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Hepatitis C Criteria

Harvoni® (Ledipasvir/Sofosbuvir) Approval Criteria:

  1. Member must be 18 years of age or older; AND 
  2. An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-1 with a METAVIR fibrosis score of F2 or greater; AND
  3. 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
  4. Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  5. 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
  6. The following regimens and requirements based on prior treatment experience, baseline viral load, and cirrhosis will apply: 
    1. Treatment-naïve without cirrhosis who have a pre-treatment HCV-RNA less than 6 million IU/mL: 
      1.  Harvoni® (ledipasvir/sofosbuvir) 90mg/400mg once daily for 8 weeks
       
    2.  Treatment-naïve with or without cirrhosis: 
      1.  Treatment-naïve patients who are cirrhotic or have a pre-treatment HCV-RNA greater than 6 million IU/mL
      2.  Harvoni® (ledipasvir/sofosbuvir) 90mg/400mg once daily for 12 weeks
       
    3.  Treatment-experienced without cirrhosis: 
      1. Treatment-experienced patients who have failed previous treatment with either peginterferon alfa, ribavirin, or an HCV protease inhibitor
      2. Harvoni® (ledipasvir/sofosbuvir) 90mg/400mg once daily for 12 weeks
       
    4.  Treatment-experienced with cirrhosis: 
      1. Treatment-experienced patients who have failed previous treatment with either peginterferon alfa, ribavirin, or an HCV protease inhibitor
      2. Harvoni® (ledipasvir/sofosbuvir) 90mg/400mg once daily for 24 weeks
       
    5. New regimens will apply as approved by the FDA
     
  7. Member must sign and submit the Hepatitis C Intent to Treat contract; AND
  8. Member’s pharmacy must submit the Hepatitis C Therapy Pharmacy Agreement for each member on therapy; AND
  9. 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
  10. 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
  11. Must have documentation of initiation of immunization with the hepatitis A and B vaccines; and
  12. Member must not have decompensated cirrhosis; AND
  13. Member must not have severe renal impairment (estimated Glomerular Filtration Rate [eGFR] <30mL/min/1.73m2); AND
  14. 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
  15. 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
  16. 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.
  17. Prescribing physician must verify that they will work with the member to ensure the member remains adherent to hepatitis C therapies; AND
  18. 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.
  19. 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.
  20. Due to superior SVR rates and shortened treatment durations with Harvoni®, authorization of Sovaldi™ or Olysio™ for genotype-1 will require a patient-specific, clinically significant reason why Harvoni® is not an option.

Olysio™ (Simeprevir) Approval Criteria:

  1. Member must be 18 years of age or older; AND
  2. An FDA approved diagnosis of Chronic Hepatitis C (CHC) (genotype 1) with a METAVIR fibrosis score of F2 or greater; AND
  3. HCV genotype testing must be confirmed and indicated on prior authorization request; and
  4. 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
  5. 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
  6. As indicated by the FDA, Olysio™ must be used as a component of a combination regimen.
    1. Olysio™ will be approved for combination therapy only.
    2. Triple therapy: Olysio™ + RBV + PEG-IFN x 12 weeks
    3. After completion of Olysio™ therapy member must continue on RBV and PEG-IFN therapy for:
      1. an additional 12 weeks for treatment naïve patients and prior relapsers including those with cirrhosis
      2. an additional 36 weeks for prior non-responder patients (including partial and null-responders), including those with cirrhosis  
    4. New regimens will apply as approved by the FDA  
  7. Member must not have previously failed treatment with a hepatitis C protease inhibitor (non-responder or relapsed); AND
  8. Member must not have decompensated hepatic disease (Child Turcotte Pugh (CTP) class B or C); AND
  9. Member must sign the intent to treat contract; AND
  10. 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
  11. Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
  12. 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
  13. 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
  14. 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.
  15. 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.
  16. 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: 

  1. Member must be 18 years of age or older; AND
  2. An FDA approved diagnosis of Chronic Hepatitis C (CHC) with a METAVIR fibrosis score of F2 or greater; AND
  3. 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
  4. Sovaldi™ must be used as a component of a combination regimen; AND
  5. Member must be eligible for ribavirin (RBV) therapy. Approvals will not be granted for regimens without RBV; AND
  6. Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
  7. The following regimens and requirements based on genotype will apply:
    1. Genotype 1:
      1. Triple therapy: Sovaldi™ + Pegylated Interferon (PEG-IFN) + RBV x 12 weeks
      2. Members who are PEG-IFN ineligible may be approved for total treatment duration of 24 weeks with a patient-specific, clinically significant reason why member cannot use PEG-IFN.  
    2. Genotype 2:
      1. Dual therapy: Sovaldi™ + RBV x 12 weeks  
    3. Genotype 3:
      1. Dual therapy: Sovaldi™ + RBV x 24 weeks  
    4. Genotype 4:
      1. Triple therapy: Sovaldi™ + PEG-IFN + RBV x 12 weeks
    5. Hepatocellular Carcinoma:
      1. Dual therapy: Sovaldi™ + RBV x 48 weeks or until time of liver transplant (whichever occurs first)
      2. Approvals will only be granted for HCV infected members (regardless of genotype) with hepatocellular carcinoma meeting the MILAN criteria (MILAN criteria defined as presence of a tumor 5cm or less in diameter in patients with single hepatocellular carcinomas and not more than three tumor nodules, each 3cm or less in diameter in patients with multiple tumors and no extrahepatic manifestations of the cancer or evidence of vascular invasion of tumor).
    6. New regimens will apply as approved by the FDA  
  8. Member must sign the intent to treat contract; AND
  9. 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
  10. Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
  11. Member must not have decompensated hepatic disease (Child Turcotte Pugh (CTP) class B or C); AND
  12. 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
  13. Member must not be taking the following medications: rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, oxcarbazepine, tipranavir/ritonavir, didanosine or St. John’s wort; AND
  14. 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.
  15. 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.
  16. 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.

Victrelis® (Boceprevir) and Incivek® (Telaprevir) Approval Criteria:

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

Prior Authorization Forms:

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