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This website is intended for US residents only

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Enrollment Form

TO BE COMPLETED BY THE PATIENT/CAREGIVER

STEP 1: Patient Information
Sex
Required if patient is under 18 years of age.
Is Patient Insured? *
Policyholder same as patient?
Does patient have secondary insurance? *

IPSEN CARES Copay Program

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.

Consent to Receive Text Messages, Voice Calls, and Emails

Ipsen may offer certain support services via text message, voice calling, and email. These may include educational materials and information about programs that support patients for the purpose of helping you/the patient stay on your prescribed therapy. If you agree to receive texts, voice calls, and email at the phone numbers and email you have provided, check the appropriate boxes below. By checking these boxes, you are certifying that the phone numbers and email belong to you and not a family member or other third party.†

Consent to Receive Marketing Information

Ipsen may share marketing information via mail, text message, or email. This may include telemarketing, advertisements, disease state awareness materials, and educational materials about Ipsen products and programs that support patients. If you agree to receive mail, texts, or email marketing information from Ipsen, check the box below. Please note that you are not required to provide this consent in order to receive support from the IPSEN CARES program or as a condition of purchasing any goods or services.†

Consent for use of Personal Health Information

NOTE: If you are providing this consent on behalf of the patient, your signature will certify that you are authorized to agree as indicated on the patient’s behalf, and that references to “you” shall mean “the patient.”

PATIENT AUTHORIZATION FOR IPSEN CARES

By signing this Patient Authorization Form, I am registering for the IPSEN CARES Services program, administered by Ipsen Biopharmaceuticals, Inc, its affiliates, employees, contractors, and agents that have been hired or contracted to administer the Support Services program on its behalf (collectively “Ipsen”). This authorization is valid for 1 year from the date the form is signed. 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.

I authorize my healthcare providers (including those pharmacies that may receive my prescription for SOHONOS (palovarotene)) to disclose personal health information (PHI) about me, including health information relating to my medical condition, prescription, and insurance coverage in order for Ipsen to:

  • Enroll me in IPSEN CARES
  • Establish my insurance benefit eligibility and potential out-of-pocket costs for SOHONOS
  • Communicate with my healthcare providers and health plans about my treatment plan
  • Provide support services, including patient education and access assistance
  • Provide assistance with treatment logistics, including coordination with the specialty pharmacy
  • Facilitate my participation in patient programs as I have requested or may request, including coordinating with my caregivers and providing educational support about my condition
  • Determine any potential involvement in future patient consulting activities with Ipsen and contacting me in relation to these activities

I agree that, using the contact information I provide, Ipsen may contact me for reasons related to the IPSEN CARES program and support services and may leave messages for me that may disclose that I am on treatment. 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 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 protect my PHI by using and disclosing it only for the purposes described above or as required by law.

I authorize Ipsen to share my PHI and to discuss my case history and treatment plan, including my PHI, with the individual(s) named below for the sole purpose of facilitating my treatment. I understand that if I am listing other treating healthcare providers here, I may need to follow up with them to complete their authorization process.

Additional Healthcare Providers

I understand I can withdraw this authorization by calling IPSEN CARES at 844-484-1234 or email such revocation to IPSEN CARES at support@ipsencares.com, but it will not change any actions taken before I withdraw authorization. Withdrawal of 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 my 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 programs (for example, Ipsen will no longer provide assistance accessing insurance benefits, coordinating therapy, or providing disease education), but it will not affect my eligibility to obtain medical treatment, my/the patient’s ability to seek payment for this treatment, or affect my insurance enrollment or eligibility for insurance coverage.

†You may opt out of individual communications or the program entirely at any time by calling 844-484-1234 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 the terms set forth in this form. Consent to being contacted by text messages is not a condition of participation in the Support Services programs or the purchase of any products or services. If you do not agree to receive text messages but you nevertheless text IPSEN CARES, IPSEN CARES will respond to your text only to confirm that you have chosen to receive a text. I understand that my cellular service carrier’s data and text messaging rates may apply. I agree that Ipsen may use and disclose my contact information (including name, address, phone number) to provide these services and Ipsen may also contact me to solicit my opinions regarding treatment and Ipsen’s products and services. Such uses of contact information will be consistent with the Ipsen privacy policy at https://www.ipsen.com/us/privacy-policy/ and the terms set forth in this form.

NOTE: If you are providing this consent on behalf of the patient, your signature will certify that you are authorized to agree as indicated on the patient’s behalf and that references to “you” shall mean “the patient.”

Your genetic information is protected by laws in your state. That means you have choices about whether to take a genetic test, whether and whom you allow to access genetic information about you, whether you would like your genetic information to be retained for specific purposes, and whether and how you allow the genetic information to be disclosed.

If you wish to participate in IPSEN CARES, please read this consent form carefully.

You may refuse to provide consent to allow us to access or disclose all or some of your genetic information, but your refusal will mean that you cannot participate in IPSEN CARES. Refusal to sign will not affect your eligibility to obtain medical treatment, your ability to seek payment for this treatment, or affect your insurance enrollment or eligibility for insurance coverage.

If you have any questions about the program or wish to withdraw your consent, please call 844-484-1234.

If we make any substantive changes to the program that impacts the disclosures included in this form, we will provide you with a new consent form and, if required by law, obtain a new consent from you.

Genetic Information

Ipsen will access and retain the following categories of genetic information about you (collectively, your “Personal Genetic Information”): genetic markers.

How We Will Use Your Genetic Information

To the extent necessary to assist you in securing insurance coverage and coordination with the specialty pharmacy for access to the product, the information may be disclosed to your provider of health insurance.

Purposes for Which We Access, Use, and Retain Your Genetic Information

Ipsen may receive the genetic information described above for the following purposes:

  • To enroll you in and provide services under the IPSEN CARES
  • To facilitate your participation in other patient programs as you have requested or may request
  • To comply with legal and regulatory requirements

Disclosure of Your Genetic Information

As noted, Ipsen may disclose your Personal Genetic Information to your provider of health insurance to the extent necessary to assist you in securing insurance coverage for product and to the specialty pharmacy for coordination for your access to the product. Ipsen may also disclose this information to authorized employees and contractors for the purposes identified above. Ipsen may also disclose your genetic information to other third parties, including government agencies, to the extent permissible under applicable state laws.

Ipsen takes reasonable security measures to protect your genetic information from accidental loss and from unauthorized access, use, acquisition, alteration, or disclosure when the genetic information is in transit and at rest. However, once your genetic information has been disclosed by a third party, it may no longer be protected by federal privacy laws and the third party may be permitted to re-disclose it. Therefore, we cannot guarantee that your genetic information will remain confidential after being disclosed to third parties and government agencies. If your genetic information becomes known to others, it may negatively affect your insurability, employability, and social discrimination.

How We Will Store Your Genetic Information

While you are part of IPSEN CARES, Ipsen will retain all genetic information gathered about you in our database. This information will only be accessible to Ipsen staff who need to access it in order to administer, support, or evaluate the program. If you choose to leave, or become ineligible for, the program, the collected genetic information will be archived and not undergo further analysis except to meet our obligations to maintain records of the services offered by our program, to meet legal requirements, and to protect ourselves against legal claims linked to the program. We will retain this information for as long as necessary to meet these objectives and for as long as permitted or required by applicable law.

By signing this form, you direct us to retain your genetic information indefinitely upon completion of the program, subject to the above retention period and your right to withdraw this consent..

Your Rights With Respect to the Genetic Information We Collect About You

You have the right to receive a copy of this consent form signed by you and to access your genetic information. To exercise your rights described under this section, please call 844-484-1234.

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

IMPORTANT SAFETY INFORMATION & INDICATION for SOHONOSTM (palovarotene)

What is the most important information I should know about SOHONOS?

 

SOHONOS can cause birth defects (deformed babies) if taken during pregnancy. Females who are pregnant or who plan to become pregnant must not take SOHONOS.
  • Your healthcare provider will ask you to take a pregnancy test 1 week before starting treatment with SOHONOS, periodically during treatment, and 1 month after you stop treatment.
  • You must use effective birth control (contraception) starting at least 1 month before starting treatment with SOHONOS, during treatment, and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you.
  • If you become pregnant or think you may be pregnant during treatment with SOHONOS, stop taking SOHONOS and call your healthcare provider right away.

Because SOHONOS can cause birth defects, SOHONOS is only for people who can understand and agree to carry out all instructions for pregnancy prevention.

SOHONOS can cause bone growth changes. Children may stop growing while taking SOHONOS. Bone growth changes such as permanent early closure of the growth plate in growing children have happened with SOHONOS. Your healthcare provider will closely monitor your child’s bone growth and height during treatment with SOHONOS.

Who should not take SOHONOS?

Do not take SOHONOS if you are pregnant, or allergic to medicines known as retinoids or any of the ingredients in SOHONOS.

What should I tell my healthcare provider before taking SOHONOS?

Before taking SOHONOS, tell your healthcare provider about all your medical conditions, including:
  • have bone loss (osteoporosis), weak bones or any other bone problems
  • have or had mental health problems
  • have or have had kidney problems
  • have or have had liver problems
  • are breastfeeding or plan to breastfeed. It is not known if SOHONOS passes into your breastmilk. Breastfeeding is not recommended during treatment with SOHONOS and for at least 1 month after the last dose of SOHONOS. Talk to your healthcare provider about the best way to feed your baby if you take SOHONOS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOHONOS and certain other medicines can interact with each other, sometimes causing serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist when you get a new medicine.

What should I avoid while taking SOHONOS?

  • Do not get pregnant while taking SOHONOS.
  • Avoid excessive exposure to sunlight and ultraviolet lights (tanning machines). SOHONOS may make your skin more sensitive to the exposure and you may burn more easily. Apply sunscreen and wear protective clothing and sunglasses when in sunlight.
  • Avoid driving at night until you know if SOHONOS has affected your vision. SOHONOS may decrease your ability to see in the dark.
  • Do not donate blood while taking SOHONOS and for 1 week after stopping SOHONOS.

What are the possible side effects of SOHONOS?

SOHONOS can cause serious side effects, including:
  • skin-related events such as dry skin, lip and eye, hair loss, itching, redness, rash, and skin peeling. You may be at increased risk of developing skin and soft tissue infections while taking SOHONOS. If you develop these symptoms, your healthcare provider may tell you to use moisturizer, sunscreen, or artificial tears.
  • bone mineral density problems (bone thinning) which can increase the risk of fractures in adults and children. Your healthcare provider should check you for this during treatment with SOHONOS.
  • new or worsening mental health problems that may include depression, anxiety, mood changes, and suicidal thoughts and behaviors. If you have a history of mental health problems, you may be at a higher risk of developing these side effects. Call your healthcare provider if you develop new or worsening mental health symptoms during treatment with SOHONOS. Your healthcare provider should monitor you for signs of depression and refer you for appropriate treatment, if necessary.
  • vision problems (night blindness) which may cause difficulty seeing at night or in low lit areas. Your healthcare provider should send you to see an eye specialist if you experience vision problems.
The most common side effects of SOHONOS include:
  • dry skin
  • dry lips
  • hair loss
  • itching
  • redness
  • rash
  • skin peeling
  • drug eruption
  • skin irritation
  • swelling and small cracks in corner of the mouth
  • nausea
  • muscle and joint pain
  • dry eyes
  • headache
  • fatigue

These are not all the possible side effects of SOHONOS. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

WHAT IS SOHONOS?

SOHONOS is a prescription medicine used to reduce the amount of new heterotopic ossification in adults and children 8 years of age and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). SOHONOS is not recommended for females younger than 8 years of age or males younger than 10 years of age.

Please see full Prescribing Information, including Medication Guide with IMPORTANT WARNING.