Retrospective Assessment of AE-Related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

NCT05874817 | Completed

• 1 other identifier: CTMT212AUS62
• Study Type: observational
• Target: 17,517
• Locations: 1 country
• Sites: 1

Brief Summary

This was a retrospective cohort study using Truven Health Analytics' MarketScan Commercial Claims and Encounters and Medicare Supplement and Coordination of Benefit administrative claims databases. The analysis was conducted using the most recent 5 years of data from the database, 01 January 2015, to 28 February 2021 (study period). 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 of end of continuous eligibility or end of the study period.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with adverse events (AEs) following first systemic adjuvant therapy

  Up to 5 years

Secondary Outcomes (5)

• Percentage of patients with AEs following first systemic adjuvant therapy completion/discontinuation

  Up to 5 years

• Healthcare resource utilization (HCRU) associated with AEs following first systemic adjuvant therapy

  30 days

• Healthcare costs associated with AEs following first systemic adjuvant therapy

  30 days

• HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation

  30 days

• Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• Patients with at least one diagnosis of malignant melanoma of skin (The International Classification of Diseases, 9th Revision, Clinical Modification \[ICD-9\] codes: 172.0-172.9 or V10.82; ICD-10 (10th revision) codes: C43.0 C43.10, C43.11, C43.111, C43.112, C43.12, C43.121, C43.122, C43.20, C43.21, C43.22, C43.30 C43.31 C43.39 C43.4, C43.51, C43.52, C43.59 C43.60, C43.61, C43.62, C43.70, C43.71, C43.72, C43.8 C43.9 D03.0 D03.10 D03.11, D03.111, D03.112, D03.12, D03.121, D03.122, D03.20 D03.21 D03.22 D03.30 D03.39 D03.4 D03.51 D03.52 D03.59 D03.60 D03.61 D03.62 D03.70 D03.71 D03.72 D03.8 D03.9 Z85.820) 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.

You may not qualify if:

• Patients with a diagnosis of non-melanoma primary malignancy (ICD-9: 140.xx-165.xx, 170.xx-171.xx, 173.xx-195.xx, 200.xx-208.xx; ICD-10: C00.x - C14.x, C41.x, C49.x, C50, C51) during the 6 months pre-index period.
• Patients with chemotherapy or interferon alpha before index date.
• Patients with pregnancy (ICD-9: 630.xx-679.xx, V22.xx-V24.xx, V27.xx-V28.xx; ICD-10: O00 - O99) any time during the study period.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 25, 2023
• Study Start: May 1, 2021
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

US (1)