Background Nowadays in cancer diagnosis and treatment a number of tests are used based on identification of different biomarkers. Testing capabilities in the field of oncology have been greatly enhanced with the development of molecular-genetic methods, and great prospects are opening up for the application of predictive and pharmacogenetic tests in the use of targeted anti-cancer therapy and predicted response to treatment. Such medical technologies are still expensive. However, considering the practical necessity of molecular-genetic methods for health care, it is important to evaluate these technologies in terms of health economics.
Purpose To analyse the Russian market of test systems for oncology biomarkers and the possibility of their use in the Russia healthcare system in the framework of health technology assessment.
Materials and methods A systematic review of articles was conducted using PubMed, the Cochrane Library and published reports and market reviews.
Results In the period from 2007 to 2012 it is estimated the world market for in vitro diagnostics (IVD) increased dramatically due to the development of molecular diagnostic tests and rapid test kits. Experts point out that a key factor in the growth segment of molecular diagnostics in recent years has been precisely the emergence of new oncology tests required to prescribe targeted treatment. At the moment, the IVD diagnostics segment in Russia is estimated at 300 million USD, and the annual growth rate for 2014 is projected at 10–20%. The price of tests for oncology biomarkers depends on the technology:
– for most routine immunological and chemical tests it lies between 10 and 15 USD;
– for molecular genetic tests the cost varies from 40 to 4000 USD per procedure.
In addition to KRAS and EGFR testing which are practiced in the Russian Federation, this review discussed the practical value of:
testing for EML4-ALK mutation for crizotinib in non-small lung cancer;
BRAF V600E testing for vemurafenib in melanoma;
HER2/neu-testing for trastuzumab in breast cancer.
Thus, the Russian IVD market is a fast-growing market, with an actively growing cancer diagnostics segment. However, this literature review was the first economic evaluation conducted of these medical technologies in the Russian Federation.
Conclusions The study revealed that health technology assessment of diagnostic test systems in oncology in the Russian Federation is relevant and requires rigorous analysis.
No conflict of interest.
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