Osteoporosis - teriparatide

Authority to supply teriparatide (Forteo®) for patients as the sole PBS subsidised treatment of severe osteoporosis through the Pharmaceutical Benefits Scheme (PBS) under Section 85 arrangements of the National Health Act 1953.

Restriction details

All patients for initial treatment must have:

• a very high risk of fracture
• a Bone Mineral Density (BMD) T-score of -3.0 or less
• had two or more fractures due to minimal trauma
• experienced at least one symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at an adequate dose.

All applications must:

• be completed by a specialist or consultant physician
• include details of prior anti-resorptive therapy, fracture history including the date(s), site(s), and the symptoms associated with the fracture(s) which developed during the course of anti-resorptive therapy
• include the date and score of the qualifying BMD measurement.

The restrictions are:

• initial PBS subsidised treatment with teriparatide for patients with severe osteoporosis
• initial PBS subsidised, continuing treatment for patients who started treatment with teriparatide before 1 May 2009.
• continuing treatment for patients who have previously received PBS subsidised treatment with teriparatide.

Patients are eligible for a lifetime maximum of 18 months therapy (18 pens).

View a full transcript of the Schedule of Pharmaceutical Benefits restriction details.

Item details

Dose

Teriparatide is available as a preloaded pen with 28 daily doses.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.

Who is eligible for the PBS?

Toxicity and severity descriptors

To ensure the eligibility of patients can be fully assessed, a comprehensive list of toxicity descriptors is available. This should be used in conjunction with the application when demonstrating a patient's inability to tolerate anti-resorptive therapies. The intolerance must be of a severity to necessitate permanent treatment withdrawal.

• Anti-resorptive agent toxicity and severity descriptors [PDF, 46Kb]
• Anti-resorptive agent toxicity and severity descriptors [RTF, 126Kb]

Lodgement

All initial applications must be in writing and must include a completed authority prescription.
The postal address for all written applications is:
Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
GPO Box 9826
Hobart TAS 7001
(No stamp required if posted in Australia)

Applications for continuing treatment may be made in writing or may be obtained by calling Medicare Australia on 1800 700 270, and selecting option 2, between 8.00 am to 5.00 pm  Eastern Standard Time, Monday to Friday (call charges may apply).

Application forms

• Initial PBS subsidised treatment of osteoporosis - teriparatide (Form 4223) [PDF, 226Kb]
  Lodge this form for a patient starting initial PBS subsidised treatment with teriparatide for severe osteoporosis. The patient and prescriber acknowledgements must  be completed.

Important: the information on this website is correct at the time of publishing and is subject to change.

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Last updated: 1 May, 2009