Inclusion of molecular monitoring (BCR-ABL1) in the treatment of chronic myeloid leukemia in the Brazilian Public Health System (SUS): an urgent need for treatment management

ABSTRACT Introduction: Chronic Myeloid Leukemia (CML) is a myeloproliferative disease that affects mainly adults between 50 and 55 years. In Brazil, information from the Sistema Único de Saúde (SUS) Outpatient Information System indicates that 12,531 patients had the Autorização de Procedimento Ambulatorial (APAC) approved for the CML treatment in 2017. Disease monitoring through molecular response evaluation is critical to the care of CML patients. The quantitative PCR test (real-time polymerase chain reaction) provides adequate evaluation parameters that allow the health professional to intervene at the right moments in order to reduce the chance of progression of the disease, providing the best outcome to the patient, including the possibility of treatment discontinuation for eligible patients. Although the test is included in the Clinical Protocol and Therapeutic Guidelines (PCDT) of CML, it is not possible to monitor the molecular response within SUS since there is no reimbursement for this test. Objective: Obtain expert recommendations on the importance, financing, and reimbursement of molecular monitoring in SUS. Methods: Six CML experts with different perspectives participated in the panel. The discussion was based in the main publications about the quantitative PCR test in CML monitoring. Results: Experts' recommendations: Molecular monitoring should be part of the integral treatment of patients with CML to reduce the chances of disease progression and costs to the health system; The government should put into practice what is provided in the PCDT of Chronic Myeloid Leukemia in Brazil: performing the monitoring of the molecular response via quantitative PCR; The government should create a code with adequate nomenclature and reimbursement value in SIGTAP, so that the test is carried out and covered by the public health network, as it is contained in the PCDT of the disease and the existing APAC does not cover the operational costs for its performance; Patients with chronic phase CML should perform a quantitative PCR every 3 months and, after reaching the MMR, should perform the examination every 6 months, as recommended by international guidelines; Patients should be monitored in reference laboratories that are standardized according to the international scale; The laboratories that are within the reference public centers could absorb all the test demand in Brazil, and other centers could be qualified through an ABHH accreditation; Adequate molecular monitoring may allow some patients to stop taking drugs and selffinancing the molecular test for all SUS patients Conclusion: A solution for the molecular test (BCR-ABL1) funding is urgent to ensure the monitoring of CML patients in SUS. The savings that might be generated with patients that stop taking the medication when adequately monitored may finance the test.

Influência da levodopa sobre a fase oral da deglutição em pacientes com Doença de Parkinson / Influence of levodopa on the oral phase of swallowing in patients with Parkinson's disease

Este estudo objetiva realizar levantamento bibliográfico para verificar a possível influência da Levodopa sobre a fase oral da deglutição de indivíduos com Doença de Parkinson. Foi realizado levantamento bibliográfico em periódicos indexados no Science Direct, periódicos Capes, LILACS, SciELO, MedLine e Scopus e livros. Para busca foram utilizados os termos disfagia, medicamentos, levodopa, Parkinson, dysphagia, drugs, swallowing disorders, Parkinson's disease, disfagia, las drogas e enfermedad de parkinson. Foram identificados 16 artigos internacionais e 25 nacionais, após a leitura de todos os artigos identificados foram selecionados 32, utilizaram-se ainda quatro livros e um resumo de anais de congresso. Para tal seleção utilizou-se como critério de inclusão aqueles artigos que considerassem o comprometimento causado pela Doença de Parkinson, especialmente na fase oral da deglutição, bem como os efeitos da levodopa sobre a mesma, e como critério de exclusão a influência do fármaco na fase faríngea, pois geralmente ele parece ter maior efeito na fase oral. Existe discordância na literatura quanto aos possíveis efeitos da Levodopa na deglutição. Quando estes ocorrem, geralmente afetam a fase oral desta função, uma vez que as dificuldades que o portador da Doença de Parkinson já apresenta são maximizadas pela xerostomia decorrente da administração deste fármaco. Em virtude da grande diversidade dos resultados dos estudos encontrados, faz-se necessária a realização de estudos controlados para uma elucidação mais detalhada dos efeitos da Levodopa na deglutição.

The purpose of this study is to conduct a literature review in order to verify the possible influence of Levodopa on the oral phase of deglutition in individuals with Parkinson disease. The survey was conducted in journals indexed in Science Direct, Capes periodicals, LILACS, SciELO, MedLine and Scopus, as well as in books. For this survey, the terms disfagia/dysphagia/disfagia, medicamentos/drugs/las drogas, levodopa, Parkinson/Parkinson disease/ enfermedad de Parkinson and swallowing disorders were used. It was possible to identify 16 international and 25 national scientific articles. After reading every identified papers, 32 were selected in addiction to four books and one abstract published in scientific conference proceedings were used. For such selection, the inclusion criteria were the papers which considered the impairments caused by Parkinson´s disease, especially during the oral phase of swallowing, as well as the effects of levodopa about it. As exclusion criteria, the drug influence during pharyngeal phase was considered, because it usually seems to have higher effect during oral phase. There is disagreement in the literature surveyed considering Levodopa possible effects in deglutition. When these effects occur, they generally affect the oral phase of this function, since difficulties already present in Parkinson Disease carriers are maximized by the xerostomia due to the administration of this drug. Considering the vast range of results found in the studies surveyed, developing controlled studies for a detailed elucidation of Levodopa effects in deglutition becomes necessary.