PBAC's latest decision on Naproxen and esomeprazole: Not recommended (2013). Considered for 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.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2012
Submissions
2
2012 → 2013
Eligible population
Patients 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.
Therapy area
Rheumatology
Line of therapy
Not applicable
Evidence base
Cost-minimisation
Primary endpoint
Surrogate
Comparator
mixed comparator: meloxicam and celecoxib
Economic model
Cost-minimisation
ICER note
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.
Why PBAC said no
Reasons cited in the latest PSD: 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