For Healthcare Providers For Patients

COMPASS ENROLLMENT INSTRUCTIONS
For Healthcare Providers
To prescribe JUXTAPID please follow these steps:
1. If you haven’t already, enroll in the JUXTAPID REMS Program* via juxtapidremsprogram.com.
• Review the JUXTAPID Prescribing Information and Prescriber Training Module
• Complete and submit the one-time online JUXTAPID REMS Prescriber Enrollment Form
2.Complete and sign the JUXTAPID REMS Prescription Authorization Form.
NOTE: A new JUXTAPID REMS Prescription Authorization Form is required to be submitted for each new prescription.
3.Complete and sign the enclosed Compass Enrollment Form and copy both sides of the patient’s insurance card.
Your office should not share any patient information with Aegerion unless it has a valid patient authorization on file.
4.Have your patient read the 2 enclosed Compass Patient Authorizations and request that the patient sign each one.
These authorizations enable Aegerion to receive the patient’s personal and health information so that Compass can
provide support services to your patient such as insurance support, financial assistance and nutritional counseling.
5. Submit the following 3 forms via fax to 1-855-898-2498.
• Completed and signed JUXTAPID REMS Prescription Authorization Form (may also email to [email protected])
• Completed and signed Compass Enrollment Form with a copy of both sides of the patient’s insurance card
• Signed Compass Patient Authorizations
Please be sure to fill out all sections of all forms. Incomplete areas may delay the start of treatment.
For Patients
1.Read the 2 enclosed Patient Authorizations and sign each one if you would like to receive JUXTAPID product support
services from Compass such as insurance support, financial assistance and nutritional counseling.
What’s Next?
2. Your Healthcare Provider will fax necessary paperwork to us.
3.You’ll be contacted by a Compass Care Manager within 2 business days to confirm your insurance coverage and
delivery details, and to coordinate additional Compass support services.
•
Please note this call might come from an unfamiliar phone number
•
Your prescription will be shipped directly to you
Questions? Call Compass at 1-85-JUXTAPID (1-855-898-2743), Monday through Friday, 8:00 -7:00 ET
*Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted program called the JUXTAPID REMS Program.
Further information is available at juxtapidremsprogram.com or by calling 1-85-JUXTAPID (1-855-898-2743).
Compass • 1-855-898-2743 (phone) • 1-855-898-2498 (fax)
©2015 Aegerion Pharmaceuticals, Inc. All rights reserved. JUXTAPID is a registered trademark of Aegerion Pharmaceuticals. JUX/US/215 11-15
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COMPASS ENROLLMENT FORM
HEALTHCARE PROVIDER: Please complete all sections of this form
and fax to 1-855-898-2498.
I. PATIENT INFORMATION
Patient is (choose one):
New
Currently Receiving JUXTAPID
Patient Name (First MI Last):______________________________________________________________________________________________________________
Address:___________________________________________________________ City:_________________________ State:_________Zip:______________
Date of Birth: _____ /_____ / _____ Gender:
Male
FemaleEmail:___________________________________________________________
Primary Contact:
Patient
Legal Representative (if applicable):__________________________________________________________________________
Preferred Phone:____________________________________________________ Alternate Phone:_________________________________________________
II. INSURANCE INFORMATION
Please complete the information below or send a copy of the front and back of the insurance card.
Primary Insurance Secondary Insurance
Policy Holder Name:________________________________________________ Primary Insurance Phone:____________________________________________ Primary Policy #:____________________________________________________ Primary Group #:____________________________________________________ Policy Holder Name:______________________________________________
Secondary Insurance Phone:_______________________________________
Secondary Policy #: ______________________________________________
Secondary Group #:______________________________________________
III. MEDICAL ASSESSMENT
REMS Attestation:
Patient has clinical/laboratory diagnosis consistent with HoFH.
Current Cholesterol Lowering Drugs and Dosage: (if applicable)
3
ICD-10 Diagnosis Code:
E78.0/Pure Hypercholesterolemia (including HoFH)
Other: _________ /________________________________________________
Allergies:
None or
Specify:___________________________________
Height: _________ inches Weight: _________ lbs.
Pretreatment Lab Information:
Measured ALT, AST, ALP and total bilirubin?
Yes
No
During the first year, measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first.
Negative pregnancy test for childbearing women?
Yes
No
Additional Pretreatment Lab Information (most recent):
Test
LDL – C (Treated)
LDL – C (Untreated)
Triglycerides
Result
Date
mg/dl
mg/dl
mg/dl
Yes
No If Yes, frequency:________________
Patient on Apheresis?
Date of First Apheresis:______________________________________________
Positive patient history of hypercholesterolemia
Yes
No
or premature CVD?
Family History on Both Sides?
Yes
No
Therapy
Atorvastatin
Simvastatin
Rosuvastatin
Ezetimibe
Alirocumab
Evolocumab
Niacin
BAS (Bile Acid Sequestrants)
Fibrates
Dose
Treatment Duration
10
20
40
80
5
10
20
40
5
10
20
40
10
75
150
140
420
Tried/Failed Cholesterol Lowering Drugs and Dosage:
3
Therapy
Atorvastatin
Simvastatin
Rosuvastatin
Ezetimibe
Alirocumab
Evolocumab
Niacin
BAS (Bile Acid Sequestrants)
Fibrates
Dose
Treatment Duration
10
20
40
80
5
10
20
40
5
10
20
40
10
75
150
140
420
Unknown
IV. PRESCRIBER INFORMATION
Prescriber Name:___________________________________________________ Phone:____________________________________________________________ Fax:_______________________________________________________________ Office Contact Name: ____________________________________________
Office Contact Phone:_____________________________________________
NPI #:___________________________________________________________
Tax ID #:___________________________________________________________ License #:________________________________________________________
REVIEW AND SIGN THE ACKNOWLEDGMENT AND AUTHORIZATION
I acknowledge that I have obtained authorization to release the patient’s personal health information and the information on this form and any prescription
(“personal information”) to Aegerion, its affiliates and their representatives, agents, and contractors, for the purposes of providing product support services,
including but not limited to conveying personal information to dispensing pharmacies. I further certify that any service provided through Compass on behalf
of any patient is not made in exchange for any express or implied agreement or understanding that I would recommend, prescribe, or use JUXTAPID or any
other Aegerion product or service for anyone, and my decision to prescribe JUXTAPID was based solely on my determination of medical necessity, and that I
will not seek reimbursement for any medication or service provided by or through Compass from any government program or third-party insurer.
I authorize Aegerion to provide HoFH and JUXTAPID education, including compliance and persistency support, for this patient. I agree to inform the
patient in advance that this education will be conducted by an Aegerion employee, it does not include individual treatment or medical advice to the
patient, and it does not replace the medical treatment and care provided by me as their Healthcare Provider. I acknowledge that the education provided
by Aegerion does not replace any obligation I have to inform the patient of the risks associated with JUXTAPID or any other treatment I may prescribe.
Prescriber Signature: _________________________________________________ Date:___________________________________________________________
Compass • 1-855-898-2743 (phone) • 1-855-898-2498 (fax)
©2015 Aegerion Pharmaceuticals, Inc. All rights reserved. JUXTAPID is a registered trademark of Aegerion Pharmaceuticals. JUX/US/215 11-15
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COMPASS PATIENT AUTHORIZATIONS
PATIENT: Please read the following. If you agree, print your name and date of birth
at the top of the authorizations, sign and date each section, and fax to 1-855-898-2498.
Patient Name (print):________________________________________________________________________________
Date of Birth: _____ /_____ / _____
I. AUTHORIZATION TO SHARE HEALTH INFORMATION
I authorize any health plan, physician, healthcare professional, hospital, clinic, pharmacy provider or other healthcare provider
(collectively, “Healthcare Providers”) to disclose my personal health information, including information relating to my medical
condition, treatment, care management, and health insurance, as well as all information provided on this form and any prescription,
personal health information obtained by Healthcare Providers prior to the date of this authorization (“Personal Health Information”),
to Aegerion Pharmaceuticals, Inc., its affiliates and their representatives, agents, and contractors (collectively, “Aegerion”) for the
following purposes: for Aegerion to provide product support services, including coordination of benefits and therapy; reimbursement support; investigating insurance coverage; compliance and persistency support; communicating with me by mail, email,
text message or telephone about my medical condition, treatment, care management, and health insurance; and internal use by
Aegerion, including data analysis. I understand that my Personal Health Information disclosed under this authorization may be
re-disclosed by Aegerion and no longer protected by federal privacy laws. I understand, however, that Aegerion agrees to undertake reasonable efforts to maintain my Personal Health Information in a secure manner and not to disclose it to third parties without
a legitimate reason for doing so. I understand that I may refuse to sign this Authorization and that my treatment, payment, enrollment or eligibility for benefits, including my access to therapy, is not conditioned on my signing this Authorization. I understand
that I am entitled to a signed copy of this Authorization. This Authorization expires one year from the date of execution, or one
year after the date of my last shipment of product, whichever is later. I understand that I may revoke this Authorization at any time
by sending written notice of revocation to Compass at Aegerion Pharmaceuticals, Inc., 1 Main Street, Suite 800, Cambridge, MA
02142, which becomes effective upon receipt by any Healthcare Provider subject to federal privacy laws, except to the extent that
action already has been taken in reliance on this Authorization. I understand that my Healthcare Providers may receive remuneration
from Aegerion in exchange for Personal Health Information.
Patient Signature: __________________________________________________ Date:___________________________________________________________
Legal Representative Signature: ______________________________________ (if applicable)
Date:___________________________________________________________
II. AUTHORIZATION FOR COMPASS SERVICES AND COMMUNICATIONS
I certify that all of the information provided on this form is complete and accurate. I authorize Aegerion to collect Personal Health
Information from me, my caregivers, and Healthcare Providers, and to use and disclose such Personal Health Information to
provide product support services, including but not limited to coordination of benefits and therapy; reimbursement support;
investigating insurance coverage; disease and product education; compliance and persistency support; and communicating with
me by mail, email, text message or telephone about my medical condition, treatment, care management, and health insurance.
I understand that any education I receive from Aegerion will not provide individual treatment, medical care or medical advice, and
does not replace the medical treatment and care provided by a Healthcare Provider.
I further authorize Aegerion, and companies working with Aegerion, to contact me by mail, email, fax, and telephone call for marketing purposes or otherwise provide me with information about Aegerion products, services, and programs or other topics of interest,
conduct market research or otherwise ask me about my experience with or thoughts about such topics. I understand and agree
that any information that I provide may be used by Aegerion to help develop new products, services, and programs. I understand
that Aegerion will not sell or transfer my personal data to any unrelated third party for marketing purposes without my express
permission. I understand that I may revoke this authorization and choose not to receive services or information from Aegerion
by sending written notice of revocation to Compass at Aegerion Pharmaceuticals, Inc., 1 Main Street, Suite 800, Cambridge, MA
02142. I confirm that I am the subscriber for the telephone number(s) provided and the authorized user for the email address(es)
provided, and I agree to notify Aegerion promptly if any of my number(s) or address(es) change in the future.
Patient Signature: __________________________________________________ Date:___________________________________________________________
Legal Representative Signature: ______________________________________ (if applicable)
Date:___________________________________________________________
Compass • 1-855-898-2743 (phone) • 1-855-898-2498 (fax)
©2015 Aegerion Pharmaceuticals, Inc. All rights reserved. JUXTAPID is a registered trademark of Aegerion Pharmaceuticals. JUX/US/215 11-15
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AUTORIZACIONES DEL PACIENTE DE COMPASS
PACIENTE: Lea las siguientes autorizaciones. Si está de acuerdo, escriba su nombre
en letra de imprenta y su fecha de nacimiento en la parte superior de las autorizaciones,
fírmelas, escriba la fecha en cada sección y envíelas por fax al 1-855-898-2498.
Nombre del paciente (en letra de imprenta):_________________________________________________________ Fecha de nacimiento: _____ /_____ /_____
I. AUTORIZACIÓN PARA DIVULGAR INFORMACIÓN MÉDICA
Autorizo a cualquier plan de salud, médico, profesional de atención médica, hospital, clínica, proveedor de farmacia u otro
proveedor de atención médica (en conjunto, “proveedores de atención médica”) a divulgar mi información médica personal, tales
como la información relacionada con mi condición médica, tratamiento, administración de la atención y seguro médico, además
de toda la información que aparece en este formulario y en cualquier receta, información médica personal que obtengan los
proveedores de atención médica antes de la fecha de esta autorización (“información médica personal”), a Aegerion Pharmaceuticals, Inc., sus filiales y sus representantes, agentes y contratistas (en conjunto, “Aegerion”) para los siguientes propósitos: para
que Aegerion proporcione servicios de apoyo del producto, que incluye la coordinación de los beneficios y la terapia; apoyo de los
reembolsos; investigación de la cobertura del seguro; apoyo de cumplimiento y persistencia; comunicación conmigo por correo
postal, correo electrónico, mensajes de texto o por teléfono sobre mi condición médica, tratamiento, administración de la atención
y seguro médico; y para el uso interno de Aegerion, tal como el análisis de datos. Entiendo que mi información médica personal
que se divulgue en virtud de esta autorización puede volver a ser divulgada por Aegerion y ya no estará protegida por las leyes
federales de privacidad. Sin embargo, entiendo que Aegerion acepta hacer los esfuerzos razonables para mantener mi información
médica personal de manera segura y no la divulgará a terceros sin una razón legítima para hacerlo. Entiendo que puedo negarme
a firmar esta autorización y que mi tratamiento, pago, inscripción o elegibilidad para los beneficios, incluido mi acceso a la terapia,
no están condicionados según si firmo o no esta autorización. Entiendo que tengo derecho a obtener una copia firmada de esta
autorización. Esta autorización vence en un año a partir de la fecha de ejecución, o un año después de la fecha de mi último envío del
producto, lo que suceda más tarde. Entiendo que puedo revocar esta autorización en cualquier momento si envío una notificación de
revocación por escrito a Compass a Aegerion Pharmaceuticals, Inc., 1 Main Street, Suite 800, Cambridge, MA 02142. Esta
notificación de revocación entra en vigencia en el momento en que cualquier proveedor de atención médica sujeto a las leyes
federales de privacidad la recibe, excepto que ya se haya tomado alguna medida en función de esta autorización. Entiendo que mis
proveedores de atención médica pueden recibir remuneración de parte de Aegerion a cambio de información médica personal.
Firma del paciente: _________________________________________________ Fecha:__________________________________________________________
Firma del representante legal: _______________________________________ (si corresponde)
Fecha:__________________________________________________________
II. AUTORIZACIÓN PARA LOS SERVICIOS Y LAS COMUNICACIONES DE COMPASS
Certifico que toda la información que se proporciona en este formulario es completa y precisa. Autorizo a Aegerion para que obtenga información médica personal de parte de mí, mis cuidadores y los proveedores de atención médica, y para usar y divulgar
dicha información médica personal para proporcionar servicios de apoyo del producto, que incluyen entre otros, la coordinación
de los beneficios y la terapia, el apoyo de los reembolsos, la investigación de la cobertura del seguro, la capacitación sobre la
enfermedad y el producto, el apoyo de cumplimiento y persistencia y la comunicación conmigo por correo postal, correo electrónico, mensajes de texto o por teléfono sobre mi condición médica, tratamiento, administración de la atención y seguro médico.
Entiendo que cualquier educación que obtenga de Aegerion no constituirá un tratamiento individual, atención médica o recomendación médica, y no reemplaza el tratamiento médico y la atención médica que proporciona el proveedor de atención médica.
También autorizo a Aegerion y a las empresas que trabajan con Aegerion a comunicarse conmigo por correo postal, correo
electrónico, fax o teléfono para fines de marketing o que de otra manera me proporcionen información sobre los productos,
servicios y programas de Aegerion, u otros temas de interés, realizar investigación de mercado, o de otra manera preguntarme
sobre mi experiencia con estos asuntos o mi opinión sobre ellos. Entiendo y acepto que toda la información que proporciono
puede ser usada por Aegerion para desarrollar productos, servicios y programas nuevos. Entiendo que Aegerion no venderá ni
transferirá ningún dato personal a terceros no vinculados para fines de marketing sin mi permiso expreso. Entiendo que puedo
revocar esta autorización y decidir no recibir servicios ni información de Aegerion si envío una notificación de revocación
por escrito a Compass a Aegerion Pharmaceuticals, Inc., 1 Main Street, Suite 800, Cambridge, MA 02142. Confirmo que soy el
suscriptor de los números de teléfono y el usuario autorizado de las direcciones de correo electrónico que se proporcionan,
y acepto notificar a Aegerion de inmediato si alguno de estos números o dirección cambia en el futuro.
Firma del paciente: _________________________________________________ Fecha:__________________________________________________________
Firma del representante legal: _______________________________________ (si corresponde)
Fecha:__________________________________________________________
Compass • 1-855-898-2743 (phone) • 1-855-898-2498 (fax)
©2015 Aegerion Pharmaceuticals, Inc. All rights reserved. JUXTAPID is a registered trademark of Aegerion Pharmaceuticals. JUX/US/215 11-15
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