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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT05848219
Collaborator
(none)
543
Enrollment
1
Location
6.3
Actual Duration (Months)
85.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    543 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Healthcare Resource Utilization and Costs in Metastatic Melanoma Patients Initiated Dabrafenib + Trametinib and Encorafenib + Binimetinib
    Actual Study Start Date :
    Oct 16, 2021
    Actual Primary Completion Date :
    Apr 27, 2022
    Actual Study Completion Date :
    Apr 27, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. All-cause healthcare resource utilization (HCRU) among patients treated with dab/tram versus enco/bini [Up to 2.5 years]

    2. All-cause healthcare costs among patients treated with dab/tram versus enco/bini [Up to 2.5 years]

    3. Melanoma-specific HCRU among patients treated with dab/tram versus enco/bini [Up to 2.5 years]

    4. Melanoma-specific healthcare costs among patients treated with dab/tram versus enco/bini [Up to 2.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigational Site East Hanover New Jersey United States 07936

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05848219
    Other Study ID Numbers:
    • CTMT212AUS59
    First Posted:
    May 8, 2023
    Last Update Posted:
    May 8, 2023
    Last Verified:
    Apr 1, 2023
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of May 8, 2023