A Cross Sectional Epidemiological and Survival Analysis of All Patients with Plasma Cell Disorders Recorded between 2011- 2017 in the Social Insurance System of Turkey

Background and Aim: The incidence and outcomes of patients with cancer diagnoses are reported annually as SEERs in few but not all countries. Clinical trials or myeloma group studies have documented the survival of patients with plasma cell disorders to improve with the approval of new drugs, early diagnosis and better follow-up. The outcome of patients included in clinical trials do not represent the real world data. There are two major pharma sponsored international prospective or retrospective analysis of real World data where patients from Turkey are also included (Mohty et al Clin Lymphoma Myeloma Leuk 2018 and Kumar et al. Leuk Lymphoma 2018). However the results do not confer to patients of any country in particular. According to the SGK's 2016 annual report, 98,6% of the population of Turkey is covered by the Healthcare Insurance System (SGK). Electronic data recording system (2007) and e- prescribing (2010) have been introduced to the healthcare system in Turkey. The aim of this study is to analyze and report the epidemiological features of patients who are recorded and received drugs approved and reimbursed by the Turkish Healthcare system .

Patients and Methods: The study is performed following Ethical Committee approval by Ankara University and also by permission for publication from SGK. Patients recorded with the ICD of C90 between 2011-2017 and has received either of these medications: Melphalan, Thalidomide, Bortezomib, Lenalidomide, Bendamustine or high dose therapy with stem cell support(ASCT) were included in the analysis. This approach was taken to prevent false ICD entry or exclude patients with Monoclonal Gamopathy of Undetermined Significance or Smoldering Multiple Myeloma who are not being treated. Additionally patients who were privately insured or received drugs within clinical trials or compassionate/early access programs were also excluded. Patients registered earlier than 2011 were not included in the analysis to allow survival analysis. Statistical analysis were performed using the SQL, SPSS, MS Office software packages.

Results: A total of 10146 patients were evaluated as eligible. Annual number of patients during the 2011-2017 period were as follows: 1168, 824, 2245, 1811, 1537, 1183, 1378. Males/females: 5655/4491, Median age of patients were constant with a minor increase from 63.8(2011) to 65.2(2017). ASCT (once or more)was received by 4060 (40%)patients. Overall survival (OS) of patients improved if diagnosed younger (Fig 1a), if they are female (Fig 1b) and received ASCT(Fig 1d). There was no OS benefit if ASCT was given more than once. Approval and reimbursement of novel drugs such as Bortezomib and Lenalidomide were achieved in 2005 and 2010 respectively. Both Carfilzomib and Pomalidomide are approved but only conditionally reimbursed since 2015 and 2016. Patients who started treatment during more recent years (after 2015)are able to survive longer than those who started earlier(Fig 1c).

Conclusions: This is the first and most extensive epidemiological report for Multiple Myeloma from Turkey. It informs about annual incidence of patients eligible for treatment (approximately 1400), treatment success (OS: median 4 years) during a seven year period. Our results are supporting the survival advantage of ASCT (median 5 vs. 2 years, p=0.000) and younger age(p=0.000) plus female gender (p=.0.005). Patients who initiated treatment recently have better OS than patients starting earlier (p=0.001). More detailed survival and cost benefit analyses are aimed to be presented during the meeting.

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