Patricia Lacruz, general manager of Cartera Común de SNS’s Pharmacy Services.
al Ministry of Sanidad has published el second information of results in health of a medicine included in Valtermed, the information system to determine the therapeutic and economic value of the National Health System (SNS) formats. This document evaluates the security and efficiency of the inotuzumab ozogamicina (Besponsa), by Pfizerwhich is indicated for the treatment of patients with lymphocytic leukemia aguda.
The study indicates that, as well as how stable the pharmacoclinic protocol is, “perform the menu of the respective evaluationsan initial (approximately to the middle), other than 2 months or three months; place every 3 months lasting 1 year and every 6 months lasting the second year”. Continuous variations are progressing or following local protocols, such as deberá evaluation including men morphological study and fluid cytometry in medulla parasea for CD22 (inotuzumab).
Of course, Sanidad consists of, at the moment, and having high interest in the results that are recruited for this information, “no robust other conclusions can be drawn with the available data that it is necessary to have a registered major in all patients which is initially treated ”and, as in all studios, results in more“ wide plazo ”.
Based on the observed data, out of the 49 patients who initially treated with inotuzumab ozogamicin, Valtermed has data on the evaluation of the respondent in 42 cases. Using this Last digit as a reference, I have an effect of 57 per cent“Aunque este dato you can overestimate real effectiveness if it is not available in the record of the evaluation of the respondent in the 14 due to the knowledge of the patients who have initiated treatment ”, segala señala el informa.
These results are “notoriously distances from the holders in the clinical phase pivotal phase III aleatorizado abierto (B1931022)”, Which with a sample of 164 patients in the group treated with inotuzumab ozogamycin obtained a cup of 80.7 per patient. The embargo, in its analysis, states that “care should be taken that the analysis of results in the pivotal field is intended to be treated”, in order that the analysis in respect of the treatment performed with Valtermed’s data “is used as the ultimate use of the ultimate evaluation of the respective performance performed on patients”.
Valtermed’s data, “peores” that the clinical assay
If it refers to the objective last of the treatment that is, recur allogeneic transplantation of hematopoietic progenitors (alo-TPH)16 patients are receiving treatment again, which equates to 32.6 per cent of the 49 patients who receive treatment, and a 38.1 per cent of the 42 who have given the men an evaluation of the respondent. De ellos, un patiente recibe el transplanta “sin haber respondi previamente al tratamiento”. No obstruction, in the pivotal clinical setting, the 47 per patient (77 out of 164 patients on this set) of those receiving the treatment who had some alo-TPH and, by all means, “Valtermed’s data are only those in the clinical case”.
If you are aware of the need for RC morphological news or RC with EMR prevail and recoil alo-TPH, in the latest evaluation, a 62.5 per patient (15 out of 24 patients) of patients receiving some TPH. Finally, of the 16 transplant patients, 5 (31.3 per cent) received EVO / SOS after receiving the transplant and 7 (43.8 per patient) underwent the transplant. It is interesting to note that in Valtermed, 3 (12.5 per patient) patients recaen tras al menos an evaluation with RC morphologically or RC with EMR and porosity, do not take an allo-TPH.
Index of superimposition and reverse effects
Relation to the supervivencia following the initiation of treatment, a total of 29 patients underwent follow-up from the first infusion (66 per patient), 7 (15.9 per patient) of those receiving transplants, with a superimposition media of 75.89 semanas.
The median follow-up of 44 patients was about 33.7 weeks (7.75 months). Este valor “es very similar to obtained in the clinical case B1931022, which has a median of 7.7 months ”. For other reasons, the superimposition traces the initiation of treatment up to 2 years (approximately 105 weeks) at 26 per cent, resulting in slightly higher relative to the clinical result.
When asked, the Indian Ministry is informed that “we must follow the present you can not make a direct comparison between the clinical case and Valtermed datadebito that there are many restrictions ”.
When it comes to insurance, notified adverse effects on a total of 31 patients. As an embargo, only the effects of adversity were recorded at 81.6 per cent (40) of patients, compared to 49 currently treated. The reported adverse effects with the highest frequency are thrombocytopenia and neutropenia. In general, in consonance with the technical file, the adverse effects related to the trajectories of the blood and the lymphatic system are not the most notified.
¿Qué es Valtermed?
Valtermed is the National Health System (SNS) corporate information system that was born in September 2018, the fruit of the consensus in the Permanent Pharmacy Commission of the SNS Interterritorial Council, co-governing body in medical and legal matters pa .s.
To be in the market in November 2019 with the objective of to share the knowledge of therapeutic effectiveness, decis, of the results of efficacy obtained in real clinical practice, of new drugs that present elevated clinical incidence and for which it is not necessary to generate evidence to better the use of medicines in the USSR and refuse excellence of our public sanitation system, through the study, analysis and evaluation, rigor and method. The Valtermedson Datasheet is based on pharmacy-clinical protocols for medicines that are based on consensus, professional and professional consent.
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