São Paulo Court Orders SulAmérica to Cover Off-Label Chemotherapy
Judges uphold R$ 10,000 moral damages award, tightening limits on insurers’ reliance on label restrictions.
By Brazil Stock Guide – The Tribunal de Justiça de São Paulo — São Paulo state’s appellate court and the largest in Brazil — upheld a ruling ordering SulAmérica to fund an off-label chemotherapy treatment for a cancer patient and to pay R$ 10,000 in moral damages. The case involved the prescription of gemcitabine for an indication not expressly listed on the drug’s approved label.
Gemcitabine, originally marketed as Gemzar by Eli Lilly and now widely available as a generic in Brazil, is a standard chemotherapy agent used in multiple cancer protocols. SulAmérica denied coverage, arguing the prescribed use was not included in the label approved by Brazil’s health regulator, the Agência Nacional de Vigilância Sanitária (Anvisa), and therefore qualified as experimental treatment excluded under the contract.
Reporting Justice Regina Aparecida Caro Gonçalves said precedent from the Superior Tribunal de Justiça bars insurers from denying coverage of drugs registered with Anvisa when prescribed by a licensed physician, even if used outside label specifications. The court noted the treatment was supported by internationally recognized clinical guidelines, including NCCN, ESMO and ASCO.
The ruling reflects three strands of Brazil’s evolving health law framework: established STJ case law protecting medically justified prescriptions; a flexible interpretation of the mandatory coverage list issued by Brazil’s private health insurance regulator, the Agência Nacional de Saúde Suplementar (ANS), particularly after Law 14,454/22; and a judicial distinction between experimental therapies and off-label use grounded in recognized scientific evidence.
The unanimous decision highlights growing judicial scrutiny in Brazil’s private health insurance market. In oncology, where off-label prescribing is common practice, strict reliance on label wording or regulatory lists is increasingly proving insufficient in court.