Patient involvement at NICE: In whose interest is it anyway?

NICE new blog

The National Institute for Health and Care Excellence (NICE) released a new blog on how NICE manages the potential interests of patient experts in August 2023. Leela Barham looks at the backstory that prompted this blog and adds some wider context to the debate.

NICE management of conflicts of interest from patient involvement

On 8th January, Jacoline Bouvy, programme director of medicines evaluation at NICE, published a blog that looks at how NICE manages potential conflicts of interest of patient experts. That blog focuses on the added value that hearing from those that use services, carers, and the public brings to NICE committee’s work to produce guidance on the use of new medicines. 

It also points out that there is often pressure on NICE from those with an interest in what those pieces of guidance say, which is managed by “robust processes” including policy for declaring and managing interests, financial, and non-financial. That applies just as much to patient groups as it does to others, including manufacturers of the new medicine. 

It’s worth noting too that there can be people involved in NICE appraisals who wear multiple hats; some clinicians can have some responsibilities for managing budgets too, some patient organisations might receive government funding for other activities. That’s not always clear. (Hat tip to a patient group chief exec who reminded me of that). 

Observer investigation prompted NICE blog

But why have Jacoline and NICE produced the blog now? NICE has involved patients – be that individual patients or their representative groups – since it began its work in 1999 and it’s not news that they have an interest when NICE decides whether treatments will be made available on the NHS. Similarly, it’s not news that pharmaceutical companies have funded patient groups either.

It’s not referenced, but it’s not a stretch to think that it has come as a result of an Observer investigation that led with the headline on 22ng July, “Revealed: drug firms funding UK patient groups that lobby for NHS approval of medicines.” 

The investigation has looked at 173 appraisals from NICE since April 2021. In 138 of those, the Observer says, patient groups had a financial link to the manufacturer of the new treatment or have received funding from them since the appraisal. It is perhaps more of a surprise that it’s not all of them. It can be hard to do the work of a patient group on goodwill alone, although some do, and more power to them. 

The Observer adds that the interests of the patient groups in the 138 appraisals were not all clearly disclosed in NICE transparency documents. Yet, it’s worth noting, just as the NICE blog does, that even if declarations are improved that might not result in the exclusion of the patient expert from the appraisal.

The Observer piece is just the most recent to look into the issue. 

Calls for reform to NICE conflict of interest processes

The Observer article includes quotes from Professor Martin McKee, a public health expert and former president of the British Medical Association, suggesting that industry funding of patient groups has been a concern for a long time and that the way conflicts are managed isn’t “fit for purpose”. 

A call is made for the government to discuss how to solve the problem of “a massive conflict of interest” by former NICE staffer Dr Leeza Osipenko. 

Head of investigations at Transparency International UK, Steve Goodrich, is quoted as saying that payments raised “serious questions as to whose interests” patient groups were representing in NICE appraisals. He, too, adds his voice to a call for reform, suggesting that transparency is not always enough, and that “there needs to be a fundamental rethink about the resourcing of patient groups to ensure they don’t just act as puppets for the industry.”

The Observer article also adds that most appraisals have input from one or two patient groups. They suggest that this means that those with financial interests can be the only ones providing a patient voice to NICE committees.

No change to NICE policy

The NICE blog addresses a practical point raised in the Observer article; the current policy at NICE is that patient groups declare interests for the latest 12-month period. NICE says it’s looked at this, but that “if a financial interest has ceased to be relevant to the appraisal and ceased to be a relevant interest more than 12 months ago, it is unlikely that, if declared, it would result in a decision to exclude the person from participating in the meeting.”

It is also pointing out that patient groups and experts add value to decision-making; it’s better with them than without. 

So, it seems that NICE, at the moment at least, has no plans for a radical change in their conflict of interest policy and how it’s implemented. 

Wider efforts for transparency

NICE’s blog also points to wider mechanisms to allow anyone to find out who funds who, citing Disclosure UK, a database that is accessible to anyone who wants to find out about funding from pharmaceutical companies to healthcare professionals, healthcare organisations, and in recent years, other stakeholders, too. 

NICE says that Disclosure UK has increased transparency of financial payments made to patient groups. Yet, it doesn’t note that all Disclosure UK results are in a central list of web links. Companies can choose whether to add a link that will lead to individual company websites and often another link to find patient organisation funding. It’s hard, then, to know - without a lot of time and more number crunching - how much funding a specific company gives to all the patient organisations they work with.

Not mentioned by NICE, but if anyone wants to know just how much each patient organisation receives in funding from the industry, then they can work the other way around: people can look at charity financial accounts, and charity rules require those patient organisations who are charities to report their funding sources to the charity commission. (Another hat tip to the patient group CEO for this point, too).

Yet more work is needed to see if there would be any patient groups not on the Disclosure UK list or who don’t receive industry funding and, hence, free from any perception of conflict. These would, presumably, be the ideal patient groups to hear from; that is, if they exist. 

But credit where credit is due: this year is the first year that Disclosure UK includes links to company data on funding members of the public. The public in this case includes patients and journalists (nice to see that there’s acknowledgement of the interests of the media, as well). 

Does patient involvement make any difference anyway?

The Observer and NICE’s blog seem to be focused on perception; that’s why it’s a tricky area. It’s hard to argue against more transparency, but that would not necessarily equal exclusion and, if it did, it would, as NICE’s blog points out, lead to inconsistent treatment of patient groups versus companies. 

In any case, what would a patient group have said if it had not received funding from the industry? That is something we can’t know.

It’s also difficult to know what difference patient involvement at NICE – or, indeed, any HTA agency; NICE is not alone in proactively seeking out patients' perspectives when they make decisions about new medicines – makes. 

There’s quite a bit of research that has tried to find out what difference patient involvement makes to HTA decision-making, but has struggled to answer that beyond some warm words. As just one example, NICE staffers with responsibility for public and patient involvement have looked at the evolution of the impact of patient input in HTAs at NICE in an article published in 2021. They concluded that “the impact of patient input is not necessarily explicit in changing a recommendation, but provides context, reassurance, and new information to the committee decision-making process in HTAs.” 

Some research suggests that patient involvement can achieve little in HTA when the bigger pieces of the evidence puzzle are unconvincing. That makes intuitive sense.

(As an aside, there seems to be little that looks at the cost of patient involvement. It probably would illustrate that it comes at a high cost and it would take a brave person to ask if it’s really worth it).

Targeting patient involvement?

It may be that, for everyone’s benefit, patient involvement should become refocused to where it adds the most value to appraisals, avoiding wasted effort from patient groups whose input won’t change anything, freeing up NICE committee and staffers’ time (although. would we need so many patient involvement-focused staff at NICE?). 

If patient involvement were focused on where it can make a difference, it would follow also that conflict of interest processes and the efforts to implement them effectively would be targeted to where the biggest risk of conflict of interest is.

4 September, 2023