Limited Coverage Drugs – Daclatasvir

Generic Name

daclatasvir (for use in combination with sofosbuvir (Sovaldi™) with or without ribavirin (RBV))

Strength

30 mg, 60 mg

Form

tablet

As of February 4, 2020, Special Authority requests for Daklinza will no longer be approved. The manufacturer is no longer making the product and its use has been discontinued. For patients with approved requests prior to February 4, 2020, coverage will continue until July 29, 2020.  

Special Authority Criteria

For the treatment of treatment-naïve or treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype 3 infection who meet ALL the following criteria:

A. Fibrosis stage of F0 or greater (Metavir scale or equivalent);

Special Authority requests for patients must include a fibrosis score test performed in the last 12 months. Acceptable methods include liver biopsy, transient elastography (FibroScan®) and serum biomarker panels (AST-to-Platelet Ratio Index (APRI)) either alone or in combination). Supporting documentation must be submitted.

AND

B. Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist, or other prescriber experienced with treating hepatitis C;

AND

C. Laboratory confirmed hepatitis C genotype 32;

AND

D. Laboratory confirmed quantitative HCV RNA test must be done within the previous 12 months3;

AND

E. Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug (with the exception of sofosbuvir).

 
Treatment regimens for genotype 3 CHC adult patients: Approval Period

Treatment-naïve and treatment-experienced1 with no cirrhosis.

12 weeks in combination with sofosbuvir

Treatment-naïve and treatment-experienced1 with compensated cirrhosis4 or decompensated cirrhosis5

OR

Treatment-naïve and treatment-experienced1 liver transplant recipients with no cirrhosis or with compensated cirrhosis4.

12 weeks in combination with sofosbuvir and RBV

Notes

1. Treatment-experienced is defined as patients who have been previously treated with PegIFN/RBV regimen and have relapsed or not responded.   

2. Special Authority requests for patients must include the most recent genotyping test report.

3. Special Authority requests for patients must include the most recent HCV RNA test performed in the last 12 months.

4. Compensated cirrhosis is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6).

5. Decompensated cirrhosis is defined as cirrhosis with a CPS = B or C (7 or above). Special Authority requests for patients with decompensated cirrhosis must include a clinical history or ultrasound imaging diagnosis, laboratory test reports, and fibrosis score test performed in the last 12 months. Acceptable methods include liver biopsy, transient elastography (FibroScan®) and serum biomarker panels (AST-to-Platelet Ratio Index (APRI)) either alone or in combination. Supporting documentation must be submitted.

Practitioner Exemptions

  • None

Special Notes

  • None

Additional Information