Naproxen And Esomeprazole
Symptomatic treatment of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis in patients who require an NSAID and are at increased risk of gastrointestinal ulcerations in whom lower doses of naproxen or other NSAIDs are insufficient.
Decisions on record
- Meeting Nov 2012 Not recommended Patients with an increased risk of gastrointestinal ulceration, who require NSAID therapy for symptomatic management of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis with an inflammatory component and in whom lower doses of naproxen or other NSAIDs have proven insufficient. If a to
- Meeting Mar 2012 Not recommended Patients with an increased risk of gastrointestinal ulceration, who require NSAID therapy for symptomatic management of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis with an inflammatory component and in whom lower doses of naproxen or other NSAIDs have proven insufficient. If a to
Access path
- Mar 2012Not recommended
Inappropriate comparator (celecoxib alone not accepted; mixed comparator of meloxicam and celecoxib more appropriate)…
- Mar 2012Not recommended
inappropriate comparator, uncertainty regarding validity of surrogate outcome (endoscopically-detected ulcers) for…
- Nov 2012Not recommended
inappropriate comparator (should include meloxicam, not celecoxib alone), uncertainty regarding validity of surrogate…
- Jul 2013Not recommended
Inappropriate comparator (celecoxib as sole comparator not accepted; meloxicam should be included), uncertainty…
From the public summary
The PBAC considered that evidence for the comparative effectiveness and safety of Vimovo against both meloxicam and celecoxib would be required for the following outcomes: • Pain • Gastrointestinal outcomesPSD · Jul 2013
• Cardiovascular outcomes The PBAC considered that the sponsor should propose non-inferiority limits for minimum clinically important differences for each outcome. If surrogate outcomes, including endoscopically-detected ulcers, are used, then the submission should include an assessment of each proposed surrogate according to the framework used in the STFOWG report.PSD · Jul 2013
Cost-effectiveness
Cost-minimisation analysis proposed; PBAC did not accept the cost-minimisation approach was adequately justified due to uncertainty in non-inferiority for gastrointestinal outcomes and uncertainty regarding cost implications to PBS.
The PBAC considered that the net savings with listing naproxen/esomeprazole were unlikely. PBAC · 2012
Decision context
PopulationPatients with osteoarthritis, rheumatoid arthritis or ankylosing spondylitis who require an NSAID and are at increased risk of gastrointestinal ulcerations in whom lower doses of naproxen or other NSAIDs are insufficient.
Why it was knocked back
- Inappropriate comparator (celecoxib as sole comparator not accepted; meloxicam should be included), uncertainty regarding validity of endoscopic ulcers as surrogate for patient-relevant outcomes, inadequate non-inferiority evidence for gastrointestinal outcomes against both meloxicam and celecoxib, uncertainty in cost-minimisation analysis validity, plausible scenarios where listing could result in increased costs to PBS rather than savings, no evidence of improved compliance, concern regarding use in acute musculoskeletal conditions and switching from lower doses or over-the-counter NSAID therapy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Not recommended | mixed comparator: meloxicam and celecoxib | — | Cost-minimisation · Surrogate |
| Nov 2012 | Not recommended | meloxicam and celecoxib (mixed comparator) | — | RCT · gastric ulcer incidence |
| Mar 2012 | Not recommended | meloxicam and celecoxib (mixed comparator) | — | RCT · endoscopically detected ulcers |
| Mar 2012 | Not recommended | mixed comparator of meloxicam and celecoxib | — | RCT |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts specify identical populations: NSAID-requiring patients with three named conditions, GI ulceration risk, and insufficient lower-dose NSAID response.