Download Peginterferon and Ribavirin Combination Therapy with/without

New York State Medicaid Preferred Drug Program Fax Number: (800) 268-2990
Peginterferon and Ribavirin Combination Therapy with/without Olysio™ Prior Authorization Worksheet
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
If requesting Olysio in combination with Sovaldi, please use the Sovaldi Combination Therapy 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:
DIRECTIONS:
DRUG:
DOSAGE FORM:
STRENGTH:
DIRECTIONS:
DRUG:
DOSAGE FORM:
STRENGTH:
DIRECTIONS:
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.
© 2016, Magellan Health, Inc. All Rights Reserved.
Magellan Medicaid Administration
Peginterferon and Ribavirin Combination Therapy with/without Olysio
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):
COMPLETE ALL QUESTIONS IN ONLY ONE OF THE FOLLOWING TWO BOXES
TRIPLE THERAPY: OLYSIO, PEGINTERFERON, AND RIBAVIRIN
Olysio
STRENGTH:
DIRECTIONS:
Pegasys
STRENGTH:
DOSAGE FORM:
STRENGTH:
DIRECTIONS:
Ribavirin
Other
QUANTITY:
DIRECTIONS:
QUANTITY:
REFILLS:
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
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
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.
DUAL THERAPY: PEGINTERFERON AND RIBAVIRIN
Pegasys
Ribavirin
Other
STRENGTH:
DOSAGE FORM:
STRENGTH:
DIRECTIONS:
DIRECTIONS:
QUANTITY:
QUANTITY:
REFILLS:
REFILLS:
Will the patient be on ribavirin in combination with the Injectable Hepatitis C Agent?
Yes
No
Yes
No
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?
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)?
Revision Date: November 2016
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
Peginterferon and Ribavirin Combination Therapy with/without Olysio
Prior Authorization Worksheet
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
Simeprevir (Olysio®)
Approved by the Food and Drug Administration (FDA) in November 2013, simeprevir is an oral hepatitis C virus (HCV) NS3/4A
protease inhibitor intended for use in combination with peginterferon alfa and ribavirin (PR) for genotype (GT) 1- or 4-infected
patients or in combination with sofosbuvir in HCV GT 1-infected patients.1
Advantages of simeprevir
Simeprevir is taken once daily with food in combination with PR or sofosbuvir (Sovaldi®).1 Simeprevir is a direct acting antiviral (DAA)
agent that inhibits HCV NS3/4A, preventing the cleavage of viral polyproteins during HCV replication. Use of simeprevir in
combination with PR or sofosbuvir has been shown to increase rates of sustained virologic response (SVR) in both treatment-naïve
and treatment-experienced patients with or without cirrhosis. In phase III trials, the 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; PR=peginterferon alfa and ribavirin; 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 when administered for 12 or 24 weeks. 3
Cautions
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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.
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.
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 is not recommended for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Hepatic
laboratory testing before and during therapy is recommended. Therapy should be discontinued if an elevation in bilirubin is
accompanied by liver transaminase increases or clinical signs and symptoms of hepatic decompensation.
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.
Symptomatic bradycardia can occur when simeprevir is co-administered with sofosbuvir and amiodarone. The combination is
not recommended, but if the combination cannot be avoided cardiac monitoring is recommended.
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 HCV as newer HCV DAA agents become available and treatment evidence emerges. There are no comparative efficacy
data available to date among the HCV DAA agents, but it is likely that guidelines for optimal regimens will continue to evolve.
Updated: 3/15/17
Patient-specific factors and economic factors must be taken into consideration when deciding to initiate therapy. The goal of
treatment is undetectable HCV RNA at SVR12.
Olysio® treatment regimen and duration recommendations:
Simeprevir and sofosbuvir for mono-infected patients with HCV GT 1 infection1
GT 1 TN and TE*
Treatment regimen and duration
Without cirrhosis
simeprevir + sofosbuvir for 12 weeks
With cirrhosis
simeprevir + sofosbuvir for 24 weeks
GT=genotype; TN=treatment naïve; TE=treatment experienced; *treatment experienced patients include prior relapsers, prior partial responders, and prior null
responders who failed pegylated interferon-based therapy
Simeprevir and PR therapy in patients with HCV GT 1 or 4 infection1
GT 1 or 4 infection
Treatment regimen and duration
TN patients and prior relapsers*
Without cirrhosis and with/without HIV co-infection OR with cirrhosis
and without HIV co-infection
Simeprevir + PR for 12 weeks FOLLOWED by an additional 12 weeks of PR
(for a total treatment duration of 24 weeks)
With cirrhosis and with HIV co-infection
Simeprevir + PR for 12 weeks FOLLOWED by an additional 36 weeks of PR
(for a total treatment duration of 48 weeks)
Prior non-responders (including partial§ and null responders¥)
With/without cirrhosis and with/without HIV co-infection
Simeprevir + PR for 12 weeks FOLLOWED by an additional 36 weeks of PR
(for a total treatment duration of 48 weeks)
GT=genotype; HIV=human immunodeficiency virus; PR=peginterferon alfa + ribavirin; TN=treatment naïve
*Prior relapse=HCV RNA not detected at the end of prior peginterferon alfa therapy and HCV-RNA detected during follow-up
§Prior partial responder=prior on-treatment ≥2 log10 HCV RNA reduction from baseline at week 12 and HCV RNA detected at end of pegylated interferon therapy
¥Null responder=prior on-treatment ≥2 log10 HCV RNA reduction from baseline at week 12 during prior pegylated interferon therapy
References: 1. Simeprevir (Olysio®) product information. Janssen Corporation, a subsidiary of Johnson & Johnson (J&J); 2016. 2. Data on file. Janssen Corporation,
subsidiary of J&J; 2013. 3. Lawitz et al. Lancet 2014; 384:1756-65.
Updated: 3/15/17
Simeprevir Initiation and Monitoring
Once patient readiness for chronic HCV treatment has been determined, the algorithms below outline key decision points for
initiating and monitoring combination therapy including simeprevir. Additionally, test for evidence of HBV infection by measuring
HBsAg, anti-HBs, and anti-HBc.
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 and should use 2 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
Has the patient been diagnosed with HCV GT 1 without NS3
Q80K polymorphism or GT 4 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 PR for 12 weeks
Repeat quantitative HCV RNA at the end of treatment week 4.
Is HCV RNA ≤25 IU/ml?
Yes
Is the patient treatment naïve or a prior relapser* without
cirrhosis and with/without HIV co-infection OR with cirrhosis and
without HIV co-infection?
No
Is the patient a prior non-responder**
including those with/without cirrhosis
and with/without HIV co-infection OR
treatment naïve or a prior relapser
with cirrhosis and HIV co-infected?
Yes
Continue PR for additional 12 weeks for total treatment duration
of 24 weeks
Yes
Continue PR for additional 36 weeks
for total treatment duration of 48
weeks
Obtain HCV RNA 12 weeks after the end of treatment to determine SVR12
GT=genotype; HIV=human immunodeficiency virus; PR=peginterferon alfa + ribavirin; SVR12=sustained virological response
*Prior relapse=undetectable HCV RNA at the end of prior interferon-based therapy and detectable HCV RNA during follow-up
**Non-responder includes partial (prior on- treatment ≥2 log 10 HCV RNA reduction from baseline at week 12 and HCV RNA detected at end of pegylated interferon therapy)
and null responder (prior on-treatment ≥2 log 10 HCV RNA reduction from baseline at week 12 during prior pegylated interferon therapy)
Updated: 3/15/17
Algorithm 2: Simeprevir in combination with sofosbuvir for treatment-naïve and treatment-experienced* patients
mono-infected with genotype 1
Has the patient been diagnosed with HCV GT 1 and is not HIV coinfected?
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 ≤ 25 IU/mL?
No
Discontinue therapy
Continue therapy
Obtain HCV RNA 12 weeks after the end of treatment to determine SVR12
GT=genotype; SVR12=sustained virological response
*Treatment experienced patients include prior relapsers, prior partial responders and prior null responders who failed prior peginterferon alfa therapy.
Updated: 3/15/17