New York State Medicaid Preferred Drug Program
Hepatitis C Protease Inhibitors Prior Authorization Worksheet
(Olysio™, Victrelis®)
Fax Number: (800) 268-2990
If your fax includes the standardized fax form, only the Member Name, ID, Date of Birth, and Clinical Criteria need to be
completed and faxed as an attachment to process your request
The Sovaldi Prior Authorization Worksheet must be used for all Sovaldi PA requests. If requesting Olysio in combination with
Sovaldi, please use the Sovaldi Prior Authorization Worksheet to initiate the PA request.
Enrollee Information
ENROLLEE NAME:
ENROLLEE MEDICAID ID NUMBER (2 LETTERS, 5 NUMBERS, 1 LETTER):
ENROLLEE DATE OF BIRTH:
Prescriber Information
PRESCRIBER NAME:
CONTACT PERSON:
10-DIGIT NPI NUMBER:
OFFICE PHONE NUMBER:
(
)
OFFICE FAX NUMBER:
-
(
)
-
Clinical Criteria
DIAGNOSIS (PLEASE CHECK ALL THAT APPLY):
CHRONIC HEPATITIS C INFECTION
HEPATOCELLULAR CARCINOMA AWAITING LIVER TRANSPLANTATION
HEPATITIS C VIRUS (HCV) GENOTYPE:
PLEASE PROVIDE PREVIOUS HCV THERAPY COMPLETED PRIOR TO THE DATE OF THIS REQUEST? (IF APPLICABLE):
DRUG:
DOSAGE FORM:
STRENGTH:
DIRECTION:
DRUG:
DOSAGE FORM:
STRENGTH:
DIRECTION:
DRUG:
DOSAGE FORM:
STRENGTH:
DIRECTION:
HOW MANY WEEKS OF PREVIOUS THERAPY HAVE BEEN COMPLETED PRIOR TO THE DATE OF THIS REQUEST?
BASELINE RNA LEVEL:
DATE TAKEN:
PLEASE PROVIDE HCV RNA LEVEL AT THE APPROPRIATE WEEK, BASED ON CURRENT THERAPY:
WEEK 4 HCV RNA LEVEL:
DATE TAKEN:
WEEK 8 HCV RNA LEVEL:
DATE TAKEN:
WEEK 12 HCV RNA LEVEL:
DATE TAKEN:
WEEK 24 HCV RNA LEVEL:
DATE TAKEN:
PLEASE CHECK THE BOX THAT BEST DESCRIBES THE PATIENT:
Treatment-naïve
Without cirrhosis
Compensated liver disease including cirrhosis
Decompensated liver disease.
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
Hepatitis C Protease Inhibitors
Prior Authorization Worksheet
Answer the following if requesting a nonpreferred Ribavirin product (Form Cannot be Processed without Required
Explanation):
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):
YOU WILL NEED TO COMPLETE ALL QUESTIONS IN ONLY ONE OF THE FOLLOWING THREE BOXES, and
then sign the attestation that follows.
TRIPLE THERAPY: OLYSIO, PEGINTERFERON, AND RIBAVIRIN
Olysio
STRENGTH:
DIRECTION:
Pegasys
Pegintron
STRENGTH:
DOSAGE FORM:
Ribavirin
Other
STRENGTH:
DIRECTION:
QUANTITY:
REFILLS:
DIRECTION:
QUANTITY:
QUANTITY:
REFILLS:
REFILLS:
Has the patient previously failed therapy with Incivek, Olysio, or Victrelis?
Yes
No
Has the patient previously failed therapy with Sovaldi?
Yes
No
Will the patient be on peginterferon and ribavirin in combination with Olysio?
Yes
No
Is HCV RNA ≤25 IU/mL at week 4?
Yes
No
Is HCV RNA ≤25 IU/mL at week 12?
Yes
No
Please note: Olysio efficacy in combination with peginterferon & ribavirin is substantially reduced in patients infected with HCV genotype
1a with an NS3 Q80K polymorphism. Screening for NS3 Q80K polymorphism is strongly recommended prior to initiation of therapy;
alternative therapy should be considered in patients with the polymorphism.
TRIPLE THERAPY: VICTRELIS, PEGINTERFERON, AND RIBAVIRIN
Victrelis
STRENGTH:
DIRECTION:
Pegasys
Pegintron
STRENGTH:
DOSAGE FORM:
Ribavirin
Other
STRENGTH:
DIRECTION:
QUANTITY:
REFILLS:
DIRECTION:
QUANTITY:
QUANTITY:
REFILLS:
REFILLS:
Has the patient previously failed therapy with Incivek, Olysio, or Victrelis?
Yes
No
Has the patient previously failed therapy with Sovaldi?
Yes
No
Will the patient be on peginterferon and ribavirin in combination with Victrelis?
Yes
No
Did the patient complete four consecutive weeks of therapy with ribavirin and peginterferon within 30 days of
the initial request?
Yes
No
Is HCV RNA undetectable at week 8 (= week 8 of peginterferon and week 4 of Victrelis)?
Yes
No
Is HCV RNA <100 IU/mL at week 12 (= week 12 of peginterferon and week 8 of Victrelis)?
Yes
No
Is HCV RNA undetectable at week 24 (= week 24 of peginterferon and week 20 of Victrelis)?
Yes
No
Please note: Merck has decided to voluntarily discontinue the manufacturing and distribution of Victrelis by December 2015. Merck
recommends that no new patients be initiated on Victrelis.
Revision Date: May 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.
Page 2
Magellan Medicaid Administration
Hepatitis C Protease Inhibitors
Prior Authorization Worksheet
DUAL THERAPY: PEGINTERFERON AND RIBAVIRIN
Pegasys
Pegintron STRENGTH:
Ribavirin
Other
STRENGTH:
DOSAGE FORM:
DIRECTION:
DIRECTION:
QUANTITY:
QUANTITY:
REFILLS:
REFILLS:
Will the patient be on ribavirin in combination with the Injectable Hepatitis C Agent?
Yes
No
Please check the box that demonstrates the patient’s response at week 12:
No early virologic response (EVR) [HCV RNA decreased < 2 log]
Partial EVR [HCV RNA decreased ≥2 log]
Complete EVR [HCV RNA negative]
Please check the box that demonstrates the patient’s response at week 24:
HCV RNA negative
HCV RNA positive
If requesting Injectable Hepatitis C treatment for genotype 2 or 3 beyond 24 weeks, please answer the following:
Does the patient have a comorbidity requiring adjustment to the expected duration of therapy for patients with genotype 2 and 3?
Yes
No
If yes, list comorbid condition(s):
If requesting Injectable Hepatitis C treatment beyond 48 weeks, please answer the following:
Has the patient demonstrated a delayed virologic response (partial EVR at week 12 and HCV RNA negative at week 24)?
Yes
No
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: May 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
Simeprevir (Olysio™)
Approved by the Food and Drug Administration (FDA) in November 2013, simeprevir is an oral HCV NS3/4A protease inhibitor for
use in combination with peginterferon alfa and ribavirin (PR) in chronic hepatitis C (CHC) genotype (GT) 1 or GT 4 infection including
CHC/HIV co-infected patients and those with cirrhosis.1 Simeprevir can also be used in combination with sofosbuvir (Sovaldi®) for
CHC GT1 infection including patients with cirrhosis.
Advantages of simeprevir
Simeprevir is taken once daily with food in combination with PR or sofosbuvir. Simeprevir is a direct acting antiviral (DAA) that
inhibits HCV NS3/4A, preventing the cleavage of viral polyproteins during HCV replication. In clinical trials, treatment duration was
determined by response-guided-therapy criteria. Primary endpoint was defined as undetectable HCV RNA (<25 IU/mL) at 12 weeks
post treatment (SVR12).
Phase III Trials:
Trial
Subjects
Treatment arm*
QUEST 1 and 22
(pooled analysis)
785
Treatment-naïve
PROMISE2
393
Treatment- experienced
SMV12+PR24/48
PR48 (control)
SMV12+PR24/48
PR48 (control)
Overall
SVR rate (%)
80%
50%
79%
37%
Genotype 1a
SVR rate (%)
Genotype 1b
SVR rate (%)
75%
47%
70%
28%
85%
53%
86%
43%
*By weeks on each component; SMV = simeprevir
The combination of simeprevir and sofosbuvir in HCV-infected patients (COSMOS) trial, a phase 2, randomized, open-label trial,
demonstrated the safety and efficacy of this treatment regimen.3
Cautions







Simeprevir efficacy in combination with PR is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K
polymorphism. Screening for NS3 Q80K polymorphism is strongly recommended prior to initiation of therapy; alternative
therapy should be considered in patients with the polymorphism due to reduced efficacy observed in clinical trials.
Simeprevir should not be used as monotherapy. Additionally the dose must not be reduced nor should treatment be
interrupted. Treatment with simeprevir must not be reinitiated in these patients.
Simeprevir should not be used if a patient has previously failed therapy that included simeprevir or another HCV NS3/4A
protease inhibitor (e.g., boceprevir or telaprevir).
Simeprevir should not be used in patients with severe hepatic impairment (Child-Pugh Class C).
If HCV RNA levels exceed 25 IU/mL at week 4, discontinuation of the treatment regimen is recommended.
Higher rates of rash (including photosensitivity), pruritus and nausea occurred in simeprevir-treated patients vs. patients
receiving PR alone. If a severe rash develops, simeprevir should be discontinued and not restarted.
Simeprevir is metabolized by cytochrome P450 (CYP) 3A; co-administration with a moderate or strong inducer or inhibitor of
CYP3A is not recommended. Simeprevir inhibits organic anion transporting polypeptide (OATP) 1B1/3 and P-glycoprotein (P-gp)
transporters; therefore, co-administration of drugs that are substrates for OATP1B1/3 and P-gp transporters may result in
increased plasma concentration of those drugs.
Where does simeprevir 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 among 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. Baseline genotype must be
established as simeprevir is approved for HCV GT 1 and GT 4. Whether simeprevir is given in combination with PR or sofosbuvir, it is
essential to assess response with HCV RNA viral load at treatment weeks 4 and 12 to determine duration of treatment. The goal of
treatment is undetectable HCV RNA 12 weeks post-treatment (SVR12).
References: 1. Simeprevir (Olysio) product information. Janssen Corporation, a subsidiary of Johnson & Johnson (J&J); 2014. 2. Data on file. Janssen Corporation, subsidiary of J&J; 2013.
3. Lawitz et al. Lancet 2014; 384:1756-65.
Revision Date: December 9, 2015
Simeprevir Initiation and Monitoring
Once patient readiness for CHC treatment has been determined, the algorithms below outline key decision points for initiating and
monitoring combination therapy including simeprevir. The algorithms are available on the NY MPEP website at:
http://nypep.nysdoh.suny.edu.
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 two methods of non-hormonal birth
control throughout treatment. Also note, HCV RNA testing should be conducted with a sensitive assay.
Algorithm 1: Simeprevir in combination with PR for Treatment-naïve, Prior Relapsers and Prior Non-responders and for
those CHC/HIV co-infected
Has the patient been diagnosed with HCV GT 1 or GT 4 without
NS3 Q80K polymorphism and received quantitative HCV RNA
testing?
No
Seek alternative treatment options or
conduct testing prior to treatment
Yes
Begin treatment with simeprevir 150 mg once daily with food in
combination with peginterferon alpha and ribavirin
No
Repeat quantitative HCV RNA at the end of treatment week 4
Stop treatment in all patients
Is HCV RNA ≤25 IU/ ml?
No further HCV RNA testing
Yes
Continue simeprevir with peginterferon alpha and ribavirin to
the end of treatment week 12
No
Repeat quantitative HCV RNA. Is HCV RNA≤25 IU/ ml?
Yes
Is the patient treatmentnaïve, including those with
cirrhosis?
OR
Is the patient a prior
relapser, including those
with cirrhosis?*
No
Is the patient a prior non-responder
(including partial and null responders)
including those with cirrhosis?**
Yes
Continue peginteferon alfa and ribavirin for additional 12 weeks
for total treatment duration of 24 weeks
Yes
Continue peginterferon alfa and
ribavirin for additional 36 weeks for
total treatment duration of 48
weeks***
Obtain HCV RNA 12 weeks after the end of treatment to determine sustained
virological response (SVR12)
*Prior relapser: undetectable HCV RNA at the end of prior interferon-based therapy and detectable HCV RNA during follow-up
**Prior partial responder: prior on-treatment ≥2 log10 IU/ml reduction in HCV RNA from baseline at Week 12 and detectable HCV RNA at end of prior
interferon-based therapy. Prior null responder: prior on-treatment <2 log10 reduction in HCV RNA from baseline at Week 12 during prior interferonbased therapy.
***If HCV RNA ≥25 IU/ml discontinue peginterferon alfa and ribavirin for non-responders (including partial and null responders).
Revision Date: December 9, 2015
Algorithm 2: Simeprevir in Combination with Sofosbuvir for Treatment-naïve and Treatment-experienced* Patients
Mono-Infected With or Without Cirrhosis
Has the patient been diagnosed with HCV genotype 1?
No
Seek alternative treatment
options or conduct testing
prior to treatment
Yes
Yes
Has the patient been diagnosed with cirrhosis?
Yes
No
Simeprevir 150 mg and sofosbuvir 400 mg
once daily with food for a total of 24 weeks
Simeprevir 150 mg and sofosbuvir 400 mg once
daily with food for a total of 12 weeks
Repeat quantitative HCV RNA at the end of
treatment week 4 and week 12
Repeat quantitative HCV RNA at the end of
treatment week 4
Is HCV RNA ≤25 IU/ ml?
Is HCV RNA ≤25 IU/ ml?
Is HCV RNA ≤25 IU/ ml?
No
Discontinue therapy
Yes
Continue therapy
Obtain HCV RNA 12 weeks after the end of treatment to determine sustained
virological response (SVR12)
*Treatment-experienced patients include prior relapsers, prior partial responders and prior null responders who failed prior peginterferon alfa therapy.
Revision Date: December 9, 2015