Download Zepatier (genotypes 1 and 4) - NYS Medicaid Pharmacy Prior

New York State Medicaid Preferred Drug Program
Zepatier™ 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
Chronic Hepatitis C Infection
HCV Genotype:
Has documentation confirming genotype been submitted?
Has the patient had a baseline quantitative HCV RNA level completed?
Baseline quantitative HCV RNA:
IU/ml
Date completed:
Yes
1b
Yes
Yes
No
4
No
No
Was hepatic laboratory testing completed at baseline?
Yes
No
Does the patient have moderate (Child-Pugh B) to severe hepatic impairment (Child-Pugh C)?
(Zepatier is contraindicated in patients with moderate (Child-Pugh B) to severe hepatic impairment (Child-Pugh C))
Yes
No
If HCV Genotype 1a, has patient been tested for the presence of NS5A resistance-associated polymorphisms?
Yes
No
1a
Was screening for evidence of current or prior Hepatitis B virus (HBV) infection completed?
Yes
No
Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs,
and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up
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?
Yes
No
Yes
No
Yes
Yes
No
No
Yes
Yes
No
No
TREATMENT HISTORY
Was the current Zepatier regimen initiated at another healthcare facility or previously
covered by another health plan?
IF YES, how many weeks of previous therapy have been completed prior to the date of this request?
Please check the box that best describes the patient’s HCV treatment status:
Treatment-naïve
Treatment-experienced
If treatment experienced, is the patient a non-responder to:
pegylated interferon + ribavirin
pegylated interferon + ribavirin + HCV protease inhibitor (telaprevir, boceprevir or simeprevir)
other:
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.
© 2016, Magellan Health Services, Inc. All Rights Reserved.
Magellan Medicaid Administration
Zepatier 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
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:
WEEK 8 (±2 WEEKS) HCV RNA LEVEL:
DATE TAKEN:
WEEK 8 (±2 WEEKS) HEPATIC LABORATORY
TESTING
DATE TAKEN:
WEEK 12 (±2 WEEKS) HCV RNA LEVEL:
DATE TAKEN:
WEEK 12 (±2 WEEKS) HEPATIC LABORATORY
TESTING FOR PATIENTS RECEIVING 16
WEEKS OF THERAPY
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:
HCV
Genotype
Specific Patient Population with or without Cirrhosis
(if applicable)
Treatment
Regimen
Treatment
Duration
1a
Treatment-naïve or PegIFN/RBV-experienced without baseline NS5A
polymorphisms±
Zepatier
12 weeks
1a
Treatment-naïve or PegIFN/RBV-experienced with baseline NS5A
polymorphisms±
Zepatier + RBV
16 weeks
1b
Treatment-naïve or PegIFN/RBV-experienced*
Zepatier
12 weeks
PegIFN/RBV/PI-experiencedˆ
Zepatier + RBV
12 weeks
Treatment-naïve
Zepatier
12 weeks
PegIFN/RBV-experienced*
Zepatier + RBV
16 weeks
1a≠,
1b
4
4
±
For genotype (GT) 1a, testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended to determine
appropriate regimen and treatment duration. SVR12 rates were lower in patients with one or more baseline NS5A resistance-associated
polymorphisms at amino acid positions 28, 30, 31, or 93.
*Peginterferon alfa + ribavirin (RBV)
ˆPeginterferon alfa + RBV + HCV NS3/4A protease inhibitor (boceprevir, simeprevir or telaprevir)
≠Optimal
Zepatier-based treatment regimen/duration for PegIFN/RBV/PI-experienced GT1a patients with baseline NS5A polymorphisms
at positions 28, 30, 31, 93 has not been established.
Patients with HCV/HIV-1 co-infection should also follow the regimens above.
Please provide dosing information for the treatment regimen selected above:
Zepatier DIRECTIONS: 1 tablet daily with or without food
Ribavirin
Other Ribavirin Product
Other
Revision Date: November 2016
QUANTITY:
REFILLS:
STRENGTH:
DIRECTIONS:
QUANTITY:
REFILLS:
STRENGTH:
DIRECTIONS:
QUANTITY:
REFILLS:
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 2
Magellan Medicaid Administration
Zepatier Prior Authorization Worksheet
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: November 2016
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
Elbasvir / Grazoprevir (Zepatier™)
Approved by the Food and Drug Administration (FDA) in January 2016, elbasvir/grazoprevir (Zepatier™) is a fixed-dose combination
tablet that contains 2 directing-acting antiviral (DAA) agents indicated, with or without ribavirin (RBV), for the treatment of chronic
hepatitis C (HCV) in genotypes (GT) 1 or 4 infection in adults.1 Elbasvir is an HCV NS5A inhibitor and grazoprevir is an HCV NS3/4A
protease inhibitor. Each fixed-dose tablet contains 50 mg of elbasvir and 100 mg of grazoprevir.
Prior to initiating elbasvir/grazoprevir, with or without RBV, hepatic laboratory testing should be completed for all patients.1 NS5A
resistance-associated polymorphism testing is also recommended for patients with HCV GT 1a infection. 1 Elevation of alanine
aminotransferase (ALT) of up to 5 times the upper limit of normal (ULN) was noted in 1% of patients in clinical trials at or after week
8 of therapy. Elevated ALT levels were observed more frequently in females and in the Asian population. Hepatic laboratory testing
should be completed when initiating therapy and at weeks 8 and 12 for patients receiving 16 weeks of therapy and when clinically
indicated. Elbasvir/grazoprevir should be discontinued if the patient experiences an elevation in ALT accompanied by signs or
symptoms of liver inflammation, or increasing conjugated bilirubin, alkaline phosphatase (ALP), or international normalized ratio
(INR). The product is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C).
Elbasvir/grazoprevir is a substrate of cytochrome P450 3A (CYP3A) and is primarily metabolized by CYP3A. 1 Additionally,
elbasvir/grazoprevir is a substrate of P-glycoprotein (P-gp) and organic anion transport polypeptide (OATP) 1B1 and 1B3. The
metabolism of elbasvir/grazoprevir can alter the concentrations of other drugs and conversely other drugs may alter the plasma
concentrations of elbasvir/grazoprevir. The product is contraindicated with OAPT1B1/3 inhibitors, strong CYP3A inducers and
efavirenz (Sustiva®), a non-nucleoside reverse transcriptase inhibitor. Co-administration of elbasvir/grazoprevir with moderate
CYP3A inducers is not recommended as they might decrease the plasma concentration of elbasvir/grazoprevir.
Advantages of elbasvir/ grazoprevir
Elbasvir/grazoprevir is administered once daily, with or without RBV. 1 No dosage adjustment is needed for renal impairment,
including patients on hemodialysis, or patients with mild hepatic impairment (Child-Pugh A). The product is contraindicated in
patients with moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C). In clinical trials, higher elbasvir/grazoprevir
plasma concentrations were noted in females and Asians; however, no dosage adjustment is recommended based on gender or
race. The efficacy of the product was evaluated in 2 placebo-controlled trials and 4 uncontrolled Phase 2 and 3 clinical trials.
Cautions1






Prior to initiating therapy with any HCV direct acting antiviral (DAA) agent, all patients should be tested for evidence of
current or prior hepatitis B virus (HBV) infection by measuring hepatitis B surface antigen (HBsAg), hepatitis B surface
antibody (anti-HBs) and hepatitis B core antibody (anti-HBc). In patients with serologic evidence of HBV infection, monitor
for clinical and laboratory signs of hepatitis flare or HBV reactivation during treatment with a DAA agent and during posttreatment follow-up.
Elbasvir/grazoprevir is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C).
Co-administration of elbasvir/grazoprevir is contraindicated with OATP1B 1/3 inhibitors, strong CYP3A inducers, and
efavirenz. Additionally, co-administration of elbasvir/grazoprevir with moderate CYP3A inducers is not recommended as
they might decrease the plasma concentration of elbasvir/grazoprevir.
Hepatic laboratory testing should be completed when initiating therapy, at week 8, at week 12 for patients receiving 16
weeks of therapy, and when clinically indicated. ALT evaluation, up to 5 times ULN, was generally reported at or after week
8 of treatment and occurred more frequently in females and in Asians. No dose adjustment is required based on gender or
race.
HCV NS5A amino acid polymorphisms at position M28, Q30, or Y93 was associated with reduced efficacy of
elbasvir/grazoprevir. NS5A resistance-associated polymorphism testing is recommended for all patients with HCV GT 1a
infection.
Currently there are no data on elbasvir/grazoprevir in pregnant women and the benefits and risks should be evaluated
before prescribing to a pregnant woman. The combination of elbasvir/grazoprevir and RBV is contraindicated in pregnant
women due to teratogenicity of RBV.
Updated: 2/23/2017
Where does elbasvir/grazoprevir 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 chronic HCV 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 at least 12 weeks’ post-treatment (SVR12).
Elbasvir/grazoprevir treatment regimen and duration recommendations
Genotype
1a
1b
1a or 1b
4
Patient Population
Recommended Treatment Duration
TN or PEG/ RBV experienced WITHOUT
baseline NS5A polymorphisms
TN or PEG/RBV experienced WITH
baseline NS5A polymorphisms
TN or PEG/RBV experienced
PEG/RBV/PI experienced*
TN
PEG/RBV experienced
12 weeks
16 weeks + RBV
12 weeks
12 weeks + RBV
12 weeks
16 weeks + RBV
References: 1. Zepatier™ prescribing information. Merck & Co. Inc., 2016.
PEG=pegylated interferon; PI=HCV NS3/4A protease inhibitor; RBV=ribavirin; TN=treatment-naïve
*Patients who have failed treatment with pegylated interferon + ribavirin + HCV NS3/4A protease inhibitor: boceprevir, simeprevir
or telaprevir
Updated: 2/23/2017
Elbasvir/grazoprevir Initiation and Monitoring
Prior to initiating elbasvir/grazoprevir therapy, hepatic laboratory testing is recommended. NS5A resistance-associated
polymorphism testing is recommended for patients with HCV GT 1a. Additionally, test for evidence of HBV infection by measuring
HBsAg, anti-HBs, and anti-HBc.
Has the patient been diagnosed with HCV
genotype 1 or 4 and received quantitative HCV
RNA testing
Genotype 1a or 1b
No
Stop
No
Genotype 4:
TN: 12 weeks
PEG/RBV experienced: 16 weeks + RBV
16 weeks + RBV
T
TN:
12 weeks*
PEG/RBV experienced:
12 weeks*
PEG/RBV/ PI experienced**:
12 weeks + RBV
Obtain HCV RNA level 12 weeks after the end of treatment to determine sustained virological response (SVR
12)
anti-HBc= hepatitis B core antibody; anti-HBs= hepatitis B surface antibody; DAA= direct acting antiviral; HBsAg= hepatitis B surface
antigen; PEG= pegylated interferon; PI = HCV NS3/4A protease inhibitor; RBV= ribavirin; TN= treatment-naïve
*Genotype 1a TN or PEG/RBV experienced with baseline NS5A polymorphisms: elbasvir/grazoprevir therapy with RBV for 16 weeks is
recommended
**Patients who have failed treatment with pegylated interferon + ribavirin + HCV NS3/4A protease inhibitor: boceprevir, simeprevir
or telaprevir
Updated: 2/23/2017