FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

Advanced search
Vol 13, No 1 (2020)

Original Article 

5-12 1024

Aim: to evaluate the pharmacoeconomic efficacy of the application of the atesolizumab (PD-L1 inhibitor) preparation compared with other control point inhibitors (PD-1 inhibitors) in patients with advanced non-small cell lung cancer (NSCLC) after chemothe rapy.

Materials and methods. Study design included a retrospective analysis of literature data and modeling. Based on the calculations conducted in a Microsoft Excel model, we analyzed the effect of minimizing costs on using comparable drugs with comparable efficacy; we evaluated how the provision of all patients with NSCLC will impact the health system budget taking into consideration the fact that all these patients are currently provided with PD-1 inhibitors in the second and third lines and with the atezolizumab preparation. For calculations, we used the prices stated in the state register of maximum selling prices; the weighted average maximum wholesale premium was calculated according to the Federal Antimonopoly Service (FAS).

Results. In the analysis of cost minimization, atesolizumab proved itself to be highly clinically and economically effective. It allowed reducing the costs by 28.6% over 3 years compared with the use of nivolumab, and by 31.3% compared with the use of pembrolizumab in the second- and third-line NSCLC treatment regimen. Analysis of the impact on the budget showed that if all 848 patients currently receiving PD-1/PD-L1 inhibitors in the second- and third-line NSCLC treatment regimens had been initially provided with atesolizumab, this would have reduced the pressure on budget by 21.90% or 664.25 million rubles for 3 years.

Conclusion. The use of the atesolizumab preparation is pharmacoeconomically reasonable and appropriate in comparison with the use of nivolumab and pembrolizumab. It will allow reducing the cost of PD-1/PD-L1 inhibitors in the second- and third-line NSCLC treatment regimens. 

13-22 674

Aim: to conduct a pharmacoeconomic analysis of chemotherapy taking into account the types of malignant neoplasms of the bronchi and lung, and to calculate pharmacoeconomic efficiency.

Materials and methods. The materials for the study were the data of the Moscow Cancer Hospital n.a. D.D. Pletnev for 2019. The cost of drugs was calculated according to the data of the website (for June 2019).

Results and discussion. For 300 patients with squamous non-small cell lung cancer, it is required 3205.5 courses of chemotherapy of I (1747.5) and II (1458) lines. For 200 patients with non-small cell non-squamous EGFR positive lung cancer, it is required 1,413.1 courses of chemotherapy and targeted therapy. For 70 patients with non-squamous cell non-small cell lung cancer with ALK mutation, it is required 450.2 courses of chemotherapy and targeted therapy. For 280 patients with non-squamous cell non-small cell lung cancer lung cancer without mutations, it is required 7515 chemotherapy courses. For 150 patients with small cell lung cancer, it is required 1,656.8 courses of chemotherapy. Thus, a total sample of 1000 patients, excluding the type of malignant neoplasm of broncus and lung are required 14,239.8 chemotherapy courses. The determined cost of 67,000 rubles for the average chemotherapy course per patient takes into account the necessary colony stimulating factors, antiemetic, infusion solutions, etc.; in the case of treatment with erlotinib (the length of the course is 8 months), the cost is 663,408.0 rubles; in the case of treatment with crizotinib (the length of the course is 11 months course), the cost is 2044110.0 rubles. The average cost of drug therapy for one patient with malignant neoplasm of bronchus and lung is 1136155.9 rubles.

Conclusion. We determined the pharmacoeconomic dependence of a chemotherapy on the type of malignant neoplasms of bronchus and lung and the main anticancer drug used. The median of the overall survival rate of patients with malignant neoplasms of bronchus and lung was 42 months. The average cost of drug therapy was 27051.3 rubles per month. The median survival rate without therapy is 3 months. Thus, therapy can extend the patient’s life by an average of 39 months. The cost of a month of a saved life is 29132.2 rubles. 

23-34 2104

Introduction. Chondroitin sulfate (CS) and glucosamine sulfate (GS), widely used as chondroprotectors, can maintain the normal functioning of the urinary system but their effect has not been analyzed systematically.

Aim: to perform a systematic analysis of the possibilities of using CS and GS in patients with pathology of the kidneys and urinary system.

Materials and methods. Predictive analysis of 2,093 publications on the interactions of CS/GS with the functioning of the kidneys and other organs of the urinary system found at the request “(urinary OR bladder OR kidney) AND (glucosamine OR chondroitin)” by methods of the theory of topological data analysis.

Results. Disorders of cholesterol and glucosamine metabolism are characteristic of cystitis, glomerular nephritis, urinary tract infections (UTIs), urolithiasis, proteinuria, and formation of diabetic nephropathy. In addition to inhibiting the pro-inflammatory cascade NF-kB, CS/GS contribute to eliminating the deficiency of glycosaminoglycans in the pathology of urothelium, inhibit urolithiasis, inhibit the synthesis of pro-inflammatory nitric oxide NO in macrophages, and modulate O-glycosylation processes.

Conclusion. The results of fundamental and clinical studies show that subsidies of CS/GS substances of pharmacological quality per os and CS instillation in the bladder (in particular, in combination with hyaluronic acid) are the means of choice for patients suffering from osteoarthritis and diseases of the urinary system. Highly purified pharmacological CS substances are part of the preparation Chondroguard.

36-42 636

Introduction. Twin reversed arterial perfusion (TRAP) syndrome is one of the types of complications of monochorial twins (MT) with a frequency of occurrence of 1:35000 births. It is characterized by the presence of the main vessel instead of a normal 4 chambers heart and intrauterine developmental abnormalities. This pregnancy requires monitoring using dynamic ultrasound diagnostics every 7 days, in accordance with current recommendations. The treatment is intrauterine laser coagulation of blood vessels of the “acardial fetus” (AP) in order to prevent the development of a threatening condition for the “fetal pump” (PP). 

Aim: to demonstrate the possibilities of comprehensive conservative management of monochorial pregnancy complicated by TRAP.

Materials and methods. An ultrasound examinations were performed on a weekly basis in monochorionic pregnancy, complicated by TRAP within the period 12-38 weeks. Serum concentrations of biochemical markers PAPP-A (pregnancy-associated plasma protein-A) and β-hGC (β-subunit of human chorionic gonadotropin) were studied in the first trimester to predict adverse perinatal outcomes.

Results. The possibility of prolonging a pregnancy complicated by TRAP without performing intrauterine surgical intervention, during which quite serious complications can occur in this category of pregnancies, has been demonstrated. In a patient with monochorionic twins complicated by TRAP, totally 27 ultrasound examinations were performed within the period 12-38 weeks. This approach made it possible to dynamically monitor the condition of a pregnant and healthy fetus and to prolong pregnancy without surgery until the full term.

Conclusions. Following the existing guidelines, without tailoring for individual risk, may lead to an unreasonable increase in surgical interventions. In turn, surgery is not only accompanied by a high risk of complications (up to 15%), but also constitute a certain financial burden on the budget, determined by the state on the level of 208,000 rubles. Performing routine ultrasound examinations according to the examination protocol for monochorionic pregnancy will contribute to avoiding the complications associated with surgery and better selection for surgery as well as reducing the government costs. 

43-51 1732

Aim: to present a mathematical model of the development of COVID-19 in Moscow along with the analysis of some scenarios of epidemic control and possible epidemic consequences.

Materials and Methods. The modeling of the epidemics was based on the extended SEIR model proposed lately in the group of Prof. R. Neher and realized as a freely available software program. The authors based the choice of the parameters of modeling on published data on the epidemiological properties of the novel coronavirus SARS-CoV-2 and open access data on the registered cases of COVID-19 in Moscow for 8-27 March 2020.

Results. Five potential scenarios of the development of COVID-19 epidemics are studied. The scenarios are differed by the levels of the control measures: Null Scenario corresponded to the lack of protective measures, Scenario A – mild measures of the epidemic control (closing of schools and universities, recommendations for senior citizens to stay inside), Scenario B – medium level of control (closing of all public places, recommendation for the citizens to stay inside), Scenarios C and D – complete lockdown (from the beginning of May 2020 within Scenario C and from the beginning of April 2020 within Scenario D). It was shown that within the Null Scenario, the lethality from the novel coronavirus in Moscow will exceed 100 thousand people, and the number of critically ill patients on the peak of the epidemics will exceed the capacities of the system of healthcare. Scenarios A and B did not provide for a radical decrease in the fatality rate, and the number of critically ill patients at the peak of epidemics will still exceed the capacities of the system of healthcare. Besides, within Scenario B, the epidemics will last for more than a year. Scenarios C and D will allow for the control of epidemics and a significant decrease in the rate of letha lity (by 30 and 400 times, respectively). At the same time, these two scenarios prevent the population from developing herd immunity, which would result in the population susceptibility to repeated epidemics outbreaks.

Conclusion. The scenarios intended for the slow development of herd immunity in the conditions of epidemic control would not bring sufficient results: the lethality would remain unacceptably high, the capacities of the system of healthcare would be overloaded, and the time of limiting measures would be unacceptably long. Such measures as complete lockdown would stop the present epidemics. The earlier they are introduced, the more efficient will be the results. To prevent further repeated outbreaks of the epidemics, it is necessary to establish a system of available, quick, and efficient testing in combination with point isolation of the infected patients and their contacts. 

52-63 6099

Aim: the study was aimed to develop a reagent kit for the real-time RT-PCR diagnostics of virus causing COVID-19.

Materials and Methods. Three target sites were chosen in the genome SARS-CoV-2. The testing included 220 samples, 48 artificially created positive samples (made from patients’ biomaterial) and 172 clinical samples (scrapes from nasal and pharyngeal cavities, bronchoalveolar lavage, expectoration, endotracheal/nasopharyngeal aspirate, feces, post-mortem material), obtained from two medical centers. Preliminary, the obtained biomaterial was analyzed with a reagent kit of comparison. The evaluation was performed with a confidential interval CI 95%. The calculation of CI for the sensitivity and specificity was made based on the distribution of χ2.

Results. The authors developed a technology of novel coronavirus infection (COVID-19) real-time RT-PCR diagnostics for the application in practical healthcare and proposed the variants of testing at all the stages (preanalytical, analytical, and post-analytical, including automated results processing). The proposed reagent kit meets the requirements of the World Health Organization and the Ministry of Healthcare of the Russian Federation. The study results demonstrated high sensitivity and specificity. The sensitivity was 100% (95% CI) 95.6–100%; the specificity was 100% (95% CI) 96.7–100%.

Conclusion. The proposed reagent kit was registered in the RF as a medical product; the registration certificate No. RZN 2020/9948 dated 01.04.2020. The application of the reagent kit in network laboratories will provide patients with access to testing for the virus causing COVID-19 and contribute to quick differential diagnostics, improvement of pandemic control, and accurate statistics on the spread of the virus. 

Review article 

64-70 774

Oncological diseases rank high in the structure of population morbidity and mortality. They entail considerable direct and indirect economic costs. In the past decades, the cost of oncotherapy has increased significantly, which is largely conditioned by high prices of antitumor drugs, which on average increased by ten times in the past ten years. At the same time, many innovative medications have only minor advantages over cheaper old medications because they are registered based on the data on the achievement of the surrogate endpoint – extension of progression-free survival. The high cost of oncotherapy is associated with financial toxicity that affects negatively the patients’ quality of life, their adherence to treatment and consequently survival. To reduce the cost of oncotherapy, it is necessary to conduct pharma-economic analysis, the results of which can serve as the basis to negotiate price-cutting with the manufacturers, as well as to use high-quality generics and biosimilars as effective and safe as their originals, and to monitor effectiveness and safety of all antitumor drugs within the pharmacovigilance framework.

Foreign Experience 

71-83 934
The article presents the description of structural, organizational and methodological issues of health technology assessment (HTA) of French drugs as well as the state-reimbursable list of drugs. The HTA is conducted by an independent public body – French National Authority for Health (HAS). HAS evaluates medical products, procedures, services and technologies from a medical and economic points of view to make cost recovery decisions. HAS consists of two committees providing HTA: Transparency Committee and the Economic and Public Health Assessment Committee. Thus, the French HTA consists of two separate components within the same agency. The result of HAS evaluation of a drug is a conclusion on the level of clinical value and clinical added value, as well as the methodological quality of the studies and the size of the target patient population. Based on the evaluation results, HAS gives recommendations for the National Union of Health Insurance Funds, the Economic Committee for Healthcare Products and Ministry of Health and publishes its opinion on the HAS website. HAS decisions are of a recommendatory nature – the final decision whether to include the drug in reimbursement lists are made by the Ministry of Health and published in the Official Journal of French republic.

Letters to the editors 


88-96 559
The annual Interregional research and practical conference “Epilepsy and Paroxysmal Conditions as an Interdisciplinary Problem” was held in Moscow 19/02/2020, bringing together neurologists and epileptologists from Russia. The event was dedicated to the memory of Gagik N. Avakyan, who was President of Russian League Against Epilepsy (RLAE) for many years. The paper contains key messages of the plenary session.

ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)