Mini ReviewAbstract
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on the sustainability of the healthcare system and the patient’s quality of life, suggesting urgent changes in outdated structures.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
Mini Review
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 [1]. 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 [2]. 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 [3].
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 [4].
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 [5].
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 [7].
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 [10].
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 [8]. 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
[11]. 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 [12].
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 [13]. 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 [14]. 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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