NICE leads global shift: How health equity is influencing drug approvals

Trinity Life Sciences’ Managing Director and Head of Value Center of Excellence, Mary Fletcher-Louis, spoke with Access Insider about how the UK’s National Institute for Health and Care Excellence (NICE) is spearheading a global shift in pharmaceutical decision-making by incorporating health equity considerations into drug submissions.

NICE provides guidance and evidence-based recommendations on emerging treatments and technologies for the National Health Service (NHS). According to its website, NHS is “legally obliged to fund and resource medicines and other treatments recommended by NICE’s technology appraisals.”

The organization, a Health Technology Assessment (HTA) body, evaluates whether a newly developed drug should receive government funding, according to Fletcher-Louis. Trinity Life Sciences partners with life sciences companies to commercialize their products, offering services such as consulting, market research, and analytics. In her role, Fletcher-Louis helps the pharmaceutical industry communicate the value of the drugs that scientists develop.

In a recent study, Fletcher-Louis and her team examined whether HTA agencies in multiple countries were requesting health equity data as part of the submission process. These countries included the UK, Canada, and Australia, and their respective HTA agencies including NICE, CDA-AMC and the Pharmaceutical Benefits Advisory Committee (PBAC). Other HTA agencies that were reviewed include France’s French National Authority for Health, Germany’s Gemeinsame Bundesausschuss, Italy’s Agenzia Italiana del Farmaco, and Spain’s Agencia Española de Medicamentos y Productos Sanitarios.

The findings revealed that NICE (UK) and the HTA agencies in Canada and Australia are actively requesting healthy equity data. The study further investigated whether these agencies were using the data in their decision-making process. Among the agencies, NICE was found to be taking the lead.

Mary Fletcher-Louis, Managing Director and Head of Value Center of Excellence, Trinity Life Sciences

“One of the elements of value that NICE has begun to factor into its decision-making is health equity,” Fletcher-Louis said. “While cost-effectiveness analysis will remain central to NICE’s evaluation methodology, NICE will soon provide guidance around distributional cost-effectiveness analysis (DCEA), a quantitative method for incorporating equity impact assessment into decision making.”

Fletcher-Louis further explained how NICE has developed transparent mechanisms to compare vastly different medical interventions, for example, these methods allow NICE to weigh the benefits of a migraine treatment against a pancreatic cancer drug.

“These are drastically different interventions but through NICE’s processes there is a consistent and transparent way of figuring out which is cost effective. Should we pay for one, for both, or for neither based on their cost effectiveness,” she said.

After developing a drug and demonstrating its efficacy and safety, pharma companies then submit their evidence to HTA agencies to demonstrate the drug’s value for money, according to Fletcher-Louis. NICE and other HTA agencies are exploring how to incorporate a product’s impact on health equity into their assessments.

This has the potential to reshape global market access strategies for pharma companies. While other countries (e.g., Canada and Australia) have requested health equity data, NICE has transparently used this information in its decision-making process, sometimes even recommending drugs for reimbursement despite cost-effectiveness thresholds not being met, when health equity benefits are substantial.

“My team and I are helping the industry to figure out when health equity is relevant, and then to communicate the health-equity related value in a way that is acceptable to health care payers. One of the things we have to really stay on top of is how are HTA organizations like NICE … and others making their decisions? What are the drivers of decision making?” she said.

Fletcher-Louis approaches health equity in three main categories:

• Therapy area-related health equity: This focuses on diseases that disproportionately affect certain populations. For example: “Some illnesses like sickle cell disease disproportionately impact certain populations. So people with African or Caribbean ancestry are more likely to suffer from sickle cell disease and those same populations correlate with reduced access to quality health care.”

• Drug-related health equity: This category examines how a drug itself can correct health inequities in a population. For instance, developing a drug that can be administered in local clinics rather than requiring patients to travel long distances for treatment.

• Health system-related health equity: This relates to pharmaceutical industry investments in health systems of lower- and middle-income countries.

“What we have discovered is that the pharma industry is doing a huge amount of work to try and rectify inequity in health outcomes in these three ways,” she said. “At the same time, organizations like NICE, are working really hard to try and lead the way in making sure that health technology assessment is taking account of whether a drug makes health inequity better or worse.”

However, Fletcher-Louis said research revealed a disconnect within the pharma industry.

“We’ve also found that the teams in industry that are doing the work in health equity aren’t necessarily the ones that are working with NICE to get their drugs paid for.

“What we’re trying to do is raise awareness that NICE cares about health equity and give some extra exposure to the fact that the industry is doing great stuff to meet the health equity needs,” she said.

Additionally, the study analyzed every drug that had been assessed by NICE in 2024, discovering which of these drugs had health equity considerations mentioned in their assessments.

Assessed therapeutics

Out of 68 drug assessments, Fletcher-Louis noted, 42 of them mentioned health equity considerations. More importantly, in three specific cases, health equity issues directly influenced the decision to approve drug access.

“They’re no longer only taking account of traditional cost-effectiveness considerations, but they’re also looking at who suffers from a particular disease,” she explained. “NICE has taken account of whether a disease is more likely to impact certain under-served populations.”

One notable example is Evkeeza, a therapeutic that treats familial hypercholesterolemia. The drug was evaluated using a cost-effective model that allows for transparent comparison between different drugs, according to Fletcher-Louis.

Despite not being cost-effective for all age groups, “the committee at NICE decided that a negative recommendation in young people could be discriminatory, so they recommended it for the full population ... to avoid inequity in relation to age,” she said.

Another case involves Casgevy, a drug to treat β-thalassaemia. Like sickle cell disease, this condition is more likely to hit certain vulnerable populations.

“The committee decided that they would allow a higher cost-effectiveness threshold because this disease disproportionately impacts vulnerable people.” she said.

For therapeutic Vyalev, a treatment used for advanced Parkinson’s disease, Fletcher-Louis said that NICE considered rural accessibility as a key factor in its assessment.

As regulatory agencies increasingly value equity-driven approaches, the pharmaceutical industry must adapt its strategies for presenting evidence to payers.

Health equity: strategies and challenges

Fletcher-Louis shared her insights on ways pharmaceutical companies can strategically incorporate health equity into their submissions, for example, investing in R&D.

“Investing in research and development in the therapy areas that disproportionately impact vulnerable populations is one thing that the industry can do,” Fletcher-Louis said, adding that she’s seeing it for sickle cell disease and β-thalassaemia, both genetic blood disorders.

There’s also growing investment in investigating the drivers of disparities in health outcomes, she noted. For example, Pfizer created the Institute of Translational Equitable Medicine to address equity in health research, such as the difference in breast cancer outcomes between black and white women.

Additionally, Fletcher-Louis noted that companies are focusing on drug features that improve equitable access. For instance, cell and gene therapies may replace treatments that require frequent infusions, which could mean long-distance travel monthly, she explained.

“If you can reduce that to once, then you’re reducing a barrier to access,” she said.

Lastly, engaging in policy work and working with patients and advocacy groups to improve access.

Overall, “we’re seeing a lot happening out of the UK and NICE. We’re seeing Canada as well really at the forefront of driving methodologies around health equity in HTA decision making. I think we’re seeing patient groups increasingly finding their voice and lobbying very effectively and with data.

“It’s happening at the patient level, it’s happening at the level of government agencies, and the industry is doing it. I feel like we’re at a moment where things are coming together in relation to health equity,” Fletcher-Louis said.

NICE recently consulted on proposed methodologies for incorporating manufacturer-submitted health equity data into its decision-making, and its health inequalities modular update is currently in development.

This article was updated on 4/3/25.

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