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A525 estimate was based on prevalence data for URDs for which patented drugs are currently available and for which drugs are in clinical development and hence may be expected to be launched in the foreseeable future. A power function was used to estimate the relation between (decreasing) prevalence and (increasing) cost per patient. For drugs in development, we applied phase duration data and attrition rates from the Tufts Center for the Study of Drug Development database. Results: A total of 18 drugs under patent protection for non-oncological URDs were identified. Furthermore, 29 drugs for non-oncological URDs under development that have the potential of reaching the market by 2021 were found. Total budget impact over 10 years was estimated to be € 14,112 and € 4,965 million for approved and pipeline URD drugs, respectively (total: € 19,077 million). Relative to total pharmaceutical expenditures in Europe, spending on drugs for URDs is estimated to rise from 0.7% at present to 1.6% in 2021. Univariate sensitivity analyses and extreme scenario analyses suggesting robustness of this projection will be presented. ConClusions: Our analysis does not support concerns regarding an uncontrolled growth in expenditures for drugs for URDs. Nevertheless, continuous monitoring of the budget impact as an input to rational policy making is recommended.
Ophthalmology Journal, 2016;9(2):30-35 Received: 24.02.2016 Accepted: 24.03.2016 G Objective. The aim of the study was to conduct clinical economic analysis of aflibercept (AFL) treatment compared to that of ranibizumab (RBZ) in patients with wet age-related macular degeneration (wAMD) in the Russian Federation Healthcare healthcare conditions. Materials and methods. Only direct medical costs were taken into account in this studyconsidered. These included costs of
Aleksei Sergeevich Kolbin, PhD, Professor, head of the clinical pharmacology and evidencebased medicine department at the First Pavlov Saint Petersburg State Medical University, Professor of the pharmacology department of the medical faculty at the Saint Petersburg State University Topicality of the issueThe authors touch upon an issue critical for children in neonatality and the first years of lifeimmune prevention of respiratory syncytial virus (RSV) infection [1]. It not only features severe course in the setting of no evidence-based effective and safe etiotropic therapy, but also lays a heavy disease burden (DB) on the society. DB may be numerically represented with a WHO indicator DALY (disability-adjusted life year). This indicator characterizes the disease burden in years of life in relation to disability. In other words, it is equivalent to losing 1 healthy life year. It is known that DALY (Score/1,000) for RS infection is 67.7, whereas for adenovirus it is 49.7, for herpes -34.4, for influenza A -6.8 [2, 3]. RS infection burden is comprised of two main components -high hospitalization frequency in children with RSV and consumption of healthcare resources by children under 2 years of age. At the same time, there are technologies of controlling this medical and social issue -immune prevention of RS infections with monoclonal antibodies. Palivizumab is considered to be such a vaccine. There is evidence (meta-analysis of clinical trials) that immune prevention has reduced mortality more than 4 times in the group of children born before the 32 nd gestation week [4]. Prevention of RS infection is a standard practice in children born before the 30 th gestation week regardless of the economic development level. Unfortunately, the Russian Federation does not partake in this process (unlike, say, Ecuador), although preservation and rehabilitation of children's health is proclaimed the priority of Russian healthcare. Advantages of the articleThe article by V.I. Ignatyeva et al. is set forth according to the traditional scheme of clinical economic analysis (standards of "Clinical economic analysis", general provision of OST 91500.14. . The author substantiates topicality of the issue, scientific novelty and practical implications of the work, defines the aim of the study and lists methods of pharmacoepidemiological and clinical economic analysis. The obtained data were statistically manipulated using difference significance criteria. The study involved detailed analysis of palivizumab immune prevention results in Moscow in the season of 2012/2013. The article features detailed calculation of expenses per 1 disability-adjusted life year and proves that the taken measures prevented economic loss due to infantile mortality decrease. The results demonstrate that use of palivizumab for preventing RS infection ought to be considered clinically and economically sound. The article is a complete scientific study; it is well illustrated, written in the literary language and is rather readable despite complicated nature of ...
Objectives: To perform pharmacoeconomic analysis of golimumab (GOL) vs adalimumab (ADA) and infiliximab (INF) for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) in Russia MethOds: Indirect comparison demonstrated that compared drugs have similar efficacy and safety. Costminimization analysis was performed to compare the cost for 1-year treatment with GOL, ADA and INF in doses according to the approved recommendations. Expected cost for treating all eligible patients with RA, AS and PA with TNF-α -inhibitors in Russia were calculated in a model, assuming that INF is used in the 1 st line therapy during one year and ADA or GOL in the 2d line therapy during the 2d year. Number of patients to be treated with TNF-α -inhibitors was calculated based on state statistical data and data on the percentage of patients who do not respond to therapy with synthetic disease-modifying antirheumatic drugs (DMARDs) and first-line biologic DMARDs from clinical trials. Results: INF dosing regimen is different for RA and other rheumatic diseases, 1 year treatment with INF costs € 16,212 for RA and € 24,319 for AS and PA. GOL and ADA have the same dosing regimen for all rheumatic diseases and costs € 16,544 and € 24,243 per year correspondingly. If all eligible patients with rheumatic diseases in Russia receive biologic DMARDs when necessary, treatment with GOL in the 2d line is less expensive than ADA, difference in costs is € 89,062,427 (for all eligible patients per year). It allows treating additional 4959 patients RA, 278 AS patients and 147 PA patients per year. cOnclusiOns: GOL is cost-saving vs ADA for the 2d line therapy of rheumatic diseases in Russia. 1-year treatment with GOL is less expensive that INF for AS and PA and may be considered as the 1 st line option.
A641and capecitabine monotherapy in terms of incidence of diarrhea, vomiting, stomatitis/mucositis. The hand-foot syndrome occurrred in less than 5% in case of tegafur. Tegafur (in monotherapy or in combination with calcium folinate) is less costly than capecitabine. The difference in costs in favor of tegafur monotherapy amounted to € 1,956.97 per 1 patient per 6 months or € 3,778.53 per year; of tegafur + calcium folinate -€ 2,168.12 and € 4,220.06 per 1 patient per 6 and 12 months, respectively. ConClusions: Tegafur is a cost-saving option compared with capecitabine with similar efficacy and safety.objeCtives: There is new RCT phase 3 clinical evidence that bendamustinrituximab (B-R) is more effective in terms of progression free survival compared to the standard of care CHOP-rituximab (CHOP-R) in indolent non-Hodgkin lymphoma (iNHL). Based on this RCT, we performed a cost-utility analysis of B-R compared to CHOP-R in the treatment of follicular iNHL (stage III and IV) in the Czech Republic. Methods: We developed a life-time Markov cohort model with 28-day cycle length and 5 health states, i.e. on treatment, rituximab maintenance (R-M), stable disease, progression and death. Additionally, we modeled adverse effects of treatment and four sub-states during progression (observation, imunochemotherapy, R-M, post R-M). Transition probabilities and utilities were derived from published literature. Resource use (costs) was calculated from health care payer's perspective in cooperation with major Czech hemato-oncologic experts. Costs and outcomes were discounted by 3.5%. Probabilistic sensitivity analysis (PSA) with 1000 iterations using a willingness to pay (WTP) threshold equal to 3 times GDP per capita (40 100 EUR) in the Czech Republic was performed. Results: Over a life-time horizon, B-R compared to CHOP-R brings additional 1.21 QALY (7.47 vs. 6.26) and 1.31 LYG (9.74 vs. 8.43). The incremental total costs were 1,368 EUR (total life time costs for B-R and CHOP-R were 43,080 EUR and 41,712 EUR, respectively). ICERs thus equal to 1,133 EUR/QALY and 1,044 EUR/LYG. The results of the PSA show that B-R is costeffective in 100% iterations under the WTP threshold; and simultaneously in 99.3% iterations is cost-effective while using threshold equal to 7,300 EUR. ConClusions: B-R proved that it is a highly cost-effective therapy in patients with follicular iNHL. The higher costs of initial bendamustin treatment are in the long-term horizon offset by substantial savings of progression costs. There is 100% probability of B-R being cost-effective at the selected WTP threshold.
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