On the economic efficiency of the care situation for patients with spastic movement disorder

Spastic movement disorder (SB) occurs as a result of damage to the central nervous system. Accordingly, SB is a symptom of numerous underlying diseases, including stroke, multiple sclerosis and infantile cerebral palsy [1, 2]. A current extrapolation from data from the Leipzig forums suggests that around 530,000 patients are affected by SB that requires treatment. A lack of care or inadequate care can have a significant impact on the quality of life of those affected. In addition to sometimes severe impairments in everyday life, contractures, ulcerations and pain can occur as accompanying illnesses. This often results in a higher need for care or a higher level of care classification [2, 3]. SB cannot be cured, but its severity and comorbidities can be reduced. Suitable therapeutic procedures are described in the specialist literature and the corresponding guidelines [4-8]. However, it can be assumed that the reality of care in Germany shows a different picture. A survey should therefore clarify what the treatment of those affected is like [9]. A total of 109 general practitioners from Germany were surveyed by post about their patient clientele with SB and their care. Since the treatment decision of the respective doctor should not be interfered with, a non-interventional, retrospective study design was chosen. The questionnaire sent out included a total of 26 questions on general information about the patient clientele, non-invasive and drug therapy and collaboration with other specialist disciplines. On average, each GP provides care to approximately 24 patients with SB.

>> As part of the process cost analysis, the resource consumption resulting from the SB therapy is first determined from the categories requested. In a further step, costs are assigned to the information on the individual supply areas. The monetary assessment takes place from the perspective of statutory health insurance (GKV) and statutory nursing care insurance (GPV) in Germany. The individual areas include the costs for medical care from the general practitioner, for non-invasive therapeutic measures, drug therapy and nursing care. The costs are determined for a period of one year. In order to be able to make statements about the costs incurred by caring for patients with SB, these are extrapolated to the total population in Germany affected by SB. In order to support the information from the survey and to be able to make statements about possible incorrect care, a Delphi panel was also surveyed. This consists of five neurologists who specialize in the treatment of central movement disorders.1
Resource consumption
The data on resource consumption comes from the survey on the care of patients with SB in Germany. In addition, guidelines and specialist literature regarding the usual regimens, dosages or treatment intervals as well as supply data from the Leipzig forums were consulted.
Cost
The costs for antispastic medications and medications for analgesia and for the treatment of depression come from the Lauer Tax 2019. Costs for treatments by general practitioners or other specialists come from the database of the Uniform Assessment Standard (EBM) of the National Association of Statutory Health Insurance Physicians (KBV). In addition, the cost data is supplemented by research using common internet search engines.
Results
Since the general practitioners were asked about their entire patient clientele with SB, the information is general. A separate consideration of the individual supply areas initially seems sensible.

Costs of visits to the general practitioner
Patients with SB visit their family doctor with varying frequency. In the survey, the general practitioners stated that 36.7% of patients come to the practice 3 to 6 or 6 to 12 times a year because of SB. 13.8% visit the doctor more often than 12 times, 11.9% 1 to 3 times. The survey does not contain any specific information on doctor's visits, which is why an average frequency of 6 visits per year is assumed due to the SB.
Once per quarter, the insured flat rate 0300X can be billed according to the underlying age group. The survey shows that for 92.7% general practitioners, patients aged 30 and over are primarily affected by SB. For this reason, the average of the flat rates for insured persons by age group of 17.16 euros is included in the calculation.
Since patients with SB can be assumed to have at least one long-term, life-changing illness and continuous medical treatment and care is necessary, if these requirements are met, a chronic surcharge of 13.69 euros can also be charged once per treatment case. For further doctor visits within a quarter, the fee schedule item (GOP) 03230 Conversation is charged at 9.48 euros. This results in an average of 142.37 euros per patient per year (Table 1). Assuming that the total number of patients with SB in Germany, 530,000, are cared for by general practitioners, the annual costs of general practitioner care would be up to 75.5 million euros.

Costs of non-invasive therapy procedures
Various non-invasive therapy methods are available for the treatment of SB. As part of the survey, physiotherapy, orthoses/plaster casts were
de and acupuncture queried. On average, all patients receive physical therapy “frequently.” According to general practitioners, orthoses and plaster casts are used frequently in 17.3% of patients, while acupuncture is only used frequently in 4.3%.
Physiotherapeutic treatments at intervals of 30 to 45 minutes twice a week are recommended, initially for 6 weeks [7]. Since the survey does not provide any specific information on the interval and duration of physiotherapy for the individual patient, it is assumed for the cost calculation that patients with SB receive physiotherapy twice a week on average once a year for a period of 6 weeks.
The physiotherapy treatment, also on a neurophysiological basis as an individual treatment (20501), is used, among other things, for spastic paralysis. Physiotherapy for the treatment of central movement disorders after the age of 18 according to Bobath, Vojta and using proprioceptive neuromuscular facilitation (PNF) as an individual treatment (20710, 20711, 20712) is aimed at adult patients with spastic paralysis due to damage to the brain or Spinal cord aligned. The flat rate fees for these therapy procedures in the range of 20 to 35 minutes are included in the cost analysis. According to the remuneration agreement in accordance with Section 125 SGB V for the billing of physiotherapeutic services, massages and medical baths, the treatments are between 19.58 euros and 27.75 euros, the average is 25.71 euros (Table 2).
For position number 20501 the costs are 234.96 euros per year per patient, for position numbers 20710, 20711 and 20712 the costs are 333.00 euros each. Assuming an equal distribution of the individual measures, the average value is 308.52 euros. Based on the total number of patients, the annual expenditure on physiotherapeutic treatments would be 163.6 million euros.
Plaster casts are now rarely used in the treatment of SB. However, orthoses are available in numerous designs, each with very different functions. They serve to redress, i.e. to correct misalignments, and can fix, relieve, mobilize or improve the ability to stand and walk, and can be used to support contracture prevention.
The costs for orthoses and plaster casts can vary significantly depending on the area of application, size and manufacturer. The patient has to pay 10% of the aid himself, but in total not more than 10 and not less than 5 euros. Average prices for the most frequently used orthoses are included in the cost analysis. These are hand orthoses for the upper extremities and orthoses for the ankle, foot and leg in the lower extremities. In the list of aids of the National Association of Statutory Health Insurance Funds, these are listed under the aid numbers 23.02.-, 23.03.-, 23.06.- and 23.07.-.
Taking into account the patient's own contribution, the average price for orthoses is 113.05 euros. Assuming that around 17.3% of patients are often prescribed orthoses, the total costs for all patients with SB would be around 10.4 million euros.
Acupuncture for the treatment of SB is generally not reimbursed by statutory health insurance. However, some health insurance companies sometimes subsidize acupuncture treatments as part of bonus programs. To calculate the costs, however, it is assumed that patients have to pay for acupuncture treatments themselves as an IGeL service.

Drug costs
According to the general practitioners surveyed, patients who have developed SB requiring treatment are provided with antispastic medication at a rate of 48.7%. These can be divided into oral antispastic medications, injections with botulinum toxin A (BoNT/A) and intrathecal baclofen.
The prices of the individual medicines are average prices, determined based on the pharmacy sales prices of the Lauer Taxe 2019. The statutory pharmacy discount of 1.77 euros as well as an additional payment from the patient were deducted. For the oral antispastic medication, this was set at a flat rate of 5.00 euros. For the BoNT/A preparations and the intrathecal baclofen, the varying patient surcharges as well as any additional manufacturer discounts were taken into account.

Oral antispastic medications
Baclon preparations are used as oral antispastic medications.
fen, tizanidine, tolperisone, dantrolene, clonazepam, diazepam, gabapentin, levodopa (L-DOPA) and memantine. For gabapentin, the minimum effective dose for the treatment of SB is 1,200 mg/day; a dosage in the range of 2,400-3,600 mg/day is recommended, for this reason only preparations of 400 mg or more are taken into account. The pack size N2 was chosen, which is intended for long-term therapy with special medical supervision for a treatment period of 30 days. Tetrahydrocannabinol is considered as a spray in size N1 (Table 3). The cost calculation also included how frequently the general practitioners said they used each individual preparation.
The average cost per patient for oral antispastic medications is 105.24 euros per year. Assuming that general practitioners estimate that around 48.7% of patients are treated with antispastic drugs, the annual costs for the total number of patients with SB would be 27.2 million euros.

Botulinum toxin type A
The dosage of the individual preparations for injection treatment with BoNT/A depends on various factors. In particular, the severity and location of the spasticity, but also age, weight and general condition as well as the patient's response to possible previous treatments are crucial and should be taken into account individually in the treatment. Different dosages are recommended for the preparations Botox, Dysport and Xeomin for each treatment session.
The average units included in the cost analysis are based on a survey of 70 specialized neurologists2 and roughly correspond to the recommendations in the specialist information for the individual preparations. An average of 300 units of Botox or Xeomin are used in the therapy of SB. At Dysport the average is 1,000 units. The drug prices included in the cost breakdown are based on the current prices of the Lauer tax and the average dosages used according to the survey. An exact comparison of the average costs of BoNT/A preparations is not possible due to different approvals for muscle groups and dosages, so these can only provide an indication. The survey data from the Leipzig Forums also show that an average of 3.3 treatments are carried out per year.
It was assumed that the respective injection treatment would be billed via the EBM. The services calculated were the GOP 16211 basic flat rate for those aged 6 to 59 or 16212 basic flat rate from the age of 60 as well as the GOP 16220 neurological consultation, neurological treatment, advice, discussion and/or clarification, here billed once per session as a model.
Based on an average of 3.3 treatments per year, this results in 3,596.80 euros per patient per year for the preparations with BoNT/A (1,055.41 euros/treatment) and 113.95 euros (34.53 euros/treatment) for medical treatment . According to general practitioners, around 9.4% of their patients are treated with BoNT/A, so the total annual cost for injection treatment with BoNT/A would be 179.1 million euros.

Intrathecal baclofen
If a patient receives baclofen intrathecally via a pump, very different maintenance doses may be necessary between individuals after individual dosage adjustment. For spinal spasticity the average dose is 300-800 µg/day (range 10-1,000 µg/day), for cerebral spasticity the mean dose is 275 µg/day (range 22-1,400 µg/day) [10]. When considering costs, average prices for baclofen preparations are taken into account in the maintenance dose for adults that can be found in the specialist information.
The medication pump must be re-implanted at intervals of approximately 5 years. Here, the additional fee ZE09 fully implantable medication pump with programmable variable daily profile of the G-DRG version 2019 in the amount of 9,873.60 euros is included proportionally in the calculation. In addition, the baclofen pump must be refilled by a doctor approximately every three months. When using a baclofen pump, the GOP 30740 inspection of a plexus, epidural or spinal catheter inserted for long-term analgesia or the functional check and/or refilling of a medication pump and/or a programmable stimulation device must also be charged once a quarter.
On average, each patient costs 225.50 euros per quarter for the preparations, which corresponds to 902.00 euros per year. An additional 48.04 euros are charged annually for refilling the baclofen pump, and the costs for implanting the medication pump in the amount of 2,022.76 euros are also calculated pro rata. The survey revealed that approximately 2.5% of patients with SB received an intrathecal baclofen pump. Based on the total population, this would lead to total costs of 38.8 million euros per year.

Analgesics
Since spastic paresis often causes severe pain for the patient, more than half of the patients (54.2%) also receive analgesics. The prices for prescribed analgesics are based on the pharmacy sales prices listed in the Lauer Tax 2019. The average prices for the N2 pack size for 30 days were determined for the individual preparations. The statutory pharmacy discount of EUR 1.77 and the patient's additional payment of EUR 5.00 were taken into account, which were deducted from the pharmacy sales prices. In some cases, the pharmacists' mandatory discounts and the additional payments for patients differ from the standard rate, which is why paracetamol has an average mandatory discount of 0.08 euros and an additional payment of 1.50 euros; for acetylsalicylic acid (ASA) it is 0.10 euros and 2.00 euros Euro. In addition, the additional payment for the preparations hydromorphone, oxycodone and pregabalin is an average of 7.50 euros. For ASA, only preparations with 500 mg of active ingredient are included in the calculation, as there is no pain-relieving effect at lower doses. In addition, the average prices of the individual analgesic groups are weighted according to their share of the total prescriptions for analgesics (Table 6).
For the acetanilide group, the average cost is 0.12 euros for 30 days. NSAIDs are estimated at an average of 5.56 euros, opioids at 40.73 euros. An average of 4.38 euros is calculated for the pyrazolones and 21.72 euros for the co-analgesics. Overall, the monthly price for the supply of analgesics is 75.51 euros. Based on one year, the cost is 906.12 euros. Since around half of all patients with SB require analgesics, the total costs would be around 260.3 million euros.

Antidepressants
Patients who suffer from SB always experience limitations due to their serious underlying illness. If the patient's general condition worsens further due to the SB, for example because the patient's freedom of movement is restricted or suffers from severe pain, many of the patients will also suffer from depression. The number of people affected by stroke is estimated to be around a third [11].
On average, the general practitioners surveyed suspect that 44.8% of their patients with SB also suffer from depression. 72.5% of the doctors treat the depression themselves; around half of the doctors (47.7%) also involve another specialist in the treatment. The survey did not ask about any specific measures to treat depression, which is why we can only assume that the general practitioner uses antidepressants. The most commonly used group of antidepressants today are selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SNRIs). As an example, the preparations citalopram, fluoxetine and sertraline in pack size N2 were chosen to reflect the drug costs for the treatment of depression. The mandatory pharmacy discount and the patient's additional payment were deducted from the pharmacy sales prices.
The monthly costs for drug therapy for depression are 18.33 euros per patient, and for a year these are 219.96 euros. If half of the total population were to suffer from depression and around 72.5% of those affected were to be provided with antidepressants, the annual costs for drug therapy alone would be 37.9 million euros.
Total costs of GKV
The total costs of SB medical care average around 1,500 euros per patient per year. Extrapolated to the total population of 530,000 patients, this amounts to almost 793 million euros per year (Table 8).
Costs of care
If a patient is considered to be in need of care and has been awarded an appropriate level of care, he or she is entitled to care allowance or care benefits in kind. The respective amounts to which the patient is entitled vary depending on the level of care. A proportional combination of benefits in kind and care allowance is also possible. Patients of all levels of care are also entitled to a dedicated relief amount of 125.00 euros per month. To calculate the costs arising from the need for care, the entitlement to care benefits in kind is assumed; any expenses due to inpatient care or other management expenses are also not taken into account. It is also assumed that all patients have statutory nursing care insurance.
On average, 76.9% of patients with SB have a level of care. Based on the total number of patients with SB in Germany of 530,000 affected, this corresponds to around 407,570 patients with SB who have a level of care.
Since patients with care level 1 are only entitled to the earmarked relief amount each month, the expenses for the GPV are a maximum of 17.1 million euros per year, according to the general practitioners' information on distribution. The expenditure for patients with care level 2 is around 915.7 million euros. Since, according to the general practitioners surveyed, patients most often have care level 3, expenditure here is the highest at 2.4 billion euros per month. Care level 4 costs 1.8 billion euros, while care level 5 costs 756.9 million euros. The total annual expenditure for the care of patients with SB is therefore around 5.9 billion euros (Table 9).
Well over half of these patients (65.3%) have an increased level of care due to SB, which corresponds to approximately 266,143 patients. Assuming that the level of care for those affected can be reduced with guideline-compliant, evidence-based treatment, there is potential for savings for long-term care insurance (Table 10).
Taking into account the respective shifts within the individual levels of care (65.3% of patients are classified one level of care lower), this amounts to almost 1.5 billion euros. The total cost of care would be 4.4 billion euros annually. However, it should be taken into account that the care of the SB and also the success of the therapy depend on many factors, so that this savings potential can only be viewed as hypothetical.
Discussion and conclusion

SB is a complex complication of numerous underlying diseases and is therefore difficult to treat. Accordingly, care can have significant economic effects on the German healthcare system. This is one of the reasons why it is important that there is no lack of specialist or therapeutic care or incorrect care.
Since there is no epidemiological data on SB for Germany, extrapolation can only be carried out on the basis of health insurance data. The information from the survey therefore provides an initial overview of the costs incurred by providing self-service (Table 11). Based on the information from the survey, (family) medical care, physiotherapy, oral antispastic medications, injection treatments with BoNT/A and analgesics are particularly relevant here. The highest costs are incurred by the care required by patients, although it should be noted that the need for care arises from a variety of factors. Nevertheless, the general practitioners' statements suggest that there is considerable potential for savings if the treatment of SB should be optimized through guideline-compliant, evidence-based care. In addition, it can be assumed that from a social perspective there will be losses in productivity, as the group of 30 to 65 year olds is particularly affected by SB.
In reality, the care of those affected sometimes differs significantly from the ideal SB care described in the specialist literature and guidelines. Accordingly, it is to be expected that optimizing the supply of self-service services will have an impact on costs. With the help of the Delphi panel, the care services and their costs are to be related to guideline-compliant and evidence-based care. The experts sometimes see significant deviations between the current and ideal care (Table 12).
Only assumptions can be made about the actual economic effects. The experts on the Delphi panel agree that, in addition to the coverage areas surveyed, there are other relevant factors that can impact the overall costs. These include, above all, complications that may arise, which may require follow-up treatment (including hospital stays). Improving the mobility of those affected would also reduce transport costs. According to the experts, additional costs can also arise from additional remedies and aids and psychological care for patients.
It is assumed that the number of doctor visits could increase slightly if SB care is optimized, due to additional appointments with a specialized neurologist. The average number of physiotherapeutic treatments will also increase. General practitioners have indicated that they often prescribe physiotherapy. Nevertheless, the Delphi panel expects an increase here with regard to the current supply situation, as a higher frequency of therapy units makes sense. A slight increase in the use of orthoses is expected, as specific positioning orthoses should be increasingly used to prevent contractures and pressure ulcers. Guideline-based, evidence-based care will have a particular impact on drug therapy for spasticity. Intrathecal baclofen and injections with BoNT/A are used significantly too rarely. In return, if care is optimized, the number of prescriptions for oral antispastic medications will be significantly reduced. According to the Delphi panel's assessment, guideline-compliant care will not have an impact on the prescriptions of analgesics, and the number of prescriptions for antidepressants will also remain approximately the same.
The monetary evaluation of these assumptions shows that guideline-based therapy in the area of medical care can initially mean an increase in costs of around 9.5%, but in the long term a significant reduction in the accompanying and secondary diseases of SB can be assumed. At almost 1.5 billion euros, there is great potential for savings, particularly in the area of care needs. Taking into account the additional costs for healthcare services, the savings potential for the German healthcare system would still be considered high at more than 1.4 billion euros annually. Optimizing care not only means a significant increase in quality of life for the patient, but can also be of great economic importance. <<