Value-based pricing and putting epidemiology into practice
I see epidemiology as the study of health and disease in populations. It can be observational (e.g. cohort studies) or experimental (e.g. clinical trials). Last week, I blogged about the increase in research funding and how more “bang-for-buck” may be expected from public- and private-funded research in hard economic times. Moreover, the best kind of health research is the kind that influences practice, or even better, translates into the policy sphere. However, shortcomings in design of research on the one hand, and clinical practice and policy on the other, mean that much epidemiology is not used or useful.
Clinical trials attempt to tell us whether a drug has a benefit in a particular clinical setting. Cost-effectiveness studies go further, allowing us to assess the relative cost of a drug versus the benefit gained (often by quality-adjusted life-years, QALYs). This epidemiologic research is vital because drugs make up a huge proportion of healthcare spending, for both the individual and the health system. Amazingly, there is no system in the NHS (or for that matter in the world) for directly correlating the amount of money spent or profit made by a certain drug with the health effects of that drug. The pharmaceutical industry has enjoyed the unique status among other manufacturing industries where sale of its products is not determined by their value. This aspect may contribute to the many conflicts of interest, scope for manipulation and lack of clinical data.
There have been many calls for changes in physician-pharma relationships and in the way pharma deals with its intellectual property rights, but few calls for change in the way pharma interacts with health systems. Well that is about to change. The UK Department for Health this week ended a 3 month consultation about value-based pricing (VBP). The government is hoping to roll out this scheme in 2014 and plans to incentivise innovation in drug research by rewarding pharma companies based on the “value” of their products.
A non-profit organisation, Incentives for Global Health, to which I am a medical advisor, is promoting a similar proposal on a global scale: the Health Impact Fund. This global fund aims to incentivise drug development and distribution based on the health impact of the drugs.
Both value-based pricing and the Health Impact Fund must face scrutiny, improvement and testing. However, not only do they both represent opportunities to change the way in which epidemiologic data is collected and used in this research area, they have the potential to radically improve the way in which health systems use limited resources on the expensive resources which are drugs. Have a look at my podcast on IDEAS-LAB about value-based pricing
Increase in UK and global research funding-value for money?
Last week, the UK government unveiled plans to put £775 million of extra research funding into the NHS over the next 5 years. In addition, the newly appointed Chief Medical Officer, Professor Dame Sally Davies, is also Director General of Research and Development and Chief Scientific Adviser for the Department of Health and NHS, and so has a longstanding passion for raising the profile of health research.
If we look around the world, health research funding has also grown substantially, with US$ 160.3 billion spent in 2005, up from US$ 125.8 billion in 2003. In 2005, the UK was the third largest spender on health research at US$4.2 billion, after the US and Japan. The World Health Report 2012, boldly titled “No Health Without Research” will focus on the role of research and evidence in the improvement of global health. Over the last 5 years, the World Health Organization has been making a sustained effort at the international level to encourage research initiatives in public health, including:
- The 2005 World Health Assembly Resolution 58.34, which called upon WHO member states to “establish or strengthen mechanisms to transfer knowledge in support of…. evidence-based health-related policies.”
- The Bamako Call to Action, which urged governments to allocate at least 2% of budgets of ministries of health to research and to earmark at least 5% of funding for research, including support for knowledge translation practices.
There is no doubt that more funding and resources, both in the UK and globally, will lead to more research and hopefully more evidence for clinical practice and policy, but will this lead to improvement of health or health systems? The Global Forum for Health Research found that 97% of spending on health R&D continues to be by high-income countries, with only 3% by low- and middle-income countries. Unsurprisingly, most of this money goes towards generating products, processes and services tailored to needs of the health-care markets of the richer countries. In the UK as well, there are differences of opinion over whether money in research is well spent and whether universities manage health research better than the NHS, and about the amount of resource that is wasted in the current research infrastructure.
There has been a trend towards more funding for translational research in recent years (i.e. research that actually changes practice), both globally and in the UK. Particularly since large amounts of public money are invested in research, the scientific machine must try harder to make research relevant to the health of all sectors of the population, and make the most efficient use of this research. Worldwide, ‘global health financing’ has aimed to address this issue, by channelling external finance towards the health sector of low and middle income countries in order to meet the needs of predominantly poor population groups. The increase in private funding for global health now accounts for 25% of all development aid for health. However, inadequate monitoring and tracking of resources may have complicated and fragmented health systems. This is an important lesson for UK research funding.
The next paradigm shift is the change in the manner in which research is communicated and disseminated. The usefulness of research cannot only be measured by publications because of lack of access to journals and lack of access to research institutions. Blogging, Twitter and mobile technologies are examples of media already filling a void in research communication and will play a growing role. New metrics for evaluation of health research which assess its health and broader societal impact may not be far off. The bottom line is that more funding for health research is very welcome but it must be adequately allocated, monitored and tracked to ensure that the resources are properly used and not wasted.
The Pubmed Index and lessons from ethnicity and stroke
I have started using what I have termed the “Pubmed index” to show trends on a particular topic in medical research. In essence, after an unrestricted search in Pubmed to find how many articles mention my search terms, I look at how many hits I get by restricting the search to 10, 5 and 1 years, to find out how much of that research has been done recently, and how “hot” the topic is. “Ethnicity” and “stroke” gives 2411 references, of which 1719 hits are in the last 10 years, 1067 in the last 5 years, and 182 in the last year. In other words, most of the work on ethnicity and stroke has been done in the last 10 years, and the topic is still being researched.
This makes sense because 10-15 years ago, data from the UK and North America showed that there were differences between black and white populations in stroke. For example, there was an excess of haemorrhagic stroke in black populations. In America, this ethnic group had reduced access to stroke services and higher mortality rates, leading to the so-called “stroke belt” in the South-eastern region of the US. The research base for racial or ethnic disparities in stroke has increased across ethnic groups, including Hispanics and South Asians. More recently, with epidemiologic transition and rising prevalence of chronic diseases, data is showing differences in stroke subtypes and risk factors between black and white populations in sub-Saharan Africa.
Ethnicity research has faced hurdles, partly because inadequate definitions and partly due to concerns about political correctness, and ethnic minorities are still under-represented in clinical trials in stroke. With increasing migration within and between populations, a greater consensus is required regarding future studies of ethnic disparities. More comparisons need to be made between ethnic groups as “immigrant populations” versus the ethnic groups in “home populations”, to consider what the effects of migration on disease in its own right are.
Prospective studies which follow populations over time, like the REGARDS(REasons for Geographic And Racial Differences in Stroke) Study in the US, are a preferred methodology than retrospective studies. There has been surprisingly little research about ethnicity in relation to other “non-modifiable risk factors”, such as family history or genome-wide scans, which will help in characterising how ethnicity is associated with risk factors, behaviour, treatment and disease outcomes.
This week, the BMJ published a study online showing that black patients and patients from higher socioeconomic groups were more likely to be admitted to stroke units than white patients and poorer patients in an area of London. These results are interesting because historically data about ethnic disparities, regardless of the country or the setting, has invariably shown that ethnic minorities have less access to services. A rapid response to the article, rightly concludes that we need to know more accurately what is happening overall in the population, rather than having isolated studies. As unwarranted variations in population medicine are increasingly studied and linked with changes in health policy, proactive, rather than reactive studies of ethnicity are required. In other words, it is not enough to just describe variations and disparities, we need to move towards explanations and potential actions which can reduce disparities, and need better population-wide surveillance.