Technivie (ombitasvir/paritaprevir/ritonavir) prior authorization and coverage
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This document governs prior authorization, approval criteria, quantity limits, and approval duration for Technivie (ombitasvir/paritaprevir/ritonavir) for treatment of chronic hepatitis C virus (HCV) infection, including HCV/HIV-1 co-infection, for Amerigroup members (excludes plans without pharmacy benefits and Medicare).
No material clinical or coverage changes in this revision.
Coverage Criteria for Technivie
Initial Authorization Criteria
Covered when ALL of the following are met:
Technivie approval criteria
I. Age and diagnosis
- 1: Individual is 18 years of age or older.
- 2: Documentation of chronic hepatitis C infection including genotype and a positive HCV RNA result.
II. Life expectancy and substance use
- 3: Individual does not have a short life expectancy (less than 12 months) from non‑liver comorbid conditions that cannot be remediated by HCV treatment, transplantation, or other directed therapy.
- 4: Individuals who abuse alcohol or intravenous drugs are enrolled in a substance abuse program.
- III. Genotype and liver status: Individual has HCV genotype 4 with compensated liver disease (with or without cirrhosis).
IV. Antiviral regimen and prior therapy
- 5: Technivie will be used in an antiviral regimen as follows: in combination with ribavirin for treatment‑naïve or prior peginterferon/ribavirin experienced individuals with compensated cirrhosis or without cirrhosis.
6
- 6A: Documented trial of authorized generic Epclusa (sofosbuvir/velpatasvir) OR Mavyret (medication samples/coupons/discount cards excluded).
- 6B: Individual is currently on and completing a course of therapy with the requested regimen.
- 6C: Documented hypersensitivity (severe allergic reaction) to any ingredient in authorized generic Epclusa OR Mavyret that is not also in Technivie.
- 6D: Individual is concurrently using an agent that cannot be substituted or temporarily discontinued and is contraindicated or not recommended for concomitant use with the preferred regimen(s).
- V. Co‑infection note: Per product labeling and AASLD/IDSA guidance, Technivie may be used in individuals co‑infected with HIV‑1; individuals co‑infected should be on a suppressive antiretroviral regimen to reduce the risk of HIV‑1 protease inhibitor resistance.
Technivie is not approved for use in individuals with decompensated cirrhosis. The product also must not be used concurrently with contraindicated or not-recommended agents, including but not limited to strong or moderate CYP3A4 inducers (examples: phenytoin, St. John’s Wort, efavirenz-based regimens, phenobarbital, rifampin, rifabutin, rifapentine, carbamazepine) and agents that are highly dependent on CYP3A clearance or otherwise contraindicated (examples: alfuzosin, colchicine, ranolazine, dronedarone, amiodarone, flecainide, propafenone, quinidine, ergot derivatives, ethinyl estradiol–containing products, cisapride, lovastatin, simvastatin, lurasidone, pimozide, sildenafil for pulmonary hypertension [Revatio], triazolam, oral midazolam, certain HIV protease inhibitors and ritonavir-boosted regimens, rilpivirine-based regimens, voriconazole, salmeterol, atorvastatin, everolimus, sirolimus, tacrolimus, tipranavir/ritonavir, etravirine, and cobicistat-containing regimens).
Re-treatment with Technivie is not approved when the individual failed to achieve a sustained virologic response (SVR) or relapsed after a prior completed regimen that included an NS3/4A protease inhibitor, NS5A inhibitor, or NS5B polymerase inhibitor. For this policy, SVR is defined as HCV RNA ≤25 IU/mL; requests for Technivie for re-treatment under these circumstances will be denied.
Provider Actions, Prior Authorization and Documentation
Prior authorization, quantity limit, and approval duration
Prior authorization is required for Technivie. Quantity limit: 2 tablets per day. Approval duration is determined by genotype, treatment status, and cirrhosis status — for example, Genotype 4 (treatment-naïve or prior P/R experienced) when given with ribavirin is approved for 12 weeks.
- Prior authorization required for Technivie.
- Quantity limit = 2 tablets per day.
- Example approval duration: Genotype 4 + RBV = 12 weeks.
Step therapy: trial of Epclusa or Mavyret required
A trial of an authorized generic Epclusa (sofosbuvir/velpatasvir) OR Mavyret is required prior to approval (medication samples/coupons/discount cards do not count), unless the member is currently completing the requested regimen, has documented hypersensitivity to those agents, or is using a contraindicated concurrent agent that cannot be substituted.
- Authorized generic Epclusa or Mavyret trial required; samples/coupons excluded.
- Exceptions: currently completing requested regimen; documented hypersensitivity to Epclusa/Mavyret ingredients not shared with Technivie; or unavoidable contraindicated concomitant agent.
Required documentation to support approval
Submit documentation confirming chronic hepatitis C infection including HCV genotype and a positive HCV RNA result, evidence the patient is ≥18 years old, and documentation that life expectancy exceeds 12 months or that comorbid conditions are remediable by HCV treatment or transplant.
- Positive HCV RNA result and documented genotype.
- Patient age ≥18 years.
- Life expectancy >12 months or remediable by HCV treatment/transplant.
Co-infection documentation and HBV monitoring
For HCV/HIV-1 co-infected individuals, document that the patient is on a suppressive antiretroviral regimen. Prior to and during DAA therapy consider HBV testing and monitor for HBV reactivation per the DAA safety guidance.
- Document suppressive antiretroviral regimen for HCV/HIV-1 co-infected patients.
- Test for current or prior HBV infection before DAA initiation and monitor for HBV reactivation during and after therapy; manage HBV as indicated.
Common denial triggers
Requests may be denied if the patient has decompensated cirrhosis, is using contraindicated concomitant agents, is combining Technivie with other NS3/4A, NS5A, or NS5B agents, or is seeking re-treatment after prior failure or relapse following such regimens.
- Decompensated cirrhosis is not approved.
- Contraindicated concomitant agents include strong/moderate CYP3A4 inducers and drugs highly dependent on CYP3A clearance (examples listed in policy).
- Not approved in combination with another NS3/4A protease inhibitor, NS5A inhibitor, or NS5B polymerase inhibitor.
- Re-treatment requests after prior SVR failure or relapse following a regimen containing NS3/4A, NS5A, or NS5B agents may be denied.
Background
Technivie (ombitasvir/paritaprevir/ritonavir) is a direct-acting antiviral regimen indicated for treatment of chronic hepatitis C virus infection; this policy focuses on use for HCV genotype 4 with compensated liver disease. Use must follow labeling and guidance regarding drug–drug interactions and is not recommended with certain concomitant agents or in decompensated cirrhosis.
Definitions and Key Terms
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