Can hydrophilic coated catheters be beneficial for the public healthcare system in Brazil? - A cost-effectiveness analysis in patients with spinal cord injuries

Truzzi, José Carlos; Teich, Vanessa; Pepe, Camila

doi:10.1590/S1677-5538.IBJU.2017.0221

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Sumário

Original Article • IBJUInt. braz j urol 44 (1) • Jan-Feb 2018 • https://doi.org/10.1590/S1677-5538.IBJU.2017.0221 copy

Can hydrophilic coated catheters be beneficial for the public healthcare system in Brazil? - A cost-effectiveness analysis in patients with spinal cord injuries

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Introduction

Detrusor sphincter dyssynergia affects 70% to 80% of all spinal cord injury patients, resulting in increased risk of urinary tract infections (UTIs) and potential exposure to antimicrobial resistance. In Brazil, local guidelines recommend intermittent catheterization as the best method for bladder emptying, and two catheter types are available: the conventional uncoated PVC and the hydrophilic coated catheters.

Objective

To evaluate the cost-effectiveness of two types of catheters for intermittent catheterization from the perspective of the Brazilian public healthcare system.

Materials and Methods

A Markov model was used to evaluate cost-effectiveness in those with spinal cord injuries. A primary analysis was conducted on all possible adverse events, and a secondary analysis was performed with urinary tract infections as the only relevant parameter. The results were presented as cost per life years gained (LYG), per quality-adjusted life years (QALY) and per number of urinary tract infections (UTIs) avoided.

Results

The base scenario of all adverse events shows a cost-effective result of hydrophilic coated catheters compared to uncoated PVC catheters at 57,432 BRL (Brazilian Reais) per LYG and 122,330 BRL per QALY. The secondary scenario showed that the use of hydrophilic coated catheters reduces the total number of UTIs, indicating that an additional cost of hydrophilic coated catheters of 31,240 BRL over a lifetime will reduce lifetime UTIs by 6%.

Conclusions

Despite the higher unit value, the use of hydrophilic coated catheters is a cost-effective treatment from the perspective of the Brazilian public healthcare system.

Keywords
Cost-Benefit Analysis; Spinal Cord Injuries; Intermittent Urethral Catheterization; Urinary Tract Infections

Source	Catheter type	Patients (N)	UTI Incidence	Mean Followup months	UTIs per month	Weighted average ¹ 1 number of patients x UTI per month	Relative Risk (RR): Hydrophilic coated vs PVC
UTI rates in the uncoated PVC catheter population
Cardenas et al. (2011) ^a	Conventional PVC	114	-	3-6	0.48	54.49	-
Sarica et al. (2010) ^b	Conventional PVC	21	4.00	1.5	2.67	56.00	-
Cardenas et al. (2009) ^c	Conventional PVC	23	1.65	12	0.14	3.16	-
De Ridder et al. (2005) ^d	Conventional PVC	61	-	12	0.38	23.18	-
	Total	219
UTI rates in the hydrophilic coated catheter population
Cardenas et al. (2011) ^a	Hydrophilic coated	105	-	3-6	0.48	50.30	1.00
Sarica et al. (2010) ^b	Hydrophilic coated	21	1.00	1.5	0.67	14.00	0.25
Cardenas et al. (2009) ^c	Hydrophilic coated	22	0.77	12	0.06	1.41	0.47
De Ridder et al. (2005) ^d	Hydrophilic coated	61	-	12	0.34	20.74	0.89
	Total	209
Hydrophilic-coated versus conventional uncoated pvc catheter treatment effect							0.84 (16% reduction) ² 2 mean relative risk weighted by the number of patients in each study - (RR a X N a) + (RR b X N b) + (RR c X N c) + (RR d X N d) / (N a + N b + N c + N d)

Parameters		Value	Source/assumption
Monthly adverse event rates (conventional PVC)
	Urinary tract infections	62.48%	De Rider et al. (2005), Cardenas et al. (2009) Cardenas et al. (2011), Sarica et al. (2010)
	Bladder stones	0.12%	Perrouin-Verbe et al. (1995), Chai et al. (1995)
	Kidney stones	0.12%	Assumed same bladder stones
	Urethral injury	0.19%	Perrouin-Verbe et al. (1995), Chai et al. (1995)
	Urosepsis	0.32%	Perrouin-Verbe et al. (1995), Chai et al. (1995), Weld et al. (2000)
Treatment effect (hydrophilic coated vs PvC)
	Urinary tract infections	0.84	Table 1
	Bladder stones	0.90	Clark et al. (2016)
	Kidney stones	0.90	Clark et al. (2016)
	Urethral injury	0.90	Clark et al. (2016)
	Urosepsis	0.90	Clark et al. (2016)
Costs
	Monthly cost, PVC catheter^* * Assuming the practice of four catheterizations per day for bladder emptying and the use of half a tube of lubricant per catheterization (2 tubes per day)	R$ 74.27	Banco de Preços em Saúde (¹⁹19. Ministério da Saúde (Brasil). Banco de Preços em Saúde (BPS) [Internet]. Portal da Saúde. 2016. Available at. <http://portalsaude.saude.gov.br/index.php/cidadao/principal/banco-de-precos-em-saude> http://portalsaude.saude.gov.br/index.ph... )
	Monthly cost, hydrophilic coated catheter^* * Assuming the practice of four catheterizations per day for bladder emptying and the use of half a tube of lubricant per catheterization (2 tubes per day)	R$ 608.27	Market Price
	Monthly cost, lubricant^* * Assuming the practice of four catheterizations per day for bladder emptying and the use of half a tube of lubricant per catheterization (2 tubes per day)	R$ 132.75	Banco de Preços em Saúde (¹⁹19. Ministério da Saúde (Brasil). Banco de Preços em Saúde (BPS) [Internet]. Portal da Saúde. 2016. Available at. <http://portalsaude.saude.gov.br/index.php/cidadao/principal/banco-de-precos-em-saude> http://portalsaude.saude.gov.br/index.ph... )
	Urinary tract infections, per event	R$ 554.16	SIGTAP/ TABNET (²⁰20. Ministério da Saúde (Brasil). Sistema de Gerenciamento e da Tabela de Procedimentos, Medicamentos e OPM do SUS [Internet]. Portal da Saúde. 2016. Available at. <http://sigtap.datasus.gov.br> http://sigtap.datasus.gov.br... , ²¹21. Ministério da Saúde (Brasil). Tabnet-DATASUS [Internet]. Portal da Saúde. 2016. Available at. <http://www2.datasus.gov.br/DATASUS/index.php?area=02> http://www2.datasus.gov.br/DATASUS/index... )
	Urinary tract infections, antibiotics^ Antibiotic therapy – 1st line (ciprofloxacin 500 mg every 12h for 7 days, oral use; resistance rate = 34%); Antibiotic therapy – 2nd line (cefuroxime 500 mg every 12h for 7 days, oral use; resistance rate = 3.4%) and Antibiotic therapy – 3rd line (ceftriaxone 1 g every 12h for 7 days, parenteral).	R$ 60.50	Banco de Preços em Saúde (¹⁹19. Ministério da Saúde (Brasil). Banco de Preços em Saúde (BPS) [Internet]. Portal da Saúde. 2016. Available at. <http://portalsaude.saude.gov.br/index.php/cidadao/principal/banco-de-precos-em-saude> http://portalsaude.saude.gov.br/index.ph... )
	Urosepsis	R$ 708.36	SIGTAP/ TABNET (²⁰20. Ministério da Saúde (Brasil). Sistema de Gerenciamento e da Tabela de Procedimentos, Medicamentos e OPM do SUS [Internet]. Portal da Saúde. 2016. Available at. <http://sigtap.datasus.gov.br> http://sigtap.datasus.gov.br... , ²¹21. Ministério da Saúde (Brasil). Tabnet-DATASUS [Internet]. Portal da Saúde. 2016. Available at. <http://www2.datasus.gov.br/DATASUS/index.php?area=02> http://www2.datasus.gov.br/DATASUS/index... )
	Urethral injury	R$ 605.33	SIGTAP/ TABNET (²⁰20. Ministério da Saúde (Brasil). Sistema de Gerenciamento e da Tabela de Procedimentos, Medicamentos e OPM do SUS [Internet]. Portal da Saúde. 2016. Available at. <http://sigtap.datasus.gov.br> http://sigtap.datasus.gov.br... , ²¹21. Ministério da Saúde (Brasil). Tabnet-DATASUS [Internet]. Portal da Saúde. 2016. Available at. <http://www2.datasus.gov.br/DATASUS/index.php?area=02> http://www2.datasus.gov.br/DATASUS/index... )
	Kidney stones	R$ 524.30	SIGTAP/ TABNET (²⁰20. Ministério da Saúde (Brasil). Sistema de Gerenciamento e da Tabela de Procedimentos, Medicamentos e OPM do SUS [Internet]. Portal da Saúde. 2016. Available at. <http://sigtap.datasus.gov.br> http://sigtap.datasus.gov.br... , ²¹21. Ministério da Saúde (Brasil). Tabnet-DATASUS [Internet]. Portal da Saúde. 2016. Available at. <http://www2.datasus.gov.br/DATASUS/index.php?area=02> http://www2.datasus.gov.br/DATASUS/index... )
	Bladder stones	R$ 721.95	SIGTAP/ TABNET (²⁰20. Ministério da Saúde (Brasil). Sistema de Gerenciamento e da Tabela de Procedimentos, Medicamentos e OPM do SUS [Internet]. Portal da Saúde. 2016. Available at. <http://sigtap.datasus.gov.br> http://sigtap.datasus.gov.br... , ²¹21. Ministério da Saúde (Brasil). Tabnet-DATASUS [Internet]. Portal da Saúde. 2016. Available at. <http://www2.datasus.gov.br/DATASUS/index.php?area=02> http://www2.datasus.gov.br/DATASUS/index... )
	Major renal impairment, per month	R$ 82.60	SIGTAP/ TABNET (²⁰20. Ministério da Saúde (Brasil). Sistema de Gerenciamento e da Tabela de Procedimentos, Medicamentos e OPM do SUS [Internet]. Portal da Saúde. 2016. Available at. <http://sigtap.datasus.gov.br> http://sigtap.datasus.gov.br... , ²¹21. Ministério da Saúde (Brasil). Tabnet-DATASUS [Internet]. Portal da Saúde. 2016. Available at. <http://www2.datasus.gov.br/DATASUS/index.php?area=02> http://www2.datasus.gov.br/DATASUS/index... )
	Renal failure, per month	R$ 2,589.02	SIGTAP/ TABNET (²⁰20. Ministério da Saúde (Brasil). Sistema de Gerenciamento e da Tabela de Procedimentos, Medicamentos e OPM do SUS [Internet]. Portal da Saúde. 2016. Available at. <http://sigtap.datasus.gov.br> http://sigtap.datasus.gov.br... , ²¹21. Ministério da Saúde (Brasil). Tabnet-DATASUS [Internet]. Portal da Saúde. 2016. Available at. <http://www2.datasus.gov.br/DATASUS/index.php?area=02> http://www2.datasus.gov.br/DATASUS/index... )
Utility decrements
	Urinary tract infection	0.060	NICE Model (¹⁷17. Bermingham SL, Hodgkinson S, Wright S, Hayter E, Spinks J, Pellowe C. Intermittent self catheterisation with hydrophilic, gel reservoir, and non-coated catheters: a systematic review and cost effectiveness analysis. BMJ. 2013;346:e8639.)
	Urinary tract infection, resistant	0.104	NICE Model (¹⁷17. Bermingham SL, Hodgkinson S, Wright S, Hayter E, Spinks J, Pellowe C. Intermittent self catheterisation with hydrophilic, gel reservoir, and non-coated catheters: a systematic review and cost effectiveness analysis. BMJ. 2013;346:e8639.)
	Kidney stones	0.050	Clark et al. (2015)
	Bladder stones	0.050	Clark et al. (2015)
	Urethral injury	0.104	NICE Model (¹⁷17. Bermingham SL, Hodgkinson S, Wright S, Hayter E, Spinks J, Pellowe C. Intermittent self catheterisation with hydrophilic, gel reservoir, and non-coated catheters: a systematic review and cost effectiveness analysis. BMJ. 2013;346:e8639.)
	Urosepsis	0.160	NICE Model (¹⁷17. Bermingham SL, Hodgkinson S, Wright S, Hayter E, Spinks J, Pellowe C. Intermittent self catheterisation with hydrophilic, gel reservoir, and non-coated catheters: a systematic review and cost effectiveness analysis. BMJ. 2013;346:e8639.)
	Major renal impairment	0.155	NICE Model (¹⁷17. Bermingham SL, Hodgkinson S, Wright S, Hayter E, Spinks J, Pellowe C. Intermittent self catheterisation with hydrophilic, gel reservoir, and non-coated catheters: a systematic review and cost effectiveness analysis. BMJ. 2013;346:e8639.)
	Renal failure	0.250	NICE Model (¹⁷17. Bermingham SL, Hodgkinson S, Wright S, Hayter E, Spinks J, Pellowe C. Intermittent self catheterisation with hydrophilic, gel reservoir, and non-coated catheters: a systematic review and cost effectiveness analysis. BMJ. 2013;346:e8639.)
Mortality multipliers
	Urinary tract infection	0.000	Model structure
	Urinary tract infection, resistant^* ***** Resistance rate to ciprofloxacin = 34%.	145.270	Clark et al. (2015)
	Urinary tract infection, weighted^** ****** s 145.2734% + 0.00*66%	49.390	Calculated based on Schito et al. (2009) (¹³13. Schito GC, Naber KG, Botto H, Palou J, Mazzei T, Gualco L, et al. The ARESC study: an international survey on the antimicrobial resistance of pathogens involved in uncomplicated urinary tract infections. Int J Antimicrob Agents. 2009;34:407-13.)
	Urosepsis	797.600	Clark et al. (2015)
	Major renal impairment	18.000	Clark et al. (2015)
	Renal failure	54.000	Clark et al. (2015)

	Cost (BRL)	QALYs	LYG	UTI
Conventional PVC	17,255	2.550	5.689	54.73
Hydrophilic coated	48,476	2.805	6.233	51.53
Incremental values	31,221	0.255	0.544	-3.20
ICER (BRL/QALY gained)		122,330 BRL per QALY
ICER (BRL/LYG)		57,432 BRL per LYG

	Cost (BRL)	QALYs	LYG	UTI
Conventional PVC	17,255	2.550	5.689	54.73
Hydrophilic coated	48,495	2.805	6.233	51.53
Incremental values	31,240	0.255	0.544	-3.20
ICER (BRL/QALY gained)		122,406 BRL per QALY
ICER (BRL/LYG)		57,468 BRL per LYG
ICER (BRL/UTI avoided)		9,778 BRL saved per UTI avoided

Parameters	Value tested	ICER (BRL/QALY)	Source
Deterministic results		122,330	-
Lubricant tube per day
Base case	2	-	Table 2
Alternative	4	86,831	ANVISA guideline
Alternative	1	140,079	Assumed
Resistance level for antibiotics
Base case	34%	-	D'Addazio et al. (2015), Table 2
Alternative	16%	122,527	Kiffer et al. (2011)
Alternative	45%	122,206	Assumption
UTI reduction ^* * The studies come with different UTI rates based on published information
Base case	16%	-	Table 1
	26%	76,796	Li et al. (2013)
Alternative	53%	40,188	Community data, Cardenas et al. (2009)

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[1] Correspondence address: José Carlos Truzzi, MD, PhD, Rua Diogo de Faria, 775 / 84 - Vila Clementino, São Paulo, SP, 01407-200, Brasil. Telephone: + 55 11 9 8181-2052 E-mail: jctruzzi@hotmail.com