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Yosprala — Blue Cross Blue Shield of New Mexico

Osteoarthritis

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