Personalised medicine (PM) is defined as a choice of a medical approach relevant to the individual characteristics of a particular patient and/or different patient subgroups, classified on the basis of their susceptibility to a disease or their response to a specific treatment.
PM is often an inseparable entity of a pharmaceutical or a medical device and complementary diagnostics for detecting the eligible patient.
Complementary diagnostics is diagnostic or imaging tools providing essential evidence for effective and safe implementation of a specific medicine in a well-defined patient population.
That kind of diagnostics improves clinical outcomes by targeting patients that would benefit most from the treatment, cuts down costs by excluding patients in whom positive outcomes are not anticipated and side effects are probable.
That makes complementary diagnostics one of the mainstays of PM because without its diagnostic and therapeutic guidelines the full range of targeted treatment advantage is compromised
The concept of complementary diagnostics is relatively simple and it is unquestionably a benefit to patients. Nevertheless, there are some issues which hamper the assessment of its value, financing and reimbursement. Solving of these problems is crucial for providing a broad coverage and reimbursement of the combination of targeted treatment and complementary diagnostics.
To accomplish that it is required to:
- Describe and study factors that have impact on payers` decision-making for diagnostic tests;
- Study the capability of health technology assessment (HTA) agencies to assess properly the complementary diagnostics value;
- Appraise complementary diagnostics and outline the importance of clinical utility from the perspective of financing institutions decisions.
