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

Metastatic Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05848219
• Other study ID #: CTMT212AUS59
• Status: Terminated
• Start date: October 16, 2021
• Est. completion date: April 27, 2022

Study information

• Verified date: April 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 543
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Locations

Country	Name	City	State
United States	Novartis Investigational Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause healthcare resource utilization (HCRU) among patients treated with dab/tram versus enco/bini		Up to 2.5 years
Primary	All-cause healthcare costs among patients treated with dab/tram versus enco/bini		Up to 2.5 years
Primary	Melanoma-specific HCRU among patients treated with dab/tram versus enco/bini		Up to 2.5 years
Primary	Melanoma-specific healthcare costs among patients treated with dab/tram versus enco/bini		Up to 2.5 years