ORGANIZATION: FGU NCESMP Roszdravnadzora, Moscow, Russia; Laboratory of Pharmacoeconomics, Moscow Medical Academy, Moscow, Russia PROBLEM OR ISSUE ADDRESSED: Need to perform more rigorous assessments of new medical regimes in colorectal cancer therapy (mCRC)  that present budgetary and utilization management challenges to our health plan.   GOALS: Comparative pharmacoeconomic analysis of direct medical costs of mCRC therapy using the following treatments: XELOX and FOLFOX4, XELOX + BV and FOLFOX4 + BV. OUTCOMES ITEMS USED IN THE DECISION: Clinical efficacy, safety and cost-effectiveness. IMPLEMENTATION STRATEGY: Costs of diagnosis, medical services and hospitalization were based on the price-list for diagnostic and therapeutic procedures of Cancer Research Center n.a. N.N.Blokhin RAMS. The medical services patient should receive during the treatment and the frequency of their appointments were taken from the standards of medical care for patients with colon and rectum cancer. The cost of hospitalization was based on the cost of one day of hospitalization, number of hospitalization days during each course and the number of anticancer therapy courses. Cost analysis of anticancer drugs and related drugs were based on the information about maximum selling import prices, registered and entered into the State Register of prices of vitally essential drugs. The cost of other drugs was based on a database of retail prices for drugs in pharmacies, which was subsequently reduced by trade discount.  Drug therapy  calculating was based on the unit value costs of the active substance (mg, ml), total daily dose (DD) and the equivalent course dose (CD). DD and CD for anticancer and related drugs have been based on the instruction for medical use on these drugs (taking into account the average body surface area 1,7 and mass 70 kg). The DD and CD for drugs used for side effects treatment have been taken from standard medical care. The calculation is based on one year duration of treatment, which includes 16 courses of XELOX and XELOX + BV (1course = 3weeks, then a week break) and 24 courses (1 course = 2 weeks) of FOLFOX4 and FOLFOX4 + BV regimes. The ultimate value of equivalent course dose of drugs for certain side-effects relief was based on the CD value for each drug and side-effects frequency for each regimes in trial NO16966. RESULTS: In was calculated that the cost of diagnosis was 16,757 rubles and the medical services - 379,815 rubles per year. The mCRC therapy as a first line by XELOX was 1 172 731 rubles (capecitabine - 179 966 rubles, oxaliplatin - 525 994 rubles), by XELOX + BV – 2 526 110 rubles (capecitabine - 179 966 rubles, oxaliplatin - 525 994 rubles, bevacizumab – 1 335 356 rubles), FOLFOX4 - 1 487 627rubles (FU and calcium folinat - 127 250 rubles, oxaliplatin - 515 879 rubles,) FOLFOX4 + BV – 2 843 558 rubles (FU and calcium folinat - 127 250 rubles, oxaliplatin - 515 879 rubles, bevacizumab – 1 335 356 rubles). The cost saving in applying the regime XELOX compared to FOLFOX4 regime amounted to 314 896 rubles. In applying the regime of XELOX in combination with BV in comparison with the regime of FOLFOX4 in combination with BV amounted to 317 448 rubles. Sensitivity analysis showed that the decrease and increase of the cost of capecitabine and bevacizumab in 20% for XELOX and XELOX + BV does not exceed the cost of regimes FOLFOX and FOLFOX4 + BV. From the pharmacoeconomic point of view the most optimal is the use of XELOX and XELOX + BV regimes. The combination therapy using capecitabine is more appropriate due to lower costs for neutropenia treatment. Long FU infusion leads to higher costs associated with an increased risk of infectious complications, as well as with a large number of hospitalization days. LESSONS LEARNED: It is necessary to develop methodological approaches to build an effective drug supply system for patients with colorectal cancer, aimed at optimazing and rationalization of pharmacotherapy, based on data from clinical and pharmacoeconomic studies.