Why Real World Evidence Matters: Lessons from the NHS 10-Year Plan

deanjames art
Sep 8
4 min read

Updated: Oct 6

In modern healthcare, every new medicine or device faces a crucial question: is it worth it? With limited budgets, growing patient needs, and rapid innovation, health systems must weigh the benefits of new technologies against their costs. This is where Real World Evidence (RWE) comes in—a tool that supports decisions and ensures taxpayer money is spent wisely.

The NHS 10-Year Plan in the UK is a powerful example. It prioritises delivering high-quality care in a financially sustainable way. For innovators, that means demonstrating not just that their treatment works in theory, but that it delivers value in practice.

The Role of NICE and HTAs

In the UK, the National Institute for Health and Care Excellence (NICE) plays a central role in assessing whether a medicine or medical device should be adopted by the NHS. They do this through a Health Technology Assessment (HTA)—a systematic evaluation of the clinical effectiveness, safety, and, crucially, the cost-effectiveness of a new technology.

A key part of this assessment is something called QALY—the Quality-Adjusted Life Year.

What is a QALY?

A QALY is a way of measuring health outcomes by combining both the quantity and the quality of life that a treatment provides.

One year of perfect health = 1 QALY.
One year with illness or reduced quality of life = less than 1 QALY (e.g., 0.7).
Treatments are assessed based on how many QALYs they add compared to existing care.

For example, if a cancer drug extends life by two years but those years are lived at 0.8 quality (because of side effects), that’s 1.6 QALYs. NICE then looks at the cost of achieving those QALYs. If the treatment costs £50,000, the cost per QALY is £31,250.

This calculation allows NICE to answer the tough question: is this medicine or device worth taxpayers’ hard-earned cash?

Why Real World Evidence Changes the Game

Clinical trials are vital, but they have limitations. They take place under controlled conditions, often with carefully selected patient groups. Real life is messier. Patients may be older, have multiple health conditions, or respond differently to treatment than trial participants.

That’s where Real World Evidence (RWE) comes in. By collecting and analysing data from real patients in everyday healthcare settings, we can see how treatments truly perform. This is sometimes called moving from Real World Experience (RWE-X) to Real World Evidence (RWE-V).

Key Questions Addressed by RWE

Does the medicine deliver the same benefits outside the trial setting?
Are side effects more or less common in real populations?
Does the treatment reduce hospital visits, GP appointments, or other healthcare costs?

This evidence can be fed back into the NICE HTA process, strengthening—or sometimes challenging—the original assumptions.

From Data to Decisions

For innovators, the journey doesn’t end once regulatory approval is granted. Regulators ask: is it safe and effective? Health authorities ask: is it affordable and valuable?

By proactively gathering Real World Evidence, companies can:

Support faster adoption by proving ongoing value.
Build trust with clinicians and patients by demonstrating real impact.
Respond to health authority reviews with robust, credible data.

And for the NHS (or any health system), this process is equally valuable. It ensures that investments in new medicines and devices are guided not only by projections but by evidence grounded in reality.

The Global Perspective

Although this example comes from the NHS, the principle applies worldwide. Every country faces the same fundamental challenge: limited budgets and unlimited needs. Whether it’s Medicare in the US, public insurance systems in Europe, or ministries of health in emerging economies, the demand for proof of value is universal.

Real World Scientists and Your Enquiry

At Real World Scientists (RWSci), we help innovators, policymakers, and health systems bridge this gap. We design studies, collect and interpret data, and turn real-world experience into powerful evidence. For those developing medicines or devices, this means more than compliance—it means building a compelling case that your innovation truly makes a difference.

Because ultimately, the question is not just: Does it work? The question is: Is it worth it—for patients, for clinicians, and for the public who fund it?

The Importance of Demonstrating Real-World Value

In today's healthcare landscape, demonstrating real-world value is essential. It goes beyond clinical efficacy; it encompasses the overall impact on patient outcomes and healthcare systems. By focusing on real-world evidence, companies can ensure that their innovations meet the needs of patients and healthcare providers alike.

Engaging with Stakeholders

Engaging with stakeholders early in the process can help identify the key outcomes that matter most. This collaboration can lead to more relevant studies and data collection efforts. By understanding the perspectives of patients, clinicians, and health authorities, innovators can tailor their approaches to address specific concerns and priorities.

The Future of Healthcare Innovation

As we look to the future, the integration of real-world evidence into the healthcare decision-making process will only grow. With advancements in data collection and analysis, we can expect to see more robust evidence supporting the value of new treatments. This shift will ultimately lead to better patient outcomes and more efficient healthcare systems.

Final Thought

The NHS 10-Year Plan sets out an ambitious vision for care that is both innovative and sustainable. Real World Evidence is the backbone of that vision, ensuring that new treatments are not only effective in theory but valuable in practice.

So, if you are developing a new medicine or device, don’t wait until NICE or your health authority asks for the data. Start with the enquiry now: How can we demonstrate real-world value?