ParacetamolAPOHEALTH PARACETAMOL PAIN RELIEF
Fast effective temporary relief of pain and discomfort associated with headache, muscular aches, period pain, arthritis/osteoarthritis, toothache, migraine headache, cold & flu symptoms, tension headache, sinus pain/headache and backache. Reduces fever.
Decisions on record
- Meeting Jul 2020 Recommended Palliative care
- Meeting Nov 2014 Not recommended 665 mg tablet: modified release, 96 tablets Paracetamol Osteo Tab® AFT Pharmaceuticals Pty Ltd New listing (Minor submission) Pain Restricted Benefit listing for the relief of persistent pain associated with osteoarthritis. Sponsor Comment: Sponsor noted the PBAC comments and is conducting further w
Access path
- TGA registered · APOHEALTH PARACETAMOL PAIN RELIEF
TGA label narrower than the PBS population
- Nov 2014Not recommended
No bioequivalence statement issued by the TGA provided; no clinically relevant data presented to demonstrate equivalent…
- ↻ resubmittedJul 2020Recommended
Comparator changed: Panadol Osteo → Panadol 24 (paracetamol suppositories 500 mg, 24 pack)
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the listing of Panadol 10 on the condition that it only be supplied through the Palliative Care schedule, on the same conditions as the current Panadol 24.PSD · Jul 2020
6.2 The PBAC noted the importance of continued access to paracetamol suppository products for a small, targeted group of palliative care patients for whom the product is currently subsidised.PSD · Jul 2020
6.9 The minor submission did not present a formal economic comparison.PSD · Nov 2014
6.8 The submission claimed that Paracetamol Osteo-Tab is comparable to the originator product.PSD · Nov 2014
6.2 The PBAC noted that while no consumer comments were received through the Consumer Comments facility on the PBS website, one (1) organisation – GlaxoSmithKline Australia Pty Ltd, the sponsor of Panadol Osteo provided comments in support of not listing the product.PSD · Nov 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as no clinical improvement demonstrated over comparator
The PBAC considered that it was not possible to ascertain a cost-effectiveness premium for Panadol 10 over Panadol 24. PBAC · 2020
Decision context
PopulationPatients intolerant to alternative therapy and undergoing palliative care requiring analgesia or fever relief
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended | Panadol 24 (paracetamol suppositories 500 mg, 24 pack) | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Not recommended | Panadol Osteo | — | Single-arm · Other |
Consumer voice
One organisation (GlaxoSmithKline Australia Pty Ltd) provided comments supporting non-listing of Panadol Osteo. Separate correspondence from Generic Partners Pty Ltd expressed the view that the submission warranted a major PBAC submission.
while no consumer comments were received through the Consumer Comments facility on the PBS website, one (1) organisation – GlaxoSmithKline Australia Pty Ltd, the sponsor of Panadol Osteo provided comments in support of not listing the product Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients intolerant to alternatives and undergoing palliative care; TGA label permits all patients with listed conditions.