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Photobiomodulation for Oral Mucositis – A Microcosting and Budget Impact Analysis from a Brazilian Perspective

ABSTRACT

Objective:

To measure the costs of preventive and therapeutic protocols of Photobiomodulation (PBM) for oral mucositis (OM) and their budgetary impact on Brazil’s Ministry of Health (BMH).

Material and Methods:

A partial economic analysis was performed to estimate the costs using a bottom-up approach from a social perspective. Monetary values were assigned in Brazilian reais (BRL). The costs of the preventive protocol were calculated for five, 30, and 33 consecutive PBM sessions, depending on the antineoplastic treatment instituted. The costs of the therapeutic protocol were calculated for 5 or 10 sessions. The annual financial and budgetary impact was calculated considering the groups of oncologic patients with a higher risk of development of OM, such as those with head and neck and hematological cancer and pediatric patients.

Results:

The cost of a PBM session was estimated at BRL 23.75. The financial impact of providing one preventive protocol per year for all oncologic patients would be BRL 14,282,680.00, 0.030% of the estimated budget for hospital and outpatient care of the BMH in 2022. The financial and budgetary impacts of providing one treatment for OM for all patients in one year would be BRL 2,225,630.31 (0.005%, most optimistic scenario) and BRL 4,451,355.63 (0.009%, most pessimistic scenario).

Conclusion:

The budgetary impact of implementing PBM protocols in the Brazilian Healthcare System is small, even in a pessimistic scenario.

Keywords:
Low-Level Light Therapy; Stomatitis; Oncology Service, Hospital; Models, Economic

Introduction

Cancer is a highly incident public health issue, especially in developing countries, and is the second leading cause of death worldwide[11 Instituto Nacional do Câncer. José Alencar Gomes da Silva. Estimativa 2016: incidência de câncer no Brasil. Rio de Janeiro: INCA, 2015. 122p. [In Portuguese].]. According to data from the Global Cancer Observatory of the International Agency for Research on Cancer (IARC), through the database GLOBOCAN for 185 countries and 36 types of cancer, for the year 2020, there were estimated 19.3 million new cases and 10 million cancer deaths worldwide. Considering that national rates estimated remain constant, a burden of cancer incidence is predicted for 2040, with an increase of 47% worldwide[22 Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2021; 71(3):209-249. https://doi.org/10.3322/caac.21660
https://doi.org/10.3322/caac.21660...
, 33 Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Piñeros M, Znaor A, et al. Cancer statistics for the year 2020: An overview. Int J Cancer 2021; 149:778-789. https://doi.org/10.1002/ijc.33588
https://doi.org/10.1002/ijc.33588...
].

The current oncological treatment modalities include surgery, chemotherapy, radiotherapy, or a combined approach. Radiotherapy and chemotherapy promote the inhibition of cell division in tumor cells but may also damage healthy cells[44 Curra M, Soares Junior LAV, Martins MD, Santos PSDS. Chemotherapy protocols and incidence of oral mucositis. An integrative review. Einstein 2018; 16(1):eRW4007. https://doi.org/10.1590/s1679-45082018rw4007
https://doi.org/10.1590/s1679-45082018rw...
]. The oral mucosa is sensitive to radiotherapy and some chemotherapy protocols, which often trigger the onset of oral mucositis (OM). OM consists of an acute and painful inflammation clinically manifested as erythema, scaling, or ulcers. It is one of the most debilitating comorbidities affecting cancer patients[55 Ritwik P. Dental care for patients with childhood cancers. Ochsner J 2018; 18(4):351-357. https://doi.org/10.31486/toj.18.0061
https://doi.org/10.31486/toj.18.0061...
].

Patients experiencing severe oral mucositis (SOM) may need to interrupt the scheduled antineoplastic treatment and require support medication and parenteral nutrition, which frequently culminates in a more extended hospital stay and a more significant economic burden. Annually, at least 20% of cancer patients have their survival reduced by up to 5 years as a direct impact of OM. This condition alone is responsible for an annual increment of USD 4.9 billion in the costs of antineoplastic treatments[66 McCullough RW. US oncology-wide incidence, duration, costs and deaths from chemoradiation mucositis and antimucositis therapy benefits. Future Oncol 2017; 13(30):2823-2852. https://doi.org/10.2217/fon-2017-0418
https://doi.org/10.2217/fon-2017-0418...
]. Hence, the management of OM should be considered a priority in cancer care.

Previous studies have demonstrated that permanent oral health care reduces SOM-related interruptions in antineoplastic treatments[77 Ribeiro ILA, de Castro RD, Costa RC, Damascena LCL, de Lucena NNN, Maracajá PMB, et al. Integrated oral care contributes positively to the course of treatment of oncopediatric patients. Eur J Pediatr 2021; 180(9):2757-2764. https://doi.org/10.1007/s00431-021-04024-z
https://doi.org/10.1007/s00431-021-04024...
]. To date, Photobiomodulation (PBM) using low-level light therapy is the most indicated intervention for preventing and treating OM[88 Mallick S, Benson R, Rath GK. Radiation-induced oral mucositis: a review of current literature on prevention and management. Eur Arch Otorhinolaryngol 2016; 273(9): 2285-2293. https://doi.org/10.1007/s00405-015-3694-6
https://doi.org/10.1007/s00405-015-3694-...
]. The laser light induces a better response to mucosal inflammation while ameliorating painful symptoms and edema. As a result, it promotes biostimulation and wound healing[99 Figueiredo ALP, Lins L, Cattony AC, Falcão AFP. Laser therapy in the control of oral mucositis: A meta-analysis. Rev Assoc Med Bras 2013; 59(5):467-474. https://doi.org/10.1016/j.ramb.2013.08.003
https://doi.org/10.1016/j.ramb.2013.08.0...
, 1010 Jadaud E, Bensadoun R. Low-level laser therapy: a standard of supportive care for cancer therapy-induced oral mucositis in head and neck cancer patients? Laser Ther 2012; 21(4):297-303. https://doi.org/10.5978/islsm.12-RE-01
https://doi.org/10.5978/islsm.12-RE-01...
].

The main advantage of PBM for the management of OM is its safety. In general, no adverse effects are reported, and the treatment is easy to apply, fast, non-invasive, and painless, which increases patient acceptability. However, adherence may be impaired in cases of limited mouth opening or among individuals with post-chemotherapy nausea and emesis[1111 Gobbo M, Merigo E, Arany PR, Bensadoun RJ, Santos-Silva AR, Gueiros LA, et al. Quality assessment of PBM protocols for oral complications in head and neck cancer patients: Part 1. Front Oral Health 2022; 3:945718. https://doi.org/10.3389/froh.2022.945718
https://doi.org/10.3389/froh.2022.945718...
]. In addition, psychological conditioning among pediatric patients may be required throughout the treatment course[1212 Gobbo M, Verzegnassi F, Ronfani L, Zanon D, Melchionda F, Bagattoni S, et al. Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT. Pediatr Blood Cancer 2018; 65(8):e27098. https://doi.org/10.1002/pbc.27098
https://doi.org/10.1002/pbc.27098...
].

The Diagnostic and Therapeutic Guidelines for Head and Neck Cancer (Ordinance SAS/MS No. 516, of 17 June 2015) recommends using PBM to treat and prevent OM lesions. The intervention has been successfully implemented across several oncology centers in Brazil[77 Ribeiro ILA, de Castro RD, Costa RC, Damascena LCL, de Lucena NNN, Maracajá PMB, et al. Integrated oral care contributes positively to the course of treatment of oncopediatric patients. Eur J Pediatr 2021; 180(9):2757-2764. https://doi.org/10.1007/s00431-021-04024-z
https://doi.org/10.1007/s00431-021-04024...
, 1313 Salvador DRN, Soave DF, Sacono NT, de Castro EF, Silva GBL, E Silva LP, et al. Effect of photobiomodulation therapy on reducing the chemo-induced oral mucositis severity and on salivary levels of CXCL8/interleukin 8, nitrite, and myeloperoxidase in patients undergoing hematopoietic stem cell transplantation: A randomized clinical trial. Lasers Med Sci 2017; 32(8):1801-1810. https://doi.org/10.1007/s10103-017-2263-1
https://doi.org/10.1007/s10103-017-2263-...
, 1414 Martins AFL, Nogueira TE, Morais MO, Oton-Leite AF, Valadares MC, Batista AC, et al. Effect of photobiomodulation on the severity of oral mucositis and molecular changes in head and neck cancer patients undergoing radiotherapy: A study protocol for a cost-effectiveness randomized clinical trial. Trials 2019; 20(1):97. https://doi.org/10.1186/s13063-019-3196-8
https://doi.org/10.1186/s13063-019-3196-...
], considering that, among the possible therapies available to manage OM, it has the highest level of scientific evidence and is also recommended by the Multinational Association for Supportive Care in Cancer (MASCC)[1212 Gobbo M, Verzegnassi F, Ronfani L, Zanon D, Melchionda F, Bagattoni S, et al. Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT. Pediatr Blood Cancer 2018; 65(8):e27098. https://doi.org/10.1002/pbc.27098
https://doi.org/10.1002/pbc.27098...
, 1515 Noirrit-Escclassan E, Valera MC, Vignes E, Munzer C, Bonal S, Daries M, et al. Photobiomodulation with a combination of two wavelengths in the treatment of oral mucositis in children: The PEDIASE feasibility study. Arch Pediatr 2019; 26(5):268-274. https://doi.org/10.1016/j.arcped.2019.05.012
https://doi.org/10.1016/j.arcped.2019.05...
, 1616 Miranda-Silva W, Gomes-Silva W, Zadik Y, Yarom N, Al-Azri AR, Hong CHL, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis: sub-analysis of current interventions for the management of oral mucositis in pediatric cancer patients. Support Care Cancer 2021; 29(7):3539-3562. https://doi.org/10.1007/s00520-020-05803-4
https://doi.org/10.1007/s00520-020-05803...
, 1717 Nunes LFM, de Arruda JA, Souza AF, Costa Silva RC, Moreira Lanza CR, Kakehasi FM, et al. Prophylactic photobiomodulation therapy using 660 nm diode laser for oral mucositis in pediatric patients under chemotherapy: 5-year experience from a Brazilian referral service. Lasers Med Sci 2020; 35(8):1857-1866. https://doi.org/10.1007/s10103-020-03060-9
https://doi.org/10.1007/s10103-020-03060...
]. Economic analyses have indicated that PBM is cost-effective both for the prevention and treatment of OM, thereby optimizing the financial costs related to hospitalization, nutritional support, and the use of opioids[1818 Kauark-Fontes E, Rodrigues-Oliveira L, Epstein JB, Faria KM, Araújo ALD, Gueiros LAM, et al. Cost-effectiveness of photobiomodulation therapy for the prevention and management of cancer treatment toxicities: A systematic review. Support Care Cancer 2021; 29(6):2875-2884. https://doi.org/10.1007/s00520-020-05949-1
https://doi.org/10.1007/s00520-020-05949...
].

In 2017, Brazil's Ministry of Health (BMH) team discussed, within the scope of the 55th Meeting of the National Committee for the Incorporation of Technologies (CONITEC), the incorporation of PBM as a standard procedure in the Brazilian Healthcare System (BHS). A budgetary impact analysis was recommended to incorporate this technology in the public health sector. From this perspective, this study developed a micro-cost and budgetary impact analysis of the implementation of PBM for the treatment/prevention of OM induced by radiotherapy or chemotherapy during permanent oral health care in cancer patients admitted to the BHS.

Material and Methods

Study Design

This study was designed as a partial economic assessment based on the collection of publicly available secondary data. The survey was conducted following the Methodological Guidelines for Economic Evaluations of the Brazilian Ministry of Health[1919 Brasil. Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Diretrizes metodológicas: Diretriz de Avaliação Econômica / Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos, Departamento de Ciência e Tecnologia. 2. ed. Brasília: Ministério da Saúde; 2014. 132 p. [In Portuguese].] and the Consolidated Standards for Reporting Health Economic Evaluations (CHEERS)[2020 Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR health economic evaluation publication guidelines good reporting practices task force. Value Health 2013; 16(2):231-250. https://doi.org/10.1016/j.jval.2013.02.002
https://doi.org/10.1016/j.jval.2013.02.0...
].

Data Collection

A microcosting analysis with a bottom-up approach estimated the direct costs of PBM for OM. The perspective of the analysis was that of Brazil's Ministry of Health. The direct costs of each PBM session were estimated in three stages: identification, quantification, and monetization. A panel of specialists with five expert professionals was responsible for identifying the parameters and inputs needed to perform the technique within the scope of the BHS.

For the quantification of inputs, consumer goods [personal protective equipment (PPE) and disposable materials] were accounted for in each session. The low-power laser device, considered a durable good, had an estimated lifespan of 5 years[1919 Brasil. Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Diretrizes metodológicas: Diretriz de Avaliação Econômica / Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos, Departamento de Ciência e Tecnologia. 2. ed. Brasília: Ministério da Saúde; 2014. 132 p. [In Portuguese].]. Its percent usage was divided per session. The dentist's workforce was quantified by the quotient between the weekly working hours of a hospital dentist (30 hours) and the estimated time for each session. The duration of each PBM session was estimated at 20 minutes.

The monetization stage searched for Brazilian representative values for each necessary input. For consumer goods and durable goods, a price survey was carried out in the three major virtual stores of dental products nationwide (Dental Cremer, Dental Speed, and Surya Dental). The average of the prices obtained the estimated value for each item. For durable goods, the total value of each item was divided according to the quantification previously described. The professional workforce was valued based on the salary paid to a dentist by the Brazilian Company of Hospital Services (Empresa Brasileira de Serviços Hospitalares - EBSERH).

The total cost of the preventive and therapeutic PBM protocols for OM was calculated by multiplying the number of sessions by the monetary value of one session. Considering that the number of sessions varies according to the severity of the cases[1111 Gobbo M, Merigo E, Arany PR, Bensadoun RJ, Santos-Silva AR, Gueiros LA, et al. Quality assessment of PBM protocols for oral complications in head and neck cancer patients: Part 1. Front Oral Health 2022; 3:945718. https://doi.org/10.3389/froh.2022.945718
https://doi.org/10.3389/froh.2022.945718...
], the total treatment costs were estimated for a more optimistic scenario, where five sessions would be necessary for the remission of the condition, and for a more pessimistic scenario, in which ten sessions would be required for the complete remission of OM lesions. The costs of the preventive protocol were calculated for five sessions for patients undergoing chemotherapy treatments, 30 sessions for patients undergoing hematopoietic stem cell transplantation (HSCT), and 33 sessions for patients receiving radiotherapy in the head and neck region[1212 Gobbo M, Verzegnassi F, Ronfani L, Zanon D, Melchionda F, Bagattoni S, et al. Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT. Pediatr Blood Cancer 2018; 65(8):e27098. https://doi.org/10.1002/pbc.27098
https://doi.org/10.1002/pbc.27098...
, 1414 Martins AFL, Nogueira TE, Morais MO, Oton-Leite AF, Valadares MC, Batista AC, et al. Effect of photobiomodulation on the severity of oral mucositis and molecular changes in head and neck cancer patients undergoing radiotherapy: A study protocol for a cost-effectiveness randomized clinical trial. Trials 2019; 20(1):97. https://doi.org/10.1186/s13063-019-3196-8
https://doi.org/10.1186/s13063-019-3196-...
].

As this is a partial economic analysis, without a temporal context, discounts and corrections for inflation were not included. Furthermore, costs directly related to building maintenance and lost productivity or out-of-pocket costs for patients and their families were not considered.

Next, the financial impact of the PBM protocol on the annual budget of the Brazilian Ministry of Health was measured. For this purpose, the groups of cancer patients most affected by OM lesions were considered: head and neck cancer patients, those with hematological neoplasms (submitted or not to HSCT), and pediatric patients[2121 Chaudhry HM, Bruce AJ, Wolf RC, Litzow MR, Hogan WJ, Patnaik MS, et al. The incidence and severity of oral mucositis among allogeneic hematopoietic stem cell transplantation patients: A systematic review. Biol Blood Marrow Transplant 2016;22(4):605-616. https://doi.org/10.1016/j.bbmt.2015.09.014
https://doi.org/10.1016/j.bbmt.2015.09.0...
, 2222 Wuketich S, Hienz SA, Marosi C. Prevalence of clinically relevant oral mucositis in outpatients receiving myelosuppressive chemotherapy for solid tumors. Support Care Cancer 2012; 20(1):175-183. https://doi.org/10.1007/s00520-011-1107-y
https://doi.org/10.1007/s00520-011-1107-...
, 2323 Farias Gabriel A, Silveira FM, Curra M, Schuch LF, Wagner VP, Martins MAT, et al. Risk factors associated with the development of oral mucositis in pediatric oncology patients: Systematic review and meta-analysis. Oral Dis 2022; 28(4):1068-1084. https://doi.org/10.1111/odi.13863
https://doi.org/10.1111/odi.13863...
]. The annual incidence of each group of cancer in Brazil was estimated from the average of the incidences of five consecutive years obtained via the Hospital Records of Cancer (RHC) platform of the National Cancer Institute (INCA, in Portuguese). The years selected for the search were 2014 to 2018, the last year the records were fully updated. The number of patients undergoing HSCT in 2018 was obtained through the Brazilian Transplant Registry, the official vehicle of the Brazilian Association of Organ Transplantation.

The costs of the preventive PBM protocol were calculated for 100% of the patients undergoing cancer therapy and were also simulated considering three possibilities (one, three, and six protocols per year). Patients with head and neck cancer and those undergoing HSCT are not eligible for more than one protocol per year.

For the therapeutic protocol, the incidence for each tumor group was determined through literature searches. It was estimated at 80% for patients with head and neck tumors[2424 Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, et al. Mucositis incidence, severity, and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol 2003; 66(3):253-262. https://doi.org/10.1016/s0167-8140(02)00404-8
https://doi.org/10.1016/s0167-8140(02)00...
], 28.5% among those with hematological neoplasms not submitted to HSCT[2525 Dutra LMRF, Araújo AM, Alves BLP, Santos EJF. Analysis of adverse reactions to chemotherapy in onco-hematologic patients. Braz J Dev 2022; 8(7):51362-51384. https://doi.org/10.34117/bjdv8n7-178 [In Portuguese].
https://doi.org/10.34117/bjdv8n7-178...
], 85% for patients with hematological cancer submitted to HSCT[2626 Barrach RH, Souza MP, Silva DP, Lopez PS, Montovani JC. Oral changes in individuals undergoing hematopoietic stem cell transplantation. Braz J Otorhinolaryngol 2015; 81(2):141-147. https://doi.org/10.1016/j.bjorl.2014.04.004
https://doi.org/10.1016/j.bjorl.2014.04....
], and 60% in pediatric cancer patients[2727 Pires HF, Bezerra PMM, Silva VB, Ribeiro ILA, Serpa EBM, Sousa SA, et al. Occurrence and severity of oral mucositis in Brazilian pediatric cancer patients. Pesqui Bras Odontopediatria Clin Integr 2020; 20:e5621. https://doi.org/10.1590/pboci.2020.085
https://doi.org/10.1590/pboci.2020.085...
]. The estimated number of patients needing PBM was calculated by the product of the prevalence of OM by the annual incidence of each type of tumor.

The estimated number of patients affected annually by OM was multiplied by the costs of treatment protocols in both scenarios. Nevertheless, most patients undergoing antineoplastic protocols are affected by OM more than once a year; hence, the costs were calculated for patients considering three different possibilities, as follows: one, three, and six PBM protocols per year.

The financial and budgetary impacts of the preventive and therapeutic PBM protocols were calculated considering the budget for hospital and outpatient care in the year 2022 (BRL 47.097 billion), according to data from the Transparency Portal (https://www.portaltransparencia.gov.br/funcoes/10-saude?ano=2022).

Results

PBM requires a few inputs, as shown in Table 1. Financial investment is required to acquire a low-power device, hire qualified personnel, and buy biosafety items. Despite its high investment value, the laser device has the lowest percentage of the final cost of the session (1.14% - BRL 0.27). Professional labor is the component that most impacts the costs (90.36% - BRL 21.46). The total estimated cost of a PBM session was BRL 23.75.

Table 1
Microcosting analysis of a single PBM session for the treatment of OM lesions.

The total cost of PBM depends on the number of required sessions. Regarding the preventive protocol, for patients with cancer in the head and neck region needing 33 preventive sessions, the costs of OM prevention will be BRL 783.75. As for adult patients undergoing transplantation, requiring 30 consecutive preventative sessions, the costs will be BRL 712.50. Considering the other adult and pediatric cancer patients for whom a preventive protocol of 5 sessions is adopted, the fees will be BRL 118.75. The costs of the therapeutic protocol in a more optimistic scenario were estimated at BRL 118.75, compared to BRL 237.50 in a more pessimistic scenario. Table 2 shows the sensitivity analysis performed to evaluate the treatment in different contexts.

Table 2
Sensitivity analysis of the cost (BRL) of the complete PBM protocol for OM lesions in two alternative scenarios.

The budgetary impact of OM management varies for each type of cancer, according to the prevalence of OM, and it also depends on the number of sessions instituted. Supposing that all individuals with hematological neoplasms (not transplanted) and childhood cancer were submitted to a PBM preventive protocol with five sessions, all individuals with head and neck cancer to 33 sessions, and all transplanted patients to 30 sessions, the budgetary impact of offer one protocol per year would be BRL 14,282,680.00. This amount corresponds to 0.030% of the budget for hospital and outpatient care in the Brazilian healthcare system in 2022 (Table 3). Considering steady cancer incidence rates and the worst-case scenario (6 treatments per year), implementing the preventive protocol for five years would have an estimated cost of BRL 399,944,775.00.

Table 3
The annual budgetary impact of a preventive protocol for OM (five PBM sessions). The main groups of cancer patients were considered, and the analysis was carried out from the perspective of the Brazilian Healthcare System.

In Brazil, an average of 14,797 patients with head and neck tumors are treated annually, of which 11,838 are estimated to be affected by OM. If these patients undergo PBM therapy (five sessions) at least once a year, the financial impact on the Ministry of Health's budget would be BRL 1,405,715.00. In a more pessimistic scenario, in which patients need 10 PBM sessions to remission lesions, the total cost would be BRL 2,811,525.00. If there is a need for more than one treatment per year, the impact increases, as seen in Tables 4 (most optimistic scenario) and 5 (most pessimistic scenario).

Table 4
The annual financial impact of a 5-session PBM protocol for OM lesions (most optimist scenario), considering three groups of cancer patients, from the perspective of the Brazilian Healthcare System.

In Brazil, hematological neoplasms affect an average of 10,857 adult patients yearly. Among them, 1,335 individuals need HSCT. These patients have a very high incidence of OM: approximately 1135 individuals will develop severe degrees of OM annually. The cost to ensure they receive the PBM therapeutic protocol is BRL 134,751.56 (5 sessions) and BRL 269,503.13 (10 sessions).

Childhood cancer affects an average of 5,083 children and adolescents (0-19 years) per year, with a higher prevalence of OM than that in adult patients. The estimates indicate that 3,050 Brazilian pediatric patients experience OM each year. Treating them would have an approximate cost of BRL 362,163.75 for a 5-session treatment and BRL 724,327.50 for a 10-session treatment.

From the perspective of the BHS, in a more optimistic scenario, one annual PBM treatment would have a financial and budgetary impact of BRL 2.225.630.31 and 0.005%. Considering the most pessimistic scenario, the economic and budgetary impact would be of BRL 4,451,355.63 and 0.010%, double (Tables 4 and 5).

Table 5
The annual financial impact of a 10-session PBM protocol for OM lesions (most pessimistic scenario), considering three groups of cancer patients, from the perspective of the Brazilian Healthcare System.

Discussion

The results of our study indicate that implementing PBM protocols into the Brazilian healthcare system would have a small budgetary impact. Even considering the most pessimistic scenario, in which the patient undergoes six annual treatments for a more severe condition, needing ten PBM sessions, the estimated budgetary impact would not exceed 0.053%. Likewise, the preventive protocol was also estimated to have a little economic burden. This scenario reveals that administering PBM for OM has excellent potential and viability for the healthcare system.

The benefits of this technology are well established. Campos et al.[2828 Campos TM, do Prado Tavares Silva CA, Sobral APT, Sobral SS, Rodrigues MFSD, Bussadori SK, et al. Photobiomodulation in oral mucositis in patients with head and neck cancer: a systematic review and meta-analysis followed by a cost-effectiveness analysis. Support Care Cancer 2020; 28(12):5649-5659. https://doi.org/10.1007/s00520-020-05613-8
https://doi.org/10.1007/s00520-020-05613...
] investigated the cost-effectiveness of the PBM to oral mucositis in patients with head and neck cancer. They demonstrated that the group submitted to preventive PBM had an incremental effectiveness of 132.2 compared to the placebo group. They found that the laser treatment costs were approximately US$ 7.22 per case avoided[2828 Campos TM, do Prado Tavares Silva CA, Sobral APT, Sobral SS, Rodrigues MFSD, Bussadori SK, et al. Photobiomodulation in oral mucositis in patients with head and neck cancer: a systematic review and meta-analysis followed by a cost-effectiveness analysis. Support Care Cancer 2020; 28(12):5649-5659. https://doi.org/10.1007/s00520-020-05613-8
https://doi.org/10.1007/s00520-020-05613...
]. Another study revealed that a specialized oral care program with PBM for patients undergoing HSCT reduced hospital costs and the frequency of severe degrees of OM[2929 Bezinelli LM, de Paula Eduardo F, da Graça Lopes RM, Biazevic MG, de Paula Eduardo C, Correa L, et al. Cost-effectiveness of the introduction of specialized oral care with laser therapy in hematopoietic stem cell transplantation. Hematol Oncol 2014; 32(1):31-39. https://doi.org/10.1002/hon.2050
https://doi.org/10.1002/hon.2050...
]. The PBM is also related to the decrease in radiotherapy interruptions due to OM and in scores of oral health-related quality of life in patients with head and neck cancer[3030 Lopes Martins AF, Nogueira TE, Morais MO, de Sousa-Neto SS, Oton-Leite AF, Valadares MC, et al. Cost-effectiveness randomized clinical trial on the effect of photobiomodulation therapy for prevention of radiotherapy-induced severe oral mucositis in a Brazilian cancer hospital setting. Support Care Cancer 2021; 29(3):1245-1256. https://doi.org/10.1007/s00520-020-05607-6
https://doi.org/10.1007/s00520-020-05607...
].

Although the costs of the preventive protocol exceed the costs of OM treatment, other expenditures are associated with the occurrence of OM. The dissemination of PBM for the prevention and treatment of cancer-related comorbidities can improve the patient’s quality of life[3131 Jabłoński P, Musiał M, Wiench R, Stefanik N, Olchowy C, Matys J, et al. Photobiomodulation therapy in the treatment of oral mucositis - A case report. Medicine 2022; 58(5):618. https://doi.org/10.3390/medicine58050618
https://doi.org/10.3390/medicine58050618...
], reduce the need for nasogastric or parenteral nutrition[3232 Vitale MC, Modaffari C, Decembrino N, Zhou FX, Zecca M, Defabianis P. Preliminary study in a new protocol for the treatment of oral mucositis in pediatric patients using hematopoietic stem cell transplantation (HSCT) and chemotherapy (CT). Lasers Med Sci 2017; 32(6):1423-1428. https://doi.org/10.1007/s10103-017-2266-y
https://doi.org/10.1007/s10103-017-2266-...
], maintain the patient's body weight[3333 Sousa Melo A, Andrade CL, de Lima Dantas JB, Medrado ARAP, Martins GB, Lima HR, Carrera M. Impact of photobiomodulation for oral mucositis on body weight and BMI of patients with head and neck cancer. Support Care Cancer 2022; 30(6):4897-4904. https://doi.org/10.1007/s00520-022-06899-6
https://doi.org/10.1007/s00520-022-06899...
], shorter hospital stays[77 Ribeiro ILA, de Castro RD, Costa RC, Damascena LCL, de Lucena NNN, Maracajá PMB, et al. Integrated oral care contributes positively to the course of treatment of oncopediatric patients. Eur J Pediatr 2021; 180(9):2757-2764. https://doi.org/10.1007/s00431-021-04024-z
https://doi.org/10.1007/s00431-021-04024...
, 3434 Bezerra PMM, Sampaio MEA, Dos Santos FG, Ribeiro ILA, Santiago BM, de Sousa SA, et al. The effectiveness of an oral health education and prevention program on the incidence and severity of oral mucositis in pediatric cancer patients: a non-randomized controlled study. Support Care Cancer 2021; 29(12):7877-7885. https://doi.org/10.1007/s00520-021-06387-3
https://doi.org/10.1007/s00520-021-06387...
] and, consequently, reduce hospital-related costs[1818 Kauark-Fontes E, Rodrigues-Oliveira L, Epstein JB, Faria KM, Araújo ALD, Gueiros LAM, et al. Cost-effectiveness of photobiomodulation therapy for the prevention and management of cancer treatment toxicities: A systematic review. Support Care Cancer 2021; 29(6):2875-2884. https://doi.org/10.1007/s00520-020-05949-1
https://doi.org/10.1007/s00520-020-05949...
]. Further statistical models should simulate the cost-opportunity relationship of the administration of PBM in patients undergoing cancer therapy.

The incremental costs associated with comorbidities related to cancer therapy are estimated at 4.9 billion US dollars[66 McCullough RW. US oncology-wide incidence, duration, costs and deaths from chemoradiation mucositis and antimucositis therapy benefits. Future Oncol 2017; 13(30):2823-2852. https://doi.org/10.2217/fon-2017-0418
https://doi.org/10.2217/fon-2017-0418...
]. Hence, preventing and treating OM in patients undergoing antineoplastic treatment can significantly reduce hospital-associated costs. The amount spent on PBM is substantially lower than the costs associated with the increase in hospital stay and other morbidities associated with the progression of OM lesions. Future studies should demonstrate the savings obtained with the implementation of this technology.

There are some challenges to the implementation of this treatment in the Brazilian healthcare system, such as (i) the incorporation of PBM in the table of procedures of the healthcare system, (ii) the acquisition of equipment by oncological hospital units, and (iii) the training of professionals capable of handling low-power laser equipment.

The incorporation of the protocols into the healthcare system will allow hospital units to register the procedures and agree on the transfer of resources between the federative departments. This can be a strategic approach to save and optimize financial resources. As for acquiring equipment, an initial investment in capital resources is required. Therefore, hospital units or outpatient clinics should raise capital resources in the approximate amount of BRL 5,000.00 (five thousand Brazilian reais) for each piece of equipment to be acquired. Although the capital acquisition resources are low, some services may experience difficulty obtaining the devices due to the item's origin or the bureaucracy for purchase via the public service.

The protocols can be incorporated into the healthcare system in different hospital modalities (hospitalization, day hospital, outpatient clinic). Furthermore, an additional percentage of the calculated amount should be added to account for inflationary losses, given the long periodicity with which the table of procedures is updated. Considering that the budgetary impact is small, the protocols can be registered in the table of procedures with approximately 25% of the amount estimated by the microcosting technique. When considering the procedure with a 25% higher amount (BRL 29.69), the financial and budgetary impact of the preventive protocol applied six times per year would be BRL 28,695,307.89 (0.06% of the budget), which is considered to be very low.

Previous studies have demonstrated the importance of having a dentist in the interdisciplinary team in reference to cancer hospitals. This strategy ensures specialized oral care surveillance for cancer patients, enabling the administration of preventive and therapeutic protocols for OM. The patient has a better prognosis when OM lesions are diagnosed and treated early[77 Ribeiro ILA, de Castro RD, Costa RC, Damascena LCL, de Lucena NNN, Maracajá PMB, et al. Integrated oral care contributes positively to the course of treatment of oncopediatric patients. Eur J Pediatr 2021; 180(9):2757-2764. https://doi.org/10.1007/s00431-021-04024-z
https://doi.org/10.1007/s00431-021-04024...
, 3434 Bezerra PMM, Sampaio MEA, Dos Santos FG, Ribeiro ILA, Santiago BM, de Sousa SA, et al. The effectiveness of an oral health education and prevention program on the incidence and severity of oral mucositis in pediatric cancer patients: a non-randomized controlled study. Support Care Cancer 2021; 29(12):7877-7885. https://doi.org/10.1007/s00520-021-06387-3
https://doi.org/10.1007/s00520-021-06387...
]. Thus, dental professionals should be qualified and trained on the peculiarities of cancer care, particularly regarding protocol indications, energy dosage, and device handling, as they should be trained on the management of OM with laser photobiomodulation, for instance, via online education platforms such as the UNA-SUS (in Portuguese), in Brazil.

Conclusion

The implementation of photobiomodulation for the treatment and prevention of oral mucositis would have very low financial and budgetary impacts on the Brazilian Healthcare system. Hence, the incorporation of PBM in this context is economically viable. The challenges posed by disseminating this technology from the healthcare system's perspective are manageable and can be overcome with effective management and education measures.

Data Availability

The data used to support the findings of this study can be made available upon request to the corresponding author.

  • Financial Support
    The present study received a research grant from the Coordination of Superior Level Staff Improvement (CAPES) of the Ministry of Education – Brazil.

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Edited by

Academic Editor: Wilton Wilney Nascimento Padilha

Publication Dates

  • Publication in this collection
    02 Feb 2024
  • Date of issue
    2024

History

  • Received
    23 Jan 2023
  • Reviewed
    18 Apr 2023
  • Accepted
    14 May 2023
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