Academic title: Treatment-Specific Interrupted Time Series Analyses of Judicial Deference to Health Technology Assessment in Brazil
Published in: BMC Health Services Research
Authors: Mathieu JP Poirier, Tina Nanyangwe-Moyo, Natalia Pires de Vasconcelos, Daniel Wang, Gigi O Lin, Ana Luiza Chieffi, Cauê Freitas Mônaco, Zun Ge Mao, Steven J Hoffman
Key takeaways
- Our study examined thousands of court decisions for Brazil’s ten most frequently litigated treatments between 2011 and 2015 and found no change in court decisions after implementing health technology assessments (HTAs).
- The establishment of Brazil’s HTA (CONITEC) did not change the proportion of court decisions that were aligned with HTA recommendations. Courts almost always ruled in favour of patients who claimed their constitutional right to health.
- While this allows some individuals to access treatments through legal channels, it also can result in the use of untested and ineffective treatments and exacerbates inequities by privileging those with access to legal assistance.
- Ignoring HTA recommendations weakens the role of evidence-based medicine and cost-effectiveness analyses, reducing the efficiency and sustainability of public health financing.
Introduction
Health technology assessments (HTAs) are essential tools for systematically evaluating health technologies and can improve the quality of patient care by prioritising cost-effective treatments based on the best available evidence. Their outputs can guide national health coverage decisions for medical devices, procedures and drugs.
However, implementing HTA recommendations in low- and middle-income countries (LMICs) can face challenges of limited awareness among decision makers, insufficient funding, and a lack of technical expertise. While much of the evidence supporting the use of HTAs comes from high-income countries (HICs), there is a gap in evidence on the real-world impacts of HTAs in LMICs with a constitutional right to healthcare.
A Real-World Example of HTAs:
In 2011, Brazil created CONITEC (Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde), a new HTA agency designed to inform Ministry of Health coverage decisions. However, courts often rule in favour of patients who claim their constitutional right to health through legal action. This pattern has resulted in unintended negative impacts, such as diverting public funds toward those who can afford legal representation, instead of allocating resources based on public health priorities and HTA recommendations.
Our study analyzed a large dataset of court claims to evaluate the effect of CONITEC recommendations on court decisions for ten of Brazil’s most frequently litigated treatments using rigorous quasi-experimental methods. Regardless of whether HTA recommended for or against coverage, positive court decisions decreased by less than 2.1% after an HTA recommendation was provided.
Our previous study identified a similar consistent pattern in Brazilian court rulings. CONITEC recommendations were rarely mentioned in court decision-making, and patients filing lawsuits for treatment coverage often received positive rulings, regardless of whether CONITEC supported those treatments.
Conclusion
The study found no significant change in court decisions for ten of Brazil’s most frequently disputed treatments between 2011 and 2015, regardless of the HTA recommendations to the national health system. These findings highlight a misalignment between the goal of health system financing informed by HTAs, and court rulings which often do not question the claims put forward by patient litigants.
When courts regularly rule in favour of individuals initiating lawsuits without considering the cost-effectiveness of treatments being provided, it can lead to significant economic and public health consequences. For example, a large portion of the public health budget may go toward complying with ineffective treatments. This diversion can prevent funds from being distributed equitably to meet broader public health needs, ultimately widening the gap in healthcare access for everyone.
Policy Recommendations:
To strengthen the role of HTAs in healthcare decision-making and address the inequitable effects of individual patient claims for treatment coverage, policymakers should take steps toward improving the alignment of court decisions with public health priorities.
Specific measures could include:
- Brazil is creating technical teams to assist lower courts’ decision-making and verification of evidence and considering a rule that would limit court provision of non-listed treatments to those that are yet to be assessed by CONITEC.
- Raising awareness of HTAs and evidence-based decision-making through training programs and partnerships between health policymakers and judicial institutions. Uruguay is an excellent model of this – the Ministry of Health holds education sessions for defence attorneys and judges on the use of HTA evidence.
- International networks, such as Health Technology Assessment International (HTAi) and the International Network of Agencies for Health Technology Assessment (INAHTA), can offer national-level capacity building programmes and share successful case studies of HTA implementation strategies.
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