Cost-effectiveness evaluation post approval

If the benefit-risk assessment is positive (i.e. if the benefits outweigh the risks), you might think that a decision on a new medicine is straightforward. This is not necessarily the case. New medicines are typically expensive. Can healthcare systems afford to treat all patients with the newest (and most expensive) medicines? The legislation in MS of the EU will also normally deal with the cost evaluation of new medicines. Policy-makers and regulators will need to balance cost against the potential advantage of new treatments. For example, a new medicine may have a positive benefit-risk ratio. However, what if it is only marginally better than an older medicine and the cost is maybe 100 times higher? Would this be considered appropriate value for money?

Several tools may be used for cost-effectiveness evaluations. In many EU countries a formal Health Technology Assessment (HTA) is required. The result of the HTA is used to conclude whether or not to allow hospitals and doctors to prescribe the new medicine under the country’s insurance and/or reimbursement system. In many countries, pharmaceutical companies must negotiate prices with the health authorities before placing their medicine on the market. In other countries, reimbursement will not be granted if the authorities consider the value for money of the new medicine to be insufficient (e.g. if they are considered not to offer an added value over existing treatments).