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Does Russia need a treat-to-target initiative?

3 Июня 2019, 14:22

Does Russia need a treat-to-target initiative?

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Adopting a global strategy to improve outcomes locally

The international initiative treat RA to target (T2T) [ 1 ] has been widely accepted throughout the world. Targeted therapy using pre-specified parameters in order to achieve remission demonstrates a big advantage over conventional treatment strategies and is being introduced into practice [ 2–4 ]. At the same time, many serious questions arise about the practical application of the T2T strategy [ 5 ]. The T2T strategy requires a stable state-regulated system of reimbursement of medical expenses. Is it possible to use the T2T approach in countries where there is no such health care system? How realistic is the use of this strategy in a country like the Russian Federation, where, despite the great economic potential, the health system is far from perfect and is being reformed?

In 2010 in Russia, 252 100 patients with RA had been officially registered. According to the epidemiological data [ 6 ], the prevalence of RA in Russia has reached 0.61%, and the estimated number of patients with RA according to the last census (2010) is ∼871 720 people. In Moscow and other large Russian cities there are some large rheumatology centres, but in remote and agricultural regions, rheumatologic care is not easily accessible. In clinical practice only 18% of RA diagnoses were verified within 6 months of the onset of symptoms.

The state drug supply system has been up and running in Russia for several years. There are now eight biologics approved for the treatment of RA and other inflammatory diseases in Russia: infliximab, adalimumab, etanercept, rituximab, abatacept, tocilizumab, certolizumab and golimumab. Recently tofacitinib has also been approved. Unfortunately, guidelines from the Association of Rheumatologists of Russia are advisory in nature, according to legislation. The reimbursement system in Russia is based on the so-called obligatory medical (health) insurance. An employer must pay ∼5% of an employee’s total salary per month for this purpose. This obligatory insurance covers only low-cost medicines. High-cost medicines are normally covered by special government programmes: high-technology medical aid for inpatients—for outpatients, an additional reimbursement programme—and special regional reimbursement programmes. All of these programmes have their own drug supply budgets, and their availability is usually limited to certain quotas. The patient should receive, depending on residence, type of hospital, etc., a specified quota for initiation or continuation of treatment with biologics. So the availability of biologics is limited due to a lack of access to rheumatologic care, a complicated and bureaucratized multichannel system of reimbursement and a lack of continuity between the different care levels.

‘What is to be done?’ (N. G. Chernyshevsky, the famous Russian writer and publicist of the 19th century). Russian rheumatologists consider the development of scientific research a fundamentally important area for optimization of medical care. A number of Russian physicians have greatly influenced the development of rheumatology (e.g. V. M. Bechterev, M. P. Konchalovsky and V. T. Talalaev). Research in the area of RA was led by Professor V. A. Nasonova [European League Against Rheumatism (EULAR) president, 1979–81]. Areas of special clinical research interest were early RA, immunology, clinical heterogeneity and prognosis of RA, and new treatments, including biologics [ 7 ]. In 2003 the research programme RADICAL (the Russian acronym corresponds to the name Early Arthritis, Diagnosis, Criteria and Active Treatment) started at the Institute of Rheumatology, Russian Academy of Medical Sciences (RAMS). The Russian biologics registry ARBITER started in 2005, and the Russian National register of patients with RA started in 2012. Also important is the direction of collaboration with foreign scientists, as Russian rheumatologists have been involved in several large independent international projects. Thus Russia has a good scientific basis for the development of high standards of rheumatological care.

The first meeting of the T2T initiative was held on 3 June 2010 in St Petersburg. In October 2010 a special survey was conducted among leading Russian rheumatologists ( n = 62), which showed a very high level of agreement with the T2T recommendations (Dr D. Karateev, unpublished personal communication). Meetings of the Expert Council of Rheumatology of the Ministry of Health Service of the Russian Federation over the past 2 years have confirmed that the principles and recommendations of T2T are critically important for Russian rheumatology practice. A decision was made to include the main statement of T2T into a new version of the Russian National guidelines for RA [ 8 ].

Why was the T2T initiative considered so important and what can its implementation achieve? The answer lies in the fact that the principles and recommendations of T2T describe the proper strategy for patient management and suggest the optimal organization of care. The principle of maximum long-term preservation of social activity for RA patients breaks the stereotype; a patient with arthritis is often regarded as a potentially handicapped person. The concept of active management of patients with the achievement of a certain goal is counter to the common practice of visits to the doctor only due to flares. The need to maintain treatment goals during the entire course of the disease can be the rationale for long-term supply of drugs. The need for careful monitoring of treatment and the use of special tools to assess disease activity enhance the role of the specialist rheumatologist. Finally, Russian rheumatologists realize that the weight of the international recommendations, if approved at the state level, will enable a more reasoned dialogue with medical authorities. To prove the effectiveness of the T2T recommendations in a Russian cohort of patients, an investigator-initiated strategic trial, REMARCA (Russian investigation of methotrexate and biologics in early active inflammatory arthritis) was initiated, supported by an independent grant from RAMS [ 9 ]. The first results of the REMARCA trial were reported at the EULAR Congress in Madrid, Spain in 2013 [ 10 ].

At present, the Russian health care system is in the process of reform, with the transition to single-channel funding from the obligatory insurance foundations for most types of treatment. Russian rheumatologists are actively working with the Ministry of Health and regional medical authorities to improve the situation with diagnosis and drug supply. New standards of medical care for patients with rheumatic diseases have been developed that have already been approved or are in the process of approval. Russian rheumatologists understand that they need to support the T2T project to improve the practical aspects of medical care for patients with RA.