Recent Funding Decisions in Australia and implications for the Health Technology Assessment (HTA) Review 

To list new medicines, pharmaceutical companies must demonstrate that their products offer value for money to the funding body. This is part of the Health Technology Assessment (HTA) process, overseen by the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia.

Recently, the HTA Policy and Methods Review recommended enhancing transparency in decision-making and improving timely access to safe and effective medicines. However, it remains unclear which factors influence PBAC’s funding decisions, as the last comprehensive analysis was conducted over 15 years ago.

Our research aimed to investigate the factors influencing PBAC’s decisions and the time it takes for medicines to be reimbursed under the Pharmaceutical Benefits Scheme (PBS). We analysed Public Summary Documents (PSDs) to capture the characteristics of PBAC submissions and explore the relationship between submission components and funding outcomes.

We examined all submissions considered at PBAC meetings between March 2020 and March 2024. Our results showed that 35% of decisions were based on cost-minimisation analysis (CMA), while 42% were based on cost-utility analysis (CUA). The success rate for receiving a recommendation for funding ranged from 39% for CUAs to 82% for CMAs.

Additionally, the incremental cost-effectiveness ratio (ICER) was found to be a statistically significant predictor for the probability of a recommendation for funding. Our analysis showed that the higher the ICER, the less likely it is for a medicine to be recommended (Figure 1). However, the impact on the success rate is small; for example, the probability of a recommendation decreased by only 0.88% if the ICER increased by $10,000 from the average value of approximately $124,000, holding everything else constant.

If a medicine had been previously considered by the PBAC, the chance of a recommendation increased by 30%, whereas for submissions that were perceived by the PBAC to include a flawed economic model, the probability of a recommendation was 32% lower compared to submissions based on a valid economic model. This suggests that a resubmission will likely be required to achieve a recommendation if a flawed economic model is presented. For first-time submissions, the probability of recommendation did not change significantly based on economic model validity. However, submissions for paediatric populations had a 17.98% higher probability of recommendation compared to non-paediatric populations.

Regarding the time from a recommendation for funding to PBS listing, it was found that listing occurred, on average, 7 months after a recommendation, with listing delays going up to approximately 40 months.

In conclusion, funding decisions for new medicines in Australia appear to be influenced by various submission components, notably prior considerations by the PBAC and economic model validity. The high need for resubmissions and the delay in accessing medicines after a recommendation for funding prevent timely access to medicines in Australia. These insights support the current recommendations of the HTA Review, which advocate for the development of a transparent decision-making framework that provides more timely access to safe and effective medicines.