Intrathecal Baclofen Therapy in Patients With Multiple Sclerosis: Improved Outcomes and Reduced Costs Through Identification of Catheter Malfunction.

INTRODUCTION: Two patients previously implanted with intrathecal Baclofen (ITB) pumps for management of intractable spasticity due to multiple sclerosis (MS) were referred to our center for ongoing management of their spasticity. Initial evaluation of these patients revealed high levels of spasticity in the presence of ITB doses 10 times the average daily dose of our other MS patients. CLINICAL FACTS: High doses of ITB required frequent clinical visits and result in high drug and procedure costs. Both patients' daily doses were greater than 1000 mcg/day resulting in clinical visits every 1-2 months with drug and procedure costs ranging from 16 to 23 thousand dollars annually based on Medicare national average pricing for physician's office. Of the 59 MS patients receiving ITB therapy at our institution, the mean, median, and mode daily doses for ITB are 184, 115, and 159 mcg/day, respectively. The high ITB doses in these patients and poor spasticity control raised suspicion for pump/catheter malfunction and prompted immediate troubleshooting. FINDINGS: One patient's catheter was found to be disconnected from the pump and the other's catheter tip was outside the intrathecal space. In both cases, the patients were not receiving the therapy. After pump/catheter replacement, both patients received excellent clinical benefits from ITB at significantly lower daily doses. This reduction in dose resulted in decreased frequency of medication refills (twice annually) which resulted in decreased cost of care (12-19 thousand dollars savings annually per patient). DISCUSSION: These cases illustrate the need for early ITB pump troubleshooting to identify catheter problems, improve efficacy, and avoid unnecessary healthcare costs.

Baclofen in gamma-hydroxybutyrate withdrawal: patterns of use and online availability.

PURPOSE: Gamma-hydroxybutyrate (GHB) withdrawal is a life-threatening condition that does not always respond to standard treatment with benzodiazepines. Baclofen has potential utility as a pharmacological adjunct and anecdotal reports suggest that it is being used by drug users to self-manage GHB withdrawal symptoms. Here, we investigate current patterns of use and the online availably of baclofen. METHODS: Data triangulation techniques were applied to published scientific literature and publicly accessible Internet resources (grey literature) to assess the use of baclofen in GHB withdrawal. An Internet snapshot survey was performed to identify the availability of baclofen for online purchase and the compliance of retailers with the UK regulations. Data were collected according to pre-defined criteria. RESULTS: A total of 37 cases of baclofen use in GHB withdrawal were identified in the scientific literature, as well as 51 relevant discussion threads across eight Internet forums in the grey literature. Baclofen was available to purchase from 38 online pharmacies, of which only one conformed to the UK regulations. CONCLUSIONS: There is limited published evidence on the use of baclofen in GHB withdrawal, but both scientific and grey literature suggests clinical utility. Online pharmacies are readily offering prescription-only-medication without prescription and due to inadequate regulation, pose a danger to the public.

Cost-effectiveness of Intrathecal Baclofen Therapy in severe refractory non-focal disabling spasticity: a Spanish hospital perspective.

BACKGROUND: Current knowledge about long-term economic consequences of Intrathecal Baclofen Therapy (ITB Therapy®) is incomplete. METHODS: A markov model was developed to estimate long-term clinical and economic outcomes with ITB Therapy® and conventional medical management of severe refractory non-focal disabling spasticity. Clinical and cost inputs were obtained through a non-interventional, prospective, observational study in a Spanish neurorehabilitation hospital. RESULTS: ITB Therapy® increased remaining lifetime costs by €35,605 and resulted in a gain of 1.06 quality-adjusted life-years (QALYs), thus showing an incremental cost-effectiveness ratio (ICER) of €33,619/QALY gained. In alternative scenarios, reflecting other clinical settings and management options, considerably lower ICER values were obtained. In particular, opportunities were identified to improve efficiency by setting clinically and economically sound targets for post-operation length of stay. CONCLUSION: In the Spanish setting, ITB Therapy® resulted in an ICER close to €30,000/QALY gained; potential ways to reduce costs and further enhance efficiency can be identified.

Medical cost impact of intrathecal baclofen therapy for severe spasticity.

OBJECTIVES: To evaluate the economic effects of intrathecal baclofen (ITB) for patients with severe spasticity based on costs of care before and after implantation of an intrathecal drug delivery system. MATERIALS AND METHODS: An actuarial projection of post-implant experience in the absence of ITB intervention was used to simulate a continued conventional medical management protocol (ITB-free) by assuming a reasonable trend rate based on health-care industry standards. Cost projections were developed over a 30-year time horizon at various reimplantation rates. The model was informed by retrospective analysis of commercial administrative claims data from 409 pediatric and adult spasticity patients who received a pump implant (ITB-experienced) within a 3-year service period (January 2006 to January 2009). Common indications associated with pump implant included multiple sclerosis (N = 124), cerebral palsy (N = 131), and spinal cord injury (N = 40). RESULTS: ITB was less costly than the conventional protocol over our baseline implantation cycle. Costs in the month of implant and in the year following were cumulatively $26,375 more than with the conventional protocol. However, ITB financial break-even occurs between the second and third years post-implant. The lifetime analysis indicates that savings for ITB are $8009 per patient per year compared with conventional therapy. Most of the savings are derived from reductions in inpatient admissions, physician office visits, and outpatient physiotherapy. CONCLUSIONS: The results suggest that spasticity patients receiving ITB would expect to experience a reduction in cumulative future medical costs relative to anticipated costs in the absence of a pump implant. This finding complements the existing literature on the cost-effectiveness of ITB.

Cost-effectiveness analysis of baclofen and chlordiazepoxide in uncomplicated alcohol-withdrawal syndrome.

OBJECTIVES: Benzodiazepines (BZDs) are the first-line drugs in alcohol-withdrawal syndrome (AWS). Baclofen, a gamma-aminobutyric acidB (GABAB) agonist, controls withdrawal symptoms without causing significant adverse effects. The objective of this study was to compare the cost-effectiveness of baclofen and chlordiazepoxide in the management of uncomplicated AWS. MATERIALS AND METHODS: This was a randomized, open label, standard controlled, parallel group study of cost-effectiveness analysis (CEA) of baclofen and chlordiazepoxide in 60 participants with uncomplicated AWS. Clinical efficacy was measured by the Clinical Institute Withdrawal Assessment for alcohol (CIWA-Ar) scores. Lorazepam was used as supplement medication if withdrawal symptoms could not be controlled effectively by the study drugs alone. Both direct and indirect medical costs were considered and the CEA was analyzed in both patient's perspective and third-party perspective. RESULTS: The average cost-effectiveness ratio (ACER) in patient's perspective of baclofen and chlordiazepoxide was Rs. 5,308.61 and Rs. 2,951.95 per symptom-free day, respectively. The ACER in third-party perspective of baclofen and chlordiazepoxide was Rs. 895.01 and Rs. 476.29 per symptom-free day, respectively. Participants on chlordiazepoxide had more number of symptom-free days when compared with the baclofen group on analysis by Mann-Whitney test (U = 253.50, P = 0.03). CONCLUSION: Both study drugs provided relief of withdrawal symptoms. Chlordiazepoxide was more cost-effective than baclofen. Baclofen was relatively less effective and more expensive than chlordiazepoxide.

Costs and quality of life in multiple sclerosis patients with spasticity.

BACKGROUND: The resource use and health-related quality of life (HRQoL) of patients with multiple sclerosis (MS) spasticity are not well known. The purpose of this study was to obtain estimates of resource utilization, costs, and HRQoL, for patients with different levels of MS spasticity in southern Sweden. MATERIAL AND METHODS: Cross-sectional data on spasticity severity (using a Numerical Rating Scale, NRS), resource use and HRQoL (using EQ-5D) were collected using a patient questionnaire and chart review. Patients were recruited through a clinic in southern Sweden. The study reviews direct medical, direct non-medical and indirect costs. RESULTS: Total costs were estimated to €114,293 per patient and year. Direct medical costs (€7898) accounted for 7% of total costs. Direct non-medical costs (€68,509) accounted for 60% of total costs. Total costs increased with severity of spasticity: for patients with severe spasticity, the total cost was 2.4 times greater than those for patients with mild spasticity. HRQoL decreased as spasticity increases. CONCLUSION: The results of this study show that MS spasticity is associated with a substantial burden on society in terms of costs and HRQoL.

Cost-effectiveness analysis of intrathecal baclofen therapy in Japan.

Intrathecal baclofen (ITB) therapy was approved for health insurance coverage in 2005 for the treatment of patients whose spasticity could not be adequately controlled by conventional therapy, and is currently being used to treat around 300 patients nationwide in Japan. Various reports have examined the efficacy and safety of ITB therapy, but no report has evaluated the patient quality of life and medical costs in Japan. A cost-utility analysis of ITB was conducted by time period in six severely spastic patients admitted to our university hospital between 2005 and 2010 for ITB therapy. The average cost of ITB therapy per quality-adjusted life year (QALY; number of years survival in perfect health) 5 years after surgery was 1,554,428 yen, below the 6 million yen willingness-to-pay threshold for 1 QALY. This study shows that ITB therapy in Japan is an outstanding treatment in medicoeconomic terms.

Intrathecal baclofen in multiple sclerosis: too little, too late?

The majority of patients with multiple sclerosis (MS) have symptoms of spasticity that increasingly impair function as the disease progresses. With appropriate treatment, however, quality of life can be improved. Oral antispasticity medications are useful in managing mild spasticity but are frequently ineffective in controlling moderate to severe spasticity, because patients often cannot tolerate the adverse effects of increasing doses. Intrathecal baclofen (ITB) therapy can be an effective alternative to oral medications in patients who have a suboptimal response to oral medications or who cannot tolerate dose escalation or multidrug oral regimens. ITB therapy may be underutilized in the MS population because clinicians (a) are more focused on disease-modifying therapies rather than symptom control, (b) underestimate the impact of spasticity on quality of life, and (c) have concerns about the cost and safety of ITB therapy. Delivery of ITB therapy requires expertly trained staff and proper facilities for pump management. This article summarizes the findings and recommendations of an expert panel on the use of ITB therapy in the MS population and the role of the physician and comprehensive care team in patient selection, screening, and management.

Intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a cost-effectiveness analysis.

In a Dutch national study, we recently established the effectiveness and safety of continuous intrathecal baclofen infusion (CITB) in children with intractable spastic cerebral palsy (CP). Because prospective studies on the cost-effectiveness of CITB in children with spastic CP are lacking, we conducted a cost-effectiveness analysis alongside our prospective national study. We compared the costs and health effects of CITB with those of standard treatment only, from the health care perspective for a 1-year period. Health effects were expressed in terms of a visual analogue scale for individual problems and quality-adjusted life years (QALYs). We included eight females and seven males, aged between 7 and 17 years (mean age 13y 8mo [SD 3y]). Eleven children had spastic CP and four had spastic-dyskinetic CP. One child was clsssified on the Gross Motor Function Classification System at Level III, two at Level IV, and 12 at Level V. CITB was more effective and more costly than standard treatment only. Gaining one QALY cost on average 32,737 euros. We conclude that based on the threshold-willingness to pay for one QALY in the Netherlands (80,000 euros), our results confirm the cost-effectiveness of CITB for carefully selected children with intractable spastic CP.

Cost-effectiveness of intrathecal baclofen therapy for the treatment of severe spasticity associated with cerebral palsy.

Spasticity is relatively common among children with cerebral palsy. This condition can be painful, can severely impair a child's ability to perform basic tasks, and can place an enormous emotional and financial burden on the family. Intrathecal baclofen delivered via an implantable pump is an effective treatment option for children unresponsive to oral medication and needing generalized motor control. However, the initial investment for the delivery device and its surgical placement can be a barrier to access. A cost-effectiveness analysis of intrathecal baclofen for adults in the British health care system concluded that intrathecal baclofen offered good value for the money. No similar analysis of intrathecal baclofen has been conducted in the context of the US health care system, and no study has specifically examined cost-effectiveness of intrathecal baclofen in a pediatric population. The aim of this article is to assess the cost-effectiveness of intrathecal baclofen among children with severe spasticity of cerebral origin who have not responded to less invasive treatments such as oral medications relative to alternative medical and surgical therapy. The authors used mathematical modeling and computer simulation to estimate the incremental cost per quality-adjusted life-year for identical cohorts of children treated with intrathecal baclofen or alternative therapy over a 5-year episode of treatment. Data on treatment costs representative of these children were derived from a health insurance claims database that included both commercial and Medicaid data. Utility values used to construct quality-adjusted life-years were obtained from a panel of expert clinicians who used the Health Utilities Index-2 to rate health states associated with the course of treatment. On average, intrathecal baclofen therapy increased the 5-year cost of treatment by $49 000 relative to alternative treatment. However, this was accompanied by an average gain of 1.2 quality-adjusted life-years. The net result was an incremental cost-effectiveness ratio of $42 000 per quality-adjusted life-year, a figure well within the $50 000 to $100 000 range that is widely accepted as offering good value for the money.

Cost-effectiveness comparison of tizanidine and baclofen in the management of spasticity.

OBJECTIVE: Baclofen and tizanidine are both used for the treatment of muscle spasticity of spinal origin. Their effectiveness, cost and adverse-effect profiles differ. This paper sets out to estimate the cost effectiveness of each drug, and the impact of changing from baclofen to tizanidine. DESIGN: A simplified but realistic model of physician behaviour and patient response was developed as a decision tree and populated with data derived from the available published clinical comparative trials. We considered patients with spasticity caused by multiple sclerosis or spinal cord injury. The outcome measure used was 'cost per successfully treated day' (STD). Costs were estimated from the perspective of the UK National Health Service at 2000 values. RESULTS: Expected cost for a cohort of 100 patients over 1 year was estimated to be pound 181 545 with baclofen and pound 211 930 with tizanidine. The estimated number of STDs was 20,192 with tizanidine and 17,289 with baclofen. The overall cost effectiveness of managing spasticity using baclofen and tizanidine was very similar ( pound 10.50 and pound 10.49 per STD respectively). The incremental cost effectiveness (ICE) of using tinzanidine as an alternative to baclofen for first-line treatment was pound 10.47 per STD. Sensitivity analysis found the model to be robust to changes in key parameters CONCLUSION: Drug cost should not be a determining factor in making this treatment choice, as the cost effectiveness ratios are similar for both products.

Functional benefits and cost/benefit analysis of continuous intrathecal baclofen infusion for the management of severe spasticity.

OBJECT: Intrathecally delivered baclofen has been used as a treatment for severe spasticity since 1984. Despite this, there are uncertainties surrounding the benefits of treatment and the costs involved. The authors assessed the evidence of benefits and identified costs and the cost/benefit ratio for continuous intrathecal baclofen infusion in the treatment of severe spasticity. METHODS: A systematic literature review was conducted to estimate the effect of continuous intrathecal baclofen infusion on function and quality-of-life (QOL) measures in patients with severe spasticity. Outcomes were related to standard QOL scores to estimate potential gains in quality-adjusted life years (QALYs). Information on the costs of continuous intrathecal baclofen infusion was obtained from hospitals in the United Kingdom. This information was combined to estimate the cost/benefit ratio for the use of continuous intrathecal baclofen infusion in patients with different levels of disability from severe spasticity. Studies indicate that bedbound patients are likely to improve their mobility and become able to sit out of bed. Patients with severe spasm-related pain are likely to have major improvement or complete resolution of this pain. Many other benefits are also reported. Such benefits are related to costs per QALY in the range of 6,900 pounds to 12,800 pounds ($10,550-$19,570 US). CONCLUSIONS: In carefully selected patients who have not responded to less invasive treatments, continuous intrathecal baclofen infusion is likely to lead to worthwhile functional benefits. Continuous intrathecal baclofen infusion has an acceptable cost/benefit ratio compared with other interventions that are funded by the health service.

[Value of intrathecal baclofen in the treatment of severe tetanus in the tropical milieu]. / Place du baclofene intrathecal dans le traitement du tetanos grave en milieu tropical.

Tetanus continues to be a cause of high mortality in developing countries, where resources for muscle relaxation and respiratory support are not readily available. Baclofen, a GABAB receptor agonist, directly restores physiologic inhibition of alpha motoneuron, that is blocked by tetanus toxin. Its use has been suggested at high dosage by intrathecal (i.t.) route, as part of the treatment of tetanus-induced contractures, and to limit the need for general anesthesia and for tracheal intubation in afflicted patients. This review reports personal experience and focuses on published data about i.t. baclofen for severe tetanus. Although statistical analysis are difficult to perform, i.t. baclofen appears to be effective in resolving muscle rigidity and in avoiding the need for deep sedation and for tracheal intubation, thus achieving lower mortality. Nevertheless, i.t. baclofen has a narrow therapeutic range, and a large interindividual pharmacodynamic variability. Thus, its use should be reserved for patients who would have been intubated without it. I.t. baclofen is a fairly simple and cost-effective modality, with significant advantages for management of severe tetanus, especially in tropical environment.

Cost analysis of the treatment of severe spinal spasticity with a continuous intrathecal baclofen infusion system.

OBJECTIVE: The purpose of our study was to analyse and evaluate the costs of continuous intrathecal baclofen administration as a modality in the treatment of severe spasticity in the Netherlands. DESIGN: A cost analysis was conducted as part of a prospective, multicentre, multidisciplinary, randomised and placebo-controlled clinical trial. The study covered the period from December 1991 to September 1995. The data on medical consumption and costs were collected over a 3-year period from different sources: administrative databases of health insurance companies, hospital registries and a patient survey. These data were structured by means of a flowchart analysis of the medical decision-making by specialists and general practitioners (GPs). They included data on in- and outpatient care, home care and care in nursing homes. The cost analysis was conducted using data from 18 patients included in the trial and from 15 so-called 'match' patients. The latter group are patients with comparable diseases leading to spasticity and living in comparable circumstances. Next to absolute costs (direct and indirect) of care and treatment for the 2 groups of patients, cost differences between the 2 groups were considered (differential cost analysis). SETTING: Per patient cost data, collected prospectively for 2 years during the phase of clinical evaluation, and retrospectively 1 year before implantation. The data were collected on patients from in- and outpatient care, home care and care in nursing home settings. PATIENTS AND PARTICIPANTS: The trial patients (8 men) had a mean age of 46 years; 11 patients had multiple sclerosis and 7 patients had spinal cord injuries. The match patients (7 men) had a mean age of 48 years; 9 patients had multiple sclerosis and 6 patients had spinal cord injuries. INTERVENTIONS: Trial patients were treated with a subcutaneously implanted programmable continuous infusion pump (SynchroMed, Medtronic), filled with baclofen (a muscle relaxant) to treat patients with chronic disabling spasticity who did not respond to a maximum dose of oral baclofen, dantrolene and tizanidine. MAIN OUTCOME MEASURES AND RESULTS: An analysis of hospital stay between both groups showed a significant difference during the implantation year. The average number of hospital days per patient in the year in the treated group was 31.5 days and in the match group was 18.7 days. Significant cost differences between both groups in the year that started with pump implantation and the following year can be attributed mostly to the costs of implantation of the pump and related hospitalisation days. The total costs of patient selection, testing, implanting the pump and follow-up amounted to $US28,473 for the first year. Savings must be taken into consideration as well. The savings of direct costs were due to withdrawal of oral medication (estimated annual total of between $US1950 and $US2800 per patient). Indirect savings on employment and nursing home costs, amounted annually to $US1047 and $US5814, respectively. Scenarios make it possible to consider policy consequences. The case of 'extending' the indications for this treatment to a larger population has been calculated and visualised. CONCLUSIONS: The costs of the therapy (continuous intrathecal infusion of baclofen) can be attributed mostly to implantation of the pump and related hospitalisation days. Savings originated from withdrawal of oral medication, job preservation and avoidance or delay of admission to a nursing home.

Intrathecal baclofen in cerebral palsy movement disorders.

Intrathecal baclofen reduces spasticity in individuals with cerebral palsy. Intrathecal doses are far lower than oral doses and the effects are considerably greater, and the side effects are fewer. Response to intrathecal baclofen must be confirmed by a screening trial before implantation of a pump for chronic infusion. Intrathecal baclofen reduces spasticity in the upper and lower extremities and is often associated with improved gait and upper extremity function. Quality of life improves for patients and caregivers. The Medtronic pump has been exceedingly reliable and typically functions for 4 or 5 years. The currently available intrathecal catheter is associated with far fewer complications than the initial catheter. Baclofen overdoses are unusual and are usually caused by pump programming errors rather than pump malfunction. Preliminary studies suggest that continuous intrathecal baclofen infusion reduces generalized dystonia in cerebral palsy. Screening to determine response of dystonia to intrathecal baclofen is by continuous infusion. The doses required to reduce dystonia are higher than those for cerebral spasticity. Additional investigations are underway to quantify the effects of continuous intrathecal baclofen infusion on communication, disability, and dystonia.

Cost analysis of continuous intrathecal baclofen versus selective functional posterior rhizotomy in the treatment of spastic quadriplegia associated with cerebral palsy.

The purpose of the study was to analyze the relative cost of selective functional posterior rhizotomy (SFPR) and continuous intrathecal baclofen in the treatment of children with severe spastic quadriplegia related to cerebral palsy. No attempt was made to analyze the efficacy of the two types of treatment. Nine children with spastic quadriplegia secondary to cerebral palsy in whom continuous intrathecal baclofen was attempted were matched as closely as possible with a group of 10 patients with spastic quadriplegia out of a total of 100 children who had undergone SFPR in the same time period. Clinical care flow charts were created to identify the various points of contact with members of the health care team, so that cost points could be identified and costs calculated. The cost per patient up to 1 year a after treatment CDN$ 64,163.10 for patients with implanted pumps for continuous intrathecal baclofen versus CDN$ 16,913.54 for SFPR. When adjustments were made to exclude costs and savings associated with research protocols, the average for the baclofen group decreased to approximately CDN$ 63,000, with minimal change for the SFPR group. The higher cost per patient on baclofen was related to the cost associated with screening patients who did not go on to have implantation of a continuous infusion pump, and to additional hospitalization for complications in the baclofen group. It is cautioned that this cost analysis was based on the experience at British Columbia's Children's Hospital, and the results may not be generalizable to other institutions or to other patient populations.