The desirability and feasibility of economic studies of drugs post-launch

Excerpt

Post-launch economic studies have attracted more interest since some jurisdictions have requested economic data as part of their formal decision-making process on the pricing, reimbursement or use of drugs. There has been a growing realisation that much of the data required by reimbursement agencies cannot easily be provided before the drug is marketted. For example, it is difficult to know whether the clinical effect observed in short-term clinical trials is maintained in the long run. Also, it is difficult to know how well patients will adhere to the new drug in regular clinical practice and the long-term consequences of their withdrawal from therapy. Prior to launch it may also have been difficult to compare the drug in head-to-head clinical trials with the most relevant alternative products. This could be because drug-licensing agencies during phase III have mandated particular comparators or the use of a placebo. Alternatively, it could be because the main competitor products at that time were themselves investigational drugs. Since post-launch studies are not generally mandated by licensing authorities, the principal reason for companies to undertake such research is to gather more data or evidence that will maximise the financial return from the product either by maintaining price or by increasing market access. …