- What patient-specific access schemes are being reformed?
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The Special Access Scheme refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. Patients are grouped into two categories under the scheme: Category A patients are defined as 'persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment'. Category B patients are all other patients that do not fit the Category A definition. Notifications for Category A patients and applications for Category B patients under the Special Access Scheme are made to the TGA by registered medical practitioners, preferably the treating doctor.
The Authorised Prescriber Scheme refers to arrangements where a medical practitioner may be granted authority to become an authorised prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients (or classes of recipients) with a particular medical condition. To become an Authorised Prescriber, practitioners must have the endorsement of an appropriate ethics committee or clinical college; and are required to address a number of criteria including the clinical justification for use of the product, the risk-benefit of the choice of treatment and informed consent procedures.
- What changes are occurring for patient-specific access to therapeutic products?
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These reforms will see modifications to the SAS, including the development and implementation of transparent criteria for the streamlined approval of access to certain unapproved therapeutic products for use in patients who have a non- life threatening condition. These products would need to be inherently lower in risk or have well-established patterns of use.
Particular products, along with proposed indications for use that are considered to represent an 'acceptable risk' for that product will be included on a list. Where a prescriber wants to prescribe a product on the list, provided it is for the proposed indication/s and meets any other criteria established for the product (such as, for example, dose and frequency), then its supply will be approved.
If the product is not on the list or the prescriber wishes to use it for a different purpose, the application will be subject to assessment by a TGA Medical Officer. These reforms will remove this requirement for products that are either inherently lower in risk or have well-established patterns of use for particular indications.
In addition, an integrated, online system to manage SAS notifications will be established.
Streamlining the authorised prescriber process will simplify requirements for practitioners. They will need to submit to the TGA:
- a copy of the ethics committee or clinical college application
- the ethics committee or clinical college approval letter, including any specified conditions of approval
- a one page application that identifies the practitioner, the sponsor, and the medicine or device to be used.
- Why introduce these changes?
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Streamlined approval processes for certain products under the SAS will result in faster access for certain patients to products not on the ARTG.
The new online system will provide greater capacity to capture important data regarding supply patterns, and allow for faster notification of approvals to prescribers.
Streamlining the authorised prescriber process will simplify requirements for practitioners wishing to become Authorised Prescribers of therapeutic products not on the ARTG.
- Will patient safety be jeopardised?
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No.
The integrated, online system to manage the SAS will increase the efficiency of the scheme and facilitate the use of data analytics and auditing to identify trends in use and ensure the scheme is being used appropriately.
- What are the main steps involved to implement the reforms?
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Transparent criteria will be developed for access via streamlined approval processes to certain therapeutic products not on the ARTG for use in patients who have a non-life threatening condition. These criteria will be based on a combination of the inherent risk of the product and a well-established pattern of use for particular indications.
The integrated online system, making use of ‘smart-form’ technology to pre-populate selected fields and provide data for real-time monitoring, will be developed.
- When will the changes be implemented?
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The reforms will be progressively rolled out by the TGA over the next 18 to 24 months, with new regulatory pathways for some medicines in place within 12 months.
- Further information
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