Impact of high-cost drugs for individual patient use

Abstract

Aim: To document and describe the individual patient use (IPU) scheme at St Vincent’s Hospital,Sydney in terms of submissions and approvals and assess the financial impact of the scheme on the hospital drug expenditure. Method: All submissions for IPU approvals received between January 1997 and December 2001 were reviewed. Submissions were collected on a calendar year basis. Data collection and analysis included identification of approved medication and indication,off-label or approved indication,prescriber,ward,outcome of therapy,person deciding the approval,approval date duration and expiry,amount of medication dispensed and the cost of therapy. The annual cost and proportion of overall drug expenditure for each approval was calculated. Results: The number of approvals had a trend to increase each year. 67. l% of the IPU approvals were for off-label indications. Requested feedback on clinical outcomes was provided only in 18% of cases. The drug acquisition cost of the IPU scheme more than doubled in the period between 1999 and 2001. Similarly the proportion of the drug expenditure on IPU drugs increased significantly (p < 0.001) from 1.6% in 1999 to 3.6% in 2001. Conclusion: The results indicated that the number of approvals and submissions for IPU had a tendency to increase. The financial impact of the IPU scheme increased over the years reviewed.