A PARTNERSHIP BETWEEN ACADEMY AND GOVERNMENT FOR IMPROVING PHARMACEUTICAL CARE Prof. Augusto Guerra, PhD & Prof. Francisco Acurcio, PhD Federal University of Minas Gerais Brazil Contact: Prof. Francisco de Assis Acurcio & Prof. Augusto Afonso Guerra Jr Coordenação

evaluate the compliance of the patient treatment request with the Brazilian or the State Protocols; produce Technical Appraisals of judicial requests for medicines and specific demands about medicines utilization; support judicial and administrative decisions. OUR MAIN ACTIVITIES Sep/2011→ Aug/2013 First 12 months: 75,939 patient treatment requests evaluated 10%-20% increase per year In two years produced 9,480 individual Technical Appraisals to assist in the defense of the State with respect to request processes of drugs and/or procedures filed against him.

 Studies to evaluate the performance of new and incorporated drugs subject of public finance  Comparative effectiveness research  Cost/effectiveness - pharmacoeconomics  Disinvestment protocols and Value Based Price  Medicines Policies and Access  Academic detailing for Prescribers  Judicial demands in Health Major interests

 Provides medicines for patients high cost treatment due unitary cost or chronic use.  e.g.: Cost per patient year USD 300, Gaucher’s disease or USD 2, Schizophrenia  Drugs are prescribed and dispensed in accordance with the established criteria in Clinical Protocols and Therapeutic Guidelines. Specialized Component High cost medicines Brazilian National Program

RECENT TECHNICAL APPRAISALS Published 1Efficacy and safety of sorefenib in the treatment of kidney cancer 2Efficacy and safety of rituximab in the treatment of B-cell non- Hodgkin limphoma 3Efficacy and safety of ursodeoxycholic acid in the treatment of primary biliary cirrhosis 4Efficacy and safety of trastuzumab in the treatment of breast cancer 5Efficacy and safety of temozolomide in the treatment of low grade astrocytomas 6Efficacy and safety of ranibizumab and bevacizumab in the treatment of Age-Related Macular Degeneration 7Amphotericin B formulations for the treatment of fungal infections in patients with HIV/AIDS 8Efficacy and safety of sorefenib in the treatment of liver cancer In revision 1Efficacy and safety of drug- eluting stents for coronary artery disease 2Effectiveness of drug-eluting stents for coronary artery disease 3Cost-effectiveness of drug- eluting stents for coronary artery disease 4Efficacy and safety of kidney transportation machines 5Efficacy and safety of testosterone treatment for male sexual disorder

Desenvolvimento de modelos para tomada de decisão em saúde Stent Farmacológico Stent Convencional Qual é mais custo-efetivo?

Value Based Price Preço Baseado no Valor Terapêutico Relação de custo por ano de vida ganho R$4.853,99

PROJETO PESQUISA  Estudo de viabilidade de técnicas de visitação médica para detalhamento acadêmico de prescritores sobre  medicamentos disponibilizados no SUS: Estudo de Caso - A doença de Alzheimer Academic Detailaing

APAC/SIA Ambulatory Information System AIH/SIH Hospital Information System SIM Mortality Information System Produce an unique Identifier per Patient Data Integration Record Linkage

 First version – 60 months follow up  Jan/2000 until dec/2004  Second Version – 84 months follow up  Jan/2000 until dec/2006  Third Version – 132 months follow up  Jan/2000 until dec/2010 (assembling) » Dec/2013 (mortality) – 164 months Links to state bases – Transplants; Other Medicines; Notifiable Diseases Databases assembled Probabilistc Linkage started in 2003

Medicine use from birth to age two years: the 2004 Pelotas (Brazil) Birth Cohort study. Oliveira EA, Bertoldi AD, Domingues MR, Santos IS, Barros AJD. Rev. Saúde Pública. 2010;44(4):

Birth cohort differences in the use of medications in a Brazilian population of older elderly: the Bambuí Cohort Study of Aging (1997 and 2008). Loyola Filho AI, Firmo JOA, Uchôa E, Lima-Costa MF, Ai LF, Jo F, et al. Cad. Saúde Pública. 2011;27 Suppl 3:S435-43

Non-afherence among patients initianting antiretroviral therapy: a challenge for health professionals in Brazil. AIDS. 2005, suppl.4, pp. S5-S13. BONOLO PF, CESAR CC, ACURCIO FA, CECCATO MGB, PADUA CM, ALVARES J, CAMPOS LN, CARMO RA, GUIMARÃES MDC. AIDS

Initial antiretroviral therapy in a 20-year observational cohort of patients followed at a reference center in the city of São Paulo, Brazil. Ruiz EAC, Ramalho M, Tancredti MV, Moatti JP, Monteiro ALC, Fonsi M, et al. Rev bras epidemiol. 2011;14(1):86-97

Brazilian Longitudinal Study of Adult Health (ELSA-Brasil): Objectives and Design. Aquino EML, Barreto SM, Bensenor IM, Carvalho MS, Chor D, Duncan BB et al. Am J Epidemiol. 2012;175(4):

Drug Utilization Studies  Studies that addresses the marketing, distribution, prescription and use of drugs in a society, with special emphasis on medical, social and economic use of that (WHO)  They can be quantitative and / or qualitative  It is the initial step of a journey whose goal is to solve a specific problem related with a drug Suñé AF, Valsecia M. Promoción de um mejor uso de los medicamentos: El papel de los estudios de utilización de medicamentos. In: Barros JAC (org.). Os fármacos na atualidade. Antigos e novos desafios. Brasília: ANVISA, Cap.7, p

Aspects of self-medication in Brazil. Arrais PSD, Coelho HLL, Batista MCDS, Carvalho ML, Righi RE, Arnau JM. Rev. Saúde Pública. 1997;31(1):71-7.

CARVALHO MFC, ROMANO-LIEBERI NS, BERGSTEN-MENDES G, SECOLI SR, RIBEIRO E, LEBRÃO ML et al. CARVALHO MFC, ROMANO-LIEBERI NS, BERGSTEN-MENDES G, SECOLI SR, RIBEIRO E, LEBRÃO ML et al. Polypharmacy among the elderly in the city of São Paulo, Brazil – SABE Study. Rev bras epidemiol. 2012;15(4):

ROZENFELD S,ROZENFELD S, FONSECA MJM, ACURCIO FA.. Drug utilization and polypharmacy among the elderly: a survey in Rio de Janeiro City, Brazil. Rev Panam Salud Publica. 2008, vol.23, n.1, pp FONSECA MJM, ACURCIO FA.

Prescription, dispensing, and regulation of psychoactive anorexigenic drugs in Belo Horizonte, Minas Gerais, Brazil. Cad. Saúde Pública. 2008, vol.24, n.8, pp CARNEIRO MFGCARNEIRO MFG, GUERRA JUNIOR AA, ACURCIO FA.GUERRA JUNIOR AA,ACURCIO FA

Characterization of lawsuits for the supply of “essential” medicines in the State of Rio de Janeiro, Brazil. Cad. Saúde Pública. 2010, 26 (3): PEPE VLE, VENTURA M, SANT’ANA JMB, FIGUEIREDO TA, SOUZA VR, SIMAS L, OSORIO- DE-CASTRO COSPEPE VLE, VENTURA M, SANT’ANA JMB, FIGUEIREDO TA, SOUZA VR, SIMAS L, OSORIO- DE-CASTRO COS.

Probabilistic Record Linkage Probabilistic Record Linkage is a technique which allow finding diverse data from a same person or entity in different databases or in the same. This last case is so-called deduplication The procedure establishes probabilities for each variable when it matches and when it doesn’t... Probabilities “m” and “u”

Epidemiological profile of high cost medicines users in the Brazilian Health System. Rev. bras. estud. Popul , vol.26, n.2, pp ACURCIO FA, BRANDÃO CMR, GUERRA JÚNIOR AA, CHERCHIGLIA ML, ANDRADE EIG, ALMEIDA AM, SILVA GD, QUEIROZ OV, FALEIROS DR.

Cyclosporine versus tacrolimus in immunosuppressive maintenance regimens in renal transplants in Brazil: Survival Analysis from 2000 to Ann Pharmacother. 2010, vol.44, n.1, pp GUERRA JÚNIOR AA, CESAR CC, CHERCHIGLIA ML, ANDRADE EIG, QUEIROZ OV, SILVA GD, ACURCIO FA.

 Partnership for research and academic mobility between researchers, professors and graduate students.  Towards enhance methods and adopting new perspectives  Partnership towards collaborative research and publishing papers. Looking forward