International Guidelines For Pharmacoeconomics Analyses - Vive La Différence?

Michael Drummond PhD, 2006-2007 ISPOR President and Professor of Health Economics, University of York, York, UK

A growing number of jurisdictions now require economic evaluations as part of the decision-making process for the pricing and/or reimbursement of medicines. The review by Tarn and Smith [1], now available on the ISPOR website www.ispor.org, considers 30 sets of guidelines, many of which were produced as guidance for those submitting dossiers to the authorities.

The conclusion of the review by Tarn and Smith, consistent with that by Hjelmgren et al. [2], is that although there are many similarities among the various national guidelines, there are also several differences. How do such differences arise, does this matter and what can be done about the situation?

There are a number of reasons why differences arise. First, there may be justifiable variations in national perspectives. Issues in this category could include the choice of discount rate and the incorporation of equity considerations. Secondly, since methods develop over time, guidelines developed several years ago may reflect the state of the art at the time, rather than the methods that would be preferred today. Thirdly, guidelines may reflect the methodological interests and (dare I say) biases of the individuals developing them.

We might take the view that such diversity is a good thing - vive la différence! However, the variations in local requirements increase the burden on those making submissions in more than one jurisdiction. Also, where out-of-date methods are being prescribed this may lead to a sub-optimal assessment of the cost-effectiveness of a new drug in a given setting. For example, an insistence on data only from RCTs may mean that some of the advantages of a product cannot easily be demonstrated.

Whilst it is important to respect the local preferences of decision-makers in different settings, perhaps the time has come to have a debate about the extent to which requirements differ and whether these differences are justified [3]. Such a debate may serve to improve the methodological standards in all settings and identify the key areas of methodological debate.

ISPOR, with its international perspective, drawing on membership from academia, decision-makers and industry, is uniquely placed to take the lead in such a debate. As a first step, a plenary session at the next European meeting is being planned, where the methodological content of several European guidelines will be compared and the scope for harmonisation assessed.

References

1. Tarn TY, Smith MD. Pharmacoeconomic guidelines around the world. ISPOR CONNECTIONS 2004;10:4-5.

2. Hjelmgren J, Berggren F, Andersson F. Health economic guidelines - similarities, differences and some implications. Value Health 2001;4:225-50.

3. Sculpher MJ, Drummond MF. Analysis sans frontières: can we ever make economic evaluations generalisable across jurisdictions? Pharmacoeconomics 2006;24:1087-100.

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