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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Hepatitis C

Drug
ribavirin
Daklinza™  (daclatasvir)
Epclusa®  (sofosbuvir/ velpatasvir)
Harvoni®  (sofosbuvir/ ledipasvir)
Infergen ®  (interferon alfacon-1)
Intron-A ®  (interferon alfa-2b)
Pegasys ®  (peginterferon alfa-2a)
Peg-Intron ®  (peginterferon alfa-2b)
Peg-Intron Redipen/pak ®  (peginterferon alfa-2b)
Olysio™  (simeprevir)
Sovaldi™  (sofosbuvir)
Technivie™  (ombitasvir, paritaprevir, ritonavir)
Viekira Pak™  (ombitasvir, paritaprevir, ritonavir dasabuvir)
Viekira XR™  (ombitasvir, paritaprevir, ritonavir dasabuvir)
Zepatier™  (elbasvir and grazoprevir)
Note: Precertification review for Daklinza, Epclusa, Harvoni, Infergen, Intron-A, Olysio, Peg-Intron, Pegasys, Sovaldi, Technivie, Victrelis, Viekira Pak, Viekira XR, and Zepatier are handled through Aetna Specialty Precert Unit at 1-866-503-0857
Refer to Medical CPB 400
 http://aetnet.aetna.com/mpa/cpb/400_499/0404.html for precertification criteria for these drugs.


Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Daklinza, Epclusa, Harvoni, Infergen, Intron-A, Olysio, Pegasys, Peg-Intron/ Redipen/pak, Sovaldi, Technivie, Viekira Pak, Viekira XR, and Zepatier are subject to precertification. If precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet all of the following precertification criteria.

    For those patients meeting clinical criteria for lower cost regimens with comparable efficacy, the use of the determined regimen will be required unless the patient has a contraindication or intolerance to any of the ingredients within the regimen.

    When referring to treatment criteria and recommendations for members who are cirrhotic, the same recommendations apply to those members with Hepatocellular Carcinoma.

    Patients with Hepatitis B/ Hepatitis C co-infection are best managed by an experienced Gastroenterologist or Hepatologist.

    Drug interactions and contraindications can be located in FDA label information.

    Due to the lack of clinical evidence, requests for Hepatitis C therapy beyond the recommended duration as identified in the below sections are not considered to be medically necessary and will not be approved regardless of immunosuppression.

    Modifications made to prior authorization approved Hepatitis C drug regimens/durations will not result in approval of additional medication.

    For HCV reinfection, testing for the presence of virus with NS5A resistance-associated polymorphisms is required.

     

    For Daklinza (In order to be eligible for the maximum number of tablets, member must meet both initial and reauthorization criteria.) 

    For initial authorization (6 week maximum), provider must submit medical records documenting the diagnosis of Chronic Hepatitis C with Genotype and subtype, if applicable (i.e., Genotype 1a, 1b, 2, 3; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease:

    1. Liver Biopsy
    2. Metavir scores
    3. Fibroscan score
    4. APRI score
    5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
    6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician

    AND meet the criteria specified below

    A documented viral load taken within 6 months of beginning therapy, AND

    Viral load will be submitted by prescriber 12 weeks after completion of therapy, AND

    A documented contraindication or intolerance or allergy or failure of Preferred Branded Products, AND

    Daklinza should not be administered with phenytoin, carbamazepine, rifampin, St. John’s Wort, or in combination with another Direct Acting Agent (DDA) and amiodarone.

    Consult the full prescribing information prior to use for potential drug-drug interactions.

    AND

    A documented diagnosis of hepatitis C Genotype 1a with or without HIV,

        AND

    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) without cirrhosis (Max Time of Approval 12 weeks +Sovaldi) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) with compensated cirrhosis without polymorphisms at amino acid positions 28, 30, 31, 93 (Max Time of Approval 24 weeks +Sovaldi) (168 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) with decompensated cirrhosis (Max Time of Approval 12 weeks +Sovaldi + low dose RBV) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) with decompensated cirrhosis and RBV intolerant (Max Time of Approval 24 weeks +Sovaldi) (168 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) post liver transplantation (Max Time of Approval 12 weeks +Sovaldi + low dose RBV) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) post liver transplantation and RBV intolerant (Max Time of Approval 24 weeks +Sovaldi) (168 tablets total)

    OR

    A documented diagnosis of hepatitis C Genotype 1b with or without HIV,

        AND

    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) with or without compensated cirrhosis (Max Time of Approval 12 weeks +Sovaldi) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) with decompensated cirrhosis (Max Time of Approval 12 weeks +Sovaldi + RBV) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) with decompensated cirrhosis and RBV intolerant (Max Time of Approval 24 weeks +Sovaldi) (168 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) post liver transplantation (Max Time of Approval 12 weeks +Sovaldi + low dose RBV) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV/±PI (Incivek, Victrelis, Olysio)) post liver transplantation and RBV intolerant (Max Time of Approval 24 weeks +Sovaldi) (168 tablets total)

    OR

    A documented diagnosis of hepatitis C Genotype 2 with or without HIV,

        AND

    • Member is treatment naïve or treatment experienced (PEG/RBV) without cirrhosis and RBV intolerant (Max Time of Approval 12 weeks +Sovaldi) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV) with compensated cirrhosis (Max Time of Approval 16 - 24 weeks +Sovaldi) (112 - 168 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV) with decompensated cirrhosis (Max Time of Approval 12 weeks +Sovaldi + low dose RBV) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV) post liver transplantation (Max Time of Approval 12 weeks +Sovaldi + low dose RBV) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV) post liver transplantation and RBV intolerant (Max Time of Approval 24 weeks +Sovaldi) (168 tablets total)

    OR

    A documented diagnosis of hepatitis C Genotype 3 with or without HIV,

        AND

    • Is PEG intolerant or ineligible, AND
    • Member is treatment naïve without cirrhosis and RBV intolerant (Max Time of Approval 12 weeks +Sovaldi) (84 tablets total), OR
    • Member is treatment experienced (PEG/RBV) without cirrhosis without polymorphisms at amino acid position 93 and RBV intolerant (Max Time of Approval 12 weeks +Sovaldi) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV) with compensated cirrhosis without polymorphisms at amino acid position 93 and RBV intolerant (Max Time of Approval 12 weeks +Sovaldi) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV) with compensated cirrhosis and RBV intolerant (Max Time of Approval 24 weeks +Sovaldi) (168 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV) with decompensated cirrhosis (Max Time of Approval 12 weeks +Sovaldi + RBV) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV) post liver transplantation (Max Time of Approval 12 weeks +Sovaldi + low dose RBV) (84 tablets total), OR
    • Member is treatment naïve or treatment experienced (PEG/RBV) post liver transplantation and RBV intolerant (Max Time of Approval 24 weeks +Sovaldi) (168 tablets total)

    For initial authorization, 6 week maximum for 12 or 24 week regimen, (in order to be eligible for the maximum number of tablets, member must meet both initial and reauthorization criteria):

    • Initial authorization criteria above has been met, AND
    • HCV RNA levels have declined > 2 log10 IU/ mL at 4 weeks of therapy

    Note: There are no treatment guidelines or FDA-approved therapies for retreatment with Daklinza after failure of a Daklinza regimen.

     

    **Pegylated Interferon (Peg) ineligible/intolerance is defined as meeting one or more of the following criteria:

    • Neutrophils <750 cells/mm3,results within the past month
    • Hemoglobin < 10g/dL, results within the past month
    • Platelets <50 000 cells/ mm3, results within the past month
    • Autoimmune hepatitis or other autoimmune condition known to be exacerbated by Peg
    • Known hypersensitivity to drugs used to treat HCV

    (Not an all inclusive list)

     

    For Epclusa

    For initial authorization, provider must submit medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype, if applicable (i.e., genotype 1a, genotype 1b; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease:

    1. Liver Biopsy
    2. Metavir scores
    3. Fibroscan score
    4. APRI score
    5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
    6. Physical findings or clinical evidence consistent with cirrhosis as attested by theprescribing physician

    AND meet the criteria specified below:

    • A documented viral load taken within 6 months of beginning therapy, AND
    • Epclusa should not be taken in members with severe renal disease or kidney failure, AND
    • Member has not had a liver transplant, AND
    • Epclusa should not be taken with amiodarone; or with P-glycoprotein inducers (i.e.,rifampin, St. John’s Wort) as these may decrease sofosbuvir plasma concentrations, leading to reduced therapeutic effect. Consult the full prescribinginformation prior to use for potential drug-drug interactions. AND

    • A documented diagnosis of hepatitis C Genotype 1a or 1b with or without HIV, AND
      • Member is treatment-naïve with or without compensated cirrhosis- Max Time of Approval 12 weeks (84tablets total) OR
      • Member is treatment-experienced with or without compensated cirrhosis (failed after PEG/ RBV or PEG/ RBV + HCV PI) - Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 12 weeks (84 tablets total) + RBV OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and is RBV ineligible or intolerant** and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 24 weeks (168 tablets total)

    OR

    • A documented diagnosis of hepatitis C Genotype 2 with or without HIV, AND
      • Member is treatment-naïve with or without compensated cirrhosis and RBV intolerant- Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment-experienced with or without compensated cirrhosis (failed after PEG/ RBV or PEG/ RBV + HCV PI) and RBV intolerant - Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment-experienced with compensated cirrhosis (failure after a DAA other than a protease inhibitor, a resistance profile needs to be obtained with appropriate results) - Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 12 weeks (84 tablets total) + RBV OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and is RBV ineligible or intolerant** and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 24 weeks (168 tablets total) OR
      • Member is treatment experienced (failure after a DAA other than a protease inhibitor, a resistance profile needs to be obtained with appropriate results) with decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 12 weeks (84 tablets total) + RBV OR
      • Member is treatment experienced (failure after a DAA other than a protease inhibitor, a resistance profile needs to be obtained with appropriate results) with decompensated cirrhosis and is RBV ineligible or intolerant** and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 24 weeks (168 tablets total)

    OR

    • A documented diagnosis of hepatitis C Genotype 3 with or without HIV, AND
      • Member is treatment-naïve with or without compensated cirrhosis and PEG/ RBV intolerant - Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment-experienced with or without compensated cirrhosis (failed after PEG/ RBV or PEG/ RBV + HCV PI) and PEG/ RBV intolerant- Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment-experienced with compensated cirrhosis (failure after a DAA other than a protease inhibitor, a resistance profile needs to be obtained with appropriate results) - Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 12 weeks (84 tablets total) + RBV OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and is RBV ineligible or intolerant** and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 24 weeks (168 tablets total) OR
      • Member is treatment experienced (failure after a DAA other than a protease inhibitor, a resistance profile needs to be obtained with appropriate results) with decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 12 weeks (84 tablets total) + RBV OR
      • Member is treatment experienced (failure after a DAA other than a protease inhibitor, a resistance profile needs to be obtained with appropriate results) with decompensated cirrhosis and is RBV ineligible or intolerant** and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 24 weeks (168 tablets total)

    OR

    • A documented diagnosis of hepatitis C Genotype 4 with or without HIV, AND
      • Member is treatment-naïve with or without compensated cirrhosis- Max Time of Approval 12 weeks (84tablets total) OR
      • Member is treatment-experienced with or without compensated cirrhosis (failed after PEG/ RBV or PEG/ RBV + HCV PI) - Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 12 weeks (84 tablets total) + RBV OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and is RBV ineligible or intolerant** and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 24 weeks (168 tablets total)

    OR

    • A documented diagnosis of hepatitis C Genotype 5 with or without HIV, AND
      • Member is treatment-naïve with or without compensated cirrhosis- Max Time of Approval 12 weeks (84tablets total) OR
      • Member is treatment-experienced with or without compensated cirrhosis (failed after PEG/ RBV or PEG/ RBV + HCV PI) - Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 12 weeks (84 tablets total) + RBV OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and is RBV ineligible or intolerant** and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 24 weeks (168 tablets total)

    OR

    • A documented diagnosis of hepatitis C Genotype 6 with or without HIV, AND
      • Member is treatment-naïve with or without compensated cirrhosis- Max Time of Approval 12 weeks (84tablets total) OR
      • Member is treatment-experienced with or without compensated cirrhosis (failed after PEG/ RBV or PEG/ RBV + HCV PI) - Max Time of Approval 12 weeks (84 tablets total) OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 12 weeks (84 tablets total) + RBV OR
      • Member is treatment naïve or treatment experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) with decompensated cirrhosis and is RBV ineligible or intolerant** and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max time of approval 24 weeks (168 tablets total)

    For initial authorization, 6 week maximum for 12 or 24 week regimen, (in order to be eligible for the maximum number of tablets, member must meet both initial and reauthorization criteria):

    • Initial authorization criteria above has been met, AND
    • HCV RNA levels have declined > 2 log10 IU/ mL at 4 weeks of therapy

    Note: There are no treatment guidelines or FDA-approved therapies for retreatment with Epclusa after failure of an Epclusa regimen.

     

     **Pegylated Interferon (Peg) or ribavirin (RBV) ineligible/intolerance is defined as meeting one or more of the following criteria:

    • Neutrophils <750 cells/mm3,results within the past month
    • Hemoglobin < 10g/dL, results within the past month
    • Platelets <50 000 cells/ mm3, results within the past month
    • Autoimmune hepatitis or other autoimmune condition known to be exacerbated by Peg
    • Known hypersensitivity to drugs used to treat HCV

     

    (Not an all-inclusive list)

     

    For Harvoni

    For initial authorization, provider must submit medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype, if applicable (i.e., genotype 1a, genotype 1b; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease: 

    1. Liver Biopsy
    2. Metavir scores
    3. Fibroscan score 
    4. APRI score
    5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
    6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician

    AND meet the criteria specified below:

    • A documented viral load taken within 6 months of beginning therapy, AND
    • Viral load will be submitted by prescriber 12 weeks after completion of therapy, AND
    • Harvoni should not be taken in members with severe renal disease or kidney failure. AND
    • Harvoni should not be taken with amiodarone; or with P-glycoprotein inducers (i.e., rifampin, St. John’s Wort) as these may decrease ledipasvir and sofosbuvir plasma concentrations, leading to reduced therapeutic effect. Consult the full prescribing information prior to use for potential drug-drug interactions.  AND

    • A documented diagnosis of hepatitis C Genotype 1a or 1b with or without HIV, AND
      • Member has a documented pre-treatment baseline HCV RNA less than 6 million IU/mL, AND member is treatment-naïve without cirrhosis - Max Time of Approval 8 weeks (56 tablets total) (excludes HIV co-infection) OR
      • Member has a documented pre-treatment baseline HCV RNA less than 6 million IU/mL, AND member is treatment-naïve with cirrhosis OR treatment-naïve without cirrhosis with HIV co-infection - Max Time of Approval 12 weeks (84 tablets total) OR
      • Member has a documented pre-treatment baseline HCV RNA greater than 6 million IU/mL, AND member is treatment-naïve with or without cirrhosis - Max Time of Approval 12 weeks (84 tablets total), OR
      • Member is treatment-experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) without cirrhosis - Max Time of Approval 12 weeks (84 tablets total), OR
      • Member is treatment-experienced (failed after PEG/RBV or PEG/RBV + HCV PI) with cirrhosis AND concurrent therapy with RBV - Max Time of Approval 12 weeks (84 tablets total), OR
      • Member is treatment-experienced (regardless of previous response to PEG/ RBV or PEG/ RBV + HCV PI) with cirrhosis and is RBV ineligible or intolerant** - Max Time of Approval 24 weeks (168 tablets total), OR
      • Member is treatment experienced (experienced relapse after treatment with a Sovaldi containing regimen) without cirrhosis - Max Time of approval 12 weeks with RBV OR
      • Member is treatment experienced (experienced relapse after treatment with a Sovaldi containing regimen) with cirrhosis AND concurrent therapy with RBV - Max Time of approval 24 weeks and RBV (168 tablets total), OR
      • Member is treatment naïve or treatment experienced (regardless of previous response to PEG/ RBV or PEG/ RBV + HCV PI) has decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma - Max Time of Approval 12 weeks (84 tablets total) with low dose RBV
      • Member is treatment naïve or treatment experienced (regardless of previous response to PEG/ RBV or PEG/ RBV + HCV PI) has decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma and is RBV ineligible or intolerant**- Max Time of Approval 24 weeks (168 tablets total), OR
      • Member has decompensated cirrhosis who may or may not be eligible for a liver transplant and may or may not have Hepatocellular Carcinoma who failed a previous Sovaldi containing regimen - Max Time of Approval is 24 weeks (168 tablets) + low dose RBV OR
      • Member is post liver transplantation -Max Time of Approval is 12 weeks(84 tablets) with RBV, OR
      • Member is treatment naïve post liver transplantation and is RBV ineligible or intolerant**-Max Time of Approval is 24 weeks(168 tablets), OR
      • Member is post liver transplantation AND decompensated -Max Time of Approval is 12 weeks(84 tablets) with low dose RBV 

    OR

    • A documented diagnosis of hepatitis C Genotype 4 with or without HIV AND
      • Member is treatment-naïve with or without cirrhosis - Max Time of Approval is 12 weeks (84 tablets), OR
      • Member is treatment-experienced (failure after PEG/RBV) with or without cirrhosis - Max Time of Approval is 12 weeks (84 tablets), OR
      • Member is post liver transplantation, treatment-naïve or treatment-experienced without cirrhosis or with compensated cirrhosis (regardless of previous response to PEG/RBV)- Max Time of Approval is 12 weeks (84 tablets) with RBV, OR
      • Member is treatment-naïve post liver transplantation and is RBV ineligible or intolerant** - Max Time of Approval is 24 weeks (168 tablets), OR
      • Member is post liver transplantation AND has decompensated cirrhosis - Max Time of Approval is 12 weeks (84 tablets) with low dose RBV, OR
      • Member has decompensated cirrhosis who may or may not be eligible for a liver transplant and may or may not have Hepatocellular Carcinoma - Max Time of Approval is 12 weeks (84 tablets) with low dose RBV, OR
      • Member has decompensated cirrhosis who may or may not be eligible for a liver transplant and may or may not have Hepatocellular Carcinoma and is RBV ineligible or intolerant** - Max Time of Approval is 24 weeks (168 tablets), OR
      • Member has decompensated cirrhosis who may or may not be eligible for a liver transplant and may or may not have Hepatocellular Carcinoma who failed a previous Sovaldi containing regimen - Max Time of Approval is 24 weeks (168 tablets) with RBV

    OR

    • A documented diagnosis of hepatitis C Genotype 5 with or without HIV AND
      • Member is treatment-naïve with or without cirrhosis - Max Time of Approval 12 weeks (84 tablets total), OR
      • Member is treatment experienced (failure after PEG/RBV) with or without cirrhosis - Max Time of Approval 12 weeks (84 tablets total)

    OR

    • A documented diagnosis of hepatitis C Genotype 6 with or without HIV, AND  
      • Member is treatment-naïve with or without cirrhosis - Max Time of Approval 12 weeks (84 tablets total), OR
      • Member is treatment experienced (failure after PEG/RBV) with or without cirrhosis - Max Time of Approval 12 weeks (84 tablets total)

    For initial authorization, 6 week maximum for 12 or 24 week regimen, 8 week maximum for 8 week regimen (in order to be eligible for the maximum number of tablets, member must meet both initial and reauthorization criteria):

    • Initial authorization criteria above has been met, AND
    • HCV RNA levels have declined > 2 log10 IU/ mL at 4 weeks of therapy

    Note: There are no treatment guidelines or FDA-approved therapies for retreatment with Harvoni after failure of a Harvoni regimen.

    **Ribavirin(RBV) ineligible/intolerance is defined as meeting one or more of the following criteria:

    • Neutrophils <750 cells/mm3,results within the past month
    • Hemoglobin < 10g/dL, results within the past month
    • Platelets <50 000 cells/ mm3, results within the past month
    • Autoimmune hepatitis or other autoimmune condition known to be exacerbated by Ribavirin
    • Known hypersensitivity to drugs used to treat HCV


    For Infergen

    A documented diagnosis of one of the following:

    • Chronic hepatitis C, initial treatment OR
    • Chronic hepatitis C, retreatment in patients who have failed to respond to complete therapeutic course of peglyated interferon (Pegasys, Peg-Intron)
      • Treatment failure is defined as less than a 2 log decline in viral load after undergoing at least 12 weeks of previous pegylated interferon plus ribavirin therapy with greater than 80% adherence, or a detectable viral load at end-of-treatment after completing at least 24 weeks of therapy
      • Up to 48 weeks of treatment with consensus interferon is considered medically necessary for retreatment; continued treatment with consensus interferon is considered not medically necessary for persons with poor response to re-treatment at week 12 (defined as less than 2 log10 reduction in viral load from baseline) or persons who have detectable virus at week 24

    For Intron-A

    A documented diagnosis of one of the following:

    • AIDs-associated Kaposi's sarcoma
    • Carcinoid syndrome
    • Chronic myelogenous leukemia
    • Condylomata acuminata (genital warts) (intralesional only)
    • Cutaneous T-cell lymphoma (including mycosis fungoides)
    • Desmoid tumors (fibromatosis), for unresectable disease or gross residual disease following surgery
    • Essential thrombocytopenia
    • Giant cell tumor of bone
    • Hairy cell leukemia
    • Hepatitis C (non-A, non-B hepatitis)
      • Note: Upon medical review, extended treatment with interferon alpha beyond these limits may be considered medically necessary for persons with cryoglobulinemia and for liver transplant recipients with recurrent hepatitis C infection
      • Up to a maximum of 24 weeks of interferon alpha is considered medically necessary for persons with HCV genotypes 2, 3, and 7 through 10
      • Up to maximum of 48 weeks of interferon alpha is considered medically necessary for persons with HCV genotypes 1 and 4 through 6
      • Continued treatment with interferon alpha is considered not medically necessary for persons with HCV genotypes 1 and 4 through 6 who have failed to attain an early virologic response after 12 weeks of treatment (where early virologic response is indicated by achievement of at least a 100-fold (2 log10) decrease in serum HCV from pretreatment baseline)
      •  A course of standard interferon alpha in persons with hepatitis C who have failed to respond or relapsed after an adequate course of pegylated interferon alpha or consensus interferon is considered experimental and investigational because of a lack of evidence on the effectiveness of standard interferon in these persons
    • Hyper-eosinophilic syndrome that is not adequately responsive glucocorticoids
    • Kasabach-Merritt syndrome
    • Leptomeningeal metastases of CNS tumors, intracerebrospinal fluid treatment
    • Life-threatening hemangioma of infancy (intralesional) when member is intolerant of, or the hemangioma is resistant to, corticosteroid therapy
    • Malignant melanoma
    • Meningioma, recurrent, surgically inaccessible
    • Multiple myeloma, solitary plasmacytoma, or systemic light chain amyloidosis
    • Non-Hodgkin's lymphoma (including adult T-cell lymphoma (chronic, smoldering or acute) and mycosis fungoides/Sezary syndrome)
    • Ocular herpes simples (interferon alpha eye drops)
    • Persons with chronic hepatitis B who meet all of the following criteria:
      • Member has compensated liver disease (Child-Pugh score less than or equal to 6 [class A]) AND
      • Serum aminotransferase (AST) greater than double the upper limit of normal range (AST normal range 0 to 35 u/l). A course of standard interferon alpha in persons with hepatitis B who have failed an adequate course of pegylated interferon alpha is considered experimental and investigational because of a lack of evidence on the effectiveness of standard interferon in these persons. (The use of interferon alpha is considered contraindicated in the following persons with hepatitis B: those who are HIV positive; hepatitis B surface antigen (HBs Ag) positive persons undergoing liver transplantation; and those with a history of or currently active autoimmune hepatitis
    • Renal cell carcinoma
    • Respiratory papillomatosis
    • Vulvar vestibulitis
    • Neuroendocrine tumors of the GI tract, lung and thymus

    For Olysio (In order to be eligible for the maximum number of capsules, member must meet both initial and reauthorization criteria.)

    For initial authorization (6 week maximum), provider must submit medical records documenting the diagnosis of Chronic Hepatitis C with Genotype and subtype, if applicable (i.e., Genotype 1a, Genotype 1b; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease: 

    1. Liver Biopsy
    2. Metavir scores
    3. Fibroscan score
    4. APRI score
    5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
    6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician

    AND meet the criteria specified below:

    • Member does not have decompensated liver disease
    • Member has a documented contraindication or intolerance or allergy to Preferred Branded Products OR
    • Member will be treated in combination with a Preferred Branded Product
    • Member has not been previously treated with a HCV Protease Inhibitor (i.e., Incivek, Victrelis, Olysio)

              Consult the full prescribing information prior to use for potential drug-drug interactions. 

    • Chronic Hepatitis C Virus (HCV) infection Genotype 1 with or without HIV AND
    • Member is treatment naïve Genotype 1a without cirrhosis, AND Concurrent therapy with Sovaldi (Max Time of Approval 12 weeks (84 tablets total), OR
    • Member is treatment naïve Genotype 1a with cirrhosis, AND Concurrent therapy with Sovaldi with or without RBV and NS3 Q80K polymorphism is not detected prior to treatment (Max Time of Approval 24 weeks (168 tablets total), OR
    • Member is treatment naïve Genotype 1b, without cirrhosis, AND Concurrent therapy with Sovaldi (Max Time of Approval 12 weeks (84 tablets total), OR
    • Member is treatment naïve Genotype 1b, with cirrhosis AND Concurrent therapy with Sovaldi with or without RBV (Max Time of Approval 24 weeks (168 tablets total), OR
    • Member is post liver transplantation with or without cirrhosis AND Concurrent therapy with Sovaldi with or without RBV (Max Time of Approval 12 weeks (84 tablets total), OR
    • Member is treatment experienced (failure after PEG/RBV), without cirrhosis, AND Concurrent therapy with Sovaldi (Max Time of Approval 12 weeks (84 tablets total), OR
    • Member is treatment experienced (failure after PEG/RBV), Genotype 1a with cirrhosis, AND Concurrent therapy with Sovaldi with or without RBV and NS3 Q80K polymorphism is not detected prior to treatment (Max Time of Approval 24 weeks (168 tablets total), OR
    • Member is treatment experienced (failure after PEG/RBV), Genotype 1b with cirrhosis, AND Concurrent therapy with Sovaldi with or without RBV (Max Time of Approval 24 weeks (168 tablets total),

    For reauthorization at 6 weeks (member will be eligible for the balance of therapy based on above criteria guidelines):

    • Initial authorization criteria above has been met, AND
    • HCV RNA levels are < 25 IU/ mL at 4 weeks of therapy

    For Pegasys and Peg-Intron/ Redipen/pak

    For initial authorization (12 week maximum), provider must submit medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype, if applicable (i.e., genotype 1a, genotype 1b; diagnoses further defined below) AND submit medical records documenting any  one of the following related to staging of liver disease:

    1. Liver Biopsy
    2. Metavir scores
    3. Fibroscan score
    4. APRI score
    5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension
    6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician

    AND meet the criteria specified below:

    • Member does not have decompensated liver disease AND
    • Chronic Hepatitis C Virus (HCV) infection Genotype 2 with or without HIV AND
    • Member is treatment experienced with or without cirrhosis (failure after PEG/RBV) AND Concurrent therapy with Sovaldi and RBV (Max Time of Approval 12 weeks)

    OR

    • Chronic Hepatitis C Virus (HCV) infection Genotype 3 with or without HIV  AND
      • Member is treatment naïve or treatment experienced with or without cirrhosis AND Concurrent therapy with Sovaldi and RBV (Max Time of Approval 12 weeks)

    OR

    • Chronic Hepatitis C Virus (HCV) infection Genotype 4 with or without HIV AND
      • Member is treatment naïve or treatment experienced with or without cirrhosis (failure after PEG/RBV) AND Concurrent therapy with Sovaldi and RBV (Max Time of Approval 12 weeks)

    OR

    • Chronic Hepatitis C Virus (HCV) infection Genotype 5 with or without HIV AND
      • Member is treatment naïve with or without cirrhosis AND Concurrent therapy with Sovaldi and RBV (Max Time of Approval 12 weeks), OR
      • Member is treatment experienced with or without cirrhosis (failure after PEG/RBV) AND Concurrent therapy with Sovaldi and RBV (Max Time of Approval 12 weeks)

    OR 

    • Chronic Hepatitis C Virus (HCV) infection Genotype 6 with or without HIV AND
      • Member is treatment naïve or treatment experienced with or without cirrhosis AND Concurrent therapy with Sovaldi and RBV (Max Time of Approval 12 weeks)

    For reauthorization at 12 weeks (member will be eligible for the balance of therapy based on above criteria guidelines):

    • Initial authorization criteria above has been met AND
    • HCV RNA levels show are at least a 100-fold (2 log10) decrease in serum HCV RNA from pretreatment baseline)at 12 weeks of therapy

    A documented diagnosis of Chronic hepatitis C AND all of the following:

    • Compensated liver disease (Child-Pugh score less than or equal to 6 [Class A]) AND
    • Liver inflammation (serum aminotransferase (AST) > 35 u/l) AND
    • Patient is interferon naïve or has relapsed or failed to respond to prior non-pegylated interferon Note: Upon medical review, extended treatment with peginterferon alfa-2a beyond these limits may be considered medically necessary for liver transplant recipients with recurrent hepatitis B infections

    OR

    • Chronic myelogenous leukemia (CML) AND one of the following:
    • Newly diagnosed patients who are unable to tolerate imatinib mesylate (Gleevec), OR
    • Follow-up therapy for patients who are unable to tolerate imatinib mesylate (Gleevec), dasatinib (Sprycel), or nilotinib (Tasigna)
    • Post-transplant follow-up treatment in patients with molecular relapase or those who are not in cytogenic remission

    OR

    • Advanced, recurrent, or malignant disease melanoma

    OR

    • Giant cell tumor of the bone

    For Sovaldi (In order to be eligible for the maximum number of tablets, member must meet both initial and reauthorization criteria.)

    For initial authorization (6 week maximum), provider must submit medical records documenting the diagnosis of Chronic Hepatitis C with Genotype and subtype, if applicable (i.e., Genotype 1a, Genotype 1b; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease: 

    1. Liver Biopsy
    2. Metavir scores
    3. Fibroscan score
    4. APRI score
    5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
    6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician

    AND meet the criteria specified below

    • Member has a documented diagnosis of one of the following, AND
    • A documented viral load taken within 6 months of beginning therapy, AND
    • Viral load will be submitted by prescriber 12 weeks after completion of therapy, AND
    • Sovaldi should not be administered with rifampin, St. John's Wort, or in combination with another Direct Acting Agent (DDA) and amiodarone.

    Consult the full prescribing information prior to use for potential drug-drug interactions. 

    AND 

    • Chronic Hepatitis C Virus (HCV) infection Genotype 1 with or without HIV, AND
      • Member is treatment naïve Genotype 1a without cirrhosis, AND Concurrent therapy with Olysio (Max Time of Approval 12 weeks) (84 tablets total), OR
      • Member is treatment naïve Genotype 1a, with cirrhosis AND Concurrent therapy with Olysio with or without RBV and NS3 Q80K polymorphism is not detected prior to treatment (Max Time of Approval 24 weeks) (168 tablets total), OR
      • Member is treatment naïve Genotype 1b, without cirrhosis AND Concurrent therapy with Olysio (Max Time of Approval 12 weeks) (84 tablets total) OR 
      • Member is treatment naïve Genotype 1b with cirrhosis AND Concurrent therapy with Olysio with or without RBV (Max Time of Approval 24 weeks) (168 tablets total), OR
      • Member is treatment experienced Genotype 1a or Genotype 1b (failure after PEG/RBV), without cirrhosis, AND Concurrent therapy with Olysio (Max Time of Approval 12 weeks) (84 tablets total), OR
      • Member is treatment experienced Genotype 1a (failure after PEG/RBV), with cirrhosis AND Concurrent therapy with Olysio with or without RBV and NS3 Q80K polymorphism is not detected prior to treatment (Max Time of Approval 24 weeks) (168 tablets total), OR
      • Member is treatment experienced Genotype 1b (failure after PEG/RBV), with cirrhosis AND Concurrent therapy with Olysio with or without RBV (Max Time of Approval 24 weeks) (168 tablets total), OR
      • Member is post liver transplantation Genotype 1a or Genotype 1b with a compensated liver AND Concurrent therapy with Olysio with or without RBV (Max Time of Approval 12 weeks) (84 tablets total),

    OR

    • Chronic Hepatitis C Virus (HCV) infection Genotype 2 with or without HIV treatment AND
      • Member is treatment naïve without cirrhosis AND Concurrent therapy with RBV (Max Time of Approval12 weeks (84 tablets total), OR
      • Member is treatment naïve with compensated cirrhosis AND Concurrent therapy with RBV (Max Time of Approval 16 weeks (112 tablets total), OR
      • Member is treatment experienced (failure after PEG/RBV) with or without cirrhosis AND Concurrent therapy with RBV (Max Time of Approval 16-24 weeks (112-168 tablets total), OR
      • Member is treatment experienced (failure after PEG/RBV) with or without cirrhosis AND Concurrent therapy with Pegylated Interferon and Ribavirin (Max Time of Approval 12 weeks (84 tablets total), OR
      • Member has a decompensated liver who may or may not be a candidate for liver transplantation AND Concurrent therapy with RBV (Max Time of Approval 48 weeks (336 tablets total), OR
      • Member is post liver transplantation, treatment naïve or treatment experienced, without cirrhosis, or with compensated cirrhosis or with decompensated cirrhosis AND Concurrent therapy with RBV (Max Time -of Approval 24 weeks (168 tablets total),

    OR

    • Chronic Hepatitis C Virus (HCV) infection Genotype 3 with or without HIV AND
      • Member is treatment naïve without cirrhosis and RBV intolerant (Max Time of Approval 12 weeks +Daklinza) (84 tablets total), OR
      • Member is treatment experienced (PEG/RBV) without cirrhosis without polymorphisms at amino acid position 93 and RBV intolerant (Max Time of Approval 12 weeks +Daklinza) (84 tablets total), OR
      • Member is treatment naïve or treatment experienced (PEG/RBV) with compensated cirrhosis without polymorphisms at amino acid position 93 and RBV intolerant (Max Time of Approval 12 weeks +Daklinza) (84 tablets total), OR
      • Member is treatment naïve or treatment experienced (PEG/RBV) with compensated cirrhosis and RBV intolerant (Max Time of Approval 24 weeks +Daklinza) (168 tablets total), OR
      • Member is treatment naïve or treatment experienced (PEG/RBV) with decompensated cirrhosis (Max Time of Approval 12 weeks +Daklinza + RBV) (84 tablets total), OR
      • Member is treatment naïve or treatment experienced (PEG/RBV) post liver transplantation (Max Time of Approval 12 weeks +Daklinza+ low dose RBV) (84 tablets total), OR
      • Member is treatment naïve or treatment experienced (PEG/RBV) post liver transplantation and RBV intolerant (Max Time of Approval 24 weeks +Daklinza) (168 tablets total) OR
      • Member is treatment naïve with or without cirrhosis AND Concurrent therapy with Pegylated Interferon and Ribavirin (Max Time of Approval 12 weeks (84 tablets total), OR
      • Member is treatment naïve with or without cirrhosis AND Concurrent therapy with Ribavirin (Max Time of Approval 24 weeks (168 tablets total), OR
      • Member is treatment experienced (failure after PEG/RBV) with cirrhosis AND Concurrent therapy with Ribavirin (Max Time of Approval 24 weeks (168 tablets total), OR
      • Member has decompensated cirrhosis with or without Hepatocellular Carcinoma who may or may not be a candidate for liver transplantation AND Concurrent therapy with RBV (Max Time of Approval 48 weeks (336 tablets total), OR
      • Member is treatment experienced (failure after PEG/RBV) with or without cirrhosis AND Concurrent therapy with Pegylated Interferon and Ribavirin (Max Time of Approval 12 weeks (84 tablets total), OR
      • Member is treatment naïve or treatment experienced post liver transplant with or without cirrhosis including with compensated cirrhosis AND Concurrent therapy with Ribavirin (Max Time of Approval 24 weeks (168 tablets total), OR
      • Member is treatment naïve or treatment experienced post liver transplant with decompensated cirrhosis AND Concurrent therapy with low dose Ribavirin (Max Time of Approval 24 weeks (168 tablets total) 

    OR

    • Chronic Hepatitis C Virus (HCV) infection Genotype 4 with or without HIV, AND
      • Member is treatment naïve with or without cirrhosis AND Concurrent therapy with RBV (Max Time of Approval 24 weeks (168 tablets total), OR
      • Member is treatment naïve or treatment experienced (failure after PEG/RBV) with or without cirrhosis AND Concurrent therapy with Pegylated Interferon and RBV (Max Time of Approval 12 weeks (84 tablets total), OR
      • Member is treatment experienced (failure after PEG/RBV) with or without cirrhosis AND Concurrent therapy with RBV (Max Time of Approval 24 weeks (168 tablets total),

    OR

    • Chronic Hepatitis C Virus (HCV) infection Genotype 5 with or without HIV, AND
      • Member is treatment naïve or treatment experienced with or without cirrhosis AND Concurrent therapy with Pegylated Interferon and RBV (Max Time of Approval 12 weeks (84 tablets total)

    OR

    • Chronic Hepatitis C Virus (HCV) infection Genotype 6 with or without HIV, AND
      • Member is treatment naïve or treatment experienced with or without cirrhosis AND Concurrent therapy with Pegylated Interferon and RBV (Max Time of Approval 12 weeks (84 tablets total)

    For initial authorization, 6 week maximum for 12 or 24 week regimen, (in order to be eligible for the maximum number of tablets, member must meet both initial and reauthorization criteria):

    • Initial authorization criteria above has been met, AND
    • HCV RNA levels have declined > 2 log10 IU/ mL at 4 weeks of therapy

     **Pegylated Interferon (Peg) ineligible/intolerance is defined as meeting one or more of the following criteria:

    • Neutrophils <750 cells/mm3,results within the past month
    • Hemoglobin < 10g/dL, results within the past month
    • Platelets <50 000 cells/ mm3, results within the past month
    • Autoimmune hepatitis or other autoimmune condition known to be exacerbated by Peg
    • Known hypersensitivity to drugs used to treat HCV

    (Not an all inclusive list)

    For Technivie

    For initial authorization, provider must submit medical records documenting the diagnosis of Chronic Hepatitis C with Genotype and subtype, if applicable (i.e., Genotype 4; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease:

    1. Liver Biopsy
    2. Metavir scores
    3. Fibroscan score
    4. APRI score
    5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
    6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician

    AND meet the criteria specified below:

    • A documented contraindication or intolerance or allergy or failure of Preferred Branded Products AND
    • Member does not have decompensated liver disease, AND
    • Member does not have moderate hepatic impairment (Child- Pugh B) AND
    • Member does not have cirrhosis, AND
    • Member is not co-infected with HIV AND
    • Member has not had a liver transplant AND
    • Member has not been previously treated with a HCV Protease Inhibitor (i.e., Incivek, Victrelis, Olysio) AND
    • A documented viral load taken within 6 months of beginning therapy, AND
    • Viral load will be submitted by prescriber 12 weeks after completion of therapy, AND
    • Technivie should not be taken with alfuzosin HCL, carbamazepine, efavirenz, lovastatin, midazolam, phenytoin, phenobarbital, rifampin, ergotamine, dihydroergotamine, ergonovine, methylergonovine, ethinyl estradiol-containing medications such as combined oral contraceptives, St. John’s Wort, lovastatin, simvastatin, pimozide, sildenafil when dosed as Revatio for the treatment of pulmonary arterial hypertension, triazolam, and orally administered midazolam Consult the full prescribing information prior to use for potential drug-drug interactions. AND
    • A documented diagnosis of hepatitis C Genotype 4, AND
    • Member is treatment naïve or treatment experienced (with Peg/RBV) without cirrhosis AND concurrent therapy with RBV (Max Time of Approval 12 weeks with RBV) (3 Paks total), OR
    • Member is treatment naïve or treatment experienced (with Peg/RBV) without cirrhosis AND has a creatinine clearance (CrCl) of less than 30 AND concurrent therapy with RBV (Max Time of Approval 12 weeks with RBV) (3 Paks total),

    For initial authorization, 6 week maximum for 12 week regimen, (in order to be eligible for the maximum number of tablets, member must meet both initial and reauthorization criteria):

    For reauthorization:

    • Initial authorization criteria above has been met, AND
    • HCV RNA levels have declined > 2 log10 IU/ mL at 4 weeks of Therapy.

    Note: There are no treatment guidelines or FDA-approved therapies for retreatment with Technivie after failure of a Technivie regimen.


    For Viekira XR and Viekira Pak

    For initial authorization, provider must submit medical records documenting the diagnosis of Chronic Hepatitis C with Genotype and subtype, if applicable (i.e., Genotype 1a, Genotype 1b; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease:

    1. Liver Biopsy
    2. Metavir scores
    3. Fibroscan score
    4. APRI score
    5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
    6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician

    AND meet the criteria specified below:

    • A documented contraindication or intolerance or allergy or failure of Preferred Branded Products AND
    • Member does not have decompensated liver disease, AND
    • A documented viral load taken within 6 months of beginning therapy, AND
    • Member has not been previously treated with a HCV Protease Inhibitor (Incivek, Olysio, Victrelis), AND
    • Member has not been previously treated with a Sovaldi containing regimen, AND
    • Viral load will be submitted by prescriber 12 weeks after completion of therapy, AND
    • Viekira Pak or Viekira XR should not be taken with alfuzosin HCL, carbamazepine, phenytoin, phenobarbital, gemfibrozil, rifampin, ergotamine, dihydroergotamine, ergonovine, methylergonovine, ethinyl estradiol-containing medications such as combined oral contraceptives, St. John’s Wort, lovastatin, simvastatin, pimozide, efavirenz, sildenafil when dosed as Revatio for the treatment of pulmonary arterial hypertension, triazolam, and orally administered midazolam Consult the full prescribing information prior to use for potential drug-drug interactions.

    AND

    • A documented diagnosis of hepatitis C Genotype 1a with or without HIV, AND
      • Member is treatment naïve without cirrhosis (Max Time of Approval 12 weeks + RBV) (3 Paks total), OR
      • Member is treatment naïve with cirrhosis (Max Time of Approval 24 weeks + RBV) (6 Paks total), OR
      • Member is post liver transplant without cirrhosis (Max Time of Approval 24 weeks + RBV) (6 Paks total) (Metavir fibrosis stage F0-F2 only), OR
      • Member is treatment experienced (failure after PEG/RBV) without cirrhosis (Max Time of Approval 12 weeks + RBV) (3 Paks total), OR
      • Member is treatment experienced (partial responder/relapser to PEG/RBV) with cirrhosis (Max Time of Approval 12 weeks + RBV) (3 Paks total), OR
      • Member is treatment experienced (NON/NULL responder to PEG/RBV) with cirrhosis (Max Time of Approval 24 weeks + RBV) (6 Paks total) OR
      • Member has ESRD or has renal impairment with creatinine clearance less than 30 mL/min without cirrhosis AND concurrent therapy with low dose RBV (Max Time of Approval 12 weeks) (3 Paks total)

    OR

    • A documented diagnosis of hepatitis C Genotype 1b with or without HIV, AND
      • Member is treatment naïve without cirrhosis (Max time of approval 12 weeks) (3 Paks total), OR
      • Member is treatment naïve with cirrhosis (Max time of approval 12 weeks) (3 Paks total), OR
      • Member is treatment experienced (failure after PEG/RBV) without cirrhosis (Max time of approval 12 weeks) (3 Paks total),  OR
      • Member is treatment experienced (regardless of previous response to PEG/RBV) with cirrhosis (Max time of approval 12 weeks) (3 Paks total), OR
      • Member is a post liver transplant recipient with normal hepatic function and mild fibrosis (Metavir fibrosis stage F0- F2) (Max time of approval 24 weeks + RBV) (6 Paks total) OR
      • Member has ESRD or renal impaired with creatinine clearance less than 30 mL/min without cirrhosis (Max Time of Approval 12 weeks) (3 Paks total)

    For initial authorization, 6 week maximum for 12 or 24 week regimen, (in order to be eligible for the maximum number of tablets, member must meet both initial and reauthorization criteria):

    For reauthorization:

    • Initial authorization criteria above has been met, AND
    • HCV RNA levels have declined > 2 log10 IU/ mL at 4 weeks of Therapy.

        Note: There are no treatment guidelines or FDA-approved therapies for retreatment with Viekira Pak or Viekira XR after failure of a Viekira Pak or Viekira XR regimen.

    For Zepatier

    For initial authorization, provider must submit medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype, if applicable (i.e., genotype 1a, genotype 1b; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease:

    1. Liver Biopsy
    2. Metavir scores
    3. Fibroscan score
    4. APRI score
    5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
    6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician

    AND meets the criteria specified below:

    • A documented contraindication or intolerance or allergy or failure of Preferred Branded Products AND
    • Member does not have decompensated liver disease, AND
    • Member has not been previously treated with a Sovaldi containing regimen, Harvoni, Viekira Pak, Viekira XR, Daklinza, Technivie, Zepatier AND
    • A documented viral load taken within 6 months of beginning therapy, AND
    • Viral load will be submitted by prescriber 12 weeks after completion of therapy, AND
    • Zepatier should not be taken with moderate CYP3A inducers or certain strong CYP3A inhibitors

           Consult the full prescribing information prior to use for potential drug-drug interactions.

    AND 

    A documented diagnosis of hepatitis C Genotype 1a with or without all of the following:

    • HIV
    • Cirrhosis

          AND 

    • Member is treatment naïve or treatment experienced (Peg/RBV) without baseline NS5A polymorphisms* (Max time of approval 12 weeks)(3 Cartons total) OR
    • Member is treatment naïve or treatment experienced (Peg/RBV/±PI) WITH baseline NS5A polymorphisms *(Max time of approval 16 weeks + RBV) (4 Cartons total) OR
    • Member is treatment experienced (PEG/RBV/PI (Incivek, Victrelis, Olysio)) (Max time of approval 12 weeks+RBV)(3 Cartons total) OR

    OR

    A documented diagnosis of hepatitis C Genotype 1a with renal impairment and/or receiving hemodialysis:

    • Member is treatment naïve or treatment experienced (Peg/RBV) (Max time of approval 12 weeks)(3 Cartons total)

    OR

    A documented diagnosis of hepatitis C Genotype 1b with or without all of the following:

    • HIV
    • Cirrhosis
    • Renal impairment
    • Dialysis

         AND 

    • Member is treatment naïve or treatment experienced (Peg/RBV) (Max time of approval 12 weeks)(3 Cartons total) OR
    • Member is treatment experienced (PEG/RBV/PI (Incivek, Victrelis, Olysio)) (Max time of approval 12 weeks + RBV)(3 Cartons total)

    OR

    A documented diagnosis of hepatitis C Genotype 4 with or without all of the following:

    • HIV
    • Cirrhosis
    • Renal impairment
    • Dialysis

         AND

    • Member is treatment naïve (Max time of approval 12 weeks)(3 Cartons total) OR
    • Member is treatment experienced (experienced relapse after Peg/RBV) (Max time of approval 12-16 weeks + RBV)(3-4 Cartons total)
    • Member is treatment experienced (Peg/RBV NULL/Partial responder) (Max time of approval 16 weeks + RBV)(4 Cartons total)

     *Polymorphisms at amino acid positions 28, 30, 31, or 93.

    Note: Hepatic testing (ALTs) should be completed:

    • Prior to therapy
    • Treatment week 8
    • Treatment week 12 for patients receiving 16 weeks of therapy

     

     

     

     According to the manufacturer, Epclusa, Harvoni, Olysio, Sovaldi, Viekira Pak, Viekira XR, and Zepatier can be dosed up to a maximum daily dose indicated in the table below. A quantity of these drugs will be considered medically necessary as indicated below:

    Drug Maximum Daily Dose Dosage Strength Quantity Limits
    Epclusa 400-100 mg 400-100 mg Up to 28 tablets in 28 days
    Harvoni 90-400 mg 90-400 mg Up to 28 tablets in 28 days
    Olysio 150 mg 150 mg Up to 28 capsules in 28 days
    Sovaldi 400 mg 400 mg Up to 28 tablets in 28 days
    Viekira Pak 12.5-75-50 & 250 MG 12.5-75-50 & 250 MG Up to 1 Pak every 28 days
    Viekira XR 200-8.33-50-33.33 mg 200-8.33-50-33.33 mg Up to 1 carton every 28 days
    Zepatier 50mg-100mg 50mg-100mg Up to 28 capsules in 28 days


  3. Step Therapy Criteria
  4. Under some plans, including plans that use an open or closed formulary, Daklinza, Epclusa, Olysio, Technivie, Viekira Pak, Viekira XR, and Zepatier are subject to step-therapy. Aetna considers these drugs to be medically necessary for those members who meet the following step-therapy criteria:

    • A documented regimen failure of Preferred Branded Products

    If it is medically necessary for a member to be treated initially with a medication subject to step therapy, the members treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-866-503-0857. (See criteria under section II below).

     

  5. Medical Exception Criteria
  6. Daklinza, Epclusa, Olysio, Technivie, Viekira Pak, Viekira XR and Zepatier are currently listed on the Step-Therapy list. Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that requires step-therapy criteria, unless a medical exception is granted. Aetna considers these drugs to be medically necessary for those members who meet the following criteria:

    • A documented contraindication or intolerance or allergy to Preferred Brand Products

     


Special Notes:

Liver Cirrhosis Decompensation Definition:

Patients with a Child Pugh class of B or C; signs may include one or more of the following:
bleeding varices, ascites, encephalopathy or jaundice


Response Definition:

Partial Responder:  Member experiences at least a 2-log10 (100 times) drop in HCV RNA, but has the inability to fully remove the virus from the blood by end of treatment.

NULL/NON responder: Member does not experience at least 2-log10 (100 times) drop in HCV RNA 8-12 weeks of treatment.

Relapser: Member has an undetectable HCV viral load at end of treatment regimen, but who has a detectable viral load within 12-24 weeks after stopping treatment.

 

Chronic Kidney Disease Definition:

Chronic Kidney Disease is defined as either kidney damage or glomerular filtration rate (GFR) < 60 ml/min/1.73m2 for more than or equal to 3 months.

-Moderate kidney disease is a GFR 30-59 ml/min/1.73m2 

-Severe kidney disease is a GFR 15-29 ml/min/1.73m2

-Kidney failure GFR less than 15 ml/min/1.73m2 (or receiving dialysis)

 

Abbreviation Definitions:

APRI score: AST to Platelet Ratio Index

DAA: direct-acting agent

  • 4 classes of DAAs (define by their mechanism of action and therapeutic target):
    1. nonstructural proteins 9/4 A (NS3/4A) protease inhibitors (Pis): 1st generations PI- boceprevir  and teleprivir.  2nd generations- simeprevir, grazoprevir, paritaprevir
    2. NS5B nucleoside polymerase inhibitors (NPIs): sofosbuvir

    3. NS5B non-nucleoside polymerase inhibitors (NNPIs): dasabuvir

    4. NS5A inhibitors: velpatasvir, ledipasvir, ombitasvir, daclatasvir, elbasvir

PEG: pegylated interferon

PI: protease inhibitors

RBV: ribavirin



Place of Service:

Outpatient

The above policy is based on the following references:
  1. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
  2. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
  3. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
  4. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
  5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. Olysio™ [package insert]. Titusville, NJ: Janssen Products, LP; November 2013.
  6. Olysio™ [package insert]. Titusville, NJ: Janssen Products, LP; November 2013.
  7. Sovaldi™ [package insert]. Foster City, CA: Gilead Sciences, Inc.; March 2015 American Association for the Study of Liver Diseases and the Infectious Diseases Society of America: Recommendations for Testing, Managing, and Treating Hepatitis C. http://www.hcvguidelines.org/full-report-view [accessed on 02/01/2016]
  8. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America: Recommendations for Testing, Managing, and Treating Hepatitis C. http://www.hcvguidelines.org/full-report-view [accessed on 02/10/2016]
  9. Harvoni® [package insert]. Foster City, CA: Gilead Sciences, Inc.; February 2016
  10. Viekira Pak® [package insert].Abbvie Inc.; North Chicago, IL. April 2016
  11. Intron A prescribing information. Merck and Co., Inc.Whitehouse Station, NJ. May 2015.
  12. Moynard,T, Colombo M, Bruix j, et al. Peginterferon alfa-2b and Ribavirin: Effective in Patients with Hepatitis C who Failed Interferon alfa-Ribavirin Therapy (EPIC-3). Gastroenterology. 2009;136:1618-1628.
  13. DRUGDEX System (electronic version). Thomson Reuters (Healthcare) Inc., Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com.  Accessed October 7, 2015.
  14. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2010.  Available at: www.clinicalpharmacology.com Accessed October 7, 2015.
  15. National Kidney Foundation KDOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification, and Stratification, http://www2.kidney.org/professionals/kdoqi/guidelines_ckd/p4_class_g1.htm[retrieved on 02/03/2016]
  16. Zepatier™ [package insert]. White House Station, NJ: Merck and Co., Inc.; January 2016.
  17. Daklinza™ [package insert].Princeton, NJ, Bristol-Myers Squibb Company, July 2015. Accessed February 2016.
  18. Technivie™ [package insert].North Chicago, IL AbbVie Inc., July 2015. Accessed February 2016.
  19. Epculsa® [package insert]. Foster City, CA: Gilead Sciences, Inc.; June 2016
  20. Viekira XR® [package insert].Abbvie Inc.; North Chicago, IL. July 2016

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

November 3, 2016
Aetna
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