Pharmacoeconomics issues

Arnold R, Kotsanos J. Proceedings of the Advisory Panel Meeting and Conference on Pharmacoeconomic Issues Panel 3 Methodological issues in conducting pharmacoeconomic evaluations-retrospective and claims database studies. Value Health 1999 2 82-7. 

A health system can own and operate its own drug information service (DIS) to serve the drug information needs of pharmacists, physicians, nurses, and other professional staffs within the system. In addition to drug information, the DIS focuses on drug formulary and pharmacoeconomic issues of drug products and drug use within the system. 

The pharmacoeconomic issues associated with the medical treatment of AP and CP have not been extensively examined. Aggressive medical and surgical care decreases mortality in AP, but the overall cost... 

These methods have been well developed in medical technology assessment as well as in other fields of economic research. However, there remain a number of methodological issues that confront investigators in economic evaluations of pharmaceutical therapies. This section reviews some of these issues as they arise in the design, analysis, and interpretation of pharmacoeconomic evaluations. 

A related issue in pharmacoeconomics trials is the generalizability of the health care delivery system of the patients in the study. A pharmacoeco-nomic study conducted through health a maintenance organization using its members as subjects may observe less referrals to specialist physicians than would the same clinical study in a different practice setting. This effect may be even more pronounced in multinational clinical trials, in which health care systems, physician education, and patients expectations for treatment differ by country. 

We have already addressed some of the general issues in the design and interpretation of pharmacoeconomic studies. Yet, prospective pharmacoeconomic studies, especially within phase III clinical trials, are often our only opportunity to collect and analyze information on new therapeutic products before decisions are made concerning reimbursement and formulary inclusion for these agents. We now address issues that arise in the design of these studies. 

While some prospective data collection is required for almost all pharmacoeconomic studies, the amount of data to be collected for the pharmacoeconomic evaluation is still the subject of much debate. There is no definitive means of addressing this issue at present. Phase II studies can be used to develop data that will help determine which resource consumption items are essential for the economic evaluation. Without this opportunity for prior data collection, however, we must rely upon expert opinion to suggest major resource consumption items that should be monitored within the study. Duplicate data collection strategies (prospective evaluation of resource consumption within the study s case report form with retrospective assessment of resource consumption from hospital bills) can be used to ensure that data collection strategies do not miss critical data elements. 

Selection of appropriate treatment alternatives in a clinical smdy is essential for a useful economic evaluation of a pharmaceutical therapy. This issue is both a clinical and an economic one. Comparators can be the most common alternative therapies for a condition or the lowest possible cost alternatives, even when not frequently used. However, in pharmacoeconomic studies, treatment comparators may be inappropriately selected as much for their relatively high price as for their likely effectiveness. Phase III smdies have special limitations in this regard, because agents will be compared against the... 

It could be argued that pharmacoeconomics is a serious attempt to determine if a particular drug, no matter its origin, offers value for money. This issue will continue to be of interest to everyone involved in treatment of disease by biotechnologically derived drugs. 

Both the quantity and the types of data able to be collected will be affected by the nature of the clinical study patients may be inpatients or outpatients, and this in turn will govern the nature of pharmacoeconomic data that can be recorded. It is also important whether a clinical trial is intended as a pivotal trial for registration or not if a study is pivotal, then a clinical efficacy measure will have to be the primary end point. Pharmacoeconomic parameters can still be incorporated into such a study as secondary end points, and still provide valuable information. If, on the other hand, the clinical research addresses a health system delivery issue, then the pharmacoeconomic end points may well be primary, and the study design need not be constrained by FDA-mandated requirements for the double-blind, placebo-controlled aspects of proof of efficacy. 

Acting as a resource in the formation of public policy relevant to pharmacoeconomics, healthcare outcomes assessment, and related issues of public concern. 

When used appropriately, therapeutic interchange has proven to be an extremely effective method of medication cost management. An active and well-organized P T Committee is essential to the success of any therapeutic interchange program. As the focus on the costs involved with medication therapy in health care organizations increases, P T Committees will have to become even more creative in methods used to promote, evaluate, and monitor the effects of therapeutic interchange. The evaluation of quality of life issues, pharmacoeconomics. 

Cohen D. The impact of health economics on health policy, health services and decision-making. In Salek S, ed. Pharmacoeconomics and Outcome Assessment — A global issue. Haslemere Euromed Communications Ltd, 1999. 

Over the past few years many reports have been published on pharmacoeconomics, pricing, and reimbursement issues. Most of the major market research firms that cover the pharmaceutical industry have published on these topics. Following is a list of the more recent titles, but a search in any of the market research portals using the terms pharmacoeconomic(s), pricing, reimbursement, or health economics will usually... 

Controversy surrounds the issue of study perspective. Many researchers assert that society is the only relevant and the most appropriate perspective from which to conduct a pharmacoeconomic analysis. However, in the United States, these studies can be very resource-intensive in terms of time and money. Further, organizations may need to focus solely from their own perspectives to obtain the data necessary to inform timely decision making. 

Bootman JL, Larson LN, McGhan WF, Townsend RJ. Pharmacoeconomic research and clinical trials Concepts and issues. Ann Pharmacother 1989 23 693-697. 

Although no prospective pharmacoeconomic sffidies have been performed in patients with GCSE, a number of economic issues may... 

Most companies have some form of standard operating procedure by which they generate clinical study reports. Pharmacoeconomic data should be handled and reported in a similar manner. In some cases it may be appropriate to issue the pharmacoeconomic component of a study as an appendix to a larger clinical report. This will depend on the... 

While provider compensation methods are effective in controlling a significant proportion of managed care s costs, they cannot work alone, as there are other priority issues that continually challenge managed care s ability to deliver high quality services, yet control healthcare costs. Cost containment issues that influence business decisions in managed care include medical loss ratios (MLRs) and pharmacoeconomic and outcomes data. 

Other regimens may be equally effective or even more so. However, comparative studies are sparse. With very prevalent diseases such as type 2 diabetes, pharmacoeconomics become extremely important. Thus, both the economy of society at large and the economy of the individual patient must be taken into account when choosing drug therapy. Safety issues remain important since treatment will often be continued for many years or even life-long, during which time complications, for example, nephropathy or cardiovascular disease, that may alter the safety profile of certain drugs may develop. 

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