Vimovo — Blue Cross Blue Shield of Montana

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