Ombitasvir + paritaprevir + ritonavir + dasabuvir (Viekira Pak / Viekira XR) — Coverage Criteria
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Covers prior authorization and medical necessity criteria for use of ombitasvir/paritaprevir/ritonavir with dasabuvir (Viekira Pak, Viekira XR) for treatment of chronic hepatitis C genotype 1 in eligible members; applies to Amerigroup pharmacy benefits (not Medicare or plans without pharmacy benefits).
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
based on AASLD/IDSA 2017 guidance
Genotype/subtype and cirrhosis status determine regimen and need for ribavirin
Trials exclude samples/coupons/discount cards
Not approved for individuals with decompensated cirrhosis or when used with contraindicated or not-recommended concomitant agents. Specifically, requests will be denied if the individual is using this regimen in combination with another NS3/4A protease inhibitor, another NS5A inhibitor, another NS5B polymerase inhibitor (including nucleotide agents such as sofosbuvir or non-nucleoside agents such as dasabuvir), or when the regimen is being requested for re-treatment following failure or relapse after prior direct-acting antiviral therapy that included NS3/4A protease inhibitors, NS5A inhibitors, or NS5B polymerase inhibitors.
Use is not medically necessary for individuals with decompensated (moderate to severe) liver disease (Child-Pugh B or C). Coverage is limited to members with compensated liver disease (Child-Pugh Class A); members with decompensated cirrhosis are excluded from approval.
Coding and Dosing
| Viekira Pak | ombitasvir + paritaprevir + ritonavir + dasabuvir (packaged regimen) |
| Viekira XR | ombitasvir + paritaprevir + ritonavir + dasabuvir (extended release formulation) |
| Viekira Pak | 4 tablets per day |
| Viekira XR | 3 tablets per day |
Provider Actions and Requirements
Prior authorization required; duration and quantity limits vary by genotype/status
Prior authorization is required for Viekira Pak and Viekira XR. Approval duration and quantity limits are determined by HCV genotype, treatment status, and cirrhosis status — typical approval duration is 12 weeks. Tablet-per-day limits: Viekira Pak — 4 tablets/day; Viekira XR — 3 tablets/day.
- Prior authorization required for Viekira Pak and Viekira XR.
- Total approval duration is based on genotype and treatment status (commonly 12 weeks).
- Quantity limits set by genotype/treatment/cirrhosis status: Viekira Pak = 4 tablets/day; Viekira XR = 3 tablets/day.
Prior trial with Epclusa or Mavyret required unless specific exceptions apply
Coverage generally requires a prior trial and inadequate response to an authorized generic Epclusa (sofosbuvir/velpatasvir) or Mavyret before approving Viekira regimens, unless the member is currently completing therapy, has documented severe hypersensitivity to those agents (not shared with Viekira), or is taking a concomitant agent that cannot be substituted or temporarily discontinued.
- Prior trial with inadequate response to authorized generic Epclusa OR Mavyret is required (medication samples/coupons/discount cards do not count).
- Exceptions: currently completing the requested regimen; documented severe hypersensitivity to Epclusa or Mavyret not shared by Viekira; concomitant agent cannot be substituted or held.
Document CHC diagnosis with genotype and positive HCV RNA; screen and monitor for HBV
Provide documentation confirming chronic hepatitis C infection including HCV genotype and a positive HCV RNA result. Test for current or prior hepatitis B infection before initiating DAA therapy and monitor for HBV reactivation during and after treatment.
- Document chronic hepatitis C diagnosis with genotype and positive HCV RNA.
- Test for evidence of current or prior HBV infection prior to initiation and monitor for HBV reactivation during and following DAA therapy.
Common denial triggers: decompensated cirrhosis, contraindicated concomitant agents, prohibited combinations
Requests may be denied for individuals with decompensated cirrhosis (Child‑Pugh B or C), for concurrent use with contraindicated or not‑recommended agents (including strong CYP2C8 inhibitors/inducers, strong CYP3A4 inducers, drugs highly dependent on CYP3A, certain immunosuppressants/antiretrovirals), or when used with other NS3/4A protease inhibitors, NS5A inhibitors, or NS5B polymerase inhibitors; re‑treatment requests after failure/relapse following prior DAA regimens containing those classes may also be denied.
- Decompensated cirrhosis (Child‑Pugh B or C) is a denial criterion.
- Concurrent use with contraindicated/not‑recommended agents (e.g., strong CYP2C8 or CYP3A4 modulators and certain immunosuppressants/antiretrovirals) can result in denial.
- Use in combination with other NS3/4A protease inhibitors, NS5A inhibitors, or NS5B polymerase inhibitors or re‑treatment after failure/relapse of such regimens may be denied.
Background
Ombitasvir/paritaprevir/ritonavir with dasabuvir is a direct-acting antiviral regimen indicated for treatment of hepatitis C virus genotype 1. Use requires assessment of liver disease severity and should not be combined with other protease, NS5A, or NS5B polymerase inhibitors as outlined in the coverage exclusions.
Definitions
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