​Para a Terceira Turma do Superior Tribunal de Justiça (STJ), é lícito à operadora de plano de saúde negar cobertura para medicamento de uso domiciliar à base de canabidiol não listado no Rol de Procedimentos e Eventos em Saúde da Agência Nacional de Saúde Suplementar (ANS).

O colegiado deu provimento ao recurso interposto por uma operadora contra decisão que determinou o fornecimento de pasta de canabidiol prescrita para ser utilizada em casa por uma beneficiária do plano com transtorno do espectro autista (TEA).

Após a negativa de cobertura, a mãe da paciente ajuizou ação contra a operadora com pedido de dano moral. O juízo de primeiro grau e o Tribunal de Justiça de Santa Catarina entenderam que a empresa deveria arcar com a medicação, desde que atendidos os requisitos previstos no artigo 10, parágrafo 13, da Lei 9.656/1998.

Intenção da lei é excluir medicamentos de uso domiciliar da cobertura obrigatória

Segundo a relatora do recurso da operadora no STJ, ministra Nancy Andrighi, o inciso VI do artigo 10 da Lei 9.656/1998 estabelece que os medicamentos para tratamento domiciliar não integram o plano-referência de assistência à saúde; logo, não são, em regra, de cobertura obrigatória pelas operadoras de saúde.

No entanto, a ministra lembrou que o parágrafo 13 do artigo 10 da mesma lei impõe às operadoras a obrigação de cobertura de tratamentos ou procedimentos prescritos por médico ou odontólogo assistente que não estejam previstos no rol da ANS, desde que comprovados alguns requisitos, entre eles a recomendação da Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde.

Para a ministra, os citados dispositivos devem ser interpretados em conjunto: enquanto o artigo 10, IV, retira a obrigação de cobertura domiciliar, salvo exceções legais ou previsão em contrato ou norma regulamentar, o parágrafo 13 do artigo 10 traz requisitos para a cobertura de tratamento ou procedimento excluído do plano-referência apenas por não estar previsto no rol da ANS.

Ao apresentar um panorama normativo sobre o assunto, a relatora ponderou que “a intenção do legislador, desde a redação originária da Lei 9.656/1998, é a de excluir medicamentos de uso domiciliar da cobertura obrigatória imposta às operadoras de planos de saúde”. Na sua avaliação, é por esse motivo que foram acrescentadas à lei e ao rol da ANS algumas poucas exceções à regra.

Jurisprudência sobre a cobertura de medicamentos à base de canabidiol

Nancy Andrighi comentou que o STJ tem julgado no sentido de impor a cobertura de medicamento à base de canabidiol pelas operadoras (REsp 2.107.741). Contudo, ela observou que a Terceira Turma já analisou a questão sob a ótica da forma de administração do medicamento, tendo afastado tal obrigação quando for para uso domiciliar (o processo correu sob segredo de justiça).

Entretanto, a ministra ressaltou que a cobertura será obrigatória se o medicamento, embora de uso domiciliar, for administrado durante a internação domiciliar substitutiva da hospitalar (REsp 1.873.491). Igualmente, ainda que administrado fora de unidades de saúde, como em casa, será obrigatória a sua cobertura se exigir a intervenção ou supervisão direta de profissional de saúde habilitado (EREsp 1.895.659).

O número deste processo não é divulgado em razão de segredo judicial.

Peptides have emerged as significant tools in scientific research, providing opportunities to explore molecular mechanisms and physiological processes within living research models. Tesamorelin and Ipamorelin stand out due to their potential roles in regulating growth hormone (GH) dynamics. As synthetic analogs of endogenously occurring peptides, their relevant implications in research settings may illuminate complex biological pathways and contribute to advancements in understanding growth hormone-related functions.

Tesamorelin: Growth Hormone-Releasing Hormone Activity

Tesamorelin is a synthetic peptide analog of growth hormone-releasing hormone (GHRH). Its structure is designed to mimic endogenous GHRH, enabling it to bind to specific receptors within the hypothalamus-pituitary axis. Studies suggest that this binding may stimulate the release of GH from the anterior pituitary gland. Compared to endogenous GHRH, the peptide seems to exhibit stability and resistance to enzymatic degradation, potentially increasing its utility in research implications.

It has been hypothesized that Tesamorelin might facilitate investigations into GH-dependent physiological processes, including cellular growth, repair, and metabolism. For instance, studies suggest that by modulating GH release, Tesamorelin might allow researchers to explore its downstream signaling cascades, such as the insulin-like growth factor-1 (IGF-1) pathway. The peptide’s potential to increase IGF-1 production in research models may serve as a basis for studying anabolic processes and their implications for tissue development and metabolic regulation.

Additionally, Tesamorelin’s stability is believed to aid in long-term studies, providing consistent GH stimulation over prolonged periods. This feature might be particularly relevant in exploring the role of GH in circadian rhythm regulation and its hypothesized interactions with other hormonal systems, such as cortisol and melatonin.

Ipamorelin: A Selective Growth Hormone Secretagogue

Ipamorelin is a pentapeptide classified as a growth hormone secretagogue (GHS). It is thought to act by binding to the ghrelin receptor (growth hormone secretagogue receptor, GHSR), which is widely expressed in various tissues. Unlike ghrelin, Ipamorelin does not appear to significantly stimulate appetite, which may make it a helpful tool for research focusing specifically on GH modulation without introducing confounding metabolic variables related to feeding behavior.

Research indicates that Ipamorelin’s mechanism of action might involve the selective activation of pathways linked to GH secretion without significantly influencing cortisol or prolactin release. This specificity may make it an invaluable peptide for dissecting the unique impacts of GH on cellular and systemic physiology. Researchers might expose research models to Ipamorelin to probe the mechanisms underlying skeletal muscle growth, connective tissue remodeling, and energy expenditure.

Preliminary investigations suggest that Ipamorelin’s impacts on GH secretion might be concentration-dependent, providing researchers with a means to modulate GH levels with precision. This characteristic may facilitate studies on how varying GH concentrations influence different biological processes, including lipid metabolism, mitochondrial function, and protein synthesis.

The Hypothesized Synergy of Tesamorelin and Ipamorelin

Investigations purport that the combination of Tesamorelin and Ipamorelin may offer an intriguing avenue for research, as their distinct mechanisms of action might complement one another. Tesamorelin’s activity at the hypothalamic level and Ipamorelin’s interaction with peripheral ghrelin receptors may provide a dual pathway for modulating GH release. This synergistic interaction might allow for a more comprehensive exploration of GH’s role in physiology and metabolism.

Researchers theorize that this peptide blend might amplify GH secretion more impactfully than either peptide alone, enabling a deeper investigation into GH-driven biological processes. For example, this synergy may be utilized to study the regenerative properties of GH in tissue engineering and its role in cellular senescence.

Additionally, investigations purport that the combined exposure of Tesamorelin and Ipamorelin might provide insights into the feedback mechanisms that regulate GH levels. By simultaneously stimulating GH release through multiple pathways, researchers may explore how the endocrine system adapts to maintain homeostasis. This may be particularly relevant in studies examining GH’s interactions with other hormones, such as thyroid hormones or insulin.

Implications in Research Domains

The hypothesized properties of the Tesamorelin-Ipamorelin blend are speculated to extend to several fields of research:

• Cellular Processes: The peptides’ potential to stimulate GH and, subsequently, IGF-1 might make them valuable tools in studying tissue regeneration. Research indicates that these peptides may model the processes of hypertrophy of muscular tissue, wound healing, and organ-specific repair systems.
• Metabolic Studies: By influencing GH and IGF-1 pathways, the peptide blend has been hypothesized to examine how hormonal signals regulate carbohydrate, lipid, and protein metabolism. For example, researchers may study the mechanisms of glucose uptake in skeletal muscle or lipolysis in adipose tissue.
• Neuroendocrine Interactions: Studies suggest that the peptides’ actions on GH release might also shed light on the broader neuroendocrine system. Studies may examine their influence on hypothalamic-pituitary interactions, including the regulation of other hormones like prolactin or ACTH.

Future Perspectives

As research continues to delve into the properties of Tesamorelin and Ipamorelin, their combination may pave the way for new insights into the endocrine regulation of growth and metabolism. While these peptides hold promise for advancing scientific understanding, ongoing investigations must prioritize rigorous experimental designs and remain within research parameters.

By leveraging the unique properties of these peptides, researchers may uncover novel pathways and mechanisms that contribute to growth hormone dynamics. These findings may ultimately inform a broader understanding of how hormonal signals govern physiological processes, enabling advancements across diverse scientific domains. Read this study if you are interested in learning more about peptides.

References

[i] Walker, R. F., & Kirsch, J. D. (1991). Peptide growth factors: Current applications and future directions. Journal of Clinical Pharmacology, 31(5), 394-403. https://doi.org/10.1002/j.1552-4604.1991.tb01825.x

[ii] Smith, R. G., Sun, Y., Jiang, H., Albarran-Zeckler, R., & Sensei, S. (2007). Ghrelin receptor (GHS-R1A) agonists show potential as treatments for age-related disorders. Molecular and Cellular Endocrinology, 290(1-2), 91-96. https://doi.org/10.1016/j.mce.2008.04.001

[iii] Nass, R., Pezzoli, S. S., Oliveri, M. C., Patrie, J. T., Harrell, F. E., Clasey, J. L., … & Thorner, M. O. (2008). Effects of an oral growth hormone secretagogue in older adults. The Journal of Clinical Endocrinology & Metabolism, 93(12), 4797-4805. https://doi.org/10.1210/jc.2008-1007

[iv] Yuen, K. C. J., & Miller, B. S. (2019). Therapeutic potential and safety considerations of Tesamorelin in the treatment of HIV-associated lipodystrophy. Expert Review of Endocrinology & Metabolism, 14(6), 425-433. https://doi.org/10.1080/17446651.2019.1683197

[v] Falutz, J., Allas, S., Blot, K., Potvin, D., Kotler, D., Somero, M., … & Eron, J. J. (2010). Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine, 363(13), 1246-1256. https://doi.org/10.1056/NEJMoa0910373

O município de Tarauacá deverá ser beneficiado pela recente reestruturação administrativa do setor de saúde no Acre. Com a dissolução do Instituto de Gestão de Saúde do Acre (IGESAC), a Secretaria de Estado de Saúde (SESACRE) assume a responsabilidade por bens e obrigações do órgão extinto. Essa transição visa aumentar a eficiência na gestão de recursos e ampliar o acesso aos serviços de saúde.

Entre as mudanças previstas, destaca-se a redistribuição de equipamentos e pessoal para atender melhor as demandas locais. Além disso, a centralização da gestão permitirá maior controle sobre os contratos e os investimentos em saúde. Em Tarauacá, onde o acesso a serviços médicos ainda é limitado, essa reestruturação promete resultados significativos, especialmente na atenção básica e nos programas de saúde preventiva.

A medida foi bem recebida por especialistas e gestores municipais, que veem na iniciativa uma oportunidade de fortalecer o sistema de saúde em regiões mais afastadas. O desafio agora será garantir que os recursos sejam aplicados de forma eficiente, para que os benefícios alcançados na reestruturação cheguem de fato à população de Tarauacá.