UK government refuses to discuss ‘alarming’ NICE data redactions

The UK government has brushed off a question from parliament about data redactions by NICE, a body that evaluates whether drugs and medical devices are sufficiently cost-effective to merit being provided by the UK National Health Service.

CLINICAL DATA FREQUENTLY REDACTED

Earlier this month, a study had warned that “data redaction in NICE appraisals is alarming in volume and context.”

Reviewing 418 evaluations spanning two decades, study author Leeza Osipenko found that clinical data (excluding adverse events) had been redacted in 66% of NICE appraisals, and that adverse events data had been redacted in 31% of appraisals. She noted that while “NICE processes have been rightly praised for their high level of transparency… over the years, NICE has taken a lenient position on data redaction practices.”

Pointing to the example of Germany, where transparency of appraisal documents is enshrined in law, Osipenko argued that:

“The German example clearly illustrates that industry complies with transparency if public agencies enforce it. Germany is a bigger pharmaceutical market than the UK and traditionally characterised by an earlier launch of pharmaceutical products compared with the UK thus NICE can hardly argue that protection of industry’s commercial interests jeopardises market access… Unfortunately, NICE is not following the German example.”

PARLIAMENTARY QUESTION BRUSHED OFF

Member of Parliament Sharon Hodgson challenged the government over these redactions.

Highlighting the study, she asked “what steps [the government] plans to take to improve transparency of the data that underpins NICE's conclusions”.

In a written response, Minister of State for Health Edward Argar brushed off the question with a boilerplate answer:

“NICE is committed to ensuring its processes for health technology evaluation are as transparent as possible and considers it essential that evidence on which its committees’ decisions are based is made available to stakeholders and the public.”

Till Bruckner, founder of TranspariMED, said:

“It is disappointing that the government has missed this opportunity to enter into a constructive dialogue on an issue that is important to patients, especially as there is a lot of potential middle ground in this debate. For example, NICE could consider un-redacting most clinical trial data after an embargo period, which would benefit patients without posing any danger to commercial confidentiality.”

Update 01 November 2021: A NICE spokesperson told Pink Sheet that:

“For NICE to address the unredaction of ‘all documents underpinning past decisions on the NICE website’ would require considerable resource and advanced digital solutions developed and employed. This is a significant challenge, one which is not novel to NICE, and is experienced by other related regulatory bodies.”

In 2020, a report by the charity HealthWatch UK found that NICE had redacted survival data from clinical trials of a breast cancer treatment, even though its counterparts in Germany and France made similar data publicly available.