Pobierz PDF - Advances in Clinical and Experimental Medicine

Pobierz PDF - Advances in Clinical and Experimental Medicine

original papers
Adv Clin Exp Med 2012, 21, 5, 653–663
ISSN 1899–5276
© Copyright by Wroclaw Medical University
Aleksandra Harat1, A–D, F, Paweł Sokal2, B–D, F, Piotr Zieliński2, C–F,
Marek Harat2, A–D, F, Teresa Rusicka3, A, B, D, F, Leszek Herbowski4, C, D, F
Assessment of Economic Effectiveness in Treatment
of Neuropathic Pain and Refractory Angina Pectoris
Using Spinal Cord Stimulation*
Ocena efektywności ekonomicznej leczenia bólu neuropatycznego
i lekoopornej dusznicy bolesnej za pomocą neurostymulatora rdzenia
kręgowego
Department of Preventive Medicine and Environmental Health, Nicolaus Copernicus University Collegium
Medicum in Bydgoszcz, Poland
2
Clinic of Neurosurgery, Military Hospital no. 10 in Bydgoszcz, Poland
3
Hemodynamics Laboratory, Cardiac Rehabilitation Hospital, Kowanówko, Poland
4
Ward of Neurosurgery and Neurotraumatology, Marie Curie-Skłodowska Independent Public Provincial
Hospital, Szczecin, Poland
1
A – research concept and design; B – collection and/or assembly of data; C – data analysis and interpretation;
D – writing the article; E – critical revision of the article; F – final approval of article; G – other
Abstract
Background. The implementation of new diagnostic and therapeutic technologies is related to expanding financial
needs. The escalation of expenses for health protection and simultaneous economic problems has resulted in an
interest in the subject of economic assessment. Decision makers in the health sector should have reasonable tools
that will allow them to make complex evaluations of the economic suitability of health technologies. Economic
analysis should also prove that launching new procedures can save money. Numerous studies indicate that chronic
pain and psycho-sociological variables lead to a worse quality of life. Chronic pain issues are a major public health
problem, by virtue of the difficulties in efficient therapy and the social costs reflected in incapability of work and
disability. Spinal cord stimulation is the most efficacious procedure in the treatment of chronic pain.
Objectives. The aim of the study was to estimate the costs of treatment of 37 patients suffering from refractory
angina pectoris and neuropathic pain who underwent SCS surgery between 2002 and 2008 in the Neurosurgery
Clinic of the 10th Military Hospital in Bydgoszcz in the period of two years before and two years after spinal
cord stimulation. The authors also assessed quality of life, using the SF 36 questionnaire, and degree of pain
using VAS.
Material and Methods. The issue was examined with a cost-benefit analysis. Cost was understood as the expenses
made two years before and two years after the SCS procedure. The benefits were health care expenses saved by
implementation of the SCS procedure. All the costs included in both alternative treatment techniques in a period
of 5 years underwent a discounting procedure. The authors also included the price of the neurostimulator under
a sensitivity analysis. To assess the quality of life before and after the SCS procedure, a SF 36 questionnaire was
used, and to assess the level of pain before and after the SCS procedure, the VAS scale.
Results. The costs of treatment of refractory angina pectoris and neuropathic pain are lower when using spinal cord
stimulation. In the case of refractory angina pectoris, savings reached 46% whereas in the case of neuropathic pain,
13.2%. The costs of the purchase of the device returned in three years for angina pectoris and seven years for neuropathic pain. SCS in both cases brought a reduction of the level of pain and an improvement to quality of life.
*The research was funded by the ESF and ZPORR grants for doctoral students.
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A. Harat et al.
Conclusions. SCS in both neuropathic pain and refractory angina pectoris is a procedure that brings benefits in the
form of savings. After using SCS in both cases, the quality of life improved and the level of pain was reduced (Adv
Clin Exp Med 2012, 21, 5, 653–663).
Key words: economic analysis, cost-benefit analysis, neuropathic pain, refractory angina pectoris, spinal cord stimulation.
Streszczenie
Wprowadzenie. Wdrażanie do diagnozowania i leczenia zdobyczy nowych technologii wiąże się z rosnącymi
potrzebami finansowymi. Analizy ekonomiczne mogą dostarczyć dowodów na to, że wprowadzenie określonego
standardu terapeutycznego przyniesie oszczędności finansowe w przyszłości. Zespoły bólu przewlekłego stają się
coraz istotniejszym problemem zdrowia publicznego z uwagi na trudności w skutecznym leczeniu oraz koszty
społeczne odzwierciedlone w niezdolnosci do pracy i inwalidztwie. Stymulacja rdzenia kręgowego (SCS) jest dziś
jednym z najskuteczniejszych zabiegów terapeutycznych.
Cel pracy. Ocena kosztów leczenia 37 pacjentów z bólem neuropatycznym i lekooporną dusznicą bolesną operowanych z powodu dolegliwości bólowych od 2002 do 2008 roku w Klinice Neurochirurgii 10. Wojskowego Szpitala
Klinicznego w Bydgoszczy, a także ocena jakości życia według formularza SF-36 oraz odczuwania bólu według skali
VAS.
Materiał i metody. Do badania użyto analizy koszt–korzyść. Koszty poddano operacji dyskontowania. Podjęto też
analizę wrażliwości ceny stymulatora. Do oceny skali bólu użyto skali VAS przed i po zabiegu, a jakość życia oceniono za pomocą kwestionariusza SF-36.
Wyniki. Przeprowadzona analiza wykazała, że leczenie lekoopornej dusznicy bolesnej za pomocą SCS jest tańsze o 46% w stosunku do leczenia bez implantu, a koszt implantu zwraca się średnio w ciągu trzech lat. Leczenie
bólu neuropatycznego z użyciem SCS jest tańsze o 13,2%, a koszty implantu zwracają się średnio po 7 latach.
Wszczepienie stymulatora zarówno w przypadku lekoopornej dusznicy bolesnej, jak i bólu neuropatycznego spowodowało istotne zmniejszenie odczuwanego przez pacjentów bólu, mierzonego w skali VAS. Jakość życia badana
za pomocą kwestionariusza SF-36 zarówno u pacjentów z lekooporną dusznicą bolesną, jak i u pacjentów z bólem
neuropatycznym poprawiła się istotnie.
Wnioski. SCS jest zabiegiem przynoszącym korzyści w postaci oszczędności zarówno w przypadku leczenia bólu
neuropatycznego, jak i lekoopornej dusznicy bolesnej. Po zastosowaniu SCS pacjenci odczuwają istotne zmniejszenie dolegliwości bólowych oraz ich jakość życia poprawia się (Adv Clin Exp Med 2012, 21, 5, 653–663).
Słowa kluczowe: analizy ekonomiczne, koszt–korzyść, ból neuropatyczny, lekooporna dusznica bolesna, stymulacja rdzenia kręgowego.
Pain is an unpleasant sensory and emotional
experience associated with actual or potential damage of tissue or described in terms of such damage [1]. Chronic pain is increasingly prevalent in
societies of the twenty-first century. A number of
factors cause chronic pain but the result is always
the same: an individual cannot fully function.
Neuropathic Pain
Neuropathic pain is defined as pain caused or
initiated by primary changes or disturbances in the
nervous system [1]. It can take many forms, such
as diabetic polyneuropathy (DPN), postherpetic
neuralgia (PHN), trigeminal neuralgia, complex regional pain syndrome (CRPS), phantom pain and
failed-back surgery syndrome (FBSS) – pain after
unsuccessful neurosurgical intervention [2, 3].
Experimental studies point out three components in the etiology of neuropathic pain: changes in electrical excitability of the damaged axon
membrane and the first afferent neuron of the spinal ganglion, changes in the processing of received
signals in the posterior horn of the spinal cord and
disintegration of pre-programmed response in
high-levels of CNS to situations affecting the integrity of the body. Presently, ongoing studies are
examining the mechanism of activation of microglia cells as an additional factor that may participate
in the increase of neuropathic pain [2, 3].
Treatment of neuropathic pain is more difficult than the treatment of nociceptive pain, mainly
due to the fixed nature of central and peripheral
sensitization [4].
The first step in the treatment of this type of
pain is pharmacotherapy. The first used are nonsteroidal anti-inflammatory drugs. The next step is
to add weak opiates and/or supportive medication.
In cases of further persistence of pain, the patient
is advised to use a stronger opiate and adjunctive
drug in order to improve the control of pain (antidepressants, anticonvulsants, baclofen, stimulants,
corticosteroids, anesthetics, and capsaicin applied
topically) [4, 5].
Despite the enormous progress in pharmacology in therapy against neuropathic pain, there is still
a significant number of patients treated pharmacologically who do not feel sufficient relief. Given the
assumption that effective treatment of pain is that
Economic Effectiveness in Treatment of Neuropathic Pain and Refractory Angina Pectoris
which reduces pain by at least 50%, only 30–40% of
patients are treated successfully [4].
In non-pharmacological treatment, transcutaneous electrical nerve stimulation blocks, or such invasive techniques as thermolesions are applied [4].
Spinal cord stimulation (SCS) is one of the
most common surgical techniques undertaken in
the treatment of neuropathic pain. The mechanism
of action is based on the theory of gate control by
Melzack and Wall, suggesting that stimulation of
large diameter afferent nerve fibers inhibits conduction of pain stimuli to the brain [6].
Conducted pain signals in the spinal cord
are blocked by an electric stimulus. Orthodromic
transmission of impulses causes paresthesia. Stimulation of a-beta fibers of large diameter in dorsal columns stimulates the activation mechanism
of the gate, which inhibits transmission of pain in
the fibers of small diameter in dorsal horns [7, 8].
Another mechanism explaining the effect of SCS
is a segmental block of neuronal transmission of
pain stimuli, which is caused by local changes in
the spinal cord and the neurons responsible for
leading pain [7, 8].
The indication for SCS is neuropathic pain resulting from an injury of the nervous system and
ischemic pain in peripheral artery diseases and
angina pectoris. The most frequent indication is
FBSS: pain in the dorsal region associated with adhesive postinflammatory arachnoiditis, lower back
pain or pain in the extremities caused by root or
nerve injury resistant to conservative treatment
and neurosurgical interventions in degenerative
disc disease, CPRPS type I as causalgia, and type II,
postherpetic neuralgia and phantom pain [7, 9].
A very important issue is the proper selection
of patients. The criteria for inclusion into the SCS
intervention provided by Oakley are the following:
duration of pain – 6 months, pain radiating below
the knee root of greater pain intensity than the
dorsal region, the lack of pain above dermatome
TH10, at least one surgical intervention in anamnesis, the patient’s consent, the results of a psychological exam indicating the patient has strong motivation to return to professional life [7, 10].
The effectiveness of SCS in neuropathic pain is
high. Long-term studies estimate that in a well-selected group of patients, achieved pain reduction is
about 50% with approximately 60–70% improvement of quality of life and reduction of intake of
analgesics [9, 11].
Many studies have shown that neuropathic
pain is not only a factor in lowering of the quality of life related to health, but it also burdens the
health care system and social security, generating
costs in these sectors [12, 13]. The main costs are
caused by direct medical care, loss of working ca-
655
pacity (affecting up to 43% of patients) [13] or reduced productivity, as well as home care costs.
Refractory Angina Pectoris
Angina pectoris is a form of ischemic heart
disease. Most damage is caused by atherosclerotic
plaque, platelet activation and thrombus formation. There are also other possible pathophysiological mechanisms such as coronary artery spasm,
rapid progression of stenosis within the plaque, the
primary thrombus, pulmonary artery or extracordial mechanisms [14]. It is manifested by frequent
retrosternal severe pain, which can also occur at
rest – without relation to exercise or stress [14–16].
Management is based on lifestyle modification,
pharmacotherapy and the use of revascularization
techniques such as implantation of coronary artery
bypass graft (CABG) or coronaroplasty (PCI) using balloon angioplasty, or stents and atherectomy
[14–16].
8–10% of cases of unstable angina are refractory to pharmacological treatments aimed at improving blood supply to the heart. SCS inhibits
conduction of the electrical stimulation of pain
stimuli and gives a chance for improvement for
these patients [15]. SCS is eligible to patients with
refractory angina who meet the following criteria:
–  “Advanced changes in the coronary arteries
confirmed by coronary angiography, which are not
eligible for PCI or CABG;
–  pain associated with coronary heart failure
in NYHA III or IV grade;
–  positive exercise test showing reversible
ischemia;
–  the optimal pharmacological treatment used
at least a month before, involving at least two coronary drugs (beta-blockers, long acting nitrates, calcium channel blockers and angiotensin converting
enzyme) in maximum doses” [17].
Factors excluding patients from SCS are also: an
inability to complete the exercise test, myocardial
infarction or unstable angina CCS class IV during
the last three months, abnormalities in the spine, severe valvular defect, and age over 76 years [17].
SCS in refractory angina is based on the theory
of gate control by Melzack and Wall and involves
modulation of pain impulses flowing to the dorsal
horn of the spinal cord. Consequently, following
the increased release of GABA and increased secretion of endorphins, the effect is to reduce pain,
reduce sympathetic activity, reduced myocardial
demand for oxygen and development of myocardial microcirculation [15].
Studies on the clinical effectiveness of SCS
in refractory angina have shown better supply of
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A. Harat et al.
oxygen to the heart muscle, which resulted in prolongation of exercise duration, improved heart rate
and blood pressure, increased pain threshold and
decreased duration of pain [18]. This procedure
also resulted in improvement in the functioning of
patients – who returned to active social life (previously abandoned because of frustration and frequent hospitalizations) [18, 19].
Since the use of SCS does not completely abolish the sensation of pain – only changes its intensity
and character – there is no possibility of a so-called
“silent heart attack”. There are also no reports of
the occurrence of any disturbances in patients who
have both a pacemaker and neurostimulator (however, patients should have only properly configured
bipolar pacemakers implanted) [17, 18, 20].
Economic Analysis
in Healthcare
In highly developed societies economic conditions are the domain of all fields, including modern
medicine. Expansion of new diagnostic and therapeutic technologies brings growing financial needs.
This fact, and the scarcity of financial resources, is
a major challenge for health systems around the
world, which must provide optimal community
health care. This goal can only be achieved by rationalizing expenditures, using medical knowledge
that is economically supported [15, 21].
Access to medical care largely depends on
the socio-economic development of a country, as
well as on assumptions of health and social policy
– which are linked to the macroeconomic factors
of the functioning of the health care system. Barriers in access to medical care – giving rise to an
increase in unfulfilled health needs – are the result
of an irrational allocation of resources [21, 23].
Economic analyses facing the reality of cuts in
funding for health care are intended to rationalize
choices concerning the allocation of resources in
health care. Carrying out analyses can also prove
that the introduction of a specific diagnostic or
therapeutic procedure will save money in the future and also give evidence of its clinical efficacy
[21, 23].
Cost-benefit analysis (CBA) is considered to
be a full-fledged economic evaluation. Analysis results reveal whether the costs that the procedure
absorbs are no greater than the benefits that can
be achieved. It compares both the costs and effects (benefits) of programs, which are expressed
in monetary units. The direct benefits include the
expenses that are avoided by implementing the
program. The sphere of the patient’s productivity,
expressed for example in the growth of earnings
or ability to work, are considered indirect benefits.
Improving health and reducing pain and suffering
are intangible benefits [21, 23, 24].
The result of a CBA may be the index value of
cost-benefit ratio (costs / benefits ratio C / B) or
net benefits (net benefit) – the difference between
benefit and cost. When choosing from among analyzed procedures we choose the one that has greatest net benefit or lowest C / B [15, 21, 23, 24].
Indirect costs are considered in two ways:
within the health sector are the costs incurred in
the years of life that are gained by the introduction
of patient care; outside the health care sector are
the costs related to the loss of the ability to take
up paid work or decreased productivity resulting
from the absence of the patient in the workplace
[15, 21, 23, 26].
Recipients for whom economic tools are relevant
are very numerous. Among them are both paying for
medical services and patients – for both groups efficient and cost-effective treatment is important [21].
The aim of this study was to assess the costs of treating patients with neuropathic pain and ischemic
pain during the two years prior to SCS and to compare them with a two-year postoperative period.
The breakdown of costs in the period before
and after surgery had to demonstrate:
–  to what extent the cost of treatment will reduce after implantation of a neurostimulator in the
estimated five-year period?
–  in what period after SCS its costs will offset
reductions in treatment costs?
–  which treatment method has the advantage,
taking into account one-way sensitivity analysis of
implant prices?
–  if the use of SCS affects the quality of life of
patients and the intensity of pain?
Material and Methods
The material for the study were the costs of
treatment of patients with neuropathic pain and
refractory angina pectoris in the two years prior
to SCS and two-year postoperative period; SF-36
quality of life of patients forms, before and after
SCS, and pain intensity measurements on the VAS
scale before and after surgery.
The groups surveyed included 37 patients
operated on due to pain in the period from 2002
to 2008 in the Department of Neurosurgery, 10th
Military Hospital in Bydgoszcz. The group of patients with neuropathic pain included 25 patients,
while the group of patients with angina pectoris
numbered 12.
By analyzing the records of patients, the authors established “cost centers”, occurring two
Economic Effectiveness in Treatment of Neuropathic Pain and Refractory Angina Pectoris
years before and two years after SCS. The basis for
calculating the costs for patients with neuropathic
pain consisted of the following information: costs
of medications (the amount of reimbursement paid
by the payer – NHF), hospitalization costs – associated with treatment of pain, costs of outpatient
specialist treatment, cost of rehabilitation, costs of
the neurostimulator and its implantation.
The basis for calculating the costs for patients
with ischemic pain in refractory angina pectoris
consisted of the information concerning: costs of
medications (the amount of reimbursement paid
by the payer – NHF), costs of departure of medical rescue teams, costs of treatment in hospital
emergency departments, costs of hospitalization
for cardiac branches, cost of outpatient specialist
treatment, cost of the neurostimulator and its implantation.
The study used a cost–benefit analysis. Costs
were understood as inputs consumed two years before and two years after surgery of the spinal cord
stimulator implanted in areas of cost assigned to
each of the pain syndromes. Benefits were understood as the expenditures avoided through the introduction of SCS. The value of the costs and benefits was presented in monetary units [21, 23, 27].
Costs were estimated in the following five
years (period due to the assumed average time of
neurostimulator battery life [24]), there was a need
for discounting operations (taking into account
the calculation of time, which causes the value of
goods in the possession of which we are today,
tomorrow will be lower) [21, 22, 27]. One of the
main assumptions of discounting is the declining
value of money over time.
In order to carry out discounting operations
it was necessary to take into account the discount
rate, the number of years in which expenditure
will be incurred and its future value [21, 27]. Then,
a discounting factor (DF) for each year was calculated according to the standard formula:
DF = 1 / (1 + r) ⁿ
Where “r” means the discount rate of 5% [22],
and “n” – the year in which costs are incurred.
Discounting rates for the next five years (included
in Table 1), calculated on the basis of the pattern,
were referenced to the annual costs and thus the
obtained results showed the real value of incurred
expenses in the future [21, 24, 27].
In the next stage of the calculation, a sensitivity analysis was carried out. As a sensitive parameter in the study, the authors selected the price of
the neurostimulator. The scope of its volatility was
defined as 30% and results were calculated assuming a sensitive parameter variability and stability of
other parameters [21, 23, 24].
657
Table 1. Discounting factors [22]
Tabela 1. Współczynniki dyskontowania [22]
Years
(Lata)
Discounting factors
(Współczynniki dyskontowania)
1
0.952
2
0.907
3
0.864
4
0.823
5
0.784
The study also involved pain intensity measured in VAS. It is a 10-grade scale. Value ​​0 is attributed to lack of pain, while 10 – the strongest
pain which the patient can imagine. Patients assessed pain before and after surgery SCS [28, 29].
The study also assessed the quality of life of patients before and after SCS, using the SF-36 form
(Qualimetric Incorporated No. 007635 QM). The
questionnaire consists of 36 questions, divided into sub-scales examining eight areas: physical functioning, role-physical, bodily pain, general health,
vitality, social functioning, role-emotional and
mental health. The results were calculated according to the instructions and presented on a scale of
0 to 100, with a score of 100 meaning the best performance in a given field, and 0 very serious health
condition due to pain or disability [30].
Statistical Analysis
For all calculations, the following statistical
methods of data analysis were used. Descriptive
statistics involved Shapiro-Wilk Test – to verify the
normal distribution, Student’s T test for dependent
samples, Wilcoxon’s Test of sequence of pairs. The
level of significance was p < 0.05. The statistical
analysis package was made with “Statistica”.
Results
Treatment of Neuropathic Pain
Table 2 shows the cost of treatment of 25 patients with neuropathic pain two years before and
two years after SCS surgery. SCS has no alternative, all the patients before surgery receive the best
treatment. In the case of lack of its effectiveness,
patients are qualified for the SCS.
On average, a year of treatment for patients
with neuropathic pain without the use of SCS is
earmarked at 6312 PLN.
The cost of treatment in the next 5 years,
adjusted for annual average increase in prices of
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A. Harat et al.
Table 2. Median cost of treatment of neuropathic pain with and without SCS
Tabela 2. Średni koszt leczenia bólu neuropatycznego bez i z zastosowaniem neuroimplantu
Costs during the two
years prior to surgery
– PLN
(Koszty w ciągu 2 lat
przed operacją)
Implantation of the
neurostimulator
(Wszczepienie neurostymulatora)
Costs within two
years after surgery
– PLN
(Koszty w ciągu 2 lat
po operacji)
Drug costs (Koszt leków)
7815
–
5863
Hospitalization costs
(Koszt hospitalizacji)
1284
–
2904
Cost of outpatient specialist treatment
(Koszt specjalistycznego leczenia ambulatoryjnego)
2167
–
1339
Cost of rehabilitation
(Koszt rehabilitacji)
1357
–
799
Costs of implantation of the neurostimulator (Koszt wszczepienia neurostymulatora)
–
6436
–
Neurostimulator costs
(Koszt neurostymulatora)
–
26941
–
Sum (Suma)
12623
33377
10905
drugs, totaled 32,464 PLN [21, 24]. After the discounting operations (based on discounting factors
from Table 1), the amount spent on the treatment
of patients with neuropathic pain without SCS in
the next 5 years amounted to 28,322 PLN.
In the structure of the cost of treatment of
patients with neuropathic pain without the use of
SCS, the majority involved the costs of medications – 63%, then out-patient care 17%, and 10%
for rehabilitation and hospitalization (Fig. 1).
The average annual cost of treating patients
with neuropathic pain using SCS amounted to
5453 PLN (Table 2). The five-year cost, after taking
into account increase in the prices of medications,
amounted to 28,172 PLN, and after discounting
this sum, amounts to 24,359 PLN [15, 21, 22, 24].
In the cost structure, after the application of
SCS, a prominent place is occupied by medications
55%, successively hospitalization 26%, out-patient
care 12% and rehabilitation 7% (Fig. 2).
Fig. 3 summarizes the structures of the cost of
treatment of neuropathic pain in both methods. In
all areas – with the exception of hospitalization –
savings were observed (the largest on medications
and outpatient specialist care).
The results were analyzed statistically (using
the Shapiro-Wilk normality test and Wilcoxon’s
sequence of pairs test), which showed there was
a statistically significant difference between the
expenditure on medications and outpatient specialist care before and after SCS implantation.
No significant changes were shown in the cost of
hospitalization and rehabilitation before and after SCS.
The introduction of SCS as an alternative
method of treatment of neuropathic pain resulted
in savings of 13.2%.
The neurostimulator and its implantation carries a cost of 33,377 PLN. The price of the implant
underwent sensitivity analysis [21, 22]. The results
of the sensitivity analysis showed that the cost of
the implant and the implant surgery will be reimbursed: in the case of a constant price of the neuroimplant – over 7 years; in the case of an increase
in the price of the neuroimplant – within 9 years;
in the case of a decrease in the price of the neuroimplant – within 5.5 years.
To assess the quality of life, a SF-36 questionnaire was used. For statistical purposes, the authors
used the Shapiro-Wilk test of normal distribution
and Wilcoxon’s test of sequence of pairs.
Statistical analysis showed that there is a statistically significant difference between the quality of life in the parameters: physical functioning,
role physical, role emotional, bodily pain, general
health, vitality and social functioning and mental
health as measured before surgery, and the same
parameters measured using the SF-36 after the operation.
In the area of physical functioning prior to
surgery, patients rated the quality of life at 13.8,
while after the treatment the point value increased
to 29 (p < 0.000402).
Role physical was evaluated before surgery to
659
Economic Effectiveness in Treatment of Neuropathic Pain and Refractory Angina Pectoris
medicaons
leki
medicaons
leki
hospitalizaon
hospitalizacja
hospitalizaon
hospitalizacja
out-paent care
ambulatoryjna opieka
specjalistyczna
out-paent care
ambulatoryjna opieka
specjalistyczna
rehabilitaon
rehabilitacja
rehabilitaon
rehabilitacja
10%
7%
12%
17%
10%
55%
63%
26%
Fig. 1. The structure of costs of treatment of neuropathic pain without spinal cord stimulation in a 5 year
period
Fig. 2. The structure of costs of treatment of neuropathic pain using spinal cord stimulation in a 5 year
period
Ryc. 1. Struktura kosztów leczenia bólu neuropatycznego bez zastosowania neuroimplantu w perspektywie
5 lat
Ryc. 2. Struktura kosztów leczenia bólu neuropatycznego z zastosowaniem neuroimplantu w perspektywie
5 lat
costs without the use of SCS
kwota leczenia bez zastosowania
neuroimplantu
costs with the use of SCS
kwota leczenia z zastosowaniem
neuroimplantu
25000
20000
15000
10000
5000
0
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ho li
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liz n
ac
op o
ja
u
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am ae
bu nt
lat ca
or re
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22.25. After surgery, statistically significant improvement was noted: 37.5 (p < 0.006706). In assessing the mental state, the point value of 27 before surgery significantly increased to 45.44 (p <
0.000056).
Quality of life determined by pain experienced
was assessed before treatment at 8.5. After surgery this parameter was estimated to be 30.6 (p <
0.000099).
Further parameters:
– general health: 23.5 initially, after surgery
increased to 31.66 (p < 0.000182);
– vitality: before surgery, evaluated at 19.25,
after surgery the patient’s functioning in this area
improved to a point value of 33.4 (p < 0.000247);
– social functioning: in this area before surgery, patients functioned at a level of 12 points,
and after the procedure this value increased significantly to 33.9 (p < 0.000301);
– role emotional: initially estimated at 22,
after surgery increased significantly to 53.66 (p <
0.000060).
In summary, the introduction of SCS improved
functioning in all areas covered in the SF-36 questionnaire and it was a statistically significant improvement.
Patients suffering from neuropathic pain evaluated pain intensity using the VAS before and after
surgery. For the statistical analysis, the Shapiro-
Fig. 3. The comparison of cost structures of alternative
methods of treatment of neuropathic pain in a 5 year
period
Rys. 3. Porównanie struktury kosztów alternatywnych
metod leczenia bólu neuropatycznego w perspektywie
5 lat
660
A. Harat et al.
talization – 54% of total expenditure, followed successively by medications – 25%, cost of dispatch
of medical rescue teams –10%, cost of treatment
in hospital emergency departments – 7% and outpatient care – 4% (Fig. 4).
The average annual cost of treatment of refractory angina pectoris using SCS was 2,698 PLN. After including a 3% increase in the price of medications, this resulted in 13,816 PLN [15, 21, 22, 24],
and after discounting, 11,950 PLN.
In the cost structure, as for the period before
the SCS operation, the largest costs are consumed
by hospitalization – 48% of total expenditure. Second place was taken by medications – 40% and
successive costs were dispatch of medical rescue
teams – 6%, out-patient care – 4% and aid granted
to the emergency room – 2% (Fig. 5).
Fig. 6 submits a statement of expenditures for
both methods of treatment. The greatest differences
were observed in the cost of treatment in hospital
emergency departments, dispatches of emergency
medical teams and in hospitalization, for treatment
of patients with refractory angina with SCS.
An inventory of the cost of treating patients
with refractory angina pectoris by the two alternative methods have shown that SCS therapy is more
favorable from an economic standpoint, and the
percentage difference in spending on treatment of
patients after implantation is 46%.
Wilk normality test and the Wilcoxon’s sequence
of pairs test were used.
On average, the intensity of pain before surgery was assessed at 7.84. The level of pain decreased significantly after the introduction of this
alternative method of treatment and amounted to
4.12. It was a statistically significant change (p <
0.000027).
Treatment of Refractory
Angina Pectoris
Table 3 includes the averaged cost of treatment
of 12 patients with refractory angina pectoris incurred two years before and two years after SCS.
Average annual spending on treatment of patients
with refractory angina pectoris, treated without
spinal cord stimulation is 5,075 PLN.
The study shows expenditures in the five-year
period, hence an annual drug price increase of 3%
was included [15, 21, 22, 24], which gave the total amount of 25,745 PLN. The costs of treatment
in the five years, after taking into account the decreasing value of money over time, amounted to
22,036 PLN [21, 22, 27].
By analyzing the structure of expenditures on
the treatment of patients with refractory angina
without SCS, the most cost-intensive one is hospi-
Table 3. Median cost of treatment of refractory angina pectoris with and without SCS
Tabela 3. Średni koszt leczenia lekoopornej dusznicy bolesnej bez i z zastosowaniem SCS
Costs during the
two years prior
to surgery – PLN
(Koszty w ciągu 2
lat przed operacją)
Implantation of
the neurostimulator (Wszczepienie
neurostymulatora)
Costs within two
years after surgery
– PLN
(Koszty w ciągu
2 lat po operacji)
Cost of medications
(Koszt leków)
2376
–
2086
Cost of treatment in hospital emergency departments
(Koszt leczenia na oddziale intensywnej terapii)
767
–
90
Costs of hospitalization for cardiac branches
(Koszt hospitalizacji na oddziałach kardiologicznych)
5580
–
2634
Cost of out-patient treatment
(Koszt leczenia ambulatoryjnego)
375
–
227
Cost of dispatch of medical rescue teams
(Koszt wysłania zespołu ratownictwa medycznego)
1051
–
359
Cost of implantation of the neurostimulator
(Koszt wszczepienia neurostymulatora)
–
5013
–
Neurostimulator costs
(Koszt neurostymulatora)
–
31378
–
Sum
(Suma)
10149
36391
5396
661
Economic Effectiveness in Treatment of Neuropathic Pain and Refractory Angina Pectoris
medicaons
leki
treatment in hospital emergency
departments
pomoc udzielona na izbie przyjęć
hospitalizaon for cardiac branches
hospitalizacja
out-paent specialist treatment
ambulatoryjna opieka specjalistyczna
dispatch of medical rescue teams
wizyty zespołu wyjazdowego
pogotowia ratunkowego
medicaons
leki
treatment in hospital emergency
departments
pomoc udzielona na izbie przyjęć
hospitalizaon for cardiac branches
hospitalizacja
out-paent specialist treatment
ambulatoryjna opieka specjalistyczna
dispatch of medical rescue teams
wizyty zespołu wyjazdowego
pogotowia ratunkowego
4%
4%
10%
7%
25%
40%
7%
47%
54%
Fig. 4. The structure of costs of treatment of refractory
angina pectoris without using spinal cord stimulation
in a 5 year period
Ryc. 4. Struktura kosztów leczenia lekoopornej
dusznicy bolesnej bez zastosowania neuroimplantu
w perspektywie 5 lat
costs without the use of SCS
kwota leczenia bez zastosowania
neuroimplantu
costs with the use of SCS
kwota leczenia z zastosowaniem
neuroimplantu
14000
12000
10000
8000
6000
4000
2000
po
m
m
ed
tr
ica
oc em eat
o
m
e
u
ho
dz rge en
ns
sp
ie nc t i
lo y n lek
ita
n
liz
a n de ho i
a
a i par spit
on
zb tm al
f
ie en
or
am o
pr ts
c
u
ar
bu t-p
zy
di
ję
lat a
a
ć
cb
or en
ho r
yjn t
a
s
s
di
n
sp a o pec pita ch
p
e
at
ch iek ialis liza s
cja
as tt
w of
p re
izy m
ty ed ecja atm
li e
ze ica
po sp l r styc nt
go ołu es
z
to w cu na
w y et
ia ja e
ra zdo am
tu w s
nk e
ow go
eg
o
0
2%
Fig. 5. The structure of costs of treatment of refractory
angina pectoris using spinal cord stimulation in a 5 year
period
Ryc. 5. Struktura kosztów leczenia lekoopornej
dusznicy bolesnej z zastosowaniem neuroimplantu
w perspektywie 5 lat
The results were subjected to statistical analysis, which showed a statistically significant difference between the cost of treatment in hospital
emergency departments, the cost of dispatches of
emergency medical teams and spending on medications before and after SCS.
There were no statistically significant changes
in the cost of hospitalization before and after SCS.
There were also no statistically significant changes
in the cost of outpatient specialist care before and
after surgery, but there is a statistical tendency for
their reduction.
The implant and the implant surgery is at
a cost of 36,391 PLN [21]. Results of a sensitivity analysis [21] showed that the cost of the implant and the surgery will be offset: in the case
of a constant price of the neuroimplant – over
3 years; in the case of an increase in the price of
the neuroimplant – within 4 years; in the case
Fig. 6. The comparison of cost structures of alternative
methods of treatment of refractory angina pectoris in
a 5 year period
Ryc. 6. Porównanie struktury kosztów alternatywnych
metod leczenia lekoopornej dusznicy bolesnej w perspektywie 5 lat
662
A. Harat et al.
of a decrease in the price of the neuroimplant –
within 2.5 years.
To evaluate the quality of life of patients with
angina pectoris, a SF-36 form was used. Statistical analysis was performed using the Shapiro-Wilk
normality of distribution test, the Student’s t test
and the Wilcoxon’s test.
There is a statistically significant difference between the quality of life in the parameters: physical
functioning, mental health, bodily pain, general
health, vitality and social functioning, measured
before surgery and these parameters measured after the operation. There were no statistically significant changes in the parameters role physical and
role emotional, measured before surgery and the
same parameters measured after the operation.
Assessment of physical functioning prior to
surgery was 42 and was significantly lower compared to after SCS – 57.08 (p < 0.030330).
In the area of operation associated with the
role physical, the result before treatment was 27.08
and after surgery rose slightly to 29.16. It was not
a statistically significant change (p < 0.600180).
In assessing mental health, the point value of
38 before surgery significantly increased to 53.66
(p < 0.007649).
The area of bodily pain before surgery was
rated at 9.58, and its value increased significantly
after surgery to 60.83 (p < 0.002218).
General health before surgery was rated on the
average of 16.66, and after surgery was on the order of 32.63. It was a statistically significant change
(p < 0.003346).
In the area of vitality, before treatment the value was 21.66. After the treatment it had increased
significantly to 47.50 (p < 0.000004).
Quality of life expressed in functioning associated with role emotional, before the treatment was
assessed at 50 and after surgery at 77.77 (this was
not statistically significant) (p < 0.090970).
In summary, the introduction of alternative
treatment – which is SCS – for refractory angina
pectoris has brought improvement in functioning
in all areas, but in the areas associated with role
physical and role emotional were not statistically
significant.
Patients with refractory angina pectoris independently assessed pain intensity with VAS. For
the statistical analysis, the Shapiro-Wilk normality of distribution test and Wilcoxon’s sequence of
pairs test were used.
On average, the intensity of pain before surgery was assessed at 6.91. The level of pain decreased significantly after the introduction of SCS
and amounted to 2.33. It was a statistically significant change (p < 0.002218).
Discussion
SCS in Poland is still a rare procedure, carried
out in only a few centers. There is no national publication covering the analysis of treatment costs of
a larger group of patients suffering from chronic
pain syndromes than the group covered by the research in this study. In many centers abroad, where
the importance of economic analysis in the health
sector is recognized, studies conducted indicate
that SCS is a cost-effective method and improves
the quality of life of patients [8, 10–12, 18, 19].
Cost analysis was presented from the perspective of the payer, based on data available from the
Headquarters of NHF.
The need to undertake this type of research,
among others, was emphasized by the 7th Congress
of the Polish Society of the Study of Pain, held in
September 2010 in Gdansk. Research on cost-effectiveness in various countries is a very important
contribution to the medical care sector. Various
health insurance schemes, as well as different ways
of financing SCS, require research into cost effectiveness at the national level, with the increasing
popularity of this method in a growing number of
patients undergoing this procedure.
In assessments of modern medical technology, all its aspects should be taken into account.
Cost analysis is a fundamental step that should
be taken when selecting therapy. Selection of an
appropriate methodology, passage of time in prospective studies and examination of the behavior
of sensitive parameters is essential in a proper
economic analysis. However, a holistic approach
to a patient’s health forbids the limitation only to
its physicality. The spheres of mental and social
functioning complete the picture of the usefulness
of therapy. It should therefore complement the
analysis of tools for testing the quality of life and
pain perception. Thus, the analysis gives the full
data that planners and decision makers at various
levels of the organization and implementation of
health care should take into account when allocating resources [15, 21, 23–25, 27].
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Address for correspondence:
Aleksandra Harat
Sandomierska 16
85-830 Bydgoszcz
Poland
Tel.: +48 52 585 54 08
E-mail: [email protected], [email protected]
Conflict of interest: None declared
Received: 16.08.2011
Revised: 2.01.2012
Accepted: 8.10.2012