Zepatier (elbasvir/grazoprevir) — Blue Cross Blue Shield of New Mexico

Preferred products

• Mavyret (glecaprevir/pibrentasvir)
• Epclusa (sofosbuvir/velpatasvir)

Initial criteria

• If the screening for HBV was positive for current or prior HBV infection, the 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) The 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 the patient’s age for the requested indication
• If the client has preferred agent(s) for the patient’s specific factors (e.g., age, genotype, cirrhosis status, treatment naive vs treatment experienced, previous treatment), then ONE of the following: (A) The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR (B) The requested agent is a preferred agent for the patient’s specific factors OR (C) The patient has been treated with the requested non-preferred agent in the past 30 days OR (D) The patient is currently being treated with the requested non-preferred agent and the patient is currently stable on the requested non-preferred agent [chart notes required] OR (E) 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 (F) ALL of the preferred agent(s) for the patient’s specific factors were discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes required] OR (G) The patient has an intolerance or hypersensitivity to ALL of the preferred agent(s) for the patient’s specific factors [chart notes required] OR (H) The patient has an FDA labeled contraindication to ALL of the preferred agent(s) for the patient’s specific factors OR (I) ALL of the preferred agent(s) for the patient’s specific factors are expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm [chart notes required] OR (J) ALL of the preferred agent(s) for the patient’s specific factors are not in the best interest of the patient based on medical necessity [chart notes required] OR (K) The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as ALL of the preferred agent(s) for the patient’s specific factors and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes required] OR (L) There is support for the use of the requested non-preferred agent over the preferred agent(s)
• ONE of the following: (A) The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, hepatologist, or infectious disease), or has consulted with a specialist in the area of the patient’s diagnosis OR (B) ALL of the following: 1. The patient is treatment naive AND 2. The patient does NOT have cirrhosis or has compensated cirrhosis AND 3. The requested agent is supported in AASLD guidelines for simplified treatment AND 4. The patient meets all of the qualifications for AASLD guidelines simplified treatment (see simplified treatment tables)
• The patient does NOT have any FDA labeled contraindications to the requested agent
• The patient meets all requirements and will use the requested agent in a treatment regimen noted in Table 3 (FDA labeling) or Table 4 (AASLD/IDSA guidelines for decompensated cirrhosis)
• The requested length of therapy does NOT exceed the length noted in Table 3 or 4 for the patient’s treatment regimen
• For Ohio members with Fully Insured or HIM Shop (SG) plans, approval if: (A) The patient does NOT have any FDA labeled contraindications to the requested agent AND (B) ONE of the following: 1. The patient has another FDA labeled indication for the requested agent and route of administration OR 2. The patient has another indication supported in compendia for the requested agent and route of administration OR 3. The prescriber has submitted TWO peer-reviewed journal articles supporting the proposed use as generally safe and effective (non-oncology compendia allowed: DrugDex 1/2A/2B, AHFS-DI; oncology compendia allowed: NCCN 1/2A, AHFS-DI, DrugDex 1/2A/2B, Clinical Pharmacology, Lexi-Drugs level A, or peer-reviewed literature)

Approval duration

BCBSIL and BCBSMT: 6 months; others up to duration of treatment as determined in Table 3 or 4 (at least 12 weeks BCBSNM); Ohio exception: 12 months