Tramadol Hydrochloride With ParacetamolAPO-Tramadol/Paracetamol
Not recommended PainRestricted 💬 consumer voice
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.
1
Submissions
2018–18
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2018 Not recommended Acute and chronic pain
Access path
- TGA registered · APO-Tramadol/Paracetamol
TGA label narrower than the PBS population
- Mar 2018Not recommended
Inappropriate comparator (tramadol 50 mg IR not most appropriate for chronic pain; no comparison against concomitant…
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC did not recommend the fixed dose combination (FDC) of tramadol hydrochloride 37.5 mg with paracetamol 325 mg for patients with acute pain on the basis of extensive quality use of medicines problems, questionable clinical place for the FDC, an inappropriate nominated comparator, and inadequately supported efficacy and safety compared with the relevant comparator.PSD · Mar 2018
7.2 The PBAC noted that the proposed restriction was changed by the sponsor during the evaluation process to be limited to acute pain and the Committee agreed with the ESC that there is high potential for leakage to chronic pain, where the doses in the proposed FDC are unlikely to be appropriate.PSD · Mar 2018
Economic analysis
6.32 The equi-effective doses were estimated in the submission as one tablet of the FDC of tramadol 37.5 mg/paracetamol 325 mg for one tablet of tramadol 50 mg IR. This estimation was based on the three direct randomised trials in acute pain: ZAL-06 (2 days); CAPSS-241 (6-hour); GRTF-ZAL 1 (10 days). The submission did not estimate an equi-effective dose of the FDC compared with any of the paracetamol/codeine formulations available on the PBS.PSD · Mar 2018
6.33 The submission did not use the trials in chronic pain presented in Section 2 of the submission (CAPSS-112, CAPSS-113, TRP-CAN-1, CAPSS-237, CAPSS-114, Chang 2013, CAPSS-051, CA-R0027) to inform its economic analysis. This was inappropriate since the submission anticipated that the bulk of use of the FDC would be in the chronic pain setting.PSD · Mar 2018
Clinical claim
6.26 The submission described the FDC of tramadol 37.5 mg/paracetamol 325 mg as non- inferior in efficacy and superior in safety compared with tramadol 50 mg IR in acute and chronic pain.PSD · Mar 2018
6.27 The efficacy and safety claims were not adequately supported for the treatment of acute pain when comparing the FDC of tramadol 37.5 mg/paracetamol 325 mg with tramadol 50 mg IR due to the heterogeneity of the trials and the limited applicability of the comparator to clinical practice. Furthermore, the appropriate comparator in clinical practice is tramadol IR 50 mg plus paracetamol 500 mg, which would have implications for efficacy and safety.PSD · Mar 2018
Consumer comments
6.2 The PBAC noted and welcomed the input from one health care professional via the Consumer Comments facility on the PBS website. The comment described the need for available treatments for patients with chronic pain.PSD · Mar 2018
Cost-effectiveness
Cost-minimisation analysis; no numeric ICER calculated or stated in the document.
The basis for the submission was a cost-minimisation analysis against tramadol 50 mg IR. PSD · 2018
Decision context
PopulationPatients 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.
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Not recommended | tramadol 50 mg immediate release | — | RCT · Pain intensity, pain relief rating scales, safety (adverse events and discontinuations due to adverse events) |
Consumer voice
One health care professional submitted a comment describing the need for available treatments for patients with chronic pain.
The comment described the need for available treatments for patients with chronic pain. Consumer comments · PSD
unmet needchronic pain treatmentaccess to treatments
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to acute pain only, whereas TGA label covers both acute and chronic pain without limitation.