Healthcare Resource Utilization and Costs in Metastatic Melanoma Patients Initiated Dabrafenib + Trametinib and Encorafenib + Binimetinib

April 27, 2023 updated by: Novartis Pharmaceuticals
This was a retrospective cohort study using the MarketScan health care administrative claim databases: Truven Health Analytics' MarketScan Commercial Claims and Encounters; MarketScan Medicare Supplement and Coordination of Benefit. We conducted this analysis using the most recent available data from the MarketScan database at the time of analysis, which was 01 June 2018 to 31 December 2020. We initiated this analysis from 01 June 2018 as encorafenib + binimetinib (enco/bini) was approved for patients with unresectable or metastatic melanoma with BRAF mutation at this time.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

543

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis Investigational site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

Inclusion Criteria:

  • At least one diagnosis of malignant melanoma (The International Classification of Diseases, 9th Revision [ICD-9] codes: 172.0-172.9 or V10.82; ICD-10 codes: C43.0 C43.10 C43.20 C43.30 C43.31 C43.39 C43.4 C43.59 C43.60 C43.70 C43.8 C43.9 D03.0 D03.10 D03.11 D03.12 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) in the study period.
  • A diagnosis of metastasis (ICD-9 196.x, 197.x, 198.x, 199.x & ICD-10 C77.xx, ICD-10 C78.xx, ICD-10 C79.xx, ICD-10 C80.xx) within 30 days before or 60 days after their malignant melanoma diagnosis.
  • A prescription (pharmacy or medical claim) of enco/bini or dab/tram as a 1L therapy after the metastatic melanoma diagnosis date.
  • At least ≥18 years as of the index date.
  • At least 6 months of continuous enrollment before index date and 6 months after index date.

Exclusion Criteria:

  • Patients with a diagnosis of other 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 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.
  • Patients with more than one melanoma-related drug prescription other than the index drug, on the index date.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Dabrafenib + trametinib (dab/tram)
Patients with a first diagnosis of metastatic melanoma, who received dab/tram in the United States
Encorafenib + binimetinib (enco/bini)
Patients with a first diagnosis of metastatic melanoma, who received enco/bini in the United States

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause healthcare resource utilization (HCRU) among patients treated with dab/tram versus enco/bini
Time Frame: Up to 2.5 years
Up to 2.5 years
All-cause healthcare costs among patients treated with dab/tram versus enco/bini
Time Frame: Up to 2.5 years
Up to 2.5 years
Melanoma-specific HCRU among patients treated with dab/tram versus enco/bini
Time Frame: Up to 2.5 years
Up to 2.5 years
Melanoma-specific healthcare costs among patients treated with dab/tram versus enco/bini
Time Frame: Up to 2.5 years
Up to 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2021

Primary Completion (Actual)

April 27, 2022

Study Completion (Actual)

April 27, 2022

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMT212AUS59

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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