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

NCT05848219 | Terminated

• 1 other identifier: CTMT212AUS59
• Study Type: observational
• Target: 543
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (4)

• All-cause healthcare resource utilization (HCRU) among patients treated with dab/tram versus enco/bini

  Up to 2.5 years

• All-cause healthcare costs among patients treated with dab/tram versus enco/bini

  Up to 2.5 years

• Melanoma-specific HCRU among patients treated with dab/tram versus enco/bini

  Up to 2.5 years

• Melanoma-specific healthcare costs among patients treated with dab/tram versus enco/bini

  Up to 2.5 years

Study Arms (2)

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

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigational Site

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: April 27, 2023
• First Posted: May 8, 2023
• Study Start: October 16, 2021
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: May 8, 2023

Record last verified: 2023-04

Locations

US (1)