Shire Global Charitable Access Program
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- Cora Porter
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1 << >> Shire Global Charitable Access Program Hunter Syndrome (MPSII) Treatment Application Form Instructions: Please complete the full application in order for your patients to be considered for the Shire Global Charitable Access Program. You may exit and return to the application at a later time using the same link. Required fields are marked with an asterisk(*). Applications that are missing required information will not be processed until the information is received. Do not use your browser's Back button. Use the Back and Forward buttons at the top-right or bottom-right of the page to navigate through the application. Deadline: Applications must be received by April 11th, 2014 If you miss this deadline please wait to submit your applications for the next Medical Expert Committee. We will you when there is another Medical Expert Committee meeting. Contact: Please direct any questions to ShireCAP@directrelief.org This application is a(n):* Initial Application Renewal Application Submission Requesting Person* Date of Application* Treating Physician Approval Patient's treating physician has verified information below and is aware of the submission of this application. I am the patient's treating physician. Demographic and Clinical Information
2 Treating Physician This is the physician who will administer the donated therapy to the patient if accepted for this program. Full Name* Specialty* Hospital* City* State or Region* Country* * Phone* Fax Preferred Language* Would the treating physician be willing to donate treatment services free of charge or at a reduced rate for this patient?*, the treatment can be provided free of charge, the treatment can be provided at a reduced rate, the treatment cannot be provided free of charge or at a reduced rate About the Patient Patient Initials* Date of Birth* City of Residence* Height (cm)* cm Weight (kg)* kg In which country will treatment be provided?* Patient Gender* Male Female
3 Is there a medical facility that can provide treatment?* Name of medical facility: Please describe why there is not a medical facility that can provide treatment.* What is the distance from the patient's home to the infusion site?* Please answer in kilometers. km Is there an anesthesiologist at the medical facility?* What is the distance from the infusion site to the nearest emergency medical facility?* Please answer in kilometers. km Which of the following medication or equipment are available in the case of an adverse reaction?* Pediatric Resuscitation Kit (Crash Kit) Adult Resuscitation Kit (Crash Kit) Neither Pediatric nor Adult Resuscitation Kit Patient Diagnosis Date of Initial Diagnosis* Date Patient Last Seen by Treating Physician* te: The clinical assessment must be within the last 90-days of this application. How the diagnosis was determined?*
4 Medical Assessments Which of the following assessments have been completed for this patient? Completed t Completed Musculoskeletal Assessment* Cardiac Assessment* Neurology Assessment* Respiratory Assessment* Gastrointestinal Assessment* Laboratory Assessment* Please explain why a musculoskeletal assessment has not been completed. Please explain why a cardiac assessment has not been completed. Please explain why a neurology assessment has not been completed. Please explain why a respiratory assessment has not been completed. Please explain why a gastrointestinal assessment has not been completed. Please explain why a laboratory assessment has not been completed.
5 Musculoskeletal Assessment Date of Assessment* Musculoskeletal Manifestations Decreased Joint Range of Motion* Joint Arthropathy* Surgical History Please list all surgeries and date of each surgery. Surgical History Surgery Date Surgery #1 Surgery #2 Surgery #3 Surgery #4 Surgery #5 Surgery #6 Surgery #7 Surgery #8 Surgery #9 Surgery #10 Cardiac Assessment Occurance Date of Assessment Valvular Disease* Cardiomyopathy* Congestive Heart Failure*
6 Neurology Assessment Date of Assessment* Development Assessment Assessment Assessment Test Result Instrument Used rmal Borderline Educable Trainable Profound Development Quotient* Neurologic Manifestations Seizures* Behavioral Issues* Hydrocephalus* Has the patient had a shunt placed?* Respiratory Assessment Date of Assessment* Predicted Forced Vital Capacity* % Respiratory Manifestations Sleep apnea* Obstructive airway disease* Tracheostomy* Cpap/Bipap use* Past difficulty with intubation/anesthesia*
7 Gastrointestinal Assessment GI Manifestations Enlarged Liver* Enlarged Spleen* Other Assessment Hematopoetic Stem Cell Transplantation Occurance Assessment Intervention Description Date Hematopoetic Stem Cell Transplantation* Has patient had past enzyme replacement therapy (ERT)?* Please detail any adverse reactions to ERT: Laboratory Assessment Date of Assessment* Diagnostic Enzyme Assay* If assay is applicable, Value and Unit are required. Occurance Diagnostic Enzyme Assay Applicable t Applicable Value Unit Leukocytes Fibroblast Plasma
8 Other Enzyme Assay Assessment All fields are required. If a field does not apply to this patient, please type N/A into the text box. Enzyme Assay Results* Reference Range for Enzyme Assay* Units* Type of DNA Analysis Performed* Name of Institution where DNA analysis performed* DNA mutation* Resulting amino acid change* DNA Analysis Performed?* Enzyme Assay Assessment All fields are required. If a field does not apply to this patient, please type N/A into the text box. Type of DNA Analysis Performed* Name of Institution where DNA analysis performed* DNA mutation* Resulting amino acid change* Urinary GAG Assessment All fields are required. If a field does not apply to this patient, please type N/A into the text box. Urinary GAG date* Test Results* rmal Range* Other manifestations Are there other Hunter Syndrome manifestations or concomitant medical conditions that further complicate/ exacerbate Hunter Syndrome or is further complicated or exacerbated by Hunter Syndrome?*
9 Please describe conditions* Family and Social History Does the patient have relatives who have been diagnosed with Hunter Syndrome?* What level of family involvement would the patient like?* Does the patient have external support networks available to them? For example, religious networks, community networks, or friend networks. Please describe.* How have you determined whether or not the patient and/or the patient's family understands the diagnosis, disease progression, and treatment?* Has the patient and/or family had the opportunity to ask questions about the diagnosis, disease, and treatment?*
10 Has the patient and/or family had all their questions answered?* Please describe the questions which have not been answered.* Other details about patient's family and social history: Are there challenges for the patient to access a treatment center?* Please describe the challenges for the patient to access a treatment center.* Patient Video If you would like to share a video of the patient, please paste the URL here. This will help with clinical review of this application. Dosing Recommendation If approved, please indicate dosing schedule. Recommended dose and dosing schedule for Elaprase is 0.5 mg/kg weekly. Recommended Dose* mg/kg/wk Shipping Drug Shipment Address
11 Drug Shipment Address Shipping Contact Please fill in the required text entry boxes. First Name Last Name Job Title Telephone Preferred Language of Communication English Other comments/notes Patient Authorization I certify that I have obtained a written authorization from the patient to share information disclosed in this form. Name* Date* Contact: ShireCAP@directrelief.org
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