Harvoni AG — Highmark

Preferred products

• Zepatier

Initial criteria

• Prescriber documents any previous therapies the member has used for chronic HCV with reason for discontinuation and/or failure.
• Prescriber provides the member’s cirrhosis status.
• Member is prescribed an appropriate regimen based on patient characteristics per the FDA-approved labeling and/or AASLD/IDSA guidelines.
• Prescriber attests the member or parent/guardian has been educated on the potential adverse effects of alcohol or intravenous (IV) drug abuse, including the risk of misuse, abuse, and addiction.
• If the member has alcohol use disorder, is an IV drug abuser, or has a history of substance abuse within the past 6 months, prescriber provides attestation that an offer of a referral for substance abuse disorder treatment and care management was made.
• Member has had appropriate resistance-associated substitutions (RASs) testing performed, based upon agent and genotype.
• If the request is for a non-preferred product, the member has a contraindication or is otherwise not a candidate for all preferred regimens.

Approval duration

up to 12 weeks (84 days) or remaining duration of course of therapy if already established