The Reimbursement Challenge

The reimbursement landscape for pharmaceutical products, driven largely by the expanding US market, was relatively stable until 1990s and characterised by expanding volume, limited price control and multiple physician prescribers. During this era of first and best in class, regulatory hurdles were relatively low and pipeline pruning took place only if the drug was particularly unsafe or ineffective. The market signalled its willingness to pay for key therapeutic areas and so industry responded to these large markets with clear targets by focusing its attention on them in a logical deployment of capital. Significantly, decision-making in this market was highly dispersed and totally uncoordinated.

The situation changed from 1990s onward. The increasing cost burdens of rising prices and expanding volumes (associated with life-long chronic disease therapies) led to first modest, and then more intense pushback. First in Europe, then in the US, the rise of evidence-based decision-making became apparent as pharmacoeconomics gained ground. Qualitative assessment, value for money, evidence-based protocols and head to head comparative data assessments became widely used by the new health technology assessment bodies and other entities formed to evaluate value.

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