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An initial technical scientific report combined evidence evaluation, an economic model, and budget impact analysis using cyclophosphamide as comparator, resulting in a preliminary CONITEC recommendation against rituximab. Public consultation gathered patient and technical inputs, prompting revised analyses, a clarified five-year budget impact, and a reversal to approval in June 2023 with development of the PCDT. Findings support improved equity, access, remission, fewer relapses, and better quality of life.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/clinical-guidelines-for-antineutrophil-cytoplasmic-antibodies-associated-vasculitis-pp76/445673/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/clinical-guidelines-for-antineutrophil-cytoplasmic-antibodies-associated-vasculitis-pp76/445673.png","ImageObject",300,407,{"name":92,"@type":93},"Theodore","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":44},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What problem does the report address for ANCA-associated vasculitis in Brazil?","Question",{"text":112,"@type":113},"It addresses challenges in incorporating ANCA-associated vasculitis treatments due to limited high-quality evidence and evaluates rituximab’s clinical and economic value within Brazil’s public system.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What methods were used to support the recommendation?",{"text":117,"@type":113},"A technical scientific report was developed using an evidence evaluation, an economic model, and a budget impact analysis. Cyclophosphamide was used as the comparator.",{"name":119,"@type":110,"acceptedAnswer":120},"How did public consultation affect the final decision on rituximab?",{"text":121,"@type":113},"During the consultation, 169 contributions were received, including unanimous support from patients and caregivers and technical submissions emphasizing cyclophosphamide toxicity and limited response. Revised economic analyses reduced incremental cost-effectiveness and clarified budget impact, leading CONITEC to reverse its initial recommendation and approve rituximab in June 2023.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},445673,1790834285,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":44,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":8,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":81,"preview_page_count":4},7971461740886,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","PP76 Clinical Guidelines For AntiNeutrophil Cytoplasmic Antibodies-Associated Vasculitis:  \nIncorporating Rituximab To Enhance Equity In Access And Treatment In Brazil  \nAline Rocha ([alineprocha1@gmail.com](alineprocha1@gmail.com)),  \nNitza Ferreira Muniz,  \nAna Carolina Pereira Nunes Pinto and Álvaro Atallah  \nIntroduction: Anti-neutrophil cytoplasmic antibodies (ANCA) -associated vasculitis is a rare disease with high morbidity and mortality rates, posing challenges for incorporating treatments due to limited high-quality evidence. Brazil recently developed a Clinical Protocol and Therapeutic Guideline (PCDT) after incorporating rituximab into the public healthcare system. This study explored the development of a Technical Scientific Report (TSR) addressing rituximab’s effectiveness and costs as well as stakeholder participation in shaping equitable, evidence-based recommendations. Methods: A TSR was initially developed that included an evaluation of evidence, an economic model, and a budget impact analysis. Cyclophosphamide, which is already available in the public health system, was used as the comparator. Based on this analysis, the National Committee for Health Technology Incorporation (CONITEC) issued a preliminary recommendation against incorporating rituximab for ANCA-associated vasculitis. This TSR was submitted for public consultation (6 to 25 April 2023), during which community contributions were received. All submissions were thematically analyzed, and relevant contributions were re-evaluated. The updated findings were then presented to CONITEC for a final decision, incorporating new perspectives and refined results. Results: During the public consultation, 169 contributions were received: 56 from patients and caregivers unanimously supporting rituximab’s incorporation and 113 technical submissions highlighting cyclophosphamide’s toxicity and lack of response in 25 percent of patients, and rituximab’s economic benefits. Revised economic analyses found a reduced incremental cost-effectiveness ratio when comparing rituximab with intravenous cyclophosphamide and clarified the five-year budget impact. These updates, along with strong patient participation, influenced the reversal of CONITEC’s initial recommendation, leading to rituximab’s approval in June 2023 and the development of the PCDT.  \nConclusions: The incorporation of rituximab into Brazil’s public health system and the creation of the PCDT for ANCA-associated vasculitis represents a significant advancement in treating rare diseases and may help promote remission, reduce relapses, and improve patient quality of life. By integrating patient perspectives and evidence-based practices, the PCDT strengthens equity and access, fostering comprehensive care for rare diseases in Brazil.  \nPP77 Cost-Utility Analysis Of Nivolumab For Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma In The Brazilian Public Healthcare System  \nLudmila Gargano ([ludgargano@gmail.com](ludgargano@gmail.com)), Layssa Oliveira, Haliton Oliveira Junior and Rosa Camila Lucchetta  \nIntroduction: Head and neck squamous cell carcinoma (HNSCC) is the most common malignancy ofthe oral cavity, pharynx, and larynx. Nivolumab has demonstrated significant survival benefits in patients with recurrent or metastatic HNSCC after platinum-based chemotherapy. This study evaluated the cost utility of nivolumab compared with standard chemotherapy for recurrent or metastatic HNSCC in adults in the Brazilian Unified Health System (SUS) .  \nMethods: A partitioned survival model was developed using survival data from the CheckMate-141 trial. Health states included progression-free survival (PFS), post-progression survival, and death. Estimates for overall survival (OS) and PFS were extrapolated from Kaplan-Meier curves using parametric distributions. Costs and utilities were analyzed from the SUS perspective over a five-year horizon, with a five percent annual discount rate for both costs and benefits","cbCaidkntPVzNISV","https://ap.wps.com/l/cbCaidkntPVzNISV","pdf",31707,"English","# Introduction\n# Methods\n# Results\n# Conclusions","[{\"question\":\"What problem does the report address for ANCA-associated vasculitis in Brazil?\",\"answer\":\"It addresses challenges in incorporating ANCA-associated vasculitis treatments due to limited high-quality evidence and evaluates rituximab’s clinical and economic value within Brazil’s public system.\"},{\"question\":\"What methods were used to support the recommendation?\",\"answer\":\"A technical scientific report was developed using an evidence evaluation, an economic model, and a budget impact analysis. Cyclophosphamide was used as the comparator.\"},{\"question\":\"How did public consultation affect the final decision on rituximab?\",\"answer\":\"During the consultation, 169 contributions were received, including unanimous support from patients and caregivers and technical submissions emphasizing cyclophosphamide toxicity and limited response. Revised economic analyses reduced incremental cost-effectiveness and clarified budget impact, leading CONITEC to reverse its initial recommendation and approve rituximab in June 2023.\"}]","Clinical Guidelines For AntiNeutrophil Cytoplasmic Antibodies-Associated Vasculitis - PP76 | PDF",1790712546]