Many in the medical world have embraced the growing culture of evidence-based medicine, a process by which all good quality research information on a topic is synthesized to produce appropriate guidelines for patient care and management that can be published widely by governments, managed care groups, etc. The aim is to identify treatment patterns that are clearly the most clinically effective in a given situation and adjust these guidelines to embrace the various patient subgroups and disease manifestations that occur within the particular therapeutic condition.
Incentives are normally given to medical practitioners to stay within the published guidelines in each country. These incentives can be either lack of central reimbursement to the doctor or may be local concerns for litigation. Before long certain nutraceuticals and functional foods will come under this level of scrutiny and the growing evidence suggests some may do well in certain situations.
It seems likely that another closely-related and highly important area for nutraceuticals and functional foods will be their performance in cost-effectiveness calculations. While physicians resist prescribing anything that they feel is inferior to state-of-the art treatments, they are often financially forced to seek more cost-effective solutions. Because of these concerns much original work by government agencies around the world and by organizations such as Economic Healthcare Associates (EHA) are being directed to produce guidelines for the cost-effectiveness of treatments in many conditions, to supplement the growing data on their clinical effectiveness. It seems likely, when the calculations are done, that some nutraceuticals may come out ahead for their cost-effectiveness in preventing or manipulating the development of a number of expensive-to-treat diseases, including cardiovascular health.
The Cardio Connection
For example, if it can be shown that a certain nutraceutical delays onset of symptoms in a group of patients, then it creates direct savings on the cost of managing the condition. Savings could be reduced requirements for drugs, fewer operations, fewer physician or nurse visits and much more-it needs a thorough examination of the resources used to manage the condition combined with the body of good evidence (quality research) that shows where clinical benefits are achieved and to what degree. Benefits may not just be financial; they could also be manifested as a better quality of life, assessed scientifically through appropriate therapeutic area questionnaires; people pay for feeling just that little bit better, but also to prevent or defer the onset of chronic conditions.
Savings could be created whether the nutraceutical is acting to replace what should naturally be there but may not be there in sufficient quantities in a significant proportion of patients, perhaps through poor nourishment (several vitamins come to mind). Strong savings could accrue if a nutraceutical represented part of a cohesive fundamental or supplemental treatment strategy that helped to alleviate certain cardiovascular conditions (such as omega 3 fatty acids). Several studies have also shown the benefits of certain nutraceuticals as adjuncts after various types of surgery and in some conditions the reduction of the in-hospital time by as much as 30-40%. An increase in patient throughput could create substantial differences in annual budgets of hospitals, not to mention those of a managed care organization or government.
EHA recently conducted a massive literature survey of the clinical and economic evidence for the beneficial use of a variety of nutraceuticals in a range of therapeutic areas involving chronic, expensive-to-treat diseases. Emphasis was placed on using only high quality research data in reputable sources so that appropriate meta-analyses could be generated by combining similar or overlapping studies and thus produce clear indicators of the best clinical and cost-effectiveness options for the use of certain nutraceuticals as an adjunct in the management of several diseases.
In the cardiovascular area, Medline showed that, over the past 10 years, there have been 175 publications about the use of Vitamin E in the context of coronary heart disease. Nearly 20% of these were published in 1999, clearly a field growing in interest. Other active research areas for coronary heart disease have been Vitamins B6 and B12, omega 3 fish oil and folic acid. As expected, this is a dynamically changing field and the relevance of these nutraceuticals to patient management is also influenced by other relevant discoveries in mainstream medicine, such as the recently described successful use of injecting Apo E genes themselves to promote a massive acute and long-term reduction in coronary artery plaque.
As part of our research we also looked at the entire publication list covering the cost-effectiveness issues surrounding the use of all nutraceuticals and functional foods we could find. The health economic literature only partly coincides with the clinical (Medline) literature so the use of many other database resources is required for this task. It emerged that of nearly 500 health economic studies on coronary heart disease, the main studies relevant to nutraceuticals have an overall nutritional or an anti-obesity focus. Anti-obesity strategies are highly cost-effective when viewed across a large community and not just from a cardiovascular point of view. The direct and indirect costs of obesity in the U.S. exceed $100 billion, with cardiovascular disease expenses eroding a large chunk of this national economic burden.
From the medical and health economic literature we conclude that enough reputable work has been published now to be fairly confident that evidence-based studies are likely to show that some nutraceuticals will represent a cost-effective adjunct to the management of coronary heart disease and angina also. Clinical and cost-effectiveness may be constrained to certain patient sub-groups and these need to be identified accurately for better and more successful market positioning.
We are just starting to collect data in several countries on costs and resource utilization to identify under which circumstances nutraceuticals offer both clinical and cost-effective improvements in the management of patients with coronary heart disease and/or angina and also in recovery times, therefore costs, after coronary heart by-pass surgery.
But What Of Recent Advances?
Without wishing to pre-empt the outcome of the various evidence-based medicine and evidenced-based cost-effectiveness evaluations currently being conducted, what is the current opinion in the medical and the health economic fraternities on the use of certain nutraceuticals in cardiovascular health?
Antioxidants appear very useful at slowing coronary heart disease, notably Vitamins E and C and, rather more disputedly, Vitamin A (via beta-carotene), each by their action on LDL cholesterol. Beyond cardiovascular clinical benefit, manufacturers would be well advised to consider-in any cost-effectiveness arguments on the long term use of these vitamins (particularly C and E) -including the health economic benefits in other therapeutic areas, notably cataract and macular degeneration, which are both expensive to treat and affect the same age group. Vitamin E also shows promise in protecting against Parkinson's and Alzheimer's diseases so there may be a health economic argument to add from here; this is probably very significant when the substantial prevalence of these expensive conditions in the Western world is considered.
Into any health economic analysis must go the cost of treating side effects. Current thought is that anyone taking over 400 IU of Vitamin E per day is more likely to risk generating costs for treating side effects. In an analysis for a government, this would be a particularly important aspect to include, together with an assessment of the proportion of people in the country who choose to take higher doses and generate medical care costs because of this.
Omega 3 fatty acids continue to gain cardiovascular credit, not only for their ability to reduce both triglyceride levels and blood pressure, but also because they diminish fibrinogen levels in blood, thus even further reducing the risk of cardiovascular disease. The positive effect of omega 3 fatty acids in arthritis may represent a supplementary area for manufacturers to develop for major customers a cost-effectiveness argument to combine with that for their cardiovascular benefits. Marketing material for individual customers would seem likely to be stronger by such a joint approach too.
With a massive number of relevant publications about nutraceuticals and cardiovascular health appearing over the past 1-2 years it has not been possible in the space available to attempt to review more than a hint of the clinical and cost-effectiveness evidence recently emerging in this area. However, the signs are that manufacturers would be well advised to start to prepare or commission the assembly compilation of the robust evidence they will need to promote the marketing of their products from both clinical and health economics perspectives; large and small scale customers will all demand it and competitor claims may also become a consideration. NW