ISPOR Abstract Submission Open

The ISPOR 15th Annual European Congress Abstract Submission has opened today.

Taking place at the ICC Berlin, Germany ISPOR will be accepting abstract submissions which must be submitted through ISPOR’s online abstract system by June 26th 2012.

GENERAL INFORMATION

• All research abstract, decision-maker case study abstract, workshop and issue panel proposal submissions and presentations must be in English.
• All research abstract, decision-maker case study abstract, workshop and issue panel proposal submissions and presentations must not promote any product or service.
• Expenses associated with the submission and presentation of an abstract are the responsibility of the presenter.
• European Congress registration is required for all presenters.
• The presenters of research are required to disclose financial support. Abstract review will NOT be based on this information.
• Research abstract, workshop and issue panel proposal submissions, excluding title and author information, should be no longer than 300 words. Decision-maker Case Study abstracts should be no longer than 750 words.
• The use of tables and graphs in your research abstract submission, workshop or issue panel proposals, or case studies are not allowed.
• Generic names should be used for technologies (drugs, devices), not trade names.
• Research that has been published or presented at any national or international meeting prior to this Congress is discouraged.
• Research presented at a previous ISPOR meeting is not allowed.
• Multiple abstracts on the same study are discouraged.

Electronic medical publishing: We’re not in Kansas anymore

Some day, we might say it all started at the BMJ.

Beginning with the first issue of 2010, clinical research articles in the BMJ print version are limited to structured 1-page summaries. The full text of these articles are available online and are accompanied by a host of additional features including tables and figures, commentaries, blogs, videos, rapid response tools, and podcasts.

For the readers, this is an abrupt shift, but Dr Fiona Godlee, BMJ Editor, says the change process was cautious and paced. “We have known for some time that the needs of authors and readers are different. Authors want length and lots of space, while print readers are likely to read only research abstracts.” Thus, the BMJ editorial staff concluded that original research belongs online, in an open-access format, with no word-limit restrictions, and alongside extensive backup content – a publication strategy that frees up more space in the print journal for educational content, columns, and reviews.

Is the BMJ approach an anomaly, or the start of a new trend in medical publishing? Albeit an unscientific sample, we interviewed several editors and publishers, who suggest that print versions of most journals, except perhaps for certain speciality journals, will remain intact for the foreseeable future. However, there was universal agreement among those interviewed that journals are substantially expanding the amount of content provided online. According to Dr David Hughes, Managing Director of Expert Reviews in Pharmacoeconomics and Outcomes Research, “There is an increasing need to augment articles in a more interactive way – to make the terrain less flat.” At the same time, he notes that a fixed role remains for print journals, for example in underdeveloped nations.

Dr Christine Laine, a member of the Secretariat of the International Committee of Medical Journal Editors (ICMJE) and Senior Deputy Editor of the Annals of Internal Medicine, notes that the publishing world is watching closely to see if the BMJ experiment takes off. Says Laine, “This change certainly fits with the realities of practising physicians, whose biggest pressures are related to limited time, including limited time to read medical journals.” The change also reflects current ‘green concerns’ related to paper, printing, and transportation (the reduction of which, serendipitously, translates into financial savings for journals likely to be deprived of print advert revenue). Although Laine and others have found that readers still want to ‘hold the paper’ when they perform in-depth reading, they also think that e-readers like the iPad will become the next norm. According to Laine, “People tend to use print when they are sitting down reading something in-depth, and electronic information when they are looking in a more hurried manner.” In other words, we have not yet found the e-technology that will force that final step away from the printed page.

However, Hughes believes that BMJ’s ‘hybrid’ content is well-suited to its new publication plan. That said, he indicated that format might be unfavourable for other publications or article types – such as the comprehensive reviews favoured by Dr Hughes’ publication, which would not translate well in abbreviated form.

Dr Gregory Curfman, Executive Editor of the New England Journal of Medicine (NEJM) believes that rapid turnaround is one absolute benefit that online publication offers to both researchers and journals. Says Curfman, “To keep information from the health care community simply because the printing press has not yet run does not make a lot of sense to me.” However, Curfman also believes that a ‘tipping point’ has not yet been reached where researchers will be satisfied with online publication only; authors still want the sensory experience of being able to see and hold their published work.

Christopher Carswell, Editor-in-Chief of PharmacoEconomics, offers a more cautious view of fast-track publication. He is concerned that it would be impossible for editors and peer reviewers to adequately review or revise a clinical study or health economics model under extremely tight timelines. Along similar lines, Laine warns of the need for increased editorial vigilance once online content grows and word limits disappear. If journals publish articles online without sufficient editorial input, says Laine, “this will do a disservice to the readers, who really need to understand the methodological details of the study.”

Laine cites the authorship burden imposed by space limitations when dealing with complex research methodologies such as meta-analyses or systematic reviews. Carswell agrees, and emphasizes that online access enables readers to more closely review and understand the design and content of health economics models. Says Carswell, “Whether it is a standard Markov decision tree or a regression, you just cannot include that level of detail in a printed paper. This is an effort to increase transparency.” Of interest to HOC readers, Carswell also mentioned that the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has recently implemented a task force to develop standardised guidelines for health economics and outcomes research publication preparation and submission.

Excluding these caveats, however, publishing professionals agree that making more content easily available online is a positive step forward. Curfman and others note that online readership is swelling, even as print readership shrinks somewhat. The BMJ experiment is into its fourth month, and Godlee notes that, despite some concerns expressed during the transition period of the last couple of years, not a single complaint has been registered since the new format’s introduction.

What’s next for BMJ online? How about brief commentaries from authors, as well as full access to the peer reviewer-to-author communications? In addition, the BMJ editors hope to provide authors with the bandwidth required to publish all of their data online.

Although Hughes expresses some sadness that the increased computerisation of our medical literature might lead to the death of activities such as perusing the actual journals in an actual library, he is happy to acknowledge that the benefits of serendipitous browsing might extend to the online universe.

According to Laine, no matter what course is taken, the top priority for editors should remain the same. “We need to focus on publishing papers with the potential to effect change in how we care for patients, educate physicians, or set the agenda for future research.” At the same time, to hold onto and even encourage greater readership, it is imperative for publishers to try and anticipate how physicians will use information 5 to 10 years from now. Laine says, “We need to try to be more forward looking, as opposed to always playing catch-up.” If this is the case, the next few years in the medical publishing industry should definitely be interesting

ISPOR EU 2009: Bringing the Eiffel Tower into Perspective

Sometimes, at the earlier stages of drug development, getting a drug approval, reimbursement, and access to markets can feel as daunting as standing beneath the Eiffel Tower and looking up through all the intricate metal fretwork to the narrow and distant top. It’s a long way and, as with climbing the Eiffel Tower, is best accomplished in stages (and, if you are like me, with some fear and trepidation). Once you begin the journey, you find many other people doing the same things you are (for better or worse). But once you do get to the top, there is the exhilarating feeling that the world is now at your feet, and the possibilities are tremendous.

At the 12^th Annual Conference of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) held in Paris last week, the main theme was healthcare decision-making in Europe – in essence, the pinnacle of the drug and device development process. Many of the sessions were concerned with how to attain the best decisions possible – how the decision-making process differs from country to country and the types of evidence and agreements that are welcomed by the national reimbursement agencies.

As most of us who are intimately involved in creating the evidence base and presentation materials for such decision-making know, each Health Technology Assessment (HTA) national agency has its own way of viewing and prioritising the data. So much so, that while some basic elements are the same, essentially if you have seen one HTA submission, you have seen just one HTA submission – the need to consider the next submission with fresh eyes is essential to a successful process.

This point was illustrated in a plenary session that compared three of the most influential HTA agencies in Europe: from France, England, and Germany.

Dr Laurent Degos, the Chairman of the Haute Autorité de Santé (HAS) of France, outlined the four principles for the French approach to HTA :

• Use of an independent body to carry out HTA, separate from the decision-makers
• An immediate assessment for each new product
• Separate medical and economic assessment
• Delayed multiple full HTA

By these principles, the HAS ensures that innovative products are rapidly assessed by an objective authority; that the cost of the product does not affect the medical decision, and that eventually, when there is more evidence about the comparative position of the product relative to alternative treatments, that this is reassessed in context. Essentially, the questions the French are asking of the product are:

• Is it good enough to be reimbursed?
• Is it better than any other treatment?

In Germany, on the other hand, the Institut fϋr Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) thinks of HTA assessment as answering two slightly different questions, with some underlying sub-questions:

• Do we need it?
  • Does it have patient-oriented benefit?
  • Is it better than what we already have?
  • Is it necessary?
• Is the price right?
  • Do we have alternatives?
  • What are the costs of other treatments in this field?
  • What is the relation between the additional benefit and the additional costs?

Dr Peter Sawicki, IQWiG’s Director, confirmed that the most desired level of evidence is head-to-head trials with comparative treatments; placebo-controlled trials are acceptable only if there is no comparator. Interestingly, if there is no adequate alternative, then cost-benefit analysis is not allowed – in this way the German system gives incentive for truly innovative products. And only if the answer to the first question (do we need it?) is yes, will the assessment continue to the second question. In IQWiG pricing is negotiated using an efficiency frontier – a graphical comparison of benefits and costs for all treatments in a therapeutic area to help determine an appropriate price (‘ceiling price’) for a new drug. This system is different from that of the National Institute for Health and Clinical Excellence (NICE) in England, which tends to use the quality-adjusted life-year (QALY).

NICE, as the most venerable (and possibly venerated) of the three national agencies, has 5 principles to its guidance — that its assessment must be:

• Robust
• Inclusive
• Transparent
• Independent
• Timely

Using these principles NICE tends to “muddle through elegantly,” as Sir Michael Rawlins (Chairman of NICE) put it. NICE analysis uses a Citizen’s Council to make social value judgements, performs scientific assessments on the reliability of the evidence, and makes case-by-case decisions, especially if the cost per QALY is greater than £30,000. For NICE, the QALY is ‘a tool not a rule’; and NICE, unlike IQWiG, doesn’t apply a hierarchy to the evidence. WIth more than 624 types of published guidance that spans appraisals, clinical guidelines, interventional procedures and public health, NICE’s history is impressive, and many other countries look to NICE as a benchmark for their own appraisal system.

So, is an international appraisal system likely in the near future? A resounding No! seemed to be the answer – even when considering only the scientific evidence. For those of us who enjoyed the magnificent views from the Eiffel Tower during our sojourn in Paris, the realisation that a different tower in a different country will give us an entirely new perspective seems only fitting.

“Moving and Improving Concepts and Evidence for Healthcare Decisions” – the latest ISPOR congress

Rx Communications has just returned triumphant from the 11th annual European Congress of ISPOR. ISPOR is a great place to meet old friends, find new ones, and discuss current issues with competitors, clients and collaborators. This year’s venue (Athens) provided an interesting reminder of how far we have moved in some respects from the beginnings of the civilised world, and yet how there is “nothing new under the sun”. Indeed, the ISPOR chairmen Uwe Siebert and John Yfantopolous quoted Pericles in 450 BC saying “We Athenians, as individuals, take our own decisions on policy and submit them to proper discussions; for we do not think that there is an incompatibility between words and deeds; the worse thing is to rush into action before the consequences have been properly debated”.

And debate there was. A recurring theme was the harmonisation or standardisation of HTA evaluations from agency to agency. One plenary session provoked a lively discussion of international guidelines for the evaluation of healthcare interventions, with the lead protagonists advocating the QALY (Mike Drummond) or the efficiency frontier (Jaime Caro), and with Milton Weinstein and Uwe Seibert inserting provocative questions regarding the applicability of standard approaches and the flaws in methodology.

Mike Drummond paraphrased Winston Churchill’s famous quote “democracy is a lousy form of government but it’s the best we have” by saying “QALY’s are a lousy form of measure but they are the best we have”. He added, somewhat cynically, that incremental cost per QALY is at least flexible enough to cope with the needs of politicians.

There are both methodological and political issues arising from the use of QALYs as the fundamental decision-making approach. For example, different measurement approaches for estimating the health state preference values for QALYs can give different answers, and if the concern is about the provision of social value, then equal weighting of QALYs won’t necessarily give it to us. As always, the “devil is in the detail” and in the eyes of decision-makers some QALYs are more equal than others.

On the other hand, using an efficiency frontier approach, where the value of the benefit is plotted against the total net cost, is a useful way of determining what role price plays in the estimation of value. A frontier is set depending on points specified by existing healthcare interventions, which enables one to plot what the current market sets as a reasonable return (benefit) for a given cost. However, this too has issues – it doesn’t provide a decision rule, or address societal preferences regarding the priority of various diseases.

It was an interesting debate, with no clear outcome. In some ways, it reminded me of the contentions regarding the peer-review process in publications – if you think of the QALY as a means of measuring value in healthcare, the peer review process in publications is the means of measuring value in a publication. And again, there are methodological issues and political issues in the peer review process. For example, reviewers’ opinions about the value of a manuscript can be strongly influenced by their own perceptions/positions in the therapeutic area, and in many cases the decision of the journal editor whether or not to accept the article is influenced by political considerations (the prestige of the lead author for example, or the likelihood of reprints) as much as they are influenced by the value of the research in the article.

So in my view both the QALY and peer review methods are deeply flawed – but they are the only ones we have for decision making. The question then becomes: do we “throw the baby out with the bathwater” as it were, and redesign the whole process of measuring value, or do we use these flawed measures as a guideline of value and apply commonsense and a little humanity in our decision-making?

The value of congresses such as ISPOR is that these issues are raised and debated, and with an open exchange of views and perceptions we gradually move forward in our thinking, and eventually find better ways of making decisions.

Rx attracts strong interest at Dublin ISPOR Conference

The theme of this year’s ISPOR annual European Congress – the largest ever – was ‘Expanding Horizons’, and the Rx team took this very seriously, meeting almost every one of the 1700 delegates who visited our exhibition stand.

The programme featured multiple workshops, podium presentations and forums. The first plenary session, led by Drs Michael Barry and former ISPOR president Michael Drummond focused on recent challenges Ireland faces in adopting its own fourth hurdle; the foundation of the Health Information and Quality Authority and the Health Technology Assessments (HTAs) carried out so far.

Of the 33 evaluations conducted since January 2005, 15 submissions were accepted without modification, four were accepted with modifications, and 14 were rejected. Interestingly, the timelines for evaluations in Ireland put those of NICE to shame; they are aiming for – and, it seems, largely achieving – a decision within 90 days, provided there’s enough data. Single technology assessments at NICE take between three and six months, while multi-compound HTAs still average about 18 months.

Ross Hattaway, a New Zealander working for the Health Service Executive in Ireland, presented on the ‘not-NICE’ aspects of reimbursement assessment, and explained how a pre-application consultation with the product suppliers creates a simple, fast process that allows access for innovation. A system of supplier incentives will speed up the process to a mere 40 days if the necessary work is done ahead of the decision process. Another panel member, John McLaughlin, general manager of Sanofi-Aventis in Ireland, explained that a key advantage was a history of positive working relationships between government and industry. Ireland is one of the largest exporters of drugs in the EU with pharmaceutical products accounting for one sixth of all exports.

Other congress sessions focused on compliance and adherence issues; a topic we explore further in this issue of HOC. Patient-reported outcomes were also discussed at length, and featured in a number of the excellent posters on display.
We at Rx look forward to having a strong presence, meeting old friends, making new acquaintances – and expanding our own horizons – at next year’s ISPOR European Congress, to be held in Athens next November.

HOC people – Diana Brixner

Newly-installed ISPOR president Diana Brixner, RPh, PhD, has put together a challenging agenda for the society during her term of office.

The central point of that agenda, she tells HOC, is to bridge the gap separating academics and outcomes researchers from the people who actually make economic decisions. Achieving that, she says, involves giving decision-makers a more active role on ISPOR committees in order to influence our studies

Dr. Brixner, a medicinal chemist and chair of the Department of Pharmacotherapy at the University of Utah, plans to increase even further ISPOR’s international presence and to strengthen the Society’s voice in global health policy issues. “We need to reach outward,” she says… expanding our presence into Eastern Europe, Latin America, Singapore, South Africa, and Latin America.

ISPOR’s North America meeting next year will be held in Toronto, while the European version is scheduled for Dublin this year and Athens next year. In fact, Dr. Brixner is headed to Athens shortly to work with the Greeks in jumpstarting an ISPOR chapter in that country and to lay the foundation for the November 2008 European conference.

The new president points to the fact that ISPOR has grown from 35 founders in one country in 1995, to more than 3300 members in 80 countries today. “We are viewed as the predominant society focused on patient outcomes, including economic, clinical and patient reported outcomes,” she says, adding that the organisation’s Good Research Practice Reports are used as guidance for research throughout the world; moreover, the ISPOR Medical Device and Diagnostic Outcomes Research book is nearing publication.

It epitomises another strong agenda item for the organisation – the need to continue to broaden the scope of its membership by embracing all aspects of health technology, including devices, orphan drugs, biologics, genomics, and diagnostics.

ISPOR’s 12th annual international meeting

The theme of this year’s international ISPOR meeting – held on May 20–23 in Arlington, Virginia, USA – was “new tools, new audiences for health outcomes research.”

In his valedictory address, retiring ISPOR president Dr Michael Drummond told some of the 1600 registrants to the meeting that the organisation now has more than 3300 members in 80 countries. Forty nine percent of those come from the US and 35% from Europe, while industry accounts for 38% of the membership, he said, with healthcare research and academia each accounting for 28%.

This year’s meeting attracted 64 podium presentations and 524 posters. The organisation’s forward planning strategy – Impetus 2010 – includes research excellence, promoting education, reaching out to decision-makers, and international growth.

In a plenary session titled ‘How should the media convey information about new medical technologies?’ a former JAMA editor Drummond Rennie said that “while the drug industry does exceedingly good trials,” the press is often shrill in its Pharma bashing. Peter Littlejohns of NICE agreed, saying that the press too often sensationalises healthcare issues, takes a personalised angle, quotes from so-called experts, and often presents a negative slant.

Ex-national public radio journalist Snigda Prakash said that in the Vioxx case Merck had hidden adverse cardiovascular data, and, she said, an editor of the New England Journal of Medicine said he’d been ‘hoodwinked’ in connection with the journal’s Vioxx article. A pharmaceutical industry questioner from the floor noted that the media seldom report the great advantages of drugs and the good work done by the pharmaceutical industry. Ms. Prakash said the line between advertising and editorial has become blurred. And Dr. Rennie added that better ways need to be found to educate the public about adverse effects of drugs – a move that would also be helpful to the industry.

In a session on the economics of personalised medicine, a panellist defined this as “doctors customising medical care to a person’s genetic code for better diagnosis, more effective treatment and fewer side effects.” Another panellist spoke of raising the bar – the impact of heightened awareness of the need for health economics data in the absence of regulatory mandates. The managed-care revolution in the US created a demand for evidence-based formulary placement and the need to establish the value of a new medicine, said another. Applying evidence-based criteria to high technology, he said, if the answer is No to the questions of clinical effectiveness, safety, and improved value then the drug or the technology should not be adopted; if the answer is yes, and there is no comparable product, it should be adopted.

In a session on the relevance of cost-effectiveness information for clinicians, Dr. Alan Detsky said there’s a need to teach clinicians how to make decisions based upon rational thinking. Cost-effectiveness analysis is a linear programming technique developed to maximise good health outcomes, he said. Cost consequence analysis, he added, is the cost of the prescription, the cost of effects and the cost of side effects. Those doing such analyses may be biased, he said, and concluded “two economists debating is like watching the passive aggressive Olympics.”

In her inaugural address as ISPOR president, Diana L. Brixner, R.Ph, PhD, executive director of the University of Utah’s Pharmacotherapy Outcomes Research Center, said ISPOR “should glance back, reach outward, and press forward.” She noted the enormous growth, particularly internationally, of the organisation. Founding ISPOR Executive Director Marilyn Dix Smith, Ph.D., said the organisation’s revenue is more than $3 million with a net surplus of $700,000. She said she welcomes ideas for worthwhile projects for the organisation.

ISPOR’s flagship publication Value in Health attracted some 271 submissions in the past year, said its editor Dr Josephine Mauskopf… and the organisation’s website attracts some 1.5 million hits a month.

Next year’s international conference will be held in Toronto.

ISPOR 9th Annual European meeting at Copenhagen

Rx Communications and Greenflint had great pleasure in attending the 9th annual European meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), 28–31 October in Copenhagen.

Representing Rx were marketing manager Chris Gardiner (pictured centre), editorial manager Adelina Pagliocca (left), and project manager Maggie Jones (right).

Our booth featured Rx sister company Greenflint, whose models are designed to help in early-stage decisions, cutting costs, making strategic decisions during development, and developing a promotional message.

Modelling was the theme, with attendees invited to craft models out of red and green clay.

With red clay, attendees were asked to create a communication tool, and with the green clay, to model their favourite thing.

This creative challenge produced, amongst other entries, a dove carrying an olive branch, a football match between Copenhagen and England, ‘probably’ Denmark’s best export (the famous lager), and a Christmas tree.

All entries and winners for both competitions can be viewed at the Rx and Greenflint websites.

Asking critical questions

The theme of the congress was ‘Asking critical questions’. The first plenary session was introduced by Bengt Jønsson, PhD, who initiated the discussion on the use of health technology assessment (HTA) as a basis for reimbursement and priorities in health care.

Richard Bergström, MScPharm, presented the HTA principles adopted by EFPIA and industry’s perspective on promoting good use of HTA. Audun Hågå, MSc, discussed priority decisions from a government perspective focusing on Nordic countries. One key message was the need for increased communication between industry and payers, and a decision on the best practices for Europe.

The second plenary session was a debate between Professor Paul Glasziou, PhD, FRACGP, and Ivar Sonbo Kristiansen, MD, PhD, MPH, moderated by Kjeld Møller Pedersen. This session examined questions surrounding evidence based medicine (EBM).

Dr Kristiansen questioned the use of EBM in health policy; he urged the audience to be more humble in interpreting the results of randomised clinical trials (RCT), and suggested that EBM does not improve patients’ health.

The speaker questioned the Cochrane collaboration, suggesting it is an anti-industry movement that should be consulted with caution. Professor Glasziou retaliated by providing examples of when an RCT is required, although he agreed that RCTs are not always the best approach, suggesting that the best study design depends on the type of question one is attempting to answer.

With regards to the Cochrane collaboration, Professor Glasziou explained the background and stressed that the collaboration is not anti-industry, and when used properly is a good tool to aid physicians in choosing the correct medication for their patients.

The third plenary session addressed the societal value of the QALY. Professor Dorte Gyrd-Hansen, PhD, gave a critical view demonstrating that the task of performing a linear translation from QALYs to willingness to pay (WTP) is theoretically and empirically unattainable.

The speaker stressed that we need to think carefully about study design and interpretation of results. Professor Martin Buxton, BA (Soc Sci), argued that ‘social’ WTP values are interesting but of no immediate relevance.

The speaker stressed that a health system is responsible for the entire population and a WTP threshold needs to be set. This threshold should ensure that technologies adopted are always more valuable than other new alternative and any displaced activities.

In addition to these plenary sessions, there were 28 thought-provoking workshops, 6 issue panel presentations, 64 contributed presentations, and almost 600 posters.