Harvoni — Blue Cross Blue Shield of Oklahoma
chronic hepatitis C virus (HCV) infection including any genotype as specified
Preferred products
- Mavyret
- Epclusa
Initial criteria
- Screening for HBV was positive for current or prior HBV infection and prescriber will monitor the patient for HBV flare-up or reactivation during and after treatment with the requested agent
- If the patient has an FDA labeled indication then ONE of the following: (A) Patient's age is within FDA labeling for the requested indication for the requested agent OR (B) There is support for using the requested agent for patient's age for the requested indication
- If the client has preferred agent(s) for patient's specific factors (e.g., age, genotype, cirrhosis status, treatment history), then ONE of the following applies: (A) Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR (B) Requested agent is a preferred agent OR (C) Patient has been treated with the requested non-preferred agent in past 30 days OR (D) Patient is currently stable on requested non-preferred agent [chart notes required] OR (E) Patient has tried and had inadequate response to ALL preferred agents [chart notes] OR (F) ALL preferred agents discontinued due to lack of efficacy, diminished effect or adverse event [chart notes] OR (G) Patient has intolerance or hypersensitivity to ALL preferred agents [chart notes] OR (H) Patient has FDA labeled contraindication to ALL preferred agents OR (I) ALL preferred agents expected to be ineffective or cause adherence barrier, worsen comorbidity, decrease functional ability, cause adverse reaction or harm [chart notes] OR (J) ALL preferred agents are not in patient's best interest based on medical necessity [chart notes] OR (K) Patient tried another drug in same pharmacologic class or mechanism and discontinued due to lack of efficacy or adverse event [chart notes] OR (L) There is support for use of the requested non-preferred agent over preferred agents
- ONE of the following: (A) Prescriber is a hepatologist/gastroenterologist/infectious disease specialist or has consulted such specialist OR (B) ALL of the following: (1) Patient is treatment naive AND (2) Patient does NOT have cirrhosis or has compensated cirrhosis AND (3) Requested agent is supported in AASLD guidelines for simplified treatment AND (4) Patient meets all AASLD simplified treatment qualifications (adults with chronic HCV infection of any genotype, treatment-naive, without cirrhosis or with compensated cirrhosis [Child-Pugh A])
- Patient does NOT have any FDA labeled contraindications to the requested agent
- Patient meets all requirements and will use the requested agent in a regimen noted in Table 3 (FDA labeling) or Table 4 (AASLD/IDSA guidelines for decompensated cirrhosis)
- Requested length of therapy does NOT exceed duration noted in Table 3 or 4
Approval duration
6 months for BCBSIL and BCBSMT; all other plans up to duration of treatment (at least 12 weeks for BCBSNM)