President Barack Obama’s political mantra on healthcare reform has comparative effectiveness research forming a substantial part of his strategy. In 2009′s economic stimulus plan, Congress approved $1.1 billion for comparative effectiveness research. This has been further bolstered through the Healthcare Reform Bill, passed on 23 March, by the establishment of a dedicated comparative effectiveness research (CER) institute – armed with a $500 million annual budget.
The passing of this legislation has naturally caused a huge amount of debate – with both those supporting and opposing the move clamouring for attention. Whilst some welcome the introduction of comparative effectiveness as the healthcare cost-saving opportunity that Obama purports, opponents, however, worry about its implications with regards to issues such as quality of care and insurance-coverage decisions.
Whichever side you find yourself on one thing is clear – the implications of Obama’s CER institute will be far-reaching and will have a significant impact. Comparative effectiveness will be at the heart of major healthcare decisions, whether you are a pharmaceutical supplier, healthcare provider or an insurer – or indeed any other kind of business in the healthcare arena.
So with comparative effectiveness very firmly in the spotlight and destined to stay there for some time, can you honestly say that your business understands the basic concepts that have suddenly become so critical in the US healthcare market place? You may – but do your non-health economist colleagues? And ask yourself, what could be the implications if they DON’T understand these concepts?
Rx Communications has been active in the field of health economics (HE) and CER for many years, and as such, is regarded as an expert in the field of HE and CER awareness and training.
The latest in our published series is :
Introduction to Comparative Effectiveness
Evidence Based Medicine
This short 60 pp guide explains these concepts in basic terms, covering the objectives of CER and providing a rapid read and understandable reference that you may like to pass to your colleagues.
Read an excerpt of the booklet ‘Introduction to Comparative Effectiveness and Evidence Based Medicine’ to determine if this content is right for your organisation.
This booklet is packed with useful definitions, implications and examples. Information is clearly laid out in sections and tables and will give your colleagues a better understanding of your function and the likely implications of CER on your drug and device development activities.
The book also explores other relevant issues in CER such as study methodologies and their application in CER, the role and application of evidence based medicine and how to evaluate comparative effectiveness studies. ‘Comparative Effectiveness and Evidence Based Medicine’ is available to buy here at £15.99 (plus shipping).
The book is available for content and appearance customization incorporating your company’s branding, corporate vocabulary as well as product and device case studies and examples A fully annotated presentation, is also available can be used as a ‘train the trainer’ tool or directly with delegates during training sessions.
For more details about ‘Introduction to Comparative Effectiveness and Evidence Based Medicine’ please do contact Kinza Sutton on +44 1352 706199 or firstname.lastname@example.org. Alternatively, click here to buy a copy online.
By Mary Gabb (email@example.com)
“There just isn’t, and never will be, enough money to provide every possible service” – a reminder to participants of the NICE Citizens Council (November 27–29, 2008) as they were asked to consider in what circumstances should NICE recommend interventions where the cost per QALY (quality-adjusted life-year) is above the threshold range of £20–30,000. The Council’s conclusions drew criticism from Alan Maynard, OBE, a professor of health economics.
Professor Peter Littlejohns, clinical and public health director of NICE, offered the reminder as part of the meeting’s introduction. As he noted, NICE was created by the Government in the United Kingdom (UK) in 1999, but was left to develop its own criteria for recommending technologies to the National Health Service (NHS) as well as its own threshold. The £20–30,000 range was set in 2004 and, according to the Council’s report, is divided as follows: “ £20,000 per QALY as the sum below which an effective treatment would normally be accepted; and £30,000 per QALY as the sum above which very good reasons would be needed to gain acceptance. The acceptance of interventions costing between these two figures would be subject to debate.”
During the 3-day meeting, participants considered the myriad factors affecting the decision of whether to maintain the threshold and to recommend a technology, including the certainty of the evidence under consideration, disease severity, avoiding immediate loss of life, averting a public health threat, fostering potentially valuable medical research, treatment of rare diseases, to address need and/or equity, unmet clinical need, the existence of other therapies, whether the technology is a bridge to future therapies, ease of obtaining patient compliance, and whether a technology creates extra costs or benefits outside the health arena, to carers or the wider community (e.g., a reduction in crime due to drug misuse). Overall, the committee voted on 15 circumstances that might prompt a departure from the threshold; the results are shown below.
|Circumstances potentially altering the NICE threshold||No. of votes*|
|The treatment in question is life-saving||24|
|The illness is a result of NHS negligence||23|
|The intervention would prevent more harm in the future||23|
|The patients are children||22|
|The intervention will have a major impact on the patient’s family||22|
|The illness under consideration is extremely severe||21|
|The intervention will encourage more scientific and technical innovation||21|
|The illness is rare||20|
|There are no alternative therapies available||19|
|The intervention will have a major impact on society at large||16|
|The patients concerned are socially disadvantaged||13|
|The treatment is life extending||19|
|The condition being tackled is time-limited||9|
|The illness is a result of corporate negligence||2|
|The stakeholders happen to be highly persuasive||0|
*An initial vote revealed that two of the 29 Council members felt there were no circumstances in which NICE should depart from the established threshold. These two members took no further part in the voting.
Also according to the report, NICE authorised medicines that lie above the £30,000 threshold on “only four or five occasions”. Deviations from the threshold have received criticism from Prof Maynard, Professor of Health Economics and Director of the York Health Policy Group in the Department of Health Sciences at the University of York, UK (He also noted that he was “involved in establishing NICE” in 1997). Prof Maynard argues that “this decision to ignore the efficiency rule and apply an arbitrary equity value judgment is inherently unfair for those not in the last two years of life.” This unfairness also applies to higher and more generous thresholds for those with rarer conditions. Moreover, he notes the problem of definition – “What is end-of-life? What is a rare disease? Both of these categories are rather ambiguous.”
Despite inflation and increased NHS funding, the NICE threshold has never been changed, according to report. Moreover, not every technology is appraised by NICE and “much decision-making in the NHS, including which treatments to pay for, is still local.” Prof Maynard agrees: “Essentially, we’ve got two rationing mechanisms.”
The Council report will be presented to the NICE Board in May 2009. It is available on-line and is open for comments.
Many of us in health economics and outcomes research look at Canada as one of the leaders in the field; along with Australia , Canada was one of the first countries to demand evidence of cost-effectiveness as a prerequisite for drug approval.
To those of us not intimately acquainted with its healthcare system, the recent presentation by Richard Alvarez, President and CEO of Canada Health Infoway, may have come as a bit of a shock. He described a system almost wholly reliant on paper records – a system where 37–43% of recommended treatment is never delivered, of 30–40% of women at risk of cervical cancer not being screened, of 32% of patients presenting at emergency rooms with vital pieces of their healthcare information missing.A country where it is estimated one in nine patients receives the wrong medication, and where over 24,000 patients die annually from preventable adverse events from treatment. Small wonder, then, that he is attempting to drag the ten provinces, three territories and numerous health regions into the 21st century by instituting electronic patient healthcare records.
Canada Health Infoway is a primarily government-funded organisation working with the provinces (which provide 25% of its funding) to integrate and coordinate healthcare, and Alvarez firmly believes that electronic record keeping will help solve several of their major issues. Information technology, he believes, will improve access, quality and productivity in healthcare provision, and although it may cost $CAN10 billion to institute it, ultimately all Canadian citizens will benefit from a better healthcare service.
According to Michael Wilks, Chairman of the Standing Committee of European Doctors (CPME; an organisation facing the challenges of its current 2 million doctors in 27 countries being expanded by an ever-growing EU), these are two major influences of healthcare provision. The CPME has subcommittees that deal with four areas concerning doctors at an EU level:
These subcommittees report to the Board, and the CPME also comprises a Secretariat, Executive Committee and General Assembly. The mandate of the CPME is simple; to improve the healthcare for patients, and Wilks is of the opinion that this can only be achieved by increasing the interaction with patients. In his talk at the World Healthcare Congress, Wilks discussed four issues that will influence the relationship between patients and their doctors – and therefore the quality of the healthcare they receive.
Wilks posed the question: do healthcare policies really work? He presented evidence to indicate that no, they don’t – or at least, not in isolation. Evidence suggests that the only thing really influencing healthcare was wealth.
The old style of healthcare with a single doctor-patient relationship relied on manual records, doctor’s memory, the familiarity with the patient and a continuity of care. Now the multifunctional team means that the patient is likely to see more than one doctor at a large clinical practice, and that a nurse practitioner may also be a participant in the patient’s healthcare. The coming of an electronic patient record, while perhaps improving the communication between the different healthcare providers, will only encourage the likelihood of more participants; the benefits offered by continuity and familiarity will be lost. Wilks posed the question: do we know what this will mean in terms of the quality of the relationship between patient and doctor? He said that as long as the patient was the focus of interaction and not the electronic record itself then the change may be beneficial.
Wilks talked about the obvious dangers of tobacco and poor nutrition (both excess and deficits) but talked about the interesting effect of alcohol – positive in moderation and problematic in excess. He pointed out that there are different hazards with alcohol in different age groups – that young men aged 18–24 appear to have a linear relationship between alcohol and health hazard because the main risk in this instance is the acute effects of alcohol – increased risk of driving accidents, violence and harm due to the intoxication. The role of the doctor in this case is difficult; it is hard to persuade this age group to decrease their intake. This is a different relationship than the one of typically older age groups who drink heavily – to a certain point the relationship between alcohol intake and hazard is linear, but beyond a particular limit the damage becomes disproportionately large for a small increment in intake. In these instances the doctor must focus on moving the patient to an intake below the change.
Wilks spoke about the change in ice cores indicating without doubt that we are on an exponential curve for global warming – he felt the change was inevitable given the current climate. He said that the increased temperatures would lead to changing patterns in infectious diseases, and heat-related mortality would increase dramatically. In 2025, given the current rate of change, that the average temperature in the EU would be the same as the most extreme temperature experienced in France in the last heatwave, that killed a record number of people from heat-related problems. Increased drought, more frequent and more serious natural disasters (tsunamis etc) will again alter the doctor’s workload and relationship to his or her patients. He pointed out that we currently have all the technology we need to prevent this happening, and that 1% of current GDP would at least stabilise the climatic change; but this is unlikely to happen. It was a sobering and intriguing perspective on an ecological problem that appeared (at first) to be unrelated to healthcare.
By Mary Gabb (firstname.lastname@example.org)
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.
Drs Lofland (pictured left) and Pizzi (below) are members of Jefferson Medical College’s Department of Health Policy where both are associate professors. They are co-authors of Economic evaluation in US healthcare: Principles and applications.
The health economics group at a major device manufacturer bought 100 copies of the book to disseminate within the company.
In fact, Jennifer and Laura agree that scientists don’t always understand health economics, in part because they want absolute, black-and-white answers. Health outcomes research is more of a social science, they contend, and is characterised by a lot of grey nuance. Hence, their book also serves to demystify the subject.
The pair believe that while health economics is still a relatively young discipline, broader issues in the current $1.8 trillion US healthcare system are providing the field with a higher profile and greater opportunities.
For instance, as federal and state governments increase spending on healthcare services, they’ll have to make hardnosed decisions about allocating resources; as employers face rapidly increasing healthcare costs, they want data on the costs and productivity impact of medical treatments.
In short, health economists will play a much larger role in decision-making at the highest levels… with presidential candidates of both parties wrestling with how best to streamline the US health system.
Even so, they acknowledge, in a market-based system of healthcare delivery there are political constraints engendered by competing and sometimes conflicting interests. In that sense, health economists may have to deal with politics. But there’s more consistency in how studies are designed, they believe. And we’re ripe for change, they say – a change that also expands the role of health economists into such research issues as the economic impact of such major public health issues as obesity and smoking.
One issue that bothers Jennifer and Laura is when academics are exploited for marketing and promotional purposes – for example, when companies in the pharmaceutical and biotech industries send nearly identical scientific abstracts to several conferences, or ask universities to issue press releases on findings that favour their product.
They contend that each contribution to the literature should be unique and published in a peer-reviewed scientific venue. They call on health economists working for the industry to exercise ‘etiquette’ when working with academics as this will ultimately foster credibility within the field.
As for HOC, the pair are big fans, particularly for the publication’s emphasis on the whole spectrum of communications; but they say they’d like to see more content listed in the subject line of emails… and catchier titles for articles (editor’s note: we’re working on both).