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Yosprala — Blue Cross Blue Shield of Montana

Juvenile idiopathic arthritis (JIA)

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. ONE of the following:
  • A. For Duexis or ibuprofen/famotidine requests, the patient has a diagnosis of at least ONE of the following: Rheumatoid arthritis OR Osteoarthritis
  • B. For Vimovo or naproxen/esomeprazole requests, the patient has a diagnosis of at least ONE of the following: Osteoarthritis in adults OR Rheumatoid arthritis in adults OR Ankylosing spondylitis in adults OR Juvenile idiopathic arthritis (JIA) in adolescents weighing ≥ 38 kg
  • AND the patient has at least ONE of the following risk factors for developing NSAID-induced gastrointestinal (GI) ulcers: age ≥ 65 years, prior history of peptic/gastric/duodenal ulcer, history of NSAID-related ulcer, history of clinically significant GI bleeding, untreated or active H. pylori gastritis, concurrent use of oral corticosteroids, anticoagulants, or antiplatelets
  • OR
  • B. For Yosprala or aspirin/omeprazole requests, BOTH of the following:
  • 1. The patient has indication of use of at least ONE of the following: reducing combined risk of death/nonfatal stroke, MI, or sudden death as described; or in revascularization when aspirin is already indicated
  • AND the patient has at least ONE of the following risk factors: age ≥ 55 years, prior history of peptic/gastric/duodenal ulcer, history of NSAID-related ulcer, history of clinically significant GI bleeding, untreated or active H. pylori gastritis, concurrent corticosteroids, anticoagulants, or antiplatelets
  • 2. If the patient has an FDA labeled indication, then ONE of the following: A. Patient’s age is within FDA labeling OR B. There is support for use at patient’s age
  • 3. ONE of the following:
  • A. There is support for why the use of the individual ingredients within the target combination agent, as separate dosage forms, is not clinically appropriate for the patient OR
  • B. BOTH of the following apply related to advanced metastatic cancer criteria OR
  • C. Prescriber states patient is currently treated and stable on requested agent (chart notes required) OR
  • D. Patient has tried and had inadequate response to individual ingredients as separate dosage forms (chart notes required) OR
  • E. Individual ingredients as separate dosage forms discontinued due to lack of efficacy, diminished effect, or adverse event (chart notes required) OR
  • F. Patient has intolerance or hypersensitivity to individual ingredients as separate dosage forms (chart notes required) OR
  • G. Patient has FDA labeled contraindication to individual ingredients as separate dosage forms (chart notes required) OR
  • H. Expected ineffectiveness or significant barrier to adherence/functional ability/adverse effect if separate ingredients used (chart notes required) OR
  • I. Not in best interest of patient based on medical necessity (chart notes required) OR
  • J. Patient has tried another prescription drug in same pharmacologic class or mechanism and discontinued due to lack of efficacy, diminished effect, or adverse event (chart notes required)
  • 4. Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • Same criteria as initial approval or documentation that patient continues to meet approval requirements including ongoing clinical appropriateness and absence of contraindications

Approval duration

12 months