Table 1.

Common requirements of access to high cost medicines under the PBS [15]

	"Authority prescription" requirements
Criteria for initiating treatment	• Severe active disease
	• Presence of "molecular markers" that predict a good treatment outcome
	• Failure to achieve adequate response to a step-up sequence of cheaper existing therapies
	• Patients required to sign a 'patient acknowledgement form'
A patient agreement process	• A Patient Acknowledgement Form to be signed by patients to acknowledge that treatment will only continue if the predetermined response criteria are achieved at follow-up assessment (e.g. 12 weeks for biological anti-rheumatic agents)
Criteria for continuing treatment	Clinical outcomes are evaluated according to predetermined quantifiable criteria at follow-up assessment
Restricted prescribing rights	• Prescription only by specialist physicians (e.g. rheumatologists initially for biologicals for rheumatoid arthritis. Prescribing rights were extended to clinical immunologists with expertise in the management of rheumatoid arthritis as of February 2004)
Risk sharing arrangement	• Price-volume agreement between sponsor and the government