BlueCross and BlueShield of Montana Medical Policy/Codes
Pegylated Interferon Therapy
Chapter: Drugs - Medical Benefit
Current Effective Date: November 26, 2013
Original Effective Date: November 26, 2013
Publish Date: August 26, 2013
Description

Interferons are a family of naturally occurring proteins that are produced by the immune system.  There are three classes of interferons—alfa, beta, and gamma.  Interferons assist the immune system’s attack on viruses and other foreign substances, help healthy cells defend themselves, and stop the virus from multiplying.  Peginterferon is a man-made interferon that has been “pegylated.”  Pegylation is a process in which one or more chains of polyethylene glycol (PEG) are attached to an interferon molecule; this allows the peginterferon to survive longer in the human body.  This added time in the body appears to be responsible for a higher rate of sustained virologic response (SVR) in patients whose hepatitis C virus (HCV) was treated with pegylated interferon as compared to those treated with nonpegylated interferon. 

Interferon alfa has been considered the only effective treatment of HCV.  A total of 40% of patients will show an initial response to interferon alfa, but most patients relapse soon after stopping treatment.  Ribavirin, a synthetic nucleoside analogue with antiviral activity, has also been investigated as a treatment of HCV.  Currently, oral ribavirin, in combination with interferon alfa, has received approval from the U.S. Food and Drug Administration (FDA) for treatment of HCV that has relapsed after initial treatment with interferon alfa alone and recently as a first-line therapy of HCV.  A pegylated form of interferon, designed to have a longer duration of action permitting once weekly dosing, has also received FDA approval for the treatment of HCV.

The standard of care for patients with HCV infection has been peginterferon alfa and ribavirin taken for 48 weeks.  Less than 50 percent of patients respond to this therapy.  In May 2011, the FDA approved two antiviral HCV NS3/4A protease inhibitors: boceprevir (Victrelis™, Merck & Co., Inc.) and telaprevir (Incivek™, Vertex Pharmaceuticals Inc.).  When patients with HCV genotype 1 are given triple therapy, i.e., peginterferon and ribavirin combined with one of these new antivirals, treatment time may be significantly shortened, and a significantly higher percentage of patients may achieve a sustained virological response (SVR).

The FDA labeled indication for Incivek states:  Incivek is an HCV NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 HCV in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.  Incivek must not be used as monotherapy and must only be used in combination with peginterferon alfa and ribavirin.  Incivek is an oral agent that must be administered with both peginterferon alfa and ribavirin for 12 weeks, followed by a response-guided regimen of either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on viral response and prior response status.

The FDA labeled indication for Victrelis states:  Victrelis is an HCV NS3/4A protease inhibitor indicated for the treatment of HCV genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age or older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.  Victrelis must not be used as a monotherapy.  Victrelis therapy is initiated four weeks after peginterferon and ribavirin therapy is initiated.  Response-guided therapy determines the duration of treatment based on the patient's HCV-RNA levels at treatment week eight, 12 and 24.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Pegylated interferon therapy includes the following drugs:

  • Peginterferon alfa-2a (Pegasys®)
  • Peginterferon alfa-2b (PEG-Intron®)

NOTE:

  • Dual therapy is peginterferon in combination with ribavirin.
  • Triple therapy is peginterferon in combination with ribavirin plus an oral anti-viral agent HCV NS3/4A protease inhibitor (i.e., either telaprevir [Incivek™] or boceprevir [Vectrelis™]).

Please refer to the criteria that are listed in the table below for each of the following four diagnosis groups:

A.     Cancerous and pre-cancerous conditions;

B.     Chronic hepatitis B virus (HBV);

C.     Acute or chronic hepatitis C virus (HCV), with or without human immunodeficiency virus (HIV) co-infection;

D.     Any other diagnosis.

A.  Cancerous and Pre-cancerous Conditions

Pegylated interferon may be considered medically necessary to treat cancerous or pre-cancerous conditions, for indefinite duration.

NOTE: See Legislation section for mandates regarding drugs for treatment of cancer.

B.  Chronic Hepatitis B Virus (HBV)

For initial or renewal therapy to treat adults with chronic HBV infection, pegylated interferon may be considered medically necessary when ALL of the following criteria are met:

  • Patient is starting or continuing a course of 18 months of pegylated interferon therapy, AND
  • Patient has never completed a course of 18 months of therapy with pegylated interferon therapy, AND
  • HBV infection has been confirmed by the detection of serologic markers:

o   HBV viral DNA, or

o   Hepatitis B surface antigen (HBsAG), or

o   Hepatitis B ‘e’ antigen (HBeAG).

Pegylated interferon therapy is considered experimental, investigational, and unproven for more than 18 months for treatment of HBV.

C.  Chronic Hepatitis C Virus (HCV)

Dual Therapy

peginterferon + ribavirin

Peginterferon alpha dual therapy (in combination with ribavirin) may be considered medically necessary when BOTH of the following are met:

1.      The patient has ONE of the following:

a.    A diagnosis of chronic hepatitis C, genotype 2, 3, 4-6 confirmed by serological markers; OR

b.    A diagnosis of chronic hepatitis C, genotype 1, confirmed by serological markers, and is requesting dual therapy (peginterferon plus ribavirin) instead of triple therapy (oral agent, peginterferon alpha, and ribavirin); OR

c.    A diagnosis of chronic hepatitis C, genotype 1, confirmed by serological markers, and is requesting continued dual therapy after discontinuation of HCV NS3/4A protease inhibitor oral agent as part of a triple therapy regimen; OR

d.    A diagnosis of chronic hepatitis C (any genotype) with HIV co-infection; AND

2.      The patient has NOT received 24 months or more of total peginterferon therapy.

Triple Therapy

 

INITIAL THERAPY

peginterferon + ribavirin + HCV NS3/4A protease inhibitor (i.e., either telaprevir [Incivek™] or boceprevir [Victrelis™])

 

Initial approval of Incivek + peginterferon is for 8 weeks.

 

Initial approval of Victrelis + peginterferon is 16 weeks (12 weeks after initiation of Victrelis)

Initial Therapy

Peginterferon + Ribavirin + HCV NS3/4A protease inhibitor (i.e., telaprevir [Incivek] or boceprevir [Victrelis])

Triple therapy (peginterferon in combination with ribavirin plus oral HCV NS3/4A protease inhibitor (i.e., either telaprevir [Incivek] or boceprevir [Vectrelis]) may be considered medically necessary when ALL of the following are met:

1.    The patient has a diagnosis of chronic hepatitis C genotype 1 infection confirmed by serological markers; AND

2.    The patient will receive triple therapy including peginterferon and ribavirin and oral HCV NS3/4A protease inhibitor (either telaprevir [Incivek] or boceprevir [Victrelic]); AND

3.    The patient has compensated liver disease (Child-Pugh score <6); AND

4.    The patient does NOT have HIV/AIDS; AND

5.    The patient has not attempted a prior course of therapy with a treatment regimen that includes the requested agent or any other NS3/4A protease inhibitor; AND

6.    The patient has not been administered the requested oral agent for longer than the maximum FDA labeled duration for total therapy (Incivek 12 weeks; Vitrelis 44 weeks)

NOTE:

  • Peginterferon is initiated 4 weeks before Victrelis begins.
  • Peginterferon and Incivek are both initiated at the same time

Triple Therapy

 

RENEWAL THERAPY 

 

Incivek + peginterferon + ribavirin

 

First Renewal is for:

Incivek additional 4 weeks and peginterferon + ribavirin additional 8 weeks

 

Second Renewal is for peginterferon + ribavirin only, for additional 32 weeks.  (Incivek duration is only 12 weeks)

Incivek + Peginterferon + Ribavirin—First Renewal

First renewal of triple therapy with peginterferon + ribavirin + Incivek may be considered medically necessary for 8 additional weeks when:

1.      The patient has been previously approved for triple therapy with Incivek, AND

2.      The patient has had an *HCV RNA level, measured at the 4th week of therapy, with a viral load less than 1000 IU/mL.

*NOTE:  HCV RNA level is measured using sensitive real-time reverse-transcription polymerase chain reaction (RT-PCR) assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL, e.g., Roche COBAS® TaqMan assay. 

Incivek + Peginterferon + Ribavirin—Second Renewal

Second renewal of triple therapy with peginterferon + ribavirin + Incivek for 32 additional weeks may be considered medically necessary when:

1.      The patient has been previously approved for triple therapy with Incivek, AND

2.      The patient has had an HCV RNA level, measured at the 12th week of therapy, with a viral load less than 1000 IU/mL.

NOTE:  Total therapy duration of Incivek is 12 weeks.  Total therapy duration of peginterferon + ribavirin is 48 weeks.

HCV RNA level greater than 1000 IU/mL is considered a treatment failure and further therapy may be considered not medically necessary.

Triple Therapy

 

RENEWAL THERAPY 

 

Victrelis + peginterferon + ribavirin

 

 

First Renewal is for 12 additional weeks of Victrelis + peginterferon + ribavirin

 

Second Renewal is for 20 additional weeks of Victrelis + peginterferon + ribavirin

Vectrelis + Peginterferon + Ribavirin—First Renewal

First renewal of triple therapy with peginterferon + ribavirin + Victrelis may be considered medically necessary for 12 additional weeks when:

1.      The patient has been previously approved for triple therapy with Vectrelis, AND

2.      The patient has had an *HCV RNA level, measured at week 12 (8 weeks after first Victrelis dose), with a viral load less than 1000 IU/mL.

*NOTE:  HCV RNA level is measured using sensitive real-time reverse-transcription polymerase chain reaction (RT-PCR) assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL, e.g., Roche COBAS® TaqMan assay.

Vectrelis + Peginterferon + Ribavirin—Second Renewal

Second renewal of triple therapy with peginterferon + ribavirin + Victrelis for 20 additional weeks may be considered medically necessary when:

1.      The patient has been previously approved for triple therapy with Victrelis, AND

2.      The patient has had an HCV RNA level, measured week 24 (20 weeks after first Victrelis dose), with a viral load less than 1000 IU/mL.

NOTE:  Total therapy duration of Victrelis is 44 weeks.  Total therapy duration of peginterferon is 48 weeks.

HCV RNA level greater than 1000 IU/mL is considered a treatment failure and further therapy may be considered not medically necessary.

D. Any Other Diagnosis

Pegylated interferon therapy is experimental, investigational and unproven to treat any other diagnosis.

Rationale

The FDA approved label indications for pegylated interferon therapy include Hepatitis B virus (HBV) infection, and Hepatitis C virus (HCV) infection with or without HIV co-infection.  There are two FDA approved pegylated interferon agents, Pegasys and PegIntron.  This policy will not differentiate between the two peginterferon alfa agents based on FDA indications.  Treatment for oncology diagnoses will also be approved although there are few studies evaluating peginterferon in oncology.  Available studies indicate similar efficacy between the pegylated and nonpegylated interferons for cancer indications.  However, some state statues require automatic approval of chemotherapeutic agents for patients with cancerous or pre-cancerous conditions.

Hepatitis B Virus (HBV)

The diagnosis of HBV is based on the presence of serological markers in the blood, which include Hepatitis B viral DNA (HBV DNA), hepatitis B surface antigen (HBsAG) or hepatitis B ‘e’ antigen (HBeAg).  The HBeAG is an indicator of viral replication, but some variant forms of the virus do not express HBeAg.  The policy allows peginterferon therapy if there are serologic markers confirming HBV infection.  Quantification of viral load will not be required.

The 2009 American Association for the Study of Liver Disease (AASLD) guideline for the treatment of HBV recommends initiation of treatment with any of the seven approved antiviral medications, but peginterferon, tenofovir, or entecavir are preferred.  Advantages of peginterferon include a finite duration of treatment, a more durable response, and lack of resistant mutants.  The AASLD guideline for HBV recommends duration of treatment with standard interferon for 16 weeks for HBeAg positive HBV and 48 weeks for peginterferon.  The recommended treatment duration for HBeAg-negative chronic hepatitis B is 48 weeks for both standard and peginterferon.  The European Association for the Study of the Liver (EASL) practice guideline (2009) also suggests peginterferon for 48 weeks for both HBeAg positive HBV and HBeAg negative HBV.  To accommodate the 12 month treatment duration and allow for possible disruptions in therapy, up to 18 months of peginterferon therapy will be allowed for a diagnosis of HBV.  Patients who fail to respond to interferon therapy may be retreated with lamivudine or adefovir.

Hepatitis C Virus (HCV)

Patients who react positively to enzyme immunoassay for antibody to HCV or HCV RNA, and have compensated liver disease are potential candidates for peginterferon therapy.  Antiviral therapy is not recommended routinely for patients who have decompensated liver disease; history of severe, uncontrolled psychiatric disorder; or severe hematologic cytopenia.  This policy allows an initial six months of therapy if detection of serologic markers confirms HCV infection.  Although liver biopsy has been regarded as the standard for defining liver disease status, it is not without risks including pain, bleeding, or perforation of other organs.  The procedure is subject to sampling error, requires special expertise for interpreting the histopathology, adds cost to medical care, and is anxiety-provoking for the patient.  A liver biopsy may not be necessary in persons infected with genotypes 2 or 3 HCV.  This policy will not require that a biopsy be performed.

Current treatment guidelines recommend a quantitative serum HCV RNA be performed at the initiation of or shortly before treatment, and also at week 12 of therapy.  Persons who achieve a sustained virologic response (SVR) almost always have a dramatic earlier reduction in the HCV RNA level defined often as a 2-log10 decrease or loss of HCV RNA 12 weeks into therapy.  In the absence of this type of response, the likelihood of an SVR is 0-3%.  Peginterferon therapy will be approved beyond the initial six months only if a second serum HCV RNA level shows a 2-log10 decrease. 

Duration of treatment is 12 continuous months for infection with HCV genotype 1, 4, 5, or 6 if there is a response to therapy at 12 weeks, and six continuous months for genotype 2 and 3, which may be extended to 12 continuous months if there is evidence of cirrhosis, high viral load, or delayed response (response at 24 weeks versus 12 weeks).  There is evidence that patients considered slow responders (positive HCV RNA after 12 weeks of treatment but HCV RNA negative after 24 weeks) may benefit from a 72 week course of therapy.  To accommodate this extended length of therapy and to allow for possible disruptions in therapy, this policy will allow for up to 24 months of therapy for a diagnosis of HCV.  Studies do not support the value of continuing therapy beyond 24 months for HCV.

The possibility of a shorter course of peginterferon therapy for patients infected with genotype 2 or 3 HCV has been investigated in several clinical trials.  In one, randomized, open-label study (n=283), patients with HCV genotype 2 or 3 were treated with either 12 or 24 weeks of peginterferon alfa-2b.  If a patient had a virologic response to treatment at week 4, the patient was given treatment for 12 weeks.  If no virological response was seen at week 4, the patient was given treatment for 24 weeks.  The shorter course of therapy over 12 weeks was determined to be as effective as a 24-week course in patients who have a response to treatment at 4 weeks.  Another study of similar design (N=153) including patients with HCV genotype 2 or 3 found that a course of 16 weeks is as effective as a 24-week course in patients who have a response to treatment at 4 weeks.  However, a study by Shiffman et al. randomized 1,469 patients with HCV genotype 2 or 3 to receive 180 micrograms of peginterferon alfa-2a once weekly, plus 800 milligrams of ribavirin daily, for either 16 weeks or 24 weeks; the study failed to demonstrate that the 16-week regimen was noninferior to the 24-week regimen.  The sustained virologic response rate was significantly lower in patients treated for 16 weeks than in patients treated for 24 weeks (62 percent versus 70 percent, p<0.001).  Rate of relapse was significantly greater in the 16-week group (31 percent versus 18 percent in the 24-week group, p<0.001).  Among patients with a rapid virologic response (no detectable HCV RNA ) at week 4, sustained virologic response rates were 79 percent in the 16-week group and 85 percent in the 24-week group (p=0.02).  In a phase III trial by Lagging et al. 382 patients infected with genotype 2 and 3 HCV were randomized to 12 or 24 weeks of therapy with peginterferon alfa-2a and ribivirin.  In this trial, 12 weeks of therapy was inferior to 24 weeks in the intent-to-treat population (SRV rates: 59% versus 78%, p < 0.0001) and in the subgroups of patients infected with genotype 2 (56% versus 82%, p = 0.0006) or genotype 3 (58% versus 78%, p = 0.0015).  Because of conflicting results in these shorter course studies, this policy will not restrict the duration of therapy for patients with HCV genotype 2 or 3 who demonstrate a rapid virologic response to a shorter course.

Patients who achieve undetectable HCV RNA during and at the end of therapy but relapse are likely to respond and relapse again with subsequent treatment with the same therapy.  Longer duration of therapy with peginterferon or peginterferon plus ribavirin in patients experiencing relapse is of unproven efficacy.  Nonresponders to peginterferon therapy have been considered for treatment with long-term maintenance therapy, which may possibly slow the development of fibrosis and limit the progression of cirrhosis to end-stage liver disease or hepatocellular carcinoma.  There are currently several trials in progress evaluating the long-term effect of low-dose peginterferon for patients with chronic HCV and advanced fibrosis.  One study, HALT-C (Hepatitis C Antiviral Long-Term Treatment against Cirrhosis), has been completed and published.  In this randomized, controlled trial (n=1050) of peginterferon alfa-2a, a low dose (90 mcg/week) for 3.5 years was compared with no treatment in patients with chronic HCV and advanced fibrosis who had not previously responded to therapy with peginterferon plus ribavirin. The primary endpoint was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of two or more points.  After 3.5 years of treatment, no significant differences were apparent between the groups in the rate of any primary outcome (34.1% in the treatment group versus 33.8% in the control group [Hazard Ratio 1.01; 95% CI, 0.81 to 1.27; p=0.90]).  Fifty-three patients (5%) died, 31 in the treatment group and 22 in the control group (p=0.18).  There was a significant difference in mortality between the treatment and control groups among patients with noncirrhotic fibrosis (5% versus 1.9%, p=0.04), but not among patients with cirrhosis (9.1% and 8.4%; p=0.93).  The percentage of patients with at least one serious adverse event was 38.6% in the treatment group and 31.8% in the control group (p=0.07).  Dose modifications for adverse events were frequent; by year 3.5, only 58.9% of patients who were still in the study and had not had a clinical outcome were receiving the full 90 mcg treatment dose of peginterferon.  The AASLD 2009 treatment guidelines do not recommend maintenance therapy for patients with bridging fibrosis or cirrhosis who have failed a prior course of peginterferon and ribavirin.

Pegylated interferon therapy is not FDA approved for any other indication.

2009 Update Summary

A search of peer reviewed literature through November 2009 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

2012 Update

Peginterferon for the Treatment of Hepatitis C Virus

Patients who react positively to enzyme immunoassay for antibody to HCV or HCV RNA and have compensated liver disease are potential candidates for peginterferon therapy (Ghany et al.).  Proper duration of treatment is 12 continuous months for infection with HCV genotype 1, 4, 5, or 6 if there is a response to therapy at 12 weeks.  Duration is six continuous months for genotype 2 and 3, which may be extended to 12 continuous months if there is evidence of cirrhosis, high viral load, or delayed response (response at 24 weeks versus 12 weeks) (NIH, 2002; Scottish Intercollegiate Guidelines Network, 2006)  There is evidence that patients considered slow responders (positive HCV RNA after 12 weeks of treatment but HCV RNA negative after 24 weeks) may benefit from a 72 week course of therapy. (Berg, et al.; Marcellin et al.)

Oral Agents Boceprevir and Telaprevir for the Treatment of Hepatitis C

The efficacy and safety of telaprevir was evaluated in three (ADVANCE, ILLUMINATE, and REALIZE) phase 3 trials in adult patients with HCV (genotype 1).  The efficacy and safety of boceprevir was evaluated in two phase 3 clinical trials (HCV SPRINT 2 and HCV RESPOND 2).  For both drugs, only patients with genotype 1 were treated – both treatment-naïve and patients who had failed a previous course of HCV therapy.

Telaprevir, in combination with peginterferon and ribavirin, was given for 8-12 weeks then followed by treatment with peginterferon and ribavirin.  Treatment-naïve patients were treated for a total treatment duration ranging from 24 weeks up to 48 weeks.  In the IILUMINATE trial, the viral cure rates found that there was no benefit to extending telaprevir based therapy to 48 weeks for the majority of patients.

Both boceprevir trials included a four week lead-in phase of peginterferon plus ribavirin (without boceprevir).  Then boceprevir was added for the remainder of the study.  For treatment naïve patients, the four-week lead-in was followed by the triple combination of boceprevir, peginterferon, ribavirin, and treatment duration was guided by on-treatment response for either 28 weeks or 48 weeks.  For treatment failure patients, the four-week lead-in phase was followed by the triple combination of boceprevir, peginterferon, ribavirin, and treatment duration was guided by on-treatment response for either 36 weeks or 48 weeks.

In phase 3 clinical studies for both drugs, sustained viral response (SVR) was significantly higher with protease inhibitors in combination with peginterferon and ribavirin than peginterferon plus ribavirin alone in both treatment naïve and in patients who failed prior therapy (see table below).

SVR Rates of the Addition of a Protease Inhibitor Compared to Peginterferon/Ribavirin Therapy Alone (Incivek FDA Label, FDA—boceprevir advisory committee)

Peginterferon / ribavirin 

Telaprevir / peginterferon / ribavirin

Boceprevir/ peginterferon /  ribavirin

Treatment naïve:

40-55% SVR

Treatment naïve:

69-75% SVR

Treatment naïve:

63-66% SVR

Treatment Experienced: 5-24% SVR

Treatment Experienced:

31-86% SVR

Treatment Experienced:

59-66% SVR

Clinical Guidelines 

AASLD guidelines: Retreatment of Persons Who Failed to Respond to Previous Treatment for Chronic Hepatitis C (Ghany et al.):

  • Retreatment with peginterferon and ribavirin in patients who did not achieve an SVR after a prior full course of peginterferon and ribavirin is not recommended, even if a different type of peginterferon is administered.
  • Retreatment with peginterferon and ribavirin can be considered for non-responders or relapsers who have previously been treated with non-peginterferon with or without ribavirin, or with peginterferon monotherapy, particularly if they have bridging fibrosis or cirrhosis.
  • Maintenance therapy is not recommended for patients with bridging fibrosis or cirrhosis who have failed a prior course of peginterferon and ribavirin.

The European Association for the Study of The Liver (EASL) clinical practice guidelines recommends the following regarding the use of the direct acting antiviral agents:

  • Direct acting agents should only be used according to package labeling.
  • The following potential challenges of using HCV protease inhibitors in combination with pegylated interferon alpha (PEG-INFa) and ribavirin should be considered:
    1. Rapid emergence of resistance particularly in non-responder patients, non-adherent patients, and patients not able to tolerate optimal doses of PEG-INFa and ribavirin.
    2. More strict and frequent monitoring of HCV RNA.
    3. Lower response rates to triple therapy in patients with advanced liver fibrosis.
    4. Adherence to recommended stopping rules for the antiviral agent and/or the entire treatment regimen.
    5. Additional side effects associated with protease inhibitor therapy.

Coding

Disclaimer for coding information on Medical Policies         

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

070.22, 070.23, 070.3, 070.30, 070.31, 070.32, 070.33, 070.44, 070.54, 070.7, 070.70, 070.71, 140-209.79, 622.0-622.9, 795.00-795.9, 796.0-796.79

Procedural Codes: S0145, S0148
References
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  11. Sporea, I., Danila, M., et al.  Comparative study concerning the efficacy of Peg-IFN alpha-2a versus Peg-IFN alpha-2b on the early virological response (EVR) in patients with chronic viral C hepatitis.  Journal of Gastrointestinal and Liver Disease 2006; 15(2):125-30.
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  25. European Association for the Study of the Liver.  EASL clinical practice guidelines: Management of chronic hepatitis B. J Hepatol 2009; 50:227-42.
  26. Ghany MG, Strader DB, Thomas DL, Seeff LB.  AASLD Practice Guidelines.  Diagnosis, management, and treatment of hepatitis C: an update.  Hepatology 2009; 49(4); 1335-74.
  27. McHutchison JG, Lawitz EJ, Shffman ML, et al.  Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection.  NEJM 2009; 361(6):580-93.
  28. PegIntron Prescribing Information.  Schering Corporation.  May 2009.
  29. Lyrdal D, Stierner U, Lundstam S.  Metastatic renal cell carcinoma treated with peginterferon alfa-2b.  Acta Oncologica 2009; 48(6):901-8.
  30. Awad T, Thorlund K, Hauser G, et al.  Peginterferon alpha-2a is associated with higher sustained virological response than peginterferon alfa-2b in chronic hepatitis C: systematic review of randomized trials.  Hepatology 2010; 51 (4):1176-84.
  31. Ascione A, De Luca M, Tartaglione MT, et al.  Peginterferon alfa-2a plus ribavirin is more effective than peginterferon alfa-2b plus ribavirin for treating chronic hepatitis C virus infection.  Gastroenterology 2010; 138(1):116-22.
  32. Rumi MG, Aghemo A, Prati GM, et al.  Randomized study of peginterferon-alpha2a plus ribavirin vs peginterferon-alpha2b plus ribavirin in chronic hepatitis C.  Gastroenterology 2010; 138(1):108-15.
  33. Hepatitis B/Hepatitis C Agents  (Pegasys®/Pegasys® Proclick /peginterferon alfa-2a, PegIntron®/peginterferon alfa-2b, Incivek™/telaprevir, and Victrelis™/boceprevir) Prior Authorization Criteria.  Prime Therapeutics L.L.C. (November 2011).
  34. Pegasys Prescribing Information.  Roche.  September 2011.
  35. Victrelis (boceprevir) prescribing information.  Merck.  May 2011.
  36. Incivek (telaprevir) prescribing information.  Vertex.  May 2011.
  37. Poordad F, McCone J, Bacon B, et al.  SPRINT-2 Investigators.  Boceprevir for untreated chronic HCV genotype-1 infection.  N Engl J Med 2011; 364(13):1195-1206.
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  40. Food and Drug Administration.  Background Material for Telaprevir Advisory Committee.  Division of Antiviral Products (DAVP).  April 28, 2011.  Available at www.fda.gov (accessed May 2012). 
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  42. National Institute for Clinical Excellence.  New drugs "a major benefit" for patients with chronic hepatitis C.  2012 April 25.  Available at www.nice.org.uk (accessed May 2012).
History
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Pegylated Interferon Therapy