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

NCT ID: NCT05848219

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 543 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-16
• Study Completion Date: 2022-04-27

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Dabrafenib + trametinib (dab/tram)

Patients with a first diagnosis of metastatic melanoma, who received dab/tram in the United States

No interventions assigned to this group

Encorafenib + binimetinib (enco/bini)

Patients with a first diagnosis of metastatic melanoma, who received enco/bini in the United States

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigational Site

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CTMT212AUS59

Identifier Type: -

Identifier Source: org_study_id