1. What is HTA?
Health Technology Assessment (HTA) is a set of processes used to decide whether new treatments – like medicines, vaccines, and medical devices – should be subsidised on the Pharmaceutical Benefits Scheme (PBS – for medicines) or the Medicare Benefits Scheme (MBS – for services such as diagnostic tests and appointments). Most of the cost is then paid for by the Government, making the treatment more affordable for the people who need it. HTA evaluates if treatments are superior to the current available therapy and represent good cost-benefit.
Australia’s HTA system was established in 1993, a time when the Pharmaceutical Benefits Advisory Committee (PBAC) primarily reviewed less complex drugs and single-target vaccines. It is broadly acknowledged that the system has not evolved to keep pace with modern advancements in medicines, vaccines, biotherapeutics, and genomics.
2. What is the HTA Review?
The HTA Review was agreed upon in the 2022–2027 Strategic Agreement between the Commonwealth and Medicines Australia and was led by a Reference Committee appointed by the Minister for Health and Aged Care. Between October 2022 and May 2024, the Review looked at the current HTA processes and proposed 50 recommendations to improve access, equity, and the ability to evaluate complex and emerging technologies in a timely manner.
The Review involved two public consultations; deep dive sessions with industry, patients, and government representatives; and commissioned expert papers on topics such as international HTA methods, economic evaluations, and using data from real patient experiences.
The final report, published in September 2024, made many suggestions for improvement, but the Government has not yet responded. (See ANNEX 1 for a summary of the recommendations by strategic goals.)
Alongside the Review, the Enhance HTA report recommends changes to better include the consumer’s voice in HTA. This would make HTA more patient-centred by improving communicationHow we talk to each other; how we share our knowledge, what we know with each other., support, and early involvement of consumers in the process. It makes recommendations to bring consumer input into decision-making and create ongoing collaboration between consumers, industry, and government.
3. Why does HTA matter for people with rare and less common cancers?
HTA plays a vital role in deciding whether people with rare and less common cancers can access new treatments through government funding. Currently, the system has some major problems:
Long wait times: On average, it takes 466 days from the time a new medicine is registered in Australia until it is subsidised (Medicines Australia, 2022).
Strict evidence required: The current HTA processes demand a level of evidence that is very difficult to gather for diseases that have small patient populations, like rare cancers. While it is extremely important to have an evidence-based assessment process, a more flexible approach could help, such as accepting evidence from “basket” or “umbrella” trials (where medicines are tested across multiple patient subgroups under a single protocol).
Outdated assessment methods: Medicines are still assessed based on cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs type, even though many modern therapies target genetic biomarkers. This means the same medicine may be subsidised for someone with a common cancer (e.g., breast cancer) but not for a rare cancer (e.g., sarcomacancer arising from bones and/or soft tissue), even though they have the same genetic target.
Separate assessment pathways: Medicines (PBS) and diagnostic tests (MBS) are assessed separately, so a treatment may be subsidised but the test needed to identify whether someone would benefit from the treatment may not be. These are called companion technologies as they work together. If one is subsidised but the other is not then patients will continue to miss out because of price.
Lack of transparency: The current HTA process doesn’t include patient perspectives in a way that is transparent. This limits how much consumers can input into and understand the decision-making. The Enhance HTA report says that adding a structured way for consumers to give input would help make HTA decisions better reflect what patients need and experience, creating a more inclusive, fit-for-purpose system.
4. Will the review change things for people with rare cancers?
The Review acknowledges the many issues Rare Cancers Australia has advocated for, for over a decade, which is an important step. We welcome the Report and its reflection of RCA’s submissions. If adopted, the recommendations could have a significant impact for people with rare and less common cancers. They could:
- enable quicker access to medicines for people with rare and less common cancers
- allow pan-tumour therapies to be approved based on genetics, not just the type of cancer, meaning thousands more patients would benefit from affordable medicines
- use real-world evidence to support decision-making
- amplify the consumer voice, bringing more transparency and inclusivity
- introduce a bridging fund to allow patients to access Therapeutic Goods Administration (TGA) listed treatments while they go through the HTA process.
However, these are not yet government policy. They are still just recommendations. An Implementation Group is being set up to consider the report.
5. What next?
RCA will keep advocating for a fairer, faster system that is affordable for patients. We are working with patients, clinicians, Government and stakeholders across the sector to make these important changes a reality. We want to see:
- a formal Government response to the HTA Review Report and commitment to adopt all recommendations
- fast adoption of the recommendations, including pan-tumour pathways, better use of real-world data, bridging funding, and increasing patient involvement in decision-making
- prioritisation of the needs of people with rare and less common cancers, who face clear inequity within the current HTA processes.
Without urgent action, people with rare cancers will continue to face unacceptable delays in accessing life-saving treatment.
Download a copy of our HTA Policy Briefing document to read more