Executive Summary 

• Health technology assessments (HTAs) are evaluations used by health care payers to determine the value of various health technologies and interventions such as treatment protocols, pharmaceuticals, and medical devices. 
• These assessments are reductive determinations of whether a patient’s prescribed medical intervention is of acceptable value from an average, generalized standpoint.  
• In single-payer systems, where coverage decisions are binding and alternatives limited, the harm posed by the reductive use of HTAs can be life-threatening; for patients facing serious illness, for example, HTAs can create an unnecessary barrier to care rather than the intended safeguard of fairness. 

Introduction 

Health technology assessments (HTAs) have become a central tool in single-payer health policy worldwide. Well-covered, escalating health care costs from pharmaceuticals, medical devices, and new clinical interventions are leading governments and other payers to turn to these evaluations to guide coverage and reimbursement decisions. While not currently a central component of the U.S. health care system, new policy announcements – such as the Food and Drug Administration’s Commissioner Priority Review Program – that profess to take pricing into account may indicate that the United States is slowly moving towards adopting HTAs. 

HTAs are systematic evaluations of the medical, economic, social, and ethical implications of a particular health technology. A “technology” can include drugs, surgical procedures, diagnostic tools, and even broader organizational or delivery innovations. The goal is not simply to determine whether an intervention works but whether it provides sufficient value relative to alternatives to justify its cost. 

In single-payer systems, HTAs are often at the center of scientific evidence, health economics, and public policy decisions. A typical assessment weighs clinical effectiveness, cost effectiveness, budget impact, and ethical and social considerations. HTAs are distinct from purely clinical guidelines or purely financial analyses, although these are large components of the eventual output. They instead attempt to reduce the overall impact of any health intervention to a number, without regard to personal care decisions, individual risk appetite, or unrealized potential benefit. 

HTAs in Single-payer Systems 

In single-payer systems, HTAs serve as the basis for national coverage and pricing decisions. Since a government payer is responsible for the majority of health spending, it must balance patient access with system-wide affordability. HTAs give policymakers a framework for deciding which technologies merit public reimbursement and at what price. 

The United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE) is perhaps the best-known HTA agency. NICE evaluates new medicines, devices, and interventions for the National Health Service (NHS). If a technology is deemed cost-effective – generally below a threshold of £20,000–£30,000 per QALY – it is typically recommended for coverage across the NHS. Conversely, if the cost per QALY is too high, NICE may decline to recommend it, often prompting price negotiations with manufacturers. 

Other countries have developed similar structures. Canada’s Canadian Agency for Drugs and Technologies in Health (CADTH) provides guidance to federal and provincial payers. Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) evaluates new pharmaceuticals under its statutory health insurance system, with results feeding into price negotiations. 

HTAs Are Barriers to Access 

One of the most important consequences of HTAs is that they delay or deny patient access to treatments. Because assessments can take months or even years, patients in single-payer systems often wait far longer for new medicines than those in countries without HTA requirements. In the UK, for example, cancer patients have at times faced restricted access to breakthrough therapies when NICE determined they were not cost-effective. Patients with rare diseases, where per-patient costs are inherently high, are especially vulnerable. 

Even when technologies are eventually approved, coverage is often limited by strict conditions. These restrictions may improve cost-effectiveness metrics but can leave large groups of patients without access to therapies their doctors would otherwise prescribe. For patients with life-threatening conditions, such limitations can feel like a denial of care. 

Narrow Definitions of Value 

HTAs rely heavily on narrow economic metrics such as the cost per QALY. While convenient for policymakers, this approach often fails to capture what patients truly value. The QALY framework can undervalue improvements in quality of life, incremental progress in chronic diseases, and therapies that extend survival in small patient populations. 

Patient advocacy groups have argued that such models discriminate against people with disabilities or chronic illnesses, implicitly valuing their lives less than those of healthier individuals. Moreover, by ignoring broader social and economic benefits – such as productivity gains or reduced caregiver burdens – HTAs often paint an incomplete picture of a treatment’s worth. 

Centralized Rationing 

In single-payer systems, the findings of HTAs are not just advisory but determinative. A negative assessment frequently means a drug or device will not be covered nationwide, eliminating the possibility of patient choice or private alternatives in countries where supplemental insurance is limited. This centralization effectively hands government agencies the authority to ration care. The result is uniformity, but not necessarily fairness. A technology deemed too expensive on a population level may still be the best or only option for certain patients. HTAs often overlook these individual circumstances in pursuit of system-wide efficiency. 

Discouraging Innovation 

The heavy emphasis on cost containment can also discourage medical innovation. Pharmaceutical and device manufacturers are less likely to invest in therapies for conditions that are unlikely to meet cost-effectiveness thresholds, such as ultra-rare diseases or novel technologies with high upfront costs. 

In some cases, companies withdraw products from markets altogether when price concessions demanded by HTA agencies make them financially unsustainable. Critics warn that the message to innovators is clear: Unless your product can fit neatly into HTA metrics, it may not be worth developing. This dynamic risks slowing the pace of medical progress and limiting treatment options for future patients. 

Administrative Burden and Delays 

HTAs are also criticized for their bureaucratic complexity. The process involves extensive data submissions, lengthy analyses, and multiple rounds of review. For smaller companies – such as biotech startups – these requirements can be prohibitively costly, effectively privileging larger firms that can afford compliance. 

The drawn-out nature of HTAs creates bottlenecks in patient access. By the time an intervention is finally approved, years may have passed since its initial market authorization elsewhere. For patients in urgent need, these delays translate directly into worse outcomes. 

Case Studies on Outcomes of HTAs 

Drug Rejections That Delay or Deny Lifesaving Treatment 

In July 2024, NICE rejected Enhertu (trastuzumab deruxtecan), a first-of-its-kind treatment for HER2-low metastatic breast cancer, despite clinical trial evidence showing an average of five extra months of progression-free survival. Critics called the decision “a tragedy” and “devastating” to the thousands of women affected. Similarly, Opdivo (nivolumab) was rejected for metastatic kidney cancer by NICE in 2016 due to cost concerns, despite its proven ability to prolong life. Its use in head and neck cancer faced repeated refusals – even after the Cancer Drugs Fund (CDF) allowed temporary access and long-term real-world data failed to meet NICE’s cost-effectiveness thresholds. 

Administrative Barriers That Stifle Access and Innovation 

In Canada, CADTH requires distinct research protocols for submission, which deter companies from launching new drugs in the market. Their reimbursement recommendations often pressure manufacturers for steep price cuts. Germany’s IQWiG faces methodological disputes with the Federal Joint Committee (G-BA), leading to inconsistent decisions and added complexity in determining a technology’s added benefit. 

Narrow Valuations That Undervalue Patient Benefits 

HTAs typically rely on QALYs and preset cost thresholds that fail to capture broader societal values – such as emotional relief, caregiver burden reduction, or incremental survival gains for rare conditions. NICE’s outdated thresholds (£20,000–30,000 per QALY) have stayed static since 1999, not accounting for inflation or the rising costs of innovation. The UK spends only 9 percent of its health budget on medicines compared to 15–17 percent in France, Germany, and Italy, leading to lower drug availability and greater treatment disparities between countries. Even when NICE updates methodologies to weight severity or innovation, decisions can fail to reflect urgency – for example, categorizing HER2-low breast cancer as “medium severity,” thereby justifying Enhertu’s rejection despite life-extending potential. 

Innovation Discouraged by Rigid Cost Pressures 

HTA-driven pricing demands can push companies to withdraw or avoid submitting new treatments. Gilead Sciences has withheld Trodelvy, a breast cancer drug, from UK submission, citing unachievable returns under NICE’s pricing model. This denies approximately 500 patients access to a promising therapy, despite its availability in countries including France, Germany, and the United States. Industry leaders have also warned that NICE’s rigid valuation and low investment hamper both patient care and the UK’s life sciences industry. AstraZeneca halted a multi-£100 million expansion, citing the unfavorable environment. 

HTAs Are Not Just a Pharmaceutical Concern 

When applied to medical devices, the same frameworks that govern pharmaceuticals often misfire. Devices differ fundamentally from drugs in their development, testing, and use, but HTA systems have been slow to adapt, leaving patients and providers caught in an uncertain and inefficient care environment. 

A key challenge is the lack of traditional clinical trial evidence. Drugs typically enter the market backed by randomized controlled trials. Devices, by contrast, rely more on smaller studies or registries, since large-scale trials are harder to conduct when technology changes rapidly. For example, the da Vinci surgical robot faced skepticism from early HTA reviews because randomized data were limited. While patients reported shorter recovery times and less blood loss, early assessments dismissed these benefits as “insufficiently proven,” delaying broader reimbursement and slowing adoption in some health systems. 

The short life cycle of devices compounds the problem. By the time an HTA is completed on version 1.0 of a technology, version 2.0 may already be in hospitals. This mismatch is especially visible in areas such as cardiac implants and imaging systems, where iterative improvements occur quickly. Devices are not static: Their success depends on clinician training and experience. Outcomes improve as surgeons, radiologists, or nurses gain familiarity, yet HTAs rarely capture this learning curve. In effect, technologies may be undervalued precisely at the stage when providers are still adapting to them. An undervalued older device may cast a shadow over newer, safer, or more effective versions, keeping patients from accessing timely improvements. 

The rise of AI-driven tools has exposed even deeper flaws. Radiology algorithms, for instance, are designed to detect cancers earlier and with fewer false negatives than human readers. Yet HTA frameworks built for drugs struggle with these dynamic technologies. Because AI tools are updated frequently, an HTA completed at one point in time can quickly become obsolete. Moreover, concerns about “black box” algorithms and limited explainability have led agencies to hesitate, further delaying integration into clinical practice. The consequence: Patients may miss out on earlier diagnoses while policymakers wait for perfect evidence. 

These structural mismatches have real consequences. Hospitals often delay investment in new surgical platforms or imaging systems without reimbursement certainty. Smaller innovators may abandon promising technologies because they cannot afford the cost or complexity of HTA submissions, consolidating the market around large incumbents. Meanwhile, patients may go without access to minimally invasive surgeries or advanced diagnostics that could reduce complications, speed recovery, and improve survival. 

Critics argue that HTAs, by focusing narrowly on cost-effectiveness and clinical endpoints, ignore broader system-level benefits. For example, a surgical robot may shorten hospital stays and free up beds. An AI diagnostic may cut downstream costs by catching disease earlier. Yet because these benefits are harder to quantify within standard QALY-based frameworks, they are often excluded. 

Tensions With Patients and Clinicians 

Doctors often view HTAs as undermining their clinical judgment. A physician may believe a patient would benefit from a treatment, only to be overruled by national coverage restrictions. Patients, meanwhile, can feel powerless when denied access to therapies available in other countries or to wealthier individuals able to seek private alternatives abroad. 

This creates a sense of distrust between the public and the health system. Far from appearing as impartial arbiters, HTA agencies are often perceived as faceless bureaucracies making life-or-death decisions based on budgetary math rather than patient need. In public terms, the system is viewed as mechanistic and uncaring, especially when appeals and exemptions (such as the UK’s CDF) deliver only piecemeal relief. The CDF itself has been criticized as “a policy error,” spending over £1.27 billion with limited evidence of benefit and significant side effects for many patients while also being criticized for prioritizing cancer treatments over other needed access. 

Conclusion 

While HTAs are promoted as tools for rational decision-making, their real-world impact is often controversial. By delaying patient access, undervaluing quality of life, centralizing rationing decisions, discouraging innovation, and imposing administrative burdens, HTAs can create more problems than they solve. In single-payer systems, where coverage decisions are binding and alternatives limited, the risks are even greater. For patients facing serious illness, HTAs can represent not a safeguard of fairness, but a barrier to care.