Background and Importance A marketing authorisation is a general rule in the legal framework of medicines. However, EU legislation does not regulate how drugs are ultimately used in medical practice.
The Royal Decree 86/2015 regulates the Pharmacy and Therapeutics Committee of the Balearic Islands. This P&T-Committee is an advisory panel of experts, composed by pharmacysts and physicians, which elaborate technical reports to allow or deny drugs prescribed in special situations: off-label drugs(OLDs), compassionate drugs(CDs) and drugs not included in the hospital’s pharmacotherapeutic guide(HPG).
Aim and Objectives To analyse the clinical response achieved by the treatments approved by P&T-Committee and their associated costs.
Material and Methods Prospective study of the drugs requested to the P&T-Committee between January/20-December/21.
A Microsoft-Access® database was created for collecting the variables: type of treatment (OLD,CD or not included in the HPG), level of evidence, clinical response, adverse effects and costs. Clinical response was defined as success or failure based on the therapeutic objective established by the physician at the time of the request. The cost was calculated based on the duration of the treatment until the objective was achieved or until treatment was discontinued.
The data were obtained from patients‘ electronic medical records(HP-HCIS®).
Results In total, 182 requests were approved: 30.8% successes, 29.7% failures, 6.6% interrupted because of adverse effects, 8.7% not initiated and in 24.2% insufficient time had passed for them to make a valid assessment of the real effectiveness.
Almost half of the treatments(44,5%) were considered to have a high level of evidence. In reference to the type of treatment: 57.5% were OLDs, 35.5% were drugs not included in the HPG and 7% were CDs. Oncology and Haematology submitted more than 50% of the requests.
The overall estimated cost of the 182 authorised treatments was 3.672.751,93€. The average cost per request was 20.179,93€. The medical services that have a greatest impact on the cost were Oncology(35.307,22€/treatment) and Haematology(20.686,16€/treatment).
Conclusion and Relevance The percentage of treatments analysed that achieved their therapeutic goal was very similar to those that didn’t, probably because of the high level of heterogeneity of the treatments analysed. However, we can’t ignore the high economic impact of these drugs and we need to define therapy follow-up plans.
Conflict of Interest No conflict of interest
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