Science, Society & Economics: Shaping the Future of Clinical Research: ICR 31st Anniversary Conference & Exhibition

It’s that time of year again: here at the ICR office, we are making the final preparations for our Annual Conference, which is just a few weeks away on April 19^th and 20^th. The conference is ICR’s flagship event, and a high point of the year for clinical research professionals. Delegates, speakers and exhibitors come to learn about and discuss the issues facing professionals in their work designing, managing and conducting clinical trials.

The past couple of years have been challenging for us all, in terms of time and budget to invest in our professional development and networking. We’ve listened to your feedback about previous ICR conferences, and have built on the changes we introduced last year to give you the best event possible, with a programme of relevant and informative sessions for all the diverse roles making up the ICR membership. The 2010 ICR conference makes it easier for you to reconnect with your profession, and create new opportunities for yourself and your company.

After several years in the centre of England, we are bringing the conference to London for the first time in its history. This recognises the fact that more than half our members live within a couple of hours of the city. The Hilton Metropole, a few minutes away from Paddington station, is within easy reach of national and international transport services, whether you’re coming by car, train or plane.

For the first time in nearly a decade, the conference will be held in the hotel where most of the delegates, speakers etc. are also staying. This meant that we were able to offer delegates who booked their places early preferential rates on their hotel reservations. You also have the benefit of being able to carry on discussing issues after the conference formally closes, at our networking drinks reception on the Monday evening, in the bar or over dinner, or even over a shared breakfast before the second day of the conference opens.

Another important change is that we’ve frozen delegate prices to remain at their 2009 levels, to help members in these challenging economic times. This makes the ICR conference even better value for money than other multi-stream conferences.

If you can only go to one conference…

This year, we have a varied selection of relevant, knowledgeable and experienced speakers to discuss the important issues facing us all. All of the topics to be discussed at this year’s conference will impact on the way you work now and in the future, either directly on indirectly. Whatever your role in clinical development, and whatever point you’re at in your career, it’s vital that you stay up-to-date with the latest developments and make your voice heard in the discussions about their implementation, impact and implications.

The overarching theme of the conference is that clinical research is influenced by both internal and external factors, with economics and politics often having as great an impact on the way we work to develop new treatments as developments in medical science and operating procedures. The interfaces between these areas will provide the clinical research community with its greatest challenges, and its greatest opportunities, over the coming years.

Plenary sessions: Personalised healthcare & Health economics

Plenary sessions on key topics will close each day’s proceedings.

In the first of these, speakers from AstraZeneca and Roche will look at personalised healthcare, certainly an indicator for the way many future medicines will be developed and studied. The technological, scientific and clinical advancements in pharmaceuticals R&D over the past decade has ensured that the concept of personalised healthcare is now rapidly becoming the practice of personalised healthcare, particularly in infectious disease and oncology. This important field has implications reaching into patient recruitment and informed consent, pricing and economics, biomarkers and companion diagnostics etc.

The second plenary session will close the conference with a detailed look at the economic evaluation of healthcare technologies, which is increasingly used to inform social choices about access to innovative treatments. This is a field where the UK leads much of global thinking. Professors Richard Lilford and Karl Claxton, both of whom are close to the development of these ideas and their practical application, will discuss which health technologies should be approved or covered for use, what price ought to be paid for such technologies and how much and what type of evidence is required to support coverage or approval. The changing health-economic landscape will have an increasing impact on which clinical development programmes take priority, how individual clinical trials are structured, and how additional kinds of information need to be collected and analysed.

Parallel sessions: From patient recruitment to research governance

There are too many exciting topics being covered in the 12 parallel sessions to discuss them all in detail, but here is a selection of sessions that are proving popular with early-registering delegates:

Dr Clare Morgan of the NIHR Clinical Research Network Coordinating Centre will review what the NIHR CRN is doing to improve reliability, including improving confidence around quality study feasibility assessment, access to a wider pool of committed investigators with dedicated, trained resource to support study delivery and proactive study performance management.

Gaynor Anders and Prof. Theo Raynor urge us to “think outside the box” about patient recruitment. Real progress is being made on several fronts of the challenge to meet the study participation needs of research programs. However, there is still a huge gap between those needs and the collective willingness and ability of patients to enrol in studies.

Mark Lewis MICR and Christine McGrath MICR will explore the challenges and tactics involved in applying policy-level initiatives in practice at individual Trusts, to enhance and streamline UK clinical research. They will also discuss how to improve the performance of individual R&D departments (in terms of quality, speed, added value etc.).

Another key update will come from Janet Wisely of NRES, who will discuss the latest developments in ethics review. She will look at the ongoing development of the IRAS application system, the 2009 pilot scheme in proportionate review, and the use of ethics advisers to help committees work more effectively by ensuring that proposals are well presented, with scientific referees’ reports if necessary.

Other sessions consider practical issues, such as the role of research nurses in the informed consent process, the changing clinical data requirements for medical devices, managing remote teams and the move towards risk-based inspections.

Full abstracts and speaker profiles for all conference sessions are available at www.icr-global.org/community/conferences/31st-annual-conference-exhibition.

Annual General Meeting: May 19^th

The ICR Annual General Meeting has traditionally been an important part of the Annual Conference. However, as announced last month and clarified elsewhere in this issue, we have decided that this year’s AGM deserves more time and attention than it can easily be given alongside the conference. Instead, the AGM will be held at the ICR office in Bourne End, on May 19^th, starting at 5pm. Further details will be published to members in due course.

More targeted exhibition

In addition to attending conference sessions and networking with your peers throughout the industry, many delegates also come to the conference to find out more about potential new suppliers, and the exhibition has always been an important addition to the ICR conference. This year’s exhibition is already sold out, and we are pleased to have the support of so many companies from throughout the clinical research sector.

However, after listening to your feedback over previous years about the balance of exhibiting companies and the sometimes overly intrusive attitudes of a few individual stand personnel, we have decided to reduce the size of the overall exhibition, and particularly the proportion of recruitment agencies that have been invited to exhibit. Along with our Exhibitors’ Code of Conduct, this means that you will be able to walk through the exhibition aisles without concerns, and decide without pressure which companies you’d like to talk to.

Make the most of your membership

As I write this piece, in March, many of you have already registered to attend the conference, and it is becoming obvious that several of the sessions will be well attended. If you are struggling to find the time (or the budget) to come to the full meeting, we are offering single-day conference passes at reduced rates.

As we hope you’ll agree, this year’s Annual Conference will have something for everyone: plenty to learn, plenty of business benefit, but also plenty for us all to enjoy. We are also offering special reduced rates for professionals working in academia or the public sector, and to full-time students. To reserve your place, simply fax back the form on the back of the conference flyer enclosed with this issue of CRfocus, or register online via the ICR website (www.icr-global.org/community).

OLS Blueprint: PICTf 3.0?

The UK pharmaceutical industry is one of the most significant industries to make money for ‘UK plc’ and re-invest it back into UK-based R&D, within their own organisations, in universities and throughout the NHS. As many have said, the UK ‘punches above its weight’ in our sector. Despite this, we often feel unloved, in terms of both media and public opinion and increasing constraints on revenue (eg, prescribing decisions being led by NICE guidance while reimbursement rates have been cut under the successor to the PPRS). However, the counter-balance to this top-line constraint has come in the form of various initiatives to make more of a contribution in terms of investment in education and training, infrastructure and organisational processes. As a globalised industry has far less binding ties to doing its R&D in the UK than it did 30 years ago, this policy makes a great deal of sense. Over the past decade or so, these initiatives have come under the banners of PICTf, UKCRC and, now, the Office of Life Sciences (OLS) Blueprint, which was published over the summer.

The Blueprint set out 12 key action points, which have been agreed across government, industry, the higher education sector and the NHS. This expands to 10 pages of specific policy measures, complete with timelines and budgets. The Blueprint has been widely welcomed by industry and commentators alike, and certainly, every policy measure should have a positive effect.

The measure that has received the most coverage is the Innovation Pass, ring-fenced funding for time-limited use across the NHS without appraisal by NICE (although NICE will define the criteria for medicines that can take this short-cut). This will be piloted in 2010/11 with a budget of £25m. While initially portrayed by the media as bypassing NICE, this could be a valuable experiment in ‘live appraisal’ mirroring the ‘live licensing’ model proposed by PricewaterhouseCoopers in their Pharma 2020 reports.

The policy that will be of most interest to us in the clinical research sector is the “package of measures to improve the UK environment for clinical trials”. This includes ensuring the UK “fully exploits its potential to be a world leader in heath informatics” (ie, making electronic patient records finally happen!), underlining the duty for SHAs to promote R&D, adding metrics on patient in clinical trials to Trusts’ Quality Accounts, and creating a national framework for local management of research (ie, transforming NHS R&D departments). Significantly, the last three points are essentially reworking areas covered by PICTf nearly a decade ago…

The questions that need to be asked about all these measures, though, are “Will they be implemented as planned?”, “Will they result in improvements in the productivity of UK R&D and uptake of resulting products?” and “Are they sufficiently different from previous initiatives to justify the top-line reduction in reimbursement for medicines?” The many intelligent and powerful people close to this project evidently think so. Far be it from me to disagree, but the fact that this is the third major initiative in less than a decade suggests that its predecessors did not maintain momentum in their improvements (or, more cynically, that pharma are getting increasingly itchy feet in the light of increasing competitiveness overseas).

To sound another small note of scepticism, the UK is less than 12 months from a general election, with a change of government far more possible than at any time since 1997. Although many measures in the Blueprint can be implemented almost immediately, many will take time to demonstrate success, and none will be immune from reversal under a new government.

So, I would like to raise two cheers for the OLS Blueprint: it talks a good game and will certainly have some success, but will it be enough to steady ship of UK competitiveness or just the latest in a series of defences against an insuperable drift to merely “punching our weight”? We will see…

End of term reports?

You can tell it’s summer! In the latter part of July, large parts of the clinical research establishment evidently winds down for a summer recess. In the past few days, three substantial and (to a greater or lesser extent) significant reports have thudded onto my desk (metaphorically, of course – I read them as PDFs…)

• Life Sciences Blueprint – A Statement from the Office for Life Sciences (July 14th)
• The Case for Globalisation: Ethical and Business Considerations in Clinical Research (July 21st)
• Appraising the Value of Innovation and Other Benefits: A Short Study for NICE (July 22nd)

I would like to be able to give a detailed analysis of each of these documents, discussing which of their many recommendations seem to be the most feasible and/or helpful. However, arriving so close together (and as we’re getting the August issue of CRfocus to print) I have only had time to skim them so far, so the best I can do is suggest that you take a look at them yourself.

As one early aside, it might be worth considering the OLS Blueprint (an action plan to re-energise and optimise the UK’s innovative pharmaceutical industry) in the context of PICTf, which was a series of reports, workstreams and metrics that ran in the first half of this decade. Much of what has made UK clinical research what it is today had its source in the PICTf work programmes, so it remains to be seen how much of the Blueprint builds on those developments, and how much re-addresses topics that PICTf initiatives didn’t quite manage to resolve. Also, with a UK General Election less than a year away, and a change of government certainly not beyond the realms of possibility, it might be interesting to wonder how many of the report’s 12 key action points would withstand a shift from Labour to Conservative.

Perhaps more likely to maintain its relevance should the Conservatives win power next year is the report by Professor Sir Iain Kennedy’s report on how NICE might better handle the valuing of innovation in its analysis of the economic impact of new health technologies. Although it sticks with the basic ICER/QALY framework, it makes some strong recommendations on what further research is needed and on a pilot scheme for  innovation might be rewarded. This chimes with the “Innovation Pass” idea in the OLS Blueprint, which was initially portrayed in the media as something of a snub to NICE, but is perhaps more an anomoly of publication timings.

If these two reports are quite UK-specific, the middle one is definitely global in scope. Commissioned by the ACRO (the US trade body for CROs, representing the head offices of many of the world’s major contract research organisations) the report aims to demonstrate that clinical research in the “pharmerging” countries is of a comparable standard of safety and ethics of the traditional countries (ie, USA, western Europe etc.) and speed, scale and reduced cost present a compelling case for embracing the shift of larger clinical trials to these new regions rather than railing against it. From my initial reading of the report, this seems something of a tautology: because the studies are commissioned by western sponsors, often conducted by local affiliates of western CROs and designed to collect data to support western registration with the FDA, EMEA etc. is it really surprising that the standards achieved are broadly similar. Still, it’s important for the rest of society to recognise this if they hadn’t already (much of our industry realised this some years ago).

For all three reports, there is then the question of momentum. By the time the world starts getting back to speed in September, we might have had time to ponder some of their more complex recommendations, but others might have forgotten about them entirely! So, let’s make the effort and read them now…

Twittering from the ICR conference next week

Next week will see the Institute of Clinical Research 30th Anniversary Conference & Exhibition, taking place on March 17th & 18th at the ICC in Birmingham. Of course, I will be there to:

• Cover the meeting for CRfocus (along with a team of roving reporters!)
• Help with the organisation and operation of the meeting (ICR is the parent organisation of CRfocus)
• Chairing a session on the tension between pricing and patient value, and how you can accurately assess either

I also plan to Twitter live from the conference (I’ll be too busy to live-blog like I normally do from such meetings). You can see my most recent “tweets” on the main CRfocus webpage, or follow me on Twitter itself. I’m also hoping to have time to do some other neat things, such as one or two audio interviews with delegates or speakers, and post some photos live from the meeting…

This is going to be a great conference, and I’m looking forward to it immensely. If you haven’t registered yet, take a look at the conference programme, and come along (we have passes available from a half day up to the entire meeting).

I’d love to see you there…

CRfocus: Table of Contents of March issue

Making up for the delay with February’s Table of Contents, here is the Table of Contents for the March issue of Clinical Research focus 20(03). Members of The Institute of Clinical Research can click on each link, and log in to read the full article. If you want to become a member of ICR, visit www.icr-global.org/membership for more information.

Patient recruitment & retention

Adjust the Focus on Recruitment & Retention: Enabling CRAs to Develop & Implement Site-Specific Plans

Sherry Armstrong-Wilkinson MICR

If you want recruitment and retention to succeed, then it’s time to adjust the focus on where investment is made. When selecting and training CRAs, how much time and investment do we put into developing skills and expertise that will allow them to support sites fully in the development of robust and strategic recruitment strategies? Sherry explains how a strong, dynamic relationship between investigators and CRAs is crucial for optimal site management and is vital for devising and implementing successful site-specific strategic recruitment and retention plans.

Exploring Patient Recruitment: NIHR Primary Care Research Recruitment Methods Group

Elaine Ward, Julia Miller & Brendan Delaney

As government policy is encouraging a larger number of patients to be seen by clinicians in the community, more clinical research studies require some recruitment in primary care. The Research Recruitment Methods Group came together in 2007 in a bid to begin to tackle recruitment barriers in primary care. Between them, the members of this collaborative group have had considerable experience of research conducted in general practice settings. Their aims are to improve delivery of clinical trials by exploring the factors which affect recruitment and then to develop a programme to systematically test the impacts of those factors. The authors discuss this group’s past, ongoing and future activities.

Factors Driving the Evolution of Digital Outreach for Patient Recruitment

Gaynor Anders, Mary Schwarz & Jake Perez

Most are aware that the role of digital media, particularly the internet, in recruiting patients for clinical trials has been steadily expanding in both availability and acceptance worldwide. But, what has driven the emergence of digital outreach for patient recruitment and where is it headed? The authors take a brief look at how we arrived at the present use of digital media in patient recruitment and look ahead to its future applications. They also consider the driving forces for both the past and future evolution of digital outreach for patient recruitment and the implications for the clinical trial landscape.

Planning for Success in Patient Recruitment: An Interview

Missy Orr

Missy Orr is Executive Director, Sites and Patients Services at PPD. Missy joined PPD in 2003 and oversees the global operations of patient recruitment activities. In this interview, we break down the component parts of patient recruitment, discuss why an approach might be successful in some places but not in others, and consider that patient retention doesn’t get the attention it deserves. An audio version of the complete interview is available to download.

Features

Real World Data: An Important Addition to Your Late Phase Development Plans

Samantha Marshall

Traditionally, ‘real world’ observational research has been criticized for lacking the robust scientific methodology of RCTs. However, with the shift in NHS requirements, the focus of clinical development needs to change to ensure a well-rounded development plan that includes not only RCTs but also more pragmatic research in real clinical practice. Samantha explores…

Health Technology Assessment in the UK & EU: NICE & EUnetHTA Conferences

Alan Jones

Alan gives us our regular update on the latest developments in Health Technology Assessment, how it impacts on reimbursement for the medicines and devices we help develop, and how its importance will only increase for people designing and conducting clinical trials. This extended version of the article includes more detail on both the NICE and EUnetHTA conferences than was possible in the printed version.

Viewpoint

Research Integrity vs Getting the Joke

Andrew Smith

Were ‘cellist’s scrotum’, ‘guitarist’s nipple’ and the PIGPEN study on the treatment of headlice simply a bit of light relief for overworked physicians, or dangerous distortions of the scientific record… or even disease mongering? Andrew eschews his usual humorous streak to suggest that unacknowledged hoaxes in primary medical journals might not be a great idea…

Regular update

So Long, Farewell, Auf Wiedersehen, Goodbye…: Message from the Chair

Susan Ollier MICR Csci

Susan Ollier, Chair of ICR until she reaches the end of her term of office at the Annual General Meeting on March 17th, looks over some of our recent achievements, thanks those who have made it all possible, and says a fond farewell to the colleagues and friends she has met along the way.

NICE approves Lucentis but remains in the eye of the storm

Earlier today, the National Institute for Health and Clinical Excellence (NICE) announced its final guidance, approving reimbursement for the use of ranibizumab (Lucentis) and pegaptanib (Macugen) for the treatment of age-related macular degeneration (AMD). This will please many (ie, patients, prescribers, pharma companies and, it seems, the press and the public).

But the decision will also irritate others (ie, the payers), because a course of treatment will cost NHS Trusts up to £10,000 per eye. This is particularly hard to swallow because it will indirectly end the possibility to treat AMD patients with a related drug, Avastin, that is significantly cheaper. Avastin is approved for colorectal cancer, but has been used off-label to treat AMD. The company that developed both Avastin and Lucentis has announced that it has no intention to register AMD as an indication for Avastin, on the basis that Lucentis has been modified in a number of ways that make it more a appropriate treatment. Clearly, delivering more value justifies an increased price, but many observers consider the price increase in this case to be unduly high.

Surely feeding into this decision was the innovative compromise negotiated with Novartis, who markets Lucentis in the UK, for the supplier to meet the cost of any injections required by a patient beyond the 14 specified in the guidance. This is an example of risk-sharing and value-based pricing that I, for one, applaud, and hope to see more frequently.

But despite NICE pleasing many with this announcement, they remain in the centre of a media storm following its recent decisions not to approve a number of drugs for patients with advanced kidney cancer. A few days ago, a number of eminent cancer specialists wrote of their dismay in a letter to The Times. They argued that the UK spends less than two-thirds of the European average on cancer drugs and that the models used by NICE need to be radically changed.

These are two separate points, and agreeing with one doesn’t necessarily extend to the other. The UK is widely regarded as a world leader in the field of health economics, so while I’m sure even NICE would agree that there is room to improve on their modelling, one should not assume that more sophisticated models would bring the UK into line with the rest of the EU; in fact, the models used elsewhere in the EU are likely to become more similar to those of the UK.

The one thing that does differ, though, is public attitude to value, and this is where the question becomes more one of politics than of science or economics. If a society decides to place more value on treating cancer, recognising that this would mean spending less on other conditions, perhaps without such an active patient advocacy group, then the parameters of the health economic model would change and reimbursement decisions might be different.

If a sophisticated analysis is carried out in a timely, efficient way but arrives at an answer we don’t like, the first place to look is the public values used to underpin the analysis. If these are accurate, maybe it isn’t NICE that should be criticised, but society in general.

Bigger = better for late phase clinical trials… but who pays?

The relative calm of August in the clinical research industry was ruffled a couple of weeks ago with a paper in the US health policy journal Health Affairs. In it, the authors (all well-connected clinical research academics at Duke University, led by Shelby Reed and including Robert Califf, Duke Vice Chancellor for Clinical Research and Director of Duke Translational Medicine Institute) used computer modelling of phase 3 studies to demonstrate that requiring a larger dataset of patient safety information would dramatically (and often cost-effectively) increase the power of that dataset to accurately predict adverse drug events (ADEs) in future use.

In the example given of a drug that would be prescribed to 10 million patients after launch (with 75,000 ADEs expected), increasing the size of the pre-launch safety database from 2000 to 4000 per treatment group would increase the power from 76% to 96% and increase the number of ADEs which could be predicted and avoided from 57,000 to 72,000. The value of this increase was modelled to be approximately $27,000 per life year saved, which could be expected to offset the additional cost of including more patients in the safety dataset. With more optimistic starting assumptions about the test compound, and redoublings of the size of the safety database, the incremental value of increased still further.

On a purely scientific level, this work is hardly surprising. But there are a few things that make it more notable. The inclusion of health economics into the modelling enables the benefit to be more easily understood by the policymakers and businessmen who lead the broader healthcare sector, in addition to the regular audience of clinicians and clinical research professionals. Similarly, the placement of the paper in the journal Health Affairs, which bills itself as “The Policy Journal of the Health Sphere” alongside papers on other ‘big picture’ topics in public health and policy put this argument in front of a very particular audience, at a time when the FDA is pushing patient safety and pharmacovigilance as its “big goals” under the PDUFA IV legislation passed this time last year. The authors are well respected in the field, and are also working closely with the FDA on the CTTI initiative, “a new public-private partnership aimed at modernizing the way clinical trials are conducted” which is hosted at Duke and co-chaired by Robert Califf. So, this is precisely the area where the FDA wants strong, new ideas, and these people are among the inner circle of people trying to come up with them.

Looking at the big picture, the scientific and economic arguments are strong. However, when viewed from the perspective of the organisation developing the medicine, it’s more problematic. The value is gained by the prescriber/payer over the lifetime of the drug (possibly including a “tail” in the generics sector after patent expiry) but the additional cost and time are expended up-front, before any revenue stream begins and while its patent protection ticks away.

At a time when pharma is already feeling the crunch of cost-containment in the face of impending expiry of many key blockbuster patents, the prospect of increasing the cost and timelines of late phase development are unlikely to be welcomed. The obvious route to fund this increase would be to raise the prices of the current generation of products… which in the current media climate could be perceived as profiteering and fly in the face of the recent agreements between the NHS and ABPI on the future of the Pharmaceutical Pricing Regulation Scheme (PPRS). The only plausible alternative to this would be to take more drastic cost-cutting measures, accelerating the flow of clinical trial work out of the developed world to cheaper countries to the south or east.

So, the irony of this proposal is that safer drugs tomorrow could only be delivered by more expensive drugs today or a dramatic drop in the contribution of clinical research to national economies. When (or if…) they think through these issues, some politicians will have quite a dilemma!

PPRS: Achievable Compromise or Missed Opportunity?

In 1867, Otto von Bismarck described politics as “the art of the possible”; it’s easy for commentators (myself included) to pontificate without the responsibility to implement those suggestions in the ‘real world’. With this in mind, I’m cautious of being too critical of the recent announcement of a deal¹ between the UK Department of Health and the ABPI on parts of the voluntary scheme to replace the Pharmaceutical Pricing Regulation Scheme (PPRS). This was accompanied by a consultation² from the Department of Health on a statutory alternative.

This is important in an international context, as pricing systems in many countries are benchmarked against the UK. Healthcare payers around the world will be watching with interest, to see how far prices can be squeezed in return for investment in research infrastructure, and how deeply economic models of patient value can be built into reimbursement negotiations.

Last year, I wrote³ about the beginnings of this process, as an Office of Fair Trading report recommended that the current arrangements be overhauled. I was broadly optimistic, because the OFT proposed changing the system from a complex network of controls on profits and post-launch price changes to one based more on the value of individual medicines, based on economic evaluation of their benefit to patients. However, the settlement is based on an across-the-board price cut… While it gives stability and predictability for the next 5 years (the statutory scheme will be reviewed annually), the settlement appears to be a polishing of the same ‘blunt instrument’, sweetened by a commitment to speed the uptake of newly-registered medicines.

This is certainly not the value-based pricing many had hoped for. In the days following its announcement, Jim Furniss of Bridgehead Consulting told me that he thought “the opportunity provided by the OFT report for a much-needed reform to reflect the realities of the modern pharmaceutical industry has been squandered.” Were Jim and I being too hopeful? In the short term, perhaps, but not in the longer timeframe. Implementing a value-based model across the whole range of pharmaceuticals so quickly was probably impractical, but there have been pilot schemes (such as Velcade, where the NHS will be able to recoup the costs of treatment of any patient who shows no or minimal response) and these need to be applauded, nurtured and expanded.

So, is this re-negotiation of the PPRS an equitable balance to the large investment that government has made into NHS R&D over the past few years, a ‘quick fix’ to shore up public finances while ignoring the opportunity to put patient value at its heart, or a practical compromise to help the NHS’ depleted coffers while a more sophisticated, value-based model is being developed? I’d certainly like to think that it’s the last of these, but to be confident I’ll need to see strong signals from government that a more sophisticated pricing model is indeed the intended way forward.

References

1. Association of the British Pharmaceutical Industry (ABPI) press release (18^th June 2008): “Big Progress In Government And Industry Drug Price Deal”, available via www.abpi.org.uk/press/press_releases_08/180608.asp [accessed 25th June 2008]
2. UK Department of Health (18^th June 2008): “Consultation on a statutory scheme to control the prices of branded NHS medicines”, available via www.dh.gov.uk/en/Consultations/Liveconsultations/DH_085523 [accessed 25th June 2008] This consultation closes on July 15^th 2008 (part) and September 25^th 2008.
3. Smith A (2007): “Who Wins From Value-Based Pricing? Everybody!”, CRfocus 18(3) p4