NabiximolsSATIVEX
Adjunctive treatment of moderate to severe spasticity in patients with multiple sclerosis who have not adequately responded to oral anti-spasticity agents.
Decisions on record
- Meeting Mar 2020 Not recommended Nabiximols is indicated for symptom improvement in patients with moderate-to-severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial
- Meeting Jul 2013 Not recommended Multiple sclerosis
Access path
- TGA registered · SATIVEX
TGA label narrower than the PBS population
- Jul 2013Not recommended
inadequate clinical support for superiority claim due to enrichment design limiting generalisability, high risk of bias…
- Mar 2020Not recommended
Comparator changed: standard care (multidisciplinary involving physiotherapy and…
From the public summary
The PBAC did not recommend the listing of nabiximols as an adjunctive treatment for moderate to severe spasticity due to multiple sclerosis (MS). In deciding not to recommend the listing of nabiximols, the PBAC considered the treatment effect was likely overestimated in the resubmission due to the design of the key clinical trial and that there were substantial structural issues and unrealistic assumptions in the economic model.PSD · Mar 2020
The PBAC noted there were treatment options currently available for MS-related moderate to severe spasticity, including intrathecal baclofen and botulinum toxin; 33PSD · Mar 2020
The resubmission presented a stepped economic evaluation based on Markovà 2019 and implemented a modelled cost-effectiveness and a cost-utility analysis.PSD · Mar 2020
The ESC agreed with the evaluation that the structure of the economic model did not reflect the proposed treatment algorithm as it excluded modelling costs and outcomes for non-responders to initial therapy. Figure 2 presents a diagram of what the model structure should have been (the model in its entirety) with the boxes representing what was modelled in the resubmission and suggested to represent the entire model. 21PSD · Mar 2020
The resubmission described nabiximols, as adjunctive therapy, as superior in terms of effectiveness compared with oral anti-spasticity medication alone and inferior in terms of safety in patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy.PSD · Mar 2020
The PBAC had previously considered that a claim of superior efficacy over standard care was inadequately supported (section 12, nabiximols PSD, July 2013 PBAC meeting).PSD · Mar 2020
The PBAC noted and welcomed the input from individuals (4), health care professionals (HCP) (1) and organisations (3) via the Consumer Comments facility on the PBS website. The PBAC noted comments from individuals and organisations discussed the debilitating effects of muscle spasticity in MS and the potential benefits of symptomatic improvement and improvements in quality of life.PSD · Mar 2020
The Sponsor indicated they were willing to negotiate a Risk Sharing Arrangement as part of negotiations for a ‘reasonable price for listing, which is competitive by international listing standards’ (Pre-PBAC Response). For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2020
Cost-effectiveness
ICER not stated in the PSD; economic analysis based on cost-utility but specific ICER values not published in this public summary document.
The PBAC considered that the clinical data did not adequately support a claim of superior effectiveness, the basis for the cost-utility analysis was poorly supported. PBAC · 2013
Decision context
PopulationAdults with moderate to severe spasticity due to multiple sclerosis (NRS ≥4) who have not adequately responded to oral anti-spasticity agents and demonstrate clinically significant improvement during an initial trial of therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2020 | Not recommended | standard care (oral anti-spasticity medication) | — | RCT · Percentage of patients who responded after 12 weeks of randomised treatment (NRS score improvement of 30% or more) |
| Jul 2013 | Not recommended | standard care (multidisciplinary involving physiotherapy and pharmacotherapy) | $15k–45k | RCT · PFS |
Consumer voice
Consumers and healthcare professionals highlighted the debilitating effects of muscle spasticity in MS and the potential benefits of symptomatic improvement and quality of life. Cost was identified as a barrier to treatment access, while healthcare professionals supported listing nabiximols for patients inadequately responding to first-line agents.
The PBAC noted comments from individuals and organisations discussed the debilitating effects of muscle spasticity in MS and the potential benefits of symptomatic improvement and improvements in quality of life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC adds numeric severity threshold (NRS ≥4) and explicitly specifies second-line positioning; TGA label lacks these quantified restrictions.