Evaluation of demands of inclusion, exclusion and alteration of technologies in the Brazilian Health System submitted to the National Committee on Technology Incorporation

ABSTRACT The steady increase in the number of health technologies and advances in associated research generate management challenges in the choice of technologies to be made available to the public. From 2011, the process of inclusion, exclusion and alteration of technologies to the Brazilian Unified Health System (SUS) has undergone major transformations, such as the creation of the National Committee on Technology Incorporation (CONITEC). This study analyzed the decisions of CONITEC since its inception until July 2015. The analyzed variables were: type of technology, reason for application, name of the technology, indication, claimant and CONITEC decision status. We found that the Government was the main claimant, accounting for 58.1% of the 420 cases. The most frequent request was inclusion (93.8%) and the technology type was medicine (61.4%). Of the incorporated medicines, the classes of antineoplastic/immunomodulatory were the most frequent (39.47%). Society's desire for inclusion of an increasing amount of health technology contrasts with the limited resources available to management, which causes budget concerns. Using Health Technology Assessment (HTA), advances resulting from these innovations in the process were highlighted, and challenges were identified for the management and the academic community

Evaluation of the predisposition and clinical impact of BK virus replication in kidney transplant patients

ABSTRACT The BK virus (BKV) produces a subclinical kidney infection in immunocompetent individuals. However, viremia may occur in kidney transplant patients with ongoing immunosuppression. BKV-associated nephropathy (BKVN) has no specific treatment and is a leading cause of organ transplant loss. In this study, we evaluated the predisposition and the clinical impact of BKV replication in kidney transplant patients during post-transplant monitoring in a reference institution in Brazil. Demographic, clinical and laboratory data generated during routine outpatient follow-up were retrospectively collected. BK viremia was investigated using real-time polymerase chain reaction. Of the 553 participants, 7.4% (n = 41) presented BKV replication. Of these, 16 (39%) lost their kidney graft and interstitial nephritis was identified on kidney biopsy in 50% of the cases. Among the evaluated variables, only the use of the immunosuppressant mycophenolate sodium was identified as a risk factor for viremia (OR 7.96; 95% CI 2.35 to 26.98). The graft survival estimate in BKV-positive patients was significantly reduced (24.8% vs. 85.6%) after 10 years of transplantation. We concluded that defining predisposing factors remains an important challenge for the prevention and control of BKV activity following kidney transplantation, especially considering the development of BKVN and its strong effect on graft maintenance