Approved
Is Not Paid
A practical guide to payability in Brazil for global market access teams.
Sixteen pages on what sits between an ANVISA registration, a Conitec recommendation or an ANS Rol listing and the first accepted claim in Brazil: who actually pays, through which mechanism, on what evidence and on what timeline. Free, in exchange for a work email.
Approval creates the right to sell. Coverage creates an obligation. Neither tells you who pays.
In Brazil, regulatory authorization and coverage decisions create the right to sell or the obligation to cover, but they do not tell you who will authorize the purchase, which budget will fund it, what price will be accepted, how the claim will be processed or when cash will arrive. That gap is what the paper calls payability: whether a specific buyer can and will fund a technology through a defined mechanism, at an economically viable price and within a timeline the company can survive.
The term comes from Adrijana Daragon's work on why FDA approval does not mean a US MedTech company will get paid, and it travels well, because Brazil looks from headquarters like one large market with a clear sequence of approvals, when it is two health systems containing many distinct payer, provider and procurement markets, each with its own decision bodies, payment mechanisms and speed.
Five decisions that sound like a yes from the system, and are a yes to a narrower question
ANVISA authorization is treated as market access
It establishes that the product may be commercialized under its regulatory regime, and for medicines CMED then sets regulated maximum prices for each channel, a ceiling that is neither an agreed price nor a purchase commitment.
A positive Conitec recommendation is treated as a SUS purchase order
Incorporation opens a public policy path, but availability still depends on financing, coding, protocols and procurement, and a TCU audit found that 78% of the technologies incorporated between 2021 and 2023 were not made available within the 180 days the law allows.
Inclusion in the ANS Rol is treated as guaranteed revenue
The Rol creates a coverage obligation for eligible beneficiaries of regulated private plans, more than 53 million people, but it does not set provider reimbursement, a product price or utilization volume, and the money is negotiated with each of the 667 medical operators active in the market.
Litigation is treated as a fallback channel
Since September 2025 the Supreme Court requires five cumulative criteria, including high-grade evidence and ANVISA registration, for any coverage outside the Rol, which turns the courtroom into a narrow and demanding route, and a launch plan cannot be built on it.
The payer is treated as a single entity
Brazil has at least six budget owners, the SUS, health plan operators, vertically integrated groups, private hospitals, employers and patients, and each has its own decision makers, evidence standard, payment mechanism and cash cycle.
Six chapters, from the two health systems to a self-assessment your team can score in twenty minutes
Why payability, and why Brazil
The SUS and private health insurance side by side, who covers whom, who decides, who funds and how providers are paid, and the two facts in that table that matter more than they seem.
Four gates between permission and payment
ANVISA, CMED, Conitec and the ANS Rol: what each establishes, what it does not establish, and the legal timelines against the observed ones.
Six budgets, six payment logics
SUS, health plan operators, vertically integrated groups, private hospitals, employers and patients, with how money moves in each, what they need to see and a realistic time to first revenue.
Where technologies get stuck
Seven patterns that repeat across medicines, devices and digital health, each with its early warning sign and what to settle before launch, plus a note on digital health.
The five payability questions for Brazil
Who controls the budget, who keeps the value, through what mechanism the money moves, what proof that buyer needs, and when cash arrives and what can break the model.
Payability self-assessment
Ten statements scored from 0 to 2, with three result bands, most useful when the global and the local team score it separately and then compare.
Teams deciding whether, how and through whom a technology becomes revenue in Brazil
Get the white paper
Leave your name and work email and the paper arrives in your inbox, with nothing else asked.
- The four gates and what each one does and does not establish
- The six budget owners, with decision actors, money flow and time to first revenue
- The seven patterns where technologies get stuck, with early warning signs
- The five payability questions and the self-assessment, ready to score with your team
By subscribing you agree to receive this paper and occasional notes from corina on payability and market access in Brazil. No spam, unsubscribe at any time.
The paper gives the map. The Playbook gives the model.
This white paper is the first layer of a larger piece of work, the Brazil Payability Playbook, which details each payer, process and payment mechanism described here with public data on the private market: operator profiles, where coverage meets the most friction, which operators have the economic profile of a first buyer for each route, the legal clock against the observed one, and a route assessment tool. Its Founding Edition is planned for the end of 2026, and readers of the white paper hear about it first.
The Playbook gives you the model, the sources, the parameters and the decision logic. The Brazil Payability Assessment applies them to your asset, with Brazilian costs rebuilt from public data and a budget impact in reais, when a team has a defined product, a launch decision and numbers to produce.