Hepatic Disorders

 

Daklinza
Defitelio
Epclusa
Harvoni
Mavyret
Ocaliva
Olysio
Sovaldi
Victrelis/Incivek
Vosevi
Zepatier

Hepatitis C Criteria  

Harvoni® (sofosbuvir/ledipasvir), Zepatier® (elbasvir/grazoprevir), Epclusa® (sofosbuvir/velpatasvir), Mavyret™ (glecaprevir/ pibrentasvir), and Vosevi®(sofosbuvir/velpatasvir/voxilaprevir) are the preferred direct-acting antivirals (DAAs) for the treatment of chronic HCV genotype 1. Use of an alternative regimen including Sovaldi® (sofosbuvir) and Olysio® (simeprevir) in combination, Olysio® (simeprevir) alone, or Sovaldi® (sofosbuvir) and Daklinza™ (daclatasvir) in combination for the treatment of HCV genotype 1 requires patient-specific, clinically significant reasoning why the preferred DAAs are not appropriate for the member.  

Hepatitis C Therapy Forms:

Hepatitis C Therapy Intent to Treat Contract 
Heptatitis C Therapy Pharmacy Agreement 
Hepatitis C Therapy Continuation

 daclatasvir (Daklinza™)

Approval Criteria:   

  • Member must be 18 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-3; AND
  • Daklinza™ must be prescribed by a gastroenterologist, infectious disease specialist, or transplant specialist or the member must have been evaluated by a gastroenterologist, infectious disease specialist, or transplant specialist for hepatitis C therapy within the last three months; AND
  • Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  • Member has chronic HCV infection defined by:
    • If the member has a liver fibrosis score ≥F1 (METAVIR equivalent) then only one detectable and quantifiable HCV RNA (>15 IU/mL) test within the last 12 months is required; OR
    • If the member has a liver fibrosis score <F1 (METAVIR equivalent) then the following must be met:
      • Positive (i.e., reactive) HCV antibody test that is at least six months old and has a detectable and quantifiable HCV RNA (>15 IU/mL) test six months after date of positive HCV antibody test; OR
      • Two detectable and quantifiable HCV RNA (>15 IU/mL) tests at least six months apart.  
  • The following regimens and requirements based on genotype and concomitant drug therapy will apply:
    • Genotype-1, treatment-naïve or treatment-experienced, without cirrhosis or with compensated cirrhosis:
      • Daklinza™ 60mg with Sovaldi®  for 12 weeks 
    • Genotype-1, treatment-naïve or treatment-experienced, with decompensated cirrhosis, or post-transplant:
      • Daklinza™ 60mg with Sovaldi® and weight-based ribavirin  for 12 weeks 
    • Genotype-2, treatment-naïve or treatment-experienced, without cirrhosis, RBV intolerant:
      • Daklinza™ 60mg with Sovaldi®  for 12 weeks 
    • Genotype-2, treatment-naïve or treatment-experienced, with cirrhosis, RBV intolerant:
      • Daklinza™ 60mg with Sovaldi® for 16 weeks 
    • Genotype-3, treatment-naïve or treatment-experienced, without cirrhosis:
      • Daklinza™ 60mg with Sovaldi®  for 12 weeks
    •  Genotype-3, treatment-naïve or treatment-experienced, with compensated or decompensated cirrhosis, or post-transplant:
      • Daklinza™ 60mg with Sovaldi® and weight-based ribavirin  for 12 weeks 
    • Concomitant use of moderate CYP3A inducer(s):
      • Daklinza™ 90mg (all other regimen criteria applies) 
      • Moderate Inducers: bosentan, dexamethasone, efavirenz, etravirine, modafinil, nafcillin, and rifapentine 
    • Concomitant use of strong CYP3A inhibitors:
      • Daklinza™ 30mg (all other regimen criteria applies)
      • Strong CYP3A inhibitors include the following: atazanavir/ritonavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, saquinavir, telithromycin, and voriconazole 
    • New regimens will apply as approved by the FDA 
  • Member must sign and submit the Hepatitis C Intent to Treat contract; AND
  • Member’s pharmacy must submit the Hepatitis C Therapy Pharmacy Agreement for each member on therapy; AND
  • The prescriber must verify that they will provide SoonerCare with all necessary labs to evaluate hepatitis C therapy efficacy including Sustained Viral Response (SVR-12); AND
  • Prescriber must agree to counsel members on potential harms of illicit IV drug use or alcohol use and member must agree to no illicit IV drug use or alcohol use while on treatment and post-therapy; AND
  • Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND  
  • Female members must not be pregnant and must have a pregnancy test immediately prior to therapy initiation. Male and female members must be willing to use two forms of non-hormonal birth control while on therapy and for six months after therapy completion; AND
  • Member must not be taking the following medications: carbamazepine, phenytoin, phenobarbital, rifampin, amiodarone, and St. John’s wort; AND
  • All other clinically significant issues must be addressed prior to starting therapy including but not limited to the following: neutropenia, anemia, thrombocytopenia, surgery, depression, psychosis, epilepsy, obesity, weight management, severe concurrent medical diseases, such as but not limited to, retinal disease or autoimmune thyroid disease; AND
  • Prescribing physician must verify that they will work with the member to ensure the member remains adherent to hepatitis C therapies; AND
  • Members must be adherent for continued approval. Treatment gaps of therapy longer than 3 days/month will result in denial of subsequent requests for continued therapy. 
  • Approvals for treatment regimen initiation for 12 weeks of therapy will not be granted prior to the 10th of a month in order to prevent prescription limit issues from affecting the member’s compliance.  

Daklinza Initiation Form

    

sofosbuvir/velpatasvir (Epclusa®)

Approval Criteria:   

  • Member must be 18 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-1, genotype-2, genotype-3, genotype-4, genotype-5, or genotype-6; AND
  • Epclusa® must be prescribed by a gastroenterologist, infectious disease specialist, or transplant specialist or the member must have been evaluated for hepatitis C treatment by a gastroenterologist, infectious disease specialist, or transplant specialist within the last three months; AND
  • Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  • Member has chronic HCV infection defined by: 
    • If the member has a liver fibrosis score ≥F1 (METAVIR equivalent) then only one detectable and quantifiable HCV RNA (>15 IU/mL) test within the last 12 months is required; OR
    • If the member has a liver fibrosis score <F1 (METAVIR equivalent) then the following must be met:  
      • Positive (i.e., reactive) HCV antibody test that is at least six months old and has a detectable and quantifiable HCV RNA (>15 IU/mL) test six months after date of positive HCV antibody test; OR
      • Two detectable and quantifiable HCV RNA (>15 IU/mL) tests at least six months apart. 
  • The following regimens and requirements based on cirrhosis status will apply:
  • Genotype-1, -2, -3, -4, -5, -6:
    • Treatment-naïve or treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A):
      • Epclusa® for 12 weeks 
    • Treatment-naïve or treatment-experienced with decompensated cirrhosis (Child-Pugh B and C):
      • Epclusa® + weight-based ribavirin for 12 weeks
    • New regimens will apply as approved by the FDA
  • Member must sign and submit the Hepatitis C Intent to Treat contract; AND
  • Member’s pharmacy must submit the Hepatitis C Therapy Pharmacy Agreement for each member on therapy; AND
  • The prescriber must verify that they will provide SoonerCare with all necessary labs to evaluate hepatitis C therapy efficacy including Sustained Virologic Response (SVR-12); AND
  • Prescriber must agree to counsel members on potential harms of illicit IV drug use or alcohol use and member must agree to no illicit IV drug use or alcohol use while on treatment and post-therapy; AND
  • Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
  • Member must not have severe renal impairment (estimated Glomerular Filtration Rate [eGFR] <30mL/min/1.73m2); AND
  • Female members must not be pregnant and must have a pregnancy test immediately prior to therapy initiation. Male and female members must be willing to use two forms of non-hormonal birth control while on therapy (and for six months after therapy completion for ribavirin users); AND
  • Member must not be taking the following medications: H2-receptor antagonists at doses greater than 40mg famotidine equivalent, amiodarone, omeprazole or other proton pump inhibitors, topotecan, rifampin, rifabutin, rifapentine, carbamazepine, eslicarbazepine, phenytoin, phenobarbital, oxcarbazepine, efavirenz, tenofovir disoproxil fumarate, tipranavir/ritonavir, St. John’s wort, and rosuvastatin doses exceeding 10mg; AND
  • If member is using antacids they must agree to separate antacid and Epclusa® administration by four hours; AND
  • All other clinically significant issues must be addressed prior to starting therapy including but not limited to the following: neutropenia, anemia, thrombocytopenia, surgery, depression, psychosis, epilepsy, obesity, weight-management, severe concurrent medical diseases, such as but not limited to, retinal disease, or autoimmune thyroid disease. 
  • Prescribing physician must verify that they will work with the member to ensure the member remains adherent to hepatitis C therapies; AND
  • Members must be adherent for continued approval. Treatment gaps of therapy longer than 3 days/month will result in denial of subsequent requests for continued therapy. 
  • Approvals for treatment regimen initiation for 12 weeks of therapy will not be granted prior to the 10th of a month in order to prevent prescription limit issues from affecting the member’s compliance. 

Epclusa Initiation Form

    

 ledipasvir/sofosbuvir (Harvoni®)

Approval Criteria: 

  • Member must be 12 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-1, genotype-4, genotype-5, or genotype-6; AND
  • Harvoni® must be prescribed by a gastroenterologist, infectious disease specialist, or transplant specialist or the member must have been evaluated for hepatitis C treatment by a gastroenterologist, infectious disease specialist, or transplant specialist within the last three months; AND
  • Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  • Member has chronic HCV infection defined by:
    • If the member has a liver fibrosis score ≥F1 (METAVIR equivalent) then only one detectable and quantifiable HCV RNA (>15 IU/mL) test within the last 12 months is required (must be within last 3 months if requesting 8-week regimen); OR
    • If the member has a liver fibrosis score <F1 (METAVIR equivalent) then the following must be met:
      • Positive (i.e., reactive) HCV antibody test that is at least six months old and has a detectable and quantifiable HCV RNA (>15 IU/mL) test six months after date of positive HCV antibody test; OR
      • Two detectable and quantifiable HCV RNA (>15 IU/mL) tests at least six months apart.  
  • The following regimens and requirements based on prior treatment experience, baseline viral load, and cirrhosis will apply: 
  • Genotype-1:
    • Treatment-naïve without cirrhosis who have a pre-treatment HCV-RNA less than 6 million IU/mL: 
      • Harvoni® (ledipasvir/sofosbuvir) for 8 weeks  
    • Treatment-naïve with or without compensated cirrhosis: 
      •  Treatment-naïve patients who are cirrhotic or have a pre-treatment HCV-RNA greater than 6 million IU/mL 
      •  Harvoni® (ledipasvir/sofosbuvir) for 12 weeks  
    •  Treatment-experienced without cirrhosis: 
      • Harvoni® (ledipasvir/sofosbuvir) for 12 weeks  
    • Treatment-experienced with compensated cirrhosis:
      • Harvoni® (ledipasvir/sofosbuvir) with weight-based ribavirin for 12 weeks 
      • Harvoni® (ledipasvir/sofosbuvir) for 24 weeks 
    • Treatment-naïve or treatment-experienced with decompensated cirrhosis: 
      • Harvoni® (ledipasvir/sofosbuvir) with weight-based ribavirin for 12 weeks  
  • Genotype-1 or Genotype-4:
    • Treatment-naïve or treatment-experienced liver transplant recipients with or without compensated cirrhosis:
      • Harvoni® with weight-based ribavirin for 12 weeks 
  • Genotype-4, Genotype-5, or Genotype-6:
    • Treatment-naïve and treatment -experienced, with or without cirrhosis:
      • Harvoni® (ledipasvir/sofosbuvir) for 12 weeks 
  • New regimens will apply as approved by the FDA
  • Member must sign and submit the Hepatitis C Intent to Treat contract; AND
  • Member’s pharmacy must submit the Hepatitis C Therapy Pharmacy Agreement for each member on therapy; AND
  • The prescriber must verify that they will provide SoonerCare with all necessary labs to evaluate hepatitis C therapy efficacy including Sustained Viral Response (SVR-12); AND
  • Prescriber must agree to counsel members on potential harms of illicit IV drug use or alcohol use and member must agree to no illicit IV drug use or alcohol use while on treatment and post-therapy; AND
  • Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
  • Member must not have severe renal impairment (estimated Glomerular Filtration Rate [eGFR] <30mL/min/1.73m2); AND
  • Female members must not be pregnant and must have a pregnancy test immediately prior to therapy initiation. Male and female members must be willing to use two forms of non-hormonal birth control while on therapy (and for six months after therapy completion for those on ribavirin); AND
  • Member must not be taking the following medications: rifampin, rifabutin, rifapentine, carbamazepine, eslicarbazepine, phenytoin, phenobarbital, oxcarbazepine, tipranavir/ritonavir, simeprevir, rosuvastatin, St. John’s wort, or elvitegravir/cobicistat/emtricitabine in combination with tenofovir disoproxil fumarate; AND
  • All other clinically significant issues must be addressed prior to starting therapy including but not limited to the following: neutropenia, anemia, thrombocytopenia, surgery, depression, psychosis, epilepsy, obesity, weight management, severe concurrent medical diseases, such as but not limited to, retinal disease or autoimmune thyroid disease. 
  • Prescribing physician must verify that they will work with the member to ensure the member remains adherent to hepatitis C therapies; AND
  • Members must be adherent for continued approval. Treatment gaps of therapy longer than 3 days/month will result in denial of subsequent requests for continued therapy. 
  • Approvals for treatment regimen initiation for 12 weeks of therapy will not be granted prior to the 10th of a month, and for 24 weeks of therapy prior to the 15th of a month in order to prevent prescription limit issues from affecting the member’s compliance. 

Harvoni Initiation Form

        

glecaprevir/pibrentasvir (Mavyret™)

 Approval Criteria:   

  • Member must be 18 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-1, genotype-2, genotype-3, genotype-4, genotype-5, or genotype-6; AND
  • Mavyret™ must be prescribed by a gastroenterologist, infectious disease specialist, or transplant specialist or the member must have been evaluated for hepatitis C treatment by a gastroenterologist, infectious disease specialist, or transplant specialist within the last three months; AND
  • Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  • Member has chronic HCV infection defined by: 
    • If the member has a liver fibrosis score ≥F1 (METAVIR equivalent) then only one detectable and quantifiable HCV RNA (>15 IU/mL) test within the last 12 months is required; OR
    • If the member has a liver fibrosis score <F1 (METAVIR equivalent) then the following must be met: 
       Positive (i.e., reactive) HCV antibody test that is at least six months old and has a detectable and quantifiable HCV RNA (>15 IU/mL) test six months after date of positive HCV antibody test; OR
      • Two detectable and quantifiable HCV RNA (>15 IU/mL) tests at least six months apart. 
  • The following regimens and requirements based on cirrhosis status, genotype, and treatment history will apply:
    • Treatment-naïve without cirrhosis and genotype-1, -2, -3, -4, -5, or -6:
      • Mavyret™ for 8 weeks 
    • Treatment-naïve with compensated cirrhosis (Child-Pugh A) and genotype-1, -2, -3, -4, -5, or -6:
      • Mavyret™ for 12 weeks 
    • Treatment-experienced with an NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor (PI) without cirrhosis or with compensated cirrhosis (Child-Pugh A) and genotype-1, -2, -3, -4, -5, or -6:
      • Mavyret™ for 16 weeks
      • Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
      • Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir 
    • Treatment-experienced with an NS3/4A PI without prior treatment with an NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A) and genotype-1, -2, -3, -4, -5, or -6:
      • Mavyret™ for 12 weeks
      • Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
      • Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir 
    • Treatment-experienced with pegylated interferon, ribavirin, and/or sofosbuvir without prior treatment with an NS3/4A PI or NS5A inhibitor without cirrhosis and genotype-1, -2, -4, -5, or -6:
      • Mavyret™ for 8 weeks
      • Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
      • Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir 
    • Treatment-experienced with pegylated interferon, ribavirin, and/or sofosbuvir without prior treatment with an NS3/4A PI or NS5A inhibitor with compensated cirrhosis (Child-Pugh A) and genotype-1, -2, -4, -5, or -6:
      • Mavyret™ for 12 weeks
      • Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
      • Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir 
    • Treatment-experienced with pegylated interferon, ribavirin, and/or sofosbuvir without prior treatment with an NS3/4A PI or NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A) and genotype-3:
      • Mavyret™ for 16 weeks
      • Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
      • Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir 
    • New regimens will apply as approved by the FDA 
  • Member must sign and submit the Hepatitis C Intent to Treat contract; AND
  • Member’s pharmacy must submit the Hepatitis C Therapy Pharmacy Agreement for each member on therapy; AND
  • The prescriber must verify that they will provide SoonerCare with all necessary labs to evaluate hepatitis C therapy efficacy including Sustained Virologic Response (SVR-12); AND
  • Prescriber must agree to counsel members on potential harms of illicit IV drug use or alcohol use and member must agree to no illicit IV drug use or alcohol use while on treatment and post-therapy; AND
  • Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
  • Member must not have decompensated cirrhosis or moderate or severe hepatic impairment (Child-Pugh B or -C); AND
  • Female members must not be pregnant and must have a pregnancy test immediately prior to therapy initiation. Male and female members must be willing to use two forms of non-hormonal birth control while on therapy; AND
  • Member must not be taking the following medications: carbamazepine, rifampin, ethinyl estradiol containing medications, St. John’s wort, atazanavir, darunavir, lopinavir, ritonavir, efavirenz, atorvastatin, lovastatin, simvastatin, rosuvastatin doses greater than 10mg, cyclosporine doses greater than 100mg per day; AND
  • All other clinically significant issues must be addressed prior to starting therapy including but not limited to the following: neutropenia, anemia, thrombocytopenia, surgery, depression, psychosis, epilepsy, obesity, weight-management, severe concurrent medical diseases, such as but not limited to, retinal disease, or autoimmune thyroid disease.
  • Prescribing physician must verify that they will work with the member to ensure the member remains adherent to hepatitis C therapies; AND
  • Members must be adherent for continued approval. Treatment gaps of therapy longer than 3 days/month will result in denial of subsequent requests for continued therapy.
  • Approvals for treatment regimen initiation for 12 weeks of therapy will not be granted prior to the 10th of a month in order to prevent prescription limit issues from affecting the member’s compliance. 

Mavyret Initiation Form

 

            

 simeprevir (Olysio™)

Approval Criteria:

  • Member must be 18 years of age or older; AND
  • Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  • Members with genotype 1a must be screened for the NS3 Q80K polymorphism prior to initiation of therapy. Approvals will not be granted for members with this polymorphism; AND
  • Olysio™ must be prescribed by a gastroenterologist, infectious disease specialist, or transplant specialist or the member must have been evaluated by a gastroenterologist, infectious disease specialist, or transplant specialist within the last three months; AND
  • Olysio™ must be used as a component of a combination regimen. Olysio™ will be approved for combination therapy only. 
  • Member has chronic HCV infection defined by: 
    • If the member has a liver fibrosis score ≥F1 (METAVIR equivalent) then only one detectable and quantifiable HCV RNA (>15 IU/mL) test within the last 12 months is required; OR
    • If the member has a liver fibrosis score <F1 (METAVIR equivalent) then the following must be met:  
      • Positive (i.e., reactive) HCV antibody test that is at least six months old and has a detectable and quantifiable HCV RNA (>15 IU/mL) test six months after date of positive HCV antibody test; OR
      • Two detectable and quantifiable HCV RNA (>15 IU/mL) tests at least six months apart. 
  • The following regimens and requirements based on genotype, prior treatment experience, and cirrhosis status will apply: 
  • Genotype 1a and 1b:
    • Treatment-naïve, non-cirrhotic: 
      • Olysio™ with Sovaldi™ +/- weight-based ribavirin for 12 weeks 
    • Treatment-naïve, cirrhotic: 
      • Olysio™ with Sovaldi™  +/- weight-based ribavirin for 24 weeks 
    • Treatment-experienced, non-cirrhotic:
      • Olysio™ with Sovaldi™ +/- weight-based ribavirin for 12 weeks 
    • Treatment-experienced,  cirrhotic: 
      • Olysio™ with Sovaldi™  +/- weight-based ribavirin for 24 weeks 
    • New regimens will apply as approved by the FDA  
  • Member must not have previously failed treatment with a hepatitis C protease inhibitor (non-responder or relapsed); AND
  • Member must not have decompensated hepatic disease (Child Turcotte Pugh (CTP) class B or C); AND
  • Member must sign the intent to treat contract; AND
  • Prescriber must agree to counsel members on potential harms of illicit IV drug use or alcohol use and member must agree to no illicit IV drug use or alcohol use while on treatment and post-therapy; AND
  • Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
  • Female members must not be pregnant and must have a pregnancy test immediately prior to therapy initiation. Female partners of male patients should also be checked for pregnancy for informational purposes. Male and female members must be willing to use two forms of non-hormonal birth control while on therapy and for six months after therapy completion; AND
  • Member must not be taking the following medications: efavirenz, delavirdine, etravirine, nevirapine, ritanovir and any HIV protease inhibitor (boosted or not by ritanovir), rifampin, rifabutin, rifapentine, erythromycin, clarithromycin, telithromycin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole, dexamethasone, cisapride, didanosine, milk thistle, or St. John’s wort; AND
  • All other clinically significant issues must be addressed prior to starting therapy including but not limited to the following: neutropenia, anemia, thrombocytopenia, surgery, depression, psychosis, epilepsy, obesity weight management, severe concurrent medical diseases such as but not limited to retinal disease or autoimmune thyroid disease. 
  • Members must be adherent for continued approval. Treatment gaps of therapy longer than 3 days/month will result in denial of subsequent requests for continued therapy. 
  • Due to superior SVR rates and shortened treatment durations with Harvoni®, authorization of Sovaldi™ or Olysio™ for genotype-1 will require a patient-specific, clinically significant reason why Harvoni® is not an option.   
 

Olysio Initiation

       

 sofosbuvir (Sovalidi™)

Approval Criteria: 

  • Member must be 12 years of age or older; AND
  • An FDA approved diagnosis of chronic hepatitis C (CHC) genotype-1, genotype-2,  genotype-3, or genotype-4; AND
  • Sovaldi™ must be prescribed by a gastroenterologist, infectious disease specialist, or transplant specialist or the member must have been evaluated by a gastroenterologist, infectious disease specialist, or transplant specialist within the last three months; AND
  • Sovaldi™ must be used as a component of a combination regimen; AND
  • Member must be eligible for ribavirin (RBV) or daclatasvir therapy. Approvals will not be granted for regimens without RBV or daclatasvir; AND
  • Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  • Member has chronic HCV infection defined by: 
    • If the member has a liver fibrosis score ≥F1 (METAVIR equivalent) then only one detectable and quantifiable HCV RNA (>15 IU/mL) test within the last 12 months is required; OR
    • If the member has a liver fibrosis score <F1 (METAVIR equivalent) then the following must be met:  
      • Positive (i.e., reactive) HCV antibody test that is at least six months old and has a detectable and quantifiable HCV RNA (>15 IU/mL) test six months after date of positive HCV antibody test; OR
      • Two detectable and quantifiable HCV RNA (>15 IU/mL) tests at least six months apart. 
  • The following regimens and requirements based on genotype, prior treatment experience, and cirrhosis status will apply: 
    • Genotype 1:
      • Treatment-naïve or experienced, non-cirrhotic or cirrhotic: 
      • Sovaldi® with weight-based ribavirin and peginterferon alfa for 12 weeks 
    • Genotype 2:
      • Treatment-naïve, non-cirrhotic: 
        • Sovaldi™ with weight-based ribavirin for 12 weeks
      • Treatment-naïve, cirrhotic: 
        • Sovaldi® with weight-based ribavirin for 12 or 16 weeks 
      • Treatment-experienced, non-cirrhotic or cirrhotic: 
        • Sovaldi® with weight-based ribavirin for 12 or 16 weeks 
        • Sovaldi® with weight-based ribavirin and peginterferon alfa for 12 weeks
    • Genotype 3:
      •  Treatment-naïve, non-cirrhotic
        • Daklinza™ with Sovaldi® for 12 weeks  
        • Sovaldi® with weight-based ribavirin and peginterferon alfa for 12 weeks 
        • Sovaldi® with weight-based ribavirin for 24 weeks (if interferon ineligible) 
      • Treatment-naïve, cirrhotic
        • Daklinza™ with Sovaldi® and weight based ribavirin for 12 weeks 
        • Sovaldi® with weight-based ribavirin and peginterferon alfa for 12 weeks
        • Sovaldi® with weight-based ribavirin for 24 weeks (if interferon ineligible)
      • Treatment-experienced, non-cirrhotic
        • Daklinza™ with Sovaldi® for 12 weeks
        • Sovaldi® with weight-based ribavirin and peginterferon alfa for 12 weeks
        • Sovaldi® with weight-based ribavirin for 24 weeks (if interferon ineligible)
      • Treatment-experienced, cirrhotic
        • Daklinza™ with Sovaldi® and weight based ribavirin for 12 weeks
        • Sovaldi® with weight-based ribavirin and peginterferon alfa for 12 weeks 
        • Sovaldi® with weight-based ribavirin for 24 weeks (if interferon ineligible)
    • Genotype 4:
      • Treatment-naïve or experienced, non-cirrhotic or cirrhotic: 
        • Sovaldi® with weight-based ribavirin and peginterferon alfa for 12 weeks 
  • New regimens will apply as approved by the FDA. For regimens containing Olysio™ with Sovaldi® please refer to Olysio™ criteria. 
  • Member must sign and submit the Hepatitis C Intent to Treat contract; AND
  • Member’s pharmacy must submit the Hepatitis C Therapy Pharmacy Agreement for each member on therapy; AND
  • The prescriber must verify that they will provide SoonerCare with all necessary labs to evaluate hepatitis C therapy efficacy including Sustained Viral Response (SVR-12); AND
  • Prescriber must agree to counsel members on potential harms of illicit IV drug use or alcohol use and member must agree to no illicit IV drug use or alcohol use while on treatment and post-therapy; AND
  • Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
  • Member must not have decompensated cirrhosis; AND
  • Female members must have a pregnancy test immediately prior to therapy initiation. Male and female members must be willing to use 2 forms of non-hormonal birth control while on therapy (and for 6 months after therapy completion for ribavirin members); AND
  • Member must not be taking the following medications: rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, oxcarbazepine, tipranavir/ritonavir, didanosine or St. John’s wort; AND
  • All other clinically significant issues must be addressed prior to starting therapy including but not limited to the following: neutropenia, anemia, thrombocytopenia, surgery, depression, psychosis, epilepsy, obesity, weight management, severe concurrent medical diseases, such as but not limited to, retinal disease or autoimmune thyroid disease. 
  • Prescribing physician must verify that they will work with the member to ensure the member remains adherent to hepatitis C therapies; AND
  • Members must be adherent for continued approval. Treatment gaps of therapy longer than 3 days/month will result in denial of subsequent requests for continued therapy. 
  • Approvals for treatment regimen initiation for 12 weeks of therapy will not be granted prior to the 10th of a month, and for 24 weeks of therapy prior to the 15th of a month in order to prevent prescription limit issues from affecting the member’s compliance.

Sovaldi Initiation Form  

              

boceprevir (Victrelis®) and telaprevir (Incivek®)

Approval Criteria:   

  • Use of Victrelis® or Incivek® requires a patient-specific, clinically significant reason why the member cannot use Olysio™ (simeprevir). 
  • Those members currently receiving Victrelis® or Incivek® for the diagnosis of hepatitis C will be grandfathered for therapy completion. 
 

               

sofosbuvir/velpatasvir/voxilaprevir (Vosevi™)

Approval Criteria: DRAFT

  • Member must be 18 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-1, genotype-2, genotype-3, genotype-4, genotype-5, or genotype-6; AND  
  • Vosevi™ must be prescribed by a gastroenterologist, infectious disease specialist, or transplant specialist or the member must have been evaluated for hepatitis C treatment by a gastroenterologist, infectious disease specialist, or transplant specialist within the last three months; AND
     Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  • Member has chronic HCV infection defined by: 
    • If the member has a liver fibrosis score ≥F1 (METAVIR equivalent) then only one detectable and quantifiable HCV RNA (>15 IU/mL) test within the last 12 months is required; OR
    • If the member has a liver fibrosis score <F1 (METAVIR equivalent) then the following must be met:  
      • Positive (i.e., reactive) HCV antibody test that is at least six months old and has a detectable and quantifiable HCV RNA (>15 IU/mL) test six months after date of positive HCV antibody test; OR
      • Two detectable and quantifiable HCV RNA (>15 IU/mL) tests at least six months apart. 
  • The following regimens and requirements based on treatment history will apply:
    • Adult patients without cirrhosis or with compensated cirrhosis (Child-Pugh A):
      • Genotype-1, -2, -3, -4, -5, or -6 patients who were previously treated with an HCV regimen containing an NS5A inhibitor (e.g., daclatasvir, elbasvir, ledipasvir, ombitasvir, velpatasvir):
        • Vosevi™ for 12 weeks 
      • Genotype-1a -or -3 patients who were previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor:
        • Vosevi™ for 12 weeks 
    • New regimens will apply as approved by the FDA 
  • Member must sign and submit the Hepatitis C Intent to Treat contract; AND
  • Member’s pharmacy must submit the Hepatitis C Therapy Pharmacy Agreement for each member on therapy; AND
  • The prescriber must verify that they will provide SoonerCare with all necessary labs to evaluate hepatitis C therapy efficacy including Sustained Virologic Response (SVR-12); AND
  • Prescriber must agree to counsel members on potential harms of illicit IV drug use or alcohol use and member must agree to no illicit IV drug use or alcohol use while on treatment and post-therapy; AND
  • Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
  • Member must not have decompensated cirrhosis or moderate or severe hepatic impairment (Child-Pugh B or -C); AND
  • Member must not have severe renal impairment (estimated Glomerular Filtration Rate [eGFR] <30mL/min/1.73m2); AND
  • Female members must not be pregnant and must have a pregnancy test immediately prior to therapy initiation. Male and female members must be willing to use two forms of non-hormonal birth control while on therapy; AND
  • Member must not be taking the following medications: H2-receptor antagonists at doses greater than 40mg famotidine equivalent, omeprazole doses greater than 20mg daily or other proton pump inhibitors, amiodarone, carbamazepine, eslicarbazepine, phenytoin, phenobarbital, oxcarbazepine, rifampin, rifabutin, rifapentine, atazanavir, lopinavir, tipranavir/ritonavir, efavirenz, St. John’s wort, pravastatin doses greater than 40mg, rosuvastatin, pitavastatin, cyclosporine, methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, sulfasalazine, topotecan; AND
  • If member is using antacids they must agree to separate antacid and Vosevi™ administration by four hours; AND
  • All other clinically significant issues must be addressed prior to starting therapy including but not limited to the following: neutropenia, anemia, thrombocytopenia, surgery, depression, psychosis, epilepsy, obesity, weight-management, severe concurrent medical diseases, such as but not limited to, retinal disease, or autoimmune thyroid disease. 
  • Prescribing physician must verify that they will work with the member to ensure the member remains adherent to hepatitis C therapies; AND
  • Members must be adherent for continued approval. Treatment gaps of therapy longer than 3 days/month will result in denial of subsequent requests for continued therapy. 
  • Approvals for treatment regimen initiation for 12 weeks of therapy will not be granted prior to the 10th of a month in order to prevent prescription limit issues from affecting the member’s compliance. 

 Vosevi Initiation Form

 

elbasvir/grazoprevir (Zepatier™)

Approval Criteria:

  • Member must be 18 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-1 or genotype-4; AND
  • Zepatier™ must be prescribed by a gastroenterologist, infectious disease specialist, or transplant specialist or the member must have been evaluated by a gastroenterologist, infectious disease specialist, or transplant specialist for hepatitis C therapy within the last three months; AND
  • Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  • If the member has genotype-1a, testing results for the presence of virus with NS5A resistance-associated polymorphisms must be indicated on the prior authorization request; AND
  • Member has chronic HCV infection defined by: 
    • If the member has a liver fibrosis score ≥F1 (METAVIR equivalent) then only one detectable and quantifiable HCV RNA (>15 IU/mL) test within the last 12 months is required; OR
    • If the member has a liver fibrosis score <F1 (METAVIR equivalent) then the following must be met:  
      • Positive (i.e., reactive) HCV antibody test that is at least six months old and has a detectable and quantifiable HCV RNA (>15 IU/mL) test six months after date of positive HCV antibody test; OR
      • Two detectable and quantifiable HCV RNA (>15 IU/mL) tests at least six months apart. 
  • The following regimens and requirements based on genotype, polymorphisms, and prior treatment status will apply (all regimens apply to patients with and without cirrhosis, HIV/HCV co-infected patients, and patients with or without renal impairment):
    • Genotype-1a, treatment-naïve or peginterferon alfa + ribavirin experienced without baseline NS5A polymorphisms:
      • Zepatier™ for 12 weeks  
    • Genotype-1a, treatment-naïve or peginterferon alfa + ribavirin experienced with baseline NS5A polymorphisms:
      • Zepatier™ with weight-based ribavirin for 16 weeks 
    • Genotype-1b, treatment-naïve or peginterferon alfa + ribavirin experienced:
      • Zepatier™ for 12 weeks 
    • Genotype-1a or -1b, peginterferon alfa + ribavirin + HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, teleprevir) experienced:
      • Zepatier™ with weight-based ribavirin for 12 weeks 
    • Genotype-4, treatment-naïve:
      • Zepatier™ for 12 weeks 
    • Genotype-4, treatment-experienced:
      • Zepatier™ with weight-based ribavirin for 16 weeks 
    • New regimens will apply as approved by the FDA  
  • Member must sign and submit the Hepatitis C Intent to Treat contract; AND
  • Member’s pharmacy must submit the Hepatitis C Therapy Pharmacy Agreement for each member on therapy; AND
  • The prescriber must verify that they will provide SoonerCare with all necessary labs to evaluate hepatitis C therapy efficacy including Sustained Viral Response (SVR-12); AND
  • Prescriber must agree to counsel members on potential harms of illicit IV drug use or alcohol use and member must agree to no illicit IV drug use or alcohol use while on treatment and post-therapy; AND
  • Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
  • Member must not have decompensated cirrhosis or moderate-to-severe hepatic impairment (Child-Pugh B and C); AND
  • Female members must not be pregnant and must have a pregnancy test immediately prior to therapy initiation. Male and female members must be willing to use two forms of non-hormonal birth control while on therapy (and for six months after therapy completion for ribavirin users); AND
  • The prescriber must verify that the member’s ALT levels will be monitored prior to treatment initiation, at treatment week eight, and as clinically indicated thereafter (patients receiving 16 weeks of therapy should receive additional ALT levels at treatment week 12); AND
  • Member must not be taking the following medications: phenytoin, carbamazepine, rifampin, St. John’s wort, efavirenz, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine, nafcillin, ketoconazole, bosentan, etravirine, elvitegravir/cobicstat/ emtricitabine/tenofovir, or modafinil; AND
  • All other clinically significant issues must be addressed prior to starting therapy including but not limited to the following: neutropenia, anemia, thrombocytopenia, surgery, depression, psychosis, epilepsy, obesity, weight-management, severe concurrent medical diseases, such as but not limited to, retinal disease, or autoimmune thyroid disease; AND
  • Prescribing physician must verify that they will work with the member to ensure the member remains adherent to hepatitis C therapies; AND
  • Members must be adherent for continued approval. Treatment gaps of therapy longer than 3 days/month will result in denial of subsequent requests for continued therapy. 
  • Approvals for treatment regimen initiation for 12 or 16 weeks of therapy will not be granted prior to the 10th of a month in order to prevent prescription limit issues from affecting the member’s compliance.

Zepatier Initiation Form

          

defibrotide sodium (Defitelio®)

Approval Criteria:   

  • An FDA approved diagnosis of hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation. 
  • Initial approvals will be for one month of therapy.  An additional month of therapy (maximum of 60 days) may be granted if the physician documents the continued need for therapy.    
 

        

obeticholic acid (Ocaliva™)

Approval Criteria:

  • An FDA approved diagnosis of primary biliary cholangitis (PBC); AND
  • Member must have taken ursodeoxycholic acid (UDCA) at an appropriate dose for at least one year and prescriber must confirm a lack of improvement in liver function tests, confirm that PBC is not caused by a superimposed liver disease, confirm that if the member has a superimposed liver disease it is being adequately treated, proper timing of bile acid sequestrants if co-administered with UDCA (four hours before or four hours after), and patient compliance with UDCA; AND
  • Ocaliva™ must be taken in combination with UDCA. For Ocaliva™ monotherapy consideration, the prescriber must document a patient-specific, clinically significant reason why the member is unable to take UDCA; AND
  • A quantity limit of one tablet daily will apply.