Assessment of efficacy of different botulinum toxin A concentrations in the treatment of androgenetic alopecia assessed by dermoscopy.

BACKGROUND: Androgenetic alopecia (AGA) is the most common type of progressive hair loss in men and women. AGA is characterized by the miniaturization of the hair follicle, leading to the transformation of terminal hair to vellus hair. OBJECTIVE: To evaluate the efficacy and safety of injecting two different concentrations of botulinum toxin A (BTA) for the treatment of AGA in Egyptian patients. METHODS: Adult male (Hamilton-Norwood I-VII) and female (Ludwig I-III) patients (N = 32) were assigned to receive two different concentrations BTA (33.3 and 25 U/mL) on each side of the scalp; in total, there were 15 injections administered on each side, with injection volume of 0.1 mL containing 3.3 U for the right half and 2.5 U for the left half. Treatment efficiency was assessed at baseline, Month 3 and Month 6, by degree of clinical improvement and dermoscopy assessment. RESULTS: By Month 6, proportion of male patients (N = 5) classified as Hamilton-Norwood Grade II increased from 0% to 60% (3/5), proportion of female patients (N = 27) classified as Ludwig Grade I also increased from 14.8% (4/27) to 70% (19/27). Dermoscopy result showed a significant increase in vellus hair density from baseline to Month 6 on the right side (33.3 U/mL), while no change was observed on the left (25 U/mL); however, vellus hair density was higher at Month 3 compared to Month 6. There were changes in yellow spots and peripilar sign more on the right side. Adverse reactions reported include irritation, headache, injections site pain, and nausea. CONCLUSION: The results of the present study showed that BTA is a safe and effective treatment for AGA in both genders. These findings offer a cutting-edge conceptual structure and therapeutic strategy for the management of AGA in Egyptian population.

A UK Single-Center, Retrospective, Noninterventional Study of Clinical Outcomes and Costs of Two BotulinumtoxinA Treatments for Limb Spasticity.

Service model changes at the North Staffordshire Rehabilitation Centre (UK) included switching spasticity treatment from onabotulinumtoxinA (onaBoNT-A) to abobotulinumtoxinA (aboBoNT-A). This noninterventional, retrospective, longitudinal study (NCT04396704) describes the clinical and economic outcomes in toxin-naive adults with spasticity who received onaBoNT-A (Cohort 1; 2015-2017) or aboBoNT-A (Cohort 2; 2017-2019). Outcomes included Goal Attainment Scale T (GAS-T) score, treatment satisfaction, quality of life (QoL; EQ-5D visual analog scale [VAS] score), and treatment costs. Adverse events were recorded for Cohort 2. Cohort 1 included 60 patients (mean [standard deviation] dose, 206.0 [98.8] U); Cohort 2 included 54 patients (753.7 [457.3] U). Mean (95% confidence interval) GAS-T scores for Cohorts 1 and 2 were 43.1 (39.3-46.9) and 47.8 (43.7-51.9) at Week 6, and 43.2 and 44.3 at Week 12, respectively. In both cohorts most patients were satisfied with treatment. At Week 12, QoL had not changed in Cohort 1 but had improved in Cohort 2 (EQ-5D VAS, -5). Mean estimated per-patient costs (in 2021) for Cohorts 1 and 2 were £315.56 and £249.25, respectively, at Week 6, and £343.20 and £273.21, respectively, at Week 12. Fifteen non-treatment-related serious adverse events and two deaths were recorded. These data may warrant a larger prospective study powered to compare outcomes of aboBoNT-A and onaBoNT-A.

Integrative Assessment for Optimizing Aesthetic Outcomes When Treating Glabellar Lines With Botulinum Toxin Type A: An Appreciation of the Role of the Frontalis.

Despite the perception that treatment of glabellar lines with botulinum toxin A is straightforward, the reality is that the glabellar region contains a number of interrelated muscles. To avoid adverse outcomes, practitioners need to appreciate how treatment of 1 facial muscle group influences the relative dominance of others. In particular, practitioners need to understand the independent role of the frontalis in eyebrow outcomes and the potential for negative outcomes if the lower frontalis is unintentionally weakened by botulinum toxin A treatment. In addition, practitioners must recognize how inter-individual variation in the depth, shape, and muscle fiber orientation among the upper facial muscles can affect outcomes. For optimal results, treatment of the glabellar complex requires a systematic and individualized approach based on anatomical principles of opposing muscle actions rather than a one-size-fits-all approach. This review provides the anatomical justification for the importance of an integrated assessment of the upper facial muscles and eyebrow position prior to glabellar treatment. In addition, a systematic and broad evaluation system is provided that can be employed by practitioners to more comprehensively assess the glabellar region in order to optimize outcomes and avoid negatively impacting resting brow position and dynamic brow movement.

Comparative efficacy, safety, and cost-effectiveness of abobotulinumtoxinA and onabotulinumtoxinA in children with upper limb spasticity: a systematic literature review, indirect treatment comparison, and economic evaluation.

OBJECTIVE: The objective of this study was to compare clinical- and cost-effectiveness of type A botulinum toxin (BoNT-A) therapies for management of pediatric upper limb spasticity, including AbobotulinumtoxinA (aboBoNT-A) and Onabotulinumtoxin A (onaBoNT-A). METHODS: Systematic literature review and indirect treatment comparisons were conducted of randomized controlled trials reporting efficacy and safety outcomes. Efficacy was characterized by Modified Ashworth Scale (MAS) and Ashworth Scale (AS) up to 16-weeks post-injection. Results were used to inform a cost-effectiveness model with a 1-year time horizon, linking response rates with health-related quality-of-life (HRQoL) outcomes and costs from a UK perspective. Other data sources included in the cost-effectiveness model were drug unit costs, health care resource utilization based on UK physician survey, and HRQoL impacts of adverse events associated with oral anti-spasticity therapies. Results were characterized as cost per quality-adjusted life year and cost per responder. RESULTS: Six studies were included in evidence syntheses. There was a trend towards greater response rate for aboBoNT-A which resulted in improved HRQoL and lower annual costs compared with onaBoNT-A. Safety outcomes were similar across BoNT-A therapies. In cost-effectiveness analysis, aboBoNT-A was an economically dominant therapy with respect to cost per quality-adjusted life year. The cost per responder at 1 year was estimated to be £39,056 for aboBoNT-A vs. £54,831 for onaBoNT-A. LIMITATIONS AND CONCLUSIONS: Based on observed safety and efficacy data, aboBoNT-A is estimated to result in higher treatment response and consequently increased quality-of-life and reduced costs, vs. onaBoNT-A in children with upper limb spasticity. Limitations to the study include study heterogeneity limited details available for onaBoNT-A studies (e.g. use of physical therapy), and limited availability of responder data. Where assumptions were required, they were made to be conservative towards aboBoN-A.

Cost of fremanezumab, erenumab, galcanezumab and onabotulinumtoxinA associated adverse events, for migraine prophylaxis in Spain.

Objective: To compare the cost of adverse events (AEs) associated with preventive treatment of migraine with fremanezumab, versus erenumab, galcanezumab, and onabotulinumtoxinA.Methods: A probabilistic modeling analysis was performed, using second-order Monte Carlo simulations, with 1,000 simulations, in patients with at least 4 days of migraine per month, from the perspective of the National Health System and a time horizon of 12 weeks. The frequency of AEs described in the clinical trials was analyzed with 12 weeks of treatment. Unit costs (€) of management of AEs were obtained from public health prices, expert panels, and published Spanish studies.Results: Fremanezumab would generate average savings of -€469 (95% CI -€303; -€674) versus erenumab, -€268 (95% CI -€171; -€391) versus galcanezumab, -€1,100 (95% CI -€704; -€1,608) or -€1,295 (95% CI -€835; -€1,893) versus onabotulinumtoxinA using real-life or clinical trial data, respectively.Conclusions: The different safety profile of treatment with fremanezumab, compared to erenumab, galcanezumab, and onabotulinumtoxinA, would generate savings in health-care resources in all the scenarios considered.

Assessment of laser-assisted delivery vs intralesional injection of botulinum toxin A in treatment of hypertrophic scars and keloids.

Keloids and hypertrophic scars could impair the psychological, physical, and cosmetic aspects of the patient's quality of life. Unfortunately, there is no curative treatment available till now. This study aimed to evaluate the efficacy and safety of intralesional vs topical botulinum toxin A combined with Fractional CO2 laser in the treatment of hypertrophic scars and keloids. Twenty patients with Keloids and hypertrophic scars were enrolled in the study. Each scar was divided into two halves, one subjected to intralesional injection of botulinum toxin type A once a month for 4 months and the other was subjected to four sessions of CO2 laser therapy at 1 month interval followed by topical application of botulinum toxin A. Significant improvement was noted in Vancouver Scar Scale in hypertrophic scars in laser group than intralesional botulinum toxin A. In keloid cases, the improvement was significantly higher with intralesional botulinum toxin A. Clinical improvement showed significant negative correlation with scar duration and size. Botulinum toxin A is a promising treatment for hypertrophic scars and keloids. The use of fractional CO2 laser as a mode of delivery enhanced the efficacy of botox in hypertrophic scars.

Cost effectiveness and impact on quality of life of abobotulinumtoxinA and onabotulinumtoxinA in the treatment of children with lower limb spasticity in Canada.

Background: Injectable botulinum neurotoxins are a mainstay of treatment for pediatric spasticity. AbobotulinumtoxinA and onabotulinumtoxinA are both injectable toxin therapies used to treat pediatric lower limb (PLL) spasticity in Canada. The objective of this study was to assess the cost-effectiveness of abobotulinumtoxinA vs. onabotulinumtoxinA in the treatment of PLL spasticity in Canada.Methods: A probabilistic Markov cohort model with a 2-year time horizon was developed, with health states defined by response to therapy, as characterized by the goal attainment scale (GAS). Based on randomized controlled trial evidence, response to therapy was similar or higher for abobotulinumtoxinA relative to onabotulinumtoxinA; uncertainty was incorporated into model parameters, however, as the two therapies have not been compared head-to-head. Canadian resource use and cost data were incorporated.Results: In the base case, abobotulinumtoxinA generated 1.48 quality-adjusted life years over the model time horizon, compared to 1.47 for onabotulinumtoxinA. AbobotulinumtoxinA was associated with cost savings of $123 CAD, reflecting lower costs in both medication acquisition and health services. The estimated improvement to quality of life and reduced costs result in an estimate of economic dominance for abobotulinumtoxinA over onabotulinumtoxinA. This dominant result persisted across probabilistic and scenario analyses.Key points for decision makersBased on a review of available clinical evidence, abobotulinumtoxinA was found to have significant and/or numerical efficacy benefits to onabotulinumtoxinA on functional outcomes (Goal Attainment Scale) and tone (Modified Ashworth Scale) and in the treatment of pediatric lower limb spasticityIn this cost-effectiveness analysis, abobotulinumtoxinA was found to be associated with greater quality-adjusted life years and lower costs than onabotulinumtoxinA (economically dominant)A limitation of this analysis was the uncertainty around key parameters. Specifically, the lack of head-to-head comparison data for the two therapies, and variable data regarding likely onabotulinumtoxinA dosing in PLL in clinical practice. However, across a range of plausible scenarios, the economic dominant result remained.

Long-term treatment of blepharospasm with botulinum toxin A: a service-based study over a 16-year follow-up in southern China.

OBJECTIVE: To elucidate the effect of long-term treatment with botulinum toxin A (BTX-A) for blepharospasm. Prevalence data and clinical features in southern China and influencing factors for selecting BTX-A treatment were explored. METHODS: We collected data retrospectively from 338 consecutive patients diagnosed with blepharospasm over 16 years to assess prevalence data and clinical features. Thereafter, all patients were classified into BTX-A (n = 135) or non-BTX-A (n = 203) treatment groups according to the patients' requests in order to explore the factors influencing whether BTX-A treatment was chosen. Furthermore, dynamic follow-up data were analyzed to evaluate the long-term efficacy in the BTX-A group. RESULTS: The prevalence was 23.3 per million, with an onset age of 50.3 ± 12.3 years and a female:male ratio of 2.4:1; the most common symptom was excessive blinking (91.2%). The symptom severity and psychological assessment scores were significantly decreased by treatment with BTX-A (p < 0.01), and there was no significant difference in response duration with the prolongation of BTX-A injections. Adverse events occurred 52 times (5.0%) among 1038 injections. The symptom severity and psychological assessment scores and the occurrence of eye-opening difficulty were higher, and medical expenses and the symptom tolerability rate were lower in the BTX-A group than in the non-BTX-A group (p < 0.05). CONCLUSION: The onset age was earlier than that in Western countries. However, starting BTX-A treatment early is justified, even though a higher dosage was needed to maintain reliable long-term efficacy. Additionally, symptom severity and medical expenses are the primary factors affecting whether patients select BTX-A treatment.

Clinical Assessment of 2 Licensed AbobotulinumtoxinA Injection Volumes for the Treatment of Glabellar Lines.

BACKGROUND: Two licensed reconstitution volumes may be used to achieve the recommended abobotulinumtoxinA (ABO) dose for glabellar line correction. OBJECTIVE: Comparison of efficacy, safety, and subject satisfaction concerning treatment of moderate to severe glabellar lines with 2 different ABO reconstitution volumes. MATERIALS AND METHODS: Phase IV, prospective, randomized, multicenter, subject- and evaluator-blinded study: 60 subjects received 1 ABO (50 units) treatment, administered as a 1.5- or 2.5-mL reconstitution. Primary objective was Day 30 improvements (≥1-point) in glabellar line severity. Onset of effect, duration, subject satisfaction, and treatment-related adverse events (AEs) were assessed. RESULTS: At Day 30, 90.0% and 86.7% of subjects achieved ≥1-point improvements with 1.5- and 2.5-mL reconstitutions, respectively. Median time to onset of effect was 48 hours after treatment. At 24 hours, 26.7% achieved ≥1-point improvements with the 2.5-mL reconstitution versus 6.7% with the 1.5-mL reconstitution. Maximum response was at Day 14, and >40% maintained efficacy through Day 120 in each group. High subject satisfaction was sustained throughout observation. Most AEs were mild. No serious AEs were reported. CONCLUSION: Both ABO reconstitutions were well tolerated and effective in correcting glabellar lines with no significant differences concerning efficacy or duration of effect. No serious AEs were reported.

Assessment of Skin Physiology Change and Safety After Intradermal Injections With Botulinum Toxin: A Randomized, Double-Blind, Placebo-Controlled, Split-Face Pilot Study in Rosacea Patients With Facial Erythema.

BACKGROUND: Botulinum toxin (BTX) has been used cosmetically with good clinical efficacy and tolerable safety. OBJECTIVE: This randomized, double-blind, split-face clinical study aimed to investigate the efficacy and safety of intradermal BTX in patients with rosacea. MATERIALS AND METHODS: Twenty-four participants were enrolled and randomly given intradermal injections of BTX and normal saline in both cheeks. Clinician Erythema Assessment (CEA) score, Global Aesthetic Improvement Scale (GAIS) score, skin hydration, transepidermal water loss (TEWL), melanin content, erythema index, elasticity, and sebum secretions were evaluated at baseline and 2, 4, 8, and 12 weeks. RESULTS: On the BTX-treated side, the CEA score significantly decreased and the GAIS score significantly increased. The erythema index decreased at Weeks 4 and 8. Skin elasticity was improved at Weeks 2 and 4 and skin hydration, at Weeks 2, 4, and 8. However, TEWL and sebum secretion did not show significant differences. CONCLUSION: Intradermal BTX injections reduced erythema and rejuvenated the skin effectively and safely in patients with rosacea.

Facial Assessment and Injection Guide for Botulinum Toxin and Injectable Hyaluronic Acid Fillers: Focus on the Upper Face.

Techniques for the administration of injectable fillers and neuromodulators for facial aesthetic rejuvenation and enhancement continue to evolve. As the number of physicians with limited experience in providing aesthetic treatments expands, the need for guidance and training from more experienced injectors has become apparent. The use of a slow, careful, and methodical injection technique is imperative in all treatment settings and for all facial areas. Constant attention to local anatomy, particularly arteries, veins, and nerve bundles, is critical for minimizing complications. This first article of a three-part series addresses techniques and recommendations for aesthetic treatment of the upper face. Traditionally, the upper face has been considered a basic area for treatment with neuromodulators but an advanced area for treatment with fillers. Injectable fillers may be used for temple volumization, eyebrow shaping, and forehead contouring. Neuromodulators are well suited for diminishing the appearance of dynamic facial lines such as forehead, glabellar, and crow's feet lines, and eyebrow lifting and eye-aperture widening. These techniques may be used independently or together, sequentially or concurrently, to address rejuvenation of individual or multiple facial regions. Overall, this series provides a practical framework of techniques for physicians who desire to perform safe and effective aesthetic treatments using a multimodal approach.

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.

Muscle structure and stiffness assessment after botulinum toxin type A injection. A systematic review.

BACKGROUND: Botulinum toxin type A manages spasticity disorders in neurological central diseases. Some studies have reported that it might induce muscle changes. METHODS: We present a literature review abiding by the PRISMA statement guidelines. The purpose was to explore the structural and passive biomechanical muscle properties after botulinum toxin type A injections in healthy and spastic limb muscles, on animals and humans, as well as methods for evaluating these properties. We searched the PubMed and Cochrane Library databases using the following keywords: "Botulinum toxin" AND ("muscle structure" OR "muscle atrophy") and, "Botulinum toxin" AND "muscle elasticity". RESULTS: From the 228 initially identified articles, 21 articles were included. Histological analyses were performed, especially on animals. A neurogenic atrophy systematically occurred. In humans, one year after a single injection, the histological recovery remained incomplete. Furthermore, 2D ultrasound analyses showed a reduction of the gastrocnemius thickness and pennation angle. MRI volumetric analysis evidenced muscular atrophy six months or one year after a single injection. Passive muscle stiffness depends on these structural changes. On the short term, the biomechanical analysis showed an elastic modulus increase in animals whereas no change was recorded in humans. On the short term, ultrasound elastography imaging showed a decreased elastic modulus. DISCUSSION: To date, few data are available, but all show a structural and mechanical muscle impact post injections, specifically muscle atrophy which can linger over time. Further studies are necessary to validate this element, and the possibility of change must be taken into account particularly with repeated injections. Thus, in clinical practice, 2D ultrasound and ultrasound elastography are two non-invasive techniques that will help physicians to develop an efficient long term monitoring.

Switch from abobotulinumtoxinA (Dysport®) to incobotulinumtoxinA (Xeomin®) botulinum toxin formulation: a review of 257 cases.

OBJECTIVE: To explore the dose equivalence ratio and treatment costs for abobotulinumtoxinA and incobotulinumtoxinA for patients with focal dystonias. DESIGN: Patient chart review. SUBJECTS/PATIENTS: Adult patients with blepharospasm (n = 19), cervical dystonia (n = 122), hemifacial spasm (n = 91) or segmental/generalized dystonia (n = 19) at a neurology outpatient clinic. METHODS: Patients were switched from established abobotulinumtoxinA therapy to incobotulinumtoxinA at a ~4:1 unit ratio. Dose requirements, injection intervals, treatment efficacy, and adverse events were evaluated for a period of ≥ 1 year. RESULTS: Patients were switched from abobotulinumtoxinA to incobotulinumtoxinA with a mean dose ratio of 4.07 (standard deviation (SD) 0.50). After switching, incobotulinumtoxinA dose requirements remained stable; the mean (SD) dose ratio at the end of the review period (52-219 weeks after switching) was 3.89 (SD 0.58). Injection intervals also remained stable after switching. Adverse events were injection site pain (n = 45) and bruising (n = 4). Five patients (2.0%) discontinued incobotulinumtoxinA treatment: 4 stopped receiving injections, and 1 reverted to abobotulinumtoxinA. Switching to incobotulinumtoxinA reduced the mean toxin expenditure to 76.7% of the cost of abobotulinumtoxinA. CONCLUSION: For patients with conditions commonly treated in dystonia clinics, switching from abobotulinumtoxinA to incobotulinumtoxinA, given at equivalent doses (~4:1 unit ratio) at similar intervals, was effective, well tolerated and achieved cost savings.

Dysport (botulinum toxin type A) in routine therapeutic usage: a telephone needs assessment survey of European physicians to evaluate current awareness and adherence to product labeling changes.

BACKGROUND: Botulinum neurotoxin type A is a well-established treatment for a number of conditions involving muscle hyperactivity. Dysport (Ipsen Ltd, Wrexham, United Kingdom) is a botulinum neurotoxin type A preparation that has been available for a number of therapeutic uses for over 20 years in the European Union (EU). This survey was part of the EU botulinum toxin risk management plan to identify potential educational needs of injectors by collecting data on their routine practice administration of Dysport and their awareness of potential adverse events (AEs) that are included in the current product labeling. METHODS: Dysport-experienced injectors in 5 EU countries were surveyed via telephone about their experience of Dysport in patients with cervical dystonia, adult upper and lower limb spasticity, pediatric cerebral palsy, and blepharospasm/hemifacial spasm. RESULTS: The reconstitution dilution volume most often used was 2.5 mL per 500 U for all indications. The mean total dose ranged from 387 to 530 U for cervical dystonia, 508 to 773 U for upper limb spasticity, 600 to 832 U for lower limb spasticity, 375 to 700 U for pediatric cerebral palsy, and 54 to 213 U for blepharospasm/hemifacial spasm. The potential AEs most commonly mentioned by surveyed physicians were dysphagia for cervical dystonia, arm muscle weakness for upper limb spasticity, leg muscle weakness for lower limb spasticity, and pediatric cerebral palsy and ptosis for blepharospasm/hemifacial spasm. CONCLUSIONS: The results indicate that product-labeling recommendations are generally applied in clinical practice and that there is a good familiarity with potential AEs based on clinical condition. Nevertheless, the survey shows that experienced injectors do sometimes deviate from the manufacturers labeling recommendations, highlighting the importance of ongoing education.

The cost-effectiveness of onabotulinumtoxinA for the prophylaxis of headache in adults with chronic migraine in the UK.

BACKGROUND: Although chronic migraine is associated with substantial disability and costs, few treatments have been shown to be effective. OnabotulinumtoxinA (Botox, Allergan Inc., Irvine, CA) is the first treatment to be licensed in the UK for the prophylaxis of headaches in adults with chronic migraine. This study aims to evaluate the cost-effectiveness of onabotulinumtoxinA in this indication in the UK. METHODS: A state-transition (Markov) model was developed comparing onabotulinumtoxinA to placebo. Efficacy data and utility values were taken from the pooled Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical trials program (n = 1384). Estimates of resource utilisation were taken from the International Burden of Migraine Study (IBMS), and stopping rules were informed by published medical guidelines and clinical data. This study estimated 2-year discounted costs and quality-adjusted life years (QALYs) from the UK National Health Service perspective. RESULTS: At 2 years, treatment with onabotulinumtoxinA was associated with an increase in costs of £1367 and an increase in QALYs of 0.1 compared to placebo, resulting in an incremental cost-effectiveness ratio (ICER) of £15,028. Treatment with onabotulinumtoxinA reduced headache days by an estimated 38 days per year at a cost of £18 per headache day avoided. Sensitivity analysis showed that utility values had the greatest influence on model results. The ICER remained cost-effective at a willingness to pay threshold of £20,000-£30,000/QALY in the majority of scenario analyses as well as in probabilistic sensitivity analysis, where onabotulinumtoxinA was cost-effective on 96% of occasions at a threshold of £20,000/QALY and 98% of occasions at £30,000/QALY. CONCLUSION: OnabotulinumtoxinA has been shown to reduce the frequency of headaches in patients with chronic migraine and can be considered a cost-effective use of resources in the UK National Health Service. The uncertainties in the model relate to the extrapolation of clinical data beyond the 56-week trial.

Continuation of long-term care for cervical dystonia at an academic movement disorders clinic.

Patients with cervical dystonia (CD) receive much of their care at university based hospital outpatient clinics. This study aimed to describe the clinical characteristics and treatment experiences of patients who continued care at our university based movement disorders clinic, and to document the reasons for which a subset discontinued care. Seventy patients (77% female) were recruited from all patients at the clinic (n = 323). Most (93%) were treated with botulinum neurotoxin (BoNT) injection, and onabotulinumtoxinA was initially used in 97%. The average dose of onabotulinumtoxinA was 270.4 U (range 50-500) and the median number of injections was 14 (range: 1-39). Twenty one patients later received at least one cycle of rimabotulinumtoxinB (33%); of those, 10 switched back to onabotulinumtoxinA (48%). The initial rimabotulinumtoxinB dose averaged 11,996 units (range: 3000-25,000 over 1-18 injections). Twenty one patients (30%) discontinued care. Reasons cited included suboptimal response to BoNT therapy (62%), excessive cost (24%), excessive travel burden (10%), and side effects of BoNT therapy (10%). Most patients (76%) did not seek further care after leaving the clinic. Patients who terminated care received fewer treatment cycles (5.5 vs. 13.0, p = 0.020). There were no other identifiable differences between groups in gender, age, disease characteristics, toxin dose, or toxin formulation. These results indicate that a significant number of CD patients discontinue care due to addressable barriers to access, including cost and travel burden, and that when leaving specialty care, patients often discontinue treatment altogether. These data highlight the need for new initiatives to reduce out-of-pocket costs, as well as training for community physicians on neurotoxin injection in order to lessen the travel burden patients must accept in order to receive standard-of-care treatments.

Analysis of botulinum toxin products and litigation in the United States.

BACKGROUND: Botulinum neurotoxin (BoNT) has diverse cosmetic and therapeutic applications, spanning multiple medical specialties. Recent lawsuits alleging complications from its clinical use have raised significant questions about medicolegal risk. OBJECTIVE: To identify and assess legal cases related to clinical complications of BoNT products. METHODS AND MATERIALS: Using the LexisNexis Academic online database, a search of U.S. federal and state cases between 1985 and 2012 was performed. A second search of U.S. newspapers and wires was also completed. In all but one case, the plaintiffs' legal complaints were obtained for review. RESULTS: Twenty-four relevant legal cases were found, mostly in state courts. All cases alleged adverse effects from onabotulinumtoxinA, and each named its manufacturer, Allergan, Inc., as a defendant. Most lawsuits against Allergan, Inc. were dismissed or settled. In three cases, physicians were codefendants, including one dermatologist. In two cases, jury verdicts resulted in multimillion-dollar judgments in favor of the plaintiffs. None of the lawsuits named a dermatologist when the complication arose from on-label indications and cosmetic use. CONCLUSION: Lawsuits related to complications from BoNT products are uncommon, are more likely to result from therapeutic than cosmetic applications, and typically involve product liability claims against the manufacturer.