Cost of Adverse Drug Events on Health Resources Utilizaton in Older Adult Singaporeans

Abstract

A517number of expedited approval programs. The objective of this study was to evaluate these programs by examining whether drugs included in them have provided larger health gains than drugs excluded from them. Methods: We considered the FDA's priority review, accelerated approval, and fast-track programs. We estimated health gains in terms of quality-adjusted life-years (QALYs) for drugs approved for the first time between 1999 and 2011, relative to treatments available at the time of their approval. We identified QALY estimates from published cost-utility analyses, and comparative effectiveness studies that estimated relative effectiveness using QALYs. We excluded studies that compared drugs to placebo or no treatment when an alternative active treatment was available, and to be conservative we excluded estimates from studies supported by the pharmaceutical industry. We compared QALY gains for drugs included in the designation programs vs. drugs excluded from them using Mann Whitney U tests. Results: We identified QALY gain estimates for 102 drugs, representing approximately 40% of drugs approved between 1999 and 2011. We included 15 of 37 drugs approved through accelerated approval, 54 of 149 drugs approved through priority review, and 24 of 65 drugs approved through fast-track designation. Drugs in the priority review program had mean QALY gains of 0.35 vs. -0.02 for drugs excluded (p= 0.011). Drugs included in the accelerated approval program had mean QALY gains of 0.43 vs. 0.13 for drugs excluded (p= 0.039). Drugs included in the fast-track designation program had mean QALY gains of 0.34 vs. 0.12 for drugs excluded (p= 0.014). ConClusions: This study suggests that drugs included by FDA in accelerated review programs have larger clinical gains than drugs excluded from the programs.

Economic burden of adverse drug reactions and potential for pharmacogenomic testing in Singaporean adults

“…At a rate of US$570,400 per 1000 patients, the direct annual ADR burden in Singapore is estimated to be US$168 million, almost 5% of the annual operating healthcare expenditure [31]. The median cost of US$2951 was also much higher than the SGD1015 (~US$734) reported previously in elderly patients from the same institution, likely because of different ADR detection methods (ICD codes vs. manual review) [3]. In this study, bleeding and/or elevated INR due ADR adverse drug reaction, INR international normalized ratio a Suspected drugs were classified according to the Anatomical Therapeutic Chemical (ATC) classification system [42].…”

“…Data on ADR-associated costs in Singapore are scant. In a recent study, ADRs were identified using International Classification of Diseases (ICD) codes in patients ≥ 65 years old, and the median hospitalization cost per patient with ADRs was estimated to be $1015 (2013 SGD, approximately US $811) [3]. On the higher end, the median cost of hospitalization for chemotherapy-induced febrile neutropenia in cancer patients was $3964 (2012 SGD, approximately US $3171) [4].…”