Yosprala — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following:
• A. BOTH of the following:
• 1. For Duexis or ibuprofen/famotidine requests, the patient has a diagnosis of at least ONE of Rheumatoid arthritis OR Osteoarthritis; OR for Vimovo or naproxen/esomeprazole requests, the patient has a diagnosis of at least ONE of Osteoarthritis in adults OR Rheumatoid arthritis in adults OR Ankylosing spondylitis in adults OR Juvenile idiopathic arthritis in adolescents weighing ≥ 38 kg.
• 2. 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, concurrent use of anticoagulants, concurrent use of antiplatelets.
• OR B. For Yosprala or aspirin/omeprazole requests: BOTH of the following:
• 1. The patient has an indication of at least ONE of: reducing combined risk of death and nonfatal stroke after ischemic events; reducing risk of death and nonfatal MI with prior MI or unstable angina; reducing risk of MI and sudden death in chronic stable angina; use after revascularization with existing aspirin indication.
• 2. The patient has at least ONE of the following GI ulcer 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 oral corticosteroids, anticoagulants, or antiplatelets.
• AND if the patient has an FDA labeled indication, ONE of the following: (A) age is within FDA labeling, OR (B) there is support for using the agent for the patient’s age for the indication.
• AND ONE of the following:
• A. There is support for why use of separate ingredients is not clinically appropriate OR
• B. BOTH of the following: (1) The prescriber has stated or documented diagnosis of stage 4 advanced, metastatic cancer and agent is used for cancer or associated condition, AND (2) Use is consistent with best practices and evidence-based literature approved by FDA.
• C. The prescriber states the patient is currently treated with and stable on the agent [chart notes required].
• D. The patient has tried and had an inadequate response to the individual ingredients used separately [chart notes required].
• E. The individual ingredients used separately were discontinued due to lack of efficacy/effectiveness, adverse event, or diminished effect [chart notes required].
• F. The patient has intolerance or hypersensitivity to individual ingredients [chart notes required].
• G. The patient has an FDA labeled contraindication to the individual ingredients [chart notes required].
• H. The separate dosage forms are expected to be ineffective, cause adherence barriers, worsen comorbidity, decrease functional ability, cause adverse reaction, or cause harm [chart notes required].
• I. The separate dosage forms are not in the best interest of the patient based on medical necessity [chart notes required].
• J. The patient has tried another prescription drug in same class as ingredients used separately and discontinued due to lack of effect or adverse event [chart notes required].
• AND the patient does NOT have any FDA labeled contraindications to the requested agent.

Reauthorization criteria

• The member resides in Ohio AND
• The plan is Fully Insured or HIM Shop (SG) AND BOTH of the following:
• A. The patient does NOT have any FDA labeled contraindications to the requested agent AND
• B. ONE of the following:
• 1. The patient has another FDA labeled indication for the requested agent and route of administration OR
• 2. The patient has another compendia-supported indication OR
• 3. The prescriber has submitted two peer-reviewed articles supporting the proposed use as generally safe and effective.

Approval duration

12 months