Cost effectiveness of statins in men vs women

30 October 2003

In the debate on statins and on their cost raised by Messori et al. (1) and by Jenkins (2), some points need further comments. Messori et al. (1) have tried to construct an index that expresses the degree of appropriateness of spending on statins in Italy. One advantage of their index lies in its general validity (because this method of cost assessment can be applied to other drug classes as well). However, one disadvantage is that their clinical data regarding statins are based only on the meta- analysis published by Ross et al.(3), which is questionable under some aspects. For example, the number need to treat reported by Ross et al. (3) reflects not only a mixed prescription of statins for primary and secondary prevention, but also a mixed used in men and in women (with preponderance of men).

Hence, the question whether mortality is reduced in women receiving statins remains unsettled (2). Also in the recent large-scale MRC/BHF Heart Protection Study (4), the total mortality benefit for women was not statistically significant (even though, unfortunately, no explicit figures were presented to document the non-statistical reduction of mortality in the women enrolled in this study).

A joint interpretation of the arguments presented by Messori et al. (1) and by Jenkins (2) shows that spending by prescribing statins to both men and women can be acceptable on a cost-effectiveness basis mainly because there seems to be a selective substantial benefit in men. Can this cost-effectiveness ratio be further improved by prescribing statins to men only? This question is difficult to answer, but its economic implications are macroscopic. If, for example, women are supposed to represent 50% of the Italian expenditure in statins, the saving resulting from a selective prescription in men would be around 300 million Euros per year. Similar figures can be expected from the UK market.

To help decision-makers and clinicians clarify this controversial issue, we think that the time has come to undertake a systematic review of the clinical studies assessing the effectiveness of statins in women. In fact, any pharmacoeconomic argument makes little sense when there is still uncertainty on the clinical benefits of a drug treatment.

REFERENCES

1) Messori A, Santarlasci B, Trippoli S, Vaiani M. Spending on statins. eBMJ http://bmj.com/cgi/eletters/327/7420/933-b#38400, 20 Oct 2003

2) Jenkins AJ. Might money spent on statins be better spent? BMJ 2003; 327: 933-b

3) Ross SD, Allen IE, Connelly JE, Korenblat BM, Smith ME, Bishop D, Luo D. Clinical outcomes in statin treatment trials: a meta-analysis. Arch Intern Med. 1999;159(15):1793-802.

4) Heart Protection Study Collaborative Group. MRC/BHF heart protection study of cholesterol lowering in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: 7-22.

Competing interests: None declared

Competing interests: None declared

Franca Vacca, researcher

Filippo Pelagotti, and Andrea Messori

Laboratorio SIFO di Farmacoeconomia, Careggi University Hospital, 50134 Firenze, Italy

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