MEDICINE TREATMENT COST OF RHEUMATOID ARTHRITIS BEFORE AND AFTER TREATMENT WITH BIOLOGICAL DRUGS. 3 June 2011

Transcription

1 MEDICINE TREATMENT COST OF RHEUMATOID ARTHRITIS BEFORE AND AFTER TREATMENT WITH BIOLOGICAL DRUGS 3 June 2011 Ilanca Roux, Martie S. Lubbe, Johanita R. Burger, Johan C. Lamprecht SASOCP CONFERENCE 2-5 JUNE 2011

2 INTRODUCTION The past years dramatic change in the immunotherapy of autoimmune diseases 1 advances in molecular immunology and rapid technical evolution new class of medicines called biologics 2.

3 INTRODUCTION continue WHAT ARE BIOLOGICS? Biologics = medicine comprising various compound classes 3 Traditional biologics: blood products, human/animal cells and antitoxins 3 Modern biologics: biotechnology derived pharmaceuticals, i.e. monoclonal antibodies, cytokines and growth factors 4 Referred to as biopharmaceuticals, or therapeutic biologics 4 Typically bundled under name: biologics or immunotherapies 5

4 INTRODUCTION continue USES OF THERAPEUTIC BIOLOGICS A large number of therapeutic biologics have recently entered the market to treat immune-mediated disesases especially auto-immune diseases 8, like RHEUMATOID ARTHRITIS RHEUMATOID ARTHRITIS: chronic, inflammatory, destructive and sometimes deforming collagen disease that has an autoimmune component. 9 If left untreated joint deformity and destruction 9

5 INTRODUCTION continue DESIRED OUTCOME OF RA PATIENTS Achieve remission of RA at an early stage in order to prevent long-term structural damage and disability 5 The two primary goals: to reduce patients pain and discomfort, and try to prevent or minimise physical disability associated with the disease progress. 10

6 INTRODUCTION continue Initiate therapy: NSAID / COX-2 INHIBITOR Local / low-dose systemic corticosteroids while waiting for DMARD to be started / to be effective Adequate response with decreased disease activity Inadequate response (ongoing active disease after 3 months of maximal therapy) NSAIDs SELECTIVE COX-2 INHIBITORS GLUCOCORTICOIDS DMARDs No previous MTX treatment Suboptimal response to MTX treatment MTX Other monotherapy Combination therapy Other monotherapy Combination therapy Figure 1.1 Treatment algorithm of RA 11 BIOLOGICS Infliximab Adalimumab Etanercept COX = cyclo-oxygenase DMARD = diseases modifying antirheumatic drug; NSAID = non-steroid antiinflammatory drug; MTX = methotrexate; RA = rheumatoid arthritis.

7 OBJECTIVES To investigate the medicine treatment cost of rheumatoid arthritis (RA) before and after treatment with biological drugs in the private health care sector of South Africa

8 METHODOLOGY A quantitive retrospective drug utilisation review was performed on medicine claims data of a pharmacy benefit management company (PBM) in South Africa. Data for a four year period (1 Jan to 31 Dec. 2008) were used to determine the medicine treatment cost of 141 RA patients before and after treatment with biological drugs (namely infliximab, adalimumab and etanercept). Research data were analysed by using the Statistical Analysis System for Windows 9.1 (SAS 9.1 ). Microsoft Excel and Microsoft Word were also used to illustrate various results of the analysed data through tables and graphs. Ethical considerations: Permission to conduct this study was obtained from the board of directors of the PBM as well as the ethical committee of the North-West University. (Ethical application number: NWU S5).

9 SELECTION OF STUDY POPULATION Figure 1.2 Selection of the study population

10 DATA ANALYSIS Data of the study population was analysed according to three phases: Phase one: period between 2005 and 2008 during which the patient only used non-biological drugs (other medicine generally indicated to treat RA) Phase two: period between 2005 and 2008 during which the patient used a biologic drug to treat RA Phase three: period between 2005 and 2008 during which the patient no longer used a biologic

11 RESULTS TOTAL MEDICINE TREATMENT COST FOR RA PATIENTS DURING EACH PHASE Table 1.1 Average cost per medicine item for RA patients Phase Frequency (n) Mean ± SD Total cost Phase 1 17, ± ,254, Phase 2 15, ± ,184, Biologics 2,565 (17.09%) ± ,708, (93.5%) Other 12, ± ,475, Phase 3 5, ± , Frequency = number of medicine items claimed per phase. SD = Standard Deviation. Total medicine treatment cost for RA patients: n = R Average coste per medicine item = d-value > 0.8 CPI (Cost Prevalence Index) = 5.46

12 RESULTS TOTAL MEDICINE TREATMENT COST FOR RA PATIENTS DURING EACH PHASE Table 1.1 Average cost per medicine item for RA patients Phase Frequency (n) Mean ± SD Total cost Phase 1 17, ± ,254, Phase 2 15, ± ,184, Biologics 2,565 (17.09%) ± ,708, (93.5%) Other 12, ± ,475, Phase 3 5, ± , Frequency = number of medicine items claimed per phase. SD = Standard Deviation. Total medicine treatment cost for RA patients: n = R Average coste per medicine item = d-value > 0.8 CPI (Cost Prevalence Index) = 5.46

13 RESULTS continue Phase 1 Phase2 Phase 3 Phase 1 Phase2 Phase 3 Figure 1.3 Number of medicine items claimed for RA patients during each treatment phase

14 Percentage RESULTS continue Prevalence of pharmacological groups during RA treatment Phase 1 Phase 2 Phase Cytostatics Corticosteroids Analgesics COX-inibitors Selective COX-2 inhibitors Pharmacological groups Spescific cyclooxygenase inhibitors Figure 1.4 Prevalence of pharmacological groups claimed during each phase of RA treatment

15 CONCLUSION Although biological drugs used in the treatment of RA are very expensive, it seems that the number of other medication prescribed to RA decreased after treatment with biologics. However, treatment outcomes were not measured in this study and the impact of biological therapies on RA patients disease progress was not established. Furthermore, the composition of Rx claimed for RA patients before and after treatment with biologics was no investigate, and therefore it was difficult to establish exactly why the number of medicine items and prescriptions claimed for RA patients decreased from phase one to phase three of their treatment. Further research is needed to investigate future medicine treatment cost of RA patients treated with biologics drugs.

16 REFERENCES 1. Nepom, G.T Therapy of autoimmune diseases: clinical trials and new biologics. Current opinion in immunology, 14: Available: Academic Search Premier. 2. Van Eden, W., Lisse, J., Prakken, B. & Alabani, S Biologics and postbiologics: novel immunotherapeutics for the induction and maintenance of remission. Drug Discovery Today, 00(00):1-7. Available: ScienceDirect. 3. Walsh, G Biopharmaceuticals: biochemistry and biotechnology. 2 nd ed. West Sussex: Wiley. 551 p. Available: Google Books. 4. Tang, L., Persky, A.M., Hochhaus, G. & Meibohm, B Pharmacokinetic aspects of biotechnology products. Journal of pharmaceutical sciences, 93(9): Available: ScienceDirect. 5. Goff, C.V., Hoffman, J.C. & Vogenberg, R Biologic therapy management: the need for value-based health benefits models. A peer-reviewed white paper by the Biologic Finance and Access Council. Managed care, 17(3): Date of access: 20 Feb Webster, C., Copmann, T., Garnick, R., Green, J., Hayes, M., Woollett, G.R., Lubiniecki, A., Murano, G., Seamon, K., Zezza, D. & Landis, J Biologics: can there be abbreviated applications, generics, or follow-on products? Date of access: 23 Feb Huges, B. & Hann, L.E The production of biopharmaceuticals. (In Boehncke, W.H. & Radeke, H., eds. Biologics in general medicine. New York: Springer. p ) Available: Google Books. 8. Kong, J.S.W., Teuber, S.S. & Gershwin, M.E Potential adverse events with biologic response modifiers. Autoimmunity review, 5(7): Available: ScienceDirect. 9. Myers, T., ed Mosby s dictionary of medicine, nursing & health professions. 7 th ed. Columbia, MO: Mosby Elsevier p. 10. Tikly, M Modern management of rheumatoid arthritis: making a case for early aggressive medical treatment. South African family practitioner, 51(4): Date of access: 23 Feb South Africa Medical Schemes Act, 1998 (Act no. 131 of 1998). Regulations made in terms of the Medical Schemes Act, 1998: therapeutic algorithms for chronic conditions (Notice no. 1402, 2003.) Government gazette, 25537:53-111, 6 Oct pdf Date of access: 25 Mar

17 Prof M.S. Lubbe in her capacity as study promoter Dr J.C Lamprecht Serfontein in his capacity as co-promoter Mrs J.R. Burger in her capacity as cp-promoter North-West University (MUSA) for funding