As the end of the 2005-2010 Parliament approaches, and the political classes gear themselves up for the general election, each of the political parties’ health teams will be looking to prove that they have the big ideas to take the NHS forward in a period of tight public finance but escalating public expectation.
In this short series of opinion pieces, Health Mandate’s team of expert health policy consultants look at some of the big issues that will shape the political and the NHS landscape in the next parliament. Today’s piece sees Rachel Rowson examine the future in access to treatments.
Access to treatments what is the right prescription?
Who gets health care and how much they receive is both a moral and practical challenge to society and of personal interest to us all. As the NHS cannot and will not afford all treatments for all patients, hard decisions must be made to determine who will get access to treatments and who will have their access denied.
The National Institute for Health and Clinical Excellence (NICE) was first proposed by the new Labour government in its 1997 White Paper, The New NHS and was formally established in 1999. NICE was created as part of the Government’s strategy to address “unacceptable variations in performance and practice” and to remove “the lottery in care with patients being denied treatment available in neighbouring areas”.
Ten years on from the establishment of NICE and the health world has changed dramatically. So, have we now reached a point where the drug rationing process is in need of an urgent overhaul to make it relevant for the next decade?
Has NICE done a good job?
NICE has been given one of the hardest jobs in the healthcare world, rationing access to treatments. It has remained a controversial body from day one and continues to be a source of contention in the UK media because access – or lack of access – to treatments is a highly emotive topic. No one wants to find themselves or their loved ones unable to get the treatment that they need if they become ill. But internationally NICE has a reputation as the ‘gold-standard’ and the template to be emulated in health technology assessment. So is NICE a body to be loved or loathed?
The introduction of NICE meant that for the first time a national decision making framework was put in place to make robust and rational decisions about what the country would pay for, based on clinical and cost effectiveness. Providing guidance for the NHS on what treatments should and shouldn’t be routinely available reduced the postcode lottery and gave certainty to patients about what they could expect from their treatment. Also, importantly, NICE has played a role in creating greater certainty in PCT financial planning. All of these factors have improved patient experience and certainty for the NHS.
But, despite these great leaps forward the media and patients have been quick to uncover the flaws and drawbacks in the process. Guidance can often be slow and published a long time after a drug has its safety licence leading to a period of ‘NICE blight’. There are methodological problems with the appraisal process. The affordability of a treatment is not taken into account and quality of life is not given enough weight in the decision making process. Also, despite the fact that NICE technology appraisals are mandatory, guidance has not been implemented universally across the NHS. On top of all of this, the NICE process is making our prescribing practices increasingly divergent from the rest of Europe.
NICE Plus – what might Labour do next?
Labour has undoubtedly improved the system of access to treatments through the NICE process, but it is unlikely that the electorate will give them credit for this. NICE has not remained static in the last ten years and has in fact shown a great deal of flexibility. To tackle some of its challenges two significant changes have been made in the process which point towards where the Labour Party is headed in access to treatments.
Firstly, patient access schemes (when the pharmaceutical company picks up the tab for some of the cost of the treatment) are becoming much more common. This has resulted in some treatments which previously would have been rejected by NICE on the grounds of cost effectiveness being made available in the NHS. But as the schemes must be proposed by the pharmaceutical company there is no consistency in approach and no knowing whether one might be offered. Also some of these systems can be a bureaucratic burden on the NHS which is only now being taken into consideration when a scheme is proposed.
Secondly, social value judgements are becoming more important in the decision making process. We are finally making decisions about what we as a society really think about healthcare and how it should be distributed; who should be given – and in what circumstances – more than their fair share of healthcare. Following substantial lobbying by patient groups and the media in response to the top-up review, NICE implemented a new set of guidance for treatments at end-of-life in small patient populations. This is the first time where the NICE decision making framework has been changed for patients in a particular set of circumstances.
Labour seems keen that NICE continues as it is. The independence of NICE will remain a fundamental principle, but as the Department of Health is becoming more involved in the process it is likely that politicians will have an increasing role in the process. Flexibility and responsiveness to public desires will increasingly be added into how decisions are made and the evolution of the process is likely to happen at an increasing pace. However the fundamental principles of clinical and cost effectiveness will remain.
The shift from cost to value
The rhetoric of the Conservative health team on access to treatments is fairly damning of the NICE process, although they are supportive of what NICE is trying to achieve. According to their thinking, patients in England are denied treatments which are readily available elsewhere in Europe and the rest of the world; NICE and drug pricing structures don’t work together to promote value; the NICE technology appraisal process is not transparent, and is methodologically flawed; and the current system introduces unacceptable delays in access. The Conservatives are, therefore, hoping that their widely touted value based pricing model will be able to fix these failings.
At Conservative Spring Conference Andrew Lansley said: “we will reform the way drugs are priced so that drug companies will be paid according to the value that a drug offers to patients and to society, rather than the current system where NICE rules drugs out because the cost is too high – and the patients suffer.”
Quick to criticise and point out the flaws of the NICE technology appraisal process, the Conservatives are very reluctant to give away details about what their value based pricing system would actually look like. What is clear is that a value based pricing system would combine drug pricing and decisions about access, but it is becoming increasingly apparent that these are, by necessity, only crude designs because they have no civil service support. They have said that any value based pricing system will not be implemented until at least 2014, so a whole parliament will have passed before this becomes a reality. This presents a significant challenge to the next parliament in how exactly the transition between the NICE technology appraisal process and value based pricing will be achieved.
It is likely that their system will be even more complicated than the current NICE technology appraisal process, combining health technology assessment (similar to the current NICE process) and considering this alongside a measure of the innovation that a new drug provides and the number of patients that will benefit from it. The main change and the diametric shift will be that under this system the price that the NHS will be prepared to pay for a treatment will be established at the end of this process and then it will be down to the drug manufacturer whether they are happy to meet this expectation.
There are many questions about this system where answers are not yet available. How do we measure value? How long will the whole process take?
What is the right prescription?
There are strong reasons to consider value rather than cost more explicitly in decisions about whether a treatment should be made routinely available on the NHS.
What is going to be crucial in the future is working out what we as a society want from our health care system. If we work with the assumption that the NHS is here to stay and that taxation, and therefore the NHS budget, is going to stay largely the same in the future then we are going to have to start making some hard choices so that people know what to expect from the NHS and it is not a shock when people come to access services and are told that the NHS won’t fund them.
Rationing of treatments through the NICE process and value based pricing both have their advantages and drawbacks. In reality value based pricing cannot be implemented swiftly and the landscape is likely to be very different in 2014 when it could become a reality. We need to work with the framework that we have and make NICE stronger and give it the freedom to take a more holistic approach to decision making. If this is done effectively then the principles of NICE and value based pricing will converge and ultimately we will end up with a hybrid of both systems.
The policy trend suggests that the next big development in access to treatments will be bringing coherence to patient access schemes. This will reduce the burden on the NHS, make it easier to compare treatments in the NICE framework and make decisions more transparent. If this is done effectively then we will see a move towards a value based model which could act as a bridge towards a more explicit value based pricing system as proposed by the Conservatives.
Fundamentally, as a society we need to think long and hard about what is it that we really want our healthcare system to provide. We need to start coming to terms with the situation that if we are unwilling to tolerate a significant rise in taxation, and therefore deciding as a society that we want to put more money into the healthcare system, then we can’t have everything.