Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Study Overview
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Brief Summary
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This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy [IO], or targeted therapy [TT] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.

Official Title
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Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Drug: Nivolumab
* Drug: Ipilimumab + nivolumab
* Drug: Pembrolizumab
* Drug: Dabrafenib + trametinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients with at least one diagnosis of malignant melanoma of skin anytime from the start of data collection until the start of study period. Patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the National Comprehensive Cancer Network (NCCN) guidelines version 2.2020. The first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy. The first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma. Patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. The index date was the date of first prescription of study drug, IO (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib. At least 18 years of age at the time of adjuvant treatment initiation. Patients with at least 6 months of continuous enrollment prior to the index date. Patients with at least 6 months of continuous enrollment after the index date. If necessary, there were additional criteria of absence of secondary malignancy (including metastatic site). Exclusion Criteria Patients with a diagnosis of non-melanoma primary malignancy during the 6 months pre-index period. Patients with chemotherapy or interferon alpha before index date. Patients with pregnancy any time during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunotherapy (IO)<br>Patients receiving IO | Drug: Nivolumab<br>* Patients receiving nivolumab<br>Drug: Ipilimumab + nivolumab<br>* Patients receiving ipilimumab + nivolumab<br>Drug: Pembrolizumab<br>* Patients receiving pembrolizumab<br>|
| Targeted therapy (TT)<br>Patients receiving TT | Drug: Dabrafenib + trametinib<br>* Dabrafenib + trametinib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients on first systemic adjuvant therapy with adverse avents (AEs) |  | Up to approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation. |  | Up to approximately 5 years | 
| Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy |  | Up to approximately 5 years | 
| Healthcare costs associated with AEs on first systemic adjuvant therapy |  | Up to approximately 5 years | 
| HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation |  | Up to approximately 5 years | 
| Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation |  | Up to approximately 5 years |