At its September 2026 intracycle meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) considered the Review of low-cost PBS-listed antidepressants and recommended changes to Pharmaceutical Benefits Scheme (PBS) restrictions for fourteen medicines. These medicines are citalopram, clomipramine, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserin, mirtazapine, moclobemide, nortriptyline, paroxetine, sertraline and venlafaxine. The recommended changes are intended to better align PBS-subsidised access with contemporary Australian clinical practice. Implementation of the PBAC recommendations will occur in accordance with standard post-PBAC listing processes and timeframes.
Background
At its September 2023 meeting, as part of its consideration of the Post-market Review (PMR) workplan, the PBAC supported the Department considering, on a rolling basis, whether medicines that had transitioned to the F2 formulary may be suitable for review of their PBS restrictions. At its September 2024 meeting, the PBAC supported further work to consider whether broader PBS access may be appropriate for several low-cost PBS-listed antidepressants.
Accordingly, the Department reviewed selected low-cost PBS-listed antidepressants to assess whether their PBS restrictions remained appropriate. The review compared the restrictions with TGA-approved indications and Australian clinical guidelines and estimated the financial impact of potential changes.
PBAC outcome
The PBAC recommended the following changes to the PBS restrictions for the fourteen antidepressants:
- 30-day solid oral dosage forms (tablets, capsules and orally disintegrating tablets): change from Restricted Benefit to Unrestricted Benefit, with the indication and eligibility criteria removed.
- 60-day solid oral dosage forms: retain Restricted Benefit status, while removing indication-specific wording and retaining the existing requirement that the patient’s condition be stable.
- Escitalopram oral liquid: retain Restricted Benefit status, remove indication-specific wording and require that the patient be unable to swallow the solid dosage form.
The PBAC considered that the changes would better align PBS-subsidised access with contemporary Australian clinical practice, noting that Australian clinical guidelines recommend many of the included antidepressants for conditions beyond their current PBS indications. The PBAC noted that the changes were supported in the pre-PBAC responses received and considered that they may reduce inequity for patients for whom out-of-pocket medicine costs are a barrier to treatment. Broader PBS subsidy arrangements may particularly benefit concessional patients, patients who have reached the annual PBS Safety Net, and eligible First Nations people registered for the Closing the Gap PBS Co-payment Program.
The PBAC accepted the Department’s financial modelling approach, including the assumption that all forecast private prescriptions would move to PBS-subsidised supply. The PBAC considered that this provided a conservative basis for estimating the financial impact and that the estimated impact was reasonable, noting that the changes would broaden subsidised access across low‑cost antidepressants in a therapeutic class associated with high use.
Although cost-effectiveness had not been formally established for every broader clinical use, the PBAC considered that the medicines were likely to represent acceptable value for money because they are already PBS-listed, are low cost and are recommended for broader uses in Australian clinical guidelines.
The PBAC recommended that the Department monitor utilisation of the included antidepressants following implementation of the restriction changes.
Further information
A Public Summary Document (PSD) for this item is available below. In-confidence information in the PSD has been redacted.