OBJECTIVES: To analyze the impact of changes in Brazil’s healthcare system legislation from 2009 (CITEC) and after 2011 (CONITEC) on lawsuits for health technologies supply and federal spending. METHODS: Survey of federal spending in health technologies supply through lawsuits. RESULTS: Lawsuits with the federal government as a defendant for health technologies supply started in 2002. Ten years later there were 3,205 individual lawsuits for which the government spent US$ 131.19 million. The number of lawsuits continued to grow, reaching 2,273 in 2008. Since 2009, the growth rate slowed, reaching the annual average of 1,579, showing a stabilizing trend over the last 3 years. Federal spending grew at an average rate of 150% per year: 221% per year until 2008, decelerating to 60% per year since 2008. The impact of these lawsuits creates a cumulative effect in federal spending because the technologies provided are for chronic diseases and continuous use. In 2012 and 2013, 5 medicines alone, all of them indicated for the treatment of rare diseases (e.g. idursulfase, galsulfase and eculizumab) represent more than 80% of the federal spending. CONCLUSIONS: Escalating lawsuits over the last decade in Brazil led to several initiatives that culminated with the publication of law 12,401/2011 that created the National Committee for Health Technology Incorporation to assist the Ministry of Health in the incorporation of new technologies in Brazil’s healthcare system. The law established a deadline of 180 days for a decision to be made, based on scientific evidence of efficiency, accuracy, effectiveness and security, and on a comparative cost-benefit evaluation in relation to the technologies already incorporated. Decision must consider social participation, be clear and comprehensible. The deceleration in the annual rates of new lawsuits and the decrease in federal spending demonstrate that HTA applied to regulation may play a critical role in this context.