Experimental and investigational treatments

Your policy would not cover any form of treatment or drug therapy which the insurance company considers to be experimental or investigational. This means that any treatments, drugs, procedures, or technologies that have not been fully approved or adopted by recognized medical authorities would not be covered under your policy.

It’s important to note that the definition of what is considered experimental or investigational can vary among insurance providers. As a general guideline, a service, technology, supply, procedure, treatment, drug, device, facility, equipment, or biological product is considered experimental or investigational when it does not comply with the following requirements:

It must have a final license and clearly stated approval from at least one of the following: EMA (European Medicines Agency), FDA (Food and Drug Administration – phase III completed), European network for Health Technology Assessment (EUnetHTA). Interim approval is not sufficient. The approval is only eligible for the corresponding medical indications and conditions. In case of procedures and approved clinical pathway guidance, it must be clearly stated as such on one of the following guidelines: NICE (National Institute for Health and Care Excellence), AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften), AHRQ National Guideline (Agency for Healthcare Research and Quality – National Guideline Clearinhouse).

All approvals and guidance must be conclusive and must not state the need for more research, or under research environment, or limited evidence, or insufficient evidence or lack of clinical utility.

It’s important for individuals to understand the terms and conditions of their insurance policy and what treatments, drugs, procedures, and technologies are considered experimental or investigational and thus not covered. It’s also essential to verify the definition of what is considered experimental or investigational with each medical insurance provider as definitions can differ. Additionally, it’s important to inquire about potential coverage options for experimental or investigational treatments and to consider these options when selecting a policy.