Note: Precertification review for Daklinza, Harvoni, Infergen, Intron-A, Olysio, Peg-Intron, Pegasys, Sovaldi, Technivie, Victrelis, and Viekira Pak are handled through Aetna Specialty Precert Unit at 1-866-503-0857 Refer to Medical CPB 400http://aetnet.aetna.com/mpa/cpb/400_499/0404.html for precertification criteria for these drugs.
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, Harvoni,Infergen, Intron-A, Olysio, Pegasys, Peg-Intron/ Redipen/pak, Sovaldi, Victrelis,Viekira Pak, Daklinza, and Technivie 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.
Patient's 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.
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:
Liver Biopsy
Metavir scores
Fibroscan score
APRI score
Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
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 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 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 RBV, OR
Member 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) + 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 - 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 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: Ther e 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 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:
Liver Biopsy
Metavir scores
Fibroscan score
APRI score
Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
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 with or without RBV (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 (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 or 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) without cirrhosis AND Concurrent therapy with RBV (Max Time of Approval 12 weeks (84 tablets total), OR
Member is treatment experienced (failure after PEG/RBV) with cirrhosis AND Concurrent therapy with RBV (Max Time of Approval 12 weeks-16 weeks (84-112 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 or treatment experienced (failure of PEG/RBV) without cirrhosis AND Concurrent therapy with Daklinza and is PEG ineligible or intolerant** - (Max Time of Approval 12 weeks ( 84 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 or without 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 with or without cirrhosis AND Concurrent therapy with Olysio with or without RBV (Max Time of Approval 12 weeks (84 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 maximumnumber of tablets, member must meet both initial and reauthorizationcriteria):
Initial authorization criteria above has been met, AND
HCV RNA levels have declined > 2 log10 IU/ mL at 4 weeks of therap
**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 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 3; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease:
Liver Biopsy
Metavir scores
Fibroscan score
APRI score
Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
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
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
Chronic Hepatitis C Virus (HCV) infection Genotype 3 with or without HIV, AND
Member is treatment naïve or treatment experienced (failure after PEG/RBV) without cirrhosis, AND Concurrent therapy with Sovaldi AND is PEG intolerant or ineligible - (Max Time of Approval 12 weeks (84 tablets 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):
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 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:
Liver Biopsy
Metavir scores
Fibroscan score
APRI score
Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
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.
If member has Genotype 1a, NS3 Q80K polymorphism is not detected prior to treatment 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 Sovaldi with or without RBV (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 (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), with cirrhosis, AND Concurrent therapy with Sovaldi with or without RBV (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 Sovaldi with or without RBV (Max Time of Approval 12 weeks (84 tablets total)
For reauthorization at 6 weeks (member will be eligible for the balance oftherapy 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 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:
Liver Biopsy
Metavir scores
Fibroscan score
APRI score
Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
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),
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 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:
Liver Biopsy
Metavir scores
Fibroscan score
APRI score
Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension)
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 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 is ESRD or renal impaired with creatinine clearance less than 30 mL/min without cirrhosis AND concurrent therapy with 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 + RBV) (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 + RBV) (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 is ESRD or renal imparied with creatinine clearance less than 30 mL/min without cirrhosis AND concurrent therapy with RBV (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 maximumnumber of tablets, member must meet both initial and reauthorizationcriteria):
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 after failure of a Viekira Pak regimen.
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 oneof the following related to staging of liver disease:
Liver Biopsy
Metavir scores
Fibroscan score
APRI score
Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension
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
Member is treatment experienced (experienced relapse after treatment with a Sovaldi containing regimen) with or without cirrhosis AND Concurrent therapy with Sovaldi and Ribavirin (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 oftherapy 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 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
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)
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
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
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)
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
For Victrelis
Initiating Therapy: (Max Time of Approval 10 weeks)
A documented diagnosis of hepatitis C Genotype 1 AND concurrent therapy with ribavirin AND Intron-A, Peg-Intron or Pegasys AND documentation of ALL of the specified criteria listed below:
Patient will NOT be taking concurrently with any of the following:
Adcirca or Revatio when used for pulmonary arterial hypertension (PAH)
triazolam Drug interactions and contraindications can be located in FDA label information.
Patient has or will receive 4 weeks of PEG-IFN and ribavirin prior to starting Victrelis
Patient has NOT previously failed nor is currently on therapy with a treatment regimen that includes a protease inhibitor (e.g., Victrelis, Olysio) HCV RNA levels will be assessed at weeks 4, 8, 12, and 24 of treatment
For Renewal at <10 weeks (Max Time of Approval 10 weeks)
A documented diagnosis of hepatitis C Genotype 1 AND concurrent therapy with ribavirin AND Inton-A, Peg Intron or Pegasys AND documented ALL of the following:
Patient will NOT be taking concurrently with any of the following:
Adcirca or Revatio when used for pulmonary arterial hypertension (PAH)
triazolam Drug interactions and contraindications can be located in FDA label information.
Patient has NOT previously failed with a treatment regimen that includes a protease inhibitor (e.g. Victrelis, Olysio)
Patient is currently receiving and has not received Victrelis in combination with ribavirin and Intron-A or Peg-Intron or Pegasys for ≥8 weeks after initial 4 weeks of lead in therapy with interferon and ribavirin therapy.
HCV RNA levels will be assessed at weeks 12, and 24 of treatment
For Renewal assessment at treatment week 12 (Max Time of Approval 20 weeks)
A documented diagnosis of hepatitis C Genotype 1 AND concurrent therapy with ribavirin AND Intron-A, Peg-Intron or Pegasys AND documented ALL of the following:
Patient will NOT be taking concurrently with any of the following:
Adcirca or Revatio when used for pulmonary arterial hypertension (PAH)
triazolam Drug interactions and contraindications can be located in FDA label information
Patient has NOT previously failed with a treatment regimen that includes a protease inhibitor (e.g. Victrelis, Olysio)
Patient is currently receiving and has received Victrelis in combination with ribavirin and Intron-A or Peg-Intron or Pegasys for ≥8 weeks after initial 4 weeks of lead in therapy with interferon and ribavirin therapy.
Patient did NOT have HCV RNA ≥100 IU/mL at week 12 of treatment
Patient has NOT received ≥20 weeks Victrelis (at week 24 of treatment)
HCV RNA levels will be assessed at weeks 24 of treatment
For Renewal assessment at treatment week 24 - For treatmentnaïve (undetectable HCV RNA at treatment wk 8) (Max Time of Approval 24 weeks)
Note: not including patients with cirrhosis, poor interferon responders or requiring retreatment
A documented diagnosis of hepatitis C Genotype 1AND concurrent therapy with ribavirin AND Intron-A, Peg-Intron or Pegasys AND documented of ALL of the following:
Patient will NOT be taking concurrently with any of the following:
Adcirca or Revatio when used for pulmonary arterial hypertension (PAH)
triazolam Drug interactions and contraindications can be located in FDA label information
Patient has NOT previously failed with a treatment regimen that includes a protease inhibitor (e.g. Victrelis, Olysio)
Patient is currently receiving or has received Victrelis in combination with ribavirin and Intron-A or Peg-Intron or Pegasys for ≥8 weeks after initial 4 weeks of lead in therapy with interferon and ribavirin therapy.
Patient did NOT have HCV RNA ≥100 IU/mL at week 12 of treatment
Patient has received ≥20 weeks Victrelis (at week 24 of treatment)
Patient has an undetectable HCV RNA at week 24 of treatment
For Renewal assessment at treatment week 24 - For treatmentnaïve (detectable HCV RNA at treatment wk 8) (Max Time of Approval 32 weeks)
Note: not including patients with cirrhosis, poor interferon responders or requiring retreatment
A documented diagnosis of hepatitis C Genotype 1AND concurrent therapy with ribavirin AND Intron-A, Peg-Intron or Pegasys AND documented ALL of the following:
Patient will NOT be taking concurrently with any of the following:
Adcirca or Revatio when used for pulmonary arterial hypertension (PAH)
triazolam Drug interactions and contraindications can be located in FDA label information
Patient has NOT previously failed with a treatment regimen that includes a protease inhibitor (e.g. Victrelis, Olysio)
Patient is currently receiving or has received Victrelis combination with ribavirin and Intron-A or Peg-Intron or Pegasys for ≥8 weeks after initial 4 weeks of lead in therapy with interferon and ribavirin therapy
Patient did NOT have HCV RNA ≥100 IU/mL at week 12 of treatment
Patient has an undetectable HCV RNA at week 24 of treatment
For Renewal assessment at treatment week 24 - For retreatment-null responders (i.e.<2-log10 drop in HCV RNA after 12 weeks of treatment) (Max Time of Approval 44 weeks)
Note: not including patients with cirrhosis, not including poor interferon responders
A documented diagnosis of hepatitis C Genotype 1AND concurrent therapy with ribavirin AND Intron-A, Peg-Intron or Pegasys AND documented ALL of the following:
Patient will NOT be taking concurrently with any of the following:
Adcirca or Revatio when used for pulmonary arterial hypertension (PAH)
triazolam Drug interactions and contraindications can be located in FDA label information
Patient has NOT previously failed with a treatment regimen that includes a protease inhibitor (e.g. Victrelis, Olysio)
Patient is currently receiving or has received Victrelis in combination with ribavirin and Intron-A or Peg Intron or Pegasys for ≥8 weeks after initial 4 weeks of lead in therapy with interferon and ribavirin therapy
Patient did NOT have HCV RNA ≥100 IU/mL at week 12 of treatment
Patient has received ≥20 weeks Victrelis at week 24 of treatment
Patient has an undetectable HCV RNA at week 24 of treatment
For Renewal assessment at treatment week 24 –For retreatment- ( Max time of approval 32 weeks)
Note: not including patients with cirrhosis, not including poor interferon responders or prior history of null response
A documented diagnosis of hepatitis C Genotype 1AND concurrent therapy with ribavirin AND Intron-A, Peg-Intron or Pegasys AND documented ALL of the following:
Patient will NOT be taking concurrently with any of the following:
Adcirca or Revatio when used for pulmonary arterial hypertension (PAH)
triazolam Drug interactions and contraindications can be located in FDA label information
Patient has NOT previously failed with a treatment regimen that includes a protease inhibitor (e.g., Victrelis, Olysio)
Patient is currently receiving or has received Victrelis in combination with ribavirin and Intron-A or Peg-Intron or Pegasys for ≥ 8 weeks after initial 4 weeks of lead in therapy with interferon and ribavirin therapy.
Patient did NOT have HCV RNA ≥100 IU/mL at week 12 of treatment
Patient has received ≥ 20 weeks Victrelis at week 24 of treatment
Patient has an undetectable HCV RNA at week 24 of treatment
For Renewal assessment at treatment week 24 –For Cirrhotic patient or Poorly IFN responsive patient (<1.0-log10 decline in HCV RNA at week 4 of treatment) (Max time of approval 44 weeks)
A documented diagnosis of hepatitis C Genotype 1AND concurrent therapy with ribavirin AND Intron-A, Peg-Intron or Pegasys AND documented ALL of the following:
Patient will NOT be taking concurrently with any of the following:
Adcirca Revatio when used for pulmonary arterial hypertension (PAH)
triazolam Drug interactions and contraindications can be located in FDA label information
Patient has NOT previously failed with a treatment regimen that includes a protease inhibitor (e.g. Victrelis, Olysio)
Patient is currently receiving or has received Victrelis in combination with ribavirin and Intron-A or Peg-Intron or Pegasys for ≥ 8 weeks after initial 4 weeks of lead in therapy with interferon and ribavirin therapy.
Patient did NOT have HCV RNA ≥100 IU/mL at week 12 of treatment
Patient has received ≥ 20 weeks Victrelis at week 24 of treatment
Patient has an undetectable HCV RNA at week 24 of treatment
According to the manufacturer, Harvoni, Olysio, Sovaldi,Victrelis, and Viekira Pak 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
Olysio
150 mg
150 mg
Up to 28 capsules in 28 days
Sovaldi
400 mg
400 mg
Up to 28 tablets in 28 days
Harvoni
90-400 MG
90-400 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
Victrelis
2400 mg
200 mg
Up to 360 tablets in 30 days
Step Therapy Criteria
Under some plans, including plans that use an open or closed formulary, Viekira Pak, Olysio, Daklinza and Technivie 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).
Medical Exception Criteria
Viekira Pak, Olysio, Daklinza and Technivie 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.
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. 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. 6. Olysio™ [package insert]. Titusville, NJ: Janssen Products, LP; November 2013. 7. Sovaldi™ [package insert]. Foster City, CA: Gilead Sciences, Inc.; March 2015 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 [retrieved on 04/05/2015] 9. Harvoni® [package insert]. Foster City, CA: Gilead Sciences, Inc.; March 2015 10. Viekira Pak® [package insert].Abbvie Inc.; North Chicago, IL. December 2014
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.
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