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 conducted the review in 2 stages:
Stage 1
Stage 1 involved a health technology assessment to determine if these devices qualify for inclusion on the PL. 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
Stage 2 involved a review of the cost-effectiveness of surgical guides and biomodels listed on the PL. Stage 2 set out to:
- review the evidence for the use of the devices, focusing on comparative cost-effectiveness to a nominated comparator in craniomaxillofacial (CMF) procedures
- analyse the PL benefits for surgical guides and/or biomodels used for implanting a device in CMF procedures.
We used this stage to determine whether changes to benefit settings were required.
Results of the review
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 CMF 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
Following stakeholder feedback and Medical Devices and Human Tissue Advisory Committee (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
An external consultant was engaged to conduct a comparative economic analysis of surgical guides and biomodels and provide advice on appropriate benefit settings.
Stage 2 found there is insufficient high-quality evidence to determine the cost-effectiveness of surgical guides and biomodels or whether current benefits reflect their clinical value. While evidence suggests these devices may reduce operative time in some complex CMF procedures, the available evidence does not support further changes to PL benefits.
All recommendations from the external consultant’s report, stakeholder feedback, internal data analysis and expert clinical advice, including advice from the MDHTAC and General Surgery Expert Clinical Advisory Group (GSECAG), were considered.
Based on the findings, we determined that the current PL benefits for surgical guides and biomodels will be maintained.
The surgical guides and biomodels post-listing review department report outlines the review process, findings and outcome.
We will continue to work with stakeholders on the implications of the condition and monitor data on claims for surgical guides and biomodels to ensure the condition continues to meet the policy intent.
Contact
