The management of hypercholesterolemia continues to be a topic of active research–reflecting, no doubt, the enormous burden of cost and illness that cardiovascular disease (CVD) represents; the importance of hypercholesterolemia as a risk factor; and the gap between current risk and minimum risk in the US population.
This research is providing new insights to guide clinical management. To begin with, we appreciate how complex are the physiologic systems that govern serum cholesterol–and are challenged to consider interventions to address multiple components of those systems to achieve desired results. More recently, we have come to understand that historical targets for lowdensity lipoprotein (LDL) cholesterol–especially in patients with (or at high risk for) CVD–may not be low enough. Finally, we have recognized the expansion of the therapeutic armamentarium–in particular, the efficacy of a cholesterol absorption inhibitor, such as ezetimibe, in combination with a statin, as a means by which to achieve LDL cholesterol control.
These findings suggest that cholesterol control targets are moving–lower levels seem to lead to better outcomes and seem increasingly achievable. This has real implications for managed care organizations (MCOs). The challenges these imply are even more noteworthy, given evidence that many patients are not managed even to current National Cholesterol Education Program goals.
There is, in these findings, great opportunity for MCOs to improve care. At the same time, there are very real issues on the financial front. Expansion of the group of patients at high risk for CVD increases the number of individuals eligible for (what is usually costly) pharmaceutical therapy. Furthermore, the lowering of targets for control will increase the intensity (and the cost) of that therapy.
While the use of higher doses of statins may have little effect on cost, the addition of new agents (like ezetimibe) that act synergistically could increase cost quite significantly.
How many patients will be prescribed ezetimibe is difficult to know. But with "usual care" achieving target less than 50% of the time (data elsewhere in this supplement)–and with a clear physiologic rationale for intervention elsewhere in the cholesterol pathway–the likelihood that ezetimibe plus a statin will become the standard of care is very high. Although that should lead to significantly better control–and better clinical outcomes–it seems certain that it will lead to higher costs in the short run. Whether the intriguing results from Sweden, that suggest lower health care costs for CVD, will persist and generalize remains to be seen. For the moment, it seems only that it will exacerbate a health care cost problem that is already formidable.
How can MCOs respond? I think they need to lay out–and communicate to their networks and to their members–rational protocols for cholesterol management. In addition, they need to consider what mechanisms they have to encourage and enable their adoption and use. Those protocols must map out treatment paths for patients with hypercholesterolemia that drive toward targets but assure that medications are added rationally and cost-effectively.
Statins will remain the first-line therapy–ideally with diet and exercise. Guidelines will need to consider when to advance statin therapy and when to add other agents. There will be enthusiasm, no doubt, to add ezetimibe–early and often. MCOs will need to provide guidance to assure that potentially cost-effective alternatives (bile acid sequestrants, niacin) are appropriately considered.
This will mean education and judicious use of incentives. Pharmacy benefits should provide members with incentives to move along the most cost-effective treatment path. Perhaps no aspect of care, though, is more amenable to measurement-based systems to influence physician decisions. The outcome of cholesterol management is measurable (and obtainable relatively inexpensively from laboratory datasets), and the cost of achieving those outcomes is readily obtainable from claims data.
The opportunity for feedback–or value-based incentives–is clear. In combination with education (of members and physicians), the potential to rationalize but also to improve care should be clear as well.