Annual Question Time - 'Health Technology Assessments: Opportunity or threat?'

Health technology assessments (HTAs) give guidance on the use of new and existing medicines, treatments and procedures within the NHS. Their aim is to ensure that the best and most cost-effective medicines reach the most appropriate patients. This is an aim shared with industry, but is it being achieved?

The PM Society’s annual Question Time set out to examine the effect of HTAs on the industry. Chaired by Claire Gillis, the meeting brought together a panel of experts to discuss the impact of HTAs, including their effect on patients and patients’ access to medicines, and whether the HTA should become an integral part of market access strategy within the industry.

From left to right: Clive Jackson, Claire Gillis, Lee Tomkins, Richard Barker

Getting it right
Claire Gillis of the WG Group firmly believes that HTAs are here to stay. Pharmaceutical and service companies must therefore optimise the complete HTA process, right through to implementation of NICE guidance. If companies do not do this, their brand will be dead in the water, in Claire’s view. Success depends on how the HTA submission is tackled. Getting the submission to its most positive point requires an integrated team. It is currently often the case that the ‘Health Outcomes’ team and the marketing team never get to meet until a crisis point is reached. What is needed is the right data in the right format at the right time, delivered to the right people. This requires everyone within the company to be aligned and to have the right value proposition, with a project plan, and accountability and responsibility resting with one person. The HTA submission is basically another piece of communication strategy and must be recognised as such.

In addition, all stakeholders must be actively involved in the process, including internal key opinion leaders, the parent company (particularly if it is based overseas), external KOLs, indeed anyone who influences the submission (patients, clinicians, non-clinical KOLs, and heath economists). What is also needed is a ‘shadow’ NICE submission panel to ratify the value proposition.

In Claire Gillis’s view, the current situation is very confusing for the NHS (the industry’s customers) because there are so many conflicting messages from NICE and the SMC. However, this means there is an opportunity for industry to provide clarity through all the disconnects in the market place and to highlight the clear messages that will optimise the patient experience.



The HTA process
In the view of Clive Jackson of the National Prescribing Centre (NPC) HTAs will continue to be an integral part of the NHS. HTA/NICE guidance is crucial and it should therefore be appropriate, easy to understand, and credible. For Clive Jackson, the fundamental take-home message is that the HTA is a multi-step process, not just the piece of paper published at the end of the process. It is vital for the industry to understand how the whole HTA process can be influenced throughout its design and implementation within the NHS.

The first step in the process is horizon scanning. It is vital to know what is in the pipeline 2-3 years out. At that point, early assessments must be made in relation to the information that should be provided to the NHS to allow them to plan ahead. Once that initial assessment has been made, topics can be prioritised.

Next comes the critical appraisal and the evidence-based outputs, whether as formal guidance (from NICE etc.) or non-NICE support information. The big issue then is how a locality takes that information and uses it. Area Prescribing Committees (APCs) are important - how APCs interpret and act on information is crucial to uptake.

The impact of HTAs on uptake depends on a number of things, including timing, clarity and quality of the evidence base. Effective information is vital, especially in the early stages, as is linkage to existing priorities (national and local), plus expertise and experience in interpreting and implementing information and guidance. Particularly important is the nature of the professional interaction on a one-to-one basis with the patient. Concordance is crucial – i.e. getting patients’ ownership.

Feedback and monitoring processes are also important – the NHS is currently not good at monitoring how guidance is being implemented. Finally, effective advance warning of what will be in the future NICE guidance programme is important, as this usually has service delivery implications as well as a budgetary impact.

The NPC’s work is an important part of the HTA process. High-quality information is supplied by the NPC to support decision-making and planning, so there is more chance of an early uptake of NICE guidance once it emerges. The NHS is very bad at advance consideration of service configuration issues, i.e. the delivery implications of guidance. The infrastructure must be in place to get the best out of the guidance.

Enhancing the impact of HTAs requires:

• Better and earlier information for the critical appraisal process
• Better quality and depth of information
• Better dissemination, promotion and support for implementation (the NPC is producing an update of its advice on how to develop effective Area Prescribing Committees, which will be available by end May 2007)
• Develop APCs and their members so they know what information is available (from NHS and industry) and how to use it appropriately to support effective decision making
• Better commissioning (practice-based commissioning groups tend not to be aware of the HTA process and their understanding needs to be improved
• Better monitoring and feedback
• More patient involvement - concordance (a fraternal or peer to peer process, as opposed to compliance which is paternal) is a crucial issue in terms of maximising the potential of the HTA implementation.

As the NHS is coming through a radical shake-up now is a good time to assess how the industry can best influence PCTs, many of which are still in reorganisational flux.

Key to this process is the information APCs have access to. Well recognised high-quality sources of information, presented in the right way, will reduce variability in the critical appraisal of the same evidence.

Partnership between NHS and the industry is important and industry should look closely at how this could be improved. New DoH guidance is to be issued shortly that will reinforce the importance of NHS partnerships with the industry to provide maximum benefit to patients.

The implementation of NICE guidance requires a range of different skills and expertise, some of which the NHS does not have. Industry has a whole range of expertise that could be very valuable in supporting the NHS in implementing HTAs, and communicating the outputs to the clinical ‘coal face’.

Medicines constitute the single biggest tranche of expenditure for the NHS next to staff, so medicines are a good place to start in establishing this type of partnership.

In supporting service configuration planning we can use acute stroke as an example. Getting the best out of a treatment means starting from the patient needing to call 999 in the case of suspected stroke, through differential diagnosis between ischaemic and haemorrhagic stroke, administration of the right drug in the appropriate form at the right time, and then recovery. Unless all these steps are in place, even though the drug may be excellent there is no point in the NHS investing in it. Advance planning is therefore crucial in minimising the time required to get these steps in place so that at launch everything is prepared.



The patient perspective
Lee Tomkins (Chairman of the Migraine Action Association) has approached a cross-section of patient groups of various sizes and discovered that 50% are completely unaware that HTAs exist. Only 10% of groups have heard of the HTA and understand what it is for. Some have been approached by pharma companies for assistance with HTA submissions, but did not fully understand why. Others spent time helping put in a submission but were disappointed to find that they were not part of the overall consideration.

When Lee Tomkins made these groups aware of the aims of HTAs they were however very interested, particularly when they realised that the HTA has a much broader impact on impact on patient access.

What is needed, in Lee Tomkins’ view, is the right balance between innovation, access to medicines, and supporting healthcare systems to pay for these medicines. Patient groups find the concept of the HTA interesting but the process itself is not patient friendly. It must be remembered that patients (and consumers) are important stakeholders who are avid for information. The key messages coming back from patient groups is that industry does not understand what is happening on the ground and that patient groups could help industry in this respect. There is a genuine need for patients to understand exactly what HTAs mean for them. The processes must therefore be simplified so that patients understand them, and therefore contribute to them.



The ABPI perspective
For Richard Barker, Director General of the ABPI, HTAs are an explosive issue at the heart of the debate on the role of the pharmaceutical industry within a reformed NHS. Whether an opportunity or threat, HTAs are a fact of life, and as such the industry must get used to them. But how should industry shape the process so that it sends the right signals, and encourages the right and most valuable innovations? Once NICE and the SMC have made their decisions how does industry embed high-value medicines in medical practice in the UK?

Speaking from the point of view of the ABPI and the industry as a whole rather than a company-specific perspective, Richard Barker stressed that the HTA is fundamental to achieving market access in the 21st century – not just in the UK but increasingly across the world. The HTA changes fundamentally what the industry has to prove. Formerly the industry only had to prove that a medicine was different and better than placebo. Now it has to prove that it delivers value at the level of the prescriber, PCTs and government.

However the HTA process is not yet a precise science and may never be so – as evidenced by the error bars in the charts in a NICE evaluation. The HTA process has the potential to disincentivise innovation because it does not recognise the value of the step-wise innovation that the industry constantly makes. ‘First of kind’ alone are not enough - we also need successive improvements, and these need to be recognised and rewarded. Self-evidently the HTA process affects patient access. Patients are at the heart of these fundamentally political decisions. Richard Barker does not suggest that NICE is politically motivated or influenced but in view of the impact of a few people on the availability of certain medicines – on herceptin or bowel cancer for example – imagine the effect if two or three million people made their views known on access to medicines. Like Claire Gillis, Richard Barker believes that the HTA represents a communications challenge and whatever is submitted to NICE needs to be at the heart of the marketing message. However the good practice guidance issued in December 2006 must not be forgotten. It is not acceptable to cite a lack of NICE guidance as a reason for not providing a treatment – as some PCTs have done.

The HTA should be an integral part of market access strategy. It is pivotal and worth the company’s best interdisciplinary thinking, since the HTA is being increasingly factored in to a whole range of issues that the industry must take seriously. The HTA therefore means a fundamental rethink on the part of industry as to the nature of the marketing task. Historically this has been persuading a prescriber of the clinical value of a medicine. Now it is an account management process, requiring dialogue with everyone from the Prime Minister, the cabinet and ministers, right the way through to PCTs, commissioning and ultimately the prescriber.



Talking points
On the question of evidence-based medicine, Andrew Hobbs (Pope Woodhead) pointed out that evidence does not really exist for chronic medicines and asked about the way forward for the industry with regard to innovative pricing structures and mechanisms for collecting long-term evidence. Richard Barker believes that evidence on use of medicines should be collected in day-to-day practice - evidence is otherwise only available from clinical trials in rather atypical groups. There is genuine excitement in the industry about the prospect of Connecting for Health helping to collect that information. If we believe in the value for money that medicines deliver then it is in the industry’s interest to prove that value over time in a normal patient population. In Richard Barker’s view, however, it is premature to talk about what is done with that information with regard to price.

On pricing, Clive Jackson believes that the earlier a pricing decision is made, the greater the margin for error. Ante-launch pricing would be useful, in an ideal world, but in not practical. In his view, industry needs to look at the impact and benefit the medicine will bring to patient care and patient outcome, as well as efficiency of the service. The whole thrust of the recent White Paper was moving care from secondary to primary. This is a major opportunity for the pharmaceutical industry – to keep people out of hospital and get them out of hospital quicker. As many as 17% of hospital admissions are due to inappropriate use of medications.

There is evidence to suggest that patients’ perspectives are changing with regard to what they want from their professional consultations. About one-third of patients (particularly the older patients) are quite happy with the traditional paternal approach, and about one-third ultimately want the GP to make the decision but would like more information to help understand why that decision has been made. The final one-third want the healthcare professional to provide the evidence but to make the decision for themselves.

Claire Gillis asked whether the prospective pricing of a service or a drug will be helped by re-reviews from NICE. Clive Jackson was not sure that re-reviews would help, but stressed they are an inevitability.

With regard to wider markets, Claire Gillis pointed out that the US and Europe are interested in the HTA process and that this provides the opportunity of educating internal customer groups as much as external customer groups. On this point, Richard Barker stressed that what is happening in the UK, specifically with NICE, has influence worldwide. This is a very powerful argument for industry to engage constructively rather then just comment on the negative aspects of the HTA process.

Ivor Eisenstadt (MPG Ltd and PM Society) noted that the uptake of guidance has been fairly mixed across the NHS and asked how the proliferation of practice-based commissioning will affect this. Clive Jackson pointed out that discussions between the NPC and PBC groups shows their thinking to be naïve - they are not looking at the more sophisticated levels of commissioning that that improve the use of medicines and therefore patient care. This represents a large task for the industry.

In Clive Jackson’s view, there are a number of reasons why uptake is very variable. First, even in an ideal world, uptake will not be exactly the same in every locality (local mortality differences, local health burden). Second, there is wide variability in the effectiveness of interpretation of the evidence because localities have very variable systems in place. In 2001 most areas had broadly similar area prescribing committees. Now, however, there are 30-40 different names for these committees, all have different remits and responsibilities, and all have different views and goals. Also, communication ranges from quite good to pretty poor. The concept of information mastering as part of the overall strategy to improve uptake is crucial.

For Richard Barker, commissioning will be a huge driving force. It will also be tremendously skill challenged – there will be relatively few people who know how to do it well. This means that for industry to pitch to commissioning as if it were a prescriber will be fundamentally counter-productive and will be looked on as trying to undermine commissioning. What is needed is a senior person engaging at senior level with PCT chief executives and whoever will write the commissioning guidelines. If the industry fails to get its mind around how best to engage with commissioning it will be missing a tremendous opportunity. In Claire Gillis’s view, a culture shift is required from both industry and the NHS in order to meet in the middle.

Held on: 24/04/2007