Abstract
Introduction
Intramuscular injection of botulinum toxin (BoNTA) is one of the primary treatments for focal spasticity. This treatment is considered costly and the level of reimbursement by health insurance has been decreasing in many countries for several years. The aim of this study was to determine the real cost of treating spasticity with BoNTA and to compare this with the level of reimbursement by the national health insurance in France in 2008 and with a new fee, specific to the injection of BoNTA in ambulatory services.
Method
A single-center, retrospective study using the 2008 database from a French secondary-care day-hospital unit (treating spasticity in adults with sequelae of stroke, multiple sclerosis or traumatic brain injuries). The level of reimbursement by the French ministry of health for BoNTA treatment for adults with spasticity constituted the “calculated cost” and corresponded to the hospital’s “budget”. The “real cost” (incurred by the hospital) included the sum of staffing and material costs as well as the number of toxin vials used. The calculated costs for 2009 and 2013 were based on the levels of reimbursement during those years. The difference between real and calculated cost for 2009 and 2013 was estimated considering that the real cost of 2008 was stable.
Results
In 2008, 364 patients received BoNTA, resulting in 870 day-hospital admissions. The calculated cost was 459,056 €/year and the real cost was 567,438 €/year (equivalent to 4.27 €/day/patient). The total budget deficit (hospital income minus hospital costs) was 108,383 €. The deficit was estimated at 222,892 € in 2009 and 241,188 € in 2013.
Conclusion
The daily cost of BoNTA treatment for spasticity is reasonable; however, because of the level of reimbursement by the national health insurance in France, the treatment is costly for French hospitals.
1
Introduction
The main treatment for focal spasticity is intramuscular injection of type A botulinum toxin (BoNTA) . Many studies have demonstrated patient satisfaction and functional improvement with this treatment .
Medico-economic studies of the financial impact of BoNTA treatment are generally based on the Delphi method. The results have generally shown that BoNTA treatment is cost-effective , mainly because of reduced indirect costs such as those related to fractures and hospital admissions after spasticity-related falls. However, more detailed analyses of the initial cost of the treatment are lacking. A recent prospective study in England compared the cost of BoNTA treatment for the upper limb with that of classical rehabilitation in 150 adult patients and found no difference in cost-effectiveness at 3 months. The methods used to evaluate costs were not clearly described but appeared to be global. Most studies have focused on the difference in cost and effectiveness between rehabilitation alone and rehabilitation with BoNTA injections . One study analysed the specific costs of BoNTA treatment for spasticity, taking into account all elements related to the treatment (toxin, staffing, equipment, etc.): the cost (about 1300 €/year) was high and was greater than the cost with its use for other symptoms such as spasmodic torticollis and blepharospasm .
The incidence of nervous system disorders causing spasticity is relatively high. For example, in France, stroke causes 100,000 hospital admissions per year . Spasticity will develop in an estimated one third of these patients . Therefore, the evaluation of costs relating to the treatment of spasticity is a public health issue, and improved knowledge of the average cost of the treatment relative to its valuation is essential. The cost of the treatment not sufficiently covered by government health insurance could inhibit the development of its use in physical medicine and rehabilitation (PMR) departments and reduce its availability to patients.
The aim of this study was to determine the average cost of BoNTA treatment for spasticity in an adult day-hospital setting and compare the cost to the level of reimbursement by the national health insurance in France in 2008, 2009 and 2013.
2
Methods
The study was designed as a single-centre retrospective study in a secondary-care day-hospital unit specialised in treating spasticity in adults. Data for BoNTA treatment in 2008 were extracted from day-hospital reports, le programme de médicalisation des systèmes d’information (PMSI; a computerized classification system that classifies hospital admissions as a function of both disease and the nature and degree of the related costs) and the pharmacy register. These data were crossed and used to calculate the “calculated cost”, which was then compared with the “real cost” of treatment.
2.1
Calculation of the “calculated cost” of treatment with BoNTA
In France, BoNTA can only be administered to patients who are admitted to a hospital, health-care centre or day-hospital (hospital use only; Article R. 5121-83 of the French Public Health Code). It can be administered within a secondary- or tertiary-care setting (in France, secondary-care includes medicine, surgery and obstetrics, and tertiary-care includes long-term care and rehabilitation).
In tertiary-care, the toxin is funded from the hospital’s annual budget or by the daily rate in private centres, which is submitted to the Quantified National Target on expenditures. This type of funding takes no account of the number of treatments and doses administered.
In secondary-care, the treatment is funded only by the case-mix–based hospital prospective payment system (T2A). In this system, resources are allocated after assessment of the level of activity produced. The value of each activity is fixed annually by the health minister via the homogeneous hospital-stay group/homogeneous patient group (GHS/GHM) mechanism (adapted from the US “diagnostic related groups”). The patient classification system (PMSI) is used to assign each patient’s stay in a GHM to which one (or sometimes several) GHSs are associated. The group determines the level of reimbursement by the national health insurance. In acute secondary-care departments (such as that in which the present study was carried out), the patient must be admitted in order to receive BoNTA. Thus, the level of reimbursement is determined by the GHM assigned to the patient. In 2008, GHMs differed depending on the pathology (stroke, cerebral palsy, traumatic brain injury, etc.) and type of symptoms (claw hand, equinus, varus foot, etc.). We used the PMSI code for BoNTA injection (acte CCAM PCLB003) to search the database for all BoNTA injections that had been performed in specialised day-hospitals in 2008. The values for each patient’s GHM were then summed. This sum constituted the “calculated cost” and corresponded to the hospital’s “income” for 2008.
In 2009, a specific GHM (GHM 01K04J) was created to ensure funding for botulinum toxin in ambulatory care. This GHM was homogenous for all patients treated with botulinum toxin and was attributed a fee of 396.03 € in 2009 (version 10 of the GHM). The fee has been lowered each year since then, decreasing to 375 € in 2013 (version 11 of the GHM). The calculated cost was estimated for 2009 and 2013 by using the GHM fees for those years, based on the number of patients treated in 2008.
2.2
Calculation of the “real costs” of treatment with BoNTA
Patients were recalled every 3 months for repeat injections. The PMR physicians (all part-time) performed the evaluations and follow-up as well as the injections. They were assisted by one nurse (full-time) and one nursing assistant. The nurse and assistant managed the appointments and all the administration.
All patients had central nervous system lesions with spasticity. The injections were often multi-site, with 3 to 10 muscle groups injected. Muscles were located by using electromyographic stimulation and patients were given inhaled nitrous oxide to aid relaxation. Each session lasted from 30 to 45 min depending on the number of muscles treated and any technical difficulties.
In 2008, 2 drugs were available: Botox ® (100 UI/vial) and Dysport ® (500 UI/vial).
The real cost of the BoNTA injections in the day-hospital was determined by summing the cost of staff, treatment, small equipment used, and consumables for 2008. This information was obtained from the finance department and the manager in charge of the unit. The cost was considered stable for 2009 and 2013 because of only minor changes in the costs incurred by our hospital between 2008 and 2013 (vials, medical material and salaries, etc.).
2
Methods
The study was designed as a single-centre retrospective study in a secondary-care day-hospital unit specialised in treating spasticity in adults. Data for BoNTA treatment in 2008 were extracted from day-hospital reports, le programme de médicalisation des systèmes d’information (PMSI; a computerized classification system that classifies hospital admissions as a function of both disease and the nature and degree of the related costs) and the pharmacy register. These data were crossed and used to calculate the “calculated cost”, which was then compared with the “real cost” of treatment.
2.1
Calculation of the “calculated cost” of treatment with BoNTA
In France, BoNTA can only be administered to patients who are admitted to a hospital, health-care centre or day-hospital (hospital use only; Article R. 5121-83 of the French Public Health Code). It can be administered within a secondary- or tertiary-care setting (in France, secondary-care includes medicine, surgery and obstetrics, and tertiary-care includes long-term care and rehabilitation).
In tertiary-care, the toxin is funded from the hospital’s annual budget or by the daily rate in private centres, which is submitted to the Quantified National Target on expenditures. This type of funding takes no account of the number of treatments and doses administered.
In secondary-care, the treatment is funded only by the case-mix–based hospital prospective payment system (T2A). In this system, resources are allocated after assessment of the level of activity produced. The value of each activity is fixed annually by the health minister via the homogeneous hospital-stay group/homogeneous patient group (GHS/GHM) mechanism (adapted from the US “diagnostic related groups”). The patient classification system (PMSI) is used to assign each patient’s stay in a GHM to which one (or sometimes several) GHSs are associated. The group determines the level of reimbursement by the national health insurance. In acute secondary-care departments (such as that in which the present study was carried out), the patient must be admitted in order to receive BoNTA. Thus, the level of reimbursement is determined by the GHM assigned to the patient. In 2008, GHMs differed depending on the pathology (stroke, cerebral palsy, traumatic brain injury, etc.) and type of symptoms (claw hand, equinus, varus foot, etc.). We used the PMSI code for BoNTA injection (acte CCAM PCLB003) to search the database for all BoNTA injections that had been performed in specialised day-hospitals in 2008. The values for each patient’s GHM were then summed. This sum constituted the “calculated cost” and corresponded to the hospital’s “income” for 2008.
In 2009, a specific GHM (GHM 01K04J) was created to ensure funding for botulinum toxin in ambulatory care. This GHM was homogenous for all patients treated with botulinum toxin and was attributed a fee of 396.03 € in 2009 (version 10 of the GHM). The fee has been lowered each year since then, decreasing to 375 € in 2013 (version 11 of the GHM). The calculated cost was estimated for 2009 and 2013 by using the GHM fees for those years, based on the number of patients treated in 2008.
2.2
Calculation of the “real costs” of treatment with BoNTA
Patients were recalled every 3 months for repeat injections. The PMR physicians (all part-time) performed the evaluations and follow-up as well as the injections. They were assisted by one nurse (full-time) and one nursing assistant. The nurse and assistant managed the appointments and all the administration.
All patients had central nervous system lesions with spasticity. The injections were often multi-site, with 3 to 10 muscle groups injected. Muscles were located by using electromyographic stimulation and patients were given inhaled nitrous oxide to aid relaxation. Each session lasted from 30 to 45 min depending on the number of muscles treated and any technical difficulties.
In 2008, 2 drugs were available: Botox ® (100 UI/vial) and Dysport ® (500 UI/vial).
The real cost of the BoNTA injections in the day-hospital was determined by summing the cost of staff, treatment, small equipment used, and consumables for 2008. This information was obtained from the finance department and the manager in charge of the unit. The cost was considered stable for 2009 and 2013 because of only minor changes in the costs incurred by our hospital between 2008 and 2013 (vials, medical material and salaries, etc.).
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