- Health Net Approved Indications and Usage Guidelines: A. Diagnosis of chronic hepatitis C (CHC) confirmed by detectable serum HCV RNA by quantitative assay in patients with genotype 1, 2 or 3. Baseline viral load by quantitative assay including genotype and treatment status of patient (treatment naive or treatment experienced) are required. AND B. Chart note documentation and copies of lab results are required. AND C. Prescribed by or in consultation with a gastroenterologist, hepatologist or infectious disease physician. AND D. Used in combination with Sovaldi (sofosbuvir). AND E. For genotype 1: A trial of Harvoni is required (Member must meet prior authorization criteria for and use Harvoni unless contraindicated). AND F. For genotype 1a with cirrhosis, laboratory testing confirming the absence of NS5A resistance associated polymorphisms at amino acid positions M28, Q30, L31 and Y93. OR G. For genotype 2, 3: Failure or clinically significant adverse effects to Epclusa (sofosbuvir/velpatasvir). AND H. One of the following clinical states to identify candidates for treatment: 1. Evidence of Stage 2 or greater hepatic fibrosis defined by one of the following: a. Liver biopsy confirming a METAVIR score F2 or greater. b. Transient elastography (Fibroscan) score greater than or equal to 7.5 kPa. c. FibroSure (also known as FibroTest) score of greater than or equal to 0.48. d. APRI score greater than 0.7. e. FIB greater than 3.25. f. ARFI score of greater than 1.34 m/s. g. MRE score of greater than 3.20 kilopascals. h. HepaScore >=0.55. i. FibroMeter >=0.411. 2. Evidence of extra¬hepatic manifestation of hepatitis C virus, such as type 2 or 3 essential mixed cryoglobulinemia with end¬ organ manifestations (e.g. vasculitis), or kidney disease (e.g. proteinuria, nephrotic syndrome or membranoproliferative glomerulonephritis). 3. HIV1 coinfection. 4. Hepatitis B coinfection. 5. Other coexistent liver disease (e.g. nonalcoholic steatohepatitis). 6. Type 2 diabetes mellitus (insulin resistant). 7. Porphyria cutanea tarda. 8. Debilitating fatigue impacting quality of life (e.g., secondary to extra¬hepatic manifestations and/or liver disease) Fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest, and causes a substantial reduction or impairment in the ability to engage in pre¬illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months]. 9. Men who have sex with men with high¬risk sexual practices. 10. Patients with a current injectable substance abuse disorder and actively participating in treatment. 11. Persons on long¬term hemodialysis. 12. Women of childbearing age who wish to get pregnant 13. HCVinfected health care workers who perform exposureprone procedures. Coverage is Not Authorized For: Non¬FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature. Authorization Limit: Daklinza with Sovaldi for Dosing Regimen: 1. GT1 treatment naive or treatment experienced with Peg¬IFN/RBV with or without protease inhibitor, and without cirrhosis: 12 weeks 2. GT1 treatment naive or treatment experienced with Peg¬IFN/RBV with or without protease inhibitor, and with cirrhosis: 24 weeks. 3. GT1 with decompensated cirrhosis (including those with hepatocellular carcinoma): 12 weeks. 4. GT1 with decompensated cirrhosis (including those with hepatocellular carcinoma) and intolerant to RBV: 24 weeks. 5. GT2, treatment naive without cirrhosis, AND, unable to tolerate RBV: 12 weeks. 6. GT2 who are not eligible to receive IFN, in whom previous treatment with Sovaldi/RBV has failed: 24 weeks. 7. GT3, treatment naive or treatment experienced with Peg IFN/RBV without cirrhosis 12 weeks. 8. GT 3, treatment naive or treatment experienced with Peg IFN/RBV with cirrhosis: 24 weeks. 9. GT 3 who are not eligible to receive IFN, in whom previous treatment with Sovaldi/RBV has failed: 24 weeks. 10. GT 1, 2 or 3 infection in the allograft, including those with compensated cirrhosis: 12 weeks. 11. GT 1, 2 or 3 infection in the allograft, including those with compensated cirrhosis and intolerant to RBV: 24 weeks.
- Step Therapy Exists in PA
- Antiviral: Hepatitis C (HCV):
Age Requirement: >= 18
Duration: 24 week(s)
Specialist Required: Yes
Documented Diagnosis: Yes
Medical Test Required: Yes
Specialist Type(s): 1 of Gastroenterologist;Hepatologist;Infectious Disease Specialist
Reauthorization Required: Yes
Duration of Reauthorization: <= 24 week(s)
Documented Genotype(s): 1 of Genotype 1;Genotype 2;Genotype 3;Genotype 4;Genotype 5;Genotype 6
History of Substance Abuse: No
If History of Substance Abuse, Drug Abstinence Duration: N/A
If History of Substance Abuse, Appropriate Clean Drug Screen: No
Policy Contains a Once in a Lifetime Restriction: No
Co-Infection with Hepatitis B Prohibited in the Policy: No
Extra-hepatic Disease Prohibited in Policy: No
Treatment Duration Extended for Hepatocellular Carcinoma: No
Concomitant Therapy with RBV: No
Concomitant Therapy with RBV + IFN: No
Concomitant Therapy with Daklinza: No
Concomitant Therapy with Sovaldi: Yes
Patient Must Not Have Been Previously Treated With a NS3-4A: No
Patient Must Not Have Been Previously Treated With a NS-5A: No
Fibrosis Score Required for Authorization: No
- Step Therapy: Antiviral: Hepatitis C (HCV):
ST Single Generic
- Prior Authorization: Antiviral: Hepatitis C (HCV):
Documented Diagnosis: Yes
Medical Test Required: Yes
Age Requirement: >= 18
Duration: 24 week(s)
Reauthorization Required: Yes
|