[Autom. eng. transl.] The subject of this report by Health Technology Assessment (HTA) is Xofigo, Radio-223 dichloride (Ra-223), the first radiopharmaceutical with specific action on bone tissue able to increase the overall survival of patients with skeletal metastases from mCRPC, without causing obvious damage to the bone marrow. The drug binds to the growing bone tissue, like the neoplastic one, emitting over time radioactive particles, called alpha, capable of determining a selective destruction of tumor cells. It is therefore an absolute novelty in the therapeutic scenario of the mCRPC, if we consider that, until now, the therapies available with specific action on the bone were drugs with a predominantly palliative role, aimed at controlling the painful symptoms and without an activity anti-tumor proper. The drug is recommended by the main Italian and international guidelines and is also the only drug for the treatment of mCRPC to have obtained the maximum score in the evaluation of the clinical benefit of ESMO oncology drugs (ESMO-MCBS) [3-6]. The process of evaluating HTA covered by this report has developed through the creation of a multidisciplinary group that analyzed and processed the information available on the new drug considering the clinical, economic, organizational and ethical impact related to its introduction and to its overall use. The goal was to create an all-encompassing assessment of technology that would allow a global vision in all its dimensions. The related characteristics of the use of Radio-223 have in fact allowed to touch different points inherent to the clinical problems of the patient with mCRPC, to the role of the drug in a therapeutic scenario that has significantly changed over the last few years, to all organizational aspects, management and regulatory associated with the use of a radiopharmaceutical, up to touch issues related to economic sustainability and access to care, of crucial importance when a new technology opens up to the market and is made available to patients. it also provided for the involvement of the "Europa Uomo" Patients Association, to have immediate feedback on the new technology by patients. In this sense, in order to take into consideration a further perspective and to try to emphasize the involvement of the associations in the decision-making processes, the association's point of view regarding the pathology and technology under investigation is reported in the appendix. Finally, a chapter was drawn up containing the key elements for decision-makers, to provide a summary of the results supporting operational decisions.
|Translated title of the contribution||[Autom. eng. transl.] Radio-223 in the treatment of castration-resistant metastatic prostate cancer (mCRPC): results of a Health Technology Assessment assessment|
|Number of pages||8|
|Journal||Italian Journal of Public Health|
|Publication status||Published - 2016|
- HTA, etica
- Radio-223 dicloruro, carcinoma della prostata metastatico resistente alla castrazione
- Radium-223 dichloride, metastatic castration-resistant prostate cancer, HTA, ethics