LignocaineLignocaine HCl
Treatment of post-herpetic neuralgia (PHN), positioning as an alternative to pregabalin and gabapentin in patients with PHN refractory to other drugs.
Decision on record
- Meeting Mar 2015 Not recommended Post-herpetic neuralgia
Access path
- TGA registered · Lignocaine HCl
TGA label narrower than the PBS population
- Mar 2015Not recommended
vs pregabalin
From the public summary
7.1 The PBAC rejected the request to list lignocaine patch for the treatment of patients with PHN on the basis of uncertain cost effectiveness compared with pregabalin.PSD · Mar 2015
The PBAC considered that there was a mismatch between the restriction, the clinical treatment algorithm, the model, and the clinical trial data.PSD · Mar 2015
6.28 The submission presented a modelled economic analysis. The type of economic evaluation presented was a cost-utility analysis. This was not consistent with the clinical evidence, as the clinical claims were inadequately supported. The economic evaluation also modelled superior efficacy in terms of pain management (i.e.PSD · Mar 2015
6.29 The model compared treatment algorithms where lignocaine patch was PBS listed to an algorithm where lignocaine patch was not. Therefore, the model had a mix of ‘treatment’ states and health states. The model considered the two alternative PBS-restrictions as separate arms. The same main comparator arm was used.PSD · Mar 2015
6.24 The submission described lignocaine patch as at least non-inferior in terms of comparative efficacy (response) but superior in terms of quality of life, and superior in terms of comparative safety compared to pregabalin. The ESC considered these claims were not adequately supported.PSD · Mar 2015
6.25 The submission described lignocaine patch as superior in terms of comparative efficacy and non-inferior in terms of comparative safety compared to placebo. The ESC considered these claims were not adequately supported.PSD · Mar 2015
6.42 The Pre-PBAC Response stated that the sponsor is willing to work with the PBAC and the Department in designing an appropriate Risk Share Agreement to manage any remaining uncertainty in the financial implications of listing lignocaine on the PBS.PSD · Mar 2015
Cost-effectiveness
ICER value not stated in the public summary document; economic model based on cost-effectiveness comparing treatment algorithms.
Decision context
PopulationAdults with post-herpetic neuralgia (PHN) refractory to treatment with other drugs (Option 1) or unsuitable for or intolerant to pregabalin (Option 2).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Not recommended | pregabalin | — | RCT · Pain reduction (≥2 points or absolute value ≤4 on NRS-3 scale at Week 4) |
Consumer voice
Four respondents (1 individual and 3 health care professionals) submitted comments via the PBS website emphasising that lignocaine is associated with fewer side effects compared with alternative therapies.
lignocaine is associated with fewer side effects compared with alternative therapies Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to PHN refractory to other drugs or unsuitable/intolerant to pregabalin/gabapentin; TGA label has no such treatment-failure requirement.