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Problems in Pharmacoeconomic Analyses—Reply

Michael Stafford, MBA
[+] Author Affiliations

Stephen J. Lurie, MD, PhDSenior Editor: IndividualAuthor
Phil B. Fontanarosa, MDExecutive Deputy Editor: IndividualAuthor

Copyright 2000 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

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JAMA. 2000;284(15):1922-1924. doi:10-1001/pubs.JAMA-ISSN-0098-7484-284-15-jlt1018
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To the Editor: The pharmaceutical industry in Australia is certainly aware that pharmacoeconomic analyses are complex and difficult to evaluate, as stated in the article by Dr Hill and colleagues,1 but we disagree with its conclusions. It is also not obvious from the article that at least 2 of the authors were involved previously in more than 1 stage of the analysis of each submission. This brings their perspective into question.

As pointed out in the Editorial by Drs Rennie and Luft,2 governments have biases, too. Kassirer and Angell3 have pointed out that cost-effectiveness analyses share many of the features of a review article. Both allow numerous judgment calls by the analyst, all of which may be biased.

In determining the relevance of the highlighted problems, it would have been helpful for Hill et al to describe their relationship to the recommendation of the Pharmaceutical Benefits Advisory Commitee (PBAC). Although they list this information in their Table 1, the authors supply no data that would have put in perspective the "problems with the interpretation of pharmacoeconomic analyses" within the unique Australian system and their relevance to the reimbursement decision.

The PBAC has a strong preference for economic evaluations based on head-to-head randomized clinical trials,4 so it is not surprising that the authors found that 62% of submissions had "uncertainty" in the estimates of comparative clinical efficacy, and 28.5% had "modelling issues." The Australian pharmaceutical industry suggests that many of these uncertainties and issues are matters of interpretation or a reflection of the uniqueness of the Australian system in contrast to the global drug development environment.

The role of economic analysis is to assist the decision-making process, not to supply perfect data unique to the Australian system.

REFERENCES

Hill  SR, Mitchell  AS, Henry  DA. Problems with the interpretation of pharmacoeconomic analyses: a review of submissions to the Australian Pharmaceuticals Benefits Scheme. JAMA. 2000;283:2116-2121.
Rennie  R, Luft  H. Pharmacoeconomic analyses: making them transparent, making them credible. JAMA. 2000;283:2156-2160.
Kassirer  JP, Angell  M. The Journal's policy on cost-effectiveness analysis. N Engl J Med. 1994;331:669-670.
Commonwealth Department of Human Services and Health,  Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the Pharmaceutical Benefits Advisory Committee: Including Major Submissions Involving Economic Analyses. Canberra: Australian Government Publishing Service; 1995.

Disclaimer: Mr Stafford is a nonvoting member of the ESC and secretary of the Health Economics Committee (HEC). The HEC of the Australian Pharmaceutical Manufacturers Association (APMA) consists of 17 representatives from member companies of the APMA.

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Hill  SR, Mitchell  AS, Henry  DA. Problems with the interpretation of pharmacoeconomic analyses: a review of submissions to the Australian Pharmaceuticals Benefits Scheme. JAMA. 2000;283:2116-2121.
Rennie  R, Luft  H. Pharmacoeconomic analyses: making them transparent, making them credible. JAMA. 2000;283:2156-2160.
Kassirer  JP, Angell  M. The Journal's policy on cost-effectiveness analysis. N Engl J Med. 1994;331:669-670.
Commonwealth Department of Human Services and Health,  Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the Pharmaceutical Benefits Advisory Committee: Including Major Submissions Involving Economic Analyses. Canberra: Australian Government Publishing Service; 1995.
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