1 Support for Dysport is within reach through Savings up to $3,750 per year for treatment costs for eligible* patients with the Dysport (abobotulinumtoxina) Copay Assistance Program Dysport is a prescription medicine that is injected into muscles and used to treat: increased muscle stiffness in elbow, wrist, and finger muscles in adults with upper limb spasticity cervical dystonia (CD) in adults increased muscle stiffness in calf muscles in children 2 years of age and older with lower limb spasticity It is not known whether Dysport is safe or effective in children under 2 years old for the treatment of lower limb spasticity. It is not known whether Dysport is safe or effective for the treatment of other types of muscle spasms. It is not known whether Dysport is safe or effective for the treatment cervical dystonia or upper limb spasticity in children under 18 years of age. Important Safety Information for Dysport Dysport (abobotulinumtoxina) may cause serious side effects that can be life threatening, including problems breathing or swallowing, and spread of toxin effects. These problems can happen within hours, or days to weeks after an injection of Dysport. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with Dysport. Call your doctor or get medical help right away if you have any of these problems after treatment with Dysport : Problems swallowing, speaking, or breathing after an injection of Dysport if the muscles that you use to breathe or swallow become weak. If these problems are severe, death can happen as a complication. People with certain breathing problems may need to use muscles in their necks to help them breathe and may be at greater risk for serious breathing problems with Dysport. Swallowing problems may last for several weeks; you may need a feeding tube to receive food or water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving Dysport have the highest risk of getting these problems. *For complete rules of eligibility, see page 5 of this brochure. Please see Dysport Full Prescribing Information including Boxed Warning and Medication Guide.
2 Ready to Help With Dysport Treatment Coverage, Access, Reimbursement & Education Support for patients prescribed Dysport Once the doctor has prescribed Dysport (abobotulinumtoxina), the Patient Access Specialists at IPSEN CARES can provide applicable patient coverage information, as appropriate, between the patient, doctor s office, insurance company, and Specialty Pharmacy By serving as a central point of contact, IPSEN CARES can help patients get started on treatment and provide support throughout the process Enrolling in IPSEN CARES Patients must enroll through the doctor s office to verify benefits. Our Patient Access Specialists will check each patient s pharmacy and medical benefits to determine if the drug is covered for the indication the treating physician has specified If there are any restrictions, IPSEN CARES will provide the information required by the insurance company that the doctor may need to complete A summary of all the information collected will be sent back to the doctor s office in a single document, called Benefit Verification Results Benefit Verifications are usually turned around within 4 business hours upon receipt of the completed enrollment form and patient authorization Doctors can help patients enroll and complete authorization in two ways: Visit Print a downloadable PDF to be filled out and faxed 2 Please see Dysport Full Prescribing Information including Boxed Warning and Medication Guide.
3 Annual renewal authorization Patients are required to sign the Dysport Patient Authorization form every 12 months to give the Patient Access Specialists at IPSEN CARES permission to access their personal health information (PHI) in order to help with treatment The form can be signed and submitted online, or by downloadable PDF, which must be filled out, printed, signed, and faxed For more information, call our IPSEN CARES Patient Access Specialists at (866) , Monday-Friday, from 8:00 am to 8:00 pm ET (5:00 am to 5:00 pm PT) Important Safety Information for Dysport (continued) Spread of toxin effects. In some cases, the effects of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, or trouble swallowing. These problems could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities. Do not take Dysport if you are allergic to Dysport or any of the ingredients in Dysport (See Medication Guide for ingredients), or are allergic to cow s milk protein; had an allergic reaction to any other botulinum toxin product, such as Myobloc (rimabotulinumtoxinb), Botox (onabotulinumtoxina), or Xeomin (incobotulinumtoxina); or have a skin infection at the planned injection site. 3
4 Dysport Copay Assistance Program With Annual Savings of $3,750* for Eligible Patients The Dysport Copay Assistance Program for eligible, commercially insured patients is available by enrolling in IPSEN CARES. Covers costs associated with Dysport (abobotulinumtoxina) and the injection (where allowable by state laws subject to terms and eligibility requirements) Each patient will receive financial assistance covering a portion of out-of-pocket costs for up to 4 treatments or for 1 year from their enrollment date, whichever comes first Savings up to: $1,500 off the cost of the first treatment $750 off the cost of each of the second, third, and fourth treatments Annual maximum of $3,750 Copay assistance with Dysport may be especially beneficial for patients with high-deductible insurance plans Enrolling in the Dysport Copay Assistance Program Is Easy Visit Call and speak with an IPSEN CARES Patient Access Specialist If eligible, the patient will receive Dysport copay assistance* to be used at doctors offices, hospitals, and pharmacies Complete and submit Explanation of Benefits (EOB) to IPSEN CARES to initiate reimbursement Important Safety Information for Dysport (continued) Before you take Dysport, tell your doctor about all your medical conditions, including if you have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig s disease], myasthenia gravis, or Lambert-Eaton syndrome), as you may be at increased risk of serious side effects, including difficulty swallowing or breathing. 4 Please see Dysport Full Prescribing Information including Boxed Warning and Medication Guide.
5 Other Ways We Can Assist For patients with government insurance For patients who have government insurance (eg, Medicare, Medicaid, TRICARE), IPSEN CARES may be able to offer the contact information for independent nonprofit foundations that offer financial assistance Free medication Uninsured patients may be eligible* for free medication through our Patient Assistance Program. To qualify, patients must be 1) uninsured, 2) US residents, and 3) meet specific income criteria. Patients may enroll through IPSEN CARES. If eligible, they will receive free medication from Ipsen * Maximum benefit paid by Ipsen Biopharmaceuticals, Inc. will be a maximum of $3,750 in annual savings, 4 treatments, or 1 year from patient s enrollment date, whichever comes first. The patient may receive up to $1,500 for the 1st Rx, and then up to $750 for the 2nd, 3rd and 4th Rx in There could be additional financial responsibility depending on the patient s insurance plan. Patient Eligibility & Terms and Conditions: Patients who are eligible to participate (i.e. prescriptions or coverage could be paid in part or in full) in any state or federally funded programs, including, but not limited to, Medicare or Medicaid, VA, DOD, or TRICARE (collectively, Government Programs ) are not eligible for copay assistance through IPSEN CARES. Patients residing in Massachusetts, Minnesota, Michigan, or Rhode Island can only receive assistance with the cost of Ipsen products but not the cost of related medical services (injection). Patients receiving free starter therapy through the IPSEN CARES TM program are not eligible for the copay assistance program while they are waiting for insurance prescription coverage to begin. Patients receiving assistance through another assistance program or foundation, free trial, or other similar offer or program, also are not eligible for the copay assistance program during current enrollment year. Patient or guardian is responsible for reporting receipt of copay savings benefit to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled through the program, as may be required. Additionally, patients may not submit any benefit provided by this program for reimbursement through Flexible Spending Account, Health Savings Account, or Health Reimbursement Account. Ipsen reserves the right to rescind, revoke, or amend these offers without notice at any time. Ipsen and/or TrialCard, Incorporated are not responsible for any transactions processed under this program where Medicaid, Medicare, or Medigap payment in part or full has been applied. Cash-paying patients are eligible to participate. Cash-pay patients are defined for purposes of this program as patients without insurance coverage or who have commercial insurance that does not cover Dysport. Medicare Part D enrollees who are in the prescription drug coverage gap (the donut hole ) are not considered cash-pay patients, and are not eligible for the copay benefit. Data related to your participation may be collected, analyzed, and shared with Ipsen for market research and other purposes related to assessing the program. Data shared with Ipsen will be de-identified, meaning it will not identify you. Void outside of the United States and its territories or where prohibited by law, taxed, or restricted. This program is not health insurance. No other purchase is necessary. Offer expires December 31, 2017; however, patients residing in Massachusetts are only eligible to receive assistance through June 30,
6 Many Eligible Patients Can Receive Copay Assistance Patients may be eligible for the Dysport Copay Assistance Program if they: have commercial insurance and are to receive Dysport (abobotulinumtoxina) for therapeutic use receive EOB from their insurance company verifying Dysport treatment and associated procedure costs (where eligible) and/or receipt from Specialty Pharmacy Provider (SPP) are not enrolled in any federally funded plan (ie, Medicare, Medicaid, TRICARE, VA, or DOD) are not receiving Dysport for cosmetic use For complete rules of eligibility, see page 5 of this brochure. Important Safety Information for Dysport (continued) Before you take Dysport, tell your doctor if you have or have had any of the following: a side effect from any botulinum toxin in the past; breathing problems such as asthma or emphysema; swallowing problems; bleeding problems; diabetes; and slow heartbeat, or other problems with your heart rate or rhythm. Tell your doctor if you have plans to have surgery, had surgery on your face, have weakness of your forehead muscles (such as trouble raising your eyebrows), have drooping eyelids, or have any other change in the way your face normally looks. Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding or planning to breast-feed. It is not known if Dysport can harm your unborn baby. It is not known if Dysport passes into breast milk. 6 Please see Dysport Full Prescribing Information including Boxed Warning and Medication Guide.
7 Five Simple Steps to Dysport Savings Here s how enrolled patients can receive their Dysport (abobotulinumtoxina) savings: 1. Patient receives treatment with Dysport. Doctor follows standard procedure for collection of patient copay 2. Doctor submits claim to patient s insurance company 3. Patient and doctor receive EOB statement; patient and/or doctor may mail or fax EOB to IPSEN CARES at IPSEN CARES program coordinator reviews EOB and initiates payment for the Dysport Copay Assistance Program by sending virtual debit card (VDC) information to the doctor s office 5. Doctor runs patient s VDC through the Dysport Copay Assistance Program to collect the remainder of patient s Dysport out-of-pocket expense Important Safety Information for Dysport (continued) Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received Dysport in the past. 7
8 Savings with copay assistance Example*: Commercially insured patient injected with Dysport (abobotulinumtoxina) 500 Units has a $1,000 deductible, then 20% coinsurance thereafter Patient out-of-pocket cost without copay program Patient out-of-pocket cost with copay program Injection 1 Deductible and Coinsurance $1,158 $0 Injection 2 Coinsurance $158 $0 Injection 3 Coinsurance $158 $0 Injection 4 Coinsurance $158 $0 Total Annual Patient Out-of-Pocket Cost $1,632 $0 *Hypothetical example for illustrative purposes only. Deductibles, coinsurance, and copays can vary by plan and benefit design. Based on an average deductible for covered workers in 2015 of $1, % of the Q ASP + 6% of Dysport 500-Unit vial. 2 Important Safety Information for Dysport (continued) Especially tell your doctor if you have received injections of botulinum toxin in the last four months or in the past. Be sure your doctor knows exactly which product you received such as Myobloc (rimabotulinumtoxinb), Botox (onabotulinumtoxina), or Xeomin (incobotulinumtoxina); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; or take a sleep medicine. 8 Please see Dysport Full Prescribing Information including Boxed Warning and Medication Guide.
9 Dysport Copay Assistance Program FAQs Q A Q A Q A Q A Q A How do patients receive Dysport copay assistance? First, a patient must satisfy the requirements of eligibility and then be enrolled in the program (for complete rules of eligibility, see page 5 of this brochure). Once a patient has successfully enrolled in the program, they will get their injection at the doctor s office. The Explanation of Benefits (EOB) must be sent to IPSEN CARES. After the EOB is processed, payment to the doctor s office will be communicated via fax for VDC. Where can the Dysport Copay Assistance Program be used? The Dysport Copay Assistance Program is meant to be used at the doctor s office or hospital. A patient does not have commercial insurance. Are they eligible for the Dysport Copay Assistance Program? Yes, uninsured patients are eligible for the Dysport Copay Assistance Program. Call IPSEN CARES to learn more about eligibility. Patients with federally funded insurance are not eligible. What if the patient is unable to use the Dysport Copay Assistance Program at their physician s office/practice or pharmacy? The patient may request payment via a mail-in rebate. The patient must submit a request for a check and valid EOB. Call IPSEN CARES to learn more about the information that needs to be provided. Once verified, a check for the patient s savings amount will be mailed to the patient within 7-10 business days. Can a patient request copay assistance for multiple treatment dates at the same time? A patient can submit an EOB for multiple visits to IPSEN CARES at the same time. Patients can go back 6 months prior to their enrollment into IPSEN CARES. 9
10 Dysport Copay Assistance Program FAQs (cont d) Q A Q A What do patients do if they are getting Dysport through their Specialty Pharmacy, but also want help with the injection fee charged at their doctor s office? Patients submit their EOBs and receipts from both their Specialty Pharmacy and doctor s office and the team will calculate the associated Dysport costs and reimburse accordingly. Please note: Any surgical, doctor, and/or laboratory expenses will be excluded from payment. If patients are reimbursed for their Specialty Pharmacy receipt, can they go back to get reimbursement for their injection costs? Yes, previous claims can be adjusted if the documentation is valid. Please submit any information that is sent separately with a label Additional Correspondence for (Date of Service) for any adjustment changes. 10 Please see Dysport Full Prescribing Information including Boxed Warning and Medication Guide.
11 Important Safety Information for Dysport (continued) Most common side effects of Dysport in people with upper limb spasticity include: urinary tract infection, muscle weakness, musculoskeletal pain, fall, depression, stuffy or runny nose and sore throat, and dizziness. Most common side effects of Dysport in people with cervical dystonia include: muscle weakness, dry mouth, feeling of tiredness, muscle pain, problems speaking, eye problems, difficulty swallowing, injection site pain, and headache. Most common side effects of Dysport in children (2 to 17 years of age) with lower limb spasticity include: upper respiratory infection, stuffy or runny nose and sore throat, flu, cough, and fever. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Dysport. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Please see Dysport Full Prescribing Information including Boxed Warning and Medication Guide. Botox, Xeomin, and Myobloc are registered trademarks of their respective owners. 11
12 Support for Dysport is within reach through Savings up to $3,750 per year for treatment costs with the Dysport Copay Assistance Program Visit For more information, call and speak with an IPSEN CARES Patient Access Specialist Important Safety Information for Dysport Most common side effects of Dysport in children (2 to 17 years of age) with lower limb spasticity include: upper respiratory infection, stuffy or runny nose and sore throat, flu, cough, and fever. Please see Dysport Full Prescribing Information including Boxed Warning and Medication Guide in pocket. References: 1. The Kaiser Family Foundation and Health Research Educational Trust. Employer Health Benefits Annual Report. Accessed December 18, Data on file. Basking Ridge, NJ; Ipsen Biopharmaceuticals, Inc. Dysport (abobotulinumtoxina) for injection, for intramuscular use 300- and 500-Unit vials. DYSPORT is a registered trademark of Ipsen Biopharm Limited. IPSEN CARES is a trademark of Ipsen S.A.S Ipsen Biopharmaceuticals, Inc. December 2016 Printed in USA DYS-US e
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