HTAnalyze

Confiança para grandes decisões em saúde.

[HTAnalyze @htanalyze]

The HTA in Brazil may be entering its most methodologically demanding phase yet. TCU Ruling 674/2026 identified major weaknesses in CONITEC’s processes, including limitations in economic evaluations, lower-quality supporting evidence and gaps in post-incorporation monitoring.

[HTAnalyze @htanalyze]

Adding the legal maximums in the fastest scenario gives about 480 days (120 + 180 + 180), roughly 16 months, and statutory maximums are not the same as real elapsed time. Understanding the difference between "published" and "available" is essential for anyone operating in Brazil.

[HTAnalyze @htanalyze]

A technology can be officially incorporated into Brazil's public healthcare system (SUS) and still take up to 180 more days to reach patients.

Why? 👇

#MarketAccess #HTA #SUS #Anvisa #CONITEC #Healthcare #Pharma #Brazil

[HTAnalyze @htanalyze]

Because publication is not the final step. From Anvisa registration to actual availability, the journey runs through legally defined stages — some standalone deadlines, others sub-steps within a single global deadline.

[HTAnalyze @htanalyze]

Anvisa's Sentinel Network is a valuable post-market surveillance asset—but it is not a data source for comparative effectiveness studies. Building RWE capabilities now is likely to pay off as HTA guidelines continue to evolve.

Read more in our article published on LinkedIn!

[HTAnalyze @htanalyze]

Real-world evidence (RWE) is already shaping regulatory and HTA decisions in leading markets.
The FDA (through its RWE Program and 2018 Framework) and NICE (2022 Framework) provide formal guidance for its use. In Brazil, the challenge is less about whether to use RWE and more 👇

[HTAnalyze @htanalyze]

about how to connect data sources (DATASUS, registries, administrative databases, and private healthcare data), ensure data quality and governance, and use the right data to answer the right research question.

[HTAnalyze @htanalyze]

The key challenge is to balance scientific rigor with democratic legitimacy in CONITEC's decision-making.

Read more in the article on LinekdIn!

[HTAnalyze @htanalyze]

In 2026, CONITEC reversed two unfavorable recommendations following strong mobilization by civil society, reinforcing the growing role of social participation in decisions on the incorporation of health technologies into Brazil's Unified Health System (SUS). 👇

[HTAnalyze @htanalyze]

While this participation brings valuable perspectives on patients' needs and real-world clinical practice, it also raises concerns about the influence of social pressure on the technical and methodological consistency of Health Technology Assessment (HTA).

[HTAnalyze @htanalyze]

real-world data (RWE) earlier in the process. Risk-sharing agreements may also gain ground, with payments conditioned on clinical outcomes.
This is a prospective analysis by HTAnalyze: the design is still under construction and may change.
Read more in the article on LinkedIn!

[HTAnalyze @htanalyze]

The Ministry of Health has signaled its intention to test, still in 2026, new forms of price negotiation for high budget-impact technologies in SUS, inspired by international experiences — particularly that of the United Kingdom. 👇
#MarketAccess #HTA #SUS #ATS

[HTAnalyze @htanalyze]

The idea is to use SUS's purchasing power to negotiate lower prices in exchange for volume predictability. In practice, this movement could change the dynamics of market access: it tends to require robust cost-effectiveness evidence, more sophisticated economic modeling, and 👇

[HTAnalyze @htanalyze]

That is what makes HTA in Brazil structurally different. Perhaps the most relevant movement in contemporary HTA is the growing need to integrate scientific evidence, HEOR, economic evaluation, operational feasibility, and regulatory context in the same decision-making framework.

[HTAnalyze @htanalyze]

HTA in Brazil goes far beyond clinical benefit and cost-effectiveness.
Here, incorporation decisions also depend on whether SUS can sustainably absorb the technology at scale.👇

#HEOR #HTA #SUS #HTAnalyze

[HTAnalyze @htanalyze]

At HTAnalyze, we support projects focused on connecting evidence, institutional context, and decision-making in complex healthcare environments.

#HEOR #HTA #HospitalBasedHTA #HealthEconomics #EvidenceSynthesis #ValueBasedHealthcare #HTAnalyze

[HTAnalyze @htanalyze]

Hospital-based HTA is becoming increasingly central to institutional healthcare decision-making.
Technology adoption now depends not only on clinical efficacy, but also...👇

[HTAnalyze @htanalyze]

As hospital environments grow more complex, HTA, HEOR, evidence synthesis, economic evaluation, and value-based healthcare are becoming progressively more integrated within governance and incorporation strategies.

[HTAnalyze @htanalyze]

sufficiently comparable, transparent, and methodologically defensible to support decision-making across regulatory and market access pathways.

At HTAnalyze, we integrate these dimensions to support more sustainable and defensible healthcare decisions.

[HTAnalyze @htanalyze]

Cost-effectiveness discussions in healthcare are becoming increasingly dependent on evidence quality, methodological consistency, and inferential confidence 🧶👇

#HealthEconomics #EvidenceSynthesis #MetaAnalysis #MarketAccess #RealWorldEvidence #Pharma

[HTAnalyze @htanalyze]

As HTA environments grow more complex, economic evaluation, HEOR, evidence synthesis, and regulatory strategy are becoming progressively more interconnected.

The discussion is no longer limited to generating data, but to demonstrating that available evidence is...