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News & Trends - Pharmaceuticals

Mind the gap: Realising the bigger potential for patient evidence in HTA

Health Industry Hub | April 5, 2023 |

Pharma News: Patients’ perspectives are important to identify preferences, estimate values and appreciate unmet medical needs in the process of research and development and subsequent assessment of new health technologies.

A report from the Health Technology Assessment (HTA) Summit conducted at the end of last year and attended by academics, industry, patient advocates and government was released yesterday.

The purpose of the Summit was to find common ground on how Australia can reform HTA policies, processes and methods to ensure patients gain timely access to novel treatments whilst recognising the government’s objective to achieve value for money.

According to Ann Single from Patient Voice Initiative (PVI) “Within the current process we hear the patient voice quite late in the product lifecycle, often only during an HTA appraisal, and it tends to be one-way. In an optimal HTA process, patient interaction would be dynamic and frequent, with opportunities for a two-way dialogue before a submission, during the evaluation and after a decision is made.”

Vanessa Stevens, CSL Vifor who was one of the speakers at the Summit commented “Patient interaction should be early, more often and more prominent. We need to improve the depth and breadth of patient involvement in HTA and beyond.”

As an emerging concept, recognition and understanding of patient-based evidence is still developing. The concepts and methods that support its application in HTA requires urgent attention.

According to Staniszewska et al 2021 “Clinical and economic forms of evidence are not enough for HTA. For HTA to be complete, we need to consider all relevant aspects of the phenomena, including patient-based evidence. There is now an urgent need for the global research and HTA community to work together to realise the full potential of patient-based evidence through conceptual and methodological development and wider recognition.”

This strengthening of the patient role in the generation of evidence is more focussed on how patients live with a condition, their experiences of a condition, an intervention or a technology, their views on the effectiveness of a treatment in relation to outcomes of importance to them, and whether a treatment is acceptable and relevant to them within the context of their lives. With these changes in the nature of questions about a medicine, medical device or technology, there has been a developing awareness of the need for research designs to also respond more intuitively in order to provide the most appropriate evidence for HTA. 

Dimitrova et al 2022 mapped the potential barriers of patient involvement in HTA, which are mostly aligned with the key themes that have emerged in the HTA Summit report. Most of the barriers coming from the perspective of the payers/HTA bodies were related to the lack of defined guidelines and rules on how and when to include patient perspectives which increased the risk for lack of trust and fear to include patients in the HTA process.

From the patients‘ perspective, the key barriers were associated with lack of sufficiently explained methodology for the patient‘s role in the HTA process. This could be attributed to the lack of organised programs in the healthcare systems for patient engagement. Also, patients pointed to the lack of fair compensation for time offered and logistics issues including traveling time and costs, documents not sent on time for review and preparatory calls or meetings during working hours.

As a result of the changing ecosystem, the Consumer Health Forum (CHF) has called for sustainable government funding in the May budget to enable consumer engagement. The patient advocacy group said “In a sector full of vested interests, seeking unbiased views can be extremely difficult. Unlike other consumer groups that receive funding from commercial entities such as pharmaceutical companies, or charities that focus on particular diseases, CHF is an independent group that seeks to represent all consumers.”

According to CHF, a major barrier to consumers engaging more with their health system and the processes that drive it is a lack of knowledge about how to get started and perform such a role. To overcome this, CHF wants to create a Health Consumers Leadership Academy to provide a range of avenues for health consumers to develop their skills. Providing further training and development options for consumers would support them to effectively operate as a constructive partner in the health system and enable them to influence policy, planning, delivery, evaluation, and monitoring of healthcare policy, systems, and processes.

Securing funding of $17.8 million over three years will allow CHF to fund improved consumer leadership, engagement, research and best practice initiatives. This will include paying consumers for their involvement in research and committees, establishing an annual conference to share and promote best practice consumer engagement and advocacy, and an awards program to recognise excellence in health consumer engagement.

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