Oxycodone Hydrochloride And Naloxone Hydrochloride DihydrateARX-Oxycodone/Naloxone

Base case ICER $15,000–$45,000 per QALY; respecified base case $45,000–$105,000 per QALY; probabilistic sensitivity analysis produced ICER >$200,000 per QALY.

The PBAC considered that the base case of between $15,000 and $45,000 per QALY gained was highly uncertain given the assumption that individuals who take prophylactic laxatives have the same probability of OIC as those who do not take laxatives and that all complications of OIC will occur. PBAC · 2010

PopulationPatients with moderate to severe chronic pain (cancer and non-cancer), particularly those experiencing opioid-induced constipation.

• Uncertain and high cost-effectiveness ratio, inappropriate comparator (oxycodone alone rather than oxycodone plus prophylactic laxatives), borderline clinical significance of BFI results, populations in key clinical trials not representative of likely Australian population, inappropriate 1-year time horizon for non-malignant pain, highly uncertain economic model with major flaws in use of proxy measures, underestimated average daily dosage, uncertain uptake rate, uncertain complication estimates based on poor-response clinician survey.

Label narrower than PBS population — PBAC restricts to chronic severe disabling pain; TGA label includes moderate pain and lacks chronicity/disability requirement.