A PARTNERSHIP BETWEEN ACADEMY AND GOVERNMENT FOR IMPROVING PHARMACEUTICAL CARE

Prof. Augusto Guerra, PhD & Prof. Francisco Acurcio, PhDFederal University of Minas Gerais

Brazil

Contact: augustoguerrajr@ufmg.brcontato@ccates.org.br

Prof. Francisco de Assis Acurcio & Prof. Augusto Afonso Guerra JrCoordenação

• 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 evaluated10%-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

300,000.00 Gaucher’s disease• or USD 2,000.00 Schizophrenia

Drugs are prescribed and dispensed in accordance with the established criteria in Clinical Protocols and Therapeutic Guidelines.

Specialized ComponentHigh cost medicines Brazilian National Program

RECENT TECHNICAL APPRAISALS

Published1 Efficacy and safety of

sorefenib in the treatment of kidney cancer

2 Efficacy and safety of rituximab in the treatment of B-cell non-Hodgkin limphoma

3 Efficacy and safety of ursodeoxycholic acid in the treatment of primary biliary cirrhosis

4 Efficacy and safety of trastuzumab in the treatment of breast cancer

5 Efficacy and safety of temozolomide in the treatment of low grade astrocytomas

6 Efficacy and safety of ranibizumab and bevacizumab in the treatment of Age-Related Macular Degeneration

7 Amphotericin B formulations for the treatment of fungal infections in patients with HIV/AIDS

8 Efficacy and safety of sorefenib in the treatment of liver cancer

In revision

1 Efficacy and safety of drug-eluting stents for coronary artery disease

2 Effectiveness of drug-eluting stents for coronary artery disease

3 Cost-effectiveness of drug-eluting stents for coronary artery disease

4 Efficacy and safety of kidney transportation machines

5 Efficacy 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 PricePreço 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/SIAAmbulatory

Information System

AIH/SIHHospital

Information System

SIMMortality 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 assembledProbabilistc Linkagestarted 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):591-600.

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):315-324

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, 2008. Cap.7, p. 217-227.

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. Polypharmacy among the elderly in the city of São Paulo, Brazil – SABE Study. Rev bras epidemiol. 2012;15(4):817-827

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. 34-43.

Prescription, dispensing, and regulation of psychoactive anorexigenic drugs in Belo Horizonte, Minas Gerais, Brazil. Cad. Saúde Pública. 2008, vol.24, n.8, pp. 1763-1772. CARNEIRO MFG, 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): 461-471PEPE 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.. 2009, vol.26, n.2, pp. 263-282. 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 2004. Ann Pharmacother . 2010, vol.44, n.1, pp. 192-201.

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