Surgical guides and biomodels – Prescribed List post-listing review

We looked at whether surgical guides and biomodels are eligible for listing on the Prescribed List (PL).

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 will review 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 new condition for surgical guides and biomodels was implemented. Reimbursement for these devices when used with medical devices listed in the following subcategories will apply only if they are used in craniomaxillofacial surgery involving insertion of a medical device in a hospital or hospital-substitute setting:

  • 07.01 – Craniomaxillofacial Reconstruction & Fixation
  • 07.02 – Craniomaxillofacial Implants
  • 07.04 – Distractor Systems of Schedule 1
  • sub-category 07.03 – Dental Implants (only applies if the implantable medical device is explicitly identified in the product name or description of the billing code for the surgical guide or biomodels).

The condition also states that the PL benefit reimbursement is limited to 3 billing codes for each surgical guide or biomodel per episode of care or procedure. This means a total of 6 benefits if both surgical guides and biomodels (maximum 3 for each) have been used in an episode of care or procedure.

The new condition is effective from 1 February 2024.

Read the full condition.

Read answers to stakeholder questions on the new condition.

Review of the condition for reimbursement of surgical guides and biomodels

We have been monitoring the impact of the condition to ensure relevant adjustments can be made if required.

The outcome of consultation on part of the condition is available here.

We have received feedback from some clinical stakeholders about the impact of the condition on some surgeries. We are working with clinical stakeholders to review the condition and improve alignment with the policy intent.

We will consults with stakeholders on the outcome of this review and any proposed amendments prior to implementation.

Stage 2

This review is ongoing.

Status

We commenced stage 2 in November 2024. Stage 2 will focus 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:

  1. 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.
  2. 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
  3. 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.

Proposed timeline

December 2024 – collate economic information from stakeholders

February 2025 – circulate draft report (from external consultant) for feedback

March 2025 – collate stakeholder feedback on draft report

March 2025 – further consultation (if required)

April 2025 – final report due from external consultant

May 2025 – present options to the Medical Device and Human Tissue Product Advisory Committee for consideration

May 2025 – departmental report published

This webpage will be updated with the status of this review.

Contact

Prescribed List post-listing reviews

Please contact us for more information about post-listing reviews of products on the Prescribed List.
Date last updated:

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