Horizon scanning report exposes critical systemic gaps demanding immediate reform

Medicines Australia has released the report from its 2024 Horizon Scanning Forum, a cornerstone of its Strategic Agreement with the Commonwealth. Convened annually, the Forum identifies key therapeutic advances likely to disrupt treatment paradigms or necessitate innovation in healthcare planning.

Building on the themes of its inaugural Horizon Scanning Forum in 2022, Medicines Australia highlighted four transformative areas: cell and gene therapies, vaccine technology for infectious diseases, novel antimicrobials, and digital health, including artificial intelligence (AI).

In her opening address, Assistant Minister for Health and Aged Care Ged Kearney MP emphasised collaboration across sectors to drive health innovation.

“We are all in this together – industry, researchers, regulators, and government – we need to work together to translate commercial advances in the lab and at the coalface.… we are working hard to get this right to support a really vibrant sector to put new tech and new medicines in reach for all Australian patients,” said Assistant Minister Kearney.

Medicines Australia CEO Liz de Somer stressed that a robust horizon scanning process is essential for a responsive HTA system, giving the Pharmaceutical Benefits Advisory Committee (PBAC) better visibility and, ultimately, reducing patient access delays.

“Inadequate horizon scanning over the last decade has contributed to the situation Australia is in today, where science and innovation have significantly outpaced our system for reimbursement of the latest innovations and weakened the PBS, to the detriment of patients,” she stated.

Consumer and patient voices were also featured in the Forum, adding essential perspectives to the horizon scanning process.

Olivia Nassaris, CEO of Parkinson’s Australia, stressed, “We need a shift in thinking from politicians to policymakers to taxpayers – to think of health as an investment, not an expense.”

Ann Single, CEO of Patient Voice Initiative (PVI), emphasised, “Relevance is the key value in allowing consumer/ patient involvement. Trying to develop a health system without a consumer, is like building a house without talking to the owner.”

The Forum highlighted critical gaps in vaccine access, with the HTA Review proposing a more streamlined process for listing vaccines on the National Immunisation Program (NIP). The benefits of expanding adult immunisation programs could be substantial, with research suggesting a return on investment up to 19 times the initial funding.

The New Frontier report that resulted from the Parliamentary Inquiry in 2020, underscored that narrow economic evaluations often obscure the longer-term societal benefits of novel health technologies. In response, the HTA Review Options Paper proposed a qualitative framework developed in consultation with stakeholders and informed by published frameworks such as those from ISPOR, US ICER, and NICE.

A significant topic of discussion was antimicrobial resistance (AMR), compounded by a lack of novel antimicrobial drugs. The current policy and reimbursement frameworks, tied to antimicrobial sales volumes, undermine stewardship efforts.

Andrew Bowskill, Director of Stakeholder Engagement for Queensland at MTPConnect and Co-chair of the Australian Antimicrobial Resistance Network (AAMRNet), noted that “only 19 novel antimicrobials have been registered for use in the EU and/ or the US since 2011. Of those, only 3 are registered in Australia; none are reimbursed through the PBS.”

MTPConnect’s second Fighting Superbugs Report has recommended piloting a fully de-linked subscription reimbursement model for antimicrobials in Australia, similar to systems used for snake anti-venom and Hepatitis C.

Access to cell and gene therapies, such as CAR T-cell treatments, was also a major concern. Associate Professor Philip Thompson from the University of Melbourne highlighted access delays of 9 to 30 months due to HTA timelines and state government agreements.

Warwick Shaw from Johnson & Johnson Innovative Medicine highlighted the challenge of equitable access, noting that some CAR T-cell therapy patients must travel over 100 kilometres, or even interstate, for treatment. The lack of public hospital activity-based funding codes and service codes further hampers equitable access to these treatments as they become standard of care for many diseases. Additionally, due to NHRA funding conditions, these therapies cannot be accessed in private hospitals.

Streamlined pathways for ultra-rare disease drugs are necessary, provided the Life Saving Drug Program (LSDP) continues funding these therapies. Standard HTA criteria, such as comparative effectiveness and cost-effectiveness, are challenging to apply to ultra-rare diseases due to limited data, necessitating a more customised evaluation approach.

Another key focus of the Forum was the role of AI and big data in transforming healthcare. These technologies are enabling real-time data analysis, personalised treatments, and enhanced patient engagement, promising more efficient care and improved outcomes. However, the rapidly evolving digital health landscape is outpacing traditional HTA processes that are not fit-for-purpose.

De Somer said, “The PBAC is already struggling with increased numbers of submissions and complexity of medicines being assessed. This is only going to increase. This is a symptom of a broken system that needs urgent reform, and the visibility that horizon scanning provides must be part of the solution.

She further added, “We need to get on with HTA reform so new therapies entering the market today can be assessed in a timely manner and made available to Australians through the PBS quickly,” de Somer concluded.

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