PBAC's latest decision on Tramadol hydrochloride with paracetamol: Not recommended (2018). Considered for Treatment of acute and chronic pain, proposed for restriction to acute pain only. The fixed dose combination contains tramadol 37.5 mg and paracetamol 325 mg.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2018
Submissions
1
2018 → 2018
Eligible population
Patients requiring pain medication for acute and chronic treatment, where aspirin and/or paracetamol alone are inappropriate or have failed; proposed restriction to acute pain only.
Therapy area
Pain
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Pain intensity, pain relief rating scales, safety (adverse events and discontinuations due to adverse events)
Cost-minimisation analysis; no numeric ICER calculated or stated in the document.
Why PBAC said no
Reasons cited in the latest PSD: Inappropriate comparator (tramadol 50 mg IR not most appropriate for chronic pain; no comparison against concomitant individual components), potential for substantial leakage to chronic pain despite acute pain restriction, tramadol doses in FDC unlikely to be appropriate for chronic pain, proposed repeats (2) inconsistent with comparator (0 repeats), paracetamol dose lower than recommended guidelines, insufficient evidence of non-inferiority in chronic pain, insufficient clinical comparison with codeine-based regimen