Cost Efficiency Analysis for Spasticity Management Based on Physician Botulinum Toxin Prescribing Habits.

OBJECTIVE: To estimate differences in botulinum toxin type A (BoNT-A) treatment costs per patient for spasticity-injecting physicians, with a focus on physicians' use of alternative BoNT-A agents other than onabotulinumtoxinA. DESIGN: Retrospective cohort study. SETTING: National Medicare data for fee-for-service beneficiaries in 2017. PARTICIPANTS: A total of 116 physicians, 6829 BoNT-A procedures, and 3051 patients were included in this analysis. Most physicians were physiatrists (84%) and used only onabotulinumtoxinA (82%). INTERVENTIONS: Type of BoNT-A selected by physicians was the independent variable of interest. Included physicians were separated into 2 groups: (1) onabotulinumtoxinA only injectors and (2) abobotulinumtoxinA and/or incobotulinumtoxinA injectors (may still use onabotulinumtoxinA). MAIN OUTCOME MEASURE: Average cost per patient per year. RESULTS: The total average BoNT-A cost per patient per year was significantly less for physicians who used abobotulinumtoxinA and/or incobotulinumtoxinA vs those who used only onabotulinumtoxinA ($3684 vs $4739; P=.01). Patients' average annual out-of-pocket costs also reflected a similar difference ($855 vs $1082; P=.02) between the groups. Doses used and numbers of injections per patient per year were not significantly different between groups. CONCLUSIONS: The present analysis demonstrated lower cost per patient for both the payer and patient when physicians used types of BoNT-A other than onabotulinumtoxinA for spasticity. Nevertheless, most physicians in this spasticity-focused study used exclusively onabotulinumtoxinA, the most expensive BoNT-A available. Reasons for this are complex and include history on the market and approved indications beyond those associated with spasticity. However, future research should continue to identify such issues with a goal of finding solutions to improve cost inefficiencies.

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.

A retrospective study to assess resource utilization and costs in patients with post-stroke spasticity in the United Kingdom.

OBJECTIVE: Post-stroke spasticity (PSS) is a common complication following stroke. This study describes the differences in healthcare resource utilization between patients who do and do not develop PSS in the UK. METHODS: Adults registered in The Health Improvement Network database with a recorded stroke between 2007 and 2011 were included. PSS was identified through Read codes; machine learning was used to retrospectively identify unrecorded PSS events. Patients with diagnosed or predicted PSS in the 12 months after stroke were matched to those with no PSS on age, sex, number of strokes, socioeconomic status, and comorbidities using the nearest neighbor algorithm. Utilization and costs associated with general practitioner visits, nurse visits, hospitalizations, referrals to specialists, laboratory tests, and medications in the 12 months after stroke were compared. RESULTS: Overall, 2,951 PSS cases were matched to 37,753 controls. During the first year, more PSS cases visited a physiotherapist (19% vs 7%) and occupational therapist (12% vs 5%) compared to controls. A greater proportion of cases were also referred to specialists (76% vs 64%) and hospitalized (33% vs 9%) compared to controls. Medication for spasticity was, on average, 14.68 prescriptions for cases and 5.64 for controls. Total mean costs per patient were £1,270 (standard deviation [SD] = 772) and £635 (SD = 273) for cases and controls, respectively. CONCLUSION: Costs after stroke for patients developing PSS are twice as high compared to patients who do not develop it, with the major driver being the number of hospital admissions. This highlights the need for better recording and closer management of PSS.

What's new in multiple sclerosis spasticity research? Poster session highlights.

Each year at the Multiple Sclerosis Experts Summit, relevant research in the field of multiple sclerosis spasticity is featured in poster sessions. The main studies presented at this year's meeting are summarized herein.

Regional disparities in botulinum toxin A (BoNT-A) therapy for spasticity in Sweden: budgetary consequences of closing the estimated treatment gap.

OBJECTIVES: As no national treatment guidelines for spasticity have been issued in Sweden, different regional treatment practices may potentially occur. This study examines botulinum toxin A (BoNT-A) treatment for spasticity on a regional level in Sweden and presents budgetary consequences of closing the estimated treatment gap. MATERIALS AND METHODS: Prevalence of spasticity in Sweden was estimated from published data. Regional sales data for BoNT-A were acquired from IMS Health. A set proportion of hospital BoNT-A use was assumed to represent treatment of spasticity. Total intervention cost of BoNT-A treatment was gathered from healthcare regional tariffs, while costs associated with spasticity were derived from publications on multiple sclerosis and stroke. RESULTS: Results show that the regional variation in treatment of spasticity with BoNT-A is large, with approximately every fourth patient being treated in Southern healthcare region compared to every tenth in the Stockholm-Gotland or Western healthcare regions. The incremental cost of filling the reported treatment gap was also assessed and was estimated at around 9.4 million EUR. However, for the incremental cost to be offset by savings in spasticity-related costs, only a small proportion of treatment responders (defined as patients transitioning to a lower severity grade of spasticity) was required (12%). CONCLUSIONS: The study revealed apparent regional disparities of BoNT-A treatment for spasticity in Sweden. The results further suggest that the incremental cost of eliminating the treatment gap has a high probability of being offset by savings in direct costs, even at a low proportion of the patients reaching clinical improvement.

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.

Cost-minimization analysis in the treatment of spasticity in children with cerebral palsy with botulinum toxin type A: an observational, longitudinal, retrospective study.

OBJECTIVE: Cost-minimization analysis of onabotulinumtoxinA and abobotulinumtoxinA, taking into account the real dose administered to children with spasticity associated with dynamic equinus foot deformity due to cerebral palsy. METHOD: A single centre, observational, longitudinal, and retrospective study which included spastic paediatric patients aged 2-to-18-years and treated with onabotulinumtoxinA or abobotulinumtoxinA from December 1995 to October 2012, in the Paediatric Neurology Unit of a first-level Spanish hospital. A longitudinal analysis of spasticity severity was made to confirm the similar efficacy of both treatments. Cost minimization was analyzed using the dose administered and the direct costs (pharmacological and medical visits costs) from the perspective of the National Health System (in euros from 2016). RESULTS: We analyzed 895 patients with paediatric spasticity: 543 were treated only with onabotulinumtoxinA, 292 only with abobotulinumtoxinA, and 60 with both treatments. The mean doses administered were 5.44 U/kg (SD = 2.17) for onabotulinumtoxinA, and 14.73 U/kg (5.26) for abobotulinumto xinA. The total annual direct cost (pharmacological and medical visits) was € 839.56 for onabotulinumtoxinA and € 631.23 for abobotulinumtoxinA, which represents a difference of € 208.34 per year in favour of treatment with abobotulinumtoxinA. CONCLUSIONS: It has been demonstrated that in real clinical practice, the cost per patient and year for treatment of paediatric spasticity was lower when abobotulinumtoxinA was used.

Objetivo: Estudio de minimización de costes de onabotulinumtoxinA y de abobotulinumtoxinA, teniendo en cuenta la dosis real administrada, en ninos con espasticidad asociada con la deformidad dinámica del pie equino debida a parálisis cerebral. Método: Estudio unicéntrico, observacional, longitudinal y retrospectivo que incluyó pacientes pediátricos espásticos entre 2 y 18 anos tratados con onabotulinumtoxinA o abobotulinumtoxinA, entre diciembre del 1995 y octubre del 2012, en el Servicio de Neurología Pediátrica de un hospital espanol de primer nivel. Se realizó un análisis longitudinal de la gravedad de la espasticidad para confirmar la similar efectividad de ambos tratamientos y proceder al análisis de minimización de costes que contempló las dosis infiltradas y los costes directos (costes farmacológicos y de visitas) desde la perspectiva del Sistema Nacional de Salud (euros 2016). Resultados: Se analizaron 895 pacientes con espasticidad infantil, 543 fueron tratados únicamente con onabotulinumtoxinA, 292 con abobotulinumtoxinA y 60 con ambos tratamientos. Las dosis medias infiltradas obtenidas fueron de 5,44 U/kg (DE = 2,17) para las infiltraciones con onabotulinumtoxinA y de 14,73 U/kg (5,26) para las infiltraciones con abobotulinumto xinA. El coste directo anual total (farmacológico y visitas) fue de 839,56 € para onabotulinumtoxinA y de 631,23 € para abobotulinumtoxinA, lo que supone una diferencia de 208,34 € al ano a favor del tratamiento con abobotulinumtoxinA. Conclusiones: Se ha mostrado que en práctica clínica real el coste por paciente y ano del tratamiento de la espasticidad infantil resulta más económico con la utilización de abobotulinumtoxinA.

Cost-effectiveness of Sativex in multiple sclerosis spasticity: new data and application to Italy.

Multiple sclerosis (MS) is a chronic progressive disease that carries a high socioeconomic burden. Spasticity (rigidity and spasms) is common in MS and contributes to MS-related disability. This study aims to evaluate the cost-effectiveness of Sativex(®) (9-delta-tetrahydrocannabinol plus cannabidiol oromucosal spray) when used as add-on therapy for management of resistant MS-related spasticity in the context of the Italian healthcare system. A previously published Markov model-based analysis for the German and Spanish context was replicated, adapting it to the Italian setting. Model parameters were updated to reflect recent findings about MS-related spasticity and use of Sativex in daily clinical practice. The base case incremental cost-effectiveness ratio for Sativex use in Italy over a 5-year period was estimated to be €4968 per quality-adjusted life-year gained (year of costing: 2013). Sativex remained an efficient option in the Italian healthcare context - below the commonly accepted incremental threshold of €30,000 per quality-adjusted life-year gained - when deterministic and probabilistic sensitivity analyses were conducted. Sativex can be regarded as a cost-effective treatment option for patients with MS-related spasticity in Italy.

The high cost of spasticity in multiple sclerosis to individuals and society.

BACKGROUND: Spasticity is an extremely common, distressing and disabling symptom of multiple sclerosis. Limited data suggest the associated health care costs correlate with increasing severity and place a high economic burden on individuals, health care systems and society. OBJECTIVE: The aim of this study was to quantify the impact of multiple sclerosis spasticity on health care resources and the associated costs at different levels of severity in people with multiple sclerosis in the United Kingdom. METHODS: An online survey was carried out to understand the resources used in the management of spasticity in multiple sclerosis. The questionnaire asked health care specialists to estimate their involvement and the resource use associated with different levels of spasticity, and the survey outputs were used to derive the resource costs. RESULTS: The level and cost of care substantially increased with the degree of spasticity. Key factors contributing to high annual costs per patient were home care, hospital admissions and high-cost items, such as hospital beds. CONCLUSIONS: Based on the survey results, it can be assumed that managing spasticity early and effectively could result in substantial cost savings, in addition to the improvements in health-related quality of life.

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.

Burden of disease in multiple sclerosis patients with spasticity in Germany: mobility improvement study (Move I).

OBJECTIVES: To describe the current management patterns of multiple sclerosis (MS) patients with spasticity in Germany and the impact of MS spasticity on quality of life (QoL) and associated costs. METHODS: Non-interventional, multicentre, cross-sectional and retrospective burden-of-disease study including 414 MS patients with spasticity (age from 25 to 80 years) from 42 clinical practices across Germany. All patients were diagnosed with MS-related spasticity based on neurological examination at least 12 months before inclusion in the study. Three different forms were completed on different aspects of the disease: the patient questionnaire, the chart documentation form and the physician questionnaire. RESULTS: Mild, moderate and severe spasticity were found in 27.3, 44.0 and 28.7 % of patients, respectively. Associated symptoms and QoL scores were worse in patients with higher degrees of spasticity. In particular, higher mean scores for sleep impairment (mild vs. severe, 2.1 vs. 4.3), mean spasm count (3/day vs. 10.1/day), mean WEIMuS fatigue score (15.8 vs. 19.8), increased walking time (9.6 vs. 20.2 s) and lower mean QoL scores (MSQoL-54 physical subscale, 54.9 vs. 39.5; EQ-5D, 0.60 vs. 0.30) were reported in patients with severe spasticity in comparison to patients with mild spasticity. Patient management mainly comprised physiotherapy (mild vs. severe, 65.5 vs. 85.7 %) and medication (84.2 vs. 64.8 %) with baclofen. The average cost for patients with mild spasticity was €2,268/year, increasing to €8,688/patient/year for patients with severe spasticity. The health insurance costs showed the same trend. CONCLUSIONS: MS patients with spasticity suffer a significant burden because of resulting disabilities and reduced QoL, especially in cases of severe spasticity. Moreover, spasticity causes high costs that increase with increasing severity.

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.

Multiple sclerosis spasticity daily management: retrospective data from Europe.

Multiple sclerosis (MS) is a distressing and debilitating disease, which often leads to a state of progressive deterioration for the individual. Spasticity is a common and disabling neurological feature with increasing presence and severity throughout the progression of MS. Management of this spasticity is a key component of day-to-day care for patients with MS. Data from recent epidemiological studies in Spain (the '6E' and '5E' studies) and Germany (the 'MOVE 1' study) confirm the frequent occurrence of spasticity symptoms in patients with MS. Despite the difficulties experienced by MS patients with spasticity, the condition is largely undertreated because current treatment options do not provide adequate control of MS spasticity. With worsening MS spasticity there is an increase in individual patient symptoms, worsening of quality of life and impairment of daily living. From a healthcare/societal perspective, MS spasticity has been shown to be associated with substantial costs. Many of these costs relate to the increased disability (and consequent need for rehabilitation and caregiver support) that are associated with moderate-to-severe spasticity. Consequently, newer drugs that can provide better symptomatic relief and may slow progression to more severe forms of disability will be a step forward in the level of care that we can provide for MS patients.

Societal costs of intrathecal drug delivery systems--an administrative analysis based on patient claims.

OBJECTIVES: To quantify the overall and disaggregated societal costs of intrathecal drug delivery systems (IDDSs) in the treatment of pain and spasticity in the United States. MATERIALS AND METHODS: A retrospective review of medical and pharmacy claims was performed on patients with IDDS. Patients were divided into three cohorts according to the conditions that their IDDSs were intended to treat pain, spasticity, or both. Patients also were stratified according to whether or not cost data were available for the implantation of their IDDSs. Total societal costs that were directly attributable to pain or spasticity were summarized, and medical/pharmaceutical encounters were enumerated. RESULTS: N = 38,951 patients (52.7% women, age 54.1 ± 14.1 years) with IDDSs were identified and included in this study. IDDS patients have an average of 34.0-52.7 (depending on cohort) medical encounters per year, of which an average of 6.3-10.1 is attributable to the condition their IDDS is intended to treat. The average societal cost of the attributable encounters is $12,233 to $20,049 per patient year (inflation-adjusted 2011 U.S. dollars); however, the distribution of these costs is extremely skewed in the positive direction. Inpatient treatment accounts for 65.9% of the societal costs incurred by IDDS patients. CONCLUSIONS: The societal costs for IDDS patients are high and extremely variable. A relatively small number of patients made an extreme number of medical encounters and represent a heavy societal cost burden. In order to reduce the growing societal cost of chronic pain and spasticity treatment, measures should be taken to reduce the resource utilization and costs of the most challenging patients.

Poststroke spasticity: sequelae and burden on stroke survivors and caregivers.

Among the estimated 20% to 40% of stroke survivors who develop spasticity, the burden of this condition on patients, caregivers, and society is substantial. Stroke survivors with spasticity may experience reductions in their ability to perform activities of daily living and in their health-related quality of life. The occurrence of spasticity in stroke survivors may also result in an increased burden on their caregivers, who exhibit poorer physical and emotional health as compared with the general population. The responsibilities that caregivers have to the stroke survivor--in terms of providing medical care, protecting from falls, and assisting with feeding and hygiene, among other tasks of daily living--must be balanced with their responsibilities to other family members and to themselves. Caregivers of stroke survivors often report a feeling of confinement with little opportunity for relief, and although social support can be helpful, it is frequently limited in its availability. In terms of the socioeconomic burden of spasticity after stroke, recent data point to a 4-fold increase in health care costs associated with stroke survivors with spasticity compared with stroke survivors without spasticity. Thus, it is important to reduce the burden of spasticity after stroke. Consequently, effective spasticity treatment that reduces spasticity and the level of disability experienced by stroke survivors will likely increase their functioning and their health-related quality of life and will also result in a diminished burden on their caregivers.

Cost-effectiveness of onabotulinumtoxinA for the treatment of wrist and hand disability due to upper-limb post-stroke spasticity in Scotland.

BACKGROUND AND PURPOSE: The objective was to evaluate the cost-effectiveness of treating upper-limb post-stroke spasticity (ULPSS) with usual care (UC) plus onabotulinumtoxinA versus UC alone in Scotland. METHODS: We developed a model to simulate costs and quality-adjusted life years (QALYs) gained from treating ULPSS. Efficacy data and health utilities were taken from clinical trials. Unit costs were taken from published Scottish sources. We compared UC plus onabotulinumtoxinA and UC alone in three scenarios: (i) a scenario from the National Health Service perspective, which included differences in onabotulinumtoxinA use, specialist visits and day-hospital visits; (ii) a scenario that only included differences in onabotulinumtoxinA use and specialist visits; and (iii) a scenario from a societal perspective that included differences in onabotulinumtoxinA use, specialist visits and caregiver burden. RESULTS: In the first scenario, the model predicted that UC plus onabotulinumtoxinA produced 0.107 QALYs at an additional cost of £1099 compared with UC alone over 5 years, resulting in an incremental cost-effectiveness ratio (ICER) of £10,271/QALY. In the second scenario, the ICER increased to £27,134/QALY. In the third scenario (societal perspective), UC plus onabotulinumtoxinA produced lower total cost and higher QALYs, and therefore was superior to UC alone. CONCLUSIONS: Based on a model, UC plus onabotulinumtoxinA improved disability, which translated into greater QALYs but also increased direct medical costs compared with UC alone; however, the resulting ICER can be considered cost-effective. Moreover, UC plus onabotulinumtoxinA can be cost-saving if reduction in caregiver burden was included. OnabotulinumtoxinA offers value for money in the management of ULPSS in Scotland.

What place for ▾ cannabis extract in MS?

Multiple sclerosis (MS) is a neurological condition that is estimated to affect around 60,000 people in England and Wales, with a lifetime risk in the UK of 1 in 1,000.(1,2) Spasticity (an increase in muscle tone) is a common symptom of MS, resulting in muscle spasms, immobility, disturbed sleep and pain.(3,4) Complex drug combinations are sometimes necessary to manage symptoms of MS, but these are often only partially effective and associated with unacceptable side effects.(5) Cannabis extract containing delta9-tetrahydrocannabinol (dronabinol) and cannabidiol are the principal extracts from the cannabis plant present in a licensed preparation (▾Sativex - GW Pharma Ltd), the first cannabinoid preparation to be approved for medical use. Sativex has been licensed "for symptom improvement in adult patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy".(6) Here we review the evidence for cannabis extract and its place in the treatment of the condition.

Cost effectiveness of oromucosal cannabis-based medicine (Sativex®) for spasticity in multiple sclerosis.

BACKGROUND: Spasticity is common in patients with multiple sclerosis (MS) and is a major contributor to disability. Sativex®, an oromucosal spray containing cannabis-based medicinal products, has been found to be effective in reducing spasticity symptoms. OBJECTIVE: Our objective was to estimate the cost effectiveness of Sativex® plus oral anti-spasticity medicines compared with the current standard treatment for moderate or severe spasticity in MS in the UK. METHODS: A Markov model was used to assess the costs and benefits of Sativex® plus oral anti-spasticity medicines or current standard treatment based on their effects on the quality of life of patients. The main outcome was the incremental cost-effectiveness ratio (ICER) in terms of costs per additional QALY gained over 5 years of treatment. One-way, multi-way and probabilistic sensitivity analyses were conducted to explore the impact of uncertainties on the findings. RESULTS: In the base case, Sativex® plus oral anti-spasticity medicines resulted in incremental costs of £7600 and a QALY gain of 0.15 per person over 5 years (ICER = £49 300 per QALY).[year 2009 data for costs]. Findings were sensitive to the costs of Sativex® (price and dose) and differences in utilities between responders and non-responders. CONCLUSIONS: Using a willingness-to-pay threshold of £30 000 per QALY, Sativex® appears unlikely to be considered cost effective by UK funders of healthcare for spasticity in MS. This is unfortunate, since it appears that Sativex® use is likely to benefit some patients in the management of this common consequence of MS.