Welcome to the November issue

By Ruth Whittington (ruth.whittington@rxcomms.com)

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.

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By David Woods (david.woods@rxcomms.com)

Writing in Pharmatech a couple of years ago, Dr Faiz Kermani observed that “many clinical trials are plagued by delays and setbacks that can cost pharmaceutical companies millions of dollars in missed sales, making the maximisation of R & D efforts a top priority.”

It is not surprising, said Dr. Kermani, who at that time was a marketing executive at Chiltern International in California, that outsourcing clinical trials has become a popular option for cutting costs and minimising time. Contract research organisations (CROs) account for about 20% of the pharmaceutical and biotech R&D budget, he wrote.

Today, Kermani works for Health Interactions in London as an account manager. He believes that if anything the trend towards outsourcing has become even more pronounced. He told HOC that in 2004, the latest year for which figures are available, leading CROs managed nearly 23,000 I–IV studies at 152,000 sites worldwide. Moreover, he says, clinical development projects in which CROs were greatly involved were submitted to the FDA more than 30 days closer to the projected submission date than were projects with less CRO involvement.

Kermani notes, too, that the international picture is changing... with much greater use of emerging market countries in Eastern Europe, Latin America, India and China. Citing a CMR International study in the UK, he says that Ukraine has had a 700% surge in its usage for patient recruitment between 2002 and 2005, while he says that the UK Trade and Investment Biotech Scoping Mission report of 2007 found that clinical trials can be conducted in China for about 10% of costs in Western countries. Finally, McKinsey has estimated that by 2010 the pharma industry will spend some $1 to $1.5 million on clinical trials in India alone.
In fact, countries now compete vigorously for conducting clinical trial application reviews. Canada is one country with a low time of approximately one month (by contrast, China takes eight months and India three and a half) and promotes its advantages in a glossy brochure. The Canadian cost advantage, it states, is 22.4% over costs in the US. And in a breakdown of annual costs of clinical trials management by country, Canada showed a profit before tax of $924,000, compared with the US at $157,000. Among the CROs doing business in Canada are Covance, Parexel, and Quintiles.

The Canadian Consul and Senior Trade Commissioner in Philadelphia, David B. Weiner, notes that Canada is competing for clinical trial business not only in the United States, but also globally. Says he: “Canada offers a number of advantages for clinical trial research. Canada is highly competitive with the US in the areas of clinical trial quality, efficiency, and costs. Some of our cost advantages include lower clinical trial recruitment costs and lower per-nurse labour costs. Most routine diagnostic procedure costs for clinical trial patients are covered through provincial health programmes. In addition, Canada's generous R&D tax incentive programme can drastically reduce the overall costs of clinical research conducted in the country.”

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“True science teaches us to doubt and, in ignorance, to refrain.”
Claude Bernard (1813–1878) – French physician

Making adherence work for your dollar (or pound, or euro…)

By Mary Gabb (mary.gabb@rxcomms.com)

As we reported in last month’s HOC, the past few years have witnessed a surge of interest in the role of adherence in health economics research, highlighted by a recent report from the National Council on Patient Information and Education (NCPIE) in the United States, which revealed the high rates of non-adherence.

So, how is the issue of non-adherence being used in health economics research? JoAnne LaFleur, Research Assistant Professor at the Pharmacotherapy Outcomes Research Center, University of Utah College of Pharmacy (Salt Lake City, UT, USA) and a member of the ISPOR special interest group on adherence/compliance, says that when adherence is factored into cost-outcomes studies, it’s probably not done well and this has important public health policy implications. She cites a recent example in which two cost-effectiveness studies in H pylori eradication (H pylori is an infectious agent thought to be associated with peptic ulcer) had made assumptions about poor patient adherence to the less costly regimen that resulted in poor cost-effectiveness outcomes with that regimen, and favourable cost-effectiveness outcomes for the more expensive regimens. As she explains, “those cost-effectiveness studies had been responsible for spurring treatment guidelines favouring the more expensive regimens. However, using a real-world dataset, the authors of this paper showed that the assumptions about patient adherence did not translate into diminished effectiveness for the less costly regimen, and in fact, previous decisions based on those cost-effectiveness studies were flawed.”

However, not all news is dire when health economics research is translated into public health policy. For example, a team at the University of Michigan, USA, has developed the concept of ‘benefit-based copay(ment)’ (lead author, Mark Fendrick, MD, Professor in the Department of Internal Medicine and the Department of Health Management and Policy and Co-Director of the Consortium for Health Outcomes Innovation and Cost Effectiveness Studies (CHOICES). David B. Nash, MD, MBA, Chairman of the Department of Health Policy at Jefferson Medical College (Philadelphia, PA, USA), says that the effect of copayment (or ‘cost sharing’) on adherence is of great relevance to health economists, although the effect of copays varies with many factors, such as the socioeconomic status of the patient or population, the level of copay, age of the patient, and the type of disease. With ‘benefit-based copay’, the benefit refers to clinical benefit, and the copay is limited to those with less serious illness. In other words, copays would be based on the actual clinical benefit a medication can give an individual, and the copays are scaled based on the importance and prevalence of the disease in a population. So, for a disease state such as asthma or heart disease – very common with serious clinical outcomes – the copay should be reduced or eliminated, to improve adherence and outcomes. As Dr. Nash states, “you have to understand the psychology of the copayment”. Importantly, copays would also vary within these long-term diseases based on the patient’s severity of the disease, and the benefit-based copay system would only be applied to drugs and diseases for which there is solid evidence that the benefit differs between patients with greater or lesser illness severity.

As health economists gain a greater understanding of the ‘psychology of copays’ and other determinants of adherence, HE research and public health policy initiatives will benefit as the research is applied to real-world scenarios.

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By David Woods (david.woods@rxcomms.com)

On January 1st 2006, Dr Dennis Gross retired from Merck after 28 years; the following day, he took up his present position as Associate Dean, Masters Programs, in the College of Graduate Studies at Thomas Jefferson University.

At Merck, he had started out as a senior research pharmacologist working on the project team that discovered the angiotensin converting enzyme inhibitors Vasotec and Prinivil. Dr Gross went on to fill senior management positions in the company, directing research operations, and serving as director of programme resources and logistics. In that capacity, he was responsible for operations and financial oversight of Merck research labs in the UK, Japan, Canada, and Italy. He reckons that, all told, he flew a million and a half miles for Merck.

During that time, he fused a business career with an academic one... serving as an adjunct professor at Jefferson from 1977. No wonder Gross is a strong proponent of bringing ‘real world’ experience to the benefit of the 350 students in his masters programme in biomedical sciences. “It adds richness and diversity to the student experience,” he says, and helps to prepare those students for what he believes will be a very different future in pharmaceuticals. Many of the professors in the department lecture on what they actually do for a living, he says, and he himself grafts onto his administrative duties a teaching schedule in pharmacology and toxicology. “I really enjoy interacting with the students,” he says, “and it really is a way of giving back some of what I learned in industry.” And those students themselves are pretty diverse – some just out of undergraduate studies; others with perhaps 10 years in the business world.

Off campus, Dennis Gross enjoys music and photography... and is a voracious reader who’s been collecting books – especially on the Middle East – for 40 years, prompted perhaps by the fact that his grandfather fought in Palestine in World War One and met the fabled Lawrence of Arabia.

Of HOC, he says: “The newsletter serves the useful purpose of exposing people in a succinct way to the issues of the day that affect them professionally.”

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By Robert Hand (robert.hand@rxcomms.com)

Under the title Legacy of Leadership, the American Medical Writers Association (AMWA) held its 67th Annual Conference on October 11–13 in Atlanta, Georgia. About 1000 medical communicators of all stripes attended. As always, AMWA offered a full programme of 95 certificate and non-certificate workshops, as well as 43 open sessions in which panels of experts addressed issues of concern to present and potential medical writers. Of note, AMWA launched its new science fundamentals certificate programme.

Formal banquets provided the setting for presenting key AMWA awards. The John P. McGovern Medal, for pre-eminent contributions to medical communication, was awarded to Julie L. Gerberding, MD, MPH, Director of the Centers for Disease Control and Prevention (CDC). In Dr. Gerberding’s absence, Steven L. Solomon, MD, Director of the Coordinating Center for Health Information and Service at CDC, accepted the award on her behalf. He then spoke of the challenges and opportunities of communicating science “in a flat world where information is perpetual, pan-global, participatory, personalised, and portable, as well as sometimes unedited, uncredentialled, unverified, untruthful, and unethical.”

The Walter C. Alvarez Award, for excellence in communicating healthcare developments and concepts to the public, went to Jeffrey P. Koplan, MD, MPH, Vice President for Academic Health Affairs at the Woodruff Health Sciences Center, Emory University in Atlanta. Dr. Koplan discussed major health challenges such as avian flu and obesity that threaten all nations and showed how working with people in other parts of the world is yielding solutions to common health problems.

AMWA’s highest award, the Harold Swanberg Distinguished Service Award, for major contributions to medical communication and the medical profession, went to Elliott Churchill, MS, MA, President of A World of Words. Churchill spoke of “mountains, molehills, and memories”, describing her long career as Senior Communications Officer at CDC, which included work with local physicians and other healthcare professionals in more than 90 countries.

Many of the workshops and open sessions focused on the nuts and bolts of medical writing and preparation of regulatory documents, training materials, and other types of documents. However, workshops also addressed principles of pharmacoeconomics, as well as ethical standards. Open sessions included public health challenges in an era of global connectivity and communication revolution; the twin epidemics of obesity and diabetes; predictive health (a novel paradigm for disease prevention); emergency health care: an emerging national crisis; health care on the margins: reaching out to the disenfranchised; and heart disease in women and AHA’s guidelines for cardiovascular disease prevention in women.

Further information about AMWA can be found at www.amwa.org.

Robert Hand is a former president of the Delaware Valley Chapter of AMWA.

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“Make it a point not to let your intellectual life atrophy through non-use. Be familiar with the classics of English literature; read the lives of the great people of the past, and keep pace with modern thought in books of travel, fiction, history, and science. A varied intellectual life will give zest to your medical studies... Let music and art shed their radiance upon your too often weary life and find in the sweet cadences of sound or the rich emotions of form and color a refinement which adds polish to the scientific person.”
William Williams Keen (1837–1932) – Eminent US surgeon

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Next month

Previous issues

If you have missed any of our earlier issues, email duncan.dibble@ rxcomms.com for a copy. See the HOC page on the Rx website for a full list of previous articles.

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David Woods and the Rx Communications team

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