Drug cost avoidance in rheumatology clinical trials

• Autores: Marta Calvín Lamas, María Teresa Rabuñal Álvarez, Francisco J. Blanco García, Isabel Martín Herranz
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 16, Nº. 4, 2014, págs. 266-272
• Idioma: inglés
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• Resumen

  • Background and objective: To determine the cost avoidance in investigational drugs in Clinical Trials (CT) conducted by a rheumatology service from January 2001 to December 2012.

    Method: A descriptive observational study using retrospective data collection of CT conducted by the rheumatology service at a tertiary level hospital in Spain. CT initiated within the study period with new indications for marketed drugs, and non-marketed drugs for indications for which there are alternatives available in Spain, were included. Any CT initiated within the study period using an investigational drug whose cost did not affect the hospital budget, in which economic assessment was not possible, without patients enrolled and lacking data were excluded. Data sources were CT files, computer applications of the CT pharmacy service, summaries of product characteristics and the pharmacy service management database. Only actual cost avoidance based on the doses administered were considered. Total Cost Avoidance (CA), CA per CT, per patient and per pathology were calculated.

    Results: Of 95 CT conducted, 44 (46.3%) were included. The most frequently studied pathology was rheumatoid arthritis (30/44 CT). The drugs investigated in the 44 included CT were anti-TNF (24), anti-CD28 (5), interleukin antagonist (10), anti-CD20 (2), intraarticular hyaluronic acid (2), and intravenous bisphosphonate (1). 297 patients were included in 44 CT. The total CA was euros 2,813,590, and the average CA was euros 63,945 per CT and euros 9,473 per patient.

    Conclusions: Drug cost avoidance is a tangible economic benefit of clinical trials