Profile of the judicialization of the Therasuit Method and its direct cost in the scope of the state of Rio de Janeiro

Dominique Souza de Moraes Roberta da Silva Teixeira Marisa da Silva Santos About the authors

ABSTRACT:

Introduction:

The lack of availability of the Therasuit Method by the Unified Health System associated with its high cost has led to the prosecution of this treatment. The study aimed to outline the profile of this judicialization, as well as to estimate the direct costs resulting from compliance with the deferred judicial decisions.

Method:

Weanalyzed the cases submitted to the Court of Justice of Rio de Janeiro between January 2013 and January 2017, in which the Therasuit Method was applied. Demographic, clinical, advocacy and legal data were extracted, as was the timing of the court’s decision and the required technology budgets.

Results:

Atotal of 11 processes was analyzed. The authors had a mean age of 6.8 years and a median of 6, the majority being male, and resident in thestate capital. Quadriparesis was the most reported condition. The gratuity of justice was requested by all, and the Public Defender’s Officewas used by 9 of the 11 processes. The judicial decisions at first instance were considered. In all of processes there was application of the legal tool called guardianship. The time of the judicial decision was on average of 266.5 days with a median of 35.5. The deferral index was 90%, totaling an annual direct cost of R$501,894.09.

Discussion:

The judicialization of this treatment can cause an unforeseen displacement of public funds, transgressing the principles of equity and the integrality of Unified Health System.

Conclusion:

It was observed a high rate of deferred processes, resulting in a high cost spent by the Public Power to attend a small portion of patients.

Keywords:
of health. Right to health. Technology assessment; biomedical. Equipment and supplies. Cerebral palsy

INTRODUCTION

Cerebral palsy (CP), also referred to as chronic non-progressive encephalopathy in children (NPEIC)11. Morais FD, Freitas JC, Viana FP, Formiga CKMR. Correlation between neurofunctional profile and sensory-motor skills of children with cerebral palsy.J Hum Growth Develop 2012;22(2): 226-32., comprises a heterogeneous group of permanent non-progressive clinical syndromes characterized by motor and postural dysfunctions22. Patterson MC, Bridgemohan C, Armsby C. Management and prognosis of cerebral palsy. UpToDate [Internet] 2017 [acessado em 10 jul. 2017]. Disponível em: https://www.uptodate.com/contents/management-and-prognosis-of-cerebral-palsy
https://www.uptodate.com/contents/manage...
,33. Cargnin APM, Mazzitelli C. Proposta de tratamento fisioterapêutico para crianças portadoras de paralisia cerebral espástica, com ênfase nas alterações musculoesqueléticas.Rev Neurocienc 2003; 11(1): 34-9.. Its therapy is focused on maximizing the quality of life through the improvement of activities of daily living, including assistance from parents and caregivers22. Patterson MC, Bridgemohan C, Armsby C. Management and prognosis of cerebral palsy. UpToDate [Internet] 2017 [acessado em 10 jul. 2017]. Disponível em: https://www.uptodate.com/contents/management-and-prognosis-of-cerebral-palsy
https://www.uptodate.com/contents/manage...
,33. Cargnin APM, Mazzitelli C. Proposta de tratamento fisioterapêutico para crianças portadoras de paralisia cerebral espástica, com ênfase nas alterações musculoesqueléticas.Rev Neurocienc 2003; 11(1): 34-9..

To this end, treatment approaches may follow several aspects based on the individual need and the degree of affection of each patient. Interventions may include physical therapy, the use of orthotics and, in certain situations, corrective surgery22. Patterson MC, Bridgemohan C, Armsby C. Management and prognosis of cerebral palsy. UpToDate [Internet] 2017 [acessado em 10 jul. 2017]. Disponível em: https://www.uptodate.com/contents/management-and-prognosis-of-cerebral-palsy
https://www.uptodate.com/contents/manage...
,33. Cargnin APM, Mazzitelli C. Proposta de tratamento fisioterapêutico para crianças portadoras de paralisia cerebral espástica, com ênfase nas alterações musculoesqueléticas.Rev Neurocienc 2003; 11(1): 34-9..

The Therasuit® device, used in the treatment with the Therasuit Method and belonging to the Intensive Physical Therapy Program (IPTP), has been adopted with the purpose of improving functional capacity and motor deficits44. Frange CMP, Silva TOT, Filgueiras S. Revisão sistemática do programa intensivo de fisioterapia utilizando a vestimenta com cordas elásticas. Rev Neurocienc 2012; 20(4): 517-26. http://doi.org/10.4181/RNC.2012.20.753.10p
http://doi.org/10.4181/RNC.2012.20.753.1...
,55. TheraSuit Metod(r). TheraSuit Info [Internet]. [acessado em 9 jul. 2017]. Disponível em: http://www.suittherapy.com/therasuit%20info.htm
http://www.suittherapy.com/therasuit%20i...
. It consists of a suit in up to six sizes, which has several elastics connected in different parts to the patient’s body with varying tensions and dimensions44. Frange CMP, Silva TOT, Filgueiras S. Revisão sistemática do programa intensivo de fisioterapia utilizando a vestimenta com cordas elásticas. Rev Neurocienc 2012; 20(4): 517-26. http://doi.org/10.4181/RNC.2012.20.753.10p
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,55. TheraSuit Metod(r). TheraSuit Info [Internet]. [acessado em 9 jul. 2017]. Disponível em: http://www.suittherapy.com/therasuit%20info.htm
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. Manufactured exclusively in the United States, the equipment is the only technology with this functionality registered both in the Food and Drug Administration (FDA)66. U.S. Food and Drug Administration. Search FDA [internet]. [acessado em 12 jul. 2017]. Disponível em: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/ldetails.cfm?lid+353268
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and, in Brazil, by the National Agency of Sanitary Surveillance (Agência Nacional de Vigilância Sanitária - ANVISA)77. Agência Nacional de Vigilância Sanitária [Internet]. Registro ANVISA nº 80431160001 - THERASUIT [acessado em 10 jul. 2017]. Disponível em: https://www.smerp.com.br/anvisa/?ac=prodDetail&anvisaId=80431160001
https://www.smerp.com.br/anvisa/?ac=prod...
. In addition, the Therasuit Method (including the device- suit) has not, so far, been submitted to evaluation by the National Commission for the Incorporation of Technologies (Conitec)88. Comissão Nacional de Incorporação de Tecnologias. Tecnologias demandadas [Internet]. Comissão Nacional de Incorporação de Tecnologias; 2014 [acessado em 6 abr. 2018]. Disponível em: http://conitec.gov.br/tecnologias-em-avaliacao
http://conitec.gov.br/tecnologias-em-ava...
.

However, the Unified Health System (Sistema Único de Saúde - SUS) offers other types of treatment to neurological patients, including those with cerebral palsy, according to the Table of Procedures, Medications, Orthotics/Prostheses and Special Materials (SIGTAP), which includes: “physical therapy care in patients with neuro-kinetic-functional disorders with and without systemic complications”, in addition to “physiotherapeutic care in disorders of the neuromotor system”99. Brasil. Ministério da Saúde. Sistema de Gerenciamento da Tabela de Procedimentos, Medicamentos, OPM do SUS. Consulta de procedimentos [Internet]. [acessado em 6 abr. 2018]. Disponível em http://sigtap.datasus.gov.br/tabela-unificada/app/sec/inicio.jsp
http://sigtap.datasus.gov.br/tabela-unif...
. Such services are performed by the health units that integrate the Physical Rehabilitation Network of the State of Rio de Janeiro1010. Rio de Janeiro. Deliberação CIB nº 1.273 de 15 de abril de 2011. Aprova a Rede de Reabilitação Física do Estado do Rio de Janeiro [Internet]. Rio de Janeiro; 2011 [acessado em 6 abr. 2018]. Disponível em: http://www.cib.rj.gov.br/deliberacoes-cib/73-2011/abril/2075-deliberacao-cib-n-1273-de-15-de-abril-de-2011.html
http://www.cib.rj.gov.br/deliberacoes-ci...
.

Thus, considering that this method is not standardized by SUS, patients have opted for the attempt to guarantee this type of treatment by judicial means in the state of Rio de Janeiro. Consequently, this behavior of health judicialization through compliance with judicial orders, according to some authors, may result in an overload of public coffers1111. Pereira DS. Tribunal de Contas da União. O orçamento público e o processo de judicialização da saúde [Internet]. Brasília: Tribunal de Contas da União; 2010 [acessado em 6 abr. 2018]. 32 p. Disponível em: http://portal.tcu.gov.br/biblioteca-digital/o-orcamento-publico-e-o-processo-de-judicializacao-da-saude.htm
http://portal.tcu.gov.br/biblioteca-digi...
,1212. Castro SHR. Impacto deslocativo no orçamento público estadual em face de decisões judiciais [monografia]. Belo Horizonte: Pontifícia Universidade Católica de Minas Gerais, PUC Minas, Brasil, 2011..

Given this scenario, it is possible to perceive the relevance of the search for information about costs with respect to which and how resources are consumed1313. Gilliland-Swetland AJ. Introduction to Metadata: Setting the 2000 [Internet]. Murtha Baca; 2016 [acessado em 10 out. 2017]. Disponível em: http://www.getty.edu/research/conducting_research/standards/intrometadata/pdf/swetland.pdf
http://www.getty.edu/research/conducting...
, with the objectives of informing actions and avoiding unnecessary investments, which disregard the logic of care of the care network, among other issues currently presented by the Brazilian health system1414. Brasil. Ministério da Saúde. Introdução à Gestão de Custos em Saúde. Brasília: Editora do Ministério da Saúde; 2013. 148 p. (Série Gestão e Economia da Saúde, v. 2).. Cost information becomes even more relevant, given they play a significant role in assisting decision-makers on the part of public administration actors1515. Alonso M. Custos no serviço público. Rev Ser Pub 1999; 50(1): 37-63. https://doi.org/10.21874/rsp.v50i1.340
https://doi.org/10.21874/rsp.v50i1.340...
.

Therefore, the study aimed at tracing the profile of the judicialization of CP treatments with the Therasuit Method, in the scope of the state of Rio de Janeiro, by analyzing the judicial proceedings submitted to the Nucleus of Technical Assistance (Núcleo de Assessoria Técnica - NAT) of the Court of Justice of the State of Rio de Janeiro (Tribunal de Justiça do Estado do Rio de Janeiro - TJERJ). Secondly, it aimed to estimate the direct costs resulting from compliance with court decisions favorable to the requests of the plaintiffs.

METHOD

The present study is a descriptive study, which included the processes submitted to the NAT of the TJERJ from January 2013 to January 2017, where treatment with the Therasuit method was requested for children (<12 years of age) and adolescents (≥ 12 and < 18 years of age)1616. Brasil. Ministério da Saúde. Estatuto da Criança e do Adolescente. 3ª ed. Brasília: Editora do Ministério da Saúde; 2008. 96 p. (Série E. Legislação de Saúde). with CP.

The respective data on the profile of the Therasuit treatment judicialization were removed from the proceedings and arranged in a form filling the following fields:

  • Demographic data: gender, age and municipality of residence (taken from the initial process).

  • Clinical data: International Classification of Diseases (ICD-10), as well as the clinical picture presented by the author as a result of CP involvement.

  • Legal data: if there was a claim of economic hyposufficiency and a request for gratuity of justice (by means of a written declaration so that the author is exempt from costs related to the judicial process due to proof of absence of one’s own and sufficient economic means for the provision of expenses of the process), whether there was a search for assistance from public defenders or private lawyers, whether the protection was anticipated and the legal basis, as well as justification of the authors to substantiate the lawsuit.

  • Legal data: if the NAT indicated the requested treatment, it was suggested alternative treatment standardized by the SUS (from the technical opinions issued), whether or not the judge accepted the NAT’s opinion and whether or not the treatment sought was approved (from the legal decision).

Judgments were considered in the first instance, as well as the time of these decisions (indicated in number of days). Data on the direct cost of treatment with the Therasuit method were estimated in national currency - real (R$) -, based on the average prices collected.

The collection of treatment values with the Therasuit method was carried out by consulting the budgets of the institutions attached to the processes, since they would be the places where the authors would carry out the treatment in case of deferment by the judge.

Considering that the budgets attached to the processes were granted in different periods, that is, in different months and years, the amounts were annualized and adjusted for the base year of 2017 (through July) according to the National Price Index to the Broad Consumer (Índice Nacional de Preços ao Consumidor Amplo - IPCA). The choice of this index is justified by the fact that it is an indicator used by the Brazilian federal government to gauge inflation targets1717. ADVNF Brasil. Indicadores Econômicos - IPCA [Internet]. [acessado em 9 out. 2017]. Disponível em: https://br.advfn.com/indicadores/ipca
https://br.advfn.com/indicadores/ipca...
.

It should be emphasized that the presentation of the sample profile was delimited to thedescriptive statistics. The characteristics of the judicialization are presented in tables and the results were weighted using measures of absolute and relative frequency. For the continuous variables, the mean and median values were estimated using the free-use statistical package R.

The study was submitted to and approved by the Ethics and Research Committee of the National Institute of Cardiology.

RESULTS

The search identified 11 processes submitted to the NAT of the TJERJ, which had their data analyzed.

The authors’ ages ranged from 2 to 15 years, with a mean of 6.8 and a median of 6 years. In the processes, the majority of subjects were male (82%) and resident in the city of Rio de Janeiro (55%).

The ICD-10s were informed in 73% of the processes analyzed and included CP, congenital hydrocephalus, epilepsy, global developmental disorders and mental retardation. Clinicalpictures were described at the same frequency, with the spastic quadriparesis (4/11) being the most common condition mentioned.

Demographic and clinical data of the processes are set out in Table 1.

Table 1.
Demographic and clinical data of the processes.

Table 2 summarizes the legal data and the time of the judicial decision in the first instance of the present study.

Table 2.
Legal and time data of the judicial decision in the first instance of the processes.

All authors (11/11) requested the benefit of gratuity of justice, and in 82% of the cases, the legal representation of the Public Defender’s Office was used.

Article 196 of the Federal Constitution of 19881818. Brasil. Constituição. Constituição da República Federativa do Brasil. Brasília, DF: Senado Federal; 1998. (which states that “health is the right of everyone and the duty of the State, guaranteed by social and economic policies aimed at reducing the risk of disease and other illnesses and universal and equal access to actions and services for their promotion, protection and recovery”) was cited on 91% of occasions as justification for the lawsuit by the authors, while Law No. 8.080 of 1990 (which deals with the conditions for the promotion, protection and recovery of health, the organization and operation of the corresponding services and other measures) was mentioned in 55% of the processes. Arguments based on article 1, item III, of FC/88, which addresses the dignity of the human being as one of the foundations of the Democratic State of Law, were mentioned in 2 of the 11 processes analyzed.

The legal tool, guardianship, whose main objective is the urgent granting of the item pleaded to the author of the action, in order to avoid the material damages resulting from the delay of the process, was requested in all cases. The time to obtain it presented a great variation of values (from 1 to 1,140 days). The average decision time, given by the judge, was 266.5 days and the median was 35.5.

In all the technical reports of the NAT (11/11) there was a suggestion of treatments made available by SUS, as shown in the SIGTAP table, for the clinical condition of the authors of the actions.

The deferral rate of the required technology was high. In only one case (1/10) was the request dismissed on the grounds that, although the author’s arguments were based on theprinciple of human dignity, the granting of therapies by judicial means to eligible citizens should consider proportionality, in the public sphere, is established in the area of the principle of the Reserve of Possible.

The total estimated annual direct cost to meet the authors of the deferred actions totaled the amount of R$ 501,894.09. Regarding the average annual cost, per author, the estimated amount was R$ 55,766.01.

It should also be mentioned that the average annual cost, per author, of the treatment offered by SUS, as shown in the SIGTAP table, is R$ 1,320.40.

DISCUSSION

According to Ventura etal.1919. Ventura M, Simas L, Pepe VLE, Schramm FR. Judicialização da saúde, acesso à justiça e a efetividade do direito à saúde. Physis [Internet] 2010 [acessado em 6 abr. 2018]; 20(1): 77-100. Disponível em: http://www.scielo.br/pdf/physis/v20n1/a06v20n1.pdf
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, Pepe etal.2020. Pepe VLE, editor. Indicadores de avaliação e monitoramento das demandas judiciais de medicamentos [Internet]. Rio de Janeiro: Fundação Oswaldo Cruz, Escola Nacional de Saúde Pública Sergio Arouca; 2011 [acessado em 5 abr. 2018]. Disponível em: http://www5.ensp.fiocruz.br/biblioteca/dados/txt_975659982.pdf
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and Chieffi etal.2121. Chieffi AL, Barradas RCB, Golbaum M. Legal access to medications: a threat to Brazil's public health system? BMC Health Serv Res [Internet] 2017 [acessado em 5 abr. 2018]; 17(1): 499. Disponível em: https://www.ncbi.nlm.nih.gov/pubmed/28724420 https://doi.org/10.1186/s12913-017-2430-x
https://www.ncbi.nlm.nih.gov/pubmed/2872...
, the judicialization of health, a phenomenon understood by the obligation to provide health goods and services to citizens, imposed on the Public Administration by the Judiciary, in which assures the citizen access to technologies and public policies, makes it possible to identify health demands and issues more objectively, as well as to encourage the creation of solutions by SUS managers to compensate for the malfunctioning of such system.

However, given the scenario presented in the present study, this phenomenon may facilitate access to treatment, but, on the other hand, disorganize the public system since the treatments offered by the SUS to patients with neurological dysfunctions such as CP cost, on average, according to the SIGTAP table99. Brasil. Ministério da Saúde. Sistema de Gerenciamento da Tabela de Procedimentos, Medicamentos, OPM do SUS. Consulta de procedimentos [Internet]. [acessado em 6 abr. 2018]. Disponível em http://sigtap.datasus.gov.br/tabela-unificada/app/sec/inicio.jsp
http://sigtap.datasus.gov.br/tabela-unif...
, R$ 5.51 per service.

Since the SUS offers a maximum of 20 outpatient visits per month99. Brasil. Ministério da Saúde. Sistema de Gerenciamento da Tabela de Procedimentos, Medicamentos, OPM do SUS. Consulta de procedimentos [Internet]. [acessado em 6 abr. 2018]. Disponível em http://sigtap.datasus.gov.br/tabela-unificada/app/sec/inicio.jsp
http://sigtap.datasus.gov.br/tabela-unif...
, the annual treatment, per author, would cost the public coffers, via SUS, R$ 1,320.40 versus R$55,766.01 using the Therasuit Method. This finding corroborates those addressed in studies which point out that the compliance with judicial orders increases public expenditures2222. Wang DWL, Vasconcelos NP, Oliveira VE, Terrazas FV. Os impactos da judicialização da saúde no município de São Paulo: gasto público e organização federativa. Rev Adm Pública 2014; 48(5): 1191-206. http://dx.doi.org/10.1590/0034-76121666
http://dx.doi.org/10.1590/0034-76121666...
,2323. Medici AC. Judicialização, integralidade e financiamento da saúde. Diagn Tratamento 2010; 15(2): 81-7..

The treatment with the Therasuit Method, when expending significant public resources, when compared to the cost incurred using SUS, can promote unplanned displacement of funds due to compliance with judicial determinations that serve few individuals, given the annual expenditure of R$ 501,894.09 to serve only nine authors whose lawsuits were granted.

At the same time, the mobilization of part of the society requesting the materialization of their right to health through the judicialization of goods and services, together with the deferrals of the lawsuits filed by the judges, evaluates individual litigation without considering collective matters2222. Wang DWL, Vasconcelos NP, Oliveira VE, Terrazas FV. Os impactos da judicialização da saúde no município de São Paulo: gasto público e organização federativa. Rev Adm Pública 2014; 48(5): 1191-206. http://dx.doi.org/10.1590/0034-76121666
http://dx.doi.org/10.1590/0034-76121666...
. Although in all the analyzed processes the benefit of gratuity ofjustice was requested, alleging hyposufficiency of the authors of the actions and, most of them, the request of the Public Defender’s aid, the judicialization of health can hurt some SUS principles, such as equity and completeness2323. Medici AC. Judicialização, integralidade e financiamento da saúde. Diagn Tratamento 2010; 15(2): 81-7.,2424. Laranjeira FO, Petramale CA. A avaliação econômica em saúde na tomada de decisão: a experiência da CONITEC. Inst Saúde [Internet]. 2013 [acessado em 8 out. 2017]; 14(2): 165-70. Disponível em: http://periodicos.ses.sp.bvs.br/scielo.php?script=sci_arttext&pid=S1518-18122013000200007&lng=pt
http://periodicos.ses.sp.bvs.br/scielo.p...
, since, according to Barroso2525. Barroso LR. Da falta de efetividade à judicialização excessiva: direito à saúde, fornecimento gratuito de medicamentos e parâmetros para a atuação judicial. Rev Jur UNIJUS [Internet] 2008 [acessado em 6 abr. 2018]; 11(15): 13-38. Disponível em: https://www.conjur.com.br/dl/estudobarroso.pdf
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, other patients, who are also hyposufficient and in need of health care that did not seek justice assistance due to a lack of knowledge and access, become deprived2626. Silva LP. Direito à saúde e o princípio da reserva do possível [monografia]. Brasília: Instituto Brasiliense de Direito Público [Internet]. [acessado em 4 abr. 2018]. Disponível em: http://www.stf.jus.br/arquivo/cms/processoAudienciaPublicaSaude/anexo/DIREITO_A_SAUDE_por_Leny.pdf
http://www.stf.jus.br/arquivo/cms/proces...
.

According to Laranjeira and Petramale2424. Laranjeira FO, Petramale CA. A avaliação econômica em saúde na tomada de decisão: a experiência da CONITEC. Inst Saúde [Internet]. 2013 [acessado em 8 out. 2017]; 14(2): 165-70. Disponível em: http://periodicos.ses.sp.bvs.br/scielo.php?script=sci_arttext&pid=S1518-18122013000200007&lng=pt
http://periodicos.ses.sp.bvs.br/scielo.p...
, the principle of equity cannot be guaranteed by judicially seeking uncritical reimbursement of high-cost items in order to serve a small portion of patients, thus failing to provide basic inputs for a large part of the affected population by highly prevalent diseases, which also depend on the health system.

However, even with evidence of the negative effects of the health judicialization process regarding SUS principles and community involvement, authors mention that the possibility of fulfilling the right to health through access to justice can be considered an advantage of the process itself and does not necessarily mean a deviation from the functions of the Judiciary Power2727. Pepe VLE, Figueiredo TA, Simas L, Osorio-de-Castro CGS, Ventura M. A judicialização da saúde e os novos desafios da gestão da assistência farmacêutica. Ciênc Saúde Coletiva [Internet] 2010 [acessado em 6 abr. 2018]; 15(5): 2405-14. Disponível em: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1413-81232010000500015&lng=en http://dx.doi.org/10.1590/S1413-81232010000500015
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,2828. Gauri V, Brinks DM. Introduction. In: Gauri V, Brinks DM. Courting social justice: judicial enforcement of social and economic rights in the developing world [Internet]. Cambridge: Cambridge University Press; 2008 [acessado em 7 abr. 2018]. 38 p. Disponível em: https://pgppij.files.wordpress.com/2017/11/gauri-e-brinks-courting-social-justice-completo.pdf
https://pgppij.files.wordpress.com/2017/...
. One concrete example was the claim of social rights, such as access to medicines and medical follow-up, to the Judiciary, by patients with HIV/SIDA in the 1990s. This fact led to the creation of public policies that began to contemplate this portion of the population through the free distribution of antiretroviral drugs2929. Brasil. Ministério da Saúde. Secretaria de Vigilância em Saúde. Programa Nacional de DST e Aids. O Remédio via Justiça: Um estudo sobre o acesso a novos medicamentos e exames em HIV/AIDS no Brasil por meio de ações judiciais. Brasília: Ministério da Saúde, Secretaria de Vigilância em Saúde, Programa Nacional de DST e Aids; 2005..

In certain situations, the Judiciary, in Brazil, in denying the provision of health goods and services in their decisions, is based on the Principle of the Possible Reserve, which deals with the limitation of available financial resources in the face of the numerous needs of the citizens3030. Ribeiro JS, Moritz GO, Sabino MMFL. Judicialização da Saúde: direitos coletivos versus direitos individuais. In: Pereira MF, Costa AM, Moritz GO, Bunn DA, editores. Coleção Gestão da Saúde Pública. Contribuições para a Gestão do SUS [Internet]. Florianópolis: Fundação Boiteux; 2013 [acessado em 7 abr. 2018]. Disponível em: http://gsp.cursoscad.ufsc.br/wp/wp-content/uploads/2013/06/Anais-GSP-Volume-4-COMPLETO.pdf
http://gsp.cursoscad.ufsc.br/wp/wp-conte...
. Thus, given the progressive and high health expenditure2222. Wang DWL, Vasconcelos NP, Oliveira VE, Terrazas FV. Os impactos da judicialização da saúde no município de São Paulo: gasto público e organização federativa. Rev Adm Pública 2014; 48(5): 1191-206. http://dx.doi.org/10.1590/0034-76121666
http://dx.doi.org/10.1590/0034-76121666...
,2323. Medici AC. Judicialização, integralidade e financiamento da saúde. Diagn Tratamento 2010; 15(2): 81-7., it is understood that the State has a reduced action, due to the lack of resources, to fully serve all users. However,only one case of dismissal by the judge was observed in the study, claiming the said Principle. It, therefore, calls for the establishment of criteria for health provision in order to allocate funds for a better management of the available resources3131. Barroso LR. Constituição, democracia e supremacia judicial: Direito e política no Brasil contemporâneo. RFD [Internet] 2012 [acessado em 8 out. 2017]; 2(21): 1-39. Disponível em: http://www.e-publicacoes.uerj.br/index.php/rfduerj/article/view/1794/2297 https://doi.org/10.12957/rfd.2012.1794
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,3232. Mazza FF, Mendes ÁN. Decisões judiciais e orçamento: um olhar sobre a saúde pública. Rev Dir Sanit 2014; 14(3): 42-65. https://doi.org/10.11606/issn.2316-9044.v14i3p42-65
https://doi.org/10.11606/issn.2316-9044....
.

In this context, we have the concept of opportunity cost, which uses limited resources in a perspective of health interventions that compete with each other due to this financial shortage. Such a concept assumes that when a wrong intervention is performed, i.e., when there is no additional benefit, the opportunity to use the same monetary value in options that could bring more gains to the population is wasted3333. Silva EN, Silva MT, Pereira MG. Estudos de avaliação econômica em saúde: definição e aplicabilidade aos sistemas e serviços de saúde. Epidemiol Serv Saúde 2016; 25(1): 205-7. https://doi.org/10.5123/S1679-49742016000100023
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.

In addition, it is emphasized that the concept of the integrality principle2323. Medici AC. Judicialização, integralidade e financiamento da saúde. Diagn Tratamento 2010; 15(2): 81-7.

be delimited by topics such as the regulation of technology incorporation based on the principles of evidence-based medicine, protocolized care [...], the correct sequence of care based on hierarchical services, with emphasis on primary care, and the special attention to cases that are beyond therapeutic possibility.

Thus, it is essential to discuss the scientific evidence on the effects of the technology in question in the treatment of children and adolescents with CP.

There are clinical premises on the use of the dynamic suit to alter joint alignment and assist in the strengthening and/or stretching of certain muscle groups, affecting posture, coordination, balance, fine and gross motor function and gait of children with CP and even other health conditions3434. Blair E, Ballantyne J, Horsman S, Chauvel P. A study of a dynamic proximal stability splint in the management of children with cerebral palsy. Dev Med Child Neurol 1995; 37(6): 544-54.,3535. Semenova KA. Basis for a method of dynamic proprioceptive correction in the restorative treatment of patients with residual-stage infantile cerebral palsy. Neurosci Behav Physiol 1997; 27(6): 639-43.,3636. Hylton N, Allen C. The development and use of SPIO Lycra compression bracing in children with neuromotor deficits. Pediatr Rehabil 1997; 1(2): 109-16.,3737. Attard J, Rithalia S. A review of the use of Lycra pressure orthoses for children with cerebral palsy. Int J Ther Rehabil 2004; 11(3): 120-6. https://doi.org/10.12968/ijtr.2004.11.3.13384
https://doi.org/10.12968/ijtr.2004.11.3....
,3838. Cusick B. Developmental orthopedics, Part IIIb. Frontal-plane developmental changes in the torso and hips. NDTA 2007; 14(4): 15-24.,3939. Bailes AF, Greve K, Schmitt LC. Changes in two children with cerebral palsy after intensive suit therapy: a case report. Pediatr Phys Ther 2010; 22(1): 76-85. https://doi.org/10.1097/PEP.0b013e3181cbf224
https://doi.org/10.1097/PEP.0b013e3181cb...
.

In addition, Liptak4040. Liptak GS. Complementary and alternative therapies for cerebral palsy. Ment Retard Dev Disabil Res Rev 2005; 11(12): 156-63. https://doi.org/10.1002/mrdd.20066
https://doi.org/10.1002/mrdd.20066...
and Martins etal.4141. Martins E, Cordovil R, Oliveira R, Letras S, Lourenço S, Pereira I, etal. Efficacy of suit therapy on functioning in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol 2016; 58(4): 348-60. https://doi.org/10.1111/dmcn.12988
https://doi.org/10.1111/dmcn.12988...
conducted studies that initially reinforced clinical claims and expectations of family members regarding the effects of such therapy on the movement and posture of children with CP. However, a systematic review with meta-analysis showed that the effect of the protocol with the Therasuit Method was of limited impact4141. Martins E, Cordovil R, Oliveira R, Letras S, Lourenço S, Pereira I, etal. Efficacy of suit therapy on functioning in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol 2016; 58(4): 348-60. https://doi.org/10.1111/dmcn.12988
https://doi.org/10.1111/dmcn.12988...
.

It should be noted that this effect was measured using the Gross Motor Function Measure-66 (GMFM-66)4242. Russell DJ, Rosenbaum PL, Avery LM, Lane M. The Gross Motor Function Measure (GMFM-66 and GMFM-88) User's Manual. Londres: MacKeith Press; 2002. and the Pediatric Evaluation of Disability Inventory (PEDI)4343. Bailes AF, Greve K, Burch CK, Reder R, Lin L, Huth MM. The effect of suit wear during an intensive therapy program in children with cerebral palsy. Pediatr Phys Ther 2011; 23(2): 136-42. https://doi.org/10.1097/PEP.0b013e318218ef58
https://doi.org/10.1097/PEP.0b013e318218...
instruments. Thefirst tool estimated the change in the motor skills of patients with CP in 66 items arranged in 5 dimensions, which included lying down and rolling; sitting down; crawling and kneeling; the upright posture; and, finally, walking, running and jumping. The PEDI questionnaire, by means of 197 items, measured the functional abilities of the respective patients and the caregiver’s assistance in the sphere of self-care, mobility and social function.

Considering that children with CP need an articulated care network between a multidisciplinary health team and their family, based not only on specific CP conditions per se, but also focused on adequate strategies that involve global aspects of their health, the existence of other therapeutic possibilities available, such as those offered by the SUS, according to the SIGTAP, namely: “physiotherapeutic care in patients with neuro-kinetic-functional disorders with and without systemic complications”, in addition to “physiotherapeutic care in the disorders of the neuromotor system”99. Brasil. Ministério da Saúde. Sistema de Gerenciamento da Tabela de Procedimentos, Medicamentos, OPM do SUS. Consulta de procedimentos [Internet]. [acessado em 6 abr. 2018]. Disponível em http://sigtap.datasus.gov.br/tabela-unificada/app/sec/inicio.jsp
http://sigtap.datasus.gov.br/tabela-unif...
, through the health units that integrate the Physical Rehabilitation Network of the state of Rio de Janeiro1010. Rio de Janeiro. Deliberação CIB nº 1.273 de 15 de abril de 2011. Aprova a Rede de Reabilitação Física do Estado do Rio de Janeiro [Internet]. Rio de Janeiro; 2011 [acessado em 6 abr. 2018]. Disponível em: http://www.cib.rj.gov.br/deliberacoes-cib/73-2011/abril/2075-deliberacao-cib-n-1273-de-15-de-abril-de-2011.html
http://www.cib.rj.gov.br/deliberacoes-ci...
.

The Ministry of Health, through the Directives of Attention to the Person with Cerebral Palsy4444. Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Departamento de Ações Programáticas Estratégicas. Diretrizes de Atenção à Pessoa com Paralisia Cerebral [Internet]. Brasília: Ministério da Saúde; 2012 [acessado em 9 out. 2017]. 75 p. (Série F. Comunicação e Educação em Saúde). Disponível em: http://www.pessoacomdeficiencia.gov.br/app/sites/default/files/arquivos/%5Bfield_generico_imagens-filefield-description%5D_70.pdf
http://www.pessoacomdeficiencia.gov.br/a...
, recommends the treatments made available by the SUS for children with CP. Thisfact corroborates what was discussed in all the Technical Opinions analyzed, in which there was a suggestion of treatment standardized by the SUS, such as those mentioned in the SIGTAP table, as an alternative to the legal claim (treatment with Therasuit Method) by the authors of the actions.

In view of the foregoing, despite the fact that the Federal Constitution of 1988 requires the materialization of the right to health (Article 196), which includes the dignity of the human person also as a principle of economic orientation (article 1, item III and article 170), the establishment of the State’s limited action (Principle of the Reserve of Possible versus equal universal access) is necessary4545. Viola LA. O direito prestacional saúde e sua proteção constitucional [dissertação]. Campos dos Goytacazes: Faculdade de Direito de Campos; 2006.. According to Viola4545. Viola LA. O direito prestacional saúde e sua proteção constitucional [dissertação]. Campos dos Goytacazes: Faculdade de Direito de Campos; 2006., the provision could be limited only to what is necessary for the purpose of protecting human life. Such a situation is not characterized in the present demand, which refers to the treatment of a chronic condition by the use of the Therasuit Method, which, according to studies3333. Silva EN, Silva MT, Pereira MG. Estudos de avaliação econômica em saúde: definição e aplicabilidade aos sistemas e serviços de saúde. Epidemiol Serv Saúde 2016; 25(1): 205-7. https://doi.org/10.5123/S1679-49742016000100023
https://doi.org/10.5123/S1679-4974201600...
,3434. Blair E, Ballantyne J, Horsman S, Chauvel P. A study of a dynamic proximal stability splint in the management of children with cerebral palsy. Dev Med Child Neurol 1995; 37(6): 544-54.,3535. Semenova KA. Basis for a method of dynamic proprioceptive correction in the restorative treatment of patients with residual-stage infantile cerebral palsy. Neurosci Behav Physiol 1997; 27(6): 639-43.,3636. Hylton N, Allen C. The development and use of SPIO Lycra compression bracing in children with neuromotor deficits. Pediatr Rehabil 1997; 1(2): 109-16.,3737. Attard J, Rithalia S. A review of the use of Lycra pressure orthoses for children with cerebral palsy. Int J Ther Rehabil 2004; 11(3): 120-6. https://doi.org/10.12968/ijtr.2004.11.3.13384
https://doi.org/10.12968/ijtr.2004.11.3....
,3838. Cusick B. Developmental orthopedics, Part IIIb. Frontal-plane developmental changes in the torso and hips. NDTA 2007; 14(4): 15-24.,3939. Bailes AF, Greve K, Schmitt LC. Changes in two children with cerebral palsy after intensive suit therapy: a case report. Pediatr Phys Ther 2010; 22(1): 76-85. https://doi.org/10.1097/PEP.0b013e3181cbf224
https://doi.org/10.1097/PEP.0b013e3181cb...
,4040. Liptak GS. Complementary and alternative therapies for cerebral palsy. Ment Retard Dev Disabil Res Rev 2005; 11(12): 156-63. https://doi.org/10.1002/mrdd.20066
https://doi.org/10.1002/mrdd.20066...
,4141. Martins E, Cordovil R, Oliveira R, Letras S, Lourenço S, Pereira I, etal. Efficacy of suit therapy on functioning in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol 2016; 58(4): 348-60. https://doi.org/10.1111/dmcn.12988
https://doi.org/10.1111/dmcn.12988...
,4242. Russell DJ, Rosenbaum PL, Avery LM, Lane M. The Gross Motor Function Measure (GMFM-66 and GMFM-88) User's Manual. Londres: MacKeith Press; 2002.,4343. Bailes AF, Greve K, Burch CK, Reder R, Lin L, Huth MM. The effect of suit wear during an intensive therapy program in children with cerebral palsy. Pediatr Phys Ther 2011; 23(2): 136-42. https://doi.org/10.1097/PEP.0b013e318218ef58
https://doi.org/10.1097/PEP.0b013e318218...
, is presented with limited effectiveness.

The limitations of the present study need to be addressed. In the perspective of scientific evidence regarding the efficacy of the Therasuit Method, there was a shortage of robust studies on the subject, which reinforces the need to advocate the use of therapies offered by SUS.

The use of the SIGTAP table as a source of treatment costs offered by SUS can be considered with underestimated values, and may present different values in relation to the current prices practiced. Nevertheless, it can be useful as a source of comparison for purposes of proportionalisation of one cost in relation to another from the perspective of the SUS, as a source of payment.

It was not possible to see the judicial decision in all the processes evaluated, since in one of them the information was not attached. In addition, the research was conducted with a small number of processes, which does not necessarily represent the entire state. However,this information can serve as a useful indicator not only to direct analyses of the epidemiological profile of the state but also to foster discussions and studies to understand why treatments standardized by SUS are not used as an option for the therapeutics of these patients. It may also stimulate the creation of new public policies or the reformulation of existing ones, by means of aid, for example, in the decisions on incorporation by the SUS, according to Law No. 12.401 of April 28th, 2011.

Furthermore, the need for consistent information about the efficacy and safety of the judicial method is emphasized, considering the existence of treatments offered by SUS for the same clinical condition.

There is also evidence of a lack of monitoring of the investment result, i.e., of the effectiveness and efficiency of public investment, considering the proportionality context in relation to the total budget allocated to health in the state of Rio de Janeiro.

CONCLUSION

The analysis of the Therasuit Method judicialization in the scope of the state of Rio de Janeiro found a high index of deferred processes, despite the indication of other therapeutic options available by the SUS, resulting in a high cost spent by the Public Power to attend a minority of patients.

Finally, given that the legislation advocates the formulation of public policies that meet the highest number of individuals according to the local epidemiological profile, together with the participation of society, and considering financial aspects4646. Brasil. Presidência da República. Lei nº 8.080, de 19 de setembro de 1990. Dispõe sobre as condições para a promoção, proteção e recuperação da saúde, a organização e o funcionamento dos serviços correspondentes e dá outras providências. Brasil; 1990., it is imperative to conduct future studies about the reflection on measures of health benefit, such as the concept of willingness to pay.

Identification/approval number of the Research Ethics Committee: The study was submitted and approved under the number 75533317.9.0000.5272 to the Ethics and Research Committee of the National Institute of Cardiology.

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  • Financial support: none

History

  • Received
    13 Dec 2017
  • Reviewed
    20 Apr 2018
  • Accepted
    23 Apr 2018
  • Online publication
    14 Mar 2019
Associação Brasileira de Pós -Graduação em Saúde Coletiva São Paulo - SP - Brazil
E-mail: revbrepi@usp.br