Adr

, increased cost; decreased cost.

, increased cost; decreased cost.

No test

Conventional chemo-Rx in all Hercep test in all—>

Pos. test: Herceptin + conv.chemo-Rx Neg. test: conv. chemo-Rx

No test

Herceptin + conv. chemo-Rx in all

Figure 2 Incremental cost-effectiveness ratio Herceptin/HerCep test.

Incr. QALYs

Incr. cost

Figure 2 Incremental cost-effectiveness ratio Herceptin/HerCep test.

expressed cost per quality-adjusted years of life) for an expensive novel treatment where a less discerning use of the novel treatment may be associated with an unacceptable ratio based on the inclusion of nonresponders. An example for such an analysis was recently conducted for the case of Herceptin and its companion diagnostic test (HerCep test) (Figure 2). In this example

[6] , it could be clearly shown that the use of the test in all patients, followed by a targeted prescription of the new drug only to those in whom it was indicated based on the test, showed an acceptable incremental cost-effectiveness ratio, and one that was clearly superior to a more indiscriminate use of the drug.

Cost-effectiveness calculations are affected by numerous factors, including the prevalence of a (positive) test result which materially affects the choice of therapy, the test performance as outlined above in terms of analytical performance and clinical validity, the context with regard to indication and intended use (see below), the magnitude of the advantage over conventional treatments that the test-guided alternative therapy provides, by the cost of tests and different treatments, and last but certainly not least, by the reimbursement environment, including pricing policies that will differ from market to market.

Yet another way of looking at the question of clinical utility with regard to medical economics would be to calculate the number needed to screen (i.e., the number of patients that need to undergo the diagnostic test to achieve a particular outcome in at least one case). The outcome could either be defined as the prevention of a death or as an adverse event. Such a definition could be reached for both efficacy markers (where the choice of a certain drug based on screening may result in more successful treatment of eligible patients, and thus lives saved as compared with standard of care therapy) and—perhaps more obviously—for safety markers where the result would be the avoidance of an adverse event.

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Project Management Made Easy

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