Regenerative medicine access
Although there aren’t many regenerative medicines or cell therapies that have been approved, there are a number of mechanisms for regenerative medicine access. Most regulatory agencies, whether the Food & Drug Administration (FDA) in the US or the European Medicines Agency (EMA) in Europe, have pathways which enable patients in dire need to access experimental treatments which may save their life. These include Expanded Access and compassionate use programs, hospital exemptions and ‘Right-to-try’. There are small differences between these, such as whether the decision lies with the regulatory body or the drug manufacturer, but they have the same outcome.
However, few insurance providers will cover experimental treatments in this way. Even when therapies are being touted by clinics as ‘approved’ (whether they are or not), patients may find securing regenerative medicine access difficult. Will they have to pay out of pocket? Another alternative is to participate in a clinical trial; find more information about pay-to-participate clinical trials here>>
In this section of our Patient Zone, access more information on securing regenerative medicine access through regulation or expanded access programs.