Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy [IO], or targeted therapy [TT] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: Nivolumab; Drug: Ipilimumab + nivolumab; Drug: Pembrolizumab; Drug: Dabrafenib + trametinib

• Study Type: Observational
• Enrollment (Actual): 618

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis Pharmaceuticals

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

This was a retrospective, noninterventional cohort study

Description

Inclusion Criteria

• Patients with at least one diagnosis of malignant melanoma of skin anytime from the start of data collection until the start of study period.
• Patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the National Comprehensive Cancer Network (NCCN) guidelines version 2.2020. The first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy.
• The first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma.
• Patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. The index date was the date of first prescription of study drug, IO (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib.
• At least 18 years of age at the time of adjuvant treatment initiation.
• Patients with at least 6 months of continuous enrollment prior to the index date.
• Patients with at least 6 months of continuous enrollment after the index date.
• If necessary, there were additional criteria of absence of secondary malignancy (including metastatic site).

Exclusion Criteria

• Patients with a diagnosis of non-melanoma primary malignancy during the 6 months pre-index period.
• Patients with chemotherapy or interferon alpha before index date.
• Patients with pregnancy any time during the study period.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immunotherapy (IO); Patients receiving IO	Drug: Nivolumab; Patients receiving nivolumab; Drug: Ipilimumab + nivolumab; Patients receiving ipilimumab + nivolumab; Drug: Pembrolizumab; Patients receiving pembrolizumab
Targeted therapy (TT); Patients receiving TT	Drug: Dabrafenib + trametinib; Dabrafenib + trametinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients on first systemic adjuvant therapy with adverse avents (AEs)	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation.	Up to approximately 5 years
Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy	Up to approximately 5 years
Healthcare costs associated with AEs on first systemic adjuvant therapy	Up to approximately 5 years
HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation	Up to approximately 5 years
Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2021
• Primary Completion (ACTUAL): January 27, 2022
• Study Completion (ACTUAL): January 27, 2022

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

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; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Nivolumab; Pembrolizumab; Trametinib; Dabrafenib; Ipilimumab
• Other Study ID Numbers: CTMT212AUS57