Glossary

An Advanced Therapy Medicinal Product (ATMP) is a term used to refer to a medicine in the field of gene therapy, somatic cell therapy, or tissue-engineering.

 

Appraisal is the process of using value judgments and policy considerations to make access decisions informed by the drug's assessment, comprising a systematic evaluation of a medicine's clinical and cost-effectiveness to decide its suitability for reimbursement and inclusion in healthcare provision.

Assessment is the systematic evaluation of a drug's clinical effectiveness, safety, and cost-effectiveness to determine its value in healthcare. It should be distinguised from appraisal, which is the subsequent process of interpreting this evidence to make decisions or recommendations regarding its approval, reimbursement, or adoption.