Estimating the Prevalence, and Describing the Medical History and Treatment Patterns of Patients with Non-radiographic Axial Spondyloarthritis in Germany – An Approach using a Claims Database PMS11 Christine König1, Kathrin Borchert1, Dominic Meise1, Sebastian Braun1, Florian Meier2, Haijun Tian3, Katharina Boehm4, Ulrich von Hinüber5 1Xcenda GmbH, Hannover, Germany; 2Wilhelm Loehe University of Applied Sciences (WLH), Fürth, Germany; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 4Novartis Pharma GmbH, Nürnberg, Germany; 5Rheumapraxis Hildesheim, Hildesheim, Germany

• For biologic treatment patterns, the number of patients with a • An MRI assessment was performed in 34% of nr-axSpA patients BACKGROUND prescription for adalimumab, certolizumab pegol, etanercept, whereas 61% had an X-ray assessment during their medical infliximab, golimumab, or no biological treatment identified by history. More than two-thirds of the nr-axSpA patients (71%) had • Non-radiographic axial spondyloarthritis (nr-axSpA) is an immune-mediated inflammatory rheumatic disease, especially Anatomical Therapeutic Chemical (ATC) codes in the outpatient at least one MRI or X-ray assessment. setting and by Operation and Procedure (OPS) codes in the affecting the spine and sacroiliac joints (1). Biological treatments inpatient setting was assessed. It is intensively discussed whether nr-axSpA should be • • Only 6% (n=51) of the nr-axSpA patient subgroup (N=852) had considered as a distinct disease or as an early stage of a prescription of biological therapy during the post-index period. ankylosing (AS) (2, 3). RESULTS Out of these, 41% (n=21) received adalimumab as first biological There is no separate code for nr-axSpA in the German • Study population, prevalence and progression rate therapy, 29% (n=15) etanercept, and 16% (n=8) golimumab ICD-10-GM coding system and it is coded with the same code (Figure 5). for AS since 2014 (4). • After applying the algorithm, a total of 869 possible nr-axSpA • The prescription level analysis revealed that the 51 patients patients were identified in the InGef database (Figure 2), • Very limited information is available regarding prevalence, patient treated with biological agents received 316 biological resulting in a 2013 prevalence of 26.2 per 100,000 persons history, and biological treatment patterns in nr-axSpA patients in prescriptions in total (mean=6.2). (0.03%) in Germany. Germany. Most of the patients (71%) received their first biological For the subgroup analysis of biological treatments, 852 patients • • prescription from rheumatologists. OBJECTIVES were available (Figure 2). • Almost two-thirds of the potential nr-axSpA patients were female Figure 5. Biological therapy in the post-index period after the • The aim of the study was to apply a claims data specific algorithm (64%), the mean age was approximately 58 years, and the other inflammatory spondylopathy diagnosis in 2013 to identify possible nr-axSpA patients in a German claims largest portion of patients (22%) were between 70-79 years old. database. Study population • The progression rate of the prevalent nr-axSpA patients to AS Potential nr-axSpA patients • Further objectives included the estimation of the prevalence, in the post-index period spanning from the index quarter until for biologic therapy assessment Inclusion criteria and the description of the medical history as well as the biologic 31 December 2014 was 13%. treatment patterns in nr-axSpA patients in Germany. n=852 Figure 2. Selection of nr-axSpA patients from the InGef METHODS research database Exclusion criteria InGef research database Patients with biological therapy Data source Inclusion criteria

• This retrospective database study used claims data from the Study population n=51 German “Institut für angewandte Gesundheitsforschung Berlin” Patients diagnosed with oSp in 2013 (InGef) research database, which has anonymized claims data of No history of back n=1,603 pain or disc disorders about 4 million insured individuals. in the pre-index period n=344 Patients with a history of • This sample represents 5.6% of the Statutory Health Insurance or disc disorders in the pre-index period population and 4.8% of the German population and has been n=1,259 Diagnosis of AS in the Adalimumab Etanercept Golimumab Other adjusted to represent the German population in terms of age and pre-index period n=390 gender. Potential nr-axSpA patients n=21 n=15 n=8 n=7 for analysis of medical history Study design and patient selection (Figure 1) Not continuously n=869 observable in the post- index period • The study considered data from 01 January 2009 through n=17 Potential nr-axSpA patients 31 December 2015. Patients continuously observable in the for analysis of biologic LIMITATIONS database from 01 January 2009 through 31 December 2014 were therapy n=852 • The identification of nr-axSpA patients with claims data is included. oSp – other inflammatory spondylopathy, AS – , nr-axSpA – non-radiographic axial spondyloarthritis challenging as there is no specific ICD-10-GM code established • The enrollment period was defined as the year 2013 leading to: in the German healthcare system to distinguish between AS and –– Pre-index period from 01 January 2009 until the index quarter Patient medical history in the outpatient sector nr-axSpA. in 2013 (16 to 19 quarters depending on the index quarter) • In the pre-index period, all patients visited outpatient physicians, • The applied algorithm is limited to the fact that the coding of other –– Post-index period from the index quarter until 31 December which included radiologists (84% of patients), orthopedists (77%), inflammatory spondylopathy might be inaccurate and incomplete. 2014 (4 to 7 quarters depending on the index quarter and the dermatologists (58%), and rheumatologists (52%) (Figure 3). • In German claims data, no results of MRI, X-ray assessments, end of post-index period) • The mean number of visits at the rheumatologists was 14.5 in and laboratory tests are available and therefore, could not be • Furthermore, a subgroup of patients observable for an 8 quarters the pre-index period (approximately 3.6 visits per year), while used for the classification of disease. post-index period until 31 December 2015 was analyzed for orthopedists where visited 12.8 times on average (approximately • Our approach to identify nr-axSpA patients is not able to biologic treatment patterns. 3.2 visits per year). distinguish between incident and prevalent nr-axSpA patients. A claims-data specific algorithm developed by Boonen and • Figure 3. Percentage of patients with outpatient visits stratified • Outpatient diagnoses are only recorded on a quarterly basis colleagues (5) to identify nr-axSpA patients was adopted to the by physician specialties in the pre-index period before the other which is why the biological prescriptions could not be clearly German setting and reviewed by two German rheumatologists. inflammatory spondylopathy diagnosis in 2013 linked to nr-axSpA. • Patients were identified as nr-axSpA patients if they showed a 100% diagnosis of other inflammatory spondylopathy (oSp) based on 100% 84% CONCLUSIONS the German ICD-10-GM code (M46.-) in 2013 (index quarter), 77% 80% had a history of at least two diagnoses of back pain (M54.-) or • The classification of nr-axSpA patients is challenging and the 58% differentiation to AS is still difficult. disc disorders (M50.- to M53.) and no diagnosis of AS (M45.-) in 60% the pre-index period. 52% • Contrary to expectations, rheumatologists were not the most 42% 40% frequently visited physicians by the potential nr-axSpA patients. % of patients Figure 1. Study design and identification approach of nr-axSpA 21% • Additional studies based on claims data would greatly benefit patients in German claims data 20% from the establishment of a separate ICD-10-GM code for Study period nr-axSpA in Germany. 0% Enrollment period General RadiologistOrthopedist DermatologistRheumatologistNeurologist Gastroenterologist practitioner REFERENCES 2009 2010 2011 2012 2013 2014 2015 • 1minimumThe analysis base: overall of the n=106, most AS frequently n=32, nr-axSpA coded n=27, diagnoses PsA n=47. in the pre- 2overallindex n=209, period AS showed n=51, nr-axSpA that most n=48, ofPsA the n=110. identified top 10 diagnoses 1. Raychaudhuri SP et al. Journal of autoimmunity. 2014;48:128-33. 16 to 19 quarters 2. Wallis D et al. The Journal of rheumatology. 2013;40(12):2038-41. pre-index period 4 to 7 quarters were related to nr-axSpA with dorsalgia coded by physicians in Index quarter post-index period 91% of nr-axSpA patients (Figure 4). 3. Rumyantseva D et al. Terapevticheskii arkhiv. 2017;89(5):33. Essential primary hypertension as a non-rheumatological 8 quarters • 4. Deutsches Institut für Medizinische Dokumentation und Information post-index period comorbidity was diagnosed in 51% of the identified patients (DIMDI) - Änderungsvorschlag für die ICD-10-GM 2014, https://www.dimdi.

Pre-index period Index quarter Post-index period of 4 to 7 quarters (Figure 4). de/dynamic/.downloads/klassifikationen/icd-10-gm/vorschlaege/ • Two diagnoses of back pain • Diagnosis of oSp (ICD-10-GM • Progression to AS (ICD-10-GM M54.-) or disc vorschlaege2014/064-axialspondyloarthri-sieper.pdf M46.-) disorders (ICD-10-GM M50.-to M53.-) Post-index period of 8 quarters Figure 4. Most frequent ICD-10-GM codes in the pre-index 5. Boonen A et al. Annals of the rheumatic diseases. 2012;71(Suppl3):624. • No diagnosis of AS (ICD-10-GM • Subgroup analysis: Use of biologic agent M45.-) period before the other inflammatory spondylopathy diagnosis oSp – other inflammatory spondylopathy; AS – ankylosing spondylitis in 2013 FUNDING 100% 100% The study was funded by Novartis Pharma AG, Basel, Switzerland. Assessment of Outcomes 91% • The diagnostic prevalence rate of nr-axSpA in Germany was 80% ACKNOWLEDGEMENTS assessed by dividing the number of patients identified by the 60% The authors thank Niraj Modi (Novartis) for medical writing support. 51% algorithm for nr-axSpA by the total number of patients in the 44% 44% 43% 43% 42% of patients 39% 38% 40% 37% Poster presented at the ISPOR Europe Congress, November 10-14, 2018, database during the study period (N=3,319,177) in 2013. % Barcelona, Spain. • The progression rate to AS was defined as the number of 20% prevalent nr-axSpA patients in 2013 with an ICD-10-GM 0% diagnosis code M45.- for AS in the post-index period of at least s ) ) )

4 quarters. Dorsalgia (M54* Any top 10 diagnosi (M47* d dorsopathies (M53*) Biomechanical lesions (M99*) The medical history was analyzed in the pre-index period and flammatory spondylopathies (M46 • Essential (primary) hypertension (I10*) Other and unspecifie Other in included the underlying comorbidities (based on ICD-10-GM Other and unspecified soft tissue disorders (M79*) Disorders of lipoprotein metabolism and other lipidemias (E78*) codes) as well as outpatient visits and the utilization of MRI or General examination without complaint or reported diagnosis (Z00*) X-rays identified by German reimbursement codes (EBM codes). Thoracic, thoracolumbar, and lumbosacral disorders (M51*)