CP-194 Evaluation of access to off-label new therapies pharmacological field and the hospital and economic impact

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Incorporation of new drugs in hospitals, for their special health, social and economic impact, are classified as high impact social and economic drugs and require a comparative analysis of their efficacy, safety and efficiency versus therapeutic alternatives available through multidisciplinary committees of pharmacists and medical specialists for each drug (SAISE) to ensure homogeneous criteria for use in all health centres of the Conselleria de Sanitat of Valencia, ensuring equal access for patients to these treatments. SAISE had established guidelines to authorise the use of off-label new therapies (OLNT).


The aim of this study was to evaluate the process of approval for the use of OLNT (requests allowed/denied treatments and time to obtain a resolution) and monthly costs of these treatments.

Material and methods

This was a retrospective study that included treatment requests received in the pharmacy service from January 2013 to April 2016 and evaluated in the corresponding SAISE. The variables were: request date, service, drug, indication, outcome and date of the resolution, and cost of treatment.


During the study period, 4704 requests were submitted to the pharmacy service, of which 183 requests were processed as OLNT; 81.8% correspond to the oncology department, 12.7% to haematology, 3.3% to digestive medicine, 1.6% to internal medicine and 0.6% to paediatrics. The most requested treatments were 26.7% bevacizumab, 10.9% abiraterone, 6% nab-paclitaxel and regorafenib, and 5% panitumumab and rituximab. The most frequent pathologies were 21.8% colorectal cancer, 13.6% prostate cancer, 12.6% glioblastoma and 7.7% pancreas cancer. 24% of these requests were denied; 25% from oncology, 16% haematology and 50% from digestive medicine. 90% were refused for insufficient information on the efficacy of treatment and the rest were for lack of information in the clinical report.


The monthly cost of the approved request was €585.985 and €145.690 for the rejected request. The average time for resolution was 30 days (11–89 days).


Due to the high cost of new drug therapies it is necessary to establish criteria to ensure that patients receive proper treatment and ensure the sustainability of the health system, although it should be a faster process because of the severity of some diseases.

References and/or acknowledgements


References and/or acknowledgements

No conflict of interest

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