PHARMACOECONOMICS. Modern pharmacoeconomics and pharmacoepidemiology

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Vol 11, No 1 (2018)
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Original Article

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The aim: to provide a comprehensive pharmacoeconomic evaluation of the antipsychotic maintenance therapy in outpatients diagnosed with schizophrenia.

Materials and methods. The analysis was conducted in two mutually complementary stages: an epidemiological study on the management of outpatients with schizophrenia, and a  subsequent pharmacoeconomic modeling. Two medical technologies were evaluated and  compared: treatment with classical antipsychotics (CA) and treatment with atypical  antipsychotics (AA). Based on a retrospective study of patients’ medical records, we selected the  parameters to be used in the clinical and economic analysis of these treatments. Direct and indirect costs were taken into account to perform the cost-effectiveness analysis,  incremental analysis, and «budget impact» analysis.

Results. We determined the costs of managing of outpatients with schizophrenia in relation to the health budget and in relation to the social burdens; the appropriateness and effectiveness of  the present costs was analyzed for different time intervals – 6, 12 and 24 months. As shown, the treatment strategies involving AA were more budget-consumptive than the CA treatments. If the  treatments were switched to the reproduced AA (up to 100% replacement of reference  medications), the costs would remain to be higher than those for the CA. The «costeffectiveness » analysis related to «the proportion of stable patients» for the horizons of 6  and 12 months indicated that the reproduced AA would be more economically effective than the  CA. However, when the observation period is increased to 24 months, this economic advantage of AA disappears, and the CA drugs have a lower CER instead. For the «number of  hospitalization-free days per year», the use of AA was more cost-effective only versus the 100% use of reproduced AA at the simulated horizon of 12 months. When estimated for the use of 100% reference AA or the combined reference + reproduced AA, the treatment with CA  remained more economically effective, regardless of the simulated period.

Conclusion. The pharmacoeconomic simulation of the antipsychotic therapy in outpatients with schizophrenia suggests the ways of treatment optimization. Among them, using AA for the  treatment of at least 15.6% of patients (those who are employed); keeping the ≥60% use of CA  to ensure the optimal resource-saving effect of the treatment; using reproduced AA at the level  of ≥70% (instead of the reference AA similar in efficacy and safety) to keep the treatment economically justified.

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Today, pharmacogenetic tests are commonly used to improve the efficacy and safety of antipsychotic (AP) treatment. However, the economic aspects of their implementation in the psychiatry clinic routine are not well studied.

Aim.To evaluate the pharmacoeconomic benefits of CYP2D6 polymorphisms genotyping in psychiatric patients.

Materials and methods. CYP2D6 genetic polymorphisms (*3, *4, *5, *6, *1ХN) were tested in  298 psychiatric in-patients. The mean AP daily doses and the hospital stay duration differed  between poor (PM), extensive (EM) and ulta-rapid (UM) metabolizers. Based on these data, a  pharmacoeconomic decision-making model was created. The model calculates direct medical costs for the patient care with and without pharmacogenetics tests.

Results. Pharmacogenetics tests (CYP2D6 genotyping) performed prior to the antipsychotic  therapy were shown to be a cost-effective strategy as it gives additional clinical and  pharmacological information, optimize the duration of AP treatment, and results in a lower direct  medical cost of in-patient care. The cost of genotyping is less than 1% of the total direct medical  costs. This strategy remains cost-effective even if the genotyping costs more than 3893.8 RUB  (199% of the current value) and also if the differences in the hospital stay durations between PM, EM and UM are not less than 5 days.

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Complicated intra-abdominal infection (IAI) requires increased health care expenditures and additional resources to compensate for an ineffective starting therapy.

Aim. To select the economically optimal algorithm for using antimicrobial agents (AMA) that would minimize the evolving drug-resistance of microbial flora exemplified by E. coli.

Methods. Based on the published data and our own clinical experience with antimicrobial drugs,  we calculated the cost of treatment of complicated IAI when either effective or ineffective  starting antibiotic therapy was applied. The developing drug-resistance of E. coli was simulated  by a mathematical model that incorporated real data on the antimicrobial drugs usage. The  model was also able to propose the optimal mode of AMA consumption, which is expected to minimize the microbial drugresistance.

Results. According to the model, the current volume of AMA consumption (which includes more than 60% of fluoroquinolones, 3d generation cephalosporins and inhibitor-protected penicillin  derivatives) will increase the proportion of the Extended-spectrum betalactamase (ESBL)-positive strains of E. coli by 7% over the next 5 years. In contrast, the proposed alternative (optimized)  mode of AMA consumption (almost complete withdrawal of inhibitor-protected penicillins and  fluoroquinolones, against an increase in carbapenems by 30% and an increase in 3d generation  cephalosporins by 20%), will decrease the proportion of ESBL (+) E. coli strains by 7%. The cost  of care of complicated IAI under the current AMA regimen will grow due to the increase in the  proportion of ESBL (+) strains of E. coli. In contrast, the alternative (optimal) AMA therapy leading to the decrease in E. coli drug-resistance is expected to reduce the cost of care of complicated IAI to the level where the real and alternative (optimized) AMA consumption expenditures are comparable.

Conclusion. The proposed mathematical model allows one to predict the changes in microbial  drug-resistance and choose the optimal algorithm of AMA consumption able to restrain the growth of drug-resistance.

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The aim is to study the clinical and economic components of antimicrobial therapy (AMT) of community-acquired pneumonia (CAP) in a hospital ptactice.

Materials and methods. Case reports of 48 patients with CAP hospitalized in FBU PMLC FMBA in the city of Nizhny Novgorod during 2016 were studied. All patients with CAP hospitalized  during that period were included in the study. A retrospective analysis of AMT was carried out based on the data from inpatient CAP cases.

Results. We compared the real number of prescriptions of antimicrobial agents for CAP in this  hospital with the number of prescriptions required by the approved standards. We found that the  real numbers exceeded the recommended standards in the cases of severe CAP as follows: 2.1- fold for 3d generation cephalosporins, 1.3-fold for fluoroquinolones, and 1.3-fold for  carbapenems. Also notable was the use of ceftaroline fosamil – the 5th generation cephalosporin, which was not part of the standard therapy. Macrolides were not given to patients with severe CAP. In the treatment of CAP of moderate severity, fluoroquinolones were used 1.2 times more  often than that recommended by the standard protocol, 3d generation cephalosporins – 1.5  times more often; macrolides – 5 times less often, as well as carbapenems (not part of the  standard) and 5th generation cephalosporins (not part of the standard). The average duration  and cost of monotherapy of moderate CAP were: 10.5 days and 731.65 rubles for ceftriaxone;  9.1 days and 1353.00 rubles – for levofloxacin; 4 days and 11035.36 rubles – for ceftaroline  fosamyl; 9 days and 16,153.35 rubles – for ertapenem. Positive clinical outcomes were noted in  85% of cases. In 15% of cases, additional AMT was required. As a starting therapy for severe  CAP, antimicrobial monotherapy was prescribed in 89.3% of cases. Its efficacy was 0.920. The treatment regimen was changed in two cases.

Conclusion. The present findings, namely the discrepancy between the real number of AMT prescriptions and the standard recommendations might be due to an ineffective previous  outpatient treatment and prolonged duration of the disease. It is important to note that the  treatment standard was adopted in 2012. Since then, a number of novel effective AMT agents  have been approved for clinical use: for example, ceftaroline fosamil – cephalos (cephalosporin of the 5th generation) is approved for the treatment of CAP, incl. in children from 2 months of age.  There is also a change in the structure of the CAP pathogens that involves bacterial associations  and the emergence of AMT resistant bacteria. The widespread use of macrolides inevitably leads  to the development of new resistant strains. According to the published reports, the following  species play an increasing role in the etiology of CAP: Streptococcus pneumoniae, Haemophilus  influenzae, and also the associations S. pneumoniae-H. Influenzae and S. pneumoniae-M.  pneumoniae. Associations of pathogens are observed in more than 60% of patients with CAP.

Foreign Experience

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The article presents a review of the international experience on the assessment of medical care in outpatients. General approaches, benefits, risks and other criteria of quality assessment are described.

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The cost of medical care has been growing around the world; this is due to a number of factors, including the growing use of costly medicines for cancer and rare (orphan) diseases. The  introduction of reproduced medicinal products instead of original ones opens the way to medical cost reduction. In the present study, various aspects of registration and application of reproduced  biological medicinal products – biosimilars – in the Russian Federation and elsewhere (USA, EU) are  addressed. We propose the basic approaches to optimize the access to biological preparations and  their analogs (biosimilars) considering the existing increase in medical costs and the need to maintain the quality of medical care.


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One of the key elements of medical care is the assessment of the patient’s condition, which allows making a diagnosis and evaluating the patient’s health status, the severity of the disease  and the prognosis of its outcome. To date, medical professionals use various methods of assessing the patient’s condition; these methods are listed in “Clinical Recommendations”  posted in the information resource of the Ministry of Healthcare of Russia.

Objective: to analyze and systemize the many methods of clinical evaluation, e. g. scores, indices, questionnaires and other approaches that appear in the clinical guidelines.

Methods. We analyzed the clinical guidelines developed by professional non-profit medical  organizations and posted on the information resource of the Ministry of Healthcare of the Russian Federation under the “Clinical Recommendations” category. A list of clinical assessment methods  derived from these guidelines was composed and potential problems in their implementation by medical organizations were identified.

Results. The unified list of clinical assessments presented in the guidelines includes 175 clinical  assessment methods. The most common methods of clinical evaluation were the VAS pain score  (in 23 clinical guidelines), the Glasgow coma scale (in 11 clinical guidelines), and the ECOG scale  (in 10 clinical guidelines).

Conclusion. The methods of clinical evaluation, indicated in the Minzdrav information resource  are narrowly specialized; they are used and interpreted by a physician. Some important  information about these methods and their validation is missing, which necessitates further  efforts by the medical community to improve and update these methods.

Review articles

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The aim of this review is to analyze the usefulness of the diagnostic sepsis marker – presepsin.

Materials and methods. A search for relevant publications on presepsin was conducted using  the PubMed database of medical and biological publications and the scientific electronic library. The review includes 42 Russian-language and English-language  sources. Particular attention was paid to comparative studies on the role of presepsin and other bio-markers in the diagnosis of sepsis.

Results. The conducted analysis brought about heterogeneous results. Presepsin was highly  sensitive in detecting late neonatal sepsis, burn sepsis, and also reflected the efficacy of therapy  in septic premature babies and severely burned patients. However, presepsin was not confirmed  as a marker of the disease severity or a prognostic marker of neonatal sepsis. The measured  levels of presepsin are significantly influenced by renal function; therefore, in patients with renal disease, other sepsis markers should be used or the normal presepsin levels should be  adjusted to higher values. Most authors recommend using presepsin in a combination with other markers of sepsis. Considering that presepsin has a good potential of detecting early signs of sepsis and also of monitoring the effects of antimicrobial therapy, further careful studies on this marker are warranted.

Conclusion. Based on the present review, more studies are needed to determine and compare  the diagnostic accuracy of various sepsis markers (C-reactive protein, procalcitonin, presepsin).

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