Mavyret — Highmark
treatment-naïve adults with hepatitis C virus (HCV) infection
Preferred products
- Mavyret
- Harvoni AG
- Epclusa AG
- Zepatier
- Vosevi
Initial criteria
- age ≥ 18 years
- diagnosis of chronic HCV (ICD-10: B18.2) OR, for Mavyret only, diagnosis of acute (ICD-10: B17) or chronic HCV (ICD-10: B18.2)
- member has not received prior HCV treatment (for treatment-naïve)
- prescriber provides cirrhosis status and liver transplant history
- prescribed regimen is appropriate based on patient characteristics per FDA-approved labeling and/or AASLD/IDSA guidelines
- prescriber attests member or parent/guardian has been educated on adverse effects of alcohol or IV drug abuse
- if member has alcohol use disorder OR IV drug abuse OR history of substance abuse within past 6 months, prescriber attests offer of referral for substance abuse treatment and care management was made
- appropriate resistance-associated substitutions (RASs) testing performed, based upon agent and genotype
- Harvoni duration requirements: if for 12 weeks, must meet ≥1 of HCV RNA >6 million IU/mL OR HIV-infected OR has cirrhosis OR prior liver transplant OR 8-week inappropriate; if for 8 weeks, must meet all of HIV-uninfected AND HCV RNA <6 million IU/mL AND no cirrhosis
- Mavyret 12-week requests require HIV/HCV co-infection OR prior liver transplant
- if request is for non-preferred product, member has contraindication or is otherwise not a candidate for all preferred regimens per table
- if request is for brand Epclusa or Harvoni, member has experienced therapeutic failure or intolerance to the authorized generic product
- for treatment-experienced: prescriber documents prior HCV therapies with reason for discontinuation/failure
- for treatment-experienced: drug selection per FDA labeling/AASLD-IDSA Table 2 regimens
- for treatment-experienced: same education, referral, and RAS testing criteria above apply