scholarly journals The use of various genetically engineered biological drugs and selective immunosuppressants within the current provider-payment model of russian diagnosis-related groups

Author(s):  
E. V. Derkach ◽  
E. A. Pyadushkina ◽  
M. V. Avxentyeva ◽  
T. V. Boyarskaya ◽  
E. E. Yagnenkova ◽  
...  

Diagnosis-Related Groups (DRG) for the payment for biological therapy were created at the stage of the pilot project and their coefficients of input intensity were not revised since then. The expansion of the range of genetically-engineered biological drugs (GEBD) and the development of new indications for biological therapy and new groups of expensive drugs (like selective immunodepressants, SI) determine the necessity in the differentiated payment for the therapy with GEBD and SI. However, at the federal level, this will be possible only after the approval of the clinical recommendations.Aim. The study aimed to identify possible applications of different GEBD and SI within the current provider-payment model of the Russian diagnosis-related group in terms of bronchial asthma (BA) and inflammatory bowel disease (IBD) - Crohn's disease and ulcerative colitis.Materials and methods. The expenses on GEBD and SI for one case of hospitalization were calculated and compared with the imposed tariffs. For the evaluation of the possibility of the provision of an expensive treatment within the existing DRG model, the authors modeled the distribution of patients with BA and IBD by different pharmaceutical treatment plans in the current practice and cases of an increase in the share of indications of more expensive therapy. The authors identified the number of patients that could have been treated without an increase in the costs of compulsory medical insurance (CHI). The authors proposed the subgroups for the differentiated payment for the treatment of BA and IBD with GEBD and SI.Results. Few variants of treatment with GEBD and SI were characterized by the costs of drugs that would exceed an average payment rate for DRG st36.003 and ds36.004 in 2020. In the model, an increase in the share of patients that received the most expensive drugs of all the registered GEBD and SI in the RF for the treatment of BA and IBD did not lead to an increase in the costs for CHI. It is possible to maintain the initial volume of the financing and increase the number of patients that receive GEBD and SI due to a decrease in the number of hospitalizations. The authors identified approximate values of the coefficient of input intensity (CII) for the subgroups that can be formed for the differentiated payment for pharmaceutical treatment with GEBD and SI.Conclusion. Despite the fact that without the recalculation of CII, there were numerous changed introduced into DRGs st36.003 and ds36.004 “Treatment with GEBD and SI” and the spectrum of the associated clinical situations expanded, it was possible to maintain the possibility of the payment for the therapy with different drugs, including the most expensive ones without an increase in the costs for the CHI system. Still, the results of the present study indicate the necessity in the optimization of the system of payment for medical care with genetically-engineered biologic drugs and selective immunodepressants through the implementation of a differentiated approach to the payment at the federal level.

Author(s):  
Christian Stöss ◽  
Maximilian Berlet ◽  
Stefan Reischl ◽  
Ulrich Nitsche ◽  
Marie-Christin Weber ◽  
...  

Abstract Purpose Despite primary conservative therapy for Crohn’s disease, a considerable proportion of patients ultimately needs to undergo surgery. Presumably, due to the increased use of biologics, the number of surgeries might have decreased. This study aimed to delineate current case numbers and trends in surgery in the era of biological therapy for Crohn’s disease. Methods Nationwide standardized hospital discharge data (diagnosis-related groups statistics) from 2010 to 2017 were used. All patients who were admitted as inpatient Crohn’s disease cases in Germany were included. Time-related development of admission numbers, rate of surgery, morbidity, and mortality of inpatient Crohn’s disease cases were analyzed. Results A total number of 201,165 Crohn’s disease cases were included. Within the analyzed time period, the total number of hospital admissions increased by 10.6% (n = 23,301 vs. 26,069). While gender and age distribution remained comparable, patients with comorbidities such as stenosis formation (2010: 10.1%, 2017: 13.4%) or malnutrition (2010: 0.8%, 2017: 3.2%) were increasingly admitted. The total number of all analyzed operations for Crohn’s disease increased by 7.5% (2010: n = 1567; 2017: n = 1694). On average, 6.8 ± 0.2% of all inpatient patients received ileocolonic resections. Procedures have increasingly been performed minimally invasive (2010: n = 353; 2017: n = 687). The number of postoperative complications remained low. Conclusion Despite the development of novel immunotherapeutics, the number of patients requiring surgery for Crohn’s disease remains stable. Interestingly, patients have been increasingly hospitalized with stenosis and malnutrition. The trend towards more minimally invasive operations has not relevantly changed the rate of overall complications.


Author(s):  
Maria Leonidovna Lazareva ◽  
Inna Alexandrovna Zheleznyakova ◽  
Maria Vladimirovna Avxentyeva ◽  
Denis Valerievich Fedyaev ◽  
Alexandr Vladimirovich Zuev ◽  
...  

Since 2013 a diagnosis-related groups (DRG) model has been introduced for the payment of medical care provided in inpatient settings and the day hospitals in Russia at the federal level. The DRG model is improved annually by the increasing of DRG number and specifying the classification criteria for attributing treatment cases to a particular group. In this article, we describe the main changes in the DRG model in 2020 compared with the last year. Main changes include the creation of new classification criteria for the formation of DRG, new DRG in the oncology profile, the changes in the DRG for epilepsy and chronic viral hepatitis C treatment, as well as for the use of genetically engineered biological drugs and selective immunosuppressants. The article also describes the innovations regarding the general approaches to paying for health care with respect to DRG: the rules for applying regional correction factors and for simultaneous payment for two DRG within one treatment case.


2021 ◽  
pp. 35-40
Author(s):  
L. N. Shilova ◽  
S. S. Spitsina

Rheumatoid arthritis is the most common rheumatic disease characterized by damage to the synovium, progressive destruction of cartilage and bone tissue. As a result of the establishment of the biological role of cytokines, it became possible to intervene in the main links of the pathogenesis of the disease, which led to inhibition of the main pathological process in RA – autoimmune inflammation.The aim. To consider the possibilities of optimizing the biological therapy of rheumatoid arthritis by identifying predictors of anti-inflammatory efficacy among clinical and laboratory markers.Basic provisions. Despite the success of genetically engineered biological drugs in the treatment of inflammatory arthritis, due to the lack of predictive biomarkers, the use of a trial and error approach, empirical therapy, is inevitable, which does not always lead to satisfactory results. The study of the main biomarkers of RA provides new insights into their potential association with various clinical phenotypes.Conclusion. This patient-centered approach offers the prospect of improving treatment outcomes through the use of specific drugs in certain patient groups.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
R Waitzberg ◽  
W Quentin ◽  
R Maoz-Breuer ◽  
R Busse ◽  
D Greenberg

Abstract Background In 2013-14, Israel stepped up the replacement of per-diem payments by Procedure-Related Group (PRG) based hospital payments, a local version of Diagnosis-Related groups (DRGs). PRGs were created for selected procedures in urology, general surgery, gynecology and ophthalmology. We analyzed how did this change affect inpatient activities, measured by the number of discharges, average length of stay (ALoS), and the case-severity Charlson Comorbidity Index (CCI). Methods We investigated the impacts of the PRG-payment reform on 15 procedures. Observations covered groups of inpatients, by age and gender, who underwent these procedures in 2005-2016 at all non-profit hospitals. We examined the effect of the payment change on the number of discharges, ALoS and CCI using a multivariable analysis of Ordinary Least Squares controlling for patients, hospital characteristics, and year fixed-effects. Results Data on 89,533 patients were examined. During the study period, the ALoS decreased except for one procedure, the number of inpatients increased for most procedures, and case severity remained stable. The multivariable analysis suggests that the transition to PRG-payments contributed to changes in ALoS or case severity for only 3 out of 15 procedures examined. The PRG-reform contributed to changes of 10%-45% in the number of patients, but there was no clear trend: it increased in 9, and decreased in 5. The changes did not follow a clear pattern according to procedures’ price changes after the reform. Conclusions Factors that may have hampered the effects of the PRG-reform are conflicting incentives created by other co-existing hospital-payment components, such as revenue caps and retrospective subsidies, and the lack of resources to increase productivity. Key messages Provider payment reforms should carefully coordinate the entire payment system, otherwise the incentives may be blurred. Uncoordinated reforms may miss their goals.


2021 ◽  
Vol 6 (4) ◽  
pp. 36-39
Author(s):  
K. Leonova

Rheumatoid arthritis, like any chronic non-infectious disease, requires constant pharmacological therapy and monitoring of treatment. To relieve exacerbation, maintain long-term remission and improve the quality of life of patients, basic anti-inflammatory drugs are used, which have passed many years of testing for efficacy and safety and are available for patients. But there is a group of drugs that have appeared relatively recently - genetically engineered biological drugs. At the moment, their use is somewhat limited due to the presence of a number of problems. With the accumulation of data on the study of the safety of genetically engineered drugs in the treatment of rheumatoid arthritis, it will be possible to solve many practical issues that arise in the attending physician during the supervision of patients.


2021 ◽  
Vol 31 (6) ◽  
pp. 776-781
Author(s):  
Sergey N. Avdeev ◽  
Alexandr V. Emelyanov ◽  
Oksana M. Kurbacheva ◽  
Irina M. Marusenko ◽  
Pavel I. Novikov ◽  
...  

The emergence of new means of administering genetically-engineered biological drugs, such as an autoinjector (pen injector device), can positively affect the organizational aspects of treating patients with severe eosinophilic asthma (SA) who need biological therapy.The aim. To determine the place of a new delivery device for benralizumab (autoinjector, pen injector device) in the clinical practice of treating eosinophilic SA.Results. The expert council considered the results of the latest clinical studies and real practice data on the use of genetically-engineered biological drugs in the form of an autoinjector. The experts discussed the safety and efficacy of this delivery device and recommended considering the possibility of switching eosinophilic SA patients to self-administration of genetically-engineered biological drugs (autoinjector form) at home. This treatment tactic is especially relevant in the current epidemiological situation since it will reduce the risks of infection compared to planned medical care in inpatient or outpatient treatment settings and reduce the burden for healthcare workers.Conclusion. The practice of switching eosinophilic SA patients to self-administration of biologics in the form of an autoinjector (pen injector device) can improve the adherence to biological therapy and quality of life of this group of patients.


Author(s):  
Н.В. Зильберберг ◽  
Я.В. Кащеева ◽  
М.М. Кохан

Псориаз – один из самых распространенных хронических дерматозов. В последние годы наблюдается рост числа больных тяжелыми, инвалидизирующими формами дерматоза, резистентными к проводимой терапии. Заболевание значительно снижает качество жизни, нарушает трудоспособность пациентов, что определяет дерматоз как социально значимый и влечет за собой необходимость совершенствования терапевтических подходов. Псориатический артрит, или псориаз артопатический, – хроническое воспалительное заболевание суставов, позвоночника и энтезисов, которое может наблюдаться у больных псориазом. В статье представлены основные актуальные сведения о патогенезе псориаза и псориатического артрита с акцентом на иммунопатологические аспекты развития заболеваний и обоснование использования блокатора провоспалительного цитокина интерлейкин-17 в терапии. Cовременные достижения в понимании механизма развития псориаза и псориатического артрита послужили обоснованием для создания группы инновационных лекарственных средств таргетного действия – генно-инженерных биологических препаратов, механизм действия которых заключается в блокаде определенных цитокинов, как циркулирующих в системном кровотоке, так и находящихся в воспаленной ткани псориатической бляшки или сустава. В статье приведены краткие сведения о результатах клинических исследований препарата секукинумаб; на клинических примерах освещен опыт эффективного лечения пациентов с псориазом и псориатическим артритом. Показано, что раннее прекращение прогрессирования воспалительного процесса при псориазе посредством биологической терапии препаратом секукинумаб приводит к снижению симптомов со стороны кожных покровов, уменьшению боли и субклинического воспаления в суставах. Высокая эффективность и безопасность препарата позволяют полностью контролировать заболевание и улучшить качество жизни у пациентов. Psoriasis is one of the most common chronic dermatoses. In recent years, there has been an increase in the number of patients with severe, disabling forms of dermatosis, resistant to the therapy. The disease significantly reduces the quality of life, disrupts patients' ability to work, which defines dermatosis as socially significant and entails the need to improve therapeutic approaches. Psoriatic arthritis, or artopathic psoriasis, is a chronic inflammatory disease of the joints, spine and enthesis, which can be observed in patients with psoriasis. The article presents the main current information about the pathogenesis of psoriasis and psoriatic arthritis with an emphasis on the immunopathological aspects of the development of diseases and the rationality for the use of the proinflammatory cytokine inhibitor interleukin-17 in the therapy. Modern advances in understanding the mechanism of development of psoriasis and psoriatic arthritis served as a rationale for the creation of a group of innovative targeted drugs – genetically engineered biological drugs, the mechanism of action of which is to block certain cytokines, both circulating in the systemic circulation and located in the inflamed tissue of psoriatic plaques or joint. In the article brief information about the results of clinical trials of secukinumab is provided; clinical examples highlight experience of effective treatment of patients with psoriasis and psoriatic arthritis. It has been shown that early cessation of the progression of the inflammatory process in psoriasis through biological therapy with secukinumab leads to a decrease in skin symptoms, a decrease in pain and subclinical inflammation in the joints. The high efficacy and safety of the drug allows complete control of the disease and improve the quality of life in patients.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1612.2-1613
Author(s):  
J. M. Bello-Gualtero ◽  
O. J. Calixto ◽  
G. Salguedo ◽  
Y. M. Chamorro-Melo ◽  
C. A. Camargo Rodríguez ◽  
...  

Background:Spondyloarthritis refers to a family of diseases, of which ankylosing spondylitis and non-radiographic axial spondyloarthritis are responsible for axial impairment. Previously, the only treatment available were NSAIDs, which control activity and stop radiological progression, but at the expense of increased adverse effects, such as cardiovascular risk, dyspepsia and chronic renal failure. For the past 2 decades, biological therapy has been available, which means an increase in care costs.Objectives:The objective of this study is to perform a budget impact analysis of biologic therapy.Methods:To do a budget impact analysis from the perspective of the payer, comparing biological therapy with coventional therapy for the treatment of spondyloarthritis. Demographic characterization of the population attended at the Central Military Hospital. Time horizon from 2012 to 2018, taking the activity count according to the hospital’s billing and the prices of the activities of the state body SISMED. Exchange rates at the end of 2018.Results:The patients attended were 117, mostly men (63, 25%), average age 46, 4 years (SD 13), with disease diagnosis time of 9, 8 years (SD 9, 6). In the budget impact analysis, it is observed that 25% of patients were on DMARDs therapy, 22% with NSAIDs and 96% with biologic therapy. The average year/patient cost with NSAIDs alone would be EUR 381, with DMARDs only EUR 9,318 and, if only biological therapy was used, EUR 423. Within the total number of patients, the average annual cost, including the possibility of combining these drugs, amounted to EUR 5,403Conclusion:Including biological therapy in the care of patients with spondyloarthritis can increase up to 24 times the annual cost per patient. This increase is not only due to higher market value, it also relates to the need for more medical procedures and diagnostic follow-up tests.References:[1]Strömbeck, et al. Cost of Illness from the Public Payers’ Perspective in Patients with Ankylosing Spondylitis in Rheumatological Care. J Rheumatol 2010;37;2348-2355.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1144.2-1144
Author(s):  
N. Zehraoui ◽  
R. Benaziez.Boutaleb ◽  
H. Hafirassou ◽  
F. Mechid ◽  
N. Bahaz ◽  
...  

Background:Biological therapies have significantly improved the management of rheumatoid arthritis (RA). These molecules are very effective, but are known for their specific risks, especially infectious. It depends on several factors including the type of molecule used.Objectives:The objective of our study is to compare the rate of infection in RA patients treated with rituximab and anti-TNFα.Methods:Prospective, observational, monocentric study. Were included RA patients (ACR / EULAR 2010 criteria) treated with rituximab and anti-TNFα (adalimumab, infliximab and Etanercept) after inadequate response to DMARDs.Demographic characteristics, comorbidities, association with methotrexate and corticosteroids were collected and compared for each group.The number, type and severity of the infections in both cases were noted.SPSS (Statistical Package for Social Science) was used for data analysis.Results:40 RA patients treated with rituximab and 31 patients who received anti-TNFα were included.Patient characteristics and Comparison of rate of infection in RA patients between the two groups are summarized in Table 1Table 1.ParametersRituximabAnti-TNFαpNumber of patients4031Average age (years)56,2846,060,01Sexratio0,140,110,7Average duration of evolution (years)15,8313,740,3Patients under corticosteroid (%)97,587,10,08Average corticosteroid dose6,415,480,3patients under methotrexate (%)37,545,20,5Diabetes (%)2016,10,7Patients with infection (%)32,551,60,1Number of infections18240,4Number of serious infections500,04Conclusion:The rate of infections in patients with RA treated with rituximab or anti-TNF was similar. However, the infections observed were more serious in patients with RA treated with rituximabReferences:[1]Fabiola Atzeni MD PhD and al. Infections and Biological Therapy in Patients with Rheumatic Diseases. IMAJ . VOL 18. march-APRIL 2016.[2]Huifeng Yun and al. Comparative Risk of Hospitalized Infection Associated with Biologic Agents in Rheumatoid Arthritis Patients Enrolled in Medicare. ARTHRITIS & RHEUMATOLOGY. Vol. 68, No. 1, January 2016, pp 56–66.[3]Manjari Lahiri and al. Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis. Best Practice & Research Clinical Rheumatology (2015) 1-16.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 327.3-327
Author(s):  
A. Karateev ◽  
E. Filatova ◽  
E. Pogozheva ◽  
V. Amirdzhanova ◽  
E. Nasonov ◽  
...  

Background:The presence of central sensitization (CS) significantly burdens the course of rheumatoid arthritis (RA). JAK inhibitors block intracellular signal pathways including the ones responsible for synthesis of mediators and cytokines causing pain and CS. The application of JAK inhibitors is supposed to relieve pain and reduce CS severity promptly.Objectives:To evaluate JAK inhibitor effect on pain and signs of CS in patients with active RA 7 and 28 days after the start of therapy.Methods:Study group included 39 patients with RA, their age was 50.9±11.1, 79.5% of women, 89.7% of RF “+”, DAS28 5.8±0.6, receiving DMARDs (methotrexate 82.0% and leflunomide 18.0%), who were administered with tofacitinib 5 mg 2 times a day due to inefficiency or intolerance of genetically engineered biological drugs. There were assessed the pain severity using Brief pain inventory (BPI) questionnaire, the presence of neuropathic pain component (NPC) using PainDETECT questionnaire and signs of CS using Central Sensitisation Inventory (CSI) questionnaire at early time after tofacitinib administration.Results:Patients initially experienced a severe pain – 5.72±2.21 according to the visual analogue scale (VAS), 53.8% had signs of central sensitization (CSI ≥ 40), 17.9% had NPC (PainDETECT ≥18). 7 days after tofacitinib intake there was statistically reliable reduction of pain severity – up to 4.37±2.2 (р=0.01), pain decrease of 29.4±17.9% (BPI), NCP – PainDETECT from 12.9±5.5 to 10.6±5.6 (р=0.047) and CS – CSI from 43.1±12.8 to 35.9±11.2 (р=0.01). The effect had increased after 28 days: pain level (VAS) was 2.84±1.57 (р=0.000), pain decrease of 43.6±29.6% (BPI), PainDETECT 29.8±12.4 (р=0.000), CSI 26.4±13.9 (р=0.000).During this period there were no serious adverse reactions.Conclusion:The application of JAK inhibitor tofacitinib allows to reach a fast analgesic effect, also due to impact on CS and NCP.Source: National Registry patients with RADisclosure of Interests: :Andrey Karateev: None declared, Ekaterina Filatova: None declared, Elena Pogozheva: None declared, Vera Amirdzhanova: None declared, Evgeny Nasonov: None declared, Alexander Lila: None declared, V Mazurov: None declared, N Lapkina: None declared, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Tatiana Salnikova: None declared, Ruzana Samigullina: None declared, Diana Chakieva: None declared, Irina Marusenko: None declared, Olga Semagina: None declared, Marina Semchenkova: None declared


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