Hepatic Disorders

Bylvay™ (Odevixibat) Approval Criteria:

• An FDA approved indication for the treatment of pruritus in members with progressive familial intrahepatic cholestasis (PFIC); and
  • Diagnosis must be confirmed by genetic testing identifying biallelic pathogenic variants in the ATP8B1, ABCB11, or ABCB4 genes (results of genetic testing must be submitted); and
• Member must be 3 months of age or older; and
• Bylvay™ must be prescribed by a gastroenterologist, hepatologist, geneticist, or other specialist with expertise in the treatment of PFIC (or an advanced care practitioner with a supervising physician who is a gastroenterologist, hepatologist, geneticist, or other specialist with expertise in the treatment of PFIC); and
• Prescriber must verify member has a history of significant pruritus that is unresponsive to treatment with ursodeoxycholic acid (UDCA) and at least 2 of the following medications, unless contraindicated:
  • Cholestyramine; or
  • Rifampin; or
  • Sertraline; or
  • Naltrexone; and
• Member must have elevated serum bile acid concentration ≥100micromol/L at baseline; and
• Prescriber must verify member does not have known pathologic variants of the ABCB11 gene predicting a non-functional or absent bile salt export pump protein (BSEP-3); and
• Members with a history of liver transplantation will generally not be approved for Bylvay™; and
• Prescriber must verify surgical intervention (e.g., biliary diversion, liver transplantation) is not currently clinically appropriate for the member; and
• Prescriber must agree to monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, direct bilirubin, and international normalized ratio (INR) at baseline and during treatment with Bylvay™; and
• Member’s current weight (taken within the past 3 weeks) must be provided on initial and subsequent prior authorization requests in order to authorize the appropriate amount of drug required according to package labeling; and
• Initial approvals will be for 40mcg/kg/day for a duration of 3 months. After 3 months of treatment, further approval may be granted at the 40mcg/kg/day dose if the prescriber documents the member is responding well to treatment and surgical intervention is still not clinically appropriate; or
• Dose increases to 80mcg/kg/day (for 3 months) and 120mcg/kg/day (for 3 months) may be approved if there is no improvement in pruritus after 3 months of treatment with the lower dose(s). Further approval may be granted if the prescriber documents the member is responding well to treatment at the current dose and surgical intervention is still not clinically appropriate; and
• If there is no improvement in pruritus after 3 months of treatment with the maximum 120mcg/kg/day dose, further approval of Bylvay™ will not be granted.

Bylvay® (Odevixibat) Approval Criteria [Alagille Syndrome (ALGS) Diagnosis]:

• An FDA approved indication for the treatment of cholestatic pruritus in members with ALGS; and
  • Diagnosis must be confirmed by genetic testing identifying a pathogenic variant in either the JAG1 or NOTCH2 genes (results of genetic testing must be submitted); and
• Member must be 12 months of age or older; and
• Bylvay® must be prescribed by a gastroenterologist, hepatologist, geneticist, or other specialist with expertise in the treatment of ALGS (or an advanced care practitioner with a supervising physician who is a gastroenterologist, hepatologist, geneticist, or other specialist with expertise in the treatment of ALGS); and
• Prescriber must verify member has a history of significant pruritus that is unresponsive to treatment with ursodeoxycholic acid (UDCA) and at least 2 of the following, unless contraindicated:
  • Cholestyramine; or
  • Rifampin; or
  • Sertraline; or
  • Naltrexone; and
• Member must have elevated serum bile acid concentration >3x the upper limit of normal (ULN) for age at baseline; and
• Members with a history of liver transplantation will generally not be approved for Bylvay®; and
• Prescriber must verify surgical intervention (e.g., biliary diversion, liver transplantation) is not currently clinically appropriate for the member; and
• Prescriber must agree to monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, direct bilirubin, and international normalized ratio (INR) at baseline and during treatment with Bylvay®; and
• Member’s current weight (taken within the past 3 weeks) must be provided on initial and subsequent prior authorization requests in order to authorize the appropriate amount of drug required according to package labeling; and
• Initial approvals will be for a duration of 3 months. After 3 months of treatment, further approval may be granted for a duration of 1 year if the prescriber documents the member is responding well to treatment and surgical intervention is still not clinically appropriate.

Cholbam^® (Cholic Acid) Approval Criteria:

• An FDA approved indication of 1 of the following:
  • Treatment of bile acid synthesis disorders due to single enzyme defects (SEDs); or and
    • Diagnosis must be confirmed by genetic testing identifying biallelic pathogenic or likely pathogenic variants in the AKR1D1, AMACR, BAAT, CYP7A1, CYP7B1, CYP27A1, DHCR7, HSD3B7, or SLC27A5 gene, or other gene with significant supporting evidence of pathogenicity (results of genetic testing must be submitted); or
  • Adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption; and
    • Diagnosis must be confirmed by genetic testing identifying biallelic pathogenic or likely pathogenic variants in the PEX1, PEX2, PEX3, PEX5, PEX6, PEX10, PEX11B, PEX12, PEX13, PEX14, PEX16, PEX19, or PEX26 gene (results of genetic testing must be submitted); and
• Treatment with Cholbam^® should be initiated and monitored by a hepatologist, or pediatric gastroenterologist, or other specialist with expertise in the treatment of SEDs or PDs; and
• The prescriber must verify that AST, ALT, GGT, alkaline phosphatase, bilirubin, and INR will be monitored every month for the first 3 months, every 3 months for the next 9 months, every 6 months during the next 3 years, and annually thereafter; and
• Cholbam^® should be discontinued if liver function does not improve within 3 months of starting treatment, if complete biliary obstruction develops, or if there are persistent clinical or laboratory indicators of worsening liver function or cholestasis; and
• Initial approvals will be for the duration of 3 months to monitor for compliance and liver function tests; and
• Continuation approvals will be granted for the duration of 1 year if the prescriber documents the member is responding well to treatment, as indicated by improvements in liver function tests; and
• A quantity limit of 120 capsules per 30 days will apply. Quantity limit requests will be based on the member’s recent weight taken within the last 30 days.

Livmarli™ (Maralixibat) Approval Criteria [Alagille Syndrome (ALGS) Diagnosis]:

• An FDA approved indication for the treatment of cholestatic pruritus in members with Alagille Syndrome (ALGS); and
  • Diagnosis must be confirmed by genetic testing identifying a pathogenic variant in the JAG1 or NOTCH2 genes (results of genetic testing must be submitted); and
• Member must be 3 months of age or older; and
• Livmarli™ must be prescribed by a gastroenterologist, hepatologist, geneticist, or other specialist with expertise in the treatment of ALGS (or an advanced care practitioner with a supervising physician who is a gastroenterologist, hepatologist, geneticist, or other specialist with expertise in the treatment of ALGS); and
• Prescriber must verify member has a history of significant pruritus that is unresponsive to treatment with ursodeoxycholic acid (UDCA) and at least 2 of the following, unless contraindicated:
  • Cholestyramine; or
  • Rifampin; or
  • Sertraline; or
  • Naltrexone; and
• Member must have evidence of cholestasis demonstrated by ≥1 of the following:
  • Total serum bile acid >3x upper limit of normal (ULN) for age; or
  • Conjugated bilirubin >1mg/dL; or
  • Fat soluble vitamin deficiency otherwise unexplainable; or
  • Gamma-glutamyl transferase (GGT) >3x ULN for age; or
  • Intractable pruritus explainable only by liver disease; and
• Members with a history of liver transplantation will not generally be approved for Livmarli™; and
• Member must not have prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy); and
• Prescriber must verify surgical intervention (e.g., biliary diversion, liver transplantation) is not currently clinically appropriate for the member; and
• Prescriber must agree to monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, direct bilirubin, and international normalized ratio (INR) at baseline and during treatment with Livmarli™; and
• Prescriber must verify the member and/or member’s caregiver has been counseled on appropriate storage, dosing, and administration of Livmarli™, including the use of a calibrated oral dosing dispenser for accurate measurement; and
• Member’s current weight (taken within the past 3 weeks) must be provided on initial and subsequent prior authorization requests in order to authorize the appropriate amount of drug required according to package labeling; and
• The request must be for the 9.5mg/mL solution; and
• Initial approvals will be for a duration of 3 months. After 3 months of treatment, further approval may be granted for a duration of 1 year if the prescriber documents the member is responding well to treatment and surgical intervention is still not clinically appropriate.

Livmarli® (Maralixibat) Approval Criteria [Progressive Familial Intrahepatic Cholestasis (PFIC) Diagnosis]:

• An FDA approved indication for the treatment of cholestatic pruritus in members with PFIC; and
  • Diagnosis must be confirmed by genetic testing identifying biallelic pathogenic variants in the ATP8B1, ABCB11, ABCB4, TJP2, or MYO5B genes (results of genetic testing must be submitted); and
• Member must be 12 months of age or older; and
• Livmarli® must be prescribed by a gastroenterologist, hepatologist, geneticist, or other specialist with expertise in the treatment of PFIC (or an advanced care practitioner with a supervising physician who is a gastroenterologist, hepatologist, geneticist, or other specialist with expertise in the treatment of PFIC); and
• Prescriber must verify member has a history of significant pruritus that is unresponsive to treatment with ursodeoxycholic acid (UDCA) and at least 2 of the following medications, unless contraindicated:
  • Cholestyramine; or
  • Rifampin; or
  • Sertraline; or
  • Naltrexone; and
• Member must have elevated serum bile acid concentration >3x the upper limit of normal (ULN) for age at baseline; and
• Prescriber must verify member does not have known pathologic variants of the ABCB11 gene predicting a non-functional or absent bile salt export pump protein (BSEP-3); and
• Members with a history of liver transplantation will generally not be approved for Livmarli®; and
• Member must not have prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy); and
• Prescriber must verify surgical intervention (e.g., biliary diversion, liver transplantation) is not currently clinically appropriate for the member; and
• Prescriber must agree to monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, direct bilirubin, and international normalized ratio (INR) at baseline and during treatment with Livmarli®; and
• Member’s current weight (taken within the past 3 weeks) must be provided on initial and subsequent prior authorization requests in order to authorize the appropriate amount of drug required according to package labeling; and
• The request must be for the 19mg/mL solution; and
• Initial approvals will be for a duration of 3 months. After 3 months of treatment, further approval may be granted for a duration of 1 year if the prescriber documents the member is responding well to treatment and surgical intervention is still not clinically appropriate.

Ocalivia^® (Obeticholic Acid) Approval Criteria: 

• An FDA approved diagnosis of primary biliary cholangitis (PBC); AND
• Member must be 18 years of age or older; and
• Member must have elevated alkaline phosphatase (ALP) ≥1.67 times the upper limit of normal (ULN) and total bilirubin (TB) ≤2 times the ULN at baseline; and
• Must be prescribed by a gastroenterologist, hepatologist, or other specialist with expertise in the treatment of PBC (or an advanced care practitioner with a supervising physician who is a gastroenterologist, hepatologist, or other specialist with expertise in the treatment of 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; and
  • Prescriber must confirm proper timing of bile acid sequestrants if co-administered with UDCA (4 hours before or 4 hours after) and member 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
• Member must not have any of the following:
  • Decompensated cirrhosis (e.g., Child-Pugh class B or C) or a prior decompensation event; or
  • Compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia); or
  • Complete biliary obstruction; and
• Prescriber must agree to monitor liver tests frequently and to discontinue Ocaliva^® if there is any evidence of liver disease progression while on treatment; and
• Initial approvals will be for a dose of 5mg once daily for a duration of 3 months. After 3 months of treatment, information regarding efficacy must be submitted; and
  • If an adequate improvement in liver function tests is not achieved with the 5mg dose, a dose of 10mg once daily may be approved for a duration of 3 months; and
• Subsequent approvals (for a duration of 1 year) may be granted if the prescriber documents the member is responding well to treatment, as indicated by improvements in liver function tests; and
• A quantity limit of one tablet daily will apply. 

Reltone™ (Ursodiol Capsule) Approval Criteria:

• An FDA approved indication for the dissolution of radiolucent, noncalcified gallstones <20mm in greatest diameter or the prevention of gallstone formation in obese members experiencing rapid weight loss; and 
• For the indication of dissolution of radiolucent, noncalcified gallstones <20mm in greatest diameter:
  • Prescriber must confirm member is not a candidate for elective cholecystectomy due to 1 or more of the following:
    • Increased surgical risk due to systemic disease; or
    • Advanced age; or
    • Idiosyncratic reaction to general anesthesia; or
    • Member refuses surgery; and
  • Prescriber must confirm the member does not have compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula; and
• For the indication of prevention of gallstone formation in obese members experiencing rapid weight loss:
  • Member’s baseline body mass index (BMI) and weight must be provided; and  
  • Member’s current weight must be provided supporting rapid weight loss compared to baseline; and
• For both FDA approved indications, a patient-specific, clinically significant reason why the member cannot use other generic formulations of ursodiol must be provided; and
• Initial approvals for the indication of dissolution of gallstones will be for the duration of 6 months, after which time the prescriber must confirm (via ultrasound imaging) partial or complete dissolution of gallstone(s). Subsequent approvals will be for the duration of 12 months; and
• Approvals for prevention of gallstone formation in obese members experiencing rapid weight loss will be for 6 months, after which time the member’s current weight must be provided to justify continued rapid weight loss and need for preventative treatment; and
• Treatment duration will be limited to a maximum of 24 months for all diagnoses.

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
• 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

Rezdiffra™ (Resmetirom) Approval Criteria:

• An FDA approved indication of noncirrhotic nonalcoholic steatohepatitis (NASH); and
• Member must be 18 years of age or older; and
• Member must have moderate-to-advanced liver fibrosis (e.g., stage F2 or F3) confirmed by at least 1 of the following:
  • FibroScan with vibration controlled transient elastography (VCTE) ≥8.5kPa and controlled attenuation parameter (CAP) ≥280dB/m; or
  • Enhanced Liver Fibrosis (ELF) biochemical test score ≥9; or
  • Liver biopsy showing stage F2 or F3 fibrosis with NASH; and
• Member must not have known liver cirrhosis (e.g., stage F4); and
• Must be used in conjunction with diet and exercise (clinical documentation of member’s diet and exercise program must be included with the request); and
• Prescriber must attest that metabolic comorbidities are being appropriately managed, including treatment for all of the following, if applicable:
  • Type 2 diabetes; and
  • Dyslipidemia; and
  • Hypertension; and
• Member must not be taking strong CYP2C8 inhibitors (e.g., gemfibrozil) or OATP1B1/OATP1B3 inhibitors (e.g., cyclosporine) concurrently with Rezdiffra™; and
• If member is taking a moderate CYP2C8 inhibitor (e.g., clopidogrel) concurrently with Rezdiffra™, prescriber must agree to reduce the dose as required in the package labeling; and
• If the member is taking a statin, prescriber must agree to adjust the statin dosage (when necessary) and monitor for statin-related adverse reactions; and
• Must be prescribed by a gastroenterologist or hepatologist (or an advanced care practitioner with a supervising physician who is a gastroenterologist or hepatologist); and
• Initial approvals will be for the duration of 6 months. Subsequent approvals (for the duration of 1 year) will be approved if the prescriber documents the member is tolerating and responding well to the medication; and
• A quantity limit of 30 tablets per 30 days 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
• 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
• 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
• 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

Zepatier^® (Elbasvir/Grazoprevir) Approval Criteria: 

• Member must be 12 years of age or older or weigh at least 30kg; 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
• 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