New York State Medicaid Preferred Drug Program
Harvoni® 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 Harvoni therapy?
Initiation
Continuation
Is the patient treatment-naïve with Harvoni?
If continuation of therapy, was the Harvoni 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
Harvoni® 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: November 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
Harvoni® 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:
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 Harvoni treatment regimen that is being prescribed:
Genotype(s)
Treatment-naïve patients without cirrhosis with baseline HCV RNA level
< 6 million IU/mL
8 weeks*
Treatment-naïve patients with or without cirrhosis
12 weeks
Treatment-experienced** patients without cirrhosis
12 weeks
Treatment-experienced** patients with cirrhosis
12 weeks†
Treatment-experienced** patients with cirrhosis
24 weeks
Treatment- naïve and treatment-experienced** patients with or without cirrhosis
12 weeks
1
4, 5, 6
Length of
Authorization
Patient Population
*Harvoni for 8 weeks can be considered in treatment naïve patients with genotype 1 infection without cirrhosis with baseline HCV RNA
less than 6 million IU/mL.
** Treatment-experienced includes patients who have failed a peginterferon alfa + ribavirin regimen with or without an HCV protease
inhibitor.
†Harvoni + ribavirin regimen for 12 weeks may be considered in treatment-experienced patients with genotype 1 infection with
cirrhosis.
For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in the table above.
Please provide dosing information for the treatment regimen selected above:
Harvoni
Ribavirin
Other Ribavirin Product
Other
Revision Date: November 2015
STRENGTH:
DIRECTION:
QUANTITY:
REFILLS:
STRENGTH:
DIRECTION:
QUANTITY:
REFILLS:
STRENGTH:
DIRECTION:
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 3
Magellan Medicaid Administration
Harvoni® 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 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 4
Ledipasvir/Sofosbuvir (Harvoni™)
Ledipasvir/sofosbuvir is the first combination pill approved for treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5, and 6
infection in adults1. Approved by the Food and Drug Administration (FDA) in October 2014, ledipasvir/sofosbuvir is a fixed dose
combination of 2 direct-acting antiviral agents against HCV and may be taken without ribavirin (RBV) or peginterferon (PEG). A
nucleotide analog, sofosbuvir interferes with the HCV life cycle by inhibiting HCV NS5B ribonucleic acid (RNA)-dependent RNA
polymerase to prevent replication of the HCV virus. Whereas, ledipasvir inhibits NS5A and interferes with viral replication.
Advantages of ledipasvir/sofosbuvir
Ledipasvir/sofosbuvir is taken orally once daily with or without food. 1 The treatment duration depends on prior treatment
experience and the presence or absence of cirrhosis (see below). The product can also be used for CHC/HIV co-infected patients.
Treatment experience is defined as patients who have failed treatment with either peginterferon plus ribavirin or peginterferon plus
ribavirin plus an HCV protease inhibitor. Published phase 3 trials have demonstrated the efficacy of ledipasvir/sofosbuvir in patients
with HCV genotype 1 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
ION-12
Population
GT 1 treatment-naïve
(including 15.7% (136/850) with cirrhosis)
ION-23
GT 1 treatment experienced
including 20.0% (88/440) with cirrhosis)
ION-34
GT 1 treatment-naive
Treatment
LDV/SOF
LDV/SOF + RBV
LDV/SOF
LDV/SOF + RBV
LDV/SOF
LDV/SOF + RBV
LDV/SOF
LDV/SOF + RBV
LDV/SOF
LDV/SOF + RBV
LDV/SOF
Duration
12 weeks
12 weeks
24 weeks
24 weeks
12 weeks
12 weeks
24 weeks
24 weeks
8 weeks
8 weeks
12 weeks
SVR12 Rates
99% (211/214)
97% (211/217)
98% (212/217)
99% (215/217)
94% (102/109)
96% (107/111)
99% (108/109)
99% (110/111)
94% (202/215)
93% (201/216)
95% (206/216)
GT=genotype; SOF = sofosbuvir; LDV = ledipasvir; RBV = ribavirin
Cautions





Coadministration of ledipasvir/sofosbuvir with amiodarone is not recommended due to risk of serious symptomatic bradycardia.
Ledipasvir/sofosbuvir should not be used with other products that contain sofosbuvir.
Ledipasvir is an inducer of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). In addition, ledipasvir and
sofosbuvir are substrates of P-gp and BCRP. Do not coadminister ledipasvir/sofosbuvir with potent P-gp inducers due to risk of
reduced ledipasvir/sofosbuvir concentrations and therapeutic effect.
For patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m 2), or end stage renal
disease, no dose recommendations are available.
Ledipasvir/sofosbuvir is pregnancy category B and should be used in pregnant women only if benefit justifies the risk to the
fetus. Safety and effectiveness of ledipasvir/sofosbuvir has not been established in pediatric patients and patients with
decompensated cirrhosis.
Where does ledipasvir/sofosbuvir 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.
Ledipasvir/sofosbuvir is a fixed dose combination product that contains 90mg of ledipasvir and 400mg of sofosbuvir in a single
tablet. The goal of treatment is undetectable HCV RNA at least 12 weeks post-treatment (SVR12).
Ledipasvir/Sofosbuvir treatment regimen and duration recommendations
Genotype
Genotype 1
Patient Population
Recommended Treatment Duration
Treatment naïve with or without cirrhosis*
12 weeks
Treatment experienced without cirrhosis
12 weeks
Treatment experienced with cirrhosis**
24 weeks
Genotype 4, 5, or 6
Treatment naïve or experienced with or without cirrhosis
12 weeks
*ledipasvir/sofosbuvir for 8 weeks can be considered in treatment-naïve GT 1 patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/ml
** ledipasvir/sofosbuvir with ribavirin for 12 weeks can be considered in treatment-experienced GT 1 patients with cirrhosis
For CHC/HIV co-infected patients follow the above dosing recommendations
References: 1. Harvoni™ prescribing information. Gilead Sciences, 2015. 2. Afdhal N, et al. N Engl J Med. 2014;370:1889-98. 3. Afdhal N, et al. N Engl J Med. 2014;370:1483-93. 4. Kowdley, K,
et al. N Engl J Med. 2014;370:1879-88.
Revision Date: November 13, 2015
Page 5
Ledipasvir/Sofosbuvir 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 be sure they are not pregnant prior to beginning treatment and should use 2 methods of nonhormonal birth control throughout treatment. Also note, HCV RNA testing should be conducted using a sensitive assay.
Has the patient been diagnosed with HCV genotype 1 and
received quantitative HCV RNA testing?
No
Genotype 4, 5
or 6
Yes
Begin treatment with
ledipasvir/sofosbuvir
for 12 weeks
Yes
Does the patient have
cirrhosis?
No
Is the patient treatmentnaïve?
No
Yes
Does the patient have pre-treatment
HCV RNA <6 million IU/mL?
No
Yes
Begin treatment with
ledipasvir/sofosbuvir for 12
weeks
Yes
Can consider treatment with
ledipasvir/sofosbuvir for 8 weeks
No
Is the patient treatment-naïve?
Begin treatment with
ledipasvir/sofosbuvir for 24 weeks OR
ledipasvir/ sofosbuvir with ribavirin
for 12 weeks
Yes
Obtain HCV RNA level 12 weeks after the end of treatment to
determine sustained virological response (SVR 12)
Revision Date: November 13, 2015
Page 6