To successfully diffuse a new medical technology and procedure into the desirable Australian market, an application to the Medical Services Advisory Committee (MSAC) is required in most cases. This is to attain a Medical Benefits Schedule (MBS) item number so that health professionals can be paid for the procedure under Australia’s universal Medicare system. An MSAC application requires a comprehensive health technology assessment (HTA) of the clinical and economic outcomes of the new technology compared to existing practice.
It is a considerable commitment to prepare a submission to MSAC for a new MBS item number and applicants are well advised to follow the published guidelines and templates that are provided by MSAC. The current guidelines for therapeutic interventions are 206 pages long and it can be a challenging document to read. However, the guidelines are very useful when preparing a submission.
The medical device industry has long been critical of the clinical evidence requirements of the current guidelines as they mimic, almost completely, the guidelines for applications to the Pharmaceutical Benefits Advisory Committee (PBAC) for a new drug to be included on Australia’s subsidised medicine scheme, the Pharmaceutical Benefits Schedule (PBS). The MSAC guidelines assume that the same type of clinical evidence is available for medical devices as is available for pharmaceuticals, ideally well designed randomised controlled and blinded clinical trials.
There are many reasons why medical device or medical procedure trials cannot have the same design as pharmaceutical trials or eliminate bias to the same degree. A sample of these are:
- It is often impossible to blind a trial participant or investigator to the intervention a patient receives so that it is impossible to completely eliminate bias.
- It is often unethical to perform placebo or ‘sham’ procedures
- Where a new intervention is promising and the alternative treatment for a chronic or degenerative condition has not generally been successful, patients may be unwilling to be randomised to a control arm where they are unlikely to see an improvement in their condition.
- Surgeon skill and learning curves will influence the outcomes of some clinical trials.
MSAC has been reviewing the current guidelines with new draft guidelines recently being made available for public comment. The proposed new guidelines are much more palatable to read and are clear and well organised. They also tentatively introduce the inclusion of ‘personal utility’ in assessment of diagnostic tests but not, unfortunately for therapeutic interventions. There are some sensible changes to the assessments of genetic testing which recognise current practice.
Unfortunately, there is a continued lack of recognition in the guidelines of the differences between the realistic type of evidence available for medical devices and that of pharmaceuticals. This is disappointing when as the medical device industry has been advocating for many years for a real acknowledgement of the usefulness of evidence such as longitudinal registries, observational data and claims databases in the assessment of medical devices. The guidelines use terms that are clearly intended for drugs rather than devices. One glaring example is the use of the term ‘units dispensed’ which is appropriate for estimating costs of pharmaceuticals but not the costs of therapeutic procedures using medical devices.
Overall, the Guidelines are an improvement but are still not well designed for a practical and efficient assessment of clinical and economic effectiveness of medical devices.
MedTechnique Consulting has helped many organisations navigate the Australian healthcare landscape, gain market access and submit successful MSAC and reimbursement applications. If you have any questions or would like to learn more about how we can help your organisation make a MSAC submission and/or access the Australian market, please contact us at
email: email@example.com or phone: + 61 448 058 600.
About the Author: Sarah Griffin, Director of MedTechnique Consulting, Experts in medical device reimbursement and market access in Australia. Sarah is a health economist, reimbursement strategist, health policy advocate and experienced speaker.
If you would like to learn more about Sarah’s speaking experience for your next event please email: Kim MacDonald, Director at Spindrift Marketing.