The work of NICE International
pharmafile | January 17, 2012 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | Kalipso Chalkidou, NICE
NICE, or the National Institute for Health and Clinical Excellence, to give it its full title, is world famous for its work in health technology assessment (HTA).
Established in 1999, NICE is a pioneer of applying clinical and cost effectiveness to medicines, and over the years has expanded its remit to include clinical guidelines and appraisals of surgical procedures and medical devices.
NICE has attracted admiration from many other healthcare payors around the world, just as it has generated controversy with patient groups and pharma companies for its decisions to block access to some treatments.
Less well known is NICE International – an offshoot of the main organisation set up in 2008 which helps other countries adopt HTA methods.
NICE decided to set up this not-for-profit division in response to requests from policymakers in other countries for guidance and help on using health technology assessment (HTA).
An international role
Kalipso Chalkidou, director of NICE International explains the unit’s aims and ways of working with international healthcare systems.
“NICE’s Board agreed to create a new body to deal with the many questions directed to it, and to help policymakers in a defined and systematic way,” she says. “We did this not because of some big-headedness, where we thought we were the best in the world and so should take it on, but because we were being asked these questions. We could either decide to help or not – and we decided to help.
“Most of the countries we work with are lower- to middle-income countries, but we do work with more developed countries such as the US.
“NICE International is not-for-profit and recoups all of its costs from governments or other bodies such as the World Bank who pay for our expenses – we said we would never used [UK] taxpayers money given to NICE.”
Do you ever take funding from pharma?
No, that would be a huge conflict of interest for us and for NICE, given what it does. We would, however, like to have more contact with pharma, especially on the ground in emerging markets, so we can see how they are working in those countries.
Why are people coming to you? Is it because drug prices are high or because these countries are simply too poor to pay for drugs?
That’s a very good question – interestingly, a lot of the questions we receive are about process, rather than technologies – questions like “How do we engage with our stakeholders? – Who are our stakeholders? – How do I seek out/eradicate conflicts of interest in our HTA process? – How do I set up an appeals process?” – and so on.
There is little infrastructure there in many of these countries for such a process – so we get even more fundamental questions like how should the HTA work and should it be a governmental body, or an arm’s length body, and so on.
Obviously some questions do revolve around specific products and their costs, and we will give them advice where we can, on these issues.
So to answer your question, it’s not that they don’t have the money – in fact, they have more money than we do as the mature markets shrink and the emerging markets grow – but it is not ultimately about rationing, but about finding quality and getting value for money.
NICE International has worked in US as well – do you sense much resistance there to your methods?
The US definitely has the infrastructure to create and maintain the necessary technical processes for HTA – but it is lacking the political will, at least on some sides. The political climate is very different to that in the UK or Europe, but there is a new report on universal healthcare coverage by the Institute of Medicine – that will discuss the merits of HTA in the US for insurers – and what drugs should be in and which should be out (coming in October – keep an eye out). We are currently working with the US on the policy side of things but we are certainly not hands on like we are in developing countries – it is not up to me whether the US wants a HTA process, but we are here to give them advice if they need it.”
Should HTA be embedded in regulatory systems – such as having an organisation like NICE within the European Medicines Agency, for instance?
I’m not sure where I stand on this.
There are some existing examples – for instance in Brazil their regulatory body does look at cost when reviewing drugs, though it is not yet a fully integrated HTA process.
I think it is moving towards this in Brazil with its new value-based pricing way of doing things.
In Europe there is definitely room for more conversations between HTA bodies and regulatory bodies, but I don’t think an integrated body like NICE within the EMA would work.
That’s because there are different payers in each country in Europe – some are tax funded like the UK, others use a private insurance system, or a hybrid of both.
Because there is such diversity I think each country should have its own HTA body specific to its needs – it must be up to the payer to decide what drugs are cost effective, rather than a centralised body such as the EMA.
Because what works in Switzerland, for example, could be disastrous in another country such as the UK.
Do you think pharma is still resistant to HTA, or is it being more engaged?
I think it varies from company to company, and sometimes even within each company. There are varying levels of willingness to embrace HTA – obviously some still have concerns, and do not want to see 160 bureaucratic HTA bodies out there.
But at the moment, it is not good enough that poor countries that cannot afford drugs are having to go without, or sell their houses to try and stay alive and pay for drugs.
I think pharma companies are now seeing that but we need to have a systematic process from the industry that will help these poorer countries and patients pay for these drugs.
Pharma must engage, must be more consistent and committed to help funding in these middle-lower income countries and their governments – there needs to be a centralised process for this to happen, rather than having some companies helping and others not.
To talk about pricing again – I know that pharma has big losses looming with patent cliffs and nothing in the pipeline to replace the major revenue it will lose or has already lost.
Companies are now looking to emerging markets to help offset these losses – but there is a conflict of interest.
Pharma will look to work with HTA authorities and governments now for a short-term gain, but perhaps not stay around for the long-term, which will not help the poor in these countries – so pharma needs to be aware of that.
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