Imbruvica 280 mg tablets — Blue Cross Blue Shield of New Mexico

Initial criteria

• Patient has an FDA labeled contraindication to the generic equivalent that is not expected to occur with the brand agent [chart notes required] OR
• Generic equivalent expected to be ineffective based on known clinical characteristics OR causes adherence barrier, worsens comorbidity, decreases functional ability, or causes adverse reaction or harm [chart notes required] OR
• Generic equivalent not in patient's best interest based on medical necessity [chart notes required] OR
• Patient has tried another drug in same pharmacologic class or mechanism as the generic equivalent and it was discontinued for inefficacy, diminished effect, or adverse event [chart notes required] OR
• Support for the use of the requested brand agent over the generic equivalent AND patient has no FDA labeled contraindications
• Request for BCBS MT Fully Insured or MT HIM member under age 18 years: no labeled contraindication, indication supported in two major peer-reviewed journal articles, and age bracket support in two major peer-reviewed journal articles OR
• Member resides in AR, IN, ME, NE, OH, or KS, plan is Fully Insured or HIM Shop (SG), patient has no FDA labeled contraindications, AND one of: other FDA labeled indication, indication supported in compendia, or one major peer-reviewed journal article supports safety and efficacy

Reauthorization criteria

• Patient previously approved for requested agent through plan’s prior authorization process
• If requested agent is Vitrakvi: patient has clinical benefit (partial response, complete response, or stable disease)
• If requested agent is Bosulif capsules: dose <500 mg OR (patient has stage IV metastatic cancer and use consistent with best practices and FDA-approved indication) OR patient stable on Bosulif OR tried and inadequate response/intolerance/hypersensitivity/contraindication to Bosulif tablets [chart notes required] OR Bosulif tablets ineffective, not in best interest, or previously discontinued due to lack of efficacy/adverse event OR support for capsules over tablets (e.g., swallowing difficulties)
• If requested agent is Imbruvica 140 mg or 280 mg tablets: patient has stage IV metastatic cancer and use consistent with best practices and FDA-approved indication OR patient stable on requested agent OR inadequate response/intolerance/hypersensitivity/contraindication to Imbruvica capsules OR Imbruvica capsules ineffective or not in best interest OR tried another agent in same class discontinued for efficacy or AE reasons
• If requested agent is Imkeldi: patient has stage IV metastatic cancer and use consistent with best practices and FDA-approved indication OR patient stable on requested agent OR inadequate response/intolerance/hypersensitivity/contraindication to alternate formulation

Approval duration

12 months