PROCUREMENT OF PROTEIN KINASE INHIBITORS IN BRAZIL: A SCOPING STUDY MILENE RANGEL DA COSTA1, ELISANGELA COSTA LIMA-DELLAMORA1 & CLAUDIA GARCIA SERPA OSORIO-DE-CASTRO2

1 - School of Pharmacy, Federal University of Rio de Janeiro 2 - Center for Pharmaceutical Policies, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation

ABSTRACT

Over the past decade the Brazilian government expenditures on medicines have increased substantially. This could be explained by the incorporation of new drugs used to treat chronic diseases like cancer. Among them, biological medicines such as protein kinase inhibitors (PKI) stand out as high-cost and fast-diffusion technologies. This study aimed to analyze the Brazilian government expenditures on PKI procurement from 2004 to 2013. The Integrated General Services Administration (SIASG) database furnished procurement data. Total expenditure was calculated from total volume and unit price. Amounts of PKIs purchased and doses were expressed in milligrams. The number of annual treatments was obtained from total purchases and the average daily dose for chronic myeloid leukemia (CML) in adult patients in chronic phase, adjusted by 365. From 2004 to 2013, Brazilian expenditures on drugs increased 570% while PKIs imatinib, desatinib and nilotinib presented a 10-fold increase and accounted for 1 billion Brazilian reais of the total expenditure on drugs. Until 2008, imatinib was the only PKI purchased. However, after incorporation of dasatinib and nilotinib their participation in PKI annual treatments increased from 10% in 2009 to 43% in 2012 in spite of a simultaneous 48% decrease in imatinib unit cost. Our results indicate that, although it has been possible to greatly extend the number of purchased PKI annual treatments in recent years, the situation may be inverted in the near future, with gradual replacement of imatinib by newer and more costly PKIs.

METHODS

Data about PKI procurement was obtained from the Integrated General Services Administration (SIASG) database which comprises the records about all purchases made by the Brazilian government since 2004. The records concerning PKI were selected and combined to create the new database and the variables of interest were drug name, pharmaceutical form and quantitative composition, year of purchase, unit price and purchased amount. The number of annual treatments was obtained from total purchased amount in milligrams and the average daily dose for chronic myeloid leukemia (CML) in adult patients in chronic phase, adjusted by 365. The mean cost of an annual treatment was calculated from the average daily dose for chronic myeloid leukemia (CML) in adult patients in chronic phase and the average price per milligram, adjusted by 365. The expenditures are expressed in Brazilian reais (R$).

From 2004 to 2012 Brazilian government expenditures with drugs increased from R$ 1.5 to 8.5 billion, a 5.7-fold increase (Figure 1) while expenditures with PKI showed a 10-fold increase and accounted for 3% of total expenditures in the period. Imatinib was the most frequently purchased PKI, followed by dasatinib, nilotinib and ponatinib, for the latter only one purchase was registered in 2013.

Until 2007, imatinib was the only PKI purchased. Dasatinib and nilotinib were incorporated later, in 2008 and 2009, respectively, and their participation in PKI annual treatments increased from 10% in 2009 to 43% in 2012 (Figure 2).

RESULTS

RESULTS

The number of annual treatments purchased from 2004 to 2013 increased for all PKI. However, as showed in Figure 3, the rate of increase was higher for imatinib when compared to others PKI. Diversely, the comparison between imatinib and others PKI overall expenditures , suggests that they have increased at comparable rates (Figure 4).

Figure 1: Brazilian government expenditures on medicines from 2004 to 2013.

Figure 2: Percentage distribution of annual treatments by year of purchase and PKI.

Figure 3: Number of annual PKI treatments purchased from 2004 to 2013.

Figure 4: Brazilian government expenditures on PKI from 2004 to 2013.

REFERENCES

Norwegian Institute of Public Healh. WHO Collaborating Centre for Drug Statistics Methodology. http: www.whocc.no

Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Portaria SAS 649 de 11 de novembro de 2008.

Aurélio Maia and Mariana Ramos from Brazilian Ministry of Health for supporting access to data.

National Council for Scientific and Technological Development for financial support.

RESULTS CONCLUSIONS

This contrast could, at least in part, be explained by the higher unit prices of newer PKI compared to imatinib and, consequently, their higher annual treatments costs. The average cost of imatinib annual treatment presented an important decrease of 48% along the period and as of 2009 it became less costly than others PKIs (Figure 5).

Figure 5: Average annual treatment cost according to PKI.

Brazilian government expenditures on medicines have increased substantially over the past decade and four drugs alone (imatinib, dasatinib, nilotinib and ponotinib) accounted for an average 3% of the total spending.

The number of purchased PKI annual treatments has been greatly extended by the Brazilian government in recent years which may imply improved access to those medicines.

However, in spite of the great decrease of imatinib annual costs from 2004 to 2013, the participation of newer, and costlier, PKIs on total annual treatment purchases has increased.

Thus, our results indicate that the access to PKI could be impaired in the near future, with gradual replacement of imatinib by newer and more costly PKIs.

PROCUREMENT OF PROTEIN KINASE INHIBITORS IN BRAZIL: A SCOPING STUDY MILENE RANGEL DA COSTA1, ELISANGELA COSTA LIMA-DELLAMORA1 & CLAUDIA GARCIA SERPA OSORIO-DE-CASTRO2

1 - School of Pharmacy, Federal University of Rio de Janeiro 2 - Center for Pharmaceutical Policies, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation

ACKNOWLEDGEMENTS