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

Severe established osteoporosis

Initial treatment - Second-line therapy

Patient must be at very high risk of fracture; AND

Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND

Patient must have had 2 or more fractures due to minimal trauma; AND

Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND

Patient must not have received treatment with PBS-subsidised teriparatide; or

Patient must have developed intolerance to teriparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND

Must be treated by a consultant physician.

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.

If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated.

If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated.

Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.

Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application.

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

Severe established osteoporosis

Continuing treatment - Second-line therapy

Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy; AND

The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND

Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.