PBS updates

Actonel EC (risedronate)

risedronate sodium 35 mg enteric tablet, 4 · ORAL · PBS code 13364J

RESTRICTED

• • First listed on the PBS: 2023-09-01.
• • Repeats: 5.
• • PBS program: GE.

Eligibility criteria for subsidised access

The following is the government's own wording from the PBS Schedule, shown unchanged.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Corticosteroid-induced osteoporosis

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND

Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND

Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.

The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Osteoporosis

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be aged 70 years or older; AND

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND

Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Established osteoporosis

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have fracture due to minimal trauma; AND

Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.

The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.

A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

Not medical advice. Voxsanity republishes public PBS data in plain English. PBS listing status and criteria can change; always confirm current subsidised availability with your doctor or pharmacist.

Source: Pharmaceutical Benefits Scheme (PBS), © Commonwealth of Australia. Data used and redistributed under permission; not modified from its original wording where displayed verbatim.