Drug for advanced breast cancer is delayed in SUS – 07/18/2023 – Health

For 20 years, the therapies available at SUS for the treatment of metastatic breast cancer have been the same, which makes it difficult to access innovative drugs with reduced side effects.

Recently, a new class of drugs was approved by Conitec, the committee responsible for defining the list of treatments included in the SUS. However, 600 days after the recommendation, the Ministry of Health has not yet defined how the therapy will be incorporated and distributed to hospitals and public health services in the country. In general, the deadline for making this assessment is 180 days after the committee’s approval.

Breakthrough therapies are a class of drugs known as CDK inhibitors, or cyclin inhibitors. They act directly on HR+/HER2- type breast tumors. In global studies, they have progressively improved patients’ quality of life and increased progression-free survival time.

There are three drugs included in this class: palbociclib, by Pfizer, abemaciclib, by Eli Lily, and ribociclib —the latter, by the pharmaceutical company Novartis, had the results of a global study presented at the congress of the American Society of Clinical Oncology (ASCO, in English) in May, with a reduction of up to 25% in tumor recurrence.

Drugs were incorporated into the ANS (National Supplementary Health Agency) list in April 2021. Since then, beneficiaries of healthcare plans have been able to get therapies directly through the agreement. Patients who depend on SUS, however, still do not have access or have to pay out of pocket. The cost of treatment, which is monthly, can reach R$ 21,000 for a box of 21 pills.

“From the cost-effectiveness evaluation point of view, this has already been done, now would be the government negotiation and distribution planning phase, and we are completely in the dark”, says Luciana Holtz, president-founder of the Oncoguia Institute.

“We don’t think it’s a silver bullet, but these therapies are an alternative for patients. The financing problem is chronic, it’s not new, but it would be important for the recommendation to be linked to a funding source”, evaluates Laura Testa, oncologist at Hospital São Luiz da Rede D’Or and head of the Breast Group at Icesp (Cancer Institute of the State of São Paulo).

The therapies, already approved in countries such as the USA, Europe, the United Kingdom, Canada and Australia, in addition to Brazil, are highly effective with increased patient survival of up to ten months compared to traditional treatment (hormone therapy alone).

Of the total number of cases of breast cancer in the country, HR+/HER2- tumors represent 65% to 70%, explains the director of the mastology center at Hospital da Mulher, André Mattar.

The lack of access to innovative therapies increases inequalities in the treatment of this, which is one of the most aggressive types of cancer, evaluates the doctor. “Brazil is the only country that approves but does not make it available. All other countries, as soon as the regulatory bodies approved it, made it available immediately”, says the doctor.

In general, the survival of a woman who is diagnosed with breast cancer in an advanced stage (with metastasis) is five years. As reported by the Sheetthe delay in diagnosis in recent years in the country has led to an increase in late-discovered tumors.

“When you compare a patient with insurance and the SUS, the private system has a longer survival compared to that of the public service. And as they are advanced stage tumors, this further increases the inequalities of access to cancer treatment in the country” , adds Mattar.

In a note sent to the report, the Ministry of Health said that Conitec evaluated, in 2021, the efficacy, safety, cost-effectiveness and budgetary impact of abemaciclib, palbociclib and ribociclib succinate for the treatment of advanced breast cancer and that, to make this incorporation effective, it is necessary to create new procedures in the SUS Table of Procedures, Medications and Orthotics, Prostheses and Special Materials (SIGTAP). “As soon as the process is completed, said procedures will be available for launch by providers and reimbursement via APAC [Autorização de Procedimentos Ambulatoriais].”

One of the main effects of an advanced breast tumor is to reach other organs such as bones, lungs and liver, which can have a significant impact on quality of life and pain. Therapy with cyclin inhibitors reduces these effects, fighting metastatic tumor cells without the effects of chemotherapy. “It has a very important impact on the quality of life of these patients with reduced toxicity, which is why it was a class of drugs that was very well received by the medical profession”, says Silvia Graziani, head of the clinical oncology service at the ICAVC (Instituto do Câncer Arnaldo Vieira de Carvalho).

In addition to access via supplemental health, another option for women facing a metastatic tumor is to seek inclusion in clinical trials. In 2022, the trader Ana Paula da Silva, 46, was invited to a study at the ICAVC to receive ribociclib in an expanded access program sponsored by the pharmaceutical company Novartis, the drug’s manufacturer.

The idea is to collect data from a study about the time of life without recurrence of the disease and the quality of life after using the drug.

She, who was diagnosed with advanced breast cancer in 2019, feels much better since starting therapy, with more willingness to perform daily activities, such as working, being with her children and grandchildren and traveling. “I unfortunately found out the cancer was already advanced, but I am very grateful to be able to receive the treatment, I no longer feel the discomfort of before and I have hope to be able to stay with my family”, she reports.

As the number of participants in studies is limited, this continues to be privileged access for a few patients. “We know that the SUS is a complex system, but what is distressing is this delay, this delay”, says Graziani.