[Cost-effectiveness of pneumococcal vaccination among patients with chronic heart failure].

Aim      To analyze the cost-effectiveness of pneumococcal vaccination in 40- and 65-year-old patients with chronic heart failure (CHF).Material and methods  Analysis was performed by Markov modeling from the perspective of the healthcare system. The evaluation was based on Russian epidemiological data taking into account results of international studies. The analyzed schedule of vaccination included one dose of 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent polysaccharide vaccine (PPSV23) after one year and vaccination with only one dose of PCV13. The time horizon of the study was 5 years. Costs and life expectancy were discounted at 3.5% per year.Results The cost-effectiveness of vaccination for both 65-year-old and 40-year-old CHF patients is very high: the incremental cost of one additional QALY (Quality-Adjusted Life Year) for PCV13+PPSV23 vaccination is 113.24 thousand rubles, while vaccination with PCV13 entails a reduction in costs by 556.50 rubles per one vaccinated patient. For vaccination of 40-year-old CHF patients with PCV13+PPSV23, the incremental costs per 1 QALY will be 519.72 thousand rubles, while for vaccination with PCV13 it will be 99.33 thousand rubles.Conclusion      Pneumococcal vaccination of CHF patients reduces the associated morbidity and mortality and is highly cost effective.

[Pharmacoeconomic aspects of combined treatment of advanced stage of Parkinson's disease]. / Farmakoékonomicheskie aspekty kombinirovannoi terapii razvernutoi stadii bolezni Parkinsona.

AIM: To assess the cost-efficiency of the fixed levodopa/carbidopa/entacapone combination and the free combination of levodopa/carbidopa with rasagiline. MATERIAL AND METHODS: An analysis was performed using the Markov model including three clinical states: duration of off-time ≤25%, duration of off-time >25% and fatal outcome. Costs of the drugs were calculated based on the results of auctions for 2016 by IMS Health data. RESULTS: In basic variant (drugs containing levodopa, 5-times a day), costs of treatment with the fixed levodopa/carbidopa/entacapone combination were 2.45 times higher than with rasagiline + levodopa/carbidopa. When taking levodopa drugs 3 times a day, costs of treatment with levodopa/carbidopa/entacapone were 1.53 times higher. Costs of treatment with rasagiline in combination with levodopa/carbidopa were lower by 10.4% even in the least beneficial variant of sensitivity analysis (maximal cost of rasagiline, maximal cost of levodopa/carbidopa and minimal cost of the fixed levodopa/carbidopa/entacapone combination). In basic variant, the cost-efficiency of treatment with rasagiline in combination with levodopa/carbidopa at the advanced stage of Parkinson's disease was 281.4 thousand roubles/QALY. CONCLUSION: Rasagiline in combination with levodopa/carbidopa is clinically and economically expedient for treatment of patients at the advanced stage of Parkinson's disease because of the reduction of costs compared to the fixed levodopa/carbidopa/entacapone combination.

[Pharmacoeconomic aspects of macitentan in the therapy of pulmonary arterial hypertension]. / Farmakoekonomicheskie aspekty primeneniya matsitentana pri terapii legochnoi arterial'noi gipertonii.

AIM: To provide a pharmacoeconomic estimate of macitentan versus bosentan in therapy for pulmonary arterial hypertension (PAH). SUBJECT AND METHODS: An analysis was carried out on the basis of a social perspective for patients, whose mean age was 50 years. A budget impact analysis was performed without discounting; with the time horizon of the study being 5 years. Assessing the cost- effectiveness of endothelin receptor antagonists used a Markov model based on the meta-analysis of clinical trials. The cost of bosentan was calculated from the 2016 registered prices with VAT. That of macitentan was estimated from the expected price of 170,000 rubles per 10-mg dose pack #28 if the drug is included in the List of Essential Medicines with VAT. The cost of sildenafil and iloprost was consistent with the January-to-November 2016 auctio. RESULTS: At cost-effectiveness assessment costs and outcomes were both discounted at an annual rate of 3,5%. RESULTS: After 5 years of therapy with macitentan in patients with baseline Functional Class (FC) II PAH, the proportion of patients with FC I-II was shown to be 2.6% more than that during therapy with bosentan (20.1 and 17.5%, respectively), and that of the died patients was 1.5% lower (69.5 and 71%, respectively). In baseline FC III PAH following 5 years, the proportion of patients with FC III PAH on initial macitentan treatment was 1% more than that on bosentan therapy (8.1 and 7.1%, respectively), and that of the died patients was 0.5% lower (87.2, and 87.7%, respectively). The cost-effectiveness analysis shows that therapy with macitentan versus bosentan not only causes some increase in life expectancy in terms of quality of life (by 0.414 and 0.230 QALYs in FC II and III PAH, respectively), but also results in a small cost decrease in FC II and III PAH (by 11,000 and 16,000 rubles per patient, respectively). Thus, macitentan is a dominant alternative versus bosentan. The budget impact analysis indicates that when bosentan is replaced with macitentan, the reduction in health care costs in the Russian Federation will amount to 1.9 million rubles over 5 years, and in all budgetary costs will be 14.7 million rubles. CONCLUSION: Treatment with macitentan in patients with FC II-III PAH is more cost-effective than that with bosentan and does not require an increase in budget costs.

[Oral vinorelbine therapy for non-small cell lung cancer: clinical and pharmacoeconomic aspects].

AIM: To evaluate clinical and pharmacoeconomic aspects of treatment for non-small cell lung cancer (NSCLC) by oral vinorelbine. MATERIAL AND METHODS: The evaluation was conducted based on randomized trials that compared NSCLC therapy by oral vinorebline with injectable form of vinorelbine and peme- trexed. Treatment costs were calculated on the basis of prices registered in 2016 including VAT and 10% of trade allow- ances. Medical services costs were calculated based on tariffs of obligatory health insurance for St. Petersburg in 2016. RESULTS: Clinical trials showed that with comparable effi- cacy and tolerability 3 of 4 patients preferred oral vinorelbine to its injectable form, although therapy costs of oral form in- creased 1,9 times. Compared with pemetrexed, therapy of pa- tients with NSCLC by oral vinorelbine allowed reducing costs 1,74 times and the savings occurred 310.0 thousand rubles per 1 patient. CONCLUSION: Currently oral vinorelbine therapy can be regarded as a mode that is comparable by efficacy and tol- erability both with intravenous injections of vinorelbine and pemetrexed therapy. As compared with intravenous vinorelbine its oral form requires additional costs but, being compared with pemetrexed, oral vinorelbine can significantly reduce the burden on the health budget.

[Gefitinib therapy in advanced non-small cell lung cancer in patients with EGFR mutations: cost-effectiveness analysis].

Therapy for advanced non-small cell lung cancer (NSCLC) is very complex clinical problem. The optimal choice of therapy demands not only the analysis of data on clinical effectiveness, but also an assessment of cost-effectiveness of the applied drugs. The current options for first- or second/third-line of lung cancer treatment are tirosine kinase inhibitors (TKI)--gefitinib, erlotinib and afatinib. According to the received results TKI first-line therapy for NSCLC in patients with EGFR mutations is not only clinically effective but also is economically acceptable from a position of the Russian budgetary health care. TKI second-line therapy for NSCLC patients who fail first-line therapy also provides improvement of the quality of life and prolonged time to progression. Comparable clinical effectiveness and safety of erlotinib and gefitinib in patients with EGFR mutations allows making drug choice on the basis of regional price characteristics. Afatinib is highly effective both in the first- and in the second/third-line of therapy in patients with the most frequent mutations (a deletion in exon 19 or a point mutation L858R in exon 21) but first-line therapy demands an increase of financial expenses caused by substantial increase of time to progression and duration of therapy. Thus TKI therapy of both the first-, and second/third-line of patients with NSCLC with EGFR mutations is characterized by acceptable cost-effectiveness.

[Cost-effectiveness of apixaban compared to other new oral anticoagulants in patients with non-valvular atrial fibrillation].

BACKGROUND: Atrial fibrillation is associated with development of thromboembolic events. New oral anticoagulants (apixaban, rivaroxaban and dabigatran) are recommended for antithrombotic therapy in patients with non-valvular atrial fibrillation (NVAF) with moderate and high risk of stroke. OBJECTIVES: The objective of this study was to evaluate the cost-effectiveness ratio of apixaban compared to dabigatran and rivaroxaban in patients with NVAF from the Russian Federation national health care system perspective. METHODS: This analysis used a Markov model that allowed estimation of the incremental cost-effectiveness ratio (ICER) for apixaban compared to rivaroxaban and dabigatran 110 mg and 150 mg over lifetime horizon for patients with NVAF. The model enclosed cardiovascular event rates based on the results of the indirect treatment comparison that combined data from the randomized clinical trials comparing clinical effectiveness and safety of apixaban, rivaroxaban and dabigatran with warfarin (ARISTOTLE, ROCKET-AF, RE-LY). The following cardiovascular events were considered: ischemic and hemorrhagic stroke, systemic embolism, intracranial hemorrhage, other major bleeds, clinically relevant non-major bleeds and myocardial infarction. Direct medical costs were determined based on the rates of the compulsory national medical insurance system. The price of the new oral anticoagulants was taken as a weighted average tender price for the year 2013. In the model both costs and benefits (quality-adjusted life years and life-years) were discounted at 3.5%. Cost-effectiveness threshold was set at 1.4 million rubles per quality-adjusted life year (QALY) gained and corresponded to the three times GDP per capita in 2013 in the Russian Federation. RESULTS: In the base case analysis it was demonstrated that apixaban compared to dabigatran 110 mg and 150 mg and rivaroxaban provided additional 0.101, 0.060 and 0.072 life years as well as additional 0.063; 0.038 and 0.041 QALYs respectively. Over lifetime horizon apixaban compared to dabigatran 110 mg and 150 mg and rivaroxaban required additional treatment costs equal to 22.78; 31.18 and 6.70 thousands rubles, respectively. With that estimated incremental cost-effectiveness ratio for apixaban compared to dabigatran 110 mg and 150 mg and rivaroxaban was 362.60, 805.54 and 162.45 thousands rubles per QALY correspondingly. CONCLUSION: Apixaban provided increased life expectancy compared to other new anticoagulants and may be considered as a cost-effective alternative to dabigatran 110 mg and 150 mg and rivaroxaban from the Russian Federation national health care system perspective.

[Pharmacoeconomic aspects of using levodopa/carbidopa intestinal gel in Parkinson's disease].

The application of levodopa/carbidopa intestinal gel (LCIG), which provides the more reliable control of the disease and decrease in progression rates compared to standard treatment, is a variant of treatment of severe forms of Parkinson's disease. An analysis of pharmacoeconomic aspects of LCIG use in foreign countries has shown that this treatment significantly improves expectancy of patients and reduces the costs of professional care. The approximate threshold values of costs per 1 QALY recommended for reimbursement of intervention costs are £30,000 in the United Kingdom and €50,000 in Sweden. In respect to intervention, LCIG can be regarded as an acceptable drug.

[Branded drugs and generics: an ambiguity of choice].

In Russia, the problem of choice between branded drugs and generics is extremely urgent because funding should be spent efficiently in conditions of strict financial restrictions. However the seeming economy in using generics which are not therapeutically equivalent to branded drugs leads to the decrease of clinical of treatment effectiveness and to the increase of treatment costs as well. The authors analyze the problem in respect to the Russian pharmaceutical market. It is concluded that the choice of the generic is reasonable if there is evidence for its therapeutic equivalence with the branded drugs. To improve the quality of medical care, one should pay special attention to the quality of generics in the market.

[Pharmacoeconomic analysis of gefitinib therapy in patients with non-cell cell lung cancer].

We performed a treatment efficacy analysis for non-small cell lung cancer (NSCLC) patients' population with EGFR mutation aimed at optimization of pharmacoeconomic factors. The employment of gefitinib leads to an increase in patients' life expectancy for a median of 1.05 years. The average cost-effectiveness of this therapy is 934.8 thousand rubles per additional year (903.9-1100.5 thousand rubles for each year). If gefitinib therapy is given only to patients with proved EGFR mutation it can decrease the average expenses by 211.6-251.8 thousand rubles per patient in comparison to undiagnosed patients's population receiving gefitinib without a decrease in clinical effect. Comparison of selective gefitinib administration with isolated chemotherapy (CT) yields an incremental cost-effectiveness ratio of 960.7 to 1010.0 thousand rubles per additional year. Therefore, the strategy of EGFR gene mutations testing in patients with inoperable NSCLC with consequent gefitinib therapy administration in patients positive for mutation lead to an increase in life expectancy and is characterized by acceptable cost-effectiveness.

Photoinduced radical processes on the spinel (MgAl2O4) surface involving methane, ammonia, and methane/ammonia.

The present study explored photoinduced radical processes caused by interaction of CH(4) and NH(3) with a photoexcited surface of a complex metal oxide: magnesium-aluminum spinel (MgAl(2)O(4); MAS). UV irradiation of MAS in vacuo yielded V-type color centers as evidenced by the 360 nm band in difference diffuse reflectance spectra. Interaction of these H-bearing molecules with photogenerated surface-active hole states (O(S)(-)•) yielded radical species which on recombination produced more complex molecules (including heteroatomic species) relative to the initial molecules. For the MAS/CH(4) system, photoinduced dissociative adsorption of CH(4) on surface-active hole centers produced •CH(3) radicals that recombined to yield CH(3)CH(3). For MAS/NH(3), a similar dissociative adsorption process led to formation of •NH(2) radicals with formation of NH(2)NH(2) as an intermediate product; continued UV irradiation ultimately yielded N(2). For the mixed MAS/CH(4)/NH(3) system, however, interaction of adsorbed NH(3) and CH(4) on the UV-activated surface of MAS yielded •NH(2) and •CH(3) radicals, respectively, which produced CH(3)-NH(2) followed by loss of the remaining hydrogens to form a surface-adsorbed cyanide, CN(S), species. Recombination of photochemically produced radicals released sufficient energy to re-excite the solid spinel, generating new surface-active sites and a flash luminescence (emission decay time at 520 nm, τ ~ 6 s for the MAS/NH(3) case) referred to as the PhICL effect.

[Cost-effectiveness of tumor necrosis factor in Crohn's disease].

UNLABELLED: Treatment of Crohn's disease (CD) is a very serious public health problem. Significant progress in this area has been provided by inhibitors of tumor necrosis factor (TNF), in particular, infliximab and adalimumab. OBJECTIVE: To estimate cost-effectiveness of induction of CD remission with TNF inhibitors. METHODS: The study was based on the Marcov modeling on the background of ACCENT I and CHARM research. Estimating the cost of hospitalization and surgery was carried out on the basis of tariffs compulsory health insurance at St. Petersburg in 2011.The research horizon was 1 year. RESULTS: It Is shown that the "cost/effectiveness" (CE) for adalimumab is lower compared withj infliximab both in CD in moderate severity, and in severe CD. In severe CD, CE for adalimumab is 903.2 thousand rubles/QALY, that is, does not exceed the tripled gross domestic product per person, considered as an acceptable upper CE limit for the budget healthcare. CONCLUSIONS: For induction of remission in patients with CD resistant to basic therapy without TNF inhibitors, it is advisable to use adalimumab, because with equal clinical efficacy of infliximab, it requires a smaller amount of additional costs.