Despite the obligation to provide CAR-T therapies imposed by the Health Insurance Plans Law, health insurance providers continue to deny coverage.

1- INTRODUCTION

The judicialization of healthcare has been growing in Brazil, both in the public and private (supplementary) healthcare sectors.

In supplementary healthcare, judicialization plays an important role due to the frequent denial of coverage for certain therapies or treatments by health insurance providers. Particularly in the oncology field, this is even more evident with the emergence of advanced therapies such as CAR-T (Chimeric Antigen Receptor T-cell therapy).

Coverage denials have become so common that patients are left with no alternative but to resort to the Judiciary Branch, which has been duly guided by the provisions of Law # 9,656, of June 3, 1998 (“Health Insurance Plans Law”), to ensure access to the prescribed treatment.

2- CAR-T THERAPY: AN INNOVATIVE, NON-INVESTIGATIONAL TREATMENT

CAR-T therapy represents an innovative approach to cancer treatment. It involves the genetic modification of the patient’s own T-cells — which play a key role in immune defense —, so that they begin to recognize and attack tumor cells.

CAR-T therapies are the result of more than 60 years of research and progress in immunotherapy and biotechnology. In Brazil, several CAR-T therapies, which are classified by the Brazilian FDA (Anvisa) as a special category of novel drugs[1], have already undergone a rigorous approval and registration process[2] former to its launch and availability in the Brazilian market.

It is well known that investigational drugs are those that may only be supplied to patients under certain conditions, which include participation in clinical trials prior to registration with Anvisa, or through specific programs such as compassionate use or expanded access. These restrictions aim to ensure safe access to promising treatments still under development.

Therefore, the fact that CAR-T therapies (already registered with Anvisa) are the result of research and technological development should not be confused with an investigational nature.

3- AN OBLIGATION OF HEALTH INSURANCE PROVIDERS

Although many advanced therapies have been approved by Anvisa for years in Brazil, health insurance providers continue to deny coverage, arguing that such drugs are (i) investigational, (ii) high-cost, or (iii) not listed in the Brazilian National Supplementary Health Agency’s (ANS ) mandatory coverage list.

As mentioned above, the first argument is invalidated by the fact that these therapies are registered with Anvisa. The second argument - high cost - is not itself sufficient to justify denial of coverage. This is because the economic premise of health insurance is precisely to distribute risks among a pool of beneficiaries, making high-cost treatments accessible to individuals who have a medical prescription and contractual coverage.

Regarding the third point, in 2023, ANS issued Technical Note No. 03/2023/GCITS/GGRAS/DIRAD-DIPRO/DIPRO, stating that advanced therapy products would not fall under the concept of “medication” in article 12, II, “d” of the Health Insurance Plans Law or article 8, III, of ANS Normative Resolution # 465/2021.

Therefore, according to ANS — a position widely criticized for contradicting Anvisa’s rules, according to which these products classify as special medicine already approved and registered in Brazil —, the inclusion of advanced therapies in the mandatory coverage list would require a separate evaluation process within the ANS.

For health insurance plans that include coverage for hospital care, article 12, II, “d”[3], of the Law mandates coverage of medications administered during hospitalization as prescribed by the attending physician.

This provision is reinforced by article 8, III[4], of ANS Normative Resolution # 465/2021, which establishes the insurer’s obligation to cover medications registered with Anvisa, even if not explicitly listed in the coverage list, when they are: (i) used in procedures with mandatory coverage (for plans without hospital care[GM1] [SA2]) or (ii) administered during hospitalization (for plans that include hospital care), which is the case for advanced therapies.

Furthermore, the Health Insurance Plans Law clearly intends to provide broad coverage for antineoplastic (oncological) treatments. The Law mandates the coverage of such treatments as a minimum requirement for both outpatient (art. 12, I, “c”[5]) and hospital plans (art. 12, II, “g”[6]).

These are not the only legal grounds supporting the obligation to cover CAR-T therapies. With the legislative amendment introduced by Law # 14,454/2022, paragraph 13 was added to article 10 of Law # 9,656/1998, which expressly obliges health insurers to cover procedures or treatments not listed as mandatory by the ANS list, whenever prescribed by a physician and meeting the following criteria: (i) proven efficacy based on scientific evidence and a therapeutic plan, or (ii) recommendation by the National Commission for the Incorporation of Technologies to the Unified Health System (Conitec) or by a renowned international body, provided that the recommendation is also valid for their own citizens.

In this context, ANS’ interpretation that advanced therapies would need to undergo a special process to be included in the coverage list unlawfully restricts a legal guarantee of access, harming beneficiaries entitled to the treatment — a situation made even worse when it comes to antineoplastic advanced therapies, given the dual legal basis ensuring their coverage.

4- JUDICIAL REVIEW BASED ON LEGALITY

An analysis of legal cases involving CAR-T therapy shows that the Judiciary Branch has been acting in a technical and careful manner, ensuring the effectiveness of the right to health whenever objective requirements are met, which prevents arbitrary decisions and reinforces the technical nature of judicial interventions.

In decisions ordering health insurers to provide the advanced therapy, courts consider the existence of a valid registration with Anvisa for the therapy, which dismisses any claim of investigational status and confirms its regular approval for the Brazilian market.

The Judiciary also requires a medical prescription and a clinical report attesting to the suitability of the therapy for the individual case, especially when no effective alternative exists — which is often the case for rare or treatment-resistant conditions. This shows the Judiciary’s diligence in ensuring that such orders are only issued in justified cases[7].

Additionally, the Technical Support Units of the Judiciary (NatJus) have issued favorable opinions regarding CAR-T therapy in many cases, highlighting its proven efficacy supported by scientific evidence[8].

Another factor considered by the courts is the approval of CAR-T therapy by other regulatory agencies, such as the U.S.’ FDA, which approved the first CAR-T therapy after decades of research showing positive results[9].

Finally, Brazilian courts also recognize that denial of coverage by insurers for drugs registered with Anvisa — when no therapeutic alternatives are available — constitutes a contract breach and places the consumer at a severe disadvantage, in violation of the Consumer Protection Code[10].

All these judicial criteria demonstrate that favorable decisions for the supply of CAR-T therapies are not arbitrary, but rather a direct result of legal, technical, and constitutional analysis — particularly the fundamental rights to life and health.

5- CONCLUSION

As demonstrated, considering the provisions of Law # 14,454/2022 — especially the clear legislative intent to ensure broad coverage for antineoplastic/oncological treatments (art. 12, I, “c” and II, “g”) — and article 12, II, “d”, which mandates coverage of medications administered during hospitalization, health insurers are legally obligated to provide registered CAR-T therapies prescribed by physicians, regardless of whether they are specifically included in the ANS mandatory coverage list.

Far from being merely voluntarist or subjective decisions, the Judiciary Branch has issued increasingly technical and responsible rulings, ensuring more effective healthcare for citizens and greater predictability for insurers.

Thus, insurers must acknowledge that CAR-T therapies are here to stay, and it is not their prerogative to decide whether or not to provide coverage when such an obligation arises directly of the Health Insurance Plans Law.

[1] Pursuant to item XVIII of article 4 of Anvisa’s Collegiate Board Resolution No. 505, of May 27, 2021 (“RDC No. 505/2021”).

[2] CAR-T therapies registered with ANVISA: Yescarta (registration No. 109290013); Kymriah (registration No. 100681180); Tecartus (registration No. 109290014).

[3] Art. 12. The offering, contracting, and validity of the products referred to in item I and §1 of art. 1 of this Law are permitted within the coverage segments set forth in items I to IV of this article, subject to the respective coverage scopes defined in the reference plan mentioned in art. 10, and in accordance with the following minimum requirements:

 II - when hospital admission is included:

[...]

 d) coverage of essential complementary tests for monitoring disease progression and diagnostic clarification, provision of medications, anesthetics, medical gases, blood transfusions, chemotherapy and radiotherapy sessions, as prescribed by the attending physician, carried out or administered during the period of hospitalization.

[4] Art. 8. In the procedures and events provided for in this Normative Resolution and its Annexes, if there is an indication from the attending professional, in accordance with article 6, §1, and respecting the criteria for accreditation, referral, reimbursement, or any type of relationship between the operator and healthcare service providers, coverage is guaranteed for:

(...)

III – fees, materials, contrast agents, medications, and other supplies necessary for their performance, provided that they are regularized and/or registered and that their indications are included in the leaflet/manual before ANVISA or made available by the manufacturer.

[5] Art. 12. [...]

I - when outpatient care is included:

[...]

c) coverage of home-based oral antineoplastic treatments, including medications for controlling adverse effects related to the treatment and adjuvants;

[6] Art. 12. [...]

II - when hospital admission is included:

[...]

g) coverage for outpatient and home-based oral antineoplastic treatments, radiotherapy procedures for cancer treatment, and hemotherapy, as procedures whose necessity is related to the continuity of care provided during the hospital stay;

[7] Court of Justice of the State of São Paulo; Civil Appeal No. 1169606-97.2023.8.26.0100; Reporting Judge: Schmitt Corrêa; Judging Panel: 3rd Chamber of Private Law; Central Civil Forum - 8th Civil Court; Date of Judgment: 09/03/2024; Date of Record: 09/03/2024

[8] Court of Justice of the State of São Paulo; Civil Appeal No. 1061341-64.2024.8.26.0100; Reporting Judge: Domingos de Siqueira Frascino; Judging Panel: Justice Center 4.0 at Second Instance – Panel IV (Private Law 1); Central Civil Forum - 43rd Civil Court; Date of Judgment: 03/28/2025; Date of Record: 03/28/2025

[9] Court of Justice of the State of São Paulo; Civil Appeal No. 1035146-28.2013.8.26.0100; Reporting Judge: João Batista Vilhena; Judging Panel: 5th Chamber of Private Law; Central Civil Forum - 27th Civil Court; Date of Judgment: 05/22/2024; Date of Record: 07/26/2024

[10] Art. 51. The following contractual clauses related to the supply of products and services are null and void, among others:

 (...)

 IV – those that establish obligations considered unfair, abusive, that place the consumer at an excessive disadvantage, or that are incompatible with good faith or equity;

 (...)

§ 1º An excessive advantage is presumed, among other cases, when it:

 (...)

 II – restricts fundamental rights or obligations inherent to the nature of the contract, in such a way as to threaten its purpose or contractual balance;

 [GM1]Acho q n entendi aqui a tradução.

 [SA2]Eu pesquisei como se diz plano ambulatorial nos EUA e encontrei esse termo. É estranho, mas parece que é o termo correto:https://www.medicare.gov/coverage/outpatient-hospital-services