PrimidoneMYSOLINE
Recommended NeurologyRestrictedNot applicable line
Management of grand mal and psychomotor (temporal lobe) epilepsy, focal or Jacksonian seizures, myoclonic jerks and akinetic attacks.
1
Submissions
2019–19
On the record
—
ICER range
Not modelled
Cost basis
Decision on record
- Meeting Nov 2019 Recommended Epilepsy
Access path
- TGA registered · MYSOLINE
TGA label narrower than the PBS population
- Nov 2019Recommended · restricted
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
3.1 The PBAC recommended the temporary listing of APO-PRIMIDONE on the PBS to address the current supply shortage.PSD · Nov 2019
3.2 The PBAC considered there is a clinical need to maintain supply of this medicine on the PBS. The PBAC considered the listing should remain during the validity of the Section 19A(1) approval by the TGA.PSD · Nov 2019
Cost-effectiveness
Not modelled — this is a temporary supply shortage substitution for an existing listed product, not a new clinical/economic evaluation.
Decision context
PopulationPatients with grand mal, psychomotor (temporal lobe) epilepsy, focal or Jacksonian seizures, myoclonic jerks and akinetic attacks requiring primidone 250 mg tablets.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients requiring primidone 250 mg tablets specifically, adding a formulation requirement not in the TGA label.