engleski

Factors influencing pharmacoeconomic assessment of new drugs in dieabetes mellitus treatment

According to the latest WHO estimate diabetes mellitus (DM) epidemics data showed that the number of patients would increase to at least 300 million by 2025 (30 million in 1985 ; 135 million in 1995). The global health expenditure on DM is calculated to total at least 376 billion USD in 2010 and 490 billion USD in 2030, i.e. 12% of the health expenditures and 1330 USD per person. The largest components of medical expenditures are hospital inpatient care, prescription medications to treat the complications of diabetes, antidiabetic agents and diabetes supplies, physician office visits, and nursing/residential facility stays. Because of limited health care funding, health care decision makers are increasingly concerned to understand the clinical and economic impact of interventions used to manage DM. Pharmacoeconomic evaluation in relation to new antidiabetic medications includes the long-term benefits of reduced micro- and macrovascular complications, costs of side-effects and changes in drug utilisation patterns, in addition to the immediate drug budget impact. To help decision makers optimizing the allocation of healthcare resources health economic modelling are employed. Cost-effectiveness is expressed as an incremental cost-effectiveness ratio (ICER), the ratio of change in costs to the change in effect. Quality of life is reduced by DM-related long-term macrovascular complications such as coronary heart disease including angina pectoris, myocardial infarction, congestive heart failure, and micro- vascular complications such as nephropathy, retinopathy and nephropathy. Long-term clinical studies like UKPDS (T2 DM) and DCCT (T1 DM) demonstrated that good glycaemic control, measured by HbA1c (surrogate marker) level reduction, reduces the risk of DM complications. Thus, the impact on HbA1c reduction is widely accepted as efficacy marker in clinical and cost-effectiveness assessment of new antidiabetic agents. Efficacy of DM medications should always be assessed against the risk of hypoglycaemia. Even more, incidence of hypoglycaemia shall be used in evaluation of direct treatment costs because severe hypoglycaemia imposes a major economic burden on healthcare systems, with the highest proportion of direct costs resulting from the small number of patients who are admitted to hospital. Furthermore, because subsequent follow-up also incurs costs, hypoglycaemic episodes requiring professional attendance outside hospital generate greater costs than those treated in the community by relatives or friends. Although people with T2 DM are often perceived to be at low risk of developing severe hypoglycaemia, studies have shown that increasing duration of insulin treatment is the important factor that determines the risk of experiencing severe hypoglycaemia. In addition to long-term complications and hypoglycaemic episodes, impact of weight reduction is also being considered recently in cost-effectiveness assessments of newer antidiabetic agents. Optimal glycaemic control accompanied with low frequency of hypoglycaemia is the key to prevent long-term diabetes complications, which are major drivers of diabetes related costs. Thus, cost-effectiveness of new drugs in diabetes mellitus treatment should be assessed against these two parameters.

diabetes mellitus; medical expenditures; pharmacoeconomics; new anti diabetic medications; hypoglycaemia; cost-effectiveness

nije evidentirano