[Clinical and economic comparison of utilization of reslizumab, mepolizumab and benralizumab in the treatment of severe eosinophilic asthma].

During last few years, the approaches to the management of patients with severe asthma have been revised. Monoclonal antibodies (MABs), inhibitors of interleukin-5 (reslizumab, mepolizumab, benralizumab) have been recently introduced for the treatment of severe eosinophilic asthma. The mentioned drugs were approved in Russia and included into the list of Vitally Essential Drugs. AIM: The aim of this study was to compare the clinical and economic consequences of the use of biological agents that antagonize IL-5 in the treatment of severe eosinophilic asthma in adults. MATERIALS AND METHODS: Two methods of clinical and economic research were used: assessment of the cost-effectiveness ratio and analysis of the budget impact. The effectiveness of the drugs was assessed using indirect comparison; special attention was paid to comparability of the patient groups in the studies chosen for such an assessment. Two approaches were used for calculation of the cost of therapy for severe asthma: using DRGs (applicable to most regions of Russia), and without the use of DRGs, which is relevant only for few Russian regions. RESULTS: Basing on the data obtained from a budget impact study without the use of DRG, it was shown that reslizumab was dominating for patients with body mass of up to 70 kg, while for the patients with body mass of 70 to 110 kg, mepolizumab was dominating, while utilization of reslizumab appeared to be somewhat more expensive. In the group of patients with body mass over 110 kg, mepolizumab also was dominating. The calculation of the cost-effectiveness ratio (CER) showed that reslizumab appeared to be dominating over two other MABs, The results of the study using the DRG demonstrated that the cost of an annual course of benralizumab in most cases in Russia would exceed the amount that can be compensated by Territorial Funds for Mandatory Medical Insurance to a healthcare institution for therapy of bronchial asthma in one adult patient with genetically engineered drugs. Therefore, further comparisons were made for reslizumab and mepolizumab only. Analysis of the impact on the budget demonstrated that treatment with reslizumab and mepolizumab would represent a similar burden for the budget. When applying cost-effectiveness analysis, reslizumab was more cost-effective than mepolizumab (regardless of patient body mass). CONCLUSION: Thus, the results of the clinical and economic study suggested that, basing on the cost-effectiveness analysis, reslizumab appeared to be the dominant IL-5 antagonist (regardless of body mass if DRG approach was used and in patients with body mass up to 110 kg, if such an approach was not used). Basing on budget impact analysis, calculations without use of DRG approach showed superiority of reslizumab over mepolizumab and benralizumab for the patients with body mass up to 70 kg and the DRG-based approach showed equal burden for the budget for reslizumab and mepolizumab for the patients with any body mass.

[Pharmacoeconomic analysis of the efficacy of natalizumab in relapsing-remitting multiple sclerosis].

OBJECTIVE: To perform pharmacoeconomic assessment of interferone-1a for intramuscular and subcortical infusions, interferon-beta-1b, glatiramer acetate and natalizumab in the treatment of relapsing-remitting multiple sclerosis (RRMS). MATERIAL AND METHODS: Modeling and "cost-effectiveness" analysis as well as evaluation of "disease cost" were performed. A model was based on the data on the efficacy of the drugs, summarized in the meta-analysis of G.Filippini et al, and treatment costs in the Russian health care system. To compare the efficacy, we used a criteria of "reduction of the risk of 1 and more relapses during 2 years of treatment compared to placebo". The analysis of treatment costs of patients with RRMS included direct treatment costs during the remission, medical care costs and costs of disease-modifying drugs (DMD). The analysis of direct costs was performed using standards of treatment of patients with multiple sclerosis. The duration of the study was 2 years. RESULTS AND CONCLUSION: Based on the meta analysis, we calculated the relative decrease of the risk of 1 and more relapses during 2 years of treatment as 3,6 % for interferon-beta-1b for intramuscular infusions (avonex), 15,2% for interferon-beta-1b for subcortical infusions (rebif), 10,5% for interferon-beta-1b for (betaferon), 21,6% for glatiramer acetate (copaxone), 42,8% for natalizumab (tisabri). For 2 years, total management costs per patient were 1567082,98 rub for avonex, 1563369,38 rub for rebif, 1322 635,80 for betaferon, 1 459 976,15 rub. for copaxone and 2 694 699,35 rub. for tisabri. The minimal cost/effectiveness ratio (62 960,27 rub.) was calculated for natalizumab. This drug was most preferable in terms of economic effectiveness.

[Use of fendivia transdermal therapeutic system in Russian patients with malignant neoplasms during palliative care: pharmacoeconomic aspects].

AIM: To make a comparative clinical and economic assessment of a transdermal therapeutic system (TTS) for fendivia and traditional opioid analgesics in patients with malignant neoplasms (MN) during palliative care. MATERIALS AND METHODS: Pharmacoeconomic analysis of opioid analgesics used in patients with MN during analgesic therapy was made using the cost-effectiveness analysis in the framework of a budget impact analysis (BIA). RESULTS: The assessment of the medical cost structure in the fendivia and morphine groups (100 patients in each group), which was made in the framework of BIA, demonstrated that the cost of pharmacotherapy in the fendivia group was comparable with that of an ambulance call for additional analgesia and correction of the side effects of performed therapy (615,804.00 and 645,337.60 rbl. monthly, respectively). At the same time, in the morphine group the cost of an ambulance call was more than 20 times that of pharmacotherapy (2,117,514.00 and 93,120.00 rbl. monthly, respectively). Thus, the total savings from applying the fendivia TTS in the group of 100 patients ranged up to 949,492.40 rbl. monthly. CONCLUSION: The application of the fendivia TTS is clinically and pharmacoeconomically valid and leads to a considerable reduction in public health care costs.

[Efficacy of сerebrolysin in acute ischemic stroke]. / Éffektivnost' tserebrolizina v ostrom periode ishemicheskogo insul'ta.

Objective. To study the effect of cerebrolysin used in dose 30 ml daily during 10 days on rehabilitation measures in patients with acute ischemic stroke. Material and methods. The 1st group consisited of 23 patients who received standard treatment and cerebrolysin, the 2nd group included 89 patients who received standard treatment only. The severity of neurological deficits (NIHSS) and the level of disability (mRS) were assessed. Results and conclusion. A significantly earlier recovery (p<0,05) and decrease in disability were identified. A more pronounced effect was seen in young patinets and when treatment started early.

[Experience of ribomunyl application in patients with chronic bronchitis].

The authors performed clinical and immunological evaluation of efficacy of treatment of patients with occupational chronic bronchitis (CB) working in contact with pneumotropic pollutants, including airway irritants and dusts. The complex therapy included an immune-correcting agent of bacterial origin, ribomunyl. The indicators to the drug administration were remission or moderate manifestations of the disease with disturbances of mucosal immunity, both isolated (imbalance of IgA, IgG and salivary lysozyme) or combined with systemic immunity disorder (decrease of neutrophilic phagocyte activity, serum IgM and IgG, and the number of T-lymphocytes). The course lasted 3 weeks; the regimen was standard: 3 tablets in the morning before meals 4 days a week. During the whole period of immune correction the patients were under clinical observation; respiratoryfunctions (RF), bronchial hyperactivity, and immune status were evaluated prior to and after the treatment. After the treatment with ribomunyl most patients displayed improvement of the symptoms and FF parameters. The study found significant improvement of a range of immunological parameters: reduction of the imbalance of salivary protective factors, elevation of the phagocyte activity of peripheral blood neutrophils, and a tendency towards increase of IgG and blood T-lymphocyte levels. The results show that clinical, functional and immune parameters normalized simultaneously, with the most evident matching in salivary immunity. The authors conclude that ribomunyl is efficient in treatment of occupational CB when administered with taking individual disturbances of mucosal and systemic immunity into account.

[Telemedicine in diagnosis and treatment of occupational skin diseases]. / Ispol'zovanie telemeditsiny dlia diagnosstiki i lecheniia professional'nykh zabolevanii zabolevanii kozhi.

Advances of new data transfer technologies in medicine enable distant consultations for far places residents. Scandinavian countries, especially Sweden, have accumulated significant experience with using television medicine in dermatology. Applying television medicine technologies in occupational dermatology is the most topical item for Nizhny Novgorod region. In these cases transfer could cover not only images of diseased skin sites, but also text (history description and other medical information). International cooperation with foreign colleagues including Swedish doctors is considered prospective.

[Predicting skin allergy in workers exposed to chemical allergens]. / Vozmozhnosti prognozirovaniia allergicheskoi patologii kozhi u rabotaiushchikh v kontakte s khimicheskimi allergenami.

A system for predicting the risk of contact dermatosis in workers handling chemical allergens (epoxy resins) was developed. The accuracy of forecast is up to 86 per cent due to use of anamnestic, clinical, and immunological data. This system can be useful for prophylaxis of contact dermatitis at enterprises where chemical allergens are used.

[Clinical and immunological aspects of surgical treatment of stomach and duodenal ulcer]. / Kliniko-immunologicheskie aspekty khirurgicheskogo lecheniia iazvennoi bolezni zheludka i dvenadtsatiperstnoi kishki.

Of 182 examined patients with the stomach and duodenum ulcer disease (UD) 104 (57.14%) of whom with complications. Antiulcerous antibodies were determined in patients according to results obtained in passive hemagglutination reaction (PHAR) using erythrocytic diagnosticums. In patients with gastric and duodenal UD the antitissue antibodies to corresponding antigens from gastric and duodenal ulcers were determined before the operation. The incidence of antibodies discovery depends on the patients condition. In 18 months after the operation the percentage of PHAR positive results have reduced down to 72.5% on average.