Getting Started With IPSEN CARES^®

Insurance Information

IPSEN CARES Copay Assistance Program (Required for patients seeking to participate in the Iqvirvo Copay Assistance Program) - Eligible patients using commercial insurance can save on out-of-pocket Ipsen medication costs. Please see Patient Eligibility & Terms and Conditions.

If you would like IPSEN CARES to triage the prescription to the Iqirvo limited specialty pharmacy network, complete the prescription information.

*Selection will be honored if permitted by patient’s insurance.

Diagnosis

Iqirvo is indicated for the treatment of adult patients with PBC in combination with ursodeoxycholic acid (UDCA) for adults with inadequate response to UDCA or as monotherapy for adults with an intolerance to UDCA.

This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Iqirvo is not recommended for people who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
 

Please see Indication and Important Safety Information below and accompanying full Prescribing Information, including Medication Guide.

Prescription and Prescriber Attestation

Complete 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: Iqirvo^® (elafibranor)

PRESCRIBER ATTESTATION
(The Prescriber must sign if this form is to be used as a prescription to be triaged to a specialty pharmacy to enroll the patient for free goods as part of the Patient Assistance Program (PAP), or to enroll a patient for free goods as part of the Temporary Patient Assistance Program (TPAP). 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. If this form is to be used to enroll a patient in free goods as part of the PAP or Temporary PAP, I certify that the therapy referenced in this form is prescribed consistent with an FDA-approved indication. 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 Iqirvo therapy to Ipsen and its agents or contractors for the purpose of seeking reimbursement for Iqirvo therapy, assisting in initiating or continuing Iqirvo 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. I certify that any 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. These medications will not be offered for sale, transfer, or otherwise diverted. Additionally, no claim for reimbursement will be submitted concerning these medications, or any services provided by IPSEN CARES, to any payor, including Medicare, Medicaid, or any other federal or state health insurance program, nor will any medications be returned for credit. If the named patient does not return for therapy, product will be returned to Ipsen. 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.

INDICATION
IQIRVO^® (elafibranor) is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Limitations of Use
Use of IQIRVO is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

IMPORTANT SAFETY INFORMATION
Myalgia, Myopathy, and Rhabdomyolysis: Rhabdomyolysis resulting in acute kidney injury occurred in one IQIRVO-treated patient who had cirrhosis at baseline and was also taking a stable dose of an HMG-CoA reductase inhibitor (statin). Myalgia or myopathy, with or without CPK elevations, occurred in patients treated with IQIRVO alone or treated concomitantly with a stable dose of an HMG-CoA reductase inhibitor. Assess for myalgia and myopathy prior to IQIRVO initiation. Consider periodic assessment (clinical exam, CPK measurement) during treatment with IQIRVO, especially in those who have signs and symptoms of new onset or worsening of muscle pain or myopathy. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain, or myopathy, or rhabdomyolysis. Patients concomitantly taking peroxisome proliferator–activated receptor (PPAR)-alpha agonists (e.g., fenofibrate, fenofibric acid) may have an increased risk of muscle injury. Monitor for signs and symptoms of muscle injury during concomitant use with IQIRVO.

Fractures: Fractures occurred in 6% of IQIRVO-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with IQIRVO and monitor bone health according to current standards of care.

Adverse Effects on Fetal and Newborn Development: IQIRVO may cause fetal harm when administered during pregnancy. For females of reproductive potential, verify that the patient is not pregnant prior to initiation of therapy. IQIRVO may reduce the effectiveness of hormonal contraceptives containing ethinyl estradiol. Advise females of reproductive potential to avoid use of hormonal contraceptives containing ethinyl estradiol and to use alternative contraception, including progestin-only contraceptives containing levonorgestrel/norgestrel, intrauterine systems, or effective non-hormonal contraceptives during treatment with IQIRVO and for 3 weeks after the last dose of IQIRVO.

Drug-Induced Liver Injury: Drug-induced liver injury occurred in one patient who took IQIRVO 80 mg once daily and two patients who took IQIRVO at 1.5-times the recommended dosage, of which one presented with autoimmune-like hepatitis. The median time to onset of elevation in liver tests was 85 days. Obtain baseline clinical and laboratory assessments at treatment initiation with IQIRVO and monitor thereafter according to routine patient management. Interrupt IQIRVO treatment if liver tests (ALT, AST, total bilirubin [TB], and/or alkaline phosphatase [ALP]) worsen, or the patient develops signs and symptoms consistent with clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting IQIRVO. Patients concomitantly taking PPAR-alpha agonists (e.g., fenofibrate, fenofibric acid) and/or PPAR-gamma agonists (e.g., pioglitazone, rosiglitazone) may have an increased risk of liver injury. Monitor for signs and symptoms of liver injury during concomitant use with IQIRVO.

Hypersensitivity Reactions: Hypersensitivity reactions have occurred in a clinical trial with IQIRVO at 1.5-times the recommended dosage. Three patients (0.2%) had rash or unspecified allergic reaction that occurred 2 to 30 days after IQIRVO initiation. Hypersensitivity reactions resolved after discontinuation of IQIRVO and treatment with steroids and/or antihistamines. If a severe hypersensitivity reaction occurs, permanently discontinue IQIRVO. If a mild or moderate hypersensitivity reaction occurs, interrupt IQIRVO and treat promptly. Monitor the patient until signs and symptoms resolve. If a hypersensitivity reaction recurs after IQIRVO rechallenge, then permanently discontinue IQIRVO.

Biliary Obstruction: Avoid use of IQIRVO in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt IQIRVO and treat as clinically indicated.

The most common adverse events (occurring in ≥5% of patients) were weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash.

Drug-Drug Interactions  
Effects of IQIRVO on Other Drugs  
IQIRVO is a weak CYP3A4 inducer. A clinical interaction study demonstrated that co- administration of IQIRVO and a combined oral hormonal contraceptive produced a decrease of ethinylestradiol. Switch to progestin-only products containing levonorgestrel/norgestrel, intrauterine systems, or effective non-hormonal contraceptives during treatment with IQIRVO and for at least 3 weeks after the last dose.

Co-administration of IQIRVO and HMG-CoA reductase inhibitors (statins): Monitor for signs and symptoms of muscle injury. Consider periodic assessment (clinical exam, CPK) during treatment. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain or myopathy.

Effects of Other Drugs on IQIRVO  
Strong CYP2C8 inhibitors: Avoid concomitant use of IQIRVO with strong CYP2C8 inhibitors (e.g., gemfibrozil). If concomitant use cannot be avoided, monitor patients for adverse reactions.

Co-administration of IQIRVO with other PPAR-alpha agonists: Monitor for signs and symptoms of liver injury and muscle injury.

Co-administration of IQIRVO with rifampin, an inducer of metabolizing enzymes, may reduce the systemic exposure of elafibranor and its active metabolite via increased metabolism and may result in delayed or suboptimal biochemical response. Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during treatment with IQIRVO.

Bile acid sequestrants may interfere with IQIRVO absorption and systemic exposure, which may reduce efficacy. Administer IQIRVO at least 4 hours before or after a bile acid sequestrant, or at as great an interval as possible.

Use in Special Populations  
Pregnancy: Based on data from animal reproduction studies, IQIRVO may cause fetal harm when administered during pregnancy. There are insufficient data from human pregnancies exposed to IQIRVO to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There is a pregnancy safety study for IQIRVO. If IQIRVO is administered during pregnancy, healthcare providers should report IQIRVO exposure by contacting Ipsen Biopharmaceuticals, Inc. at 1-844-990-0239 or www.iqirvopregnancyregistry.com

Lactation: There are no data available on the presence of IQIRVO or its metabolites in human milk, or on effects of the drug on the breastfed infant or the effects on milk production. IQIRVO is not recommended during breastfeeding and for at least 3 weeks following the last dose of IQIRVO because the risk to the breastfed child cannot be excluded.

Females and Males of Reproductive Potential: IQIRVO may cause fetal harm when administered to pregnant women. Verify the pregnancy status of females of reproductive potential prior to initiating IQIRVO. Advise females of reproductive potential to use effective contraception during treatment with IQIRVO and for 3 weeks after the final dose.

You are encouraged to report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127.

Please see full Prescribing Information for IQIRVO.

The Patient Assistance Program (PAP) is designed to provide Iqirvo at no cost to eligible patients. Patients may be eligible to receive free drug if they are experiencing financial hardship and meet financial eligibility criteria, are uninsured or functionally uninsured, residents of the U.S., and received a valid prescription for an on-label use of Iqirvo as supported by information provided in the program application. Eligibility does not guarantee approval for participation in the program. Free Iqirvo provided by the PAP is intended only for the patient named in the application and must not be sold, transferred, or otherwise diverted. Patients must not seek reimbursement for the free drug provided by the PAP. The PAP provides Iqirvo product only, and does not cover the cost of previously purchased product or medical services. The PAP is not insurance. By submitting an application for the PAP, patient agrees to abide by these program terms.

PROOF OF INCOME*

*IPSEN CARES will conduct a soft credit check as part of the process of confirming income and determining eligibility for the program.

THIRD PARTY VERIFICATION AUTHORIZATION

I understand that I am providing “written instructions” under the Fair Credit Reporting Act (“FCRA”) authorizing the IPSEN CARES Patient Assistance Program (the “Program”), Ipsen Biopharmaceuticals, Inc. (“Ipsen”), and its vendor, on an ongoing basis as needed for the duration of my participation in Program, under the FCRA, to obtain information from my credit profile or other information from a credit reporting agency (including, without limitation, Experian Health), for the purpose of determining financial qualifications and eligibility for programs administered by Ipsen and the Program. I understand that I am affirmatively agreeing to these terms in order to proceed in this financial screening process. I promise that any information, including financial and insurance information that I provide, are complete and true and, unless I have indicated otherwise, I have no drug insurance coverage, which includes Medicaid, Medicare or any public or private assistance program or any other form of insurance. If my income or health coverage changes, I will call the Program at 1-866-435-5677.

PATIENT AUTHORIZATION TO USE/DISCLOSE HEALTH INFORMATION: IPSEN CARES^® PROGRAM

I authorize my doctor(s) and their staff (including those pharmacies that may receive my prescription for Iqirvo) 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 third-party 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 Iqirvo; (3) communicate with my doctors and health plans about my treatment plan; (4) provide support services, including patient education and financial assistance for Iqirvo; (5) help get Iqirvo shipped to me or my healthcare provider; and (6) facilitate my participation in Iqirvo 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 I am eligible for assistance and related support services, (2) leaving messages for me that disclose that I am on Iqirvo 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 1 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 1 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 Iqirvo, 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 Iqirvo 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.