Consumers seek ‘equal partnership’ in HTA process: What will it take to strike the right balance?

Pharma News: Central to Australian Government’s Strategic Agreement with Medicines Australia is a series of reform initiatives designed to expedite patient access to new medicines and novel health technologies. Of particular note is the introduction of an Enhanced Consumer Engagement Process, an essential element of the agreement. Within this framework, the Office of Health Technology Assessment (Office of HTA) spearheaded the Consumer Evidence and Engagement Unit (CEEU), conducting the Conversations for Change consultation.

The report highlighted that the core aspiration for consumers participating in Health Technology Assessment (HTA) processes is achieving ‘equal partnership’ status alongside other stakeholders. A consistent message emerged from stakeholders emphasising the importance of consumer input from the outset of the clinical research and regulatory assessment stages, facilitating faster access to health technologies. This early engagement should involve government bodies, sponsors, and consumers working cohesively to cultivate trust and foster transparency.

Efforts to expand engagement must encompass diverse consumer groups and wider community representation, spanning rural and remote consumers, First Nations people, culturally and linguistically diverse communities, people with disabilities, LGBTQI+ individuals, and the general public. Furthermore, forging international collaborations becomes crucial for medical conditions affecting small patient populations.

The dialogue among stakeholders revealed existing challenges within the system. These challenges encompass transforming established processes to enable meaningful consumer participation, addressing potential conflicts of interest when partnering with consumer organisations, and ensuring pharma industry compliance. Striking the right balance is paramount, as changes should not overwhelm consumers or lengthen the pathway to accessing new health technologies. Crucially, mechanisms for increased consumer involvement should be designed with outcomes that resonate with the consumer community.

A significant call echoed across stakeholders pertains to enhanced transparency and openness. Transparency, spanning from pre-submission phases to post-committee meetings and even technology implementation, is deemed essential. A pivotal consensus emerged that consumers and consumer organisations should possess access to the same information as other stakeholders and committees.

The pharma industry’s early communication with consumer organisations about upcoming HTA applications calls for a shift in culture and established practices. Consumer organisations have expressed a need for guidance in collecting meaningful consumer data for HTA decision-making, considering the unique challenges faced by individuals who are unwell or supporting those who are.

The roadmap for strengthening consumer involvement necessitates amending existing HTA processes and guidelines to highlight the value of consumer input. Suggestions ranged from acknowledging consumer evidence in HTA guidelines, establishing dedicated consumer evidence repositories, to formalising evidence collection for improved access or post-market reviews. Stakeholders envision an HTA landscape where consumers are fully integrated into the decision-making process.

Proposed enhancements in consumer input entail meticulous consideration, particularly regarding the existing legislative framework for medicine listing. Striking a balance between heightened consumer input and timely access to new therapies requires thorough exploration. Collaborative synergy between the Therapeutic Goods Administration (TGA) and other HTA processes for addressing raised concerns, such as data sharing, may be warranted.

As Australia’s health technology landscape continues to evolve, the ongoing debate among stakeholders holds the promise of a more inclusive and effective system, ultimately leading to better health outcomes for all Australians.

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