Cost of Adverse Events Related to How Often Follow-Up Occurs Among Patients With Cancer That Has Spread

Economic Burden of Adverse Events Associated With Follow-Up Frequency Among Patients With Metastatic Melanoma

This study is a real-world retrospective claims analysis to assess and compare AE-related HCRU and medical costs among patients with different follow-up frequency after initiating a melanoma therapy.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Biological: Nivolumab; Biological: Ipilimumab

• Study Type: Observational
• Enrollment (Actual): 1828

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Bristol-Myers Squibb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who were diagnosed with metastatic melanoma and initiated at least 1 treatment for metastatic melanoma after 2011 will be identified from the IMS PharMetrics Plus US Claims Database and included in the study sample. Patients must have had continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date. The population from the CheckMate-067 (CA209-067) clinical trial will also be included. The population consists of all patients who received at least 1 dose of study drug.

Description

Inclusion Criteria:

• Diagnosed with metastatic melanoma
• Initiated at least 1 treatment for metastatic melanoma after 2011
• Continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date
• Patients who received at least 1 dose of study drug in CA209-067

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with less frequent general outpatient visits	Approximately 5 years
Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with more frequent general outpatient visits	Approximately 5 years
Treatment-related and all-cause AE costs for nivolumab/ipilimumab combination therapy for metastatic melanoma	Approximately 5 years
Treatment-related and all-cause AE costs for nivolumab monotherapy for metastatic melanoma	Approximately 5 years
Treatment-related and all-cause AE costs for ipilimumab monotherapy for metastatic melanoma	Approximately 5 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Ipilimumab
• Other Study ID Numbers: CA209-789