About the review
Surgical guides and biomodels are non-implantable, single-use personalised medical devices used in planning and decision-making before and during surgery.
We commenced the post-listing review of surgical guides and biomodels in response to:
- rapid growth in use of these devices – PL benefits paid by health insurers rose from $1.6 million in 2016–17 to $20.6 million in 2021–22
- reports suggesting overuse and inappropriate use
- uncertainty about comparative clinical effectiveness and cost-effectiveness
- uncertainty about eligibility on the PL – whether the devices are considered essential to implanting another device.
The review process
We are conducting the review in 2 stages:
Stage 1
Stage 1 involved a health technology assessment to determine if these devices qualify for inclusion on the Prescribed List. Stage 1 set out to:
- analyse the role of these devices in clinical practice, including future trends of clinical use
- review the evidence for the use of the devices, focusing on comparative clinical effectiveness and benefits
- consider the use of these devices.
We used this stage to inform a decision about eligibility for continued listing of these devices.
Stage 2
In this stage, we are reviewing the cost-effectiveness of surgical guides and biomodels in the PL to determine whether changes are required to the benefit settings.
Results
Stage 1
We engaged an external consultant to analyse the role of these devices in clinical practice.
We considered the recommendations of the external consultant's report as well as conducted further consultation with clinical experts about the use of these devices in orthopaedic practice.
Stage 1 indicated that surgical guides and biomodels are clinically effective when used for insertion of a medical device in complex craniomaxillofacial surgery. This means they are generally considered eligible for continued listing on the PL for these types of procedures. However, there is insufficient evidence to support the current listings of these devices for any other types of surgeries.
To reflect these findings, a condition for surgical guides and biomodels was implemented.
The condition was effective from 1 February 2024.
Read the full condition.
Read answers to stakeholder questions on the condition.
Review of the condition for reimbursement of surgical guides and biomodels
We continue to monitor the impact of the condition to ensure we can adjust the condition if required.
Following stakeholder feedback and MDHTAC advice, the condition was updated from the July 2025 PL.
The new condition states:
- Prescribed List reimbursement is restricted to the use of the device in craniomaxillofacial surgery procedures involving insertion of an implantable medical device, where that implantable device is listed in either sub-category 07.01 – Craniomaxillofacial Reconstruction & Fixation, or 07.02 – Craniomaxillofacial Implants, or 07.04 – Distractor Systems of Schedule 1, or sub-category 07.03 – Dental Implants, but only if the implantable dental medical device is explicitly identified in the product name or description of the billing code for the surgical guide or biomodel and is used in hospital
- Not limiting the above, for a claim for any implantation procedure (defined by the respective MBS items stated in the claim) for a patient, the Prescribed List reimbursement is limited to 6 PL benefits for any billing codes for surgical guides and/or biomodels, which have been used in an implantation procedure for a patient. This restriction is not impacted by the number of devices implanted during the procedure, for which claim has been submitted.
Read the full condition.
Stage 2
This review is ongoing.
Status
We commenced stage 2 in November 2024. Stage 2 focuses on a comparative economic analysis of surgical guides and biomodels.
The objectives of stage 2 are to determine the:
- evidence of cost effectiveness
- appropriate benefit amount for surgical guides and biomodels on the PL.
Sponsors with devices included in the review have been contacted and invited to submit information to inform the review.
We have engaged an external consultant to:
- Review the evidence for the use of surgical guides and biomodels currently listed on the PL, with a focus on cost-effectiveness to nominated comparator in CMF procedures.
- Conduct an appropriate economic analysis of the devices in scope:
- surgical guides used for implanting a device in CMF procedures on the PL
- biomodels used for implanting a device in CMF procedures on the PL
- surgical guides and biomodels in combination for implanting a device in CMF procedures on the PL
- Subject to findings from 1 and 2 above, provide options about appropriate benefits for consideration by the department.
We will use the external consultant report to inform this stage of the review along with internal data analysis, stakeholder consultation and expert advice.
The draft consultant report was provided to targeted stakeholder for review in April 2025. Feedback is being considered by the department and the external consultant.
Proposed timeline
15 May 2025 – present report to the Medical Device and Human Tissue Product Advisory Committee for consideration
June - September 2025 – further consultation (if required)
June – September 2025 – consolidate findings from the review and develop options for the delegate to consider
We update this webpage regularly with the status of this review.
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