Kareem Abdul-Jabbar and chronic myeloid leukemia: must the health plan and the SUS repeat the BCR-ABL PCR?

By Ramon Martins Andrade, attorney (OAB/RJ 188.374)

English translation of an article first published in Portuguese: read the original.

On 10 November 2009, in an interview with ABC News’ Good Morning America, Kareem Abdul-Jabbar said that he had been diagnosed in December of the previous year with Philadelphia chromosome-positive chronic myeloid leukemia and summed up what he had learned: “If I can do this as I’m told to do it, I can manage this”. The report records that he was, at that time, a spokesman for a pharmaceutical company. The account does not say which drug he took or what his tests were, and nothing is said here about his doctors. What he describes, however, holds for any patient: in CML, “doing as you are told” means taking the medication every day and repeating, for years, a blood test that measures the disease at the molecular level.

That test, the quantitative BCR-ABL PCR, is not an accessory to the treatment: it is the instrument by which the treatment is steered. It is its result that says whether the drug is working, whether it is time to switch it and, for a proportion of patients, whether it is possible to try stopping. To deny the repeat test is to deny the care, even if the tablet keeps being delivered. The article examines what science has measured, what the SUS (Brazil’s public health system) and health plans owe in Brazil, how three countries have resolved the question, and what to do when the answer is that the test “was already done at diagnosis”.

From fatal disease to chronic disease: what science has measured

The Clinical Protocol and Therapeutic Guidelines (PCDT) for adult CML, approved by Joint Ordinance No. 4 of 1 March 2021, explains the origin of the disease: the exchange of material between chromosomes 9 and 22 fuses the BCR gene to the ABL1 gene, and that fusion gene “results in the expression of a protein, a tyrosine kinase, with a central role in the pathogenesis of CML”. Tyrosine kinase inhibitors block that protein. The blood count counts cells; the PCR measures the quantity of fusion-gene transcripts in the blood, which is why a normal blood count and a good molecular response are not the same thing.

The scale of the change is in the IRIS study, which compared imatinib with the previous treatment in newly diagnosed patients in the chronic phase. With a median follow-up of 10.9 years, estimated ten-year overall survival in the imatinib group was 83.3%, and prolonged administration was not associated with unacceptable late toxicity (Hochhaus and colleagues, New England Journal of Medicine, 2017). In Sweden, among the 2,662 patients registered between 1973 and 2013, those diagnosed in 2013 would lose, on average, less than three years of life because of the disease, and the life expectancy of these patients “is approaching that of the general population” (Bower and colleagues, Journal of Clinical Oncology, 2016). The 2026 review of the 25 years of this therapy adds the condition that matters: life expectancy came close to that of the general population “for patients who respond to treatment” (Hochhaus and colleagues, Leukemia, 2026). Knowing who responds is the task of the PCR.

In October 2005, experts gathered at the National Institutes of Health in the United States recorded that real-time quantitative PCR “provides an accurate measure of the total leukemic cell mass”, that the fall in transcripts correlates with progression-free survival and that “a rising level of BCR-ABL is an early indication of loss of response and therefore of the need to reassess therapeutic strategy” (Hughes and colleagues, Blood, 2006). The group proposed that each laboratory convert its result to an internationally agreed scale and recommended following the patient by serial PCR rather than by repeated bone marrow examinations. Hence the International Scale (IS), on which 0.1% corresponds to major molecular response in any standardized laboratory; a report without the scale loses part of its clinical value.

The PCR also opened up the possibility of stopping the drug. In the European EURO-SKI study, at 61 centers in 11 countries, 758 patients who had been taking the inhibitor for at least three years and had had a confirmed deep molecular response for at least one year suspended treatment; molecular relapse-free survival was 61% at six months and 50% at 24 months, the estimated savings were 22 million euros, and the authors concluded that these patients “should be considered” for discontinuation (Saussele and colleagues, Lancet Oncology, 2018). Relapse was defined by loss of major molecular response, that is, by a PCR result: the test is the condition both for continuing and for stopping.

The rhythm of the test in the guidelines

The Brazilian protocol separates two uses of the test. At diagnosis, it provides for bone marrow karyotyping or qualitative PCR to define the transcript type. During treatment, quantitative PCR, with the result expressed on the International Scale. The response is read at milestones: at 3, 6 and 12 months, Table 2 classifies the result as optimal response, warning or treatment failure, and at 12 months the optimal response is BCR-ABL equal to or below 0.1%, the major molecular response. Loss of that response must be confirmed “in two consecutive tests, one of which ≥ 1%”. Table 10 sets the rhythm: “quantitative PCR every 3 months until MMR, thereafter every 3 to 6 months in PB”, that is, in peripheral blood, and the same chapter says that “treatment must be maintained as long as no failure, progression or grade 3 or 4 toxicity is observed, in the respective lines of therapy”. It is the PCR that says whether there has been failure; without the series, the decision to keep or switch the drug is left without its basis.

The international reference is more demanding. The 2020 recommendations of the European LeukemiaNet (Hochhaus and colleagues, Leukemia, 2020) say that quantitative PCR in blood, on the International Scale, should be performed “at least every 3 months even after an MMR is achieved and confirmed”, in order to assess later on who may try to discontinue treatment. In the SUS, the binding interval is that of the protocol in force, and the protocol is under review: at the 152nd meeting of Conitec (the national health-technology assessment committee), on 12 June 2026, the committee resolved to submit the proposed update to public consultation, as a consequence of the incorporation of asciminib, and the preliminary version rewrites the monitoring intervals. A preliminary document does not replace the ordinance in force; it is worth checking with Conitec whether the new version has already been published.

In the SUS: the test is in the protocol, but not in the payment table

Conitec’s preliminary report records, in the history of the protocol, that the 2021 version included qualitative and quantitative polymerase chain reaction “for the diagnosis and monitoring of Chronic Myeloid Leukemia (CML)”, on the basis of Recommendation Report No. 475/2019 and Ordinance SCTIE/MS No. 57/2019. The ordinance that approved the protocol says that it “is national in scope and must be used by the State, Federal District and Municipal Health Secretariats in regulating access to care, authorization, registration and reimbursement of the corresponding procedures” (art. 1, sole paragraph), and that health managers “must structure the care network, define the reference services and establish the workflows for the care of individuals with this disease at all the stages described in the Annex to this Ordinance” (art. 3). Monitoring is one of those stages.

The problem lies in the funding. A panel of experts from Hemorio, the National Cancer Institute, the Hospital das Clínicas of the University of São Paulo and the Brazilian Lymphoma and Leukemia Association (Abrale), among others, recorded that, in 2017, 12,531 patients had an Outpatient Procedure Authorization (APAC) approved for the treatment of CML and that, although the test was in the protocol, it was not possible to monitor molecular response in the SUS because there was no reimbursement for it; the recommendation was to create in SIGTAP, the SUS procedure table, a code with an adequate name and value, since the existing APAC does not cover the costs of the test (Boquimpani and colleagues, Hematology, Transfusion and Cell Therapy, 2021). In December 2025, after a public hearing at the Health Committee of the Chamber of Deputies on 27 August of that year, Abrale published a technical note stating that the procedure provided for in the SUS Table “covers only the qualitative test, and does not ensure adequate funding of the quantitative test”, with the effect of regional inequality: São Paulo accounted for 35.1% of the tests performed in the period analyzed, and there are states with no production of this type of test by the SUS at all.

The payment gap is a problem between health managers, not the patient’s. Lei 8.080/1990 (the Organic Health Law) guarantees comprehensiveness of care, “understood as an articulated and continuous set of actions and services” (art. 7, II), and art. 3 of the ordinance places on the health manager the duty to organize where the sample is collected, who processes it and how the report gets back to the hematologist. When the test is delayed beyond the protocol’s interval, the right question, in writing, is what the workflow is and who is responsible for it; the answer, or the silence, is what is later taken to the Public Defender’s Office or to the courts. The logic of demanding from the SUS what is in the protocol, and of arguing the case when the patient does not fit it, is set out in the article on the drug that exists in the SUS outside the protocol (in Portuguese).

In the health plan: the oral antineoplastic is mandatory, and so is the test that governs it

Lei 12.880/2013 inserted into art. 12 of Lei 9.656/1998 (the Health Plans Act) the “coverage of oral antineoplastic treatments for home use, including medicines for the control of adverse effects related to the treatment and adjuvants” (item I, sub-item “c”, in the outpatient plan), and carved that case out of the general exclusion of medicines for home use (art. 10, VI). Lei 14.307/2022 reinforced the rule: this coverage “is mandatory, in accordance with the medical prescription”, provided the medicine is registered with Anvisa (the Brazilian health regulator) with approved use for the purpose (art. 10, § 6), and requests to include new oral antineoplastics in the ANS list of mandatory coverage (the “rol”) must be examined “on a priority basis”, within 120 days, extendable by 60 (art. 10, § 8). Denial of the inhibitor itself is dealt with in the article on Glivec (imatinib) (in Portuguese).

The test follows the same path. In Annex I of the ANS list (RN 465/2021, consolidated up to RN 678/2026), the procedure appears as “BCR/ABL, TRANSLOCATION TESTING”, in the molecular genetics subgroup, for the outpatient, hospital with and without obstetrics, and reference segments, marked as high-complexity and with no utilization guideline. Lei 9.656/1998 guarantees, in the outpatient plan, “coverage of diagnostic support and treatment services and other outpatient procedures requested by the treating physician” (art. 12, I, “b”), and RN 465/2021 says that the listed procedures “shall be mandatorily covered once requested by: I – the treating physician” (art. 6, § 1). The firm’s reading is that the entry, with no guideline, does not make coverage conditional on the purpose or on the number of tests: the health-plan operator that authorizes the test at diagnosis and refuses the repeat test during follow-up creates a restriction that the list does not write. If the operator argues that serial quantification is a different procedure, outside the list, the discussion moves to art. 10, § 13, of the same law, which the STF (Supreme Federal Court), in ADI 7.265 (18 September 2025), made subject to cumulative requirements, among them the treating physician’s prescription, the absence of an alternative in the list, and scientific proof of efficacy and safety, which for PCR in CML is solid. The reasoning is that of the article on the test that proves the patient needs the drug (in Portuguese).

There are also deadlines. Under RN 623/2024, the operator must answer a request for a high-complexity procedure within 10 working days (art. 12) and must put the denial in writing and deliver it to the requester (art. 14). It helps to have the written request worded as “quantitative BCR-ABL1, International Scale, for monitoring of CML under treatment”, with the date therapy began and the previous results.

When the health plan does not owe the test

Not every contract covers outpatient follow-up. In the hospital-only plan, the law guarantees complementary tests “performed or administered during the period of hospital admission” (art. 12, II, “d”); the routine PCR, done outside an admission, does not come in by that route. And RN 465/2021 identifies high-complexity procedures as those “which may be subject to temporary partial coverage – CPT in cases of pre-existing diseases and injuries – DLP” (art. 1, § 1): anyone who took out the plan already knowing of the CML and accepted temporary partial coverage may find the test outside coverage during that period. In those cases, the answer runs through the SUS.

Comparative law: three ways of paying for what the guideline requires

Three countries show different ways of guaranteeing the treatment of CML and the test that accompanies it: a statutory deadline, a payment code and a parity rule.

1. England: statutory deadline for the drug, value measured by molecular response

In technology appraisal TA426, of 21 December 2016, NICE recommended imatinib for untreated chronic-phase Philadelphia-positive CML, and dasatinib and nilotinib only with the discounts agreed with the manufacturers. The committee weighed the benefit by major molecular response at 12 months, the outcome that the PCR measures, more frequent with the second-generation inhibitors than with standard-dose imatinib. And the recommendation has the force of law: the 2013 regulations require NHS England and commissioning bodies to comply with it “within 3 months” of publication.

2. France: follow-up written into the payment table

France did what the Brazilian experts asked for SIGTAP. By decision of the National Union of Health Insurance Funds of 5 March 2021, published in the Journal officiel of 1 April 2021, the nomenclature of biology procedures gained code 1035, “Recherche ou quantification du transcrit BCR-ABL”, covered at diagnosis and during follow-up of CML and of acute lymphoblastic leukemia, with qualitative PCR at diagnosis and quantitative PCR “à l’initiation du traitement et au suivi du traitement”. The decision does not set a frequency, which is left to clinical judgment: follow-up gained its own code and price.

3. United States: parity for the oral drug, with no guarantee of the outcome

In the United States, with no universal system, the answer came from the states: 43 of them and the District of Columbia passed parity laws requiring fully insured commercial plans to give the oral antineoplastic coverage and cost-sharing equivalent to those of intravenous chemotherapy; employer self-funded plans fall outside them. A study of CML patients starting a tyrosine kinase inhibitor found no association between these laws and a reduction in out-of-pocket spending or an improvement in adherence to treatment (Spargo and colleagues, Journal of Managed Care & Specialty Pharmacy, 2021). Guaranteeing the drug on paper does not guarantee the treatment.

Brazil has a little of each model: since 2013, a coverage rule for the oral antineoplastic that is broader than American parity, and a protocol that writes down the interval for the test. What is missing, according to the experts and Abrale, is the French step: a payment code of its own for follow-up in the SUS.

When the test is missing, the care is missing: duties and liability

The Code of Medical Ethics forbids the physician “to fail to use all available means of health promotion and of prevention, diagnosis and treatment of disease, scientifically recognized and within their reach” (art. 32), and, in CML, serial PCR is one of those means. The Patients’ Rights Statute, Lei 15.378/2026, guarantees timely care (art. 8), information that is “accessible, up to date and sufficient” to decide (art. 12, § 1) and access to the medical record without having to give reasons, with a copy free of charge (art. 19); in the SUS, Lei 13.460/2017 (art. 6, III) ensures access to information about oneself. These are the tools with which the series of reports is assembled and the interval without a test is proved.

The liability of the operator, the hospital or the laboratory is strict as regards the services that are their own (Consumer Protection Code, art. 14), and the analysis of the coverage request is a service of the operator’s own; where the defect lies in the physician’s act, proof of the physician’s fault is required (art. 14, § 4). The typical harm, in CML, is the loss of response not seen in time: the switch of medication that is delayed. The Superior Court of Justice (STJ) admits compensation for loss of a chance in medical error; the reference precedent is REsp 1.254.141/PR (Third Panel, Justice Nancy Andrighi reporting, decided on 4 December 2012), a case of inadequate treatment of breast cancer, not of a missing test, whose headnote sets the limit that applies to all: “The chance, however, can never reach the value of the lost good”. Whether there was a lost chance, and how much, is a matter for expert evidence, comparing the series of reports with what the protocol required at each moment.

Before deciding

In my view, the refusal of the follow-up PCR, by the operator or through delay in the SUS, is the denial of part of the treatment: the drug delivered without the test that says whether it is working does not fulfil what the law and the protocol promise. The qualitative PCR at diagnosis does not stand in for the quantitative PCR during follow-up, and the entry in the list does not separate the first sample from the ones that follow. Reading each result is for the hematologist: no isolated number authorizes stopping or switching the drug on one’s own, and discontinuation is done only under medical supervision. Keeping the reports with date, laboratory and scale, the medical request and every answer from the operator or the health unit turns a delay into a demonstrable fact. The overview of what the health plan owes in each kind of denial is in the guide to coverage denials (in Portuguese). If the follow-up test has been denied, or has stalled beyond the indicated interval, get in touch with the firm with the medical request, the contract and the answer received.

About the author

Ramon Martins Andrade (OAB/RJ 188.374) is a lawyer who graduated from UFRJ in 2011, with master’s degrees from Université Sorbonne Nouvelle and from the Naval War College (EGN, Brazilian Navy). He is currently a researcher in Human Rights and Health at ENSP/Fiocruz.

This content is for information and education only. It does not constitute legal advice, advertising of results or any guarantee of outcome, under Rule 205/2021 of the Brazilian Bar Association (OAB).