Clinical trials and drug cost savings for Italian health service.

Clinical trials Cost reduction Cost savings Drugs expenditure Investigational drug Per-patient cost Treatment costs

Journal

BMC health services research
ISSN: 1472-6963
Titre abrégé: BMC Health Serv Res
Pays: England
ID NLM: 101088677

Informations de publication

Date de publication:
26 Nov 2020
Historique:
received: 21 06 2020
accepted: 15 11 2020
entrez: 27 11 2020
pubmed: 28 11 2020
medline: 15 5 2021
Statut: epublish

Résumé

The cost of anticancer drugs is constantly growing. The aim of this study was determine the impact in terms of cost reduction for anticancer drug in the Italian Health Service due to patient participation in clinical trials. We evaluated the cost of drugs administered to patients treated in clinical trials at the National Cancer Institute of Naples in a four-week time period. Patients with a diagnosis of different cancers were considered, including adjuvant therapy and treatment for advanced disease, pharma sponsored and investigator initiated phase I, II and III clinical studies. We defined the expected standard treatment for each patient and we calculated the cost of the standard antineoplastic drugs that should be administered in clinical practice outside clinical trials. We used the market price of drugs to determine the cost savings value. Costs other than drugs were not included in the cost saving calculation. From 23.10.2017 to 17.11.2017, 126 patients were treated in 34 pharma sponsored and investigator initiated clinical trials, using experimental drugs provided free of charge by the sponsors, for an overall number of 152 cycles of therapy. If these patients were treated with conventional therapies in clinical practice the cost of antineoplastic drugs would account for 517,658 Euros, with an average of 5487 Euros saved per patients for a period of 4 weeks. Clinical trials with investigational antineoplastic drugs provided free of charge by Sponsors render considerable cost savings, with a tangible benefit in clinical and administrative strategies to reduce drug expenditures.

Sections du résumé

BACKGROUND BACKGROUND
The cost of anticancer drugs is constantly growing. The aim of this study was determine the impact in terms of cost reduction for anticancer drug in the Italian Health Service due to patient participation in clinical trials.
METHODS METHODS
We evaluated the cost of drugs administered to patients treated in clinical trials at the National Cancer Institute of Naples in a four-week time period. Patients with a diagnosis of different cancers were considered, including adjuvant therapy and treatment for advanced disease, pharma sponsored and investigator initiated phase I, II and III clinical studies. We defined the expected standard treatment for each patient and we calculated the cost of the standard antineoplastic drugs that should be administered in clinical practice outside clinical trials. We used the market price of drugs to determine the cost savings value. Costs other than drugs were not included in the cost saving calculation.
RESULTS RESULTS
From 23.10.2017 to 17.11.2017, 126 patients were treated in 34 pharma sponsored and investigator initiated clinical trials, using experimental drugs provided free of charge by the sponsors, for an overall number of 152 cycles of therapy. If these patients were treated with conventional therapies in clinical practice the cost of antineoplastic drugs would account for 517,658 Euros, with an average of 5487 Euros saved per patients for a period of 4 weeks.
CONCLUSIONS CONCLUSIONS
Clinical trials with investigational antineoplastic drugs provided free of charge by Sponsors render considerable cost savings, with a tangible benefit in clinical and administrative strategies to reduce drug expenditures.

Identifiants

pubmed: 33243262
doi: 10.1186/s12913-020-05928-6
pii: 10.1186/s12913-020-05928-6
pmc: PMC7691104
doi:

Substances chimiques

Pharmaceutical Preparations 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1089

Références

J Oncol Pharm Pract. 2019 Jul;25(5):1099-1104
pubmed: 29792122
Am J Health Syst Pharm. 2004 Jan 1;61(1):27-32
pubmed: 14725117
Br J Cancer. 2013 Oct 15;109(8):2051-7
pubmed: 24064969
Actas Urol Esp. 2015 Nov;39(9):553-7
pubmed: 26071987
Health Care Manage Rev. 2008 Apr-Jun;33(2):103-12
pubmed: 18360161
Health Aff (Millwood). 2008 Sep-Oct;27(5):1353-6
pubmed: 18780924
Am J Health Syst Pharm. 2000 Jan 1;57(1):40-3
pubmed: 10630555
Lung Cancer. 2013 Aug;81(2):236-40
pubmed: 23648072
PLoS One. 2019 Jan 8;14(1):e0210330
pubmed: 30620767

Auteurs

Francesca D'Ambrosio (F)

Scientific Directorate, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Gianfranco De Feo (G)

Scientific Directorate, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Gerardo Botti (G)

Scientific Directorate, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Arturo Capasso (A)

School of Banking Wyższa Szkoła Bankowa, WSB University in Wrocław, Wrocław, Poland.

Sandro Pignata (S)

Department of Urogynecology, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Piera Maiolino (P)

Hospital Pharmacy, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Maria Triassi (M)

Department of Public Health, Università Federico II, Naples, Italy.

Antonio Nardone (A)

Department of Public Health, Università Federico II, Naples, Italy.

Franco Perrone (F)

Clinical Trials Unit, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Michela Piezzo (M)

Breast Cancer, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Antonio Maria Grimaldi (AM)

Melanoma, Cancer Immunotherapy and Innovative Therapies Unit, Istituto Nazionale Tumori, "Fondazione G.Pascale" - IRCCS, Naples, Italy.

Ida Palazzo (I)

Hospital Pharmacy, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Immacolata De Stasio (I)

Hospital Pharmacy, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Roberta D'Aniello (R)

Hospital Pharmacy, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Alessandro Morabito (A)

Thoracic Medical Oncology, Istituto Nazionale Tumori, "Fondazione G.Pascale", IRCCS, Via Mariano Semmola, 52 -, 80131, Naples, Italy. a.morabito@istitutotumori.na.it.

Giacomo Pascarella (G)

Scientific Directorate, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH