Cost-Effectiveness of Long-Term, Targeted OnabotulinumtoxinA versus Peripheral Trigger Site Deactivation Surgery for the Treatment of Refractory Migraine Headaches.

BACKGROUND: Chronic migraines affect approximately 2 percent of the U.S. population and cost an estimated $17 billion per year. OnabotulinumtoxinA (botulinum toxin type A) is a U.S. Food and Drug Administration-approved prophylactic medication for chronic migraine headaches and is best injected in a targeted fashion into specific trigger sites. The purpose of this study was to determine the cost-effectiveness of long-term, targeted botulinum toxin type A versus peripheral trigger site deactivation surgery for the treatment of migraine headaches. METHODS: A Markov model was constructed to examine long-term, targeted botulinum toxin type A versus peripheral trigger site deactivation surgery. Costs, utilities, and other model inputs were identified from the literature. One-way and probabilistic sensitivity analyses were performed. An incremental cost-effectiveness ratio under $50,000 per quality-adjusted life-year was considered cost-effective. RESULTS: The mean cost of peripheral trigger site deactivation surgery was $10,303, with an effectiveness of 7.06; whereas the mean cost of long-term, targeted botulinum toxin type A was $36,071, with an effectiveness of 6.34. Trigger-site deactivation surgery is more effective and less costly over the time horizon of the model. One-way sensitivity analysis revealed that surgery is the most cost-effective treatment in patients requiring treatment for greater than 6.75 years. CONCLUSIONS: Based on this model, peripheral trigger site deactivation surgery is the more cost-effective option for treating refractory migraine headaches requiring treatment beyond 6.75 years. The model reveals that peripheral trigger-site deactivation surgery is more effective and less costly than long-term, targeted botulinum toxin type A over the course of a patient's lifetime.

Multidose Botulinum Toxin A for Intralaryngeal Injection: A Cost Analysis.

OBJECTIVES: Botulinum toxin A (BtxA) injection is the mainstay treatment for laryngeal dystonias. BtxA product labeling states that reconstituted toxin should be used within 4 hours on a single patient despite several studies that have demonstrated multidose BtxA to be safe and effective. Many insurance carriers mandate the use of an outside pharmacy which necessitates a single-use approach. This study compares the cost savings of multidose BtxA for laryngeal dystonia compared to single-use. STUDY DESIGN: This is a retrospective review and projected cost savings analysis. METHODS: Records and billing information were reviewed for patients receiving BtxA for intralaryngeal injection at a single laryngology division in 2015. Inclusion criteria included CPT 64617 or J0585; exclusion criteria included CPT 64616. The price of BtxA 100 unit vial for calculation was $670. RESULTS: A total of 142 patients were seen for intralaryngeal BtxA injection resulting in 337 visits over 1 year. The average BtxA dose per visit was 2.86 units with an average of 3.06 procedure visits per year. The calculated cost of BtxA treatment using a single vial approach was found to be $2,050 per patient per year. If billed instead for $7/unit with 5 units wastage charge per visit, the yearly per patient charge is $168. Single vial-use of BtxA injection thus represents a 1,118% price increase versus multidose use. When estimated for yearly prevalence of spasmodic dysphonia, multidose BtxA use would save almost $100 million annually. CONCLUSIONS: Multidose botulinum toxin A application utilizing per unit billing is significantly less expensive than per single-use vial billing and would save the health-care system significant amount of money without any sacrifice in safety or effectiveness.

[Cost-utility analysis of two formulations of botulinum toxin type A in the treatment of blepharospasm and cervical dystonia in Spain]. / Analisis coste-utilidad de dos formulaciones de toxina botulinica de tipo A en el tratamiento del blefaroespasmo y la distonia cervical en España.

INTRODUCTION: Studies on focal dystonia showed that the formulations of botulinum toxin type A, incobotulinumtoxin-A (Inco-BTA) and onabotulinumtoxin-A (Ona-BTA), have equivalent efficacy and safety. AIM: To carry-out a cost-utility analysis of Inco-BTA administered on flexible intervals vs. Ona-BTA on a fixed interval, in the treatment of blepharospasm and cervical dystonia. PATIENTS AND METHODS: A probabilistic Markov model was designed to estimate costs (euros, 2017) and benefits (quality-adjusted life years, QALY), from the Spanish National Health Service perspective and on a 5-year time horizon, of treatment of blepharospasm and cervical dystonia with Inco-BTA (6-12 month flexible intervals) versus Ona-BTA (12-month fixed intervals). It is assumed that symptoms will re-emerge some time later in both options. Result was expressed as incremental cost-utility ratio (ICUR). RESULTS: Inco-BTA and Ona-BTA costs were 3,742 and 3,366 euros respectively, in blepharospasm, and 6,673 and 6,419 euros in cervical dystonia. Patients treated with Inco-BTA remained asymptomatic for 22.12, and 21.34 more weeks than those treated with Ona-BTA, leading in 3.040 and 3.012 QALY, respectively, in blepharospasm, and 3.471 and 3.401 QALY, respectively, in cervical dystonia. Differences showed statistical significance in all cases. ICUR was estimated as 13,576 and 4,158 euros/QALY in blepharospasm and cervical dystonia, respectively. CONCLUSIONS: Treatment of blepharospasm and cervical dystonia with Inco-BTA is a cost-effective therapeutic alternative in Spain, based on the flexibility of their administration.

TITLE: Analisis coste-utilidad de dos formulaciones de toxina botulinica de tipo A en el tratamiento del blefaroespasmo y la distonia cervical en España.Introduccion. Las formulaciones de toxina botulinica de tipo A, incobotulinumtoxinA (Inco-TBA) y onabotulinumtoxinA (Ona-TBA), han demostrado eficacia y seguridad similar en los estudios de distonias focales en los que se han comparado. Objetivo. Realizar un analisis coste-utilidad de Inco-TBA, administrada en intervalos flexibles, frente a Ona-TBA, administrada en intervalos fijos, en el tratamiento del blefaroespasmo y la distonia cervical. Pacientes y metodos. Un modelo de Markov probabilistico estimo, desde la perspectiva del Sistema Nacional de Salud español y en un horizonte de cinco años, el coste (euros, 2017) y el resultado (años de vida ajustados a calidad, AVAC) del tratamiento del blefaroespasmo y la distonia cervical mediante intervalos flexibles con Inco-TBA (6-20 semanas) y fijos con Ona-TBA (12 semanas). Se asume que los sintomas reapareceran despues de un tiempo en ambos. El resultado se expreso como ratio coste-utilidad incremental (RCUI). Resultados. El coste de la Inco-TBA y la Ona-TBA fue, respectivamente, de 3.742 y 3.366 euros en el blefaroespasmo y de 6.673 y 6.419 euros en la distonia cervical. Los pacientes tratados con Inco-TBA permanecieron asintomaticos 22,12 y 21,34 semanas mas que los tratados con Ona-TBA, lo que resulto 3,040 y 3,012 AVAC, respectivamente, en el blefaroespasmo, y 3,471 y 3,401 AVAC, respectivamente, en la distonia cervical. En todos los casos, las diferencias presentaron significacion estadistica. La RCUI fue de 13.576 y 4.158 euros/AVAC, respectivamente. Conclusiones. El tratamiento del blefaroespasmo y la distonia cervical con Inco-TBA, administrada siguiendo un esquema posologico de intervalos flexibles, constituye una alternativa terapeutica eficiente en España.

Estimating the clinical effectiveness and value-based price range of erenumab for the prevention of migraine in patients with prior treatment failures: a US societal perspective.

BACKGROUND: Frequent migraine with four or more headache days per month is a common, disabling neurovascular disease. From a US societal perspective, this analysis models the clinical efficacy and estimates the value-based price (VBP) for erenumab, a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor. METHODS: A Markov health state transition model was developed to estimate the incremental costs, quality-adjusted life-years (QALYs), and value-based price range for erenumab in migraine prevention. The model comprises "on preventive treatment", "off preventive treatment", and "death" health states across a 10-year time horizon. The evaluation compared erenumab to no preventive treatment in episodic and chronic migraine patients that have failed at least one preventive therapy. Therapeutic benefits are based on estimated changes in monthly migraine days (MMD) from erenumab pivotal clinical trials and a network meta-analysis of migraine studies. Utilities were estimated using previously published mapping algorithms. A VBP analysis was performed to identify maximum erenumab annual prices at willingness-to-pay (WTP) thresholds of $100,000-$200,000 per QALY. Estimates of VBP under different scenarios such as choice of different comparators, assumptions around inclusion of placebo effect, and exclusion of work productivity losses were also generated. RESULTS: Erenumab resulted in incremental QALYs of 0.185 vs supportive care (SC) and estimated cost offsets due to reduced MMD of $8,482 over 10 years, with an average duration of treatment of 2.01 years. The estimated VBP at WTP thresholds of $100,000-$200,000 for erenumab compared to SC ranged from $14,238-$23,998. VBP estimates including the placebo effect and excluding work productivity ranged from $7,445-$13,809; increasing to $12,151-$18,589 with onabotulinumtoxinA as a comparator in chronic migraine. CONCLUSION: Erenumab is predicted to reduce migraine-related direct and indirect costs, and increase QALYs compared to SC.

Clinical practice of BOTOX® treatment for overactive bladder syndrome in Sweden: an assessment of resource use and external validity.

OBJECTIVE: The objective of this study was to assess the resource use of treating overactive bladder (OAB) patients in real-world clinical practice and to evaluate whether there is external validity in the treatment of OAB in clinical practice. MATERIALS AND METHODS: The study included 55 patients suffering from OAB and treated with BOTOX® at two Swedish clinics. The study was conducted as an anonymized retrospective chart review study. RESULTS: The estimated yearly direct cost of BOTOX treatment was €902. The mean age of patients in the study was 60 years, and 85% were women. The severity of OAB before BOTOX treatment, given by the mean number of daily leakages, equalled 4.8. The median interval between treatments was 210 days. CONCLUSIONS: Patient characteristics in the real world were similar to those in the clinical trials, showing a high degree of external validity. Treatment intervals were longer in the real world than in clinical trials, indicating that treatment cost could be lower when patients are treated as observed in real-world clinical practice.

Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial.

OBJECTIVES: This study aimed to compare the cost-effectiveness of Botox and anticholinergic (AC) medications for the management of urgency urinary incontinence (UUI). METHODS: Cost and effectiveness data were analyzed from participants in the Anticholinergic versus Botox Comparison randomized trial of daily AC medication versus 100 U of intradetrusor Botox injection. Societal costs included the following: treatment costs, patient costs, and medical and nonmedical utilization during the 6-month trial. Quality-adjusted life-years (QALYs) were calculated based on questionnaire-derived utility measures and annualized based on data collected at baseline through 6 months. We also estimated the average direct costs for each treatment through 9 months - the duration of time when approximately half the Botox participants maintained adequate symptom control. RESULTS: Data were analyzed on the 231 women who completed a 6-month follow-up in the Anticholinergic versus Botox Comparison trial (119 AC and 112 Botox). The mean reduction in UUI episodes per day was not significantly different per group. The cumulative mean direct costs through the first 6 months also were similar: $1339 for the AC group and $1266 for the Botox group with AC costs exceeding Botox costs after 5 months. Both groups had considerable QALY gains. Annualizing the 6-month trial results to a 12-month measure, the AC and Botox groups averaged 0.702 and 0.707 QALYs, respectively. Estimates through 9 months favored Botox, showing that AC participants incurred a higher cost per month of adequate symptoms control ($305) compared with Botox participants ($207). CONCLUSIONS: Botox and AC medications have similar costs and effectiveness in the first 6 months of UUI treatment. If costs and outcomes are considered through 9 months, Botox may have significantly lower costs but similar UUI symptom control as AC.

Economic impact of onabotulinumtoxinA for overactive bladder with urinary incontinence in Europe.

BACKGROUND: Overactive bladder (OAB) is a common condition that has a significant impact on patients' health-related quality-of-life and is associated with a substantial economic burden to healthcare systems. OnabotulinumtoxinA has a well-established efficacy and safety profile as a treatment for OAB; however, the economic impact of using onabotulinumtoxinA has not been well described. METHODS: An economic model was developed to assess the budget impact associated with OAB treatment in France, Germany, Italy, Spain and the UK, using onabotulinumtoxinA alongside best supportive care (BSC)-comprising incontinence pads and/or anticholinergic use and/or clean intermittent catheterisation (CIC)-vs BSC alone. The model time horizon spanned 5 years, and included direct costs associated with treatment, BSC, and adverse events. RESULTS: Per 100,000 patients in each country, the use of onabotulinumtoxinA resulted in estimated cost savings of €97,200 (Italy), €71,580 (Spain), and €19,710 (UK), and cost increases of €23,840 in France and €284,760 in Germany, largely due to day-case and inpatient administration, respectively. Projecting these results to the population of individuals aged 18 years and above gave national budget saving estimates of €9,924,790, €27,458,290, and €48,270,760, for the UK, Spain, and Italy, respectively, compared to cost increases of €12,160,020 and €196,086,530 for France and Germany, respectively. Anticholinergic treatment and incontinence pads were the largest contributors to overall spending on OAB management when onabotulinumtoxinA use was not increased, and remained so in four of five scenarios where onabotulinumtoxinA use was increased. This decreased resource use was equivalent to cost offsets ranging from €106,110 to €176,600 per 100,000 population. CONCLUSIONS: In three of five countries investigated, the use of onabotulinumtoxinA, in addition to BSC, was shown to result in healthcare budget cost savings over 5 years. Scenario analyses showed increased costs in Germany and France were largely attributable to the treatment setting rather than onabotulinumtoxinA acquisition costs.

Cost-Effectiveness of Incobotulinumtoxin-A with Flexible Treatment Intervals Compared to Onabotulinumtoxin-A in the Management of Blepharospasm and Cervical Dystonia.

BACKGROUND: Incobotulinumtoxin-A (Xeomin(®), Merz Pharmaceuticals, Sydney, New South Wales) is a formulation of botulinum neurotoxin type A that is free of complexing proteins. OBJECTIVE: To assess the cost-effectiveness of incobotulinumtoxin-A administered with flexible treatment intervals compared to onabotulinumtoxin-A (Botox(®), Sydney, New South Wales) in blepharospasm and cervical dystonia from the perspective of Australian health care providers. METHODS: A Markov state transition model was developed to perform a cost-utility analysis to compare the cost and health benefits of incobotulinumtoxin-A to that of onabotulinumtoxin-A. The cost-utility analysis compared incobotulinumtoxin-A treatment, given at minimum intervals of 6 weeks and maximum intervals of 20 weeks, with onabotulinumtoxin-A treatment, given at minimum intervals of 12 weeks and maximum intervals of 20 weeks. The Markov model consisted of three health states and followed patients in weekly cycles for 5 years. Only direct health care costs associated with the acquisition and administration of type A botulinum neurotoxins were included. Utility values were derived from a prospective, open-labeled cohort study. The primary outcome measure was the incremental cost per quality-adjusted life-year. Univariate and probabilistic sensitivity analyses were conducted. RESULTS: Incobotulinumtoxin-A was cost-effective compared to onabotulinumtoxin-A in both blepharospasm and cervical dystonia, with an incremental cost/quality-adjusted life-year gained of A$ 25,588 and A$ 23,794, respectively. CONCLUSIONS: Incobotulinumtoxin-A administered at flexible treatment intervals determined by the needs of the patient was found to be a cost-effective treatment option when compared to the administration of onabotulinumtoxin-A in the Australian health care system. The option to administer incobotulinumtoxin-A according to the needs of the patient resulted in patients experiencing symptoms for a fewer number of weeks compared to onabotulinumtoxin-A given at minimum 12-week intervals.

Effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial spasm compared to standard care: study protocol for a randomised controlled trial.

BACKGROUND: Blepharospasm and hemifacial spasm are debilitating conditions that significantly impact on patient quality of life. Cyclical treatment with botulinum toxin injections offers temporary relief, but the duration of treatment efficacy is variable. The standard model of patient care defines routine fixed-time based scheduled treatment cycles which may lead to unnecessarily frequent treatment for some patients and experience of distressing symptoms in others, if symptoms return before the scheduled follow-up period. METHODS/DESIGN: A randomised controlled trial will compare a patient-initiated model of care, where patients determine botulinum toxin treatment timing, to the standard model of care in which care is scheduled by the clinical team. A sample of 266 patients with blepharospasm or hemifacial spasm will be recruited from Moorfields Eye Hospital (MEH), London. The trial will be accompanied by a mixed-methods evaluation of acceptability of the new service. Patients who meet eligibility criteria will be assessed at baseline and those in the intervention group will be provided with instructions on how to book their own treatment appointments. Patients in both groups will be followed up 3 and 9 months into the trial and all patients will be returned to usual care after 9 months to meet safety protocols. Primary outcome measures include disease severity (questionnaire), functional disability (questionnaire) and patient satisfaction with care (questionnaire). Secondary outcomes include disease-specific quality of life (questionnaire), mood (questionnaire), illness and treatment perceptions (questionnaire and semi-structured interviews), economic impact (questionnaire) and acceptability (questionnaire and semi-structured interviews). DISCUSSION: This trial will assess the effectiveness and cost-effectiveness of a patient-led care model for botulinum toxin therapy. If the new model is shown to be effective in reducing distress and disability in these populations and is found to be acceptable to patients, whilst being cost-effective, this will have significant implications for service organisation across the NHS. TRIAL REGISTRATION: UK Clinical Research Network (UKCRN) Portfolio 18660. Clinicaltrials.gov ID NCT102577224 (registered 29 October 2015).

OnabotulinumtoxinA in the treatment of overactive bladder: a cost-effectiveness analysis versus best supportive care in England and Wales.

The cost-effectiveness of onabotulinumtoxinA (BOTOX(®)) 100 U + best supportive care (BSC) was compared with BSC alone in the management of idiopathic overactive bladder in adult patients who are not adequately managed with anticholinergics. BSC included incontinence pads and, for a proportion of patients, anticholinergics and/or occasional clean intermittent catheterisation. A five-state Markov model was used to estimate total costs and outcomes over a 10-year period. The cohort was based on data from two placebo-controlled trials and a long-term extension study of onabotulinumtoxinA. After discontinuation of initial treatment, a proportion of patients progressed to downstream sacral nerve stimulation (SNS). Cost and resource use was estimated from a National Health Service perspective in England and Wales using relevant reference sources for 2012 or 2013. Results showed that onabotulinumtoxinA was associated with lower costs and greater health benefits than BSC in the base case, with probabilistic sensitivity analysis indicating an 89 % probability that the incremental cost-effectiveness ratio would fall below £20,000. OnabotulinumtoxinA remained dominant over BSC in all but two scenarios tested; it was also economically dominant when compared directly with SNS therapy. In conclusion, onabotulinumtoxinA appears to be a cost-effective treatment for overactive bladder compared with BSC alone.

[How to convince the head of department and managing director of the importance of specialised headache clinics]. / Como convencer al jefe de servicio y al gerente de la importancia de las unidades/consultas especializadas de cefaleas.

In spite that headache is, by far, the most frequent reason for neurological consultation and that the diagnosis and treatment of some patients with headache is difficult, the number of headache clinics is scarce in our country. In this paper the main arguments which should allow us, as neurologists, to defend the necessity of implementing headache clinics are reviewed. To get this aim we should first overcome our internal reluctances, which still make headache as scarcely appreciated within our specialty. The facts that more than a quarter of consultations to our Neurology Services are due to headache, that there are more than 200 different headaches, some of them actually invalidating, and the new therapeutic options for chronic patients, such as OnabotulinumtoxinA or neuromodulation techniques, oblige us to introduce specialised headache attendance in our current neurological offer. Even though there are no definite data, available results indicate that headache clinics are efficient in patients with chronic headaches, not only in terms of health benefit but also from an economical point of view.

TITLE: Como convencer al jefe de servicio y al gerente de la importancia de las unidades/consultas especializadas de cefaleas.A pesar de que la cefalea es, con diferencia, el principal motivo neurologico de consulta, y de la complejidad diagnostica y terapeutica de algunos pacientes, el numero de consultas monograficas de cefalea (CC) y de unidades de cefalea (UC) es muy reducido en nuestro pais. En este articulo pasaremos revista a los principales argumentos que nos permitan, como neurologos, defender la necesidad de la implementacion de una CC/UC, dependiendo de la poblacion que se debe atender, en todos nuestros servicios de neurologia. Para ello deberemos, en primer lugar, vencer las reticencias internas, que hacen que la cefalea sea aun poco apreciada y atractiva dentro de nuestra especialidad. El hecho de que la cefalea justifique mas de un cuarto de las consultas a un servicio de neurologia estandar de nuestro pais y de que existan mas de 200 cefaleas diferentes, algunas de ellas realmente invalidantes, y las nuevas opciones de tratamiento para pacientes cronicos, como la OnabotulinumtoxinA para la migraña cronica o las tecnicas de neuromodulacion, obligan a introducir dentro de nuestras carteras de servicios la asistencia especializada en cefaleas. Aunque no disponemos de datos incontrovertibles, existen ya datos suficientes en la literatura que indican que esta atencion es eficiente en pacientes con cefaleas cronicas no solo en terminos de salud, sino tambien desde el punto de vista economico.

A Retrospective, Single-Center Comparative Cost Analysis of OnabotulinumtoxinA and AbobotulinumtoxinA for Cervical Dystonia Treatment.

BACKGROUND: Chemodenervation with botulinum neurotoxin (BoNT) is recommended as first-line treatment for the management of cervical dystonia. The choice of BoNT for treatment is subject to the consideration of several factors, including cost. OBJECTIVE: To compare the costs incurred by patients and payers for onabotulinumtoxinA (ONA) or abobotulinumtoxinA (ABO) for the treatment of cervical dystonia. METHODS: We conducted a retrospective, noninterventional closed cohort study of cervical dystonia patients within a single U.S. private neurological practice. Patient and payer incurred costs from medical billing records for patients satisfying inclusion and exclusion criteria treated from November 1, 2009, through January 1, 2013, were de-identified and included in the analysis. Forty-seven patients initially treated with at least 3 consecutive cycles of ONA, followed by at least 3 consecutive cycles of ABO were included, representing 282 injection cycles available for analysis. Patients were required to have had a positive response to treatment with both agents and no concomitant treatment with BoNT for any other condition during the analysis period. The analysis compared the primary endpoint of median overall payer and patient incurred costs reimbursed to the clinic under each treatment regimen. For the purposes of this cost analysis, comparable clinical outcomes on both therapies was assumed.   RESULTS: Switching from ONA to ABO resulted in an overall incurred reimbursement cost savings for payers and patients. Median costs per injection cycle for ONA were $1,925 ($0-$2,814) compared with $1,214 ($229-$2,899; P less than 0.0001) for ABO, representing an approximate 37% reduction in incurred reimbursement costs inclusive of toxin and procedure. Overall toxin reimbursement costs, patient out-of-pocket toxin costs, and the cost of unavoidable waste were also lower when patients were treated with ABO.  CONCLUSIONS: For patients treated for cervical dystonia, switching from ONA to ABO resulted in payer and patient reimbursement cost reductions in a single U.S. private practice with outcomes assumed to be similar.

Cost-effectiveness analysis of onabotulinumtoxinA (BOTOX(®)) for the management of urinary incontinence in adults with neurogenic detrusor overactivity: a UK perspective.

OBJECTIVES: To evaluate the cost effectiveness of onabotulinumtoxinA (BOTOX(®), 200 units [200 U]) for the management of urinary incontinence (UI) in adults with neurogenic detrusor overactivity (NDO) due to subcervical spinal cord injury or multiple sclerosis that is not adequately managed with anticholinergic drugs (ACHDs). PERSPECTIVE: UK National Health Service (NHS) perspective. METHODS: A Markov state-transition model was developed, which compared onabotulinumtoxinA + best supportive care (BSC) with BSC alone (comprising behavioural therapy and pads, alone or in combination with clean intermittent catheterization and possibly with ACHDs). Non-responders were eligible for invasive procedures. Health states were defined according to the reduction in UI episodes. Efficacy data and estimates of resource utilization were pooled from 468 patients on onabotulinumtoxinA in two phase III clinical trials. Drug costs (2013) and administration costs (NHS Reference Costs 2011-2012) were obtained from published sources. The time horizon of the model was 5 years, and costs and benefits were discounted at 3.5%. Scenario, one-way and probabilistic sensitivity analyses (PSAs) were conducted to explore uncertainties around the assumptions. RESULTS: In the base case, treatment with onabotulinumtoxinA + BSC over 5 years was associated with an increase in costs of £1,689 and an increase in quality-adjusted life-years (QALYs) of 0.4, compared with BSC alone, resulting in an incremental cost-effectiveness ratio of £3,850 per QALY gained. Sensitivity analyses showed that utility values had the greatest influence on model results. PSA suggests that onabotulinumtoxinA + BSC had a 100 % probability of being cost effective at a willingness to pay of <£20,000. CONCLUSION: For adult patients with NDO who are not adequately managed with ACHDs, onabotulinumtoxinA + BSC appears to be a cost-effective use of resources in the UK NHS.

Real-world economic impact of onabotulinumtoxinA in patients with chronic migraine.

OBJECTIVE: To determine whether the utilization of healthcare resources is reduced after chronic migraine patients are treated for 6 months with onabotulinumtoxinA. BACKGROUND: OnabotulinumtoxinA is indicated for headache prophylaxis in patients with chronic migraine, but its effect on healthcare resource use is unknown. METHODS: We analyzed data from an open-label study of 230 chronic migraine patients refractory to ≥2 oral prophylactics who presented to a headache specialty clinic and who were treated with two cycles of onabotulinumtoxinA. Frequency and cost of migraine-related healthcare resource use, including visits to emergency departments, urgent care, or hospitalization, were compared for the 6 months before and after initial treatment. Costs were based on publicly available sources. RESULTS: Compared with the 6 months predating initial treatment, patients had 55% fewer emergency department visits (174 vs 385), 59% fewer urgent care visits (61 vs 150), and 57% fewer hospitalizations (19 vs 45) during the 6-month treatment period (P < .01 for all). Analysis of treatment-related costs yielded an average reduction of $1219.33/patient, off-setting 49.7% of the total estimated cost for 6 months of treatment with onabotulinumtoxinA. CONCLUSIONS: Although we are unable to distinguish onabotulinumtoxinA's treatment effect from other potential confounding variables, our analysis showed that severely afflicted, treatment-refractory patients with chronic migraine experienced a significant cost-offset through reduced migraine-related emergency department visits, urgent care visits, and hospitalizations in the 6 months following treatment initiation of onabotulinumtoxinA. Future analyses will assess the longer-term effect of onabotulinumtoxinA treatment and the potential contribution of regression to the mean.

[Botulinum toxin therapy for spasticity].

Botulinum toxin (BTX) administered as an adjunct to other interventions for spasticity can act as a useful and effective therapeutic tool for treating patients disabled by spasticity. Presence of other non-reflex motor disorders (muscle stiffness, shortness, and contracture) can complicate the clinical course and disturb rehabilitative process of patients with spasticity. Treatment of spasticity using BTX can improve paralysis by correcting muscular imbalance that follows these diseases. In patients with chronic severe spasticity, we also have to address unique and difficult-to-treat clinical conditions such as abnormal posture and movement disorders. The effectiveness of BTX in treating some of these conditions is discussed. Because patients with neurological disabilities can show complex dysfunctions, specific functional limitations, goals, and expected outcomes of treatment should be evaluated and discussed with the patient, family members, and caregivers, prior to initiating BTX therapy. BTX therapy might improve not only care, passive function, but also motor functions in these patients by supplementing intensive rehabilitation with repetitive transcranial magnetic stimulation, transcranial direct-current stimulation, peripheral electrical stimulation, muscle stretching, and other rehabilitation strategies.

The cost effectiveness of Botox in Italian patients with chronic migraine.

Migraine is a primary headache which World Health Organization ranks in 19th place in the list of disabling diseases. In Europe, in 2004, the total costs for migraine were quantified by Stovner and Berg, Eur J Neurol, 12(s1) (2005) at 27 billion. The objective of this study is to provide an estimate of the incremental cost-effectiveness ratio (ICER) of the treatment of chronic migraine with Botox compared to treatment with placebo in the perspective of the Italian National Health Service and society. To do this we studied the disease progression in a cohort of 688 individuals (patients enrolled in the study PREEMPT) via the application of a Markov model. Over a period of 2 years, the total costs of the experimental arm of the model amounted to 3,274 compared with a gain of 1.34 QALYs. In contrast, the costs of the control arm amounted to 2,395 with a gain of 1.24 QALYs. It follows that the incremental costs amounted to 889 compared to an incremental gain of 0.09 QALYs in favor of the experimental arm. The relationship between costs and incremental QALYs generated an ICER of 9,407/QALY. The incremental cost-effectiveness ratio, therefore, is favorable compared to the value usually considered by NICE as a threshold limit for reimbursement which ranges between 20,000 and 40,000/QALY.