient Access Managers are fully dedicated to:

  • Facilitating eligible patients' access to their prescribed medications
  • Providing information and support for the interactions among offices, patients, and insurance companies for Ipsen medications

Actor portrayals unless otherwise noted.

We are collecting personal information to fulfill your request. Please see our Privacy Policy and our State Supplemental Privacy Policy for more information.

    • Your Enrollment Form request has been submitted to IPSEN CARES for review. A Patient Access Manager will review your submission and contact both you and your Healthcare Provider within 1 business day. If you have any questions or would like to learn more about IPSEN CARES and its support offerings, please call 866-435-5677, 8:00am to 8:00pm ET Monday through Friday.

    HOW TO ENROLL IN IPSEN CARES PATIENT SUPPORT PROGRAM

    IPSEN CARES serves as a central point of contact between patients/caregivers, healthcare providers, insurance companies, and specialty pharmacies.

    Instructions for Patients

    • You need to complete Steps 5, 6, 7,* and read Step 8 outlined in green on the Enrollment Form. Mandatory Fields are marked with an *.
    • Your healthcare provider will complete the steps outlined in blue.
    • It’s important to fill out all sections completely to prevent enrollment delays.
    1. STEP 1: Fill out the Patient Information section in Step 5.
    2. STEP 2: Fill out the Insurance Information section in Step 6.
    3. STEP 3: Fill out the IPSEN CARES Copay Program section in Step 7 if requesting this service.
    4. STEP 4: Sign the PATIENT AUTHORIZATION AND ADDITIONAL PRODUCT AND SUPPORT INFORMATION box under Step 8 after you read the information in Step 8.

    Instructions for Prescribers

    • Fill out the Prescriber Information Sections in Steps 1-4.
    • Sign and date the PRESCRIBER ATTESTATION at the end of Step 4.

    Once a completed Enrollment Form is received, an IPSEN CARES Patient Access manager will perform a benefits verification and review the patient’s coverage and out-of-pocket responsibility with both the prescriber and the patient, typically within 1 business day.

    STEP 1: Prescriber Information
    Next Step
    If you would like IPSEN CARES to triage the prescription to a specialty pharmacy, complete the prescription information in Step 4.
    Preferred Specialty Pharmacy
    Selection will be honored if permitted by patient’s insurance.
    Was Rx Sent to a Specialty Pharmacy Already?
    Next Step
    Pruritus

    Bylvay is indicated for the treatment of cholestatic pruritus in patients 3 months of age and older with PFIC and for patients 12 months of age and older with ALGS.

    Limitations of Use: Bylvay may not be effective in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein.

    Selected Safety Information

    • Liver Test Abnormalities: Obtain baseline liver tests and monitor during treatment. Dose reduction or treatment interruption may be required if abnormalities occur. For persistent or recurrent liver test abnormalities, consider treatment discontinuation.
    • Diarrhea: Treat dehydration. Treatment interruption or discontinuation may be required for persistent diarrhea.
    • Fat-Soluble Vitamin (FSV) Deficiency: Obtain baseline levels and monitor during treatment. Supplement if deficiency is observed. If FSV deficiency persists or worsens despite FSV supplementation, discontinue treatment.

     

    Please see additional Important Safety Information below in Step 4.

    Please see full Prescribing Information.

    Next Step
    Complete and sign this section if you would like IPSEN CARES to triage the prescription to a specialty pharmacy or if the patient is seeking enrollment in the PAP.
    PRESCRIPTION: Bylvay® (odevixibat)
    Sex

    Kg

    See Dosing Tables in Prescribing Information to determine dosage by patient weight in kg.

    Medication
    Bylvay
    Strength (check box of requested dose)
    Quantity
    Days Supply
    Refills
    Directions‡

    mcg total once daily

    mcg total swallowed whole once daily

    Supplies
    *200 mcg and 600 mcg strengths must be opened and sprinkled, NOT swallowed whole
    †400 mcg and 1200 mcg strengths can be opened and sprinkled OR swallowed whole
    †Daily dose must be a multiple of the listed strengths

    PRESCRIBER ATTESTATION

    If the request is limited to Benefit Verification or Copay Assistance Program support, the Prescriber, or an individual acting at the direction of the Prescriber and involved in the patient’s care may sign this form.

    By signing below, I certify that the therapy referenced in this form is medically necessary. I certify that a prescription signed by a licensed prescriber is on file for the referenced therapy and that I have received the necessary authorization from the patient and/or the patient’s guardian to release the information herein and medical and/or patient information relating to Bylvay therapy to Ipsen and its agents or contractors for the purpose of seeking reimbursement for Bylvay therapy, assisting in initiating or continuing Bylvay therapy, and/or evaluating the patient’s eligibility for Ipsen’s patient support programs administered by IPSEN CARES. I authorize Ipsen and its agents or contractors to forward a prescription by fax or other delivery mode to the designated pharmacy. I understand that I must comply with applicable state-specific prescription requirements such as e-prescribing, state-specific prescription form, fax language, etc. Non-compliance with state-specific requirements could result in outreach to me. Medications received by me or on my behalf from Ipsen in connection with any IPSEN CARES program will be used only for the named patient. I acknowledge that I have assisted the named patient in enrolling in IPSEN CARES exclusively for purposes of patient care and not in consideration for, expectation of, or actual receipt of remuneration of any sort.

    INDICATIONS

    Bylvay is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of:

    • cholestatic pruritus in patients ≥12 months of age with Alagille syndrome (ALGS)
    • pruritus in patients ≥3 months of age with progressive familial intrahepatic cholestasis (PFIC)

    Limitation of Use:  
    Bylvay may not be effective in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein.

    IMPORTANT SAFETY INFORMATION

    Contraindications  
    IBAT inhibitors, including Bylvay, are contraindicated in patients with prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy).

    WARNINGS AND PRECAUTIONS

    Hepatotoxicity  
    Bylvay treatment is associated with a potential for drug-induced liver injury (DILI). In the PFIC and ALGS trials, treatment-emergent elevations or worsening of liver tests occurred. Of the six patients who experienced DILI, two underwent liver transplant. Obtain baseline liver tests because some ALGS and PFIC patients have abnormal liver tests at baseline and monitor patients frequently for the first 6 to 8 months, and as clinically needed thereafter, for elevations in liver tests, for the development of liver-related adverse reactions, and for physical signs of hepatic decompensation. If liver test abnormalities or signs of clinical hepatitis occur in the absence of other causes, consider dose reduction or treatment interruption. Permanently discontinue Bylvay if a patient experiences the following: persistent or recurrent liver test abnormalities, or upon rechallenge, signs and symptoms consistent with clinical hepatitis, or a hepatic decompensation event.

    The safety and effectiveness of Bylvay have not been established in patients with decompensated cirrhosis. Monitor patients with compensated cirrhosis or portal hypertension more frequently and discontinue if hepatic decompensation occurs. IBAT inhibitors, including Bylvay, are contraindicated in patients with prior or active hepatic decompensation events.

    Diarrhea 
    In the PFIC and ALGS clinical trials, diarrhea was reported more frequently in Bylvay-treated patients compared to placebo. In the PFIC clinical trials, treatment interruption due to diarrhea occurred in 2 patients with 3 events. Treatment interruption due to diarrhea ranged between 3 to 7 days. One patient withdrew from the trial. In the ALGS clinical trial, no patients interrupted or discontinued treatment due to diarrhea.

    If diarrhea occurs, monitor for dehydration and treat promptly. Interrupt dosing if a patient experiences persistent diarrhea. Restart Bylvay at 40 mcg/kg/day when diarrhea resolves and increase the dose as tolerated if appropriate. If diarrhea persists and no alternate etiology is identified, stop treatment.

    Fat-Soluble Vitamin (FSV) Deficiency 
    Fat-soluble vitamins (FSV) include vitamin A, D, E, and K. PFIC and ALGS patients can have FSV deficiency at baseline. Bylvay may affect absorption of FSVs. In clinical trials, new onset or worsening of existing FSV deficiency was reported more frequently in Bylvay-treated patients compared to placebo.

    Obtain baseline INR and FSV levels and monitor during treatment along with any clinical manifestations. If FSV deficiency is diagnosed, supplement with FSV. Discontinue Bylvay if FSV deficiency persists or worsens despite adequate FSV supplementation and consider restarting once the patient is clinically stable.

    If bleeding occurs, interrupt treatment with Bylvay. Optimize treatment of FSV deficiency and consider restarting Bylvay once the patient is clinically stable.

    Adverse Reactions 
    The most common adverse reactions for Bylvay in patients with PFIC are diarrhea, liver test abnormalities, vomiting, abdominal pain, and FSV deficiency.

    The most common adverse reactions for Bylvay patients with ALGS are diarrhea, abdominal pain, hematoma, and decreased weight.

    Drug Interactions 
    For patients taking bile acid binding resins, take Bylvay at least 4 hours before or 4 hours after taking a bile acid binding resin.

    Use in Specific Populations 
    There are no human data on Bylvay use in pregnant persons to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes. Based on findings from animal reproduction studies, Bylvay may cause cardiac malformations when a fetus is exposed during pregnancy. There is a pregnancy exposure registry that monitors pregnancy outcomes in persons exposed to Bylvay during pregnancy. For more information, please call 1-855-463-5127.

    To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see accompanying full Prescribing Information, including Instructions For Use.

    Next Step
    Sex
    Required if patient is under 18 years of age.
    I give permission to Ipsen to contact me by text message for the purposes described in Step 8.
    I give permission to Ipsen to contact me as described in Step 8 with information via mail, email, phone, or text message, all of which may include marketing, advertisements, disease state awareness materials, and educational material about Bylvay and programs that support patients. I understand and agree that any information I provide may be used by Ipsen to conduct data analysis and market research, and to develop new programs and resources. Automatic dialing may be used. I understand that I am not required to provide this consent as a condition of purchasing any goods or services.
    Next Step
    Is Patient Insured? *
    Does Patient Have Secondary Insurance? *
    Next Step
    Eligible patients using commercial insurance can save on out-of-pocket Ipsen medication costs. Please see Patient Eligibility & Terms and Conditions.
    I attest that I am not enrolled in any health insurance plan from any state or federally funded programs (including, but not limited to, Medicare or Medicaid, VA, DOD, or TRICARE) and agree to the Terms and Conditions of the Copay Program.
    Next Step

    I authorize my doctor(s) and their staff (including those pharmacies that may receive my prescription for Bylvay) to disclose my protected health information (“PHI”), including health information about insurance, prescription, care management, and medical condition to Ipsen Biopharmaceuticals, Inc., and/or its affiliates, and/or its agents or thirdparty vendors that have been hired to administer the Ipsen Coverage, Access, Reimbursement & Education Support (IPSEN CARES) program (collectively, “Ipsen”) in order for Ipsen to (1) enroll me in IPSEN CARES; (2) establish my benefit eligibility and potential out of pocket costs for Bylvay; (3) communicate with my doctors and health plans about my treatment plan; (4) provide support services, including patient education and financial assistance for Bylvay; (5) help get Bylvay shipped to me or my healthcare provider; and (6) facilitate my participation in Bylvay patient programs as I have requested or may request, including the IPSEN CARES Patient Assistance Program (the “PAP”) if applicable. I agree that, using the contact information I provide, Ipsen may contact me by phone, mail, and/or email for reasons related to the IPSEN CARES program and support services, including (1) determining if I am eligible for assistance and related support services, (2) leaving messages for me that disclose that I am on Bylvay therapy and/or applied for IPSEN CARES support services and am or am not eligible for assistance; (3) operating Ipsen Cares patient programs that might help me pay for or access my medicines; and (4) confirming receipt of medications. I consent to being contacted by an IPSEN CARES program representative in order for the program to obtain further information or clarification regarding any adverse event I may experience. I also give Ipsen permission to share my PHI and other information with people and companies that work with IPSEN CARES, including; government agencies, including insurance providers; my doctor(s) and other people, or institutions who are involved in my healthcare, such as pharmacies and hospitals; and/or other organizations that might help me pay for my medication. All information that I provide may be used by Ipsen or any third party working on behalf of Ipsen in connection with IPSEN CARES. I understand that my healthcare providers may receive remuneration from Ipsen in connection with my PHI and/or for any therapy support services provided to me.

    I understand that once my PHI has been disclosed to Ipsen, it is no longer protected by federal privacy laws, and Ipsen may re-disclose it; however, Ipsen has agreed to make reasonable efforts to protect my PHI by using and disclosing it only for the purposes described above or as required by law. I can withdraw this authorization by contacting IPSEN CARES at 1-866-435-5677 or mailing a letter requesting such revocation to IPSEN CARES, 2250 Perimeter Park Dr. Suite 300 Morrisville, NC 27560, but it will not change any actions taken before I withdraw this authorization. Withdrawal of this authorization will end further uses and disclosures of PHI by the parties identified in this form except to the extent those uses and disclosures have been made in reliance upon this authorization. I understand that I may refuse to sign this form and, if I do so, I will not be able to participate in IPSEN CARES, but it will not affect my eligibility to obtain medical treatment, my ability to seek payment for this treatment, or affect my insurance enrollment or eligibility for insurance coverage. This authorization expires three years from the date signed unless a shorter time is required by law or unless I revoke my authorization before that time. I understand that I will receive a copy of the signed authorization.

    ADDITIONAL PRODUCT AND SUPPORT INFORMATION

    Text Communications
    To the extent that I have opted in under Step 5 of this form, I agree to be contacted by autodialed text messages (“texts”) at the mobile phone number I have provided for the purpose of helping me stay on therapy, which may promote or advertise the Ipsen products included in the therapy plan, and/or which may include provision of educational materials and information about programs that support patients. I certify that the number I am providing belongs to me and not a family member or third party. I understand that I may opt out of individual communications or all text communications entirely at any time by calling 1-866-435-5677 or replying “STOP” by text to any text from Ipsen. Ipsen will not sell or rent this information and will use it only in accordance with this authorization and consent. Consent to being contacted by text messages is not a condition of participation in the IPSEN CARES programs or the purchase of any products or services. I understand that my cellular service carrier’s data and text messaging rates may apply. This authorization expires three years from the date signed unless a shorter time is required by law or unless I revoke my authorization before that time. If I am providing this consent on behalf of another person, I certify that I am authorized to agree to every element of this consent on behalf of such other person, and I agree that I will be liable and will hold Ipsen harmless in the event that such other person alleges that they did not give consent.

    Marketing Information 
    To the extent that I have opted in under Step 5 of this form, I would like to receive information from Ipsen via mail, email, phone or text message, all of which may include marketing content, advertisements, disease state awareness materials and educational material about Bylvay, and programs that support patients. These text messages and voice calls may be made via the use of automatic telephone dialing systems. I certify that the number I am providing belongs to me and not to a family member or other third party. I understand that I do not have to sign this section of the form in order to participate in the IPSEN CARES program and that I may revoke this authorization to receive additional product information at any time. I agree that Ipsen and its agents may use and disclose my personal information (including name, address, phone number, and/or email) to provide this information and Ipsen may also contact me to solicit my opinions regarding Bylvay and Ipsen’s products and services. I understand and agree that any information I provide may be used by Ipsen to conduct data analysis and market research, and to develop new programs and resources. I understand that my cell phone carrier’s standard rates may apply for calls and texts to my cell phone. This authorization expires three years from the date signed unless a shorter time is required by law or unless I revoke my authorization before that time. I may revoke this authorization, by calling 1-866-435-5677 or sending a request in writing to: IPSEN CARES, 2250 Perimeter Park Dr. Suite 300 Morrisville, NC 27560. If I am providing this consent on behalf of another person, I certify that I am authorized to agree to every element of this consent on behalf of such other person, and I agree that I will be liable and will hold Ipsen harmless in the event that such other person alleges that they did not give consent.

    We are collecting personal information in order to fulfill your request. Please see Ipsen’s privacy policy at https://www.ipsen.com/us/privacy-policy/. Residents of certain states have additional rights regarding the collection, use, and disclosure of their personal information. For more information, please see Ipsen’s Supplemental State Privacy Notice at https://www.ipsen.com/us/Supplement-Website-Privacy-Notice/.

    Ipsen Logo Ipsen Corporate

    ©2024 Ipsen Biopharmaceuticals, Inc. All rights reserved. September 2024 MP-US-000563 V11.0