Allocating Resources During a Pandemic: To HTA or Not to HTA?

Cate Bailey, PhD, MApSci, BA, Monash University, Melbourne, Australia; and Ingrid Cox, MD, MSc, Dip, University of Tasmania, Hobart, Australia

The magnitude of the global pandemic and the limited availability of disease-specific treatment, prevention, and control strategies has posed tremendous financial stress on health systems and health resources globally. Development of new drugs, repurposing of existing drugs, and vaccine development have been at the forefront in most developed countries with some emerging successes from clinical trials for drugs such as remdesivir and dexamethasone. A dilemma, however, exists as to whether these clinically effective strategies are cost-effective in all settings or countries.

Do we go through the HTA (health technology assessment) process and make the most of limited available resources or do we focus on expediting treatments based on the clinical evidence given the current time constraints posed by the virus? This session proposed to discuss this dilemma from 3 perspectives, academia, the pharmaceutical industry, and a non-governmental organization.

“Decision making in the face of radical uncertainty is highly relevant with the situation we are currently facing with the pandemic and choices people must make.”—Mark Chakravarty, PhD

Decision Making Under Uncertainty
Dalia Dawoud, PhD, Cairo University, Cairo, Egypt, is a strong advocate for the use of HTA during health emergencies, and specifically during the current COVID19 pandemic as decisions are made on which treatments should be available for patients. “We need HTA because the pandemic is imposing a huge health and economic burden, and thus choices and trade-offs need to be made. These choices need to be made transparently and consistently to maintain public trust,” Dawoud said.  

HTA is particularly good at functioning under uncertainty and for considering quality and ethical considerations, she continued, thus it can be adapted to the current situation. Finally, she made the point that we need to be aware of the need for speed without sacrificing other elements in the process. HTA is uniquely situated for the current situation as decision making under uncertainty is the hallmark of the HTA process, including shared decision-making processes and finding pragmatic solutions, she stated.

 A Massive Form of Rule of Rescue
Mark Chakravarty, PhD, Novartis Pharmaceuticals, Basel, Switzerland, began his presentation by saying, “Decision making in the face of radical uncertainty is highly relevant with the situation we are currently facing with the pandemic and choices people must make. Decision making under radical uncertainty requires different tools other than those optimized for resolvable uncertainty.

Given the constraints of the pandemic, Chakravarty emphasized that sensible adaptable public policy cannot be made by quantitative assessment alone and that the narrative decision making needed to be included. He identified the current narrative guiding the COVID-19 action as “massive form of rule of rescue” with an ethical imperative to save lives, even when money might be more efficiently spent (Figure 1).

Figure 1: Radical Uncertainty

Taking all of this into consideration, Chakrarty concluded that HTA experts should aspire to ensure patient safety and the quality of care remain central, and to ensure that HTA is proportional and pragmatic and supportive of moving quickly. Experts should also provide decision makers with “rules of thumb” that can be implemented in a nonstationary and changing environment. The pandemic can also be used as a platform to engage debate on and manage the societal values and the paradoxes that have been exposed by the choices that need to be made during the pandemic.

Chakravarty emphasized that HTA had to be more flexible and dynamic and there was need to continue the work that ISPOR has already started looking at augmented value frameworks. Finally, he highlighted that HTA experts need to promote transparency, identifying what is known with resolvable uncertainty and what is simply unknown.

“We need HTA because the pandemic is imposing a huge health and economic burden, and thus choices and trade-offs need to be made.”—Dalia Dawoud, PhD

 
HTA in Diagnostic Testing
Kalipso Chalkidou, PhD, Imperial College London, London, United Kingdom, started her presentation by looking at the diagnostic environment. She emphasized that despite the WHO position on testing from the onset of the outbreak, there was no specific clinical indication for testing on an individual basis. Additionally, the performance of the available tests had not yet been assessed to the standard required of a novel test and that resource implications had not been considered.

She followed up by looking at treatments conducted including remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon and the conclusions by researchers that all had little effect on mortality, initiation of ventilation, and duration of hospital stay. She noted that the evidence has not stopped the use of the drugs by national health agencies.

With regards to vaccines, Chalkidou underscored the challenges relating to development of a safe and efficacious vaccine, access, and affordability especially in low-income countries. “We need an HTA process to get it right, and we need an HTA process to communicate it right to people. This is the time to be systematic about the evidence… [to be] open, transparent, honest, and build the trust that we desperately need with the general public,” Chalkidou concluded.

 Challenges in the HTA Process
The panel stressed the importance of HTA at the local and international level, but acknowledged that the HTA process was challenging in the current environment where so much new evidence is constantly being published. Because research into COVID 19 is moving so fast, we are at risk of making the wrong decisions due to lack of due HTA processes (such as in the case of the European commission buying up remdesivir at an undisclosed cost and which is now known not to work).

HTA is not an easy tool where the baseline is evolving quickly; however, panelists differed in their opinions on how to manage this uncertainty (Figure 2). Views ranged from considerations that although HTA is not a static platform, it is essential as there is no real alternative, to the need to wait until evidence has matured and that we can then understand the real-world usage, (ie, when we will be working under resolvable uncertainty). It is important at this stage, though, to stop a massive redistribution of value between different players and to ask whether HTA has a role in preventing this from happening.

Figure 2: Panelists (clockwise): Kalipso Chalkidou, Amanda Adler, Dalia Dawoud, Mark Chakravarty.