sofosbuvir (Sovaldi®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of chronic hepatitis C (CHC), genotype 1, 2, 3, or 4 as a component of a combination antiviral treatment regimen.

All of the following must be met as a condition for coverage:

  • Must not be used as monotherapy
  • Must have compensated liver disease by ultrasound or biopsy, stating F2, F3 or F4 fibrosis.
  • Resistance testing must be included with the prior authorization request for genotypes 1 and 3.
    • Treatment failure associated with HCV resistance to newly developed direct-acting antiviral agents is not an uncommon occurrence and poses a substantial problem to clinicians trying to re-treat patients who have failed available interferon-free treatments.
  • Documentation of intolerance to interferon alfa if applicable (see below).

This Medication is Not Approvable for the following condition(s).

  • Any condition not listed above as an approved indication

Dosing and Duration of Therapy:

Genotype 1

  • Patients who can receive interferon:  400 mg once daily + peginterferon alfa + ribavirin, 12 weeks
  • Patients who cannot receive interferon:  400mg once daily + ribavirin, 24 weeks.

Genotype 2               

  • sofosbuvir 400 mg once daily + ribavirin, 12 weeks

Genotype 3               

  • sofosbuvir 400 mg once daily + ribavirin, 24 weeks

Genotype 4 

  • sofosbuvir 400 mg once daily + peginterferon alfa + ribavirin, 12 weeks.

Hepatocellular carcinoma awaiting liver transplantation

  • Should be used in combination with ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first

Intolerance to interferon alfa with documentation of one of the following:

  • Chart note documentation of intolerance to previous trial of interferon (treatment failure is not a contraindication)
  • Autoimmune hepatitis
  • History of depression
  • Baseline neutrophil count < 1,500 cells/ul, platelet count < 90,000 cells/ul or hemoglobin < 10 g/dL
  • Pre-existing cardiac disease

                                                        

Last review date: March 2, 2015

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