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Hepatic Disorders

 

Hepatitis C Criteria

 

Viekira Pak™/Viekira XR (ombitasvir/paritaprevir/ritonavir/dasabuvir), Harvoni® (sofosbuvir/ledipasvir), Sovaldi® (sofosbuvir), and Zepatier™ (elbasvir/grazoprevir) are the preferred direct-acting antivirals for treatment of chronic hepatitis C genotype-1. Use of Sovaldi® (sofosbuvir) and Olysio® (simeprevir) in combination, Olysio® (simeprevir) alone, or Sovaldi® (sofosbuvir) and Daklinza™ (Daclatasvir) in combination for treatment of HCV genotype-1 requires patient-specific, clinically significant reasoning why Viekira Pak™/Viekira XR, Harvoni®, Sovaldi® with peginterferon and ribavirin, or Zepatier™ (elbasvir/grazoprevir) are not appropriate for the member. Detailed criteria for medications with no changes to the coverage criteria are not included in the criteria on the following pages. The criteria for each medication may include FDA approved regimens or AASLD guideline recommended regimens that are not included in the SoonerCare preferred regimens table. Preferred regimens for each genotype can be found in the preferred regimens table. Additional regimens other than those listed in the preferred regimens table may be considered based on patient-specific clinical situations.

The following table highlights the preferred regimens for each genotype in treatment naïve and PEG-IFN and RBV-experienced members (listed in alphabetical order).  Additional regimens other than those listed may be considered based on patient-specific clinical situations.

Genotype Patient Factors Preferred Regimen(s)
Genotype - 1
1 Treatment-naïve, non-cirrhotic Harvoni® for 8 or 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks 
1a: Viekira Pak™/Viekira XR + RBV for 12 weeks
1b: Viekira Pak™/Viekira XR for 12 weeks
1a: Zepatier™ for 12 weeks (without baseline RAVs) 
1a: Zepatier™ + RBV for 16 weeks (with baseline RAVs)
1b: Zepatier™ for 12 weeks 
1 Treatment-naïve, cirrhotic  Harvoni® for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
1a: Viekira Pak™/Viekira XR + RBV for 24 weeks
1b: Viekira Pak™/Viekira XR +/- RBV for 12 weeks
1a: Zepatier™ for 12 weeks (without baseline RAVs)
1a: Zepatier™ + RBV for 16 weeks (with baseline RAVs)
1b: Zepatier™ for 12 weeks 
1 Treatment-experienced, non-cirrhotic  Harvoni® for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
1a: Viekira Pak™/Viekira XR + RBV for 12 weeks
1b: Viekira Pak™/Viekira XR for 12 weeks
1a: Zepatier™ + RBV for 12 weeks (without baseline RAVs) 
1a: Zepatier™ + RBV for 16 weeks (with baseline RAVs)
1b: Zepatier™ for 12 weeks 
1 Treatment-experienced, cirrhotic  Harvoni® + RBV for 12 weeks
Harvoni® for 24 weeks (if RBV intolerant)
Sovaldi® + RBV + PEG IFN for 12 weeks
1a: Viekira Pak™/Viekira XR + RBV for 24 weeks
1b: Viekira Pak™/Viekira XR +/- RBV for 12 weeks
1a: Zepatier™ + RBV for 12 weeks (without baseline RAVs) 
1a: Zepatier™ + RBV for 16 weeks (with baseline RAVs)
1b: Zepatier™ for 12 weeks
Genotype-2
2 Treatment-naïve, non-cirrhotic  Sovaldi® + RBV for 12 weeks
Sovaldi® + Daklinza™ for 12 weeks (if RBV intolerant) 
2 Treatment-naïve, cirrhotic  Sovaldi® + RBV for 12 or 16 weeks
Sovaldi® + Daklinza™ for 16 weeks (if RBV intolerant) 
2 Treatment-experienced, non-cirrhotic   Sovaldi® + RBV for 12 weeks
Sovaldi® + Daklinza™ for 12 weeks
2 Treatment-experienced, cirrhotic  Sovaldi® + RBV for 16 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
Sovaldi® + Daklinza™ for 16 weeks 
 Genotype-3
3 Treatment-naïve, non-cirrhotic   Daklinza™ + Sovaldi® for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
Sovaldi® + RBV for 24 weeks 
3 Treatment-naïve, cirrhotic  Daklinza™ + Sovaldi® + RBV for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
Sovaldi® + RBV for 24 weeks 
3 Treatment-experienced, non-cirrhotic   Daklinza™ + Sovaldi® for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
Sovaldi® + RBV for 24 weeks 
3 Treatment-experienced, cirrhotic  Daklinza™ + Sovaldi® + RBV for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
Sovaldi® + RBV for 24 weeks  
 Genotype-4
4 Treatment-naïve, non-cirrhotic  Harvoni® for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks 
Technivie™ + RBV for 12 weeks
Zepatier™ for 12 weeks 
4 Treatment-naïve, cirrhotic  Harvoni® for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
Technivie™ + RBV for 12 weeks
Zepatier™ for 12 weeks 
4 Treatment-experienced, non-cirrhotic  Harvoni® for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
Technivie™ + RBV for 12 weeks
Zepatier™ + RBV for 16 weeks 
4 Treatment-experienced, cirrhotic  Harvoni® + RBV for 12 weeks
Sovaldi® + RBV + PEG IFN for 12 weeks
Technivie™ + RBV for 12 weeks
Zepatier™ + RBV for 16 weeks 
 Genotype-5 or Genotype-6
5 or 6 Treatment-naïve or -experienced, non-cirrhotic or cirrhotic  Harvoni® for 12 weeks
Not all regimens included are FDA approved. 
All regimens are either FDA approved or recommended in AASLD/IDSA treatment guidance.
If not specified, regimen applies to all genotypic subtypes.
RBV = ribavirin PEG IFN = peginterferon alfa  RAV = resistance-associated polymorphisms 

 

Daklinza™ (Daclatasvir) Approval Criteria:

  • Member must be 18 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-3; AND
  • Member must have a METAVIR fibrosis score of F2 or greater or equivalent scoring with an alternative test. Fibrosis testing type and scoring must be indicated on prior authorization request; 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
  • Pre-treatment viral load (HCV-RNA) must be confirmed and indicated on the petition. Viral load should have been taken within the last three months;AND
  • 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
  • Member must have no illicit IV drug use or alcohol abuse in the last six months 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.

Harvoni® (Ledipasvir/Sofosbuvir) Approval Criteria: 

  • Member must be 18 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
  • Member must have a METAVIR fibrosis score of F2 or greater or equivalent scoring with an alternative test. Fibrosis testing type and scoring must be indicated on prior authorization request; 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
  • Pre-treatment viral load (HCV-RNA) must be confirmed and indicated on the petition. Viral load should have been taken within the last three months; AND
  • 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
  • Member must have no illicit IV drug use or alcohol abuse in the last six months 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 15thof a month in order to prevent prescription limit issues from affecting the member’s compliance. 

Olysio™ (Simeprevir) Approval Criteria: 

  • Member must be 18 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) (genotype 1) with a METAVIR fibrosis score of F2 or greater or equivalent scoring with an alternative test. Fibrosis testing type and scoring must be indicated on prior authorization request; 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. 
  • 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
  • Member must have no illicit IV drug use or alcohol abuse in the last six months 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.

Sovaldi™ (Sofosbuvir) 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, or genotype-4; AND
  • Member must have a METAVIR fibrosis score of F2 or greater or equivalent scoring with an alternative test. Fibrosis testing type and scoring must be indicated on prior authorization request; 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
  • Pre-treatment viral load (HCV-RNA) must be confirmed and indicated on the petition. Viral load should have been taken within the last three months; AND
  • 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
  • Member must have no illicit IV drug use or alcohol abuse in the last six months 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.

 

Technivie™ (Ombitasvir/Paritaprevir/Ritonavir) Approval Criteria:

  • Member must be 18 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-4AND
  • Member must have a METAVIR fibrosis score of F2 or greater or equivalent scoring with an alternative test. Fibrosis testing type and scoring must be indicated on prior authorization request; AND 
    Technivie™ 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
  • Pre-treatment viral load (HCV-RNA) must be confirmed and indicated on the petition. Viral load should have been taken within the last three months; AND
  • The following regimens and requirements based on genotype, cirrhosis status, and prior treatment status will apply: 
    • Genotype-4, treatment-naïve or treatment experienced, non-cirrhotic or compensated cirrhotic:
      • Technivie™ in combination with weight-based ribavirin for 12 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 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
  • Member must have no illicit IV drug use or alcohol abuse in the last six months 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); AND
  • The prescriber must verify that the member’s ALT levels will be monitored during the first four weeks of starting treatment and as clinically indicated thereafter;AND
  • Member must not be taking the following medications: alfuzosin, carbamazepine, phenytoin, phenobarbital, rifampin, ergotamine, dihydroergotamine, ergonovine, methylergonovine, ethinyl estradiol containing medications (combined oral contraceptives), St. John’s wort, lovastatin, simvastatin, pimozide, efavirenz, sildenafil, triazolam, orally administered midazolam, atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir, rilpivirine, salmeterol and voriconazole; 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.

Victrelis® (Boceprevir) and Incivek® (Telaprevir) 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. 

Viekira Pak™/ Viekira XR (Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir) Approval Criteria:

  • Member must be 18 years of age or older; AND
  • An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-1AND
  • Member must have a METAVIR fibrosis score of F2 or greater or equivalent scoring with an alternative test. Fibrosis testing type and scoring must be indicated on prior authorization request; AND
  • Viekira Pak™/Viekira XR 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/subtype testing must be confirmed and indicated on prior authorization request; AND
  • Pre-treatment viral load (HCV-RNA) must be confirmed and indicated on the petition. Viral load should have been taken within the last three months; AND
  • The following regimens and requirements based on prior treatment experience, genotypic subtype, and cirrhosis will apply: 
    • Genotype 1a, without cirrhosis:
      • Viekira Pak™/Viekira XR  with weight-based ribavirin for 12 weeks  
    • Genotype 1a, with cirrhosis:
      • Viekira Pak™/Viekira XR with weight-based ribavirin for 24 weeks
      • Viekira Pak™/Viekira XR with weight-based ribavirin for 12 weeks may be considered for some patients based on prior treatment history.  
    • Genotype 1b, without cirrhosis:
      • Viekira Pak™/Viekira XR  for 12 weeks  
    • Genotype 1b, with cirrhosis:
      • Viekira Pak™/Viekira XR  with weight-based ribavirin for 12 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 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
  • Member must have no illicit IV drug use or alcohol abuse in the last six months 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-severae 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. 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
  • The prescriber must verify that the member’s ALT levels will be monitored during the first four weeks of starting treatment and as clinically indicated thereafter;AND
  • Member must not be taking the following medications: alfuzosin, carbamazepine, phenytoin, phenobarbital, gemfibrozil, rifampin, ergotamine, dihydroergotamine, ergonovine, methylergonovine, ethinyl estradiol, St. John’s wort, lovastatin, simvastatin, pimozide, efavirenz, sildenafil, triazolam, oral midazolam; 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, and for 24 weeks of therapy prior to the 15thof a month in order to prevent prescription limit issues from affecting the member’s compliance. 

 Zepatier™ (Elbasvir/Grazoprevir) 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
    Member must have a METAVIR fibrosis score of F2 or greater or equivalent scoring with an alternative test. Fibrosis testing type and scoring must be indicated on prior authorization request; 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
  • Pre-treatment viral load (HCV-RNA) must be confirmed and indicated on the petition. Viral load should have been taken within the last three months; AND
  • 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
  • Member must have no illicit IV drug use or alcohol abuse in the last six months 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.

obeticholic acid (Ocaliva™) 

  • 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.

Prior Authorization Forms:

Last Modified on Dec 02, 2020
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