Market access, Brazil

ANVISA approval won't get you paid in Brazil. Neither will the ANS list.

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Natália Martinez · October 2026

In Brazil, the distance between permission to sell and cash collection is wider, slower and far less visible from abroad.

Adrijana Daragon wrote this week about why FDA approval does not mean a MedTech company will get paid, and about the variable she calls payability: whether a real buyer can purchase, reimburse or fund your technology under the budget rules it actually lives by.

Her piece is about the United States, but I kept reading it as a description of Brazil. Here, the distance between permission to sell and cash collection is wider, slower and far less visible from abroad.

I have spent fifteen years on the payer and access side of this market, in a cancer hospital, a health plan operator and pharma. The pattern I see most often is not a bad product or a weak dossier. It is a team that treats one regulatory or coverage decision as if it had settled the question of who pays.

This is not only a problem with global teams looking at Brazil from headquarters. I have watched local teams inside large pharmaceutical companies plan launches on the same assumption.

Permission, coverage and payment are different events

A health technology entering Brazil may encounter several institutional gates. None of them, by itself, is a payment.

ANVISA registration authorizes the commercialization of the product. It does not guarantee coverage, procurement, utilization or a sustainable price.

For medicines, CMED defines maximum regulated prices. A price ceiling is not a negotiated price, a purchase order or a guarantee that any buyer has made room for the product in its budget. CMED's regulated prices are ceilings, including the applicable maximum prices for government purchases; they do not establish demand.

Conitec can recommend the incorporation of a technology into the SUS, after which implementation still depends on the Ministry of Health's decision, clinical protocols, financing rules, coding, procurement and local execution. A SIGTAP value may support the financing of a procedure, but it is not a guaranteed purchase price for the technology or a promise that every hospital will acquire it.

In the private market, inclusion in the ANS Rol creates a mandatory coverage obligation for eligible plans and procedures, subject to the applicable contract, segmentation and utilization criteria. Brazil had more than 53 million beneficiaries in private medical plans in June 2026.

But inclusion in the Rol does not set the provider reimbursement rate, guarantee a price for the technology or determine the commercial terms under which the procedure will be delivered. A DUT may narrow the eligible population, and the procedure may still be subject to authorization, network rules, contracting and claims management.

For implantable devices, procurement adds another layer of competition. Physicians generally cannot require an exclusive brand. When a supplied material is considered inadequate or deficient, the rules allow the indication of at least three brands from different manufacturers, when available and properly regularized. A device that earned its place through strong evidence can therefore face a commercial comparison with alternatives as soon as it reaches the operating room.

Being outside the Rol is not necessarily the end of the road. Operators may cover technologies outside the list through contracts, clinical policies or direct arrangements with providers. A significant part of the MedTech and digital health market is built this way: not through a universal coverage decision, but through a buyer deciding that the technology improves outcomes, reduces cost or solves an operational problem.

Litigation is not a substitute for a market-access strategy either. In private health insurance, the Supreme Court's September 2025 decision established five cumulative criteria for court-ordered coverage of treatments outside the ANS list, including prescription, the absence of an applicable ANS rejection or pending analysis, no adequate alternative in the Rol, evidence of efficacy and safety, and ANVISA registration.

Who controls the budget?

The useful question is not only which approval you hold. It is whose budget the money comes out of, and who controls the decision between clinical value and financial liability.

The person who uses the technology is often not the person who authorizes it, buys it or pays for it.

• The SUS decides through health technology assessment, public policy and budgetary structures. A successful case needs more than clinical benefit; it must also survive questions about comparative value, budget impact, implementation and financing.
• The health plan operator pays claims and manages medical costs across its covered population. Evidence becomes commercially relevant when it translates into lower avoidable cost, fewer complications, reduced utilization or better performance in the operator's own network.
• The vertically integrated operator owns both the insurance relationship and parts of the delivery system. A technology that reduces length of stay, improves capacity or changes the cost of care may be valued differently when the buyer and provider sit on the same balance sheet.
• The private hospital absorbs the cost of products that cannot be billed separately or that sit inside a bundle, per-diem payment or negotiated package. Adoption depends on whether the technology creates enough clinical or operational value inside that payment model.
• The employer is an important economic stakeholder because employer-sponsored contracts account for most beneficiaries in Brazil's private medical insurance market. The employer may not be the contracting party, but it feels the effect of claims, premium increases, absenteeism and workforce health.
• The patient remains an out-of-pocket buyer, but Brazil's income distribution sharply limits the addressable market for high-cost technologies.

The market is therefore not divided simply between "public" and "private." It is divided among budgets, incentives and decision rights.

The five questions, rewritten for Brazil

Whose budget?

Not "the payer," but a named operator, hospital, procurement team, clinical engineering department, state health department, employer or patient segment.

Through what mechanism?

A SUS financing and procedure structure, a TUSS-linked negotiated price, a bundled payment, a direct contract with an operator, a hospital procurement process or a corporate health program.

What proof, measured where?

Foreign evidence is necessary but rarely sufficient. Buyers want to know what the technology does to their population, workflow, network and cost structure, in reais.

When does money arrive?

The formal regulatory or coverage decision is only one milestone. The operational path from decision to code, contract, authorization, utilization, claim, payment and cash collection can take much longer. The gap between registration and recurring revenue should be planned in years, not quarters.

What breaks the model?

A DUT that excludes most eligible patients. A procedure value below the provider's cost. A procurement process that favors an incumbent. A brand-substitution requirement. Prior authorization. Claim denials. A lack of local evidence. Or a budget that was already committed before you arrived.

The real definition of access

Access in Brazil is not a single event. It is a chain:

A product can succeed at one step and fail at the next.

ANVISA tells you that you are allowed to sell. Conitec or the ANS Rol may create a path to public or private coverage. A contract may create a buyer. But only utilization, an accepted claim and cash collection prove that the market can pay.

That is the difference between being present in Brazil and being payable in Brazil.