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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000152
• 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 institution and networks

Institutions

Fondazione ReS (Ricerca e Salute), CINECA partner

Italy

Study timelines

Date when funding contract was signed

Actual: 08/01/2019

Study start date

Actual: 08/02/2019

Date of final study report

Actual: 08/05/2019

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