DAKLINZA (daclatasvir)

DAKLINZA (daclatasvir)

ORAL ADMINISTRATION

Indications for Prior Authorization:

• Treatment of chronic hepatitis C Genotype 1 or 3, taken once daily in combination with Sovaldi, with or without Ribavirin

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, stage F2, F3 or F4
• 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.
• Trial and failure of preferred agent(s) Epclusa, Harvoni, Vosevi

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

• Any condition not listed above as an approved indication.  Not approvable for patients with Stage 0 or Stage 1 Fibrosis

Dosing and Duration of Therapy

Genotype 1  Daclatasvir 60 mg once daily + sofosbuvir for 12 weeks

• Note: AASLD/IDSA 2015 guidelines recommend 24 weeks of therapy with concomitant sofosbuvir (with or without ribavirin) in patients with compensated cirrhosis and genotype 1;

Genotype 3:  Daclatasvir 60 mg once daily + sofosbuvir + ribavirin for 12 weeks

• Note: AASLD/IDSA 2015 guidelines recommend 24 weeks of therapy with concomitant sofosbuvir (with or without ribavirin in treatment-naïve patients and with ribavirin in treatment-experienced patients) with compensated cirrhosis and genotype 3