Ledipasvir/Sofosbuvir — Blue Cross Blue Shield of New Mexico

Initial criteria

• The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
• The requested agent is a preferred agent for the patient’s specific factors OR
• The patient has been treated with the requested non-preferred agent in the past 30 days OR
• The patient is currently being treated with the requested non-preferred agent and is stable on the requested agent [chart notes required] OR
• The patient has tried and had an inadequate response to ALL of the preferred agent(s) for the patient’s specific factors [chart notes required] OR
• ALL of the preferred agent(s) were discontinued due to lack of efficacy/effectiveness, diminished effect, or an adverse event [chart notes required] OR
• The patient has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL preferred agents [chart notes required] OR
• ALL preferred agents are expected to be ineffective or cause significant barrier/adverse outcome [chart notes required] OR
• ALL preferred agents are not in the best interest of the patient based on medical necessity [chart notes required] OR
• The patient has tried another prescription drug in the same pharmacologic class or mechanism of action as all preferred agents and it was discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR
• There is support for use of the requested non-preferred agent over preferred agents
• The patient meets all requirements and will use the requested agent in a treatment regimen noted in Table 11 (FDA labeling) AND
• The requested length of therapy does not exceed the length of therapy noted in Table 11 (FDA labeling) for the patient’s treatment regimen
• For members residing in Ohio, plan is Fully Insured or HIM Shop (SG) AND both of the following: patient does not have any FDA labeled contraindications to the requested agent AND one of the following applies: patient has another FDA labeled indication, another compendia-supported indication, or prescriber has submitted two peer-reviewed journal articles supporting use
• Epclusa Quantity Limit approval requires: (1) requested therapy length does not exceed FDA/AASLD labeled duration; AND (2) requested quantity does not exceed the program limit OR exceeds it with justification as follows: (a) Epclusa 200 mg/50 mg packets ≤ 2 per day with rationale for inability to take 400 mg/100 mg tablet; OR (b) Epclusa 200 mg/50 mg tablets ≤ 2 per day with rationale for inability to take 400 mg/100 mg tablet
• Harvoni Quantity Limit approval requires: (1) requested therapy length does not exceed FDA/AASLD labeled duration; AND (2) requested quantity does not exceed the program limit OR exceeds it with justification as follows: (a) Harvoni 45 mg/200 mg oral pellets ≤ 2 packets daily with rationale why tablet cannot be used; OR (b) Harvoni 45 mg/200 mg tablet ≤ 2 tablets daily and dose cannot be achieved with lower quantity of a higher strength within program limit

Approval duration

6 months (BCBSIL, BCBSMT); up to duration of treatment (≥12 weeks BCBSNM); 12 months for Ohio indication; 12 months for quantity limit per BCBSIL; up to duration of treatment for others