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scribing decision of the physician is circumscribed. Barriers to drugs have arisen in an increasingly cost-conscious health care environment [6]. Although persuaded of the clinical benefit of a new drug, the physician may not be able to prescribe it. Although drug costs per se account for a small proportion (ca. 8 percent) of total health care costs, drug budgets are under strong pressure in most countries. Barriers include national reimbursement agencies, hospital formulary committees, managed health care organizations and national or local agencies with funding responsibilities. These diverse groups will be influenced by data to allow or even recommend using a new drug. The decision criteria and the type of information on which these decisions will be based differ between these groups. An awareness of the different perspectives of the customers who ultimately guide drug use is essential (Table 2) to ensure that relevant data is collected to provide a passport of entry (see Fig. 3). |
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Savings in the drug budget can be made by using cheaper drugs offering equivalent benefit, more effective use of existing drugs, and by limiting access to drugs whose widespread use is unjustified. Cost saving, however, has to be assessed in the broader context of overall health care expenditure. Additional drug cost may well, for example, be easily justified by reduced hospital costs. Demonstrating the cost effectiveness of new medicines will be a critical factor for commercial success in the future. This represents a difficult challenge for the pharmaceutical industry and society because value demonstration is easily supportable as a concept but far from easy to apply in practice. The challenge that health economics poses for those engaged in designing drug development strategy is profound. Many of the real benefits of a new medicine and its true cost effectiveness will not be demonstrable within the scope of clinical trials supporting first registration, pricing, and launch. |
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An integrated health economics strategy is required that provides data when needed to the relevant customer. In early development, a pharmacoeconomic strategy can be developed with modeling based on epidemiological studies and the way disease management is practiced in the major territories. This will help focus clinical development strategy and highlight the key data sets best demonstrating product value in use. This type of study can be undertaken in phase 1 (or, indeed, earlier as strategic support to the discovery engagement in the disease area). Early development studies should be performed to further define current practices of disease management. This should address the best alternative options of disease intervention and the real-world direct and indirect costs and benefits of such interventions. This work provides a basis for assessing the differential impact of |
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