Objectives: To assess the cost-effectiveness of Abiraterone Acetate plus Prednisone (A-P) compared with Cabazitaxel plus Prednisone (C-P) in Dominican Republic, in patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) that have failed to chemotherapy with Docetaxel. MethOds: A three-health state cohort simulation Markov Model (progression-free, post-progression and death) was developed based on overall and progression free survival data. The time frame was 10 years. The perspective was that of the Public System of Health of Dominican Republic. The health outcomes of interest were Quality Adjusted Life Years (QALYs) and Life Years (LYs). Efficacy data was taken from clinical trials (COU-AA-301 for A-P and TROPIC for C-P). Utilities for health states and negative utilities for adverse events were estimated based on quality of life endpoints of the COU-AA-301 trial. The base year was 2012. All costs are presented in Dominican currency (Dominican Pesos -RD$). Costs and outcomes were discounted at 5%. Probabilistic sensitivity (PSA) analysis was performed to evaluate uncertainty surrounding the parameters. Results: A-P resulted in 0.79 QALYs and 1.35 LYs, per patient, respectively. C-P resulted in 0.71 QALYs and 1.28 LYs, per patient, respectively. Mean total costs per patient were: RD$ 2.204.289 for A-P and RD$ 2.732.365 for C-P. The results of the probabilistic sensitivity analysis showed that, when compared with C-Z, A-P was found dominant (associated with reduced costs and increased QALYs) in the majority of the iterations. A-P had a 75% probability of being cost effective, independent of the willingness to pay, when compared to C-P. cOnclusiOns: A-P can be considered cost-saving (dominant), when compared with C-P, in patients with Metastatic Castration-Resistant Prostate Cancer that have failed to chemotherapy with Docetaxel, from the perspective of the Public System of Health of Dominican Republic.

Objectives: To estimate cost of a sickle cell (SC) crisis, describe setting of care, and type of crisis; and compare costs of sequential crises among adult SC patients. Methods: We used a large US health plan claims database 2 Truven Commercial & Medicare Supplemental. Patients selected had $2 SC claims, presence of SC crisis between 2009-2016 (i.e., SC crisis diagnosis in emergency department [ED] or hospitalization), age $18y at index (i.e., first crisis), 1-year pre-and post-index continuous enrollment, and no crisis during 1-year pre-index period. Healthcare setting, type of crisis, and medical and pharmacy costs during the crisis encounter were measured. Costs of sequential crises were restricted to patients with fee-for-service insurance, adjusted for 2017 inflation, controlled for age, gender and comorbidities, and were compared using gamma models. Results: There were 1,583 patients (1,234 fee-for-service), mean (SD) age 38y ( 14) and 58% female. Mean number of crises during 1-year post-index was 1.9. Average time between crises was 4.2 months. Number of patients with 1+, 2+, 3+ and 4+ crises within 1 year were 1,583 (100%), 679 (43%), 306 (19%) and 160 (10%), respectively. Among these, 52%, 55%, 59% and 61% were hospitalized for the 1st-4th crises (average length of stay: w7 days), and the rest had ED visits. After one crisis, patients tended to have the same setting of care for their next crisis. Across all crises, majority were pain crises (w63%), followed by acute chest syndrome (w11%). Mean (SE) adjusted costs of 1st-4th crises were $12,685

The goal of this article is to provide an in-depth review of rare disease policies and the reimbursement of ODs in 3 European countries, two EU members (Poland, the Netherlands) and a non-EU one (Russia). A review of publicly available information on rare disorder policies and HTA processes was performed. Experts were consulted in case of unclear or scarce information. Russia has a five times higher frequency threshold for its rare disease definition than Poland and the Netherlands (both using the EU definition). The Netherlands has vastly increased its disease registries by instituting 300 expert centers via its National Plan, in Poland there are only 6 registries while in Russia one central registry exists. All 3 countries have an HTA process in place, however, the Russian one is relatively undeveloped. Access to ODs in the Netherlands is the broadest with 80 out of 83 EMA approved ODs reimbursed in 2015; Poland reimbursed 49, whereas Russia reimbursed 4 on the federal level and 43 in Moscow region. In all countries, new rare disease policies are under development. The availability of healthcare system solutions and the reimbursement of ODs differs greatly between all 3 countries. Even though both states are EU member with common regulations and access to EMA approved drugs, marked differences exist between Poland and the Netherlands in the range of policies, access to treatments and screening programs.

Objective: Budget impact analysis of teriflunomide inclusion as first-line disease modifying drugs (DMD) therapy in the List to ensure patients with relapsing-remitting multiple sclerosis (RRMS) within the programme '7 high-cost nosologies' on the budgets of Russian Federation (RF) federal and regional public authorities in the field of health care. Methods 132,89 RUB in 2017 and 16 893 811 827,74 RUB in 2018. Inclusion of teriflunomide is connected with total costs for patient management equal to 14 908 830 663,19 RUB (2017) and 16 406 368 100,05 RUB (2018). Conclusion:Inclusion of teriflunomide into the programme '7 high-cost nosologies' will cause total cost saving for budget of federal authorities of the RF in the field of healthcare of 268 666 174,08 RUB and 517 023 249,99 RUB in 2017 and 2018, respectively, and total costs of federal and regional authorities of the RF in the field of healthcare for provision of patients with multiple sclerosis will be reduced by 239 237 469,70 RUB in 2017 and by 487 443 727,70 RUB in 2018.

This article is a part of the "Road Map ISPOR" and comprehensively describes health care system in the Russian Federation - including its funding, sources of financing, free medical care, and also the rules of mandatory medical insurance. It presents the organization of the health system at both local and national levels including the division of funding for programs and health care provided to specific groups of citizens. Functioning of the departmental health care financed from public funds is also described. Apart from the mandatory insurance, the article also outlines voluntary medical insurance. Finally it describes the decision-making structure and procedures in the health care system as well as organizations carrying out health technology assessment in Russia.

1 ) and volume index (L 2 ) were used to assess the contribution extent pricing and volume do respectively to total expenditure changes in 4 types of services within and across rounds. Results: Three rounds of pricing adjustments items were included: 43 in 1 st round, 47 in 2 nd round, and 573 in 3 rd round; items with 0 volume were excluded. Volume index outnumbered price index for laboratory tests items(L 2 =165.78%;L 1 =163.69% for 3 rd round) and Chinese traditional medicine diagnostic and treatment items(L 2 =184.26%;L 1 =161.44% for 2 nd round, and L 2 =150.98%;L 1 =120.12% for 3 rd round); price index outnumbered volume index for clinical diagnostic and treatment items(L 1 =151.93%;L 2 =141.95% for 1 st round, and L 1 =144.23%;L 2 =141.23% for 3 rd round). Indexes do not exhibit an uniform trend across rounds for general medical service items. Conclusions: Volume changes contribute more than pricing to the total expenditure change for laboratory tests and Chinese traditional medicine diagnostic and treatment items; pricing contributes more for clinical diagnostic and treatment items after pricing adjustments in Shanghai. General medical service item trends vary across rounds.

The results of the literature review of drug use for the treatment of metastatic colorectal cancer (mCRC) are presented. Analysis of the data showed that cetuximab (Erbitux) and panitumumab (Vectibix) are effective drugs for mCRC patients with KRAS wild-type in the first-line therapy, and the combination of standard chemotherapy regimen FOLFOX in combination with targeted therapy cetuximab (Erbitux) is the most optimal medical technology as compared with other combinations of chemotherapy and targeted drugs.

Stimulation (SCS) provides pain relief and improves patients' health. We assessed in a naturalistic context the cost-utility of SCS in FBSS patients unresponsive to conventional medical management (CMM). METHODS: We conducted an observational, multicenter, longitudinal prospective study in which a sample of patients assigned to receive SCS in addition to CMM was observed for 24 months after the intervention. We collected before and after undergoing SCS the following data: direct and indirect costs, adopting the National Health Service (NHS) and the societal perspectives, pain status, using the Numerical Rating Scale (NRS, scoring from 0 (no pain) to 10 (maximum pain)), and HRQoL, using the SF-36 and EQ-5D. Costs and benefits pre-SCS versus post-SCS were compared to estimate the incremental cost-effectiveness and the costutility ratios. The following results focus on the cost/QALY ratio. RESULTS: Eighty patients (40% male, mean age 58 years) were recruited. Significant improvements in pain intensity and HRQoL were reached after 6 months from SCS and maintained or further improved until the end of the observational period. In particular, after 24 months from SCS the mean NRS significantly decreased (p<0.01) from 7.6 to 5.1, and the mean EQ-5D-utility significantly (p<0.01) increased from 0.07 to 0.40. The ICUR was equal to 27,519€/QALY, according to the NHS perspective. The cost-utility acceptability curve shows that if decision makers' willingness-to-pay per QALY was 45,000€, then SCS implantation would be cost effective in 97% and 99% of cases, according to the societal and NHS perspectives, respectively. CONCLUSIONS: In a 2-year observational period, SCS+CMM treatment of FBSS patients increases medical direct costs but allows to improve significantly patients' clinical health and HRQoL, resulting in a cost/QALY ratio largely lower than the commonly accepted willingness-to-pay threshold.