Key words: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, treatment access

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1 6, 21...,.,..,..,. - (RA) -,. (AS) (PsA). (Disease-modifying antirheumatic drugs, DMARDs). DMARDs RA, AS PsA. 21. RA, DMARDs. Leflunomide (Arava)., RA Methotrexate Leflunomid. DMARDs RA AS. (NSAIDs DMARDs) AS. -,, 12. TNF-.42% RA.4% AS., DMARDs... 75%., DMARDs. -,,, :,,, R. Stoilov,. Ivanova, N. Stoilov and S. Marincheva. COST ANALYSIS OF THE TREATMENT OF RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS AND PSORIATIC ARTHRITIS WITH SYN- THETIC AND BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS FOR 21 IN BULGARIA Summary. Early diagnosis and early aggressive treatment of rheumatoid arthritis (RA) are among the major factors for delaying the rate of bone-tendon destructions and, respectively, of invalidism. Such observations have also been reported in patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Regarding this, great hopes are reposed in disease-modifying antirheumatic drugs (DMARDs) and, particularly, in biologic agents. The aim of this study was to determine and evaluate the utilization of synthetic and biologic DMARDs in the treatment of RA, AS and PsA for 21 in Bulgaria. For 21, an increase of the number of RA treatments with synthetic DMARDs was registered, predominantly attributed to treatments with leflunomide (Arava). This fact can be explained by the consensus achieved by the members of the Bulgarian Society for Rheumatology that a biologic agent is to be included in the treatment of RA, only after a lack of response to methotrexate and leflunomide. In 21, expenditures for biologic DMARDs were 5 times higher compared with these for the preceding 29. This increase was attributed mostly to RA and AS treatments. The lack of sufficiently effective synthetic medicinal products (NSAIDs and DMARDs) for the treatment of AS, has stimulated the use of biologic agents. Despite the increased utilization of biologic agents in the treatment of inflammatory joint diseases in Bulgaria, the proportion of their users is too small, compared with the average 12% in the other EU countries. In our country,.42% of the RA patients and.4% of the AS patients are on TNF- blockers. This indicates that the access to expensive and highly effective treatments with biologic DMARDs is very limited in Bulgaria. The reimbursement policy of the health insurance system is the key to improving the access to biologic agent treatment. The reimbursement of only 75% of the cost of this treatment is still far beyond patient affordability. The proportion of patients treated with synthetic DMARDs is still too low. Of course, reimbursement of synthetic DMARDs is of importance, but it has no such heaviness as this of biologic agents. Rheumatologist s opinion and patient's compliance are of greater importance. Key words: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, treatment access

2 61... (RA) [5]. [1]. RA % [7, 2]. - : -.85% [28],.8% [11]. RA -.31%,.46% [21, 29],.5 1% [25]. - RA.48% [15] , - RA [15]. - RA [17], ( ) [7]., RA HAQ-DI Steinbrocker criteria V [14]. ACR 3 RA -, [3]. (NSAIDs),, - (Disease-modifying antirheumatic drugs, DMARDs). -. DMARDs - ( )., RA DMARDs,, DMARDs [16] , TNF [8, 17, 27, 3], -. - DMARDs. -, : 1) - RA DAS28 5.1; 2) - - DMARDs, -,. TNF- - (AS) (PsA). AS HLA-B % [19]. AS.8% [22],.55% [6],.13%.52% [12]., -.2.3% [15]. -,, AS PsA.5 1% [15]. - -,. - - DMARDs RA, AS PsA. : ISM Methotrexate, Leflunomide (Arava), Sulfasalazine (Salazopyrin), Penicillamine (Cuprenil), Hydroxychloroquine, Azathioprine (Imuran), Ciclosporin A, Cyclophosphamide, Adalimumab (Humira), Etanercept (Enbrel), Infliximab (Remicade), Rituximab (Mabthera) 21.;

3 62.,.,.. TNF- ; - RA, AS PsA., RA, - - [9]. - -, - [31]. DMARDs, -, RA., - RA,, -, RA. - TNF- Arava, , Methotrexate, Sulfasalazine DMARDs. DMARDs ( TNF- Adalimumab Etanercept). 1 -, DMARDs,., RA..25% - (. 1). 1., DMARDs Adalimumab (Humira) % Etanercept (Enbrel) % Infliximab (Remicade) NA NA NA NA Rituximab (Mabthera) NA NA NA NA Methotrexate % Leflunomide (Arava) % Sulfasalazine (Salazopyrin) % Penicillamine (Cuprenil) 3 NA 262 NA 786 NA Hydroxychloroquine % Azathioprine (Imuran) % Ciclosporin A NA NA NA NA Cyclophosphamide NA NA NA NA 21. TNF- (Adalimumab Etanercept) 21 (RA 125, AS 61, PsA 15) , 72, 179% TNF- (Adalimumab Etanercept) , - 144% (. 1). - TNF- -

4 63... [16] RA, TNF-. - Adalimumab (Humira) Etanercept (Enbrel).42% RA ( ). - TNF RA % - TNF- [13] % [13]., 12% R TNF- [13]., -. ( ) - (75%) % % % TNF ( ) ,.4% - AS (15 4 ), Adalimumab Etanercept. TNF- AS NSAIDs, - DMARDs KS. - TNF- AS. PsA -, 15, -, Adalimumab (Humira) Etanercept (Enbrel) -.. 1, - TNF , TNF-, %, 25%, 36% % TNF-, % (. 1,. 2).. 2, - DMARDs Enbrel Humira

5 64.,.,.. 2. DMARDs 1 - [1].. Sulfasalazine (Salasopyrin) Aurothiomalic acid NA Hydroxychloroquine Penicillamine (Cuprenil) Auranofin NA Methotrexate 1 mg/ Azathioprine (Imuran) 1978 NA 146 Cyclosprorin A NA Leflunomide (Arava) Etanercept (Enbrel) Infliximab (Remicade) NA Anakinra (Kinret) NA Adalimumab (Humira) Rituximab (Mabthera) NA Abatacept (Orencia) NA Humira Enbrel. Infliximab (Remicade), -TNF-, [2]. 1, - Humira 61%, Enbrel 39%., 65% TNF- Humira 35% Enbrel (. 2) HUMIRA, ENBREL REMICADE. 21. ( )

6 65... DMARDs RA DMARDs., 11.6% -., DMARDs,., RA. - -, -, (.. 2). Methotrexate ( ) , % RA ( 1%), Arava. Leflunomide (Arava).9% RA (.. 1). 36% TNF- - Methotrexate Leflunomide. Sulfasalazine Hydroxychloroquine, 43% 75% % Sulfasalazine (Salasopyrin).3% Hydroxychloroquine. Penicillamine (Cuprenil) Imuran, Cyclosprorin A Cyclophosphamide RA (.. 1)., , -, TNF [13].. 2, - DMARDs,, -. Methotrexate 1 mg/ 36, (Sulfasalazine, Hydroxychloroquine, Leflunomide), Arava Arava , 31%. DMARDs TNF-, 87.7 %. DMARDs , 12.3% DMARDs (. 3). 29. DMARDs , , , 47%, 53% : 1) - 2) DMARDs. 29. DMARDs 47 53%, % (.. 3)., - -,, -. -, - - DMARDs,. - - /,., /. TNF - Etanercep Adalimumab ( ) - DMARDs. TNF - RA - Methotrexate., - TNF [18].

7 66.,.,.. - TNF RA [23]. (, ) DMARDs RA , , Leflunomide 21, Azathio- prine 1878, Sulfasalazine 119, Methotrexate 78, Hydroxychloroquine 684 [24]., - DMARDs a a. -, % - TNF % % % 47 % , % , DMARDs 18%.13% % DMARDs.,. 9% -, 9%. -,,., - -, ,, ,, -., TNF - -, -, -, [4].

8 % % % ( ) ( ) TNF - RA, AS PsA [26].,.. -, -. -., [13].., - -,,, TNF,.,, - ( ), -, - [13]. - - DMARDs ( -, )., TNF., RA, DMARDs. Leflunomide (Arava) Methotrexate., RA Methotrexate Leflunomid. DMARDs -. RA AS. (NSAIDs DMARDs) - AS , -., - DMARDs , 5, 15, (,, ), [1]. DMARDs , 1 mg/

9 68.,.,.., -,.. - DSA28 ACR RA, AS, PsA TNF-., - [7].,. TNF, -,,.. 1.,.,... -., 19, 211, 4, ,.,... -, -., 19, 211, 4, A m e r i c a n College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis. Arthritis Rheum., 46, 28, 2, A d a m s, C. P. et V. V. Brantner. Estimating the cost of new drug development: is it really 82 million dollars? Health Aff. (Millwood), 25, 26, A n t o n i, M. R. et al. Cooperative of QoL in rheumatic disease: results of a survey among 6, patients across 11 European countries. Arthritis Rheum., 46, 22, ACR (abstract). 6. B r a u n, J., J. Listing et J. Sieper. Overestimation of the prevalence of ankylosing spondylitis in the Berlin study. Arthritis Rheum., 52, 25, B e n u c c i, M. et al. Cost effectiveness analysis of diseasemodifying antirheumatic drugs in rheumatoid arthritis. A systematic rewiev literature. Int. J. Rheum., 211, Article ID , 6 pages. 8. B a t h o n, J. M. et al. A comparison of etanercept and methotrexate in patient with early rheumatoid arthritis. N. Engl. J. Med., 343, 2, 22, E F P I A The European Federation of Pharmaceutical Industries and Associations annual report. org/6_publ/annual. 1. F e x, E. et al. Impact of rheumatoid arthritis on work status and social and leisure time activities in patients followed 8 years from onset. J. Rheumatol., 25, 1997, H a k a l a, M., R. Pollanen et P. Nieminen. The ARA 1987 revised criteria select patients with clinical rheumatoid arthritis from a population based cohort of subjects with chronic rheumatic diseases registered for drug reimbursement. J. Rheumatol., 2, 1993, 1, H e l m i c k, C. G. et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum., 58, 28, J ö n s s o n, B., G. Kobelt et J. Smolen. The burden of rheumatoid arthritis and access to treatment: uptake of new therapies. Eur. J. Health Econ., 8, 28, Suppl. 2, S61-S L e a r d i n i, G. et al. A multicenter cost-of-illness study on rheumatoid arthritis in Italy. Clin. Exp. Rheum., 2, 22, 4, K o b e l t, G. et F. Kasteng. Access to innovative treatmens in rheumatoid arthritis in Europe. October K o b e l t, G. et al. Modeling the progression of rheumatoid arthritis: a two-country model to estimate costs and consequences of rheumatoid arthritis. Arthritis Rheum., 46, 22, 9, K l a r e s k o g, L. et al. Therapeutic effect of the combination of etanercept and methotrexate compared wuth each treatment alone in patients with rheumatoid arthritis: doubleblind randomised controlled trial. Lancet, 363, 24, 941, M e r k e s d a l, S. et J. Ruof. Curent aspects of cost effectivness of TNF-alfa blocking agents in patients with rheumatoid arthritis. Zeitschrift fur Rheumatol., 61, 22, 3, P o d d u b n y y, D. Improving Diagnosis of Ankylosing Spondylitis and Spondyloarthritis in General, CME. Medscape, Q u a n, V. D., Chiun-Fang Chiou and R. Duboas. Review of eight pharmacoeconomic studies of the value of biologic DMARDs (Adalimumab, Etanercept and Infliximab) in the management of rheumatoid arthritis. J. Manag. Care Pharm., 12, 26, 7, R o u x, C. H. et al. Rheumatoid arthritis and spondyloarthropathies: geographical variations in prevalence in France. J. Rheumatol., 34, 27, 1, S a r a u x, A. et al. Prevalence of spondyloarthropathies in France: 21. Ann. Rheum. Dis., 64, 25, S c o t t, D. L. et G. Kingsley. Clinical effectiveness of biologics in clinical practice. Arthr. Reas Ther., 23, 21, S c h a d l i c h, P. K. et al. Modelling cost effectivness and cost utility of sequential DMAR therapy including leflunomide in rheumatoid arthritis in Germany: I. Selected DMARs and patient-related costs. FarmacoEconomics, 23, 25, 4, S i l m a n, A. J. et J. E. Pearson. Epdemiology and genetics of rheumatoid arthritis. Arthritis Res., 22, 4, suppl. 3, S m o l e n, J. S. et al. New therapies for the treatment of rheumatoid arthritis. Lancet, 37, 27, S m o l e n, J. S. et al. Predictors of joint damage in patients with early rheumatoid arthritis with high-dose methotrexate with or without concomitant infliximab: results from the AS- PIRE trial. Arthritis Rheum., 54, 26, 3, S y m m o n s, D. et al. The prevalence of rheumatoid arthritis in the United Kingdom: new estimates for a new century. Rheumatology (Oxford), 41, 22, 7, T o r r a n c e, G. W. Measurement of health state utilitifor economic appraisal: a review. J. Health Econ., 5, 1986, 1, Weinblatt, M. E. et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis reseiving methotrexate. N. Engl. J. Med., 34, 1999, 4, W o r l d Health Organisation. Dearth and DALY estimated for 22 by cause for WHO member states. In: WHO, Geneva, :. -.. " " Address for correspondence: Assoc. Prof. R. Stoilov, M. D. Clinic of Rheumatology Medical University 13, Urvitch Str. Bg 1612 Sofia

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