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ProCeed Customer Solutions
proCeed VIEKIRA HUB Referral Form PROVIDE SOLUTIONS TO
Streamline access
to VIEKIRA PAK for
your patients using
the enclosed proCeed
Customer Solutions
intake forms
FINANCIAL
ADHERENCE
BARRIERS
AND TRACK
OUTCOMES
INDICATION1
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is indicated for the
treatment of adult patients with chronic hepatitis C virus (HCV):
• genotype 1b without cirrhosis or with compensated cirrhosis.
• genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
SAFETY CONSIDERATIONS1
VIEKIRA PAK is contraindicated: in patients with moderate to severe hepatic impairment; with certain drugs
that are highly dependent on CYP3A for clearance; moderate or strong inducers of CYP3A; strong inducers and inhibitors of CYP2C8; and in patients with known hypersensitivity to ritonavir. • When VIEKIRA PAK is administered with RBV, the contraindications, warnings and precautions (particularly pregnancy avoidance), and adverse reactions for RBV also apply to this combination regimen. Refer to the RBV prescribing information. • Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation. • ALT elevations >5x upper limit of normal (ULN) occurred in 1% of all subjects and were significantly more frequent in females using ethinyl estradiol-containing medications, which are contraindicated. Perform hepatic lab testing on al patients. • Due to risk of HIV-1 protease inhibitor drug resistance, HCV/HIV-1 co-infected patients should be on a suppressive antiretroviral drug regimen.
Please for full Prescribing Information.
Fax To: 1-855-886-2481
Phone: 1-855-765-0504 PO Box 4280, Gaithersburg, MD 20885 Simplified access. Coordinated care.
1 REQUESTED SERVICES (SELECT ALL BOXES THAT APPLY)
Prescription/Benefit Verification Prior Authorization/Appeal Assistance 2 PATIENT INFORMATION
3 PRESCRIBER INFORMATION
Prescriber Name: Address (No PO Box): State License #: NPI #: City / State / ZIP: Tax ID #: Facility Name: Primary Phone #: ALT Phone #: Specialty: Hepatology Gastro ID Other: City / State / ZIP: Language: English Patient Preferred Contact Phone #: Annual Household Income: $ Number in Household: Contact E-mail Address: 4 INSURANCE INFORMATION
Please fax copy of prescription
5 DIAGNOSIS AND CLINICAL INFORMATION
and insurance cards with this
form (front and back)
No Insurance Coverage HCV Genotype 1a 1b Other Insurance Plan: Medicare Medicaid Private/Commercial Other Treatment History:
Previously Treated Insurance Company Name: Post-liver Transplant Renal Insufficiency Insurance Company Phone #: Proton Pump Inhibitor (PPI) HCV/HIV Coinfection Policy #: Group #: Compensated Cirrhosis (Child-Pugh A) Policyholder Name: Diagnosis (ICD-10 Code):
B18.2 Chronic Viral Hepatitis C Allergies (List): PBM Phone #: PBM BIN #: B19.20 Unspecified Viral Hepatitis C without Hepatic Coma PRESCRIPTION INFORMATION (PLEASE CHECK ONE BOX)
ombitasvir 12.5 mg, paritaprevir 75 mg, Take two pink-colored tablets ritonavir 50 mg fixed-dose combination po once daily (AM) and one VIEKIRA PAK
tablets; copackaged with dasabuvir beige-colored tablet po twice daily Compensated Cirrhotic (AM and PM) with a meal ombitasvir 12.5 mg, paritaprevir 75 mg, Take two pink-colored tablets VIEKIRA PAK
ritonavir 50 mg fixed-dose combination po once daily (AM) and one tablets; copackaged with dasabuvir beige-colored tablet po twice daily (AM and PM) with a meal Compensated Cirrhotic Take tabs po AM and ombitasvir 12.5 mg, paritaprevir 75 mg, Take two pink-colored tablets po VIEKIRA PAK
ritonavir 50 mg fixed-dose combination once daily (AM) and one beige- tablets copackaged with dasabuvir colored tablet po twice daily (AM and PM) with a meal Take tabs/caps po AM and tabs/caps po PM I certify that the patient and physician information contained in this form is complete and accurate to the best of my knowledge. I authorize AbbVie, its affiliates, and agents/contractors ("AbbVie Partners") to be my designated agent as needed to perform benefits investigation, to refer my patient's prescriptions to the specialty pharmacy, to receive information from specialty pharmacies on the status of the dispensing of the prescriptions and related matters, and to contact patients directly if and when patient consent is obtained to gather additional information required to perform these activities. I further authorize and request that I am provided with all information necessary for me or my staff to complete a Prior Authorization and Letter of Medical Necessity for my patient, as may be required as a result of such benefits investigation assessment. By signing this form, I authorize the Program and AbbVie Partners as my designated agent and on behalf of my patients, to forward a prescription for medication presented herein by fax or other mode of delivery to a pharmacy selected by the patient and within the Program network. By signing this form, I represent that I have obtained all necessary federal and state authorizations from my patient to allow me to release health information to AbbVie and the AbbVie Partners.
STAMP SIGNATURE NOT ALLOWED
DISPENSE AS WRITTEN
PRODUCT SUBSTITUTION PERMITTED
Please for full Prescribing Information.
Fax To: 1-855-886-2481
Phone: 1-855-765-0504 PO Box 4280, Gaithersburg, MD 20885 Simplified access. Coordinated care.
INDICATION1
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is indicated for the treatment of adult patients with chronic
hepatitis C virus (HCV):
• genotype 1b without cirrhosis or with compensated cirrhosis.
• genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
IMPORTANT SAFETY INFORMATION1
Risks Associated with RBV Combination Treatment
When VIEKIRA PAK is administered with RBV, the contraindications, warnings and precautions (particularly pregnancy avoidance),
and adverse reactions for RBV also apply to this combination regimen. Refer to the RBV prescribing information.
CONTRAINDICATIONS
VIEKIRA PAK is contraindicated:
• in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity.
• with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious
and/or life-threatening events; moderate or strong inducers of CYP3A and strong inducers of CYP2C8, which may lead to reduced efficacy of VIEKIRA PAK; and strong CYP2C8 inhibitors, which may increase dasabuvir levels and the risk of QT prolongation.
• with the following drugs: alfuzosin HCL; ranolazine; dronedarone; carbamazepine, phenytoin, phenobarbital; colchicine; gemfibrozil; rifampin; lurasidone, pimozide; ergotamine, dihydroergotamine, methylergonovine; ethinyl estradiol-containing medicines, such as combined oral contraceptives; cisapride; St. John's Wort (Hypericum perforatum); lovastatin, simvastatin; efavirenz; sildenafil (when dosed as Revatio* for pulmonary arterial hypertension); triazolam and oral midazolam.
• in patients with known hypersensitivity (e.g., toxic epidermal necrolysis or Stevens-Johnson syndrome) to ritonavir.
WARNINGS AND PRECAUTIONS
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
• Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients
with advanced cirrhosis prior to initiating therapy. Reported cases typically occurred within one to four weeks of initiating therapy.
• For patients with cirrhosis: monitor for clinical signs and symptoms of hepatic decompensation; perform hepatic lab testing, including direct bilirubin levels, at baseline and during the first 4 weeks of starting treatment and as clinically indicated; discontinue treatment in patients who develop evidence of hepatic decompensation.
Increased Risk of ALT Elevations
• Elevations of ALT to >5x the upper limit of normal (ULN) occurred in 1% of all subjects in clinical trials and were significantly more
frequent in females using ethinyl estradiol-containing medications. In female patients, discontinue ethinyl estradiol-containing medications prior to starting therapy and use alternative methods of contraception during therapy. Use caution when co-administering VIEKIRA PAK with estrogens other than ethinyl estradiol, such as estradiol and conjugated estrogens.
• Perform hepatic lab testing on all patients during the first 4 weeks of treatment and as clinically indicated thereafter. If ALT is elevated above baseline levels, repeat testing and monitor closely. Patients should be instructed to consult their doctor without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice, or discolored feces. Consider discontinuing VIEKIRA PAK if ALT levels remain persistently >10x the ULN. Discontinue VIEKIRA PAK if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing direct bilirubin, alkaline phosphatase, or INR.
Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions
• The concomitant use of VIEKIRA PAK and certain other drugs may result in known or potentially significant drug interactions,
some of which may lead to loss of therapeutic effect of VIEKIRA PAK and possible development of resistance, or clinically significant adverse reactions from greater exposures of concomitant drugs or components of VIEKIRA PAK.
HCV/HIV-1 Co-infected Patients: Risk of HIV-1 Protease Inhibitor Drug Resistance
• The ritonavir component of VIEKIRA PAK is an HIV-1 protease inhibitor and can select for HIV-1 protease inhibitor resistance.
To reduce this risk, HCV/HIV-1 co-infected patients should also be on a suppressive antiretroviral drug regimen.
ADVERSE REACTIONS
Most common adverse reactions observed:
• VIEKIRA PAK with RBV (>10% of subjects): fatigue, nausea, pruritus, other skin reactions, insomnia, and asthenia.
• VIEKIRA PAK without RBV (≥5% of subjects): nausea, pruritus, and insomnia.
* Revatio® is a trademark of its respective owner and not a trademark of AbbVie Inc. The makers of this brand are not affiliated with and do not endorse AbbVie Inc. or its products.
Reference: 1. VIEKIRA PAK [package insert]. North Chicago, IL: AbbVie Inc.
Please escribing Information.
Fax To: 1-855-886-2481
Phone: 1-855-765-0504 PO Box 4280, Gaithersburg, MD 20885 Simplified access. Coordinated care.
PROCEED PATIENT SUPPORT PROGRAM AUTHORIZATION
I hereby consent to participate in AbbVie's proCeed program, which I understand is an AbbVie sponsored coordination of care program designed to provide personalized treatment support. I consent to AbbVie, its affiliates, and agents/contractors ("AbbVie Partners") to use and disclose information that they have been provided for the following purposes: (1) enroll me in and use my personal information to provide me with the proCeed programs and related services, which include reimbursement services, financial assistance, disease management support, nurse support and care coordination ("proCeed Services"); (2) provide me with informational and marketing materials related to the use of my prescribed AbbVie products, clinical trial and market research opportunities, and other services by any means of communication, including by text, e-mail, direct mail, and/or telephone; and (3) de-identify my personal information and use or disclose the de- identified data to help improve, develop, and evaluate products, services, materials, programs, and treatment related to my condition or treatment, as well as for health economic outcomes research and market research. I understand AbbVie and AbbVie Partners will not sell or rent my personal information or otherwise use my personal information for any purpose not authorized above. I understand that this Consent to Participate is voluntary. However, I understand that if I do not sign this Consent to Participate, I cannot participate in the proCeed program. I may cancel by calling 844-277-6233. Once AbbVie receives and processes my cancellation request, AbbVie will not use my personal information going forward. I understand that cancelling my Consent to Participate will not affect any use of my information that occurred before my request was processed.
By signing below, I agree to the statements above and that I am currently 18 years of age or older.
Patient's Name (Print)
Signature
Patient DOB
Patient Gender
Home Address
Patient E-mail
Patient Phone Number
Can we leave a message?
PERSONAL REPRESENTATIVE AUTHORIZATION
Personal Representative Authorization (if applicable):
Note: If the Patient is unable to sign, is under the age of 18, or has designated signature authority, the Patient's Personal Representative may sign
this form. However, only certain individuals may qualify as the Patient's Personal Representative for purposes of this Authorization. A Patient's
Representative must have the requisite knowledge and information regarding the Patient's financial and healthcare status to verify that all responses
provided are accurate. State law may prescribe who can be a Personal Representative for purposes of this Authorization. A person or entity in the
supply chain of the product to be received through the PAP, including a healthcare provider or pharmacy receiving the medicines at no cost, may
not be named a Personal Representative. If Patient's Personal Representative is a consumer assistance or charitable organization, please list name of
entity and purpose of entity under Relationship to Patient.
Personal Representative's Name: Signature: x
Relationship to Patient:
for full Prescribing Information.
Fax To: 1-855-886-2481
Phone: 1-855-765-0504 PO Box 4280, Gaithersburg, MD 20885 Simplified access. Coordinated care.
PATIENT HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) AUTHORIZATION
I understand that the purpose of this authorization ("Authorization") is to give my permission for the disclosure and use of my protected health information to the extent it is required under state and federal law. I hereby authorize my healthcare providers, healthcare insurers, and laboratory testing facilities that have provided treatment, payment, or services to me or for me (collectively, "Healthcare Companies") to disclose information about me, my medical condition, and my treatment, insurance coverage and payment information in relation to my use of AbbVie products, (collectively, "Personal Information"), to AbbVie, its affiliates, and agents/ contractors ("AbbVie Partners"), in order for AbbVie and AbbVie Partners to use and disclose my Personal Information to: (1) enroll me in and use my Personal Information to provide me with the proCeed programs and related services (for example, financial assistance) ("proCeed Services"); (2) provide me with informational and marketing materials related to the use of my prescribed AbbVie products, clinical trial and market research opportunities, and other services by any means of communication, including by text, e-mail, direct mail, and/or telephone; and (3) de-identify my Personal Information and use or disclose the de-identified data to help improve, develop, and evaluate products, services, materials, programs, and treatment related to my condition or treatment, as well as for health economic outcomes research and market research. I understand that once AbbVie and the AbbVie Partners receive my Personal Information, they may communicate with my Healthcare Companies to provide the proCeed Services. AbbVie and the AbbVie Partners are hereby notified by the Healthcare Companies that they may use the disclosed Personal Information only for the purposes set forth above. I also understand that if my Healthcare Companies use or disclose my Personal Information for marketing purposes, they may receive financial remuneration.
I understand that I am not required to sign this Authorization and that my Healthcare Companies will not condition my treatment, payment, enrollment or eligibility for benefits on whether I sign this Authorization.
I understand that this Authorization is voluntary, and will expire in 10 years or a shorter time period if required by state law, unless I cancel it sooner. I understand that if I do not sign this Authorization, I cannot participate in certain proCeed Services. I may cancel my Authorization by calling 844-277-6233 and by notifying my Healthcare Companies. Once AbbVie receives and processes my cancellation request, AbbVie will not use my Personal Information going forward. I understand that canceling my Authorization will not affect any use of my information that occurred before my request was processed.
I understand that my Personal Information released under this Authorization is subject to re-disclosure by AbbVie and AbbVie Partners and will no longer be protected by HIPAA.
California, Rhode Island, Minnesota and Florida Only: State law prohibits the person receiving my
Personal Information from making further disclosure of it, unless another authorization for such disclosure is obtained from me or unless such disclosure is required or permitted by law.
By signing below, I agree to the statements above and that I am currently 18 years of age or older.
Patient's Name (Print)
Signature
Patient Representative's Name (Print)
Signature
Relationship to Patient
for full Prescribing Information.
Simplified access. Coordinated care.
INDICATION1
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is indicated for the treatment of adult patients with chronic
hepatitis C virus (HCV):• genotype 1b without cirrhosis or with compensated cirrhosis.
• genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
IMPORTANT SAFETY INFORMATION1
Risks Associated with RBV Combination Treatment
When VIEKIRA PAK is administered with RBV, the contraindications, warnings and precautions (particularly pregnancy avoidance), and adverse reactions for RBV also apply to this combination regimen. Refer to the RBV prescribing information.
CONTRAINDICATIONS
VIEKIRA PAK is contraindicated:
• in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity.
• with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious
and/or life-threatening events; moderate or strong inducers of CYP3A and strong inducers of CYP2C8, which may lead to reduced efficacy of VIEKIRA PAK; and strong CYP2C8 inhibitors, which may increase dasabuvir levels and the risk of QT prolongation.
• with the following drugs: alfuzosin HCL; ranolazine; dronedarone; carbamazepine, phenytoin, phenobarbital; colchicine; gemfibrozil; rifampin; lurasidone, pimozide; ergotamine, dihydroergotamine, methylergonovine; ethinyl estradiol-containing medicines, such as combined oral contraceptives; cisapride; St. John's Wort (Hypericum perforatum); lovastatin, simvastatin; efavirenz; sildenafil (when dosed as Revatio* for pulmonary arterial hypertension); triazolam and oral midazolam.
• in patients with known hypersensitivity (e.g., toxic epidermal necrolysis or Stevens-Johnson syndrome) to ritonavir.
WARNINGS AND PRECAUTIONS
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
• Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis prior to initiating therapy. Reported cases typically occurred within one to four weeks of initiating therapy.
• For patients with cirrhosis: monitor for clinical signs and symptoms of hepatic decompensation; perform hepatic lab testing, including direct bilirubin levels, at baseline and during the first 4 weeks of starting treatment and as clinically indicated; discontinue treatment in patients who develop evidence of hepatic decompensation.
Increased Risk of ALT Elevations
• Elevations of ALT to >5x the upper limit of normal (ULN) occurred in 1% of all subjects in clinical trials and were significantly more frequent in females using ethinyl estradiol-containing medications. In female patients, discontinue ethinyl estradiol-containing medications prior to starting therapy and use alternative methods of contraception during therapy. Use caution when co-administering VIEKIRA PAK with estrogens other than ethinyl estradiol, such as estradiol and conjugated estrogens.
• Perform hepatic lab testing on all patients during the first 4 weeks of treatment and as clinically indicated thereafter. If ALT is elevated above baseline levels, repeat testing and monitor closely. Patients should be instructed to consult their doctor without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice, or discolored feces. Consider discontinuing VIEKIRA PAK if ALT levels remain persistently >10x the ULN. Discontinue VIEKIRA PAK if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing direct bilirubin, alkaline phosphatase, or INR.
Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions
• The concomitant use of VIEKIRA PAK and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of VIEKIRA PAK and possible development of resistance, or clinically significant adverse reactions from greater exposures of concomitant drugs or components of VIEKIRA PAK.
HCV/HIV-1 Co-infected Patients: Risk of HIV-1 Protease Inhibitor Drug Resistance
• The ritonavir component of VIEKIRA PAK is an HIV-1 protease inhibitor and can select for HIV-1 protease inhibitor resistance. To reduce this risk, HCV/HIV-1 co-infected patients should also be on a suppressive antiretroviral drug regimen.
ADVERSE REACTIONS
Most common adverse reactions observed:
• VIEKIRA PAK with RBV (>10% of subjects): fatigue, nausea, pruritus, other skin reactions, insomnia, and asthenia.
• VIEKIRA PAK without RBV (≥5% of subjects): nausea, pruritus, and insomnia.
* Revatio® is a trademark of its respective owner and not a trademark of AbbVie Inc. The makers of this brand are not affiliated with and do not endorse AbbVie Inc. or its products.
Reference: 1. VIEKIRA PAK [package insert]. North Chicago, IL: AbbVie Inc.
2016 AbbVie Inc. North Chicago, IL 046-1849123 April 2016

Source: https://www.viekirahcp.com/content/pdf/viekira_proceed_hub_form.pdf