5.4 Authorisation Patient-specific authorisation is required for initial and continuing access to the supply of government-funded immunoglobulin products. An overview of the process for authorisation is in Figure 1 Authorisation process diagram. – AUTHORISATION PROCESS CCLLIINNIICCAALL APPROVED DDIIAAGGNNOOSSIISS CREATE SUBMIT RECEIVE AUTHORISATION DECLINED REQUEST REQUEST NOTIFICATION OBTAIN PATIENT PRIVACY CONSENT NO ASSESS ELIGIBLE FOR CRITERIA REQUEST FUNDED RECORD YES IG? AUTHORISATION IN BLOODSTAR Figure 1 Authorisation process diagram – Request for authorisation A request for authorisation for a patient is initiated by the treating clinician through BloodSTAR. The treating clinician must be registered in the system as an approved prescriber and initiates a request by entering relevant patient and diagnosis details and supporting substantiation, as prompted by the system, to enable an assessment of eligibility to be made against the Criteria. This includes information to allow a substantiated assessment to be made against requirements such as: indication for use the purpose for which therapy would be considered, to prevent or – manage a particular manifestation of the disease qualifying criteria patient selection, particular disease characteristics, disease severity, – requirements for other treatments to have been demonstrably unsuccessful before Ig is considered exclusion criteria specific indications and circumstances where Ig should not be used – dose and frequency specific to the indications and circumstances to aim for the – minimum dose to achieve optimum clinical outcome for the patient. Additional access rules apply for SCIg and NHIg as detailed at appendices A and B, respectively. Authorisation assessment The Australian Red Cross Blood Service (Blood Service) is contracted by the NBA to process all requests for authorisation and has the role of authoriser. When a prescriber completes a request for authorisation in BloodSTAR, the request is electronically referred to the Blood Service for consideration. Authorisation is established in BloodSTAR through an assessment of eligibility against the Criteria, as described above. Patients may be authorised for a single one-off dose or course of treatment over a number of months. The prescriber is notified electronically of the decision by the authoriser. If the request is authorised, the requested dispensing facility or dispenser, is also notified of the details of an authorisation through BloodSTAR.
5.4 Authorisation Patient-specific authorisation is required for initial and continuing access to the supply of government-funded immunoglobulin products. An overview of the process for authorisation is in Figure 1 – Authorisation process diagram. AUTHORISATION PROCESS CCLLIINNIICCAALL DDIIAAGGNNOOSSIISS OBTAIN PATIENT PRIVACY CONSENT CREATE AUTHORISATION REQUEST SUBMIT REQUEST RECEIVE DECLINED NOTIFICATION APPROVED NO CRITERIA ASSESS REQUEST ELIGIBLE FOR FUNDED IG? YES RECORD AUTHORISATION IN BLOODSTAR Figure 1 – Authorisation process diagram Request for authorisation A request for authorisation for a patient is initiated by the treating clinician through BloodSTAR. The treating clinician must be registered in the system as an approved prescriber and initiates a request by entering relevant patient and diagnosis details and supporting substantiation, as prompted by the system, to enable an assessment of eligibility to be made against the Criteria. This includes information to allow a substantiated assessment to be made against requirements such as: indication for use – the purpose for which therapy would be considered, to prevent or manage a particular manifestation of the disease qualifying criteria – patient selection, particular disease characteristics, disease severity, requirements for other treatments to have been demonstrably unsuccessful before Ig is considered exclusion criteria – specific indications and circumstances where Ig should not be used dose and frequency – specific to the indications and circumstances to aim for the minimum dose to achieve optimum clinical outcome for the patient. Additional access rules apply for SCIg and NHIg as detailed at appendices A and B, respectively. Authorisation assessment The Australian Red Cross Blood Service (Blood Service) is contracted by the NBA to process all requests for authorisation and has the role of authoriser. When a prescriber completes a request for authorisation in BloodSTAR, the request is electronically referred to the Blood Service for consideration. Authorisation is established in BloodSTAR through an assessment of eligibility against the Criteria, as described above. Patients may be authorised for a single one-off dose or course of treatment over a number of months. The prescriber is notified electronically of the decision by the authoriser. If the request is authorised, the requested dispensing facility or dispenser, is also notified of the details of an authorisation through BloodSTAR.
2016-immunoglobulin-governance-national-policy-updatev4.docx