Prior authorization required; brand allowed only after authorized-generic trial or completing therapy

Prior authorization is required for all Epclusa (sofosbuvir/velpatasvir) requests, including brand and authorized generic products. Brand Epclusa will only be considered after meeting the brand step-therapy exception below (completing current course) or when there is documentation of prior trial and inadequate response to the authorized generic; medication samples, coupons, and discount cards do not count as a trial.

• Prior authorization applies to both brand and authorized generic Epclusa.
• Brand approval requires prior trial and inadequate response to authorized generic, or that the member is currently completing the requested regimen.
• Samples, coupons, and discount cards are excluded from consideration as a prior trial.

Brand step therapy: authorized-generic trial required before brand Epclusa

Brand Epclusa may be approved only after the member has had a prior trial with authorized generic Epclusa and demonstrated an inadequate response, or if the member is currently on and completing a course of the requested brand regimen. Medication samples, coupons, and discount cards are excluded from counting as a prior trial.

• Authorized generic trial with documented inadequate response is required before brand approval.
• Ongoing courses may be completed with the requested brand product.
• Samples/coupons/discount cards do not qualify as a trial.

Required documentation: diagnosis, genotype, HCV RNA, age, life expectancy, liver status, substance‑use program

Provide documentation confirming chronic hepatitis C infection including genotype and a positive HCV RNA result, evidence the individual is ≥18 years of age, and that life expectancy is not <12 months from non‑liver comorbidities. Document liver disease status (compensated or decompensated) and enrollment in a substance abuse program if the individual abuses alcohol or IV drugs.

• Diagnosis of chronic hepatitis C with genotype and positive HCV RNA.
• Age ≥ 18 years.
• Life expectancy ≥ 12 months (no short life expectancy from non‑liver comorbidities that cannot be remediated).
• Liver disease status: compensated or decompensated (Child‑Pugh assessment as required).
• If alcohol or IV drug abuse, documentation of enrollment in a substance abuse program.

Denial triggers: severe CKD, contraindicated drugs, disallowed antiviral combinations, prior SOF/VEL/VOX failure

Requests may be denied for members with severe or end‑stage chronic kidney disease (requiring dialysis), for concurrent use with listed contraindicated or not‑recommended medications, for use in disallowed antiviral combinations, or for re‑treatment after prior sofosbuvir/velpatasvir/voxilaprevir failure (failure to achieve SVR or relapse).

• Severe or end‑stage CKD requiring dialysis is a denial trigger.
• Concurrent therapy with contraindicated/not‑recommended agents (e.g., amiodarone; carbamazepine; phenytoin; phenobarbital; oxcarbazepine; rifabutin, rifampin, rifapentine; St John's Wort; tipranavir/ritonavir; topotecan; efavirenz; etravirine; nevirapine; lumacaftor) may lead to denial.
• Use in combination with a non‑nucleoside or nucleotide NS5B polymerase inhibitor, another NS5A inhibitor, or an NS3/4A protease inhibitor is not allowed.
• Re‑treatment requests after prior sofosbuvir/velpatasvir/voxilaprevir failure (did not achieve SVR or relapsed) may be denied.