Hepatitis C Policy Applicability Clinical Coverage Guidelines

Transcription

bmchp.org | 888-566-0008
wellsense.org | 877-957-1300
Clinical Coverage Guidelines
Hepatitis C
BMCHP refers to Boston Medical Center HealthNet Plan in Massachusetts and Well Sense Health Plan in
New Hampshire. Boston Medical Center HealthNet Plan and Well Sense Health Plan are trade names used by
Boston Medical Center Health Plan, Inc.
Policy Applicability
BMC HealthNet Plan
MassHealth
Commonwealth Care
Commercial
ConnectorCare/Qualified Health Plan (QHP)
Well Sense Health Plan
New Hampshire Medicaid
Effective Date: 11/12/2014
Policy Number: 9.123
Policy Effective Date: 09/08/2003
Last Review Date: 07/10/2014
Approved by: Pharmacy and Therapeutics Committee
Policy Owner/Title: Pharmacy Services
Summary
BMC HealthNet Plan may authorize coverage of specific medications used in the treatment of Hepatitis C
when appropriate criteria are met.
Description of Item or Service
Chronic Hepatitis C
This guideline provides information on BMC HealthNet Plan clinical criteria and claims adjudication processing guidelines. The use of this guideline is not a guarantee
of payment and will not determine how a specific claim(s) will be paid. Reimbursement is based on member benefits and eligibility, medical necessity review, where
applicable, coordination of benefits, adherence to Plan policies, clinical coding criteria, and the BMC HealthNet Plan agreement with the rendering or dispensing
provider. Reimbursement policies may be amended at BMC HealthNet Plan’s discretion. BMC HealthNet Plan will always use the most recent CPT and HCPCS coding
guidelines. All Plan policies are developed in accordance with state, federal and accrediting organization guidelines and requirements, including NCQA.
BMCHP refers to Boston Medical Center HealthNet Plan in Massachusetts and Well Sense Health Plan in New Hampshire. Boston Medical Center HealthNet Plan and Well Sense
Health Plan are trade names used by Boston Medical Center Health Plan, Inc.
BMC HealthNet Plan – Hepatitis C
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Treatment is indicated for patients with chronic hepatitis C, circulating HCVRNA who have elevated
aminotransferase levels, evidence of moderate to severe hepatitis (e.g. METAVIR score exhibiting bridging
fibrosis or cirrhosis), compensated liver disease, and are able to adhere to their treatment regimen. It is also
appropriate for patients with milder disease (e.g. milder histologic changes, normal aminotransferase) to be
offered therapy when it is determined that there is an urgency for treatment initiation. For patients who
choose to defer therapy, periodic laboratory and histologic monitoring should be arranged by their treating
physician.
The previous standard of care for treatment of chronic hepatitis C consisted of a combination of injectable
peginterferon (weekly) and oral ribavirin therapy (daily). This regimen is no longer recommended by the
American Association for the Study of Liver Diseases (AASLD) and the Infectious. Diseases Society of America
(IDSA) due to the low sustained virologic response (SVR) compared with newer regimens that include the use
of a Direct Acting Antivirals (DAAs).
The use of a DAA in combination with peginterferon and/or ribavirin is known to be a more effective regimen
than peginterferon/ribavirin alone. DAAs target the HCV life cycle directly, and they are FDA-approved for the
treatment of chronic hepatitis C in patients with compensated liver disease who are treatment naïve or have
failed previous therapy. Victrelis® (boceprevir) and Incivek® (telaprevir) are first generation DAAs and have SVR
rates of up to 75% in clinical trials compared to approximately 40% with peginterferon/ribavirin therapy
alone. Incivek® carries a Black Box warning regarding serious skin reactions including Stevens Johnson
Syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms and Toxic Epidermal Necrolysis. Fatal
cases have been reported in patients who continued to receive Incivek® combination treatment after serious
skin reaction was identified. If skin reaction is identified, the entire regimen of Incivek ®, peginterferon and
ribavirin should be discontinued immediately and the patient promptly referred for urgent medical care.
The second generation DAAs include OlysioTM (simeprevir) and Sovaldi® (sofosbuvir). OlysioTM is approved by
the FDA for the treatment of chronic hepatitis C genotype 1 in adult patients with compensated liver disease,
including cirrhosis. Use of OlysioTM in patients with moderate to severe hepatic impairment is not
recommended. OlysioTM is an HCV NS3/4A protease inhibitor and is approved in combination with
interferon and ribavirin. Screening patients with genotype 1a at baseline for the presence of the NS3 Q80K
polymorphism is strongly recommended when OlysioTM is used in combination with interferon and ribavirin.
Alternative regimens should be considered for patients that are Q80K polymorphism positive. OlysioTM has
not been studied in patients who have had a null response to regimens with a protease inhibitor (e.g,
boceprevir, telaprevir). As a result, OlysioTM is not recommended in patients whose hepatitis C was previously
treated with a protease inhibitor.
Sovaldi® is a nucleotide polymerase inhibitor that targets HCV NS5B RNA-dependent RNA polymerase. It
disrupts the viral replication process and has been shown to have activity against all hepatitis C genotypes,
including those resistant to protease inhibitors. Sovaldi® is approved in combination with peginterferon and
ribavirin for the treatment of genotypes 1 and 4. It is also approved as a dual regimen with ribavirin for
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genotypes 2 and 3, and for all chronic hepatitis C genotypes with hepatocellular carcinoma meeting Milan
criteria (awaiting liver transplantation). Sovaldi® can also be used in patients with HCV/HIV-1 co-infection.
The addition of a second generation DAA to peginterferon/ribavirin therapy provides a treatment option with
an SVR greater than 90%. It also potentially shortens treatment duration from 48 weeks traditionally down to
12 weeks, depending on the choice of the DAA agent and the patient’s HCV genotype. Currently, AALSD
guidelines recommend regimens with a second generation DAA as the first therapy choice for chronic
hepatitis C.
With the exception of a regimen using Sovaldi®, monitoring of HCVRNA levels during the treatment course
should be done to determine whether the patient has experienced an early virologic response (EVR), which
serves as a predictor of SVR. It is recommended that peginterferon/ribavirin therapy be discontinued in the
absence of an EVR, because the likelihood of an SVR in this circumstance is very low (0 – 3%). In addition,
patients on triple drug therapy including Incivek®, OlysioTM, or Victrelis®, require HCV-RNA monitoring to
determine treatment futility. It is recommended that a treatment regimen with Incivek® be discontinued in
patients with HCV-RNA levels ≥ 1000 IU/mL at treatment week 4 or 12 or if there is confirmed detectable HCVRNA at treatment week 24. The Victrelis® treatment regimen differs slightly in that discontinuation of therapy
is recommended in patients who have HCV-RNA levels ≥ 100 IU/mL at treatment week 12 or confirmed
detectable HCV-RNA at treatment week 12. For OlysioTM, treatment is to be stopped if HCV RNA > 25IU/ml at
week 4,12 or 24; AASLD guidelines recommend week 4 as the turning point to determine the appropriateness
of completing 24-week treatment for treatment naïve patients.
Data on treatment with the combination of Sovaldi® and OlysioTM used in genotype 1 has shown an
encouraging SVR of 90% on average. This dual regimen has not been approved by the FDA but the AASLD
guidelines do recommend Sovaldi® and OlysioTM with or without ribavirin in patients with genotype 1 who are
considered interferon ineligible (see table 1 for definition) and have not previously failed treatment with a
protease inhibitor.
Table 1: Definition of “interferon-ineligible”
9
Interferon Ineligible


Intolerance to interferon
Autoimmune hepatitis and other autoimmune disorders

Hypersensitivity to pegylated interferon or any of its components

Decompensated hepatic disease

Major uncontrolled depressive illness

Baseline neutrophil count < 1500/µL, baseline platelet count below 90,000/µL, or baseline hemoglobin < 10 g/dL

History of preexisting cardiac disease
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Similarly, the use of Sovaldi®and ribavirin without peginterferon is approved by the FDA, although the study
group is small. In light of safer and more effective interferon-free treatment options being available in the
near future, AASLD/IDSA has recommended reserving the above regimen for patients in immediate need for
chronic hepatitis C treatment.
®
Table 2: Recommended Treatment Duration – Incivek
Treatment naïve and prior relapse patients
HCV-RNA
Triple Therapy
Dual Therapy
Total Treatment
Duration
24 weeks
48 weeks
Undetectable at weeks 4 and 12
First 12 weeks
Additional 12 weeks
Detectable (≤ 1000 IU/mL) at weeks 4 First 12 weeks
Additional 36 weeks
and/or 12
Prior partial and null responder patients
All patients
First 12 weeks
Additional 36 weeks 48 weeks
Note: treatment-naïve patients with cirrhosis who have undetectable HCV-RNA at weeks 4 and 12 may
benefit from an additional 36 weeks of peginterferon/ribavirin.
®
Table 3: Recommended Treatment Duration - Victrelis
Assessment (HCV-RNA Results)
At Treatment
At Treatment
Week 8
Week 24
Previously
Undetectable
Undetectable
Untreated
Detectable
Undetectable
Previous Partial
Responders or
Relapsers
Undetectable
Detectable
Undetectable
Undetectable
Previous Null
Responders
Detectable or
Undetectable
Undetectable
Recommendation
Complete triple therapy regimen at week 28
1. Continue triple therapy through week 36; then
2. Continue peginterferon/ribavirin through week
48
Complete triple therapy at week 36
1. Continue triple therapy through week 36; then
2. Continue peginterferon/ribavirin through week
48
Complete triple therapy at week 48
Note: patients with compensated cirrhosis should receive 4 weeks of peginterferon/ribavirn followed by 44
®
weeks of Victrelis in combination with peginterferon/ribavirin
Table 4: Recommended Treatment Duration – Sovaldi
Recommendation
®
Combination with P* and R*
Combination with R*
Genotype 1, 3, 4
Complete triple therapy through week 12
Complete dual therapy through week 24
Genotype 2
Complete triple therapy through week 12
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All type,
hepatocellular
carcinoma awaiting
liver transplantation
n/a
or until liver transplant, whichever occurs
first
*: P= peginterferon, R= ribavirin
Table 5: Recommended Treatment Duration – Olysio
Recommendation
TM
Previously
Untreated
1.
2.
Continue triple therapy through week 12; then
Continue peginterferon/ribavirin through week 24
Previous nonresponders
1.
2.
Continue triple therapy through week 12; then
Continue peginterferon/ribavirin through week 48
Due to the side effects and contraindications associated with peginterferon and ribavirin therapy, candidates
for therapy must be carefully screened and monitored throughout their course of therapy. Contraindications
to therapy include decompensated cirrhosis, pregnancy, uncontrolled depression or severe mental illness,
active substance abuse in the absence of concurrent participation in a drug treatment program, advanced
cardiac or pulmonary disease, severe cytopenias, poorly controlled diabetes, retinopathy, seizure disorders,
immunosuppressive treatment, autoimmune diseases, or other inadequately controlled comorbid conditions.
The table below lists common side effects associated with interferon and ribavirin.
Table 6: Common side effects associated with interferon and ribavirin therapy
Interferon
Ribavirin
Flu like symptoms, bone marrow suppression,
Hemolytic anemia, chest congestion, dry cough,
emotional effects, autoimmune disorders, hair
dyspnea, pruritis, sinus disorders, rash, gout,
loss, rash, diarrhea, sleep disorders, visual
nausea, diarrhea, teratogenicity
disorders, weight loss, seizures, hearing loss,
pancreatitis, interstitial pneumonitis, injection site
reactions
HIV Co-Infection
Special consideration does need to be given to those members who are co-infected with HIV, as a number of
antitretroviral agents do interact with Sovaldi® and OlysioTM. Please refer to table 6 for allowable antiretroviral
therapies for patients with HIV who are being treated with Sovaldi® and/or Olysio TM for hepatitis C.
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Table 7: Allowed Antiretroviral Therapy in Patients with Hepatitis C Taking Sovaldi® and Olysio
Hepatitis C Agent
Allowable Antiretroviral Therapy in Patients with HIV
Sovaldi®
All antiretroviral agents can be used EXCEPT
Olysio
TM

Didanosine

Zidovudine

Tipranavir
TM
LIMIT antiretroviral therapy to the following agents:
 Raltegravir
 Rilpivirine
 Maraviroc
 Enfuvirtide
 Tenofovir
 Emtricitabine
 Lamiviudine
 Abacavir
Acute Hepatitis C
Patients with acute Hepatitis C have a high risk of developing chronic Hepatitis C. For this reason, it is
recommended that patients diagnosed with acute Hepatitis C be considered for treatment with interferon
based therapy. Response rates are higher in treatment of acute hepatitis C (83% to 100%) than in chronic
hepatitis C and the rate of spontaneous viral resolution in these patients is less than 50%. Since some
patients will spontaneously clear the virus, treatment may be delayed for 8-12 weeks to allow for spontaneous
resolution. Current recommendations for interferon therapy are for at least 12 weeks with consideration of
24 weeks. There are no recommendations at this time for either addition or omission of ribavirin.
Clinical Guideline Statement
The Plan may authorize coverage of specific hepatitis C products for members meeting the following criteria:
Policy Applicability by Product
Medication
®
Incivek
Infergen
TM
Olysio
Pegasys
MassHealth
X
BMC Health Plan
CWC
COMM
X
X
QHP
X
X
X
X
X
X
X
X
X
X
X
X
X
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Medication
Peg-Intron
®
Rebetol sol
Brand name* ribavirin convenience pack
®
Sovaldi
BMC Health Plan
CWC
COMM
X
X
X
X
MassHealth
X
X
X
X
X
X
X
X
®
X
X
X
Victrelis
NF=non-formulary
*= brand name with interchangeable generic available will be reviewed under mandatory generic policy
QHP
X
X
NF
X
X
Prior Authorization- (Duration of approval- see Appendix A)
Chronic Hepatitis C
Approval Criteria- Chronic Hep C
All requests for chronic hepatitis C regimen require the documentation of all the
following:

Medication is prescribed by or in collaboration with a gastroenterologist,
hepatologist, or infectious disease specialist

A diagnosis of hepatitis C with detectable hepatitis C viral load

Absence of decompensated liver disease

Member has not abused illicit substances, narcotics, or alcohol for at least 6 months

Absence of untreated depression

Absence of drug-drug interactions with or contraindications to requested hepatitis C
regimen

Presence of cirrhosis or bridging/moderate to severe fibrosis stage >3 defined by
histologic scoring system* (e.g. METAVIR), fibrosis markers* (e.g. FibroTest), or
radiologic tests*; OR
HIV co-infection with nonsuppressable HIV viral load or with elevated MELD scores;
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OR
There is urgency for treatment such as: need for hepatotoxic treatment or
immunosuppression**, and extra-hepatic complications associated with HCV**

An assessment has been conducted demonstrating the member’s readiness and
likelihood of success with treatment. At a minimum, the assessment must indicate
the following:
o No history of medication and appointment non-adherence; AND
o No history of treatment failure with prior hepatitis C treatment due to nonadherence; AND
o Member has been or will be enrolled in a compliance monitoring program
offered by the prescriber or Plan’s preferred specialty pharmacy hepatitis
care management program; AND
o Other barriers to treatment completion have been addressed
Documentation of the following is also required for continuation after an initial authorization:

Medication adherence, as evidenced by pharmacy claims and/or office notes; AND

Documentation of office visit and lab work adherence
* Copy of scores or images required
** specific treatment and complication description required
In addition to the above, requests for each regimen below may be approvable when the
following criteria are met. Limitations apply (see section on Limitations).
Triple Therapy – Sovaldi/pegylated interferon/ribavirin
1. A diagnosis of HCV with genotype 1 or 4; OR
A diagnosis of HCV with genotype 2 or 3; AND
Documented treatment history of null/partial responders; AND
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Documentation that the addition of peginterferon outweighs the potential benefit
associated with the dual therapy of Sovaldi® in combination with ribavirin; AND
2. If member has HIV: antiretroviral regimen does not include didanosine, zidovudine, or tipranavir
Dual Therapy – Sovaldi/Olysio
1. A diagnosis of HCV with genotype 1; AND
2. No previous exposure to a HCV protease inhibitor (boceprevir, telaprevir, or Olysio);
AND
3. Documentation that the member is interferon ineligible (refer to table 1 for
definition of “interferon ineligible”); AND
4. The risk of deferring treatment outweighs the benefit; AND
5. If member has HIV: antiretroviral regimen is LIMITED to raltegravir, rilpivirine,
maraviroc, enfuvirtide, tenofovir, emtricitabine, lamivudine, and abacavir
Dual Therapy – Sovaldi/ribavirin
Documentation that the member is interferon ineligible (refer to table 1 for
definition of “interferon ineligible”); AND
Documentation of clinical rationale why dual therapy with Sovaldi/ribavirin
outweighs the potential benefit of Sovaldi/Olysio combination (e.g., member has
drug-drug interactions with Olysio, had a null response to a hepatitis C protease
inhibitor); AND
If member has HIV: antiretroviral regimen does not include didanosine, zidovudine,
or tipranavir; OR
Documentation that member is interferon ineligible (refer to table 1 for definition
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of “interferon ineligible”); AND
or tipranavir; OR
3. A diagnosis of HCV with genotype 2 or 3; AND
or tipranavir; OR
4. A diagnosis of HCV with any genotype with hepatocellular carcinoma awaiting liver
transplantation; AND
or tipranavir
Triple Therapy – Olysio/pegylated interferon/ribavirin
Initial Therapy
1. A diagnosis of HCV with genotype 1 monoinfection; AND
2. Absence of NS3 Q80K polymorphism; AND
3. No previous history of using a regimen inclusive of HCV protease inhibitors (i.e.,
Incivek®, Olysio™, Victrelis®); AND
4. Documented treatment history of treatment naïve, null/partial responders, or
relapsers; AND
5. If member has HIV: antiretroviral regimen is LIMITED to raltegravir, rilpivirine,
maraviroc, enfuvirtide, tenofovir, emtricitabine, lamivudine, and abacavir.
Continued Therapy
1. A HCV-RNA level of <25 IU/ML at treatment week 4
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Extended Therapy (for null and partial responder only)
Additional Therapy (for null and partial responder only)
Triple Therapy – Incivek/pegylated interferon/ribavirin
Initial Therapy
relapsers.
Continued Therapy
1. A HCV-RNA level of ≤ 1000 IU/ML at treatment week 4
Extended Therapy
1. A HCV-RNA level of ≤ 1000 IU/ML at treatment week 4 and/or 12, or is a prior
partial or null responder; AND
2. An undetectable HCV-RNA level at treatment week 24
Triple Therapy – Victrelis/pegylated interferon/ribavirin
Initial Therapy
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relapsers.
Continued Therapy
Extended Therapy (for null and partial responder only)
1. A detectable or undetectable HVC-RNA level at treatment week 8, or is a nullresponder (< 2 log drop at treatment week 12 from baseline), or a poor responder
(< 1 log drop at treatment week 4 from baseline) with previous
peginterferon/ribavirin therapy; AND
2. An undetectable HCV-RNA level at treatment week 24
Acute Hepatitis C
Approval Criteria- Acute Hep C
Pegylated Interferon with or without ribavirin
1. A diagnosis of acute HCV with any genotype
Brand name ribavirin convenience pack
Approval Criteria- brand name ribavirin
Documentation of the following:
1. The above criteria for dual or triple therapy have been met; AND
2. A failed trial of individually prescribed generic ribavirin due to poor compliance
Note: brand name with interchangeable generic available will be reviewed under mandatory generic policy
Rebetol® Solution
Approval Criteria- Rebetol® Solution*
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Approval Criteria- Rebetol® Solution*
Documentation of the following:
1. The above criteria for dual or triple therapy have been met; AND
2. Swallowing difficulties due to a clinical condition
Note: Rebetol® Solution does not require PA for members less than or equal to 12 years of age.
Appendix A
Chronic Hepatitis C
tm
Sovaldi / Ribavirin
Initial Therapy
Continuation Therapy
Approval Duration (Note: total treatment duration in parentheses)
Ribavirin
Sovaldi®
Diagnosis of chronic hepatitis C genotype 1, 3, 4
up to 8 weeks
up to 16 weeks (24 weeks)
Diagnosis of chronic hepatitis C genotype 2
up to 8 weeks
up to 8 weeks
Initial Therapy
up to 8 weeks
Continuation Therapy (beyond 12
weeks)—Member is cirrhotic and
treatment experienced(Documentation
demonstrating cirrhosis and previous
treatment is required)
All Diagnosis of chronic hepatitis C genotype, hepatocellular carcinoma awaiting liver transplantation
Initial Therapy
up to 8 weeks
up to 8 weeks
up to 40 weeks or transplant date,
up to 40 weeks or transplant date,
whichever is shorter; continuation
whichever is shorter; continuation
therapy will be approved in 8 week
therapy will be approved in 8 week
increments (up to 48 weeks total)
increments (up to 48 weeks total)
TM
TM
Sovaldi®/Olysio
Olysio
Sovaldi®
Initial Therapy
up to 8 weeks
up to 8 weeks
Sovaldi®/Peginterferon/Ribavirin
Peginterferon/Ribavirin
Sovaldi®
Initial Therapy
up to 8 weeks
up to 8 weeks
TM
TM
Olysio /Peginterferon/Ribavirin
Olysio
Initial Therapy
up to 6 weeks
up to 6 weeks
Continued Therapy
Treatment naïve or relapser
Null or partial responders
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Chronic Hepatitis C
Approval Duration (Note: total treatment duration in parentheses)
Extended Therapy (null or partial responders only)
Additional Therapy (null or partial responders only)
Up to 22 weeks (48 weeks)
Incivek®/Peginterferon/Ribavirin
Initial Therapy
up to 8 weeks
Continued Therapy
Extended Therapy
Victrelis®/Peginterferon/Ribavirin
Initial Therapy
up to 14 weeks
Continued Therapy
Extended Therapy Treatment Naïve
Undetectable at TW 8
Detectable at TW 8
Extended Therapy Partial/Relapsers
Undetectable at TW 8
Detectable at TW 8
Extended Therapy Null Responder/Poor Responder
Acute Hepatitis C
Not approvable
Not approvable
®
Incivek
up to 8 weeks
Not approvable
®
Victrelis
up to 14 weeks
Approval Duration
Peginterferon w/ or w/o Ribavirin
up to 24 Weeks
Diagnosis of chronic hepatitis C genotype 2, 3, 4
Up to 12 weeks
Initial Therapy
Initial Therapy
Appendix B
Fibroscan
2.5-7 kPa
Mild or absence of fibrosis
7-12 kPa
F2
>12.5 kPa
F3-F4
METAVIR
F0
No fibrosis
F1
Portal fibrosis without septa
F2
Portal fibrosis with few septa
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F3
numerous septa w/o cirrhosis
F4
Cirrhosis
Fibrotest METAVIR proposed conversion
Fibrotest
METAVIR
0.00-0.21
F0
0.22-0.27
F0-F1
0.28-0.31
F1
0.32-0.48
F1-F2
0.49-0.58
F2
0.59-0.72
F3
0.73-0.74
F3-F4
0.75-1
F4
Limitations
The Plan will not approve coverage of the above treatment of Hepatitis C in the following instances:






Diagnoses not listed in the policy
When the above criteria have not been met.
Members < 3 years of age for peginterferon
Members < 18 years of age for Victrelis®, Incivek®, Sovaldi® and OlysioTM
Infergen® or any regimen combination (or monotherapy) not addressed with specific approval criteria
in the policy
Member is pregnant

Request for the same regimen that has been failed previously
Clinical Background Information and References
1. Chopra S. Overview of the management of chronic hepatitis C virus. Up to Date®. Last updated Dec 3, 2013,
accessed Feb 09, 2014. Available from: http://www.uptodate.com.
2. Chopra S. Treatment regimens for chronic hepatitis C virus Diagnosis of chronic hepatitis C genotype 1. Up to
Date®. Last updated Dec 19, 2013, accessed Feb 09, 2014. Available from: http://www.uptodate.com.
15 of 17
3. Chopra S. Treatment regimens for chronic hepatitis C virus Diagnosis of chronic hepatitis C genotypes 2, 3, and 4.
Up to Date®. Last updated Feb 12, 2014, accessed Feb 26, 2014. Available from: http://www.uptodate.com.
4. American gastroenterological association medical position statement on the
management of hepatitis C. Gastroenterology 2006;130:225-230.
5. Incivek® [package insert]. Cambridge (MA): Vertex Pharmaceuticals Incorporated; Apr 2013.
6. Victrelis® [package insert]. Whitehouse Station (NJ): Schering Corporation, a subsidiary of Merck & Co. Inc.; Feb
2013.
7. Sovaldi® [package insert]. Foster City (CA): Gilead Science, Inc.; Dec 2013.
8. OlysioTM [package insert]. Titusville (NJ): Janssen Therapeutics, LP; Nov 2013.
9. Recommendations for Testing, Managing, and Treating Hepatitis C. American Association for the Study of liver
Disease (AASLD) practice guidelines. Accessed June 10, 2014. Available from http://www.aasld.org
10. Doris N., Jayant T. noninvasive assessment of Liver Fibrosis. Diagnostic and Therapeutic Advances in
Hepatology. Accessed Mar 13, 2014. Available from http://www.aasld.org
11. Xin Sun, PhD, Carrie D Patnode, PhD, MPH, et al. Interventions to Improve Patient Adherence to Hepatitis C
Treatment Comparative Effectiveness. Comparative Effectiveness Reviews, No 91. Agency for Healthcare
Research and Quality(US); Dec 2012. Accessed Mar 10, 2014. Available from: http://www.ncbi.nlm.nih.gov.
12. Michael P C., MD et al. Tests used for the noninvasive assessment of hepatic fibrosis. Up to Date®. Last updated
Dec 3, 2013, accessed Mar 11, 2014. Available from: http://www.uptodate.com
Policy History
Effective Date: 09/08/2003
Review Dates
Dates of Review/Revision:
7/14/2005 - Added additional criteria to the “Clinical Coverage Criteria”, and approvable Hepatitis B criteria for
treatment.
9/12/2005 - Added approvable criteria for non-Hepatitis indications.
9/27/2007 - P&T Annual review, -Specialty requirements for prescribers removed, -Lower age limit added for
interferon/ribavirin therapy, -Title changed from, “Hepatitis” to Hepatitis C”, -Criteria for non-Hepatitis C indications
removed,
07/10/2008 - P&T Annual Review, no changes required.
07/09/2009 - P&T Annual Review, criteria added for extended therapy for “slow responders”, criteria added for acute
hepatitis C
07/08/2010 - P&T Annual Review, no changes required
07/14/2011 - P&T Annual Review, criteria added for Victrelis®, Incivek®, Ribapak® Pak, and Rebetol®, policy applied to
Commercial
07/12/2012 - P&T Annual Review, modified criteria language for Ribapak® Pak, and Rebetol®
16 of 17
7/11/2013 – P&T Annual Review, increased initial treatment duration for all components of Incivek® triple therapy to 8
weeks, included black box warning for Incivek® into background information, modified criteria and treatment duration
for Victrelis® triple therapy for patients with compensated cirrhosis, minor formatting changes throughout.
12/13/2013 – Policy applied to ConnectorCare/Qualified Health Plan (QHP)
03/13/2014- P&T Annual Review, added criteria for Sovaldi and Olysio, removed section for dual therapy of
peginterferon in combination with ribavirin, and section for monotherapy of interferon alfacon (case by case review
since these are no longer recommended by AASLD; added general coverage requirements and limitations applicable to
all hepatitis C regimen request
Last Review/Revision Date: 07/10/2014 – P&T Annual Review. Defined interferon ineligibility, added criteria for Sovaldi
and Olysio combination, added continuation criteria and adjusted approval durations for initial and continuation criteria,
added criteria regarding antiretroviral drug-drug interactions for Sovaldi and Olysio, added extended approval criteria
for Sovaldi and ribavirin in genotype 2 with cirrhotic treatment experienced patients, added a time frame of 6 months
for absence of substance/alcohol abuse, added requirement of no history of medication and appointment
nonadherence for initial approval criteria, added pregnancy as a limitation
Next Review Date: 07/09/2015
Approval Dates
Regulatory Approval: N/A
Internal Approval: Initial approval by Pharmacy & Therapeutics Committee – September 08, 2003
Authorizing Entity: P&T Committee
Important Notes:
 Not all services are covered for all products or employer groups. This medical policy expresses the Plan's
determination of whether certain services or supplies are medically necessary, experimental or investigational
or cosmetic. The Plan has reached these conclusions based upon the regulatory status of the technology and a
review of clinical studies published in peer-reviewed medical literature. Even though this policy may indicate
that a particular service or supply is considered covered or not covered, this conclusion is not based upon the
terms of a member’s particular benefit plan. Each benefit plan contains its own specific provisions for coverage
and exclusions. Not all services that are determined to be medically necessary will necessarily be covered
services under the terms of a member’s benefit plan. Members and their providers need to consult the
applicable benefit plan document (e.g., Evidence of Coverage) to determine if there are any exclusions or other
benefit limitations applicable to this service or supply. If there is a discrepancy between this medical policy and
the benefit plan document, the provisions of the benefit plan document will govern. In addition, this policy and
the benefit plan document are subject to applicable state and federal laws that may mandate coverage for
certain services and supplies.
17 of 17

Hepatitis C Policy Applicability Clinical Coverage Guidelines

Transcription

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