Hepatic Disorders

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. 

Approval Criteria:

• Member must be 3 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
• A patient-specific, clinically significant reason the member cannot use the brand formulation.
• 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 and has a recent (within the last 3 months) detectable and quantifiable HCV RNA (>15 IU/mL); 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 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
• Members who are 6 years of age and older and request the oral pellet formulation of Harvoni® must provide a patient-specific, clinically significant reason for use of the oral pellet formulation in place of the tablet formulation; 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
• 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 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

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. 

Epclusa^® (Sofosbuvir/Velpatasvir Tablets and Pellets) Approval Criteria: 

• Member must be 3 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 1 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 and has a recent (within the last 3 months) detectable and quantifiable HCV RNA (>15 IU/mL); 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
• 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. 

 Sofosbuvir/Velpatasvir Initiation Form

Approval Criteria:

• Member must be 3 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 and has a recent (within the last 3 months) detectable and quantifiable HCV RNA (>15 IU/mL); 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
    • 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)
    •  
      • 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. 
• Members who are older than 6 years of age and request the oral pellet formulation of Sovaldi® must provide a patient-specific, clinically significant reason for use of the oral pellet formulation in place of the tablet formulation; 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
• 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

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. 

Vosevi^® (Sofosbuvir/Velpatasvir/Voxilaprevir Tablets) 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  
• 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 and has a recent (within the last 3 months) detectable and quantifiable HCV RNA (>15 IU/mL); 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 a limited life expectancy (<12 months) that cannot be remediated by treating HCV, liver transplantation, or another directed therapy; 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

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 and has a recent (within the last 3 months) detectable and quantifiable HCV RNA (>15 IU/mL); 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