naproxen-esomeprazole magnesium — Blue Cross Blue Shield of New Mexico

Initial criteria

• Target Agent(s) will be approved when ALL of the following are met:
• 1. ONE of the following:
• A. BOTH of the following:
• 1. For Duexis or ibuprofen/famotidine: diagnosis of rheumatoid arthritis OR osteoarthritis
• 2. Patient has ≥1 risk factor for NSAID-induced GI ulcers: (age ≥65 years; prior ulcer; NSAID-related ulcer; GI bleed; active H. pylori gastritis; concurrent corticosteroids; anticoagulants; antiplatelets)
• OR
• B. For Vimovo or naproxen/esomeprazole: diagnosis of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis (adults), or JIA (adolescents ≥38 kg)
• AND ≥1 NSAID-induced GI ulcer risk factor (same list as above)
• OR
• C. For Yosprala or aspirin/omeprazole: BOTH of the following:
• 1. Patient uses it for at least one of the following cardiovascular indications: previous ischemic stroke/TIA; prior MI or unstable angina; chronic stable angina; post-revascularization procedure (CABG/PTCA)
• 2. Patient has ≥1 GI ulcer risk factor (age ≥55 years; prior ulcer; NSAID-related ulcer; GI bleed; active H. pylori; corticosteroids; anticoagulants; antiplatelets)
• 2. If patient has FDA-labeled indication, then ONE of the following:
• A. Age within FDA labeling OR
• B. Supported use for patient’s age for indication
• 3. ONE of the following:
• A. Documentation that individual ingredients as separate dosage forms are not clinically appropriate OR
• B. Stage 4 metastatic cancer use (treatment or related condition) supported by peer-reviewed evidence, and consistent with best practices OR
• C. Patient currently stable on the requested combination agent [chart notes required] OR
• D. Tried and inadequate response to individual ingredients separately [chart notes required] OR
• E. Discontinued individual ingredients due to lack of efficacy or adverse event [chart notes required] OR
• F. Intolerance or hypersensitivity to individual ingredients [chart notes required] OR
• G. FDA labeled contraindication to individual ingredients [chart notes required] OR
• H. Expectation that separate components would be ineffective, worsen condition, decrease function, or cause adverse reaction [chart notes required] OR
• I. Not in best interest based on medical necessity [chart notes required] OR
• J. Tried another drug in same pharmacologic class or mechanism and discontinued due to lack of efficacy or adverse event [chart notes required]
• 4. Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months