Combination NSAIDs – Enhanced Formulary

• Consensi® (celecoxib / amlodipine)
• Duexis® (ibuprofen / famotidine)
• Vimovo® (naproxen / esomeprazole)
• Yosprala™ (aspirin / omeprazole)

• For patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate.   

• For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. Controlled trials do not extend beyond 6 months.

• For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers.

• For patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The aspirin component of Yosprala is indicated for: 
  • reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli
  • reducing the combined risk of death and nonfatal MI in patients with previous MI or unstable angina pectoris 
  • reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris 
  • use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated. 
• The omeprazole component of Yosprala is indicated for decreasing the risk of developing aspirin associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age or documented history of gastric ulcers. 

1. The patient is 18 years of age or older; AND

2. The requested medication is Consensi; AND

a. The patient is using the medication to treat hypertension; AND

b. The patient is using the medication to treat osteoarthritis; OR

3. The requested medication is Yosprala or aspirin/omeprazole (authorized generic Yosprala); AND

a. The patient has a history of a cardiovascular and/or cerebrovascular event(s) and will be using the medication for secondary prevention of such events; AND

b. The patient is at risk for developing aspirin associated gastric ulcers due to:

i. An age of 55 years or older; OR

c. The patient has a documented history of gastric ulcers; OR

4. The requested medication is Duexis or ibuprofen/famotidine (generic Duexis); AND

a. The patient is using the medication to treat osteoarthritis or rheumatoid arthritis; AND

b. The patient must meet at least one of the following criteria:

i. The patient is 60 years of age or older; OR

ii. The patient has a history of peptic ulcer disease or ulcer/GI bleeding related to NSAIDs; OR

iii. The patient’s current medication regimen includes an anticoagulant, prescription antiplatelet drug, corticosteroid or DMARD (disease-modifying and anti-rheumatic drug) therapy (e.g., methotrexate); OR

iv. The patient has a hereditary or acquired coagulation defect (e.g., hemophilia, Von Willebrand’s disease, protein C or S deficiency, thrombocytopenia or chronic renal failure); OR

5. The requested medication is Vimovo or naproxen / esomeprazole (generic Vimovo); AND

a. The patient is using the medication to treat osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; AND

b. The patient must meet at least one of the following criteria:

i. The patient is 60 years of age or older; OR

ii. The patient has a history of peptic ulcer disease or ulcer/GI bleeding related to NSAIDs; OR

iii. The patient’s current medication regimen includes an anticoagulant, prescription antiplatelet drug, corticosteroid or DMARD (disease-modifying and anti-rheumatic drug) therapy (e.g., methotrexate); OR

iv. The patient has a hereditary or acquired coagulation defect (e.g., hemophilia, Von Willebrand’s disease, protein C or S deficiency, thrombocytopenia or chronic renal failure); AND 

6. The provider has given a written statement as to why the patient is unable to utilize the individual components (either over-the-counter or prescription) of this combination medication, including a valid explanation of the undue risk this would result in for the patient’s health  [medical record documentation required].

Duration of Approval:  180 days (6 months) 

all information referenced is from FDA package insert unless otherwise noted below.

Lanza FL, et al. Members of the Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol 2009; 104:728 – 738; doi: 10.1038/ajg.2009.115; published online 24 February 2009. 

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually. 

October 2024: Criteria change (Ubrelvy, Nurtec ODT, Zavzpret): Added requirement that acute use CGRPs will not be taken concomitantly with another acute migraine therapy.

August 2024: Criteria update: Updated definition of episodic migraine to be ≥ 4 migraine headache days per month.

April 2024: Criteria change: Created an Essential only policy. Updated Nurtec QL for episodic migraine.

January 2024: Criteria change: Added the option for use of a botulinum toxin agent in combination with a CGRP receptor antagonist for patients continuing to experience 4 or more migraine headache days per month after treatment with either a 3-month trial of a CGRP receptor antagonist or a 6-month trial (2 injection cycles) of Botox. References added.

October 2023: Criteria update: Removed allowance of Botox in the last 3 months due to inability to see provider during COVID-19 pandemic. June 2023: Criteria update: Added new to market Zavzpret to policy.

May 2023: Criteria change (Qulipta): Expanded indication for Qulipta to include the preventative treatment of chronic migraine in adults.

March 2023: Criteria update: Added definitions for chronic and episodic migraine. No change to criteria intent.

July 2022: Criteria update: Any authorization for a botulinum toxin agent used for the same indication as the requested agent will be terminated.

January 2022: Criteria change: Reduced step requirement through a single triptan product for acute migraine use. Step through Emgality and Aimovig removed for Ajovy requests. Historical policy changes prior to 2022 can be obtained from BCBSNC Corporate Pharmacy