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
Last review date: September 12, 2018