It’s all about Access!

Medical Devices
Author: Piety Rocha

In Australia, there are a number of options where patients can gain access to products that have not been approved for use. Some of these options are described below.

Authorised Prescribers (AP)

Medical practitioners can be granted authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients with a particular medical condition.

Authorised Prescribers must report the number of patients treated every 6-months and the use of the product must be reported twice yearly covering each period between 1 January to 30 June and 1 July to 31 December.
There are two pathways to apply to become an Authorised Prescriber, depending on the product to be prescribed.

  1. Established History of Use Pathway  – This pathway requires one application to be submitted to the TGA for medicines deemed to have an established history of use. The list of medicines deemed to have an established history of use is available here.
  2. Standard Pathway – This pathway requires a 2-step application process for products that are not included in the list of medicines deemed to have an established history of use. Approval from a human research ethics committee (HREC) or endorsement by a specialist college must be obtained before applying to the TGA.

For information regarding the  Authorised Prescriber Scheme, please refer to the Authorised Prescriber Scheme Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors.

Special Access Scheme (SAS)

The Special Access Scheme (SAS) allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) (considered unapproved) for a single patient.

‘Unapproved’ therapeutic goods have not been evaluated by the TGA for quality, safety, efficacy or performance. Therefore, the prescribing health practitioner must consider the available evidence to support the use of the ‘unapproved’ product and any potential risks for the individual patient.

SAS Pathways

There are three SAS pathways available to access ‘unapproved’ therapeutic goods. The prescribing health practitioner is responsible for deciding which pathway is most suitable for their patient.

SAS Category A: notification for a patient defined as seriously ill
Category A patients are defined as being seriously ill if:

  • For medicines and biologicals, they have 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.
  • For medical devices, they have a condition that is reasonably likely to lead to the person’s death within less than a year or, without early treatment, to the person’s premature death.

Substances in Schedule 9 of the Poisons Standard (where the manufacture, possession, sale or use is prohibited by State or Territory law) cannot be accessed through SAS Category A.

SAS Category B: application pathway
Category B is an application pathway that can be accessed by health practitioners (usually medical or dental practitioners) if the patient does not fit the Category A definition and if the therapeutic good is not authorised for supply under the SAS Category C notification pathway. Category B applications must be approved by TGA before the ‘unapproved’ product may be supplied to the patient:

SAS Category C: application pathway
Category C is a notification pathway that allows certain types of health practitioners to supply therapeutic goods that are deemed to have an established history of use. These goods are specified in a list along with their indications and the type of health practitioner authorised to supply these products for the respective indications. There are separate lists for medicines, medical devices and biologicals. The lists can be found at Special Access Scheme rules.

For information regarding the Special Access Scheme, please refer to the  Special Access Scheme: Guidance for health practitioners and sponsors.

What’s Changed?

The Special Access Scheme (SAS) and Authorised Prescriber (AP) Online System is the preferred method of submission for SAS and AP applications and is designed to reduce administrative burden and provide medical practitioners additional reporting and management functions to assist in the management of their SAS and AP applications.

The TGA has made changes to the appearance and the navigation of the SAS and AP online system with information categorised into the relevant sections in the portal.

Additionally, the following specific changes were made to the SAS and AP dashboards.

SAS Dashboard:

  • The state specific forms for medicinal cannabis applications for NSW, ACT and VIC forms have been updated to comply with legislative changes.
  • The QLD form was removed to reflect a recent legislative change where approval is required only for those cases where the patient is considered drug dependent and a prescriber is seeking to treat them with a schedule 8 medicinal cannabis medicine.

Refer to the SAS guidance for use of the online system on the TGA Special Access Scheme page for instructions on how to use the SAS dashboard.

AP Dashboard:

  • The process for applying for nicotine products has been streamlined to a single button application available from the AP dashboard landing page.
  • Submission of six monthly patient data reports can now be done directly via the SAS and AP Online System instead of PDF form emailed to the TGA.

Refer to the Guidance for Authorised Prescriber Online System on the TGA Special Access Scheme page for instructions on how to use the SAS dashboard.

The changes described above came into effect on 22 April 2021.

If you would like further information or are in need of support for these systems, please contact us.

Disclaimer:

The contents of this article/presentation are solely the opinion of the author and do not represent the opinions of PharmaLex GmbH or its parent AmerisourceBergen Corporation. PharmaLex and AmerisourceBergen strongly encourage readers/listeners to review available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.

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