‘AI an opportunity and a challenge for HTA’

By Megan Brodie 3 weeks ago | In People, Reimbursement
  • 3 weeks ago
Dr Cliff Goodman. Source: MedNews, HTAi Seville.

24 June 2024

Rare disease therapies, advanced diagnostics and therapeutics for cancer, the new EU HTA regulation and now artificial intelligence (AI) are among the biggest challenges confronting HTA and payers globally says Dr Cliff Goodman, a global expert in health policy and valuing health technologies who has spent decades as a leading advisor to governments, not for profits, life science and other commercial entities.

After leading sustainability discussions and a symposium on precision oncology at the annual HTAi meeting in Seville last week, the former HTAi President sat down with MedNews to discuss how the field of HTA has evolved over the decades and the major challenges facing the field today in assessing new and often disruptive technologies, kicking off with new drugs for rare diseases.

“Therapies for rare disease are collectively becoming more common with many new entries being approved by the EMA and the FDA,” Dr Goodman said.

“Traditionally, we have relied on large randomised clinical trials (RCTs) for preferred evidence to value new therapies, but the evidence generated for regulatory approval of these therapies is often characterised by small, single-arm trials or with historical controls with surrogate endpoints over shorter duration.

“The field has therefore had to adjust its methodological requirements and has moved to clarify these prospectively with the life sciences companies as well as to engage patient perspectives along the way.

“In cancer it is the same. The available evidence often generates such surrogate outcomes as shorter-term progression-free survival (PFS) rather than more definitive overall survival (OS). Similarly, advances such as comprehensive genomic profiling pose challenges to assessment of diagnostics. The field must continue to adapt.

“Then along comes artificial intelligence. The power and scope of AI is expanding so quickly that HTA is going to be challenged just keeping up with the field. AI is raising a set of broader social, ethical, legal and environmental implications that we need to gear up to assess even as AI itself moves at an unprecedented pace.”

Goodman says one such challenges is that AI draws on massive bodies of information with certain inherent biases.

“This raises the propagation of bias,” he said. “Our healthcare systems have built-in racial, ethnic, and other biases. If AI draws in information that is already biased, it’s going to spit out misleading and potentially harmful findings and recommendations as well. It can present information as factual when it is not. That is a big concern.”

“What about how we use AI in clinical practice? From an efficiency standpoint, it can take on various administrative tasks, reducing clinician burden. You might also like to have AI-enabled patient consultations to respond to some common or routine questions, but what about AI taking on other roles of physicians?

“Do physicians feel threatened, and how far do we go in letting AI supplant them, in which case we might enable negligence? And where goes the human touch?”

Dr Goodman said AI offered a huge opportunity in its capacity to capitalise on enormous real world data sources including US insurance claims databases and electronic health records covering tens or hundreds of millions of lives and billions of data points. Here, AI may find correlations and other relationships to inform population-based and personalised health care.

“Again, we love the idea of using real world data synthesised into real world evidence but let’s not end up making mistakes faster and on a larger scale,” he said.

“HTA needs to have its antenna out from the get-go, not just for intended consequences and impacts of the technology, but the unintended impacts and consequences as well.”

A long history of HTA

Dr Goodman was among first people in the US to become involved in HTA, hooked while still at university and going on to do his PhD in the field in the 1980s.

He spent almost 30 years with the highly regarded Lewin Group, a healthcare consulting firm based near Washington, DC where he was Senior Vice President and Principal before going independent last year.

One of the biggest projects Dr Goodman worked on was developing evidence-based clinical practice guidelines (CPGs) for the US Veterans Administration and Department of Defence ranging from chronic diseases like hypertension and diabetes to PTSD and suicide prevention.

“What we do in HTA is often applicable to adjacent fields,” he said. “CPGs draw on HTA and there’s an overlap in the methodology, such as relying on systematic literature reviews.”

Regarding another important adaptation, Dr Goodman pointed to the difference in evidence requirements of regulators and payers.

Whereas regulators usually rely on evidence of shorter-term safety and efficacy under ideal settings for narrowly defined patient populations, payers often seek longer-term evidence of safety and effectiveness in real-world populations that look like their beneficiary populations, as well as costs and other economic information. These differences pose challenges to technology innovators.

“Regulators and payers have their respective remits which tend to call for differing bodies of evidence. This complicates the picture for innovators and can slow access,” he said.

“Recently, we have tried to encourage some alignment in those evidence requirements. In this, industry, payers and HTA have a common interest. If we can talk early about common aspects, it can support an evidence-based innovation pathway. Similarly, we seek certain convergence and best practices across HTA.”

Dr Goodman pointed to the HTA core model developed by the former European network for Health Technology Assessment (EUnetHTA) as a means of aligning evidence requirements across European-based HTA agencies.

“And next up is implementation of the new EU HTA Regulation and its Joint Clinical Assessment,” he said. “That’s a tall order, and I hope it will exemplify how HTA can evolve with the continued flow of opportunities and challenges of new healthcare technologies.”

©MedNews 2024

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