Utilization of Romiplostim in Myelodysplastic Syndromes (MDS) within the Medicare Population: A Study Based on Data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked Database – Original Analysis & Follow-up Analysis (20190354, 20150177)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  NPLATE
• Medical condition to be studied:
  Myelodysplastic syndrome

Population studied

• Short description of the study population:
  Patients aged ≥65 years at cancer diagnosis for the SEER sample and in the year of analysis for the 5% non-Myelodysplastic Syndromes (MDS) sample; had continuous Medicare Part A and Part B coverage during the time periods of the analysis; and had no Health Maintenance Organization benefits. ; In the Original Analysis, patients diagnosed with MDS in any year from 2001 to 2011 were included in the MDS cohort; and patients with no diagnosis of MDS in any year (through 2011) were included in the non-MDS cohort. For the Follow-up Analysis, patients diagnosed with MDS in any year from 2005 to 2015 were included in the MDS cohort; and patients with no diagnosis of MDS in any year (through 2015) were included in the non-MDS cohort.
• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Myelodysplastic Syndromes patients
• Estimated number of subjects:
  415000

Study design details

• Main study objective:
  To estimate the proportion of all romiplostim users who have a diagnosis of MDS registered in SEER.To estimate the proportion of SEER-registered MDS patients who are romiplostim users.
• Outcomes:
  1) romiplostim users with a diagnosis of MDS, 2) romiplostim use among MDS patients
• Data analysis plan:
  Each cohort of romiplostim users (non-MDS and MDS, by year of romiplostim initiation) was described by baseline measures, including age at romiplostim initiation (median and interquartile range IQR), sex, race (White/Other), and year of romiplostim initiation. The median (IQR) number of romiplostim administrations per person-year, history of ITP prior to romiplostim use, history of other thrombocytopenia prior to romiplostim use, and median (IQR) time between MDS diagnosis and first romiplostim administration in days were also described for each cohort.MDS patients who did and did not have romiplostim use were described by age at diagnosis (median IQR), sex, race (White/Other), and time period of diagnosis. Chemotherapy use within 180 days after MDS diagnosis, chemotherapy use prior to or within 30 days after romiplostim use, leukemia diagnosed after MDS, leukemia diagnosed before MDS, thrombocytopenia before MDS, and ITP before MDS were described.