Pharmacoeconomics of Genetically Engineered Drugs

Biotechnology is a rapidly developing area of drug development which has great growth potential. Development of genetically engineered drugs is very expensive and as these products become available the impact on healthcare costs could be vast. The cost-benefit ratio of biotechnology products needs to be established, but few relevant pharmacoeconomic studies are available. Issues in pharmacoeconomic analysis of genetically engineered drugs can be exemplified by the data available for alteplase, epoetin and interferon α-2b. One study concluded that thrombolysis with streptokinase rather than alteplase would substantially reduce the percentage of total hospital costs that were not reimbursed. However, differences in efficacy were not accounted for. Based on the superior efficacy of alteplase, a more extensive pharmacoeconomic analysis found that alteplase was more cost-effective than streptokinase when the agents were combined with aggressive reocclusion management. However, this conclusion may be altered by the finding of a more recent study that streptokinase may be at least as effective as alteplase. Economic factors involved in epoetin treatment of anaemia associated with chronic renal disease have been studied thoroughly. However, cost-effectiveness or cost-benefit analysis was not attempted, and improvement in quality of life with epoetin therapy also needs to be considered, to facilitate cost-utility analysis. Compared with chlorambucil, the use of interferon α-2b for hairy cell leukaemia resulted in significant direct and indirect cost savings, in a retrospective cost-benefit analysis. However, the validity of the results may be compromised by use of the Delphi approach (a panel of experts), rather than direct clinical trial data, to estimate disease severity and survival expectancy; and also by the comparison of treatments given in different time periods.