Download Epclusa® Prior Authorization Worksheet for Prescribers

New York State Medicaid Preferred Drug Program
Epclusa® 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?
Has the patient had a baseline quantitative HCV RNA level completed?
Baseline quantitative HCV RNA ________ IU/mL
Date completed:
Yes
5
Yes
Yes
No
6
No
No
Hepatic laboratory testing completed at baseline?
Yes
No
Please check the box that best describes the patient’s cirrhosis status?
No cirrhosis
Compensated cirrhosis (Child-Pugh A)
Decompensated cirrhosis (Child-Pugh B or C)
Yes
Yes
Yes
No
No
No
Was screening for evidence of current or prior Hepatitis B virus (HBV) infection completed?
Yes
No
1
2
3
4
___________
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
No
TREATMENT HISTORY
Was the current Epclusa® 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 non-responder to:
Pegylated interferon + 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.
© 2016, Magellan Health Services, Inc. All Rights Reserved.
Magellan Medicaid Administration
Zepatier Prior Authorization Worksheet
Pegylated interferon + ribavirin + HCV protease inhibitor (telaprevir, boceprevir or simeprevir)
Other:
Yes
No
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 12 ( ±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:
HCV Genotype
Specific Patient Population with or without Cirrhosis
(if applicable)
Treatment
Regimen
Treatment
Duration
Epclusa
Epclusa
12 weeks
12 weeks
Epclusa + RBV
12 weeks
Epclusa
Epclusa
Epclusa + RBV
12 weeks
12 weeks
12 weeks
Preferred Regimens (Genotypes 2 and 3 only)
2,3
Patients without cirrhosis
2,3
Patients with compensated cirrhosis (Child-Pugh A)
2,3
Patients with decompensated cirrhosis (Child-Pugh B and C)
Non-Preferred Regimens (Genotype 1, 4, 5, 6)*
1, 4, 5, 6
1, 4, 5, 6
1, 4, 5, 6
Patients without cirrhosis
Patients with compensated cirrhosis (Child-Pugh A)
Patients with decompensated cirrhosis (Child-Pugh B and C)
A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease
*Please consider using another Hepatitis C Direct Acting Antivirals for Genotypes 1, 4, 5 and 6:
Harvoni (genotypes 1, 4, 5, and 6)
Technivie (genotype 4)
Viekira Pak/Viekira XR (genotype 1)
Zepatier (genotypes 1 and 4)
Please provide dosing information for the treatment regimen selected above:
Epclusa DIRECTIONS: 1 tablet daily with or without food
Ribavirin
Other Ribavirin Product
Other
Revision Date: November 2016
STRENGTH:
DIRECTIONS:
STRENGTH:
DIRECTIONS:
QUANTITY:
REFILLS:
QUANTITY:
REFILLS:
QUANTITY:
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.
REFILLS:
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 non-preferred 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
Sofosbuvir/Velpatasvir (Epclusa®)
Sofosbuvir/velpatasvir (Epclusa®) is the first fixed-dose combination drug approved for the treatment of chronic hepatitis C virus
(HCV) infection in genotypes 1, 2, 3, 4, 5, and 6.1 It is indicated for patients without cirrhosis or with compensated cirrhosis (ChildPugh A), and in patients with decompensated cirrhosis (Child-Pugh B or C) in combination with ribavirin (RBV).
Sofosbuvir/velpatasvir, a fixed-dose combination of 2 direct-acting antiviral (DAA) agents, received Food and Drug Administration
(FDA) approval in June 2016. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor. Velpatasvir is a pangenotypic HCV
NS5A inhibitor. Both compounds interfere with viral replication.
Advantages of sofosbuvir/velpatasvir
Sofosbuvir/velpatasvir is taken orally once daily, with or without food, in an adult patient.1 It is available in a fixed-dose combination
tablet containing 400 mg of sofosbuvir and 100 mg of velpatasvir. Treatment duration is 12 weeks for all patients with genotype
1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) or decompensated cirrhosis (Child-Pugh B
or C). The concurrent use of RBV is recommended in patients with decompensated cirrhosis (Child-Pugh B or C). Published phase 3
trials have demonstrated the efficacy of sofosbuvir/velpatasvir in patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection. The primary
endpoint was defined as HCV RNA less than the lower level of quantification (<25 IU/mL) at 12 weeks post-treatment (SVR12).
Published phase III trials:
Trial
Population
Treatment
Duration
SVR12 Rates
GT 1, 2, 4, 5, and 6
TN and TE, without cirrhosis or with
compensated cirrhosis
Epclusa®
12 weeks
99% (618/624)
ASTRAL-12
Placebo
12 weeks
0% (0/116)
GT 2
TN and TE, without cirrhosis or with
compensated cirrhosis
Epclusa®
12 weeks
99% (133/134)
SOF + RBV
12 weeks
94% (124/132)
Epclusa®
12 weeks
95% (264/277)
SOF + RBV
24 weeks
80% (221/275)
Epclusa®
12 weeks
83% (75/90)
Epclusa® + RBV
12 weeks
94% (82/87)
Epclusa®
24 weeks
86% (77/90)
ASTRAL-23
ASTRAL-33
ASTRAL-44
GT 3
TN and TE, without cirrhosis or with
compensated cirrhosis
GT 1, 2, 3, 4, and 6
TN and TE, with decompensated
cirrhosis (Child-Pugh B)
GT = genotype; RBV = ribavirin; SOF = sofosbuvir; SVR = sustained virologic response; TE = treatment-experienced subjects (including those who have failed a
peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor); TN = treatment-naive subjects.
Updated 2/22/2017
Cautions1
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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 (antiHBs) 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 post-treatment follow-up.
Coadministration of sofosbuvir/velpatasvir with amiodarone is not recommended due to risk of serious symptomatic
bradycardia.
Sofosbuvir/velpatasvir should not be used with other products that contain sofosbuvir.
Sofosbuvir/velpatasvir should not be used with P-glycoprotein (P-gp) inducers and/or moderate CYP inducers, including
rifampin, St. John’s wort, and carbamazepine. Coadministration would decrease concentrations of velpatasvir and/or sofosbuvir
and may potentially reduce therapeutic effect.
Velpatasvir is an inhibitor of drug transporters P-gp, breast cancer resistance protein (BCRP), organic anion-transporting
polypeptide (OATP) 1B1, OATP1B3, and OATP2B1. Coadministration of sofosbuvir/velpatasvir with drugs that are substrates of
these transporters may increase the exposure of such drugs.
Drugs, such as antacids, histamine-2 (H-2) receptor antagonists and proton pump inhibitors (PPI) that increase gastric pH may
decrease the concentration of velpatasvir.
For patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m 2) or end stage renal
disease, no dosing recommendations are available.
No dosage adjustment of sofosbuvir/velpatasvir is recommended for geriatric patients or patients with hepatic impairment. For
patients with decompensated cirrhosis, clinical and hepatic laboratory monitoring (including direct bilirubin) is recommended.
Sofosbuvir/velpatasvir itself has no contraindications. The sofosbuvir/velpatasvir + ribavirin combination is contraindicated in all
patients in which ribavirin is contraindicated.
No adequate human data are available to evaluate what risk sofosbuvir/velpatasvir poses to pregnancy outcomes, if any.
Ribavirin is Pregnancy Category X. Sofosbuvir/velpatasvir + ribavirin is contraindicated in pregnant women and male partners of
pregnant women.5
Safety and effectiveness of sofosbuvir/velpatasvir has not been established in pediatric patients, human immunodeficiency virus
(HIV) co-infected patients or liver transplantation recipients.
Where does sofosbuvir/velpatasvir fit into therapy and how should it be used?
In January 2014, The American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA)
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. 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). Sofosbuvir/velpatasvir is included in the guidelines and is recommended for patients with HCV genotype 1, 2, 3, 4, 5, or 6
infection that are either treatment-naïve or experienced. Additionally, the fixed-dose combination is an option for patients with
compensated or decompensated cirrhosis.
Sofosbuvir/velpatasvir treatment regimen and duration recommendations (per FDA-approved indications)1
HCV Genotype
1, 2, 3, 4, 5, 6
RBV = ribavirin
Updated 2/22/2017
Patient Population
Recommended
Treatment Duration
Treatment-naïve or experienced without cirrhosis
12 weeks
Treatment-naïve or experienced with compensated cirrhosis (Child-Pugh A)
12 weeks
Treatment-naïve or experienced with decompensated cirrhosis (Child-Pugh B or C)
12 weeks + RBV
References:
1. Sofosbuvir and velpatasvir (Epclusa®) [package insert]. Gilead Sciences, Inc. Foster City, CA; June 2016.
http://hcvadvocate.org/hepatitis/factsheets_pdf/epclusa_pi.pdf. Accessed July 1, 2016.
2. Feld JJ, Jacobson IM, Hézode C, et al. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. NEJM. 2015;373(27):2599-2607.
3. Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. NEJM. 2015;373(27):2608-2617.
4. Curry MP, O’Leary JG, Bzowej N, et al. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. NEJM. 2015;373(27):26182628.
5. Ribavirin (COPEGUS®) [package insert]. Roche Laboratories, Inc. Nutley, NJ; December 2002.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21511_Copegus_lbl.pdf. Accessed July 2, 2016.
Updated 2/22/2017
Sofosbuvir/Velpatasvir 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 combination therapy including sofosbuvir.
Note: Ribavirin is contraindicated in pregnancy; therefore all female patients of childbearing age (or female partners of male
patients) should ensure they are not pregnant prior to beginning treatment with ribavirin and should use 2 methods of non-hormonal
birth control throughout treatment. Also note that HCV RNA testing should be conducted using a sensitive assay.
Prior to initiating HCV DAA therapy, test all patients for evidence of HBV infection by measuring HBsAg, anti-HBs, and anti-HBc
Has the patient been diagnosed with HCV
genotype 1, 2, 3, 4, 5, or 6 and received
quantitative HCV RNA testing
NO
STOP
Yes
Without cirrhosis or
with compensated (Child Pugh A) cirrhosis:
sofosbuvir/velpatasvir 1 tablet daily
for 12 weeks
Decompensated (Child Pugh B or C) cirrhosis:
sofosbuvir/velpatasvir 1 tablet daily
with ribavirin for 12 weeks
Obtain HCV RNA level 12 weeks after the end of treatment
to determine sustained virologic response (SVR 12)
anti-HBc = hepatitis B core antibody; anti-HBs = hepatitis B surface antibody; DAA = direct acting antiviral; HBsAg = hepatitis B surface antigen
Updated 2/22/2017