Brazil’s Health Ministry has formally asked Conitec to evaluate semaglutide and liraglutide for public-system coverage, opening a process that could reshape the country’s obesity-drug market.
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MARKET ACCESS · PUBLIC FORMULARY ACCESS · SEPTEMBER 26, 2026 · BRAZIL
On 24 September 2026, Brazil’s Ministry of Health, the federal body overseeing the Sistema Único de Saúde (SUS), formally filed a request with the Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec), Brazil’s health-technology assessment body, to evaluate the incorporation of glucagon-like peptide-1 (GLP-1) receptor agonists — specifically semaglutide and liraglutide — into the public health system, according to a ministry announcement. The ministry-sponsored filing shifts the procedural posture from industry petition to government sponsorship.
The timing is not incidental. President Luiz Inácio Lula da Silva, a candidate for re-election in October 2026, announced in the week before the filing that the pens would be made available through the public health system, according to Olhar Digital. The ministry’s decision to file before the election suggests the political calendar may have accelerated a push that, according to the ministry, has involved coordination with the Agência Nacional de Vigilância Sanitária (Anvisa), Brazil’s health-products regulator, since 2025.
A Market Transformed by Patent Expiry and Competition
The regulatory environment has shifted materially since Conitec last ruled on this class. In August 2025, the body rejected Novo Nordisk’s bid to incorporate semaglutide (Wegovy) on budget-impact grounds; InfoMoney put the projected cost at R$3.7 billion over five years, while Bloomberg Línea reported an estimate of more than R$8 billion for broader incorporation.
Since then, semaglutide and liraglutide have lost patent protection in Brazil, according to the ministry, and the competitive landscape has changed substantially. The ministry’s September 24 filing states that prices fell 70% in less than one year as competition widened, according to the ministry announcement. As of the filing date, 25 GLP-1 pen products had received registration from Anvisa, including 14 approvals in 2026 alone — among them domestically produced versions and generics, per the ministry.
EMS, the Brazilian pharmaceutical company, is among the domestic producers now active in this space. Novo Nordisk, meanwhile, has a separate proposal before Conitec, reported in June 2026, to supply semaglutide (Wegovy) to patients with obesity who have already had a heart attack. The proposal offers a 59% discount, with suggested prices ranging from R$396.88 to R$764.64 per pen depending on dose, according to InfoMoney.
The Fiscal Arithmetic Remains Unresolved
The ministry’s current filing explicitly covers semaglutide and liraglutide as off-patent active ingredients rather than any branded product, and cites the World Health Organization’s (WHO) late-2025 guidelines recommending policies to expand access to GLP-1 therapies for long-term obesity management. The ministry also says it is conducting studies through the Grupo Hospitalar Conceição (GHC) in Porto Alegre; Olhar Digital reports that one tracks approximately 250 patients with an indication for bariatric surgery.
Once Conitec receives the request, the body has 180 days — extendable by a further 90 days — to issue a recommendation, which must then pass through a public consultation before the ministry issues a final decision. Even after a positive ruling, the ministry must formalise a clinical protocol and negotiate financing arrangements with state and municipal governments.
The cost question has not been resolved by the filing. Conitec’s 2025 rejection was grounded in budget impact for a broad eligible population. Novo Nordisk’s narrower proposal covers post-infarction patients only. The ministry’s new filing does not specify a target population size or a revised fiscal estimate, and Conitec is expected to conduct its own budget-impact modelling. The commission may propose a more restricted eligible group than either the ministry or Novo Nordisk has outlined.
The counterargument to an optimistic reading of the filing is structural. Conitec’s 2025 rejection was not primarily a clinical finding but a fiscal one. The 70% price decline cited by the ministry is attributed to increased market competition, but the ministry has not published the baseline or the methodology behind that figure, and Conitec will apply its own price benchmarks. A lower per-unit cost does not automatically translate into an acceptable aggregate budget impact if the eligible population is large.
What to Watch
- Conitec’s decision on whether to open a public consultation on the ministry’s filing, and the population criteria it proposes — expected within the 180-day statutory window from 24 September 2026
- Results of the GHC studies in Porto Alegre, which could inform eligibility criteria for any eventual incorporation
- State and municipal financing negotiations: any positive Conitec recommendation will require intergovernmental budget agreements before SUS patients receive treatment
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The ministry’s decision to anchor its request on off-patent molecules rather than on any branded product is the detail with the longest commercial tail. If Conitec approves incorporation on generic terms, the procurement mechanism will favour competitive tendering across the 25 registered products — a dynamic that structurally advantages domestic manufacturers and generic entrants over the originator, independent of any clinical ruling on Novo Nordisk’s separate branded proposal.
Market Context: GLP-1 Competitive Pressure in Brazil
25
GLP-1 pen products registered in Brazil as of September 2026, including 14 approved in 2026
70%
Price decline for GLP-1 pens in Brazil in less than one year
Conitec Review Parameters
Statutory review period: 180 days, extendable by 90 days. Novo Nordisk proposal (post-infarction patients): 59% discount on Wegovy; unit price range R$396.88 to R$764.64.
Sources: Ministry of Health announcement (2026-09-24); InfoMoney (2026-06-23).
Why this is relevant
Patients
Millions of Brazilians living with obesity currently have no medication option through the SUS, with bariatric surgery as the primary public-system alternative and long waiting lists. A positive Conitec ruling could open GLP-1 access, but any approval would still require protocol formalisation and intergovernmental financing before patients receive treatment.
Industry
The ministry’s filing targets off-patent semaglutide and liraglutide rather than any branded product, which suggests that SUS procurement, if approved, would proceed through competitive tendering across the 25 registered products. This structurally favours domestic manufacturers such as EMS and generic entrants over Novo Nordisk, whose separate branded Wegovy proposal follows a parallel Conitec track with its own timeline.
Payers
The SUS fiscal exposure remains undefined. Novo Nordisk’s proposal is limited to post-infarction patients, but Conitec’s own modelling may define a larger eligible population. The 2025 rejection was grounded in budget impact for a broader group; the ministry’s new filing does not publish a revised population size or budget figure, leaving the aggregate cost unresolved pending Conitec’s analysis.
Caregivers
Caregivers of people with severe obesity on SUS bariatric surgery waiting lists face an indeterminate additional wait even if Conitec rules favourably, as the ministry must still formalise clinical protocols and negotiate state and municipal co-financing before any dispensing begins.
Sources: Agência Gov (Ministério da Saúde) · Olhar Digital · InfoMoney · Bloomberg Línea
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