PO Box PO -1- To apply for help in Sunovion Support. of adult patients with who elects to. ELDERLY Elderly people with. psychosis.

Transcription

1 To apply for help in affording your prescription for Latuda (lurasidone HCl) tablets, please mail or fax a completed application to Sunovion Support Prescription Assistance Program ( Program ), Boxx , Charlotte, NC or Fax: (877) Remember to include both your signature and that of your doctors, proof of incomee and your LATUDA prescription. If you have any questions or need help filling out this form, please contact us at (877) or visit INDICATION AND USAGE LATUDA is indicated for the treatment of patients with schizophrenia. Efficacy was established in four 6-week controlled studies of adult patients with schizophrenia. The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDAA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. IMRTANT SAFETY INFORMATION FOR LATUDA WARNING: INCREASED MORTALITY IN ELDERLY PATIENTSS WITH DEMENTIA-RELATED PSYCHOSIS Elderly people with dementia-related psychosis (a severe mental healthh problem) taking atypical antipsychotic drugs, including LATUDA, are at an increased risk for death compared with those taking placebo (sugar tablet). LATUDA is not approved for the treatment of people with dementia-related psychosis (see BOXED WARNING). An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis. Pleasee see additional Important Safety Information, including Boxed Warning on accompanying full Prescribing Information with your healthcare professional. Patient Information pages 4 and 5 below and discuss the Name: Date of Birth: Phone: ( ) Gender: Mailing Address: City: State: Zip: Social Security Number: Household Income Informationn 1. Is the patient a US resident (includes Puerto Rico)? YES NO NO 2. Is the patient 18 years of age or older? YES 3. Number of people in household: 4. What is total GROSS ANNUAL household income (including Social Security, Disability, Veterans, Wages, pensionn benefits, etc.)? $ 5. Please provide us with one of the following items to show total gross annual income: Current paycheck stubs or W-2 forms for all working members of household Federal Tax Return ( form 1040 or 1040EX) for priorr tax year If the patient has not filed a Federal Tax Return, visit to request a free Verification of Non-Filing. Click on "Order a Transcript" or call Use Form 4506-T and check box 7 to request verification of non filing. -1-

2 Patients Insurance Information 1. Is the patient enrolled in Medicare Part D? YES NO down only 2. Is the patient enrolled in Medicaid? YES NO Spend- 3. Does patient have prescription drug coveragee through any other benefit program that helps pay for prescription medicine, such as private insurance or VA or military benefits? YES NO From the Healthcare Professional (to be completed by the doctor who is prescribing the medicine) Treating Provider: DEA #: Site Contact: State License # Facility Name: Phone: ( ) Fax: ( ) Street Address: City: State: Zip: Prescription Information How would the patients Health Care Professional like the patient to access the prescription medicine? Shipments Sent Directly to Doctor Pharmacy Card or If Pharmacy Card is chosen, patient will need to obtain a valid prescription from the healthcaree professional to bring to the t pharmacy to access the medication. Latuda Prescription- Required for Shipments Directly to Healthcare Professional Dosage: 40mg 80mg Sig: Qty: Days Supply: 30 Days 60 Days 90 Days Number of Refills (max 6): -2-

3 Your Consent is Required to Process Application I acknowledge and agree that the above information is complete and accurate. I attest that I have no prescription insurance coverage, including Medicaid, Medicare or other public or private program, and I have insufficient financial resources to pay for the prescribed product. I understandd and acknowledge that this assistance is temporary andd that this program may be changed or discontinued at any a time without notice. Patients Signature: Date: If you cannot sign, a Legal Guardian may sign for you. Representatives Name: Representatives Signature: Date: Describe relationship to Applicant: Healthcare Professional Signature is Required to Process Application for the Sunovion Support Prescription Assistance Program My signature below certifies that the person named in this form is my patient and medication received from the Program is only for that patient s use as indicated by the US Food and Drug Administration, and the informationn provided, to my knowledge, is accurate.. I understand this Program is only for LATUDA and it will not be offered for sale, trade, or barter. I agree that I will not submit any claim for reimbursement concerning the Product to Medicare, Medicaid, or any other third party, or return such Product for credit. I also a agree that the Program has the right at any time to contact my patient, to modify or terminate the Program, and to recall or discontinue Product without notice. To the best of my knowledge, my patient does not have prescription drug insurance coverage (including Medicare, Medicaid, county funded, or other public programs) for the product being requested. Letter of Affiliation: I certify thatt I am (a) affiliated with the entity(ies) and location(s) identified on this application, (b) will be responsible in all respects for the receipt and accountability of the pharmaceutical products shipped to this entity at such location, and a (c) will immediately notify the Program if either of the foregoingg statements iss no longer true. Please indicate affiliated shipping address if different than listed in Healthcare professional section above: Street Address: City: State: Zip: Phone: Provider Signature: Date: If you no longer wish to receive communications from Sunovion, you may opt out at any time by notifying us at or ing info@sunovion.comand including UNSUBSCRIBE in the subject line. -3-

4 IMRTANT SAFETY INFORMATION FOR LATUDA WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly people with dementia-relat ted psychosiss (a severe mental health problem) taking atypical antipsychotic drugs, including LATUDA, are at an increased risk for death compared with those taking placebo (sugar tablet). LATUDA is not approved forr the treatment of people with dementia-related psychosis (see BOXED WARNING). An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis. Neuroleptic malignant syndrome (NMS): NMS is a rare and potentially fatal l side effect reported with LATUDA and similar medicines. Call your healthcare professional right away if you have high fever; stiff muscles; ; confusion; changes in pulse, heart rate, or blood pressure; sweating; or muscle pain and weakness. Treatment should be stopped if you have NMS. Tardive dyskinesia (TD): TD is a serious and sometimes permanent side effect reported with LATUDA and similar medicines. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk for developing TD and the chance that it will w become permanent is thought to increase the longer a person takes the medicinee and the moree medicine a person takes over time. TD can develop after a person has been taking the medicine for a short time at low doses, although this is much less common. There is no known treatment t for TD, but it may go away partially or completely if the person stops taking the medicine. Metabolic Changes High blood sugar: High blood sugar and diabetes have been reported withh LATUDA. Iff you have diabetes or risk factors for diabetes, such as being overweight or a family history of diabetes, your blood sugar should be tested at the beginning of and throughout treatment with LATUDA. Complications of diabetes can be serious and even life threatening. Tell your healthcaree professional if you have blood sugar problems or signs of diabetes, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry. High cholesterol and triglycerides: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Weight gain: Some patients may gain weight while taking LATUDA. Your r healthcare professional should check your weight regularly. Talk to your healthcare professional about ways to help control your weight, such as eating a healthy, balanced diet and exercising. Additional Important Warnings Light-headedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting position has been reported with LATUDA. Low white blood cell counts and related conditions have been reported d with LATUDA and similar medicines. Tell your healthcare professional if you have or had low white blood cell counts. LATUDA and medicines like it may raise the levels of prolactin. Tell your healthcare professional if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence. Tell your healthcare professional if you have a seizure disorder, have had seizures in the past, or have conditions that increase your risk for seizures. Tell your healthcare professional if you experience prolonged, abnormal muscle spasm or contraction, which may be signs of a condition called dystonia. -4-

5 LATUDA can affect your judgment, thinking, and motor skills. You should not drivee or operate hazardous machinery until youu know how LATUDA affects you. LATUDA may make you more sensitive to heat. You may have troublee cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm. The symptomss of schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your healthcare professional or go to an emergency room right away. LATUDA and medicines like it have been associated with swallowing problems. If you have had or have swallowing problems, you should tell your healthcare professional. Pregnancy: Tell your healthcare professional if you are pregnant or if you are planning to get pregnant while taking LATUDA. Breast feeding is not recommended during treatment with LATUDA. Tell your healthcare professional about all prescription and over-the-counter medicines you aree taking or plan to take, since there are some risks for drug interactions with LATUDA. Avoid drinking alcoholl while taking LATUDA. In people with schizophrenia, the most common side effects that occurred with LATUDA were sleepiness, an inner sense of restlessnesss or need to move (akathisia), movement abnormalities such as tremors, slow movement, or musclee stiffness (parkinsonism), upset stomach, and agitation. This is not a complete summary of safety information. Please discuss the full Prescribing Information for prescription LATUDA with your healthcaree professional. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA LATUDA is a registered trademark and Sunovion Support is a trademark of Sunovion Pharmaceuticals Inc. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd.., and is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd Sunovion Pharmaceuticals Inc. All rights reserved. 10/ 11 LUR R1-5-

6 Authorization and Consent to Share and Disclose Health Information with the Sunovion Support Prescription Assistance Program ( Program ) Please read and sign this form so that you or the person for whom you are assisting may be able to participate in the Program. Please note I is defined as the potential Participant. I acknowledge and agree that all the information I provide in connection with my application to the Program will be used to decide if I qualify for the Program. By signing below, I verify that the information on my application, including a copy of my proof of income documentation, is complete and accurate. I do not have any other coverage for prescription medications, including Medicaid, Medicare, or any public or private assistance programs or any other prescription insurance. I understand that any changes to my financial, prescription drug coverage, or insurance information may affect whether I am able to continue to participate in the Program. I agree to contact the Program to inform them of any changes to my income, prescription drug coverage, or insurance information. I allow my healthcare provider(s), my pharmacy(ies), and my health plan or insurers, to give medical information relating to my use or need for product(s) provided under the Program to The Lash Group, Inc. The Lash Group runs the Program on behalf of Sunovion Pharmaceuticals Inc. My medical information can include spoken or written facts about my health and payment benefits. It can include copies of records from my health provider, pharmacy, or health plan about my health or health care. People who work for The Lash Group and the Program may see my information, but they may use it only to help me get assistance to receive my Sunovion medication, to determine whether I qualify for the Program, to operate the Program, or as otherwise required or permitted by law. I allow The Lash Group and the Program the right to verify and to evaluate any financial documentation, insurance information, and medical records submitted to the Program to determine if I qualify for the Program and to operate the Program. I understand that The Lash Group and the Program have the right to contact me directly to confirm receipt of medications [or to obtain my feedback about the Program] and that the Program can revise, change, or terminate the Program at any time. I understand that I may cancel my permission and withdraw from this Program at any time. I understand that if I cancel my permission I can tell my healthcare provider, my pharmacy, and my insurer in writing that I do not want them to share any more information with The Lash Group and the Program, but it will not change any actions they took before I told them and it will terminate my participation in the Program. This authorization and consent will last for up to six months. I know that I have a right to see or copy the information my health care providers, my pharmacy, or insurers have given to The Lash Group and the Program. I understand that I am free at any time to switch my healthcare provider and it will not affect eligibility for financial assistance. This Program is offered to me regardless of any healthcare provider or pharmacy I use. I KNOW THAT I MAY REFUSE TO SIGN THIS FORM. My choice about whether to sign this form will not change the way my health care providers, pharmacies, or insurers treat me. If I refuse to sign this form, I know that this means I will not be eligible to participate in the Program. Applicant Signature: Date: Applicant Name: If you cannot sign, a Legal Guardian may sign for you: Representative Name: Date: Signature: Describe relationship to Applicant: If someone helped you with the application and you want them to answer questions for you, please give us their name and phone number: Name: Phone: Sunovion Support is a trademark of Sunovion Pharmaceuticals Inc. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd Sunovion Pharmaceuticals Inc. All rights reserved. 10/11 SEP197-11