Lipid‐modifying and glucose-lowering therapies in clinical practice The impact of guidelines and changing reimbursement schemes

Sammanfattning: cardiovascular disease, which is still a major cause of death that creates large burdens to society in terms of costs and morbidity. Dyslipidemia and type 2 diabetes mellitus are the main risk factors for cardiovascular disease, and national and international guidelines recommend lipid-modifying and glucose-lowering treatments for prevention. In 2010, about 836,000 (9% of the population) and 372,000 patients respectively were treated with these therapies in Sweden.Various pharmaceutical policies aimed at improving the efficiency of drug use have been introduced over the years. Health technology assessment (HTA) was introduced in Sweden in 2002 as a foundation for informing pricing and reimbursement decisions by the Dental and Pharmaceutical Benefits Agency (TLV). Following HTA reviews, new reimbursement schemes for lipid-modifying and glucose-lowering therapies were introduced in 2009 and 2010 respectively. To assess the impact of the changing reimbursement schemes on the use and costs of these therapies, we analyzed data from the Swedish drug registry, using a quasi-experimental design and interrupted time series analyses.Our results showed that the new reimbursement scheme for lipid-modifying treatment had a major effect on use; following the implementation of this scheme, there was a substantial increase in both discontinuation and switching to higher doses. Conversely, the new reimbursement scheme for glucose-lowering therapies had overall only a minor effect on use. Larger savings in the lipid market were anticipated but not fully realized, while even the minor anticipated changes in costs in the glucose-lowering market were not realized due to increased costs for insulins. We found that changes in reimbursement schemes might lead to unintended effects, which should be considered before implementation. Softer demand-side policies, such as recommendations and guidelines, might be a better option under some circumstances.Clinical and national guidelines are other policies aimed at improving quality of care and drug use. We assessed the impact of guidelines on the quality of lipid-modifying therapies, defined as proportions of patients attaining goal/normal levels according to guidelines for lipid management. A longitudinal retrospective observational study was carried out, covering time periods before and after initiation of lipid-modifying treatment. The findings show that about 40% of the patients attained the recommended low-density lipoprotein cholesterol goals following treatment, but only 18% attained goals/normal levels in all lipid parameters. Improvement in triglycerides was moderate, and low levels of high-density lipoprotein cholesterol persisted, showing only modest improvement following therapy. Treatment patterns were found to have a better degree of adherence to guidelines regarding low-density lipoprotein cholesterol as compared to other lipid parameters.The overall objective of treatment of type 2 diabetes mellitus is to improve glycemic control without negatively affecting quality of life. Hypoglycemia is a common side effect of intensive blood glucose control, mostly seen in patients treated with insulins. Earlier studies have suggested that hypoglycemia has a negative impact on quality of life, even in patients treated with oral glucose-lowering therapies. We carried out a cross-sectional retrospective study to assess the impact of self-reported experience of hypoglycemia on quality of life in Swedish adult patients with type 2 diabetes mellitus treated with a combination of metformin and sulfonylureas. The results showed that about 40% of the patients achieved the goal of glycemic control. About 19% reported experience of moderate or more severe hypoglycemia, and these patients were found to have lower quality of life than those patients reporting no or mild hypoglycemia, as measured by EQ-5D, a generic quality of life instrument. This could be important to consider in clinical practice.