NATIONAL ADOPTION OF NEW IMMUNOSSUPRESANTS FOR SOLID ORGANS AND STEM CELLS TRANSPLANTATIONS

Author(s)

Trindade E1, Muller S2, Canuto Santos VC3, Carneiro D'albuquerque LA1, Buehler A4, Petramale C5
1University of São Paulo Medical School, São Paulo, Brazil, 2São Paulo State Health Secretariat, São Paulo, Brazil, 3Brazilian Ministry of Health, Brasília, Brazil, 4Hospital Alemão Osvaldo Cruz, São Paulo, Brazil, 5Department of Management and Incorporation of Health Technology, Ministry of Health of Brazil, Brasília, Brazil

OBJECTIVES:: To propose new immunosuppression drugs incorporation for the Brazilian public healthcare system. METHODS:: Systematic evidence synthesis and Brazilian transplantation registries-based base-cases Kaplan-Myer survival and economic assessments were presented in specialized national congresses open public Delphi sessions to build professional Clinical and Therapeutic Protocols (PCDT) by consensus. Five consensus transplantation PCDTs with SUS’ perspective budget impact and sensitivity analysis were submitted to the Health Ministry SUS Technology Incorporation National Commission (CONITEC) plenary and voted. PCDTs were publicized in CONITEC Internet and Diário Oficial da Uniãoofficial periodic, and underwent widespread dissemination through mailings for Public Consultation. Public contributions were added to PCDTs to subsidize Health Ministry policy making. RESULTS:: The São Paulo State Health Secretariat coordinated the synthesis and economic assessments made by 115 over 10 years experienced transplantation specialists and health technology evaluators. Heart, lung, liver, pancreas and hematopoietic cells transplantation PCDTs with tacrolimus, sirolimus and everolimus alternative immunosuppression can significantly prevent 27,8%, 28,1%, 7,2%, 11,1% and 4,3% graft loss or graft versus host disease and death, respectively, for conventional cyclosporine-based refractory transplanted patients’ rescue during the first year post-transplantation, saving substantial healthcare resources used. Ten years follow-up demonstrated partial benefits sustained. Analysis demonstrated +US$689,655.17, +US$501,567.40, -US$377,802.51, +US$221.289,42 and +US$ 50.734,08 budget impact, respectively, resulted in overall US$1,085,443.55 for 2146 transplantees’ rescue. The 05 PCDTs were favorably voted by CONITEC plenary members, 155 public contributions were added by patients and stakeholders, and the Brazilian Health Ministry decided to adopt SUS reimbursement listing. CONCLUSIONS:: Democratic participation gave PCDTs real-world adjustments, SUS innovation and compliance.

Conference/Value in Health Info

2017-09, ISPOR Latin America 2017, Sao Paulo, Brazil

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PHP36

Topic

Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment, Study Approaches

Topic Subcategory

Approval & Labeling, Decision & Deliberative Processes, Hospital and Clinical Practices, Registries, Reimbursement & Access Policy, Treatment Patterns and Guidelines

Disease

Multiple Diseases

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