HTA has been growing in popularity among reimbursement agencies worldwide in the last 20 years. Its application to medical devices has been slower for a range of reasons. Its popularity has a number of drivers including the desire to find an objective basis for funding decisions for health technology.
A cost-effectiveness or a cost-utility evaluation seeks to measure the additional clinical benefit and cost of using a new medical product compared to what is now used for the same condition. In cost-utility analysis, patient quality of life and length of life is combined into a single ‘utility’ measure. This is the analysis most commonly used by the Department of Health and its major committees.
To operate effectively, HTA generally requires two major components: firstly, clinical evidence that can be used to compare products; and secondly: an economic analysis of benefits and costs. It therefore requires research – usually by the sponsor – to gather and present data as well as a systematic process of evaluation.
When assessing whether HTA is being done properly, questions can be asked such as:
- Is the process fair and transparent?
- Is the depth and complexity of the process suitable for the expected clinical risk and cost?
- Are the correct outcomes being evaluated?
- Is there a reasonable way of dealing with uncertainty given data is never perfect?
Australia was one of the first countries to use HTA to assess reimbursement for pharmaceuticals through the Pharmaceutical Benefits Advisory Committee (PBAC). Typical submissions grew from a few dozen pages in the early 1990s to thousands of pages currently.
This was followed by assessment of other medical procedures and technologies through the Medical Services Advisory Committee (MSAC) starting in the late 1990s.
The Prostheses List Advisory Committee (PLAC) and its subcommittees also assess relative cost and effectiveness for prostheses to go on the Prostheses List where a higher benefit is requested. When a medical device is on the Prostheses List, private health insurers are required to pay for it if they have relevant hospital cover for the procedure.
The Australian Government has a policy of making assessment for reimbursement of medical technology and procedures more uniform. To this end it amalgamated the Department of Health sections responsible for supporting assessment process for the Pharmaceutical Benefits Scheme (PBS), Medicare Services Schedule (MBS) and the Prostheses List into one Branch – the Office of Health Technology Assessment.
The MedTech industry, through the Medical Technology Association of Australia (MTAA) is supportive of the appropriate use of HTA for Prostheses List applications but it needs to be undertaken with care. Medical devices are different from pharmaceuticals in that:
- They are dependent on operator skill
- Blinded trials are often not practicable
- Short life cycles/incremental improvements narrow the evidence window
- Low volume reduces the quantity of evidence
- The effect on the patient is usually physical not chemical
- They may require much more company support to use
PulseLine understand that MTAA is now in a process of Prostheses Reform discussion with the Australian Government and other stakeholders. The correct use of HTA for prostheses is a key part of that discussion. The industry has recommended that a ‘prostheses-specific pathway’ be developed that bolsters the capacity of PLAC to evaluate relative effectiveness and cost of new prostheses without requiring a full MSAC deliberation that is resource-intensive and lengthy.
HTA for medical devices is here to stay. Time will tell if the processes put in place by for the Prostheses List enable patient access to good technology or hinder it.