Cost-effectiveness analysis of drug regulation: Remedy for rising costs of drug development ?

The question that Bouvy et al. raise in the February issue of Clinical Pharmacology & Therapeutics is how much society is willing to pay to minimize the risks related to the use of drugs. They argue that cost-effectiveness analysis of drug regulation should also be considered in the effort to counter the rising costs of bringing drugs to the market.

There is no such thing as zero risk. I am sure that most of you are aware that the beneficial use of drugs is always accompanied by (the risk of) side-effects. Some side-effects occur more frequent, are not life-threatening, but can have a quite annoying effect on the quality of life. Other side-effects are less frequent, but considerably more serious or even life-threatening.

To assess the risk of a sudden cardiac death resulting from a drug-induced abnormal heart rate interval, regulators require all drugs under development to be evaluated in a thorough QT/QTc (TQT) study in accordance with the ICH E14 guideline. In their study Bouvy et al. focused on the risk of a drug-induced sudden cardiac death in relation to the costs of the regulatory requirement to assess the potential arrhythmia liability of an antipsychotic drug (a so-called QT-prolongation: see Figure).

Schematic representation of normal ECG trace (sinus rhythm), with waves, segments, and intervals labeled. (Source: Wikipedia)

In brief, Bouvy et al. compared two pharmaco-economic scenarios: the health effects and costs resulting from implementing ICH E14 (“regulation” scenario) vs. not implementing ICH E14 (“no regulation” scenario). They determined the cost-effectiveness of the ICH E14 guideline for a prototype QT-prolonging antipsychotic drug entering the US and European markets. Their overall conclusion was that the health gains resulting from implementing the regulation do not outweigh the costs associated with the regulation. Consequently, they propose that cost-effectiveness analysis of drug regulation should also be considered in the effort to counter the rising costs of bringing drugs to the market

There is a lot to argue against the study results and conclusions, but also a lot for it. Being an academic study, the authors have made a number of assumptions in their study (which they subjected to a sensitivity analysis). Moreover, whether the results of a prototype QT-prolonging antipsychotic drug is applicable to other drug types remains to be determined. Nevertheless, the study by Bouvy et al. warrants further discussion on the added-value of cost-effectiveness analysis of drug regulation before implementing such measures. Of course, I realize that such a discussion is highly sensitive, and includes an important practical, social and ethical component that has not even been touched upon. Moreover, the question “how much is society willing to pay to minimize the risks related to the use of drugs ?” is certainly not easily answered, but shouldn’t be discarded either for reasons of complexity. The authors have already published a second paper in Pharmacoeconomics that deals with the general public’s willingness to pay.

The stakes are simply too high. The current economic crisis puts healthcare budgets under increased pressure. Rising costs of developing a drug may render them unaffordable in the future. Moreover, as stated by the authors “The pharmaceutical industry is one of the world’s most intensively regulated industries”. As recommended in 2004 by Rawlins: “all aspects of the drug discovery and development process should be examined for potential cost savings”, regulations included.

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