OBJECTIVES: In this paper we estimate the relationship between the financial impact of a new drug on the health care system in Australia and the probability of the drug being recommended for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC).
METHODS: Data in the PBAC summary database regarding drug-reimbursement decisions made between July 2005 and November 2009 were abstracted. Financial impact was categorized as A$0 or less, greater than A$0 up through A$10 million, and greater than A$10 million per year. Descriptive analysis, logistic analysis, survival analysis, and recursive partitioning decision analysis were used to estimate the relationship between the financial impact of a new drug indication and the probability of its reimbursement. The multivariable analyses controlled for other clinical and economic variables that have been shown to be correlated with the probability of reimbursement, including the cost per qualityadjusted life-year gained.
RESULTS: In all analyses, financial impact was a significant predictor of the probability of reimbursement. For example, in the logistic analysis, the odds ratio of reimbursement for a drug submission with a financial impact greater than A$10 million compared with A$0 or less was 0.12 (95% confidence interval [CI]: 0.03-0.55); the odds ratio of reimbursement for a drug submission with a financial impact greater than A$0 up through A$10 million compared with A$0 or less was 0.16 (95% CI: 0.04-0.60). Similar results were obtained in the survival analysis. In the recursive partition decision analysis, the first split of the data was for submissions with a positive financial impact compared with those with a negative financial impact.
CONCLUSIONS: In Australia, financial impact on the health care system is an important determinant of whether a new drug is recommended for reimbursement, even when cost-effectiveness estimates and other clinical and economic variables are controlled.
