The social and economic burden of venous leg ulcers: focus on the role of micronized purified flavonoid fraction adjuvant therapy

Abstract

Chronic venous insufficiency (CVI) occurs in a relatively large proportion of the population and is associated with significant morbidity, high cost of healthcare, loss of productivity and reduced quality of life. Lower extremity ulcers related to CVI have been estimated to affect 0.2-1% of the population in developed countries. The prevalence of venous ulcers in the US is estimated at 500,000-600,000, and increases with age. Estimates of the annual incidence of leg ulcer in the UK and Switzerland are 3.5 and 0.2 per 1000 individuals, respectively. Treatment of venous ulcers can be expensive, leading to a large economic burden on health services in many countries. The annual cost of CVI is estimated to be more than 1 billion US dollars in the US and between pound 400-600 million in the UK. Current treatments for CVI include surgery, sclerotherapy, compressive therapy (conventional therapy) and adjuvant pharmacotherapy. Various pharmacological agents have been used as adjuvant therapy but in many cases there is no definitive evidence of their efficacy. Effective treatment programs for venous leg ulcers could substantially reduce the economic impact of CVI on health services. In controlled studies, micronized purified flavonoid fraction (MPFF) adjuvant therapy has been shown to increase significantly the number of healed venous leg ulcers and to reduce significantly the healing time of ulcers compared with conventional therapy alone, potentially leading to an improvement in patients' quality of life. The treatment of venous leg ulcers with MPFF was also found to reduce overall treatment costs compared with conventional therapy alone. In a retrospective cost-effectiveness analysis based on direct medical costs only, MPFF therapy improved the cost-effectiveness ratio by 45% compared with conventional therapy. If intangible costs, such as loss of quality of life were included, the difference in cost-effectiveness ratios is likely to be even greater in favor of MPFF. Sensitivity analyzes showed that even with a 20% increase in drug price the cost-effectiveness ratio for MPFF therapy was substantially better than that for conventional therapy (1061.8 US dollars vs 1871.9 US dollars per ulcer healed). Hence, the addition of MPFF adjuvant therapy to the treatment of venous leg ulcers would be effective and potentially cost saving.