New York State Medicaid Preferred Drug Program
Technivie® Prior Authorization Worksheet
Fax Number: (800) 268-2990
Enrollee Information
ENROLLEE NAME:
ENROLLEE MEDICAID ID NUMBER (2 LETTERS, 5 NUMBERS, 1 LETTER):
ENROLLEE DATE OF BIRTH:
GENDER:
Female
Male
Prescriber Information
PRESCRIBER NAME:
CONTACT PERSON:
10-DIGIT NPI NUMBER:
OFFICE PHONE NUMBER:
(
)
-
OFFICE FAX NUMBER:
(
)
-
Are you a gastroenterologist, hepatologist, transplant physician or infectious disease specialist?
YES
NO
If no, are you working in collaboration with a specialist listed above?
YES
NO
If no, do you have clinical experience with the management and treatment of hepatitis c virus (HCV) infection?
YES
NO
Clinical experience is defined as the management AND treatment of at least 10 patients with HCV infection within the past 12 months
and at least 10 HCV-related CME credits in the last 12 months.
Clinical Criteria
MEDICAL STATUS
Diagnosis (Please check all that apply):
Chronic Hepatitis C Infection
HCV Genotype:
Has documentation confirming genotype been submitted?
Is the patient interferon ineligible?
Without cirrhosis
Compensated cirrhosis
Decompensated cirrhosis
Hepatocellular Carcinoma awaiting liver transplantation
Has documentation confirming hepatocellular carcinoma been submitted?
Status post-liver transplant
Yes
Yes
No
No
Yes
No
Please indicate liver fibrosis stage (METAVIR score) :
0
1
2
3
4
Other
Liver fibrosis should be confirmed utilizing one of the following methods: liver biopsy, transient elastography (FibroScan®) score ≥ 9.5kPa,
FibroSure® score ≥ 0.58, APRI score > 1.5 or radiological imaging consistent with cirrhosis (e.g. evidence of portal hypertension).
BASELINE RNA LEVEL:
DATE TAKEN:
Has documentation confirming baseline HCV RNA been submitted?
Yes
No
Yes
Yes
No
No
TREATMENT HISTORY
Is the patient initiating or continuing Technivie therapy?
Initiation
Continuation
Is the patient treatment-naïve with Technivie?
If continuation of therapy, was the Technivie therapy started in another health care setting?
Please check the box that best describes the patient’s HCV Treatment status:
Treatment-naïve
Prior relapser (achieved undetectable HCV RNA at end of previous treatment with peginterferon and ribavirin but detectable within
24 weeks after treatment)
Prior partial responder (≥2 log decrease in HCV RNA at week 12 of previous treatment with peginterferon and ribavirin but did not
achieve undetectable HCV RNA at end of treatment)
Prior null responder (achieved <2 log decrease in HCV RNA at week 12 of previous treatment with peginterferon and ribavirin)
For billing questions, call 1-800-343-9000.
For clinical concerns or Preferred Drug Program questions, visit www.nyhealth.gov
and http://newyork.fhsc.com or call 1-877-309-9493.
© 2015, Magellan Health, Inc. All Rights Reserved.
Magellan Medicaid Administration
Technivie® Prior Authorization Worksheet
TREATMENT HISTORY (CONT.)
Please provide previous HCV therapy completed prior to the date of this request (IF APPLICABLE):
DRUG:
DOSAGE FORM:
STRENGTH:
DRUG:
DOSAGE FORM:
STRENGTH:
DRUG:
DOSAGE FORM:
STRENGTH:
How many weeks of previous therapy have been completed prior to the date of this request?
DIRECTION:
DIRECTION:
DIRECTION:
CONCOMITANT CONDITIONS/COMORBIDITIES
Is the patient co-infected with chronic hepatitis B infection?
Is the patient co-infected with HIV/AIDS?
If yes, has the patient had undetectable viral load for the past 6 months?
Has the patient had a liver transplant?
Does the patient have co-existent liver disease, such as nonalcoholic steatohepatitis (NASH)?
Does the patient have type 2 diabetes mellitus (insulin resistant)?
Does the patient have debilitating fatigue that is impacting their quality of life
(e.g., secondary to extra-hepatic manifestations and/or liver disease)?
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
Yes
No
Does the patient have evidence of extra-hepatic manifestation of hepatitis C?
If yes, please check all that apply below:
Yes
No
Documentation of the presence of extra-hepatic manifestations based on lab results or imaging results (e.g., CBC, erythrocyte
sedimentation rate (ESR)/C-reactive protein (CRP), urinalysis, BUN/creatinine and angiography) must be submitted.
Hematological:
Cryoglobulinemia (e.g. Type 2 or 3 essential mixed cryoglobulinemia)
Lymphoma
Multiple myeloma
Renal Disease:
Proteinuria
Nephrotic syndrome
Membranoproliferative glomerulonephritis
Renal failure
Cutaneous:
Porphyria cutanea tarda
Lichen myxedematosus
Rheumatologic:
Behçet’s disease
Raynaud’s syndrome
Systemic lupus erythematosus
Rheumatoid arthritis
PREGNANCY
For female patients of child bearing potential: Has a negative pregnancy test been collected
within 30 days prior to initiation of therapy OR medical record submitted documenting pregnancy status?
Revision Date: October 2015
For billing questions, call 1-800-343-9000.
For clinical concerns or Preferred Drug Program questions, visit
www.nyhealth.gov and http://newyork.fhsc.com or call 1-877-309-9493.
Yes
No
Page 2
Magellan Medicaid Administration
Technivie® Prior Authorization Worksheet
TREATMENT READINESS
Please indicate which of the following scales/assessment tools was used to evaluate the readiness of the patient (only one is required):
SAMHSA-HRSA Center for Integrated Health Solutions – Drug & Alcohol Screening Tools – Available at:
http://www.integration.samhsa.gov/clinical-practice/screening-tools#drugs
If checked, please provide the name of SAMSHA-HRSA drug and alcohol screening tool used (required):
Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) – Available at: www.prepc.org
Has the patient demonstrated treatment readiness, including the ability to adhere to the
prescribed treatment regimen?
Yes
No
CONTINUATION OF THERAPY REQUESTS **THIS PORTION IS NOT REQUIRED FOR INITIAL THERAPY REQUESTS
WEEK 4 ( ±2 WEEKS)
HCV RNA LEVEL:
DATE TAKEN:
Has documentation confirming HCV RNA levels at the appropriate week been submitted?
Yes
No
Has the patient completed all HCV evaluation appointments and procedures and demonstrated
compliance to their treatment regimen?
Yes
No
CURRENT TREATMENT REGIMEN
Please indicate the treatment regimen that is being prescribed:
Accepted Regimens and Treatment Duration for Technivie Therapy in HCV
Diagnosis
Treatment Regimen
Length of Authorization
HCV Genotype 4
Technivie + ribavirin
12 weeks
HCV Genotype 4
Technivie
12 weeks
Please provide dosing information for the treatment regimen selected above:
Technivie
Ribavirin
STRENGTH:
DIRECTION:
Other Ribavirin Product
QUANTITY:
STRENGTH:
REFILLS:
DIRECTION:
QUANTITY:
REFILLS:
Please answer the following questions if requesting a non-preferred ribavirin product as part of treatment:
Patient has experienced a treatment failure with a preferred drug.
Yes
No
Patient has experienced an adverse drug reaction with a preferred drug.
Yes
No
There is a documented history of successful therapeutic control with a nonpreferred drug and transition to a
preferred drug is medically contraindicated.
Yes
No
Other (Please specify the clinical reason the patient is unable to use a preferred agent in the same drug class. If necessary, fax
additional pages):
Please provide any additional information that should be considered in the space below:
I attest that this is medically necessary for this patient and that all of the information on this form is accurate to
the best of my knowledge. I attest that documentation of the above diagnosis and medical necessity is available
for review if requested by New York Medicaid.
PRESCRIBER’S SIGNATURE
Revision Date: October 2015
DATE
For billing questions, call 1-800-343-9000.
For clinical concerns or Preferred Drug Program questions, visit
www.nyhealth.gov and http://newyork.fhsc.com or call 1-877-309-9493.
Page 3
Ombitasvir, Paritaprevir, and Ritonavir Tablet (Technivie™)
Technivie™ consists of ombitasvir, paritaprevir and ritonavir, in a fixed dose combination tablet. The combination is approved for
the treatment of chronic hepatitis C virus (HCV) genotype 4 infection in adults without cirrhosis. 1 Approved by the Food and Drug
Administration (FDA) in July 2015, Technivie™ consists of a fix-dose combination of ombitasvir, a HCV NS5A inhibitor, paritaprevir, a
HCV NS3/4A protease inhibitor, and ritonavir, a cytochrome P450(CYP) 3A inhibitor. The product consists of 2 direct acting antiviral
(DAA) agents, ombitasvir and paritaprevir. Ritonavir is an HIV-1 protease inhibitor and has no activity against HCV; it is a potent
inhibitor of CYP 3A metabolic enzymes and increases the overall drug exposure (i.e., area under the curve [AUC]) of paritaprevir.
Patients co-infected with HIV-1 should also be on a suppressive antiretroviral drug regimen to reduce the risk of HIV-1 protease
inhibitor drug resistance.
Technivie™ should be given with ribavirin (RBV) for patients with HCV genotype 4 infection without cirrhosis for 12 weeks. It can be
given without RBV in those patients who cannot take or tolerate RBV. The drug is not recommended in patients with moderate
hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C).
Advantages of ombitasvir, paritaprevir, and ritonavir fixed-dose tablet
The recommended oral dose of ombitasvir, paritaprevir, and ritonavir, a fixed dose combination, is two tablets taken once daily in
the morning with a meal for 12 weeks.1 Technivie™ efficacy and safety was studied in one randomized, multicenter, open-label trial,
PEARL-1. The primary endpoint of the study was defined as HCV RNA less than the lower level of quantification (<25 IU/mL) at 12
weeks post-treatment (SVR12). For patients with HCV genotype 4 infection without cirrhosis, SVR12 was achieved in 100% of the
treatment-naïve or treatment-experienced patients (e.g., defined as not achieving a virologic response with prior treatment with
pegylated interferon/ RBV) that received ombitasvir, paritaprevir, and ritonavir with RBV for 12 weeks verses 91% of treatmentnaive patients that received ombitasvir, paritaprevir, and ritonavir without RBV for 12 weeks.
Cautions








The product is contraindicated in patients with moderate hepatic impairment (Child-Pugh B) and in patients with severe hepatic
impairment (Child-Pugh C).
Paritaprevir and ritonavir are primarily metabolized by CYP3A enzymes. Co-administration of the product with drugs that are
highly dependent on CYP3A for clearance is contraindicated. Drugs that are moderate or strong inducers of CYP3A may reduce
the effectiveness of Technivie™ and are also contraindicated.
In clinical trials, elevation of alanine transaminase (ALT) up to ≥5 times the upper limit of normal (ULN) occurred in
approximately 1% of the population. ALT elevation occurred more frequently in women taking ethinyl estradiol- containing
medications. Patients should discontinue their ethinyl estradiol-containing medication prior to starting therapy and an
alternative method of contraceptive should be used. Ethinyl estradiol-containing medications can be restarted approximately 2
weeks following the completion of their HCV treatment.
Liver function tests should be performed at baseline and during the first 4 weeks of therapy. The product should be
discontinued if ALT >10 times ULN occurs or if the patient experiences signs or symptoms of liver inflammation or an increase in
their conjugated bilirubin, alkaline phosphatase (ALP) or international normalized ratio (INR) is noted.
No dose adjustment is required in patients with mild, moderate or severe renal impairment. The product has not been studied
in patient undergoing dialysis.
Patients co-infected with HIV-1 must be on a suppressive antiretroviral drug regimen to reduce the risk of HIV-1 protease
inhibitor drug resistance that could occur from exposure to ritonavir.
Technivie™ is pregnancy category B and should be used in pregnant women only if benefit justifies the risk to the fetus. In
animal reproductive studies there was no evidence of teratogenicity. When given in combination with RBV, the combination is
contraindicated in pregnant women due to teratogenicity of RBV.
Safety and effectiveness of the product has not been established in patients < 18 years of age.
Where does ombitasvir, paritaprevir, and ritonavir tablet fit into therapy and how should it be used?
In January 2014, The American Association for the Study of Liver Diseases and Infectious Diseases Society of America, in
collaboration with the International Antiviral Society – USA, launched www.hcvguidelines.org for the purpose of disseminating
expert opinion on management of CHC as newer HCV DAA become available and treatment evidence emerges. There are no
comparative efficacy data available to date for the HCV DAA, but it is likely that guidelines for optimal regimens will continue to
evolve and will need to integrate patient-specific as well as economic factors.
Many patient-specific factors must be taken into consideration when deciding to initiate therapy and baseline host and viral factors
will affect relapse rates and treatment duration. The goal of treatment is undetectable HCV RNA 12 weeks post-treatment (SVR12).
Technivie™ in combination with RBV for 12 weeks is an option for patients with HCV genotype 4 infections without cirrhosis.
References: 1.Technivie™ prescribing information. AbbVie Inc., 2015. 2. Hezode, C et al. Lancet 2015; 385 (9986): 2502-09.
Revision Date: November 13, 2015
Ombitasvir, Paritaprevir, and Ritonavir Tablet (Technivie™) Initiation and Monitoring
Once patient readiness for chronic hepatitis C virus (HCV) treatment has been determined, the algorithm below outlines
key decision points for initiating and monitoring of Technivie™.
Note: Ribavirin is contraindicated in pregnancy therefore all female patients of childbearing age (or female partners of male patients)
should be sure they are not pregnant prior to beginning treatment and should use 2 methods of non-hormonal birth control
throughout treatment. Also note, HCV RNA testing should be conducted using a sensitive assay.
Has the patient been diagnosed with HCV
genotype 4 without cirrhosis and received
quantitative HCV RNA testing?
NO
Seek alternative treatment
options or conduct testing
prior to treatment
YES
Perform baseline hepatic laboratory
testing
Start Technivie 2 tablets daily with RBV for
12 weeks*
Perform hepatic laboratory testing during
the first 4 weeks of therapy
If ALT is elevated above baseline;
monitor closely. If ALT is >10 times ULN
consider discontinuing
Obtain HCV RNA level 12 weeks after the
end of treatment to determine SVR 12
ALT = alanine aminotransferase; RBV= ribavirin; SVR = sustained virological response; ULN= upper limits of normal
*Technivie without RBV for 12 weeks may be considered in treatment naïve patients without cirrhosis who cannot take or tolerate RBV.
Revision Date: November 13, 2015