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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/32548
• EU PAS number:
  EUPAS31161
• Study ID:
  32548
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Nplate® (romiplostim) is not indicated for treatment of thrombocytopenia due to myelodysplastic syndromes (MDS) or any other cause of thrombocytopenia other than chronic ITP. On 25 June 2014, Amgen received an Information Request from the Food and Drug Administration (FDA) to examine off-label use of romiplostim with a particular interest in use among patients who have MDS. Through discussions between Amgen and the FDA, it was agreed upon that the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database would be an appropriate source of data to examine this question. Amgen conducted these analyses and submitted the report to the Agency on 20 November 2015. On 27 April 2018, the Agency requested that Amgen re-run the analysis based on the most recent release of SEER-Medicare data. The current report reflects results of both the original and updated analyses, which are referred to as the Original Analysis and Follow-up Analysis, respectively, throughout the report.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 16/11/2018

Study start date

Actual: 20/03/2019

Data analysis start date

Actual: 20/03/2019

Date of final study report

Actual: 26/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable