Oxycodone hydrochloride and naloxone hydrochloride dihydrate
Brand: Targin®
PBAC's latest decision on Oxycodone hydrochloride and naloxone hydrochloride dihydrate: Not recommended (2010). Considered for chronic severe disabling pain not responding to non-narcotic analgesics.
PBAC outcome
Not recommended
2010
ICER (AUD/QALY)
$105k/QALY
Range: $45k/QALY–$105k/QALY
Submissions
1
first 2010
Submissions
1
2010 → 2010
Eligible population
patients with chronic severe disabling pain not responding to non-narcotic analgesics
Therapy area
Pain
Evidence base
RCT
Primary endpoint
Bowel Function Index (BFI)
Key trials
OXN3001, OXN3006, OXN3401, OXN9002, OXN9502
Comparator
oxycodone plus prophylactic laxatives
Economic model
CUA
ICER note
Base case ICER was $15,000–$45,000 per QALY, but when respecified to account for laxative use, ICER ranged $45,000–$105,000 per QALY. A further multivariate probabilistic sensitivity analysis produced an ICER of greater than $200,000 per QALY.
Why PBAC said no
Reasons cited in the latest PSD: uncertain and high cost-effectiveness ratio; inappropriate comparator selection (oxycodone alone rather than oxycodone plus prophylactic laxatives); borderline clinical significance of bowel function improvement; trial populations not representative of Australian population or requested listing; inappropriate 1-year time horizon for non-malignant pain; highly uncertain risk ratio calculation; overestimated OIC complications; underestimated average daily dosage; uncertain uptake rate estimates; unsubstantiated claims regarding reduction in illicit drug use