ࡱ> FHCDE bjbjVV 4<<6 1189tHQPi&&(,){G}G}G}G}G}G}GK4Nf}G%-$li&%-%-}G11\vH---%-X1{G-%-{G--B6C@.}}-XBgGH0HBN-N,CNCS**h-M+T+S*S*S*}G}G-S*S*S*H%-%-%-%-NS*S*S*S*S*S*S*S*S* :  Check one:  FORMCHECKBOX  Enrollment  FORMCHECKBOX  Renewal PO Box 826, South San Francisco, CA 94083-0826 | Phone 1-866-ACTELION (1-866-228-3546) or Fax 1-866-279-0669 Once complete, submit this form to PAH Pathways.TM The information will be entered into the Tracleer Access Program (T.A.P.) database and forwarded to the specialty pharmacy you designate below. The specialty pharmacy will follow up as needed with prescribers and patients. Patient InformationFirst name:  FORMTEXT      MI:  FORMTEXT   Last name:  FORMTEXT      Gender:  FORMCHECKBOX  Male  FORMCHECKBOX  FemaleSSN:  FORMTEXT      DOB:  FORMTEXT       Phone #:  FORMTEXT      Address:  FORMTEXT      City:  FORMTEXT      State:  FORMTEXT   ZIP:  FORMTEXT      Legal guardian/emergency contact:  FORMTEXT      Relationship:  FORMTEXT      Phone #:  FORMTEXT      Shipping directions:  FORMCHECKBOX  Physician office  FORMCHECKBOX  Patient s home  FORMCHECKBOX  HospitalShipping attn:  FORMTEXT      Shipping address:  FORMTEXT      City:  FORMTEXT      State:  FORMTEXT   ZIP:  FORMTEXT      Diagnosis: Pulmonary arterial hypertension (check subtypes):  FORMCHECKBOX  Familial  FORMCHECKBOX  Idiopathic  FORMCHECKBOX  Scleroderma  FORMCHECKBOX  HIV  FORMCHECKBOX  Lupus  FORMCHECKBOX  Portal hypertension  FORMCHECKBOX  Congenital heart defects  FORMCHECKBOX  Pulmonary hypertension other etiologies:  FORMTEXT        FORMCHECKBOX  Other:  FORMTEXT      Required: Please submit copies of patient s current medical and prescription cards with this form. Insurance InformationPrimary insurance company:  FORMTEXT      Phone #:  FORMTEXT      Name of insured:  FORMTEXT      Policy #:  FORMTEXT       Group/Policy #:  FORMTEXT      Prescription coverage name:  FORMTEXT       Phone #:  FORMTEXT      Policy #:  FORMTEXT      Group/Policy #:  FORMTEXT      Indicate specialty pharmacy preference:  FORMTEXT AccredoFor a current list of pharmacies, call 1-866-228-3546. If no preference is indicated, this referral will be sent to the appropriate specialty pharmacy based on the patients existing benefits.I have read and agreed to the Patient Agreement on the back of this form. I have reviewed the Medication Guide with my prescriber, I consent to be enrolled in the Tracleer Access Program, and I agree to comply with the program for as long as I am prescribed Tracleer. Patient/guardian signature: Date:  FORMTEXT       Prescriber and Prescription InformationFirst name:  FORMTEXT      MI:  FORMTEXT   Last name:  FORMTEXT      Degree:  FORMTEXT      DEA #:  FORMTEXT      NPI:  FORMTEXT      Complete section below only if you are a new prescriber or your contact information has changed.Name of facility:  FORMTEXT      Specialty:  FORMTEXT      Tax ID #:  FORMTEXT      State license #:  FORMTEXT      Office contact (name and phone):  FORMTEXT      Phone #:  FORMTEXT      Fax #:  FORMTEXT      Primary address:  FORMTEXT      City:  FORMTEXT      State:  FORMTEXT   ZIP:  FORMTEXT      E-mail:  FORMTEXT      For the patient indicated on this form, please indicate whether: 1. You have reviewed pretreatment liver function tests.  FORMCHECKBOX  Yes  FORMCHECKBOX  No 2. If a female, she is of childbearing potential.  FORMCHECKBOX  Yes  FORMCHECKBOX  No 3. If a female of childbearing potential, you have confirmed a pretreatment negative pregnancy test.  FORMCHECKBOX  Yes  FORMCHECKBOX  NoPrescriber CertificationMy signature below certifies that: 1. I have read and understood the communication and educational materials for prescribers regarding the risks of Tracleer, and agree to document that I: Reviewed and discussed the Medication Guide and the risks of bosentan (including the risks of teratogenicity and hepatotoxicity) with my patients prior to prescribing Tracleer. Reviewed pretreatment liver function tests (ALT/AST/bilirubin) and confirmed that my patients are not pregnant (if applicable), and I agree to order and monitor monthly liver function tests and, if applicable, pregnancy tests. Educated and counseled females of childbearing potential (see definition on reverse side) to notify me if they suspect they may be pregnant. Educated and counseled females of childbearing potential about the need to use reliable methods of contraception (see table on reverse side) during treatment with Tracleer and for one month after treatment discontinuation. 2. I will notify Actelion Pharmaceuticals US, Inc., and/or the FDA, of any adverse events, including hepatotoxicity, and report any pregnancy during treatment with Tracleer. 3. I will counsel my patients who fail to comply with the program requirements. 4. I will renew my patients prescriptions annually by completing and submitting a new form for patients continuing therapy.  FORMCHECKBOX  Tracleer 62.5 mg (66215-0101-06) Refills #:  FORMTEXT        FORMCHECKBOX  Tracleer 125 mg (66215-0102-06) Refills #:  FORMTEXT       Dispense as Written Directions for use:  FORMTEXT      Prescriber signature: Date:  FORMTEXT      Prescriber signature: Date:  FORMTEXT      BEFORE SIGNING, SEE IMPORTANT SAFETY INFORMATION ON BACK. ( 2009 Actelion Pharmaceuticals US, Inc. All rights reserved. 07 306 01 02 0809  PO Box 826, South San Francisco, CA 94083-0826 Phone 1-866-ACTELION (1-866-228-3546) or Fax 1-866-279-0669 Patient Agreement I have reviewed the Medication Guide with my healthcare provider. I understand that a Medication Guide will be provided to me each time I receive a prescription for Tracleer, and that I must read it each time because it may have new information important to my treatment. I have been informed of the risks of treatment with Tracleer, including the risks of liver injury and birth defects. I understand that I will be contacted by Actelion, its agents, and/or a healthcare provider to receive counseling on the risks of Tracleer treatment, to ensure that I am completing the required liver function tests and pregnancy tests (for females of childbearing potentialsee definition below) and, if I am a female who becomes pregnant, to obtain information about my pregnancy. I agree to notify Actelion or my specialty pharmacy if I should change prescribers. I agree to have monthly blood tests as ordered by my healthcare provider for as long as I take Tracleer. I authorize my healthcare providers, health plans, other payers, and pharmacies to disclose my personal, medical, and health information to Actelion Pharmaceuticals US, Inc., and its employees, distributors, agents, and contractors (Actelion), and I authorize Actelion to use and disclose this information for use in implementing T.A.P. including to 1) establish my benefit eligibility; 2) communicate with my healthcare providers, health plans, other payers, and pharmacies about my medical care; 3) provide support services, including facilitating the provision of Tracleer to me; and 4) help find ways to pay for Tracleer, or for treatment or healthcare operations in progress. I understand that I may be contacted by Actelion or its delegates regarding important safety surveys while I am taking Tracleer. I understand that Actelion does not promise to find ways to pay for my Tracleer, and I know that I am responsible for the costs of my care. I understand that once my health information has been disclosed to Actelion, privacy laws may no longer restrict its use or disclosure; however, Actelion agrees to protect my information by using and disclosing it only for the purposes described above or as required by law. I acknowledge and agree that, although Actelion will have access to my personal health information, Actelion will not be providing counseling or medical advice regarding my condition. I further understand that all questions regarding my medical and health conditions should be discussed with my healthcare provider. Definition of Female of Childbearing Potential (FCBP)Female patients who are physically capable of becoming pregnant include those who are pubertal and have not yet had menses (premenarchal, Tanner stage 3, 11.5 to 13 years of age), perimenopausal and have had spontaneous menses in the last 24 months, and nonmenopausal who have not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure. Female patients who are not considered to be of childbearing potential are surgically sterile (both ovaries and/or uterus removed), postmenopausal (no menstrual period for longer than 24 consecutive months, confirmed by their healthcare provider), or incapable of pregnancy (confirmed by their healthcare provider). Reliable methods of contraception during treatment with TracleerMethods to use aloneHormone (choose 1 and use with a barrier method)Barrier (use both OR choose 1 and use with a hormone method)Intrauterine devices (IUDs) Copper T 380A IUD LNg-20 IUS (progesterone IUD) Tubal sterilizationEstrogen and progesterone Oral contraceptives Transdermal patch Vaginal ring Progesterone only Injection ImplantMale condom with spermicide Diaphragm with spermicide OR Cervical cap with spermicideA partners vasectomy still requires 1 additional method of contraception. COMPLETION OF THIS FORM IS ENTIRELY VOLUNTARY. IT IS NOT REQUIRED FOR PARTICIPATION IN THE TRACLEER ACCESS PROGRAM Authorization for Use or Disclosure of Health Information Fax To: 1-866-279-0669 Patient Name:  FORMTEXT       Date of Birth:  FORMTEXT       I have elected to participate in the following program(s):  FORMCHECKBOX  Sure Steps"! is a patient support and educational program for patients with pulmonary arterial hypertension who are on Actelion PAH therapies.  FORMCHECKBOX  LabTrac"! is a program designed to assist your physician in managing your care. LabTrac allows your physician to centrally review all of your laboratory results associated with your treatment on Tracleer. 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h!hjUCJOJQJ^JaJ4jh,h CJOJQJU^JaJmHnHu)jh,h-CJOJQJU^JaJ/jj<h,h-CJOJQJU^JaJ h,h CJOJQJ^JaJ<<<<<<<===>> >&>(>*>,>:>>> ??ԨtcHԨt7 h!hV+CJOJQJ^JaJ5j=h!h-5CJOJQJU\^JaJ hHehJCJOJQJ^JaJhfvCJOJQJ^JaJ h!hJCJOJQJ^JaJ)h!hJ5>*CJOJQJ\^JaJ hfv5CJOJQJ\^JaJ5j>=h!h-5CJOJQJU\^JaJ/jh!h-5CJOJQJU\^JaJ&h!hJ5CJOJQJ\^JaJ<>?78yl xx7$8$H$gd0xx$d7$8$H$Ngd0dP7$8$H$gdT+ !dgdHedx7$8$H$]gded7$8$H$]gdHe BdP7$8$H$^`BgdBdP7$8$H$^`Bgd ????@ef:lm XﺩЛЇucuR@#h!h=5CJOJQJ^JaJ h!h=CJOJQJ^JaJ#h)ghHeCJOJQJ\^JaJ#h)gh=CJOJQJ\^JaJ&h!h=5CJOJQJ\^JaJhHeCJOJQJ^JaJ hHe5CJOJQJ\^JaJ&h!hW5CJOJQJ\^JaJU h!hWCJOJQJ^JaJhfvCJOJQJ^JaJ h!hJCJOJQJ^JaJe Actelion Pharmaceuticals US, Inc., and agents operating the above-described Programs (collectively, Actelion) to use and disclose any and all of my individually identifiable health information, including, but not limited to, any and all spoken or written facts about my health, medications, insurance benefits, and all records maintained by Actelion in connection with the Programs (Health Information), as described in this authorization. I agree that Actelion may use and disclose my Health Information to Program representatives and third parties that work with Actelion (the Authorized Persons) in order for the Authorized Persons to provide me with marketing, promotional or educational information with respect to the Programs, PAH, related conditions and/or treatment options (the Information). I agree that I may be contacted by the Authorized Persons by phone, mail, e-mail or through other means with respect to the Information. I understand that Actelion does not sell my Health Information to the Authorized Persons but that the Authorized Persons may receive remuneration from Actelion in connection with their involvement with the Programs, including the dissemination of the Information. I understand and agree that the Authorized Persons may use and see my Health Information for the purposes described above. I understand that my Health Information may also be disclosed as needed to deal with safety, my treatment, adverse events, and related issues to the extent allowed under applicable law or as previously consented to in writing by me. I understand that if my Health Information is disclosed as allowed in this authorization, it may be redisclosed by the Authorized Persons and such redisclosure may not be protected by federal and state privacy laws. This authorization expires ten (10) years from the date I sign this document. If I change my mind before that time and do not want Actelion to continue to share my Health Information in connection with the above-referenced Programs, I can notify Actelion of such revocation in writing, signed by me or my personal representative on my behalf and delivered to PAH Pathways c/o Actelion at 5000 Shoreline Court, Suite 200, South San Francisco, CA 94080. If I notify Actelion in writing to stop sharing my Health Information in connection with the above-referenced Programs, such notice will be effective upon receipt by Actelion but will not change any actions that Actelion or others took in reliance upon this authorization before my effective revocation of this authorization. I know that I may refuse to sign this authorization. My decision not to sign this authorization or to, at any time, revoke this authorization will not affect my ability to get treatment from my healthcare providers, or to seek payment or eligibility for benefits. I understand that I have a right to receive a copy of this authorization. I agree that a copy of this authorization may be treated as a signed original. Patient Signature: Date:  FORMTEXT       Personal Representatives Section: If this form is signed by someone who is not the participant listed at the top of this authorization, describe the signer s legal authority to act for the participant:  FORMTEXT       2009 Actelion Pharmaceuticals US, Inc. All rights reserved. 07 306 01 02 0809  If you have questions about Tracleer enrollment and renewal, or if you would like more information about Tracleer, you can reach PAH Pathways, which administers T.A.P., by calling toll-free at 1-866-ACTELION (1-866-228-3546).      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