RiluzolePHARMACOR RILUZOLE
Treatment of amyotrophic lateral sclerosis (ALS), specifically in patients who experience dysphagia and/or require percutaneous endoscopic gastrostomy (PEG) tube administration.
Decisions on record
- Meeting Mar 2026 Advice provided Amyotrophic lateral sclerosis (ALS)
- Meeting Nov 2018 Recommended Amyotrophic lateral sclerosis (ALS)
- Meeting Jul 2007 Recommended Amyotrophic lateral sclerosis (ALS) no PSD
- Meeting Nov 2006 Recommended Amyotrophic lateral sclerosis no PSD
Access path
- TGA registered · PHARMACOR RILUZOLE
TGA label narrower than the PBS population
- Nov 2018Recommended · restricted
vs riluzole tablets
- Mar 2026Noted
Comparator changed: riluzole tablets → riluzole tablet
From the public summary
4.1 The PBAC advised under subsection 101(4AB) of the Act that it is of the opinion that the circumstances of the riluzole suspension listing meet the eligibility criteria under section 84AH of the Act.PSD · Mar 2026
4.2 The PBAC advised that riluzole suspension remained a suitable therapy for ALS patients, including a subgroup of patients who experience swallowing difficulties and/or require PEG tube administration. The PBAC considered that the tablet form is less suitable for this subgroup because administration may require tablet crushing, which it considered to be sub-optimal and may affect dosing accuracy and administration.PSD · Mar 2026
6.12 The submission did not present an economic analysis, and requested a list price approximately '''''% higher than the current price of riluzole tablets. Pricing matters are further discussed in the estimated PBS usage and financial implications section below.PSD · Nov 2018
6.11 The submission described the oral liquid formulation of riluzole as an improved dosage form of riluzole for the treatment of ALS. For some patients, the alternative of a liquid formulation could be considered preferable, particularly for those with difficulty swallowing or who use a PEG or would otherwise require tablets to be crushed.PSD · Nov 2018
(c) the relevant item and at least one listed brand of Riluzole suspension and riluzole tablet 50 mg (Pharmacor® Riluzole; another pharmaceutical item have the same drug; Rilutek®; Riluzole Sandoz®) share the same drug. and (d) advice (if any) given by the PBAC, that: The submission stated that riluzole suspension represents a suitable (i) the listed drug represents suitable therapy for a therapy for ALS patients.PSD · Mar 2026
The submission claimed that for ALS patients with is suitable for use by that subgroup because of dysphagia and/or requiring PEG tube administration, the tablet either or both of the form and manner of formulation is not suitable because administration in such patients administration of the drug in that other item. often involves crushing tablets and mixing with liquid/food, which it characterised as a sub‑optimal alternative to riluzole suspension.PSD · Mar 2026
Cost-effectiveness
Not applicable — this is a Category 4 submission seeking exempt item status under section 84AH of the National Health Act, not a listing application. No economic evaluation required.
In November 2018, the PBAC recommended listing riluzole suspension for the treatment of ALS on a cost minimisation basis with riluzole tablets, with a price premium as this form of riluzole offers an advantage to some patients with this disease. PSD · 2026
Decision context
PopulationPatients with amyotrophic lateral sclerosis (ALS) who experience swallowing difficulties (dysphagia) and/or require percutaneous endoscopic gastrostomy (PEG) tube administration.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Noted | riluzole tablet | — | Cost-minimisation |
| Nov 2018 | Recommended · restricted | riluzole tablets | — | Single-arm · Other |
Consumer voice
Motor Neurone Disease Australia supported listing of liquid riluzole, noting that many ALS patients experience difficulty swallowing and require PEG tubes, and that a liquid formulation would enable continued treatment for patients who would otherwise have suboptimal therapy or cease treatment.
as ALS progresses the majority of patients experience difficulty swallowing, a situation which for many results in the insertion of a PEG Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to early-stage ALS (≤5 years duration) with preserved respiratory function (FVC ≥60%) and specific functional abilities.