Why NICE’s Lack of Data Transparency Undermines Priority Setting in Low- and Middle- Income Countries

As low- and middle-income countries (LMICs) seek to deliver universal health coverage (UHC), they are finding it necessary to prioritize which services to provide, to whom, and at what cost. Health technology assessment (HTA) is increasingly being used to help identify which treatments provide the best value for money but as the capacity for conducting HTA is limited in LMICs, policy makers often rely upon evidence from established international HTA agencies to inform their decisions.

One of the most prestigious HTA agencies is the National Institute for Health and Care Excellence (NICE) in England, which has gained its reputation through highly vetted, transparent, and robust processes and recommendations. For LMICs that don’t have the capacity and/or the expertise to generate this evidence for themselves, NICE appraisals offer a wealth of information on the predicted clinical benefit, safety concerns, likely costs, and the cost-effectiveness of new treatments. Whilst other HTA agencies also have strong processes, NICE publishes their recommendations in English which has an added benefit for LMICs. Additionally, NICE documents relay complex information in an approachable layman language that is easier to comprehend. This is beneficial for LMICs as it helps to build awareness and understanding of the HTA process, methods and contextualises the results.

However, a recent study has found that there is an increasing trend towards redaction of critical data points in HTA documentation. Over 80 percent of NICE appraisals from the past 20 years redacted data such as costs, clinical outcomes, incremental quality adjusted life years (QALYs) and adverse events. This information is therefore not accessible to policy makers in LMICs, who rely on such data to guide their decision making.

Such redactions have a very negative impact for priority setting decisions in LMICs for at least three reasons.

1. NICE’s is redacting documents that are an unmatched source of public information for LMICs

For LMICs that currently do not have an institutionalised HTA process, data for national decision making is not produced by the local HTA agency, nor are they obtained from formal submissions by manufacturers but from information in the public domain.

The NICE website centralises HTA evidence, providing access to information that is often behind publisher paywalls or is otherwise not easily accessible. This significantly reduces the time and resources stakeholders in LMICs need to spend aggregating information independently from primary sources.  

If this information is redacted, then it will take LMICs much longer to collate and review the necessary evidence for each intervention which might not be feasible in the timescales they have. For countries in the process of updating their health benefits packages, there is insufficient time and capacity to gather all the necessary evidence to assess each intervention from scratch. This was the case in the Philippines, and so international estimates were used to speed up the process of getting evidence into priority setting as it was found that there was insufficient local data to inform estimates of cost-effectiveness and there wasn’t enough time to collate data.

LMICs also benefit from the commentary and analysis NICE guidelines provide on the decision making process. Redacting the evidence reduces the transparency in decision making, and makes it more difficult to understand committee’s conclusions and decisions. This can be a problem for LMICs who are tasked with interpreting how recommendations from a High Income Country (HIC) setting will apply to their jurisdiction. LMICs may need to make different decisions as they are operating with fewer resources therefore there is a need to understand the data informing the recommendations, however data redaction makes it impossible to scrutinise these decisions forcing LMICs to only rely on the committee’s conclusions.

In addition, showing the weighing of evidence and elaborating on what was considered important is illuminating and essential for building capacity in countries that are just setting up their HTA processes.

2. Redacted data in NICE appraisals makes it more difficult for LMICs to assess the evidence and develop their own recommendations

Positive recommendations by NICE creates pressure on LMICs to approve treatments, especially in countries with higher levels of health coverage as they seek to incorporate new treatments into their benefit packages. Yet, despite having less ability to pay and smaller budgets for health, LMICs often pay a similar list price to HICs for new medicines, and occasionally pay even more. Policy makers in several LMICs often use price data from countries like the UK to inform price regulation and price negotiations but in doing so they face a conundrum: how to approach medicines that were only considered to be cost-effective by NICE after substantial confidential discounts. In other words, how to reference UK prices if the only available information is list prices that they know are much higher than the real prices paid.

For example, nivolumab is an immunotherapy that was found to be cost-effective by NICE in 2021 and has a list price of GBP £1,097 for 100 mg in the UK (USD 1,443), but the decision to recommend nivolumab was made based on a confidential price that is unknown but definitely much lower than the stated list price. LMICs pay a price similar to the UK list price, Colombia and Brazil pay USD 1,318 and USD 1,679 respectively for the same unit, and have to make their recommendation decisions knowing that they are not referencing real prices and are paying prices as high, or maybe even higher, than the publicly listed price in the UK.  

NICE submissions are also increasingly redacting clinical data which is detrimental for assessments and decisions in LMICs. Understanding the potential clinical benefit of an intervention is essential for payers to determine whether they believe the treatment provides sufficient value. Whilst there is a stronger argument for redacting costs often do not translate to other jurisdictions, the clinical benefits are more likely to be generalisable and are an important consideration in the decision to recommend. Publishing the clinical data included in an HTA assessment assists stakeholders in LMICs to generalise the evidence to the local context, such as comparing the baseline characteristics of patients in trials with local populations.

Finally, redacting data can also remove the context from the committee’s comments and criticisms, making it more difficult to interpret the recommendation or understand the areas of uncertainty which can compromise the decision making for LMICs using this evidence.

3. Redacting data reduces transparency in priority setting systems, undermining the institutionalization of HTA in low- and middle- income countries

Since its creation in 1999, NICE has had an internationally renowned reputation as a rigorous and transparent institution, setting the benchmark for other HTA agencies. LMICs in the burgeoning process of institutionalizing HTA have tried to emulate NICE in terms of setting standards and best practices.

However, with the recent trend towards redaction there is increasingly a lessening in transparency in NICE Technology Appraisal documents which negatively impacts users of HTA evidence in LMICs potentially leading to mistrust in priority setting systems. The increase in redaction also sets a bad precedent for the institutionalisation of HTA in LMICs.

Conclusion

For many years NICE has been the gold standard in the global HTA ecosystem for methods, standards, and best practices. The recommendations made by NICE inform a wide range of decisions in LMICs who rely on NICE as the primary source of evidence-based decision making. Data redaction is increasing opacity in interpreting NICE recommendations, which could harm priority setting decisions in LMICs. We ask for NICE to reconsider the permissible level of redaction in their appraisals in order to benefit LMICs and retain its standing as a respected, reference agency for LMICs to follow.