Incidence of First-Line and Second-Line Myelodysplastic Syndrome in a US Commercial Claims Database

Abstract

Background: The myelodysplastic syndromes (MDS) include a group of malignancies characterized by myeloid stem cell origin and increasing incidence with age. Although treatment is available with hypomethylating agents (HMAs), 80% of patients fail to achieve remission and nearly all patients eventually develop chemoresistant disease. The incidence of MDS 1st-line HMA treatment failures has not been previously reported.Methods: We examined US commercial health insurance claims data to estimate the annual incidence of MDS and the number of MDS patients potentially eligible for 2nd-line therapy. We conducted a retrospective cohort study of patients with an MDS-associated medical claim (ICD-9-CM diagnosis code 238.7x) in the identification (ID) period (calendar year 2009). The subgroup of newly diagnosed patients had no prior MDS diagnosis in the pre-ID period (calendar year 2008); patients newly treated with HMA had a claim for HMA in the ID but not pre-ID periods. Using expert input, we defined MDS patients as potential candidates for 2nd-line therapy if they used an HMA in the ID period and stopped for ≥2 months, switched to another HMA, or remained on the first HMA for >7 months. MDS incidence rates were stratified by age (≤49, 50-64, 65-74, and ≥75 years) and sex.Results: We identified 9,209 patients with an MDS-associated claim. There were 4,151 patients newly diagnosed with MDS, yielding an overall MDS incidence of 69.9/100,000 enrollees (Table). Incidence was slightly higher among women (75.7/100,000) than men (63.1/100,000). Women between the ages of 50 and 64 years had the highest incidence (111.5/100,000) among all newly diagnosed patients stratified by age and sex.The incidence of newly treated MDS patients was 2.8/100,000 enrollees. Among this group, incidence was higher among men (3.6/100,000) than women (2.1/100,000), and when stratified by age and sex the incidence was highest among men aged 75 years or older (10.5/100,000). For each 100,000 enrollees, there were 3 new 2nd-line therapy candidates.Conclusions: The estimated incidence of MDS in the United States was 69.9 per 100,000 insured enrollees in 2009, similar to results found in other epidemiological databases (Cogle et al, Blood 2011; Goldberg et al, J Clin Oncol 2010). The incidence of MDS patients identified as eligible for 2nd-line therapy was 3/100,000. In this commercially insured patient population we estimate that approximately 9,500 people per year in the United States may be candidates for 2nd-line therapy for MDS. These data can be used to inform population-based estimates that would include Medicare patients in addition to those commercially insured of the medical and economic burden of disease faced by MDS patients.Table:Incidence of MDS Stratified by Age and GenderGenderAge Group, yearsNewly Diagnosed PatientsNewly Treated PatientsPotential 2nd Line Treatment CandidatesFemaleAll ages75.72.12.0≤4956.60.10.050-64111.52.11.165-74101.24.05.3≥7568.54.44.4MaleAll ages63.13.64.1≤4929.60.20.150-6486.52.53.865-74106.18.58.5≥7597.110.511.7AllAll ages69.92.83.0Note: Results are expressed as number of cases per 100,000 enrollees. DisclosuresCogle:Partnership for Health Analytic Research (PHAR): Consultancy, I was paid as a consultant for my expert opinion while developing the analyses Other. Kurtin:Celgene, Millenium, Onyx, TEVA, Onconova, Incyte: Consultancy. Bentley:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other. Broder:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other. Chang:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other. Lawrence:Onconova Therapeutics, Inc. : Employment. McKearn:Onconova Therapeutics, Inc. : Employment. Megaffin:Onconova Therapeutics, Inc. : Employment. Percy:Onconova Therapeutics, Inc. : Employment. Petrone:Onconova Therapeutics, Inc. : Employment, Stock Options Other. Sun:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other.