Study identification

EU PAS number

EUPAS1000000152

Study ID

1000000152

Official title and acronym

Identification of cases and estimate of direct costs of unresectable and advanced cutaneous squamous cell carcinoma: real-world data from a large Italian database

DARWIN EU® study

No

Study countries

Italy

Study description

Observational retrospective and noninterventional study that, through administrative data from the Fondazione ReS database, has assessed the prevalence of unresectable and advanced (u/a) cSCC and calculated healthcare costs charged to the Italian National Health Service (SSN). The data source is derived from anonymized healthcare administrative databases owned by the Italian Regional Health Facilities and analysed by Fondazione ReS under a specific agreement and in compliance with European privacy rules. Patients with u/a cSCC in 2015 were identified through a step-by-step strategy: the 1st step was a diagnosis (ICD-9-CM code) of ‘other malignant neoplasm; the 2nd step was diagnosis of metastasis associated with an nonmelanoma skin cancer diagnosis, or by chemotherapy/radiotherapy supplies or prescriptions of antineoplastics/immunostimulants in the absence of a diagnosis of another neoplasm of the skin’: the 3rd step was the exclusion of patients receiving vismodegib, which is labelled for the treatment of basal cell carcinoma; the 4rth and last step was the exclusion of patients experiencing surgical excision (in hospital or ambulatory setting) within 1 year from the diagnosis of advanced cSCC, to to identify unresectable cases. A 1-year follow-up was considered to collect data on healthcare utilization and related costs charged to the SSN.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Letizia Dondi 0009-0001-3168-6856

Primary lead investigator
ORCID number:
0009-0001-3168-6856

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

This study was partially supported by and unrestricted grant from Sanofi.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable