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With the discovery of new direct-acting antivirals, the cure for hepatitis C appears to be a reality, but its high price and the availability of new antivirals are a major obstacle. In Brazil, treatments for hepatitis C have been available in the public health system since the 1990s, and in 2015 were made available the antivirals sofosbuvir, daclatasvir and simeprevir. The calculation of the budgetary impact of this merger estimated expenditures between 467 and 666 million Reais (USD 121 and 172 million) per year. This study aims to present and discuss the cost and effectiveness of hepatitis C treatment with direct-acting antivirals with or without alfapeginterferon and ribavirin, based on real-life data, and compare it with the world scenario.
Methods
We analyzed the treatment data and outcomes of 253 patients from a retrospective cohort performed in a Specialized Care Service, in the city of Porto Alegre. In relation to costs, the direct costs of antiviral drugs, per unit (tablet), were considered according to financial receipts from public purchases. The total cost of the medications used by each individual in each treatment and the cost per cure obtained, expressed in Sustained Viral Response (SVR), were calculated.
Results
Most patients (66.8 percent) had genotype 1 of the hepatitis virus and 92.9 percent achieved SVR. The mean total cost of treatment of patients with genotype 1 was USD 5,862.31 and USD 6,310.34 per cure; while in patients with genotype 3 the cost was USD 5,144.27 and USD 5,974.76 per cure. The cost with the most commonly used treatment regimen, sofosbuvir, daclatasvir and ribavirin was USD 5,961.25 and USD 6,536.46 per cure. These values were 30 percent lower than the values estimated at the time of drug incorporation.
Conclusions
Cost and effectiveness data contextualize a real-life scenario in Brazil. The evaluated treatments presented good effectiveness, but high costs.
In Brazil, the National Pharmaceutical Assistance Policy was published in 2004. Pharmaceutical assistance at the primary health care level in Brazil is understood as a broad set of activities comprising regulation, planning, distribution and dispensation of essential medicines in primary health care facilities. Considering governance capacity as a key requirement for the success of a public health policy, this article aims to demonstrate the adaptation and operationalization processes of using a national survey database for a national evaluation of the pharmaceutical assistance governance in public primary health care in Brazil.
Methods:
This is a systematic study of an evaluation model on pharmaceutical assistance governance at the municipal level, and of the data collection instruments and databases used in the recent National Survey on Access, Use and Promotion of Rational Use of Medicines, in addition to the preparation of indicators protocol validated for application throughout the country. The study steps were as follows: selection of data from the survey and their adaptation to evaluation indicators nationwide; validation of an evaluation matrix adapted in a workshop with actors in the field; database construction; data analysis; and, issue of value judgment.
Results:
The adaptation of the evaluation matrix caused seventeen indicators to be reformulated. In six of these indicators, the changes referred only to the data source. As the recommended measures could not be implemented due to lack of information, sixteen indicators were excluded from the original protocol. Ultimately, the proposed protocol comprised thirty indicators presented in three dimensions (organizational, operational and sustainability).
Conclusions:
The methodology enabled the redesign of the evaluation matrix according to the specific national characteristics by crossing the data provided by the reference survey and evaluation model. The participatory process, the use of data from all actors involved in pharmaceutical assistance at the municipal level, and the use of the principles of the national health policy as the basis for selection and construction of a fitted evaluation protocol are important strengths of the new protocol proposed. The absence of international studies on evaluations using the same model is a major weakness.
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