Pharmacy Prior Authorization Criteria

Vimovo (naproxen/esomeprazole magnesium)

Indications for Prior Authorization

Vimovo (naproxen/esomeprazole magnesium)

• For diagnosis of Osteoarthritis
  Indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component is indicated for the relief of signs and symptoms of osteoarthritis in adults. Limitations of use: do not substitute Vimovo with the single-ingredient products of naproxen and esomeprazole magnesium. Vimovo is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.

• For diagnosis of Rheumatoid Arthritis
  Indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component is indicated for the relief of signs and symptoms of rheumatoid arthritis in adults. Limitations of use: do not substitute Vimovo with the single-ingredient products of naproxen and esomeprazole magnesium. Vimovo is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.

• For diagnosis of Ankylosing Spondylitis
  Indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component is indicated for the relief of signs and symptoms of ankylosing spondylitis in adults. Limitations of use: do not substitute Vimovo with the single-ingredient products of naproxen and esomeprazole magnesium. Vimovo is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.

• For diagnosis of Juvenile idiopathic arthritis (JIA)
  Indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component is indication for the relief of signs and symptoms juvenile idiopathic arthritis (JIA) in adolescent patients. Limitations of use: do not substitute Vimovo with the single-ingredient products of naproxen and esomeprazole magnesium. Vimovo is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.

• For diagnosis of Naproxen-associated gastric ulcers risk reduction
  Indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The esomeprazole magnesium component of Vimovo is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of use: do not substitute Vimovo with the single-ingredient products of naproxen and esomeprazole magnesium. Vimovo is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.

Criteria

Brand Vimovo, Generic naproxen/esomeprazole magnesium

Prior Authorization

Length of Approval: 3 Month(s)

• One of the following diagnoses:
• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Juvenile idiopathic arthritis
AND
• One of the following [2]:
• History of peptic ulcer disease
• History of gastrointestinal (GI) bleeding, obstruction, or perforation
• Erosive esophagitis
• Used in combination with aspirin
AND
• History of a minimum 30 day trial and failure, or intolerance to two of the following generics:
• etodolac
• fenoprofen
• flurbiprofen
• ibuprofen
• indomethacin
• naproxen
• ketoprofen
• ketorolac
• meloxicam
• nabumetone
• oxaprozin
• piroxicam
• sulindac
• tolmetin
• diclofenac
AND
• History of a minimum 30 day trial and failure, or intolerance to two of the following generic proton pump inhibitors:
• rabeprazole
• esomeprazole
• lansoprazole
• omeprazole
• pantoprazole
• omeprazole/sodium bicarbonate
AND
• Physician has provided rationale for needing to use fixed-dose combination therapy with brand Vimovo or generic naproxen/esomeprazole magnesium instead of taking individual products in combination

P & T Revisions

2024-03-03, 2023-01-09, 2022-08-01, 2022-01-28, 2020-04-01, 2020-01-22

References

1. Vimovo [prescribing information]. Deerfield, IL: Horizon Medicines, LLC; March 2022.
2. Solomon C. Upper Gastrointestinal Bleeding Due to a Peptic Ulcer. N Engl J Med. 2016;374:2367-2376.

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Revision History

• 2024-03-03: Annual Review - No changes
• 2023-01-09: Annual review: No criteria changes. Updated references.
• 2022-08-01: Addition of a minimum trial duration for embedded step and removal of reauthorization criteria
• 2022-01-28: 2022 Annual Review: No changes to criteria, added generic GPIs to initial PA criteria, updated background information
• 2020-04-01: Added generic
• 2020-01-22: annual review, no changes to clinical criteria

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