Neoplasms represents an important cause of mortality. One of the forms of treatment of this disease is chemotherapy, which can be administered orally, or intravenously, for example. Both in the Brazilian public health system and in the private system, there are different ways to ensure patient access to chemotherapy drugs that have been approved for commercialization. However, many improvements can be proposed in the processes that involve these forms of access to medicines. In the Brazilian private health system, there is a divergence in access between oral and intravenous chemotherapy that harms patients and the sustainability of the system. The discussions and actions related to this theme appear as a way to provoke reflections on the sustainability of the healthcare system and the patient’s quality of life, suggesting urgent changes in outdated structures.
Keywords: Chemotherapy; Oncology; Brazilian Health Technology Assessment; Brazilian’s Private Health System; Oral Chemotherapy
In the Brazilian epidemiological scenario, neoplasms represents
an important cause of mortality. Its impact has repercussions on
the constant development of healthcare projects and therapeutic
alternatives that aim to control the disease and improve the
patient’s quality of life . One of the treatments for this disease
is chemotherapy, which consists of using antineoplastic drugs that
inhibit the proliferation of cancer cells and prevent them from
spreading through the body . Antineoplastic agents have been
widely used in clinical practice and demonstrate important benefits
for patients. These drugs can be administered in different ways,
such as orally and intravenously, for example .
In Brazil, for a patient to have access to a chemotherapy drug, or any other drug, it must first be approved by ANVISA (Agência Nacional de Vigilância Sanitária) [Brazilian abbreviation that refers to national health surveillance agency in the country], which is the agency responsible for defining the criteria and the necessary steps for the release of a new medicine to the population. Therefore, medicines must undergo evaluations, with scientific basis, which attest to their quality, effectiveness and safety, through the analysis of clinical and non- clinical studies .
Approved products are also evaluated by CMED (Câmara de Regulação do Mercado de Medicamentos) [Brazilian abbreviation that refers to price regulation agency in the country], which is the agency responsible for regulating and setting price limits so that products can then be marketed .
Both in the Brazilian public health system and in the private system, there are different dynamics and ways of ensuring patient access to medicines that have been approved for commercialization. These dynamics aim to ensure that patients have access to medicines in the best possible way, in order to guarantee a sustainable and evidence-based supply system. However, many improvements can be proposed for the processes that involve these dynamics of access to medicines [6,7].
In the Brazilian private healthcare system, intravenous chemotherapy drugs are provided by healthcare plans as soon as they receive approval from ANVISA and CMED for commercialization. In other words, automatically, they become part of a list of products that the healthcare plan must, obligatorily, make available to patients who pay for this system . However, this process has not been applied to new oral chemotherapy drugs. These must undergo a second assessment, carried out by ANS (Agência Nacional de Saúde Suplementar), which, in Brazil, is the agency responsible for regulating the private healthcare system. This assessment is carried out at least every two years and decides whether a medication must be provided, or not, to those who pay for healthcare plans [7,8].
Oral chemotherapy has the same quality, safety and efficacy as intravenous therapy and can provide more comfort to the patient, mainly due to the administration convenience, that avoids hospitalizations for venous access and allows that patient stay safe and comfortable at home [2,9].
In an attempt to correct the difference between forms of access to oral and intravenous chemotherapy, the Brazilian Federal Senate approved, on June 3, 2020, the proposed law no. 6330, 2019. This proposal aims to facilitate patients’ access to oral chemotherapy, so that, after approval by Anvisa, these drugs can be automatically offered by healthcare plans, just as it is already done for intravenous chemotherapy drugs .
The proposed law is strongly based on the benefits that this correction could provide to patients, who need to wait for the long time of analysis of ANS to have the benefits of access to new oral chemotherapy treatments, which are often approved by drug regulatory agencies in the Brazilian market . The correction also proposes to benefit the health system itself, since there would be a reduction in spending on hospitalizations, freeing resources from healthcare plans to treat patients with other diseases, in addition to reducing the occurrence of lawsuits related to access to medicines . In this context, the incorporation and expansion of access to oral chemotherapies is, therefore, a strategic alternative for the care of cancer patients and a possible improvement in the sustainability of the system.
On the other hand, there are very important challenges to be considered, such as adhering to the treatment of oral therapy. As the treatment must be carried out continuously and appropriately by the patient at home, special monitoring by a multidisciplinary team is necessary, with guidance on the correct use and recognition of adverse reactions, in addition to encouraging patient coresponsibility and autonomy .
Thus, it is also essential to reinforce the concept and practice of “Pharmaceutical Assistance”, which consists of a set of actions for the promotion, protection and recovery of individual and collective health, with medicines as an essential element aiming to guarantee access to and rational use . In addition, proposals such as those presented by proposed law no. 6330, 2019, may suggest an immediate solution, if they are not planned and executed properly and may provoke an opposite effect to the proposed objective, putting at risk the sustainability of the system and the collective benefit.
In this context, it is essential that incorporations are based on studies of economic evaluation and budget impact, as well as on proven scientific evidence, which ensure collective gains and relevant clinical results for patients . All discussions related to the incorporation process of new drugs in the private healthcare system are essential to provoke changes in outdated structures, especially regarding the criteria and evaluation deadlines.
Conflicts of Interest
No conflict of interest relevant to this manuscript.
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