• Indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Sovaldi efficacy has been established in subjects with hepatitis C virus (HCV) genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant) and those with HCV/HIV-1 co-infection.

• Diagnosis of hepatitis C virus (HCV) genotype 1 through 6 infection confirmed by detectable serum HCV RNA by quantitative assay. Genotype is required to determine length of approval.

AND

• For genotype 1 and 4: Failure or clinically significant adverse effects to Zepatier (grazoprevir/elbasvir)

AND

• For genotype 2, 3, 5, 6: Failure or clinically significant adverse effects to Epclusa (sofosbuvir/velpatasvir)

AND

• Patient is 18 years of age or older

AND

• Any of the following clinical states identify candidates for treatment:
  • Evidence of Stage 2 or greater hepatic fibrosis including one of the following: Liver biopsy confirming a METAVIR score F2 or greater OR Transient elastography (Fibroscan^R), score greater than or equal to 7.5 kPa; OR FibroSure^R (also known as FibroTest) score of greater than or equal to 0.48; OR APRI score greater than 0.7; OR FIB greater than 3.25.
  • 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).
  • Persons with hepatocellular carcinoma with life expectancy greater than 12 months
  • Pre- and post-liver transplant, or other solid organ transplant
  • HIV-1 co-infection
  • Hepatitis B co-infection
  • Other coexistent liver disease (e.g. nonalcoholic steatohepatitis)
  • Type 2 diabetes mellitus (insulin resistant)
  • Porphyria cutanea tarda
  • Debilitating fatigue impacting quality of life (e.g., secondary to extra-hepatic manifestations and/or liver disease)
  • Men who have sex with men with high-risk sexual practices
  • Active injection drug users
  • Persons on long-term hemodialysis
  • Women of childbearing age who wish to get pregnant
  • HCV-infected health care workers who perform exposure-prone procedures

• Initial authorization criteria have been met, and
• Evidence of lack of adherence may result in denial of treatment reauthorization.
• Missed medical appointments related to the hepatitis C virus may result in denial of treatment authorization.

• Treatment of HCV as monotherapy.
• Quadruple therapy (Sovaldi+(Olysio)+peginterferon+ribavirin) combination
• 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

• Patients should be evaluated for readiness to initiate treatment. Patients selected for treatment shall be able and willing to strictly adhere to treatment protocols prescribed by their provider. Caution should be exercised with patients who have a history of treatment failure with prior hepatitis C treatment due to non-adherence with treatment regimen and appointments. Patients should be educated regarding potential risks and benefits of hepatitis C virus therapy, as well as the potential for resistance and failed therapy if medication is not taken as prescribed.
• Postmarketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with Sovaldi in combination with an investigational agent (the NS5A inhibitor daclatasvir) or simeprevir. For patients taking amiodarone who have no other alternative, viable treatment options and who will be coadministered Sovaldi:
  • Counsel patients about the risk of serious symptomatic bradycardia
  • Cardiac monitoring in an in-patient setting for the first 48 hours of coadministration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.
• Retreatment may be considered where there is evidence that such retreatment will improve patient outcomes according to AASLD guidelines.
• Lost medications will not be replaced and may result in denial of treatment authorization. Replacement of stolen medications will require documentation and will be adjudicated on a case-by-case basis.
• Evidence of lack of adherence may result in denial of treatment reauthorization.
• Missed medical and lab appointments may result in denial of treatment authorization.
• The use of Olysio in combination with pegylated interferon is no longer recommended by AASLD treatment guidelines for treatment of patients with genotype 1.
• Investigational services are not covered except when it is clearly documented that all of the following apply:
  • Conventional therapy will not adequately treat the intended patient's condition;
  • Conventional therapy will not prevent progressive disability or premature death;
  • The provider of the proposed service has a record of safety and success with it equivalent or superior to that of other providers of the investigational service;
  • The investigational service is the lowest cost item or service that meets the patient's medical needs and is less costly than all conventional alternatives;
  • The service is not being performed as a part of a research study protocol;
  • There is a reasonable expectation that the investigational service will significantly prolong the intended patient's life or will maintain or restore a range of physical and social function suited to activities of daily living;
  • All investigational services require prior authorization. Payment will not be authorized for investigational services that do not meet the above criteria or for associated inpatient care when a beneficiary needs to be in the hospital primarily because she/he is receiving such non-approved investigational services.
• There is no dosing recommendation for patients with severe renal impairment (estimated glomerular filtration rate < 30mL/minute/1.73m ² or with end stage renal disease due to higher exposures (up to 20 fold) of the predominant sofosbuvir metabolite.