Trends in Botulinum Toxin-Related Industry Payments to Physicians.

Objectives: To evaluate trends in botulinum toxin (BTX) industry payments to physicians. Methods: Cross-sectional analysis of nonroyalty, BTX-specific payments made by Allergan (Botox), Ipsen (Dysport), and Merz (Xeomin) to physicians using the 2016-2020 Open Payments Database. Results: Between 2016 and 2020, >$27 million in payments was made for BTX-related activities to dermatologists, neurologists, ophthalmologists, otolaryngologists, and plastic surgeons, with payments ranging from $3.9 million in 2016 to $8.7 million in 2019. 21.7% was paid to dermatologists, 57.5% to neurologists, 5.9% to ophthalmologists, 5.7% to otolaryngologists, and 9.1% to plastic surgeons. Conclusions: Growing amounts are being paid to physicians for BTX-related activities-both medical and aesthetic. Despite the variety of indications for BTX within otolaryngology, otolaryngology payments were overshadowed by other specialties, which may reflect greater BTX utilization in those specialties.

National Patterns of Filled Prescriptions and Third-Line Treatment Utilization for Privately Insured Women With Overactive Bladder.

OBJECTIVE: The aim of this study was to evaluate national patterns of care for women with overactive bladder (OAB) in an administrative data set and identify potential areas for improvement. METHODS: We performed an analysis using the OptumLabs Data Warehouse, which contains deidentified administrative claims data from a large national US health insurance plan. The study included women, older than 18 years, with a new OAB diagnosis from January 1, 2007, to June 30, 2017. We excluded those with an underlying neurologic etiology, with interstitial cystitis/painful bladder syndrome, were pregnant, or did not have continuous enrollment for 12 months before and after OAB diagnosis. Trends in management were assessed via the Cochran-Armitage test. Time to discontinuation among medications was compared using t test. RESULTS: Of 1.4 million women in the database during the study time frame, 60,246 (4%) were included in the study. Median age was 61 years [interquartile range (IQR), 50-73], and median follow-up was 2.6 years (IQR, 1.6-4.2). Overall, 37% were treated with anticholinergics, 5% with beta-3 agonists, 7% with topical estrogen, and 2% with pelvic floor physical therapy; 26% saw a specialist; and 2% underwent third-line therapy. Median time to cessation of prescription filling was longer for beta-3 agonists versus anticholinergics [median, 4.1 months (IQR, 1-15) vs 3.6 months (IQR, 1-10); P < 0.0001]. Use of third-line therapies significantly increased over the study time frame, from 1.1% to 2.2% (P < 0.0001). CONCLUSIONS: Most of the patients do not continue filling prescriptions for OAB medications, and a minority of patients were referred for specialty evaluation. Although third-line therapy use is increasing, it is used in a small proportion of women with OAB. Given these patterns, there may be underutilization of specialist referral and other OAB therapies.

Cost-effectiveness of botulinum neurotoxin A versus surgery for drooling: a randomized clinical trial.

AIM: This study compared the cost-effectiveness of botulinum neurotoxin A (BoNT-A) injections with two-duct ligation of the submandibular glands as treatment for severe drooling after one treatment cycle. METHOD: The study was part of a larger, partly single-blinded, randomized clinical trial (trialregister.nl identifier NTR3537). Data were collected between 2012 and 2017. Evaluation was at 32 weeks after one treatment cycle. Fifty-seven patients with cerebral palsy or other neurological, non-progressive disorders and severe drooling classified as having a drooling frequency ≥3 or a drooling severity ≥2, in whom conservative treatment was deemed ineffective, were randomized to treatment by BoNT-A or two-duct ligation. An incremental cost-effectiveness ratio (ICER) was calculated using the success rates as the measure of benefit. Treatment success was defined as a decrease ≥50% from baseline to 32 weeks in the subjective visual analogue scale for the severity of drooling or the objective drooling quotient. RESULTS: Fifty-three patients were analysed (22 females, 31 males; mean age 11y, range 8-22y). Average costs for one treatment cycle, which included one BoNT-A injection, were €1929 (standard error 62) for BoNT-A and €3155 (standard error 99) for two-duct ligation. Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3). The ICER was €34 per 1% gain in treatment success in favour of two-duct ligation versus BoNT-A. INTERPRETATION: The additional cost of two-duct ligation is to some extent offset by a larger treatment success rate compared with BoNT-A. WHAT THIS PAPER ADDS: Botulinum neurotoxin A (BoNT-A) is less expensive per percentage of success than two-duct ligation. The additional cost of two-duct ligation over BoNT-A is offset by greater treatment success.

Amifampridine for the Management of Lambert-Eaton Myasthenic Syndrome: A New Take on an Old Drug.

Objective: The purpose of this article is to review the literature for both 3,4-diaminopyridine (3,4-DAP) and amifampridine for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). Amifampridine (Firdapse) is the salt form of 3,4-DAP and was approved by the Food and Drug Administration for the treatment of LEMS. Data Sources: PubMed, TRIP database, and EMBASE searches were conducted without a back date (current to June 2019) utilizing the following search terms: amifampridine, 3,4-diaminopyridine, and Lambert-Eaton myasthenic syndrome. Completed trials were also reviewed at clinicaltrials.gov. Study Selection and Data Extraction: Criteria for article inclusion consisted of human subjects, age ≥18 years, phase II or III clinical trials, and English language for both drugs. Observational and pharmacokinetic studies for amifampridine were also included. Data Synthesis: Prior to the approval of amifampridine, 3,4-DAP was first-line for the management of LEMS symptoms. Two phase III trials have evaluated amifampridine to confirm efficacy, both showing superiority over placebo in the management of LEMS symptoms, with minimal adverse effects. A significant improvement in both quantitative myasthenia gravis scores and Subjective Global Impression scores was established at days 4 and 14. Relevance to Patient Care and Clinical Practice: With an improved stability profile and decreased dose variability, amifampridine will likely assume the role of first-line management of LEMS. Conclusions: Amifampridine has been shown to improve symptoms of LEMS and is generally well tolerated.

The Role of Injectables in Aesthetic Surgery: Financial Implications.

Background: The plastic surgeon competes with both core and noncore physicians and surgeons for traditional cosmetic procedures. In 2007, the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) joined efforts to form a Cosmetic Medicine Task Force to further analyze this trend. Objectives: Our objective is to document and quantify the patient capture and total collections generated in a single surgeon's practice exclusive from Botulinum Toxin A and filler injections over a 10-year period. We subsequently identified the effect and importance that fillers and Botulinum Toxin A have on an active cosmetic practice. Methods: A retrospective chart review of all male and female patients who received Botulinum Toxin A or soft tissue filler injections (noninvasive aesthetic treatment) in a single surgeons practice from January 2004 to December 2013 was undertaken. Only those patients new to the practice and who were exclusively seeking out Botulinum Toxin A or fillers were included in the study. Chart review then identified which of these selected patients ultimately underwent invasive aesthetic surgery during this 10-year period. Noninvasive and invasive aesthetic surgery total collections were calculated using billing records. Results: From January 2004 to December 2013, 375 patients entered the senior surgeon's practice specifically requesting and receiving noninvasive aesthetic treatments. Of these 375 patients, 59 patients (15.7%) subsequently underwent an aesthetic surgery procedure at an average of 19 months following initial noninvasive aesthetic treatment. Of these 375 patients, 369 were female and 6 were male. The most common initial invasive aesthetic procedure performed after injectable treatment included 22 facelifts (18.5%), 21 upper eyelid blepharoplasties (17.6%), and 15 endoscopic brow lifts (12.6%). Total collections from noninvasive aesthetic sessions and invasive surgery combined represented US$762,470 over this 10-year span. This represented US$524,771 and US$396,166 in total collections for injectables and surgery respectively. Conclusions: Noninvasive aesthetic surgery is a critical part of a plastic surgery practice. A measurable and significant number of patients who sought out a single plastic surgeon exclusively for noninvasive treatment ultimately underwent traditional invasive cosmetic surgical procedures.

Botulinum toxin A for treating spasticity in adults: costly for French hospitals?

INTRODUCTION: Intramuscular injection of botulinum toxin (BoNTA) is one of the primary treatments for focal spasticity. This treatment is considered costly and the level of reimbursement by health insurance has been decreasing in many countries for several years. The aim of this study was to determine the real cost of treating spasticity with BoNTA and to compare this with the level of reimbursement by the national health insurance in France in 2008 and with a new fee, specific to the injection of BoNTA in ambulatory services. METHOD: A single-center, retrospective study using the 2008 database from a French secondary-care day-hospital unit (treating spasticity in adults with sequelae of stroke, multiple sclerosis or traumatic brain injuries). The level of reimbursement by the French ministry of health for BoNTA treatment for adults with spasticity constituted the "calculated cost" and corresponded to the hospital's "budget". The "real cost" (incurred by the hospital) included the sum of staffing and material costs as well as the number of toxin vials used. The calculated costs for 2009 and 2013 were based on the levels of reimbursement during those years. The difference between real and calculated cost for 2009 and 2013 was estimated considering that the real cost of 2008 was stable. RESULTS: In 2008, 364 patients received BoNTA, resulting in 870 day-hospital admissions. The calculated cost was 459,056€/year and the real cost was 567,438€/year (equivalent to 4.27€/day/patient). The total budget deficit (hospital income minus hospital costs) was 108,383€. The deficit was estimated at 222,892€ in 2009 and 241,188€ in 2013. CONCLUSION: The daily cost of BoNTA treatment for spasticity is reasonable; however, because of the level of reimbursement by the national health insurance in France, the treatment is costly for French hospitals.

Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System.

OBJECTIVES: To assess the relative cost-effectiveness of two therapeutic strategies: one starting with sacral neuromodulation (SNM) versus one starting with Botulinum toxin A (BTX-A) for the management of refractory incontinent idiopathic overactive bladder (OAB) patients, from the perspective of the Italian National Health Service (INHS). METHODS: Direct medical costs (2011) and benefits (quality-adjusted life years-QALYs) were assessed over a ten-year time frame adapting to the Italian practice a published Markov model. Clinical inputs were based on the published literature and on the expert opinion. Resource consumption rates were provided by clinical experts; unit costs were collected from a single hospital accounting and from standard tariff lists and public prices. Interventional procedures and management of adverse events were costed through a micro-costing approach. The primary outcome was incremental costs per QALYs gained (i.e. differential costs divided by differential benefits). Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were conducted to assess the robustness of the model. RESULTS: Starting with SNM appears to be cost effective (i.e. under 40.000/QALY) from year three (21,259/QALY) onwards and becomes dominant (i.e. more effective and less costly) at year ten: cumulative costs were 32,975 for early SNM and 33,309 for early BTX-A, while cumulative QALYs were 7.52 and 6.93, respectively. At year ten, DSA suggests the results robustness and 99.8 % of the PSA iterations fell within the cost-effectiveness threshold. CONCLUSIONS: A therapeutic strategy starting with SNM may be considered cost effective in the midterm and cost saving in the long-term treatment of idiopathic OAB from the INHS perspective.

Five-year cost analysis of intra-detrusor injection of botulinum toxin type A and augmentation cystoplasty for refractory neurogenic detrusor overactivity.

PURPOSE: Treatment options for antimuscarinic refractory neurogenic detrusor overactivity (NDO) are botulinum toxin type A injections (BTX-A) and augmentation cystoplasty (AC). We estimated initial and cumulative 5-year costs of these treatments. MATERIALS AND METHODS: Base case is an individual with antimuscarinic refractory NDO and decreased bladder compliance. Primary analysis is from the health care payor perspective. Model probabilities and ranges were derived from literature and chart review. Reimbursements were derived from the average of insurance carriers. Complication cost calculations were based on standard practice. Decision-analysis model was made with TreeAge Pro Healthcare 2009 Software, Inc. and rolled back for cost calculation. One-way sensitivity analysis was performed on all variables, and two-way sensitivity analyses were based on these results. RESULTS: Average reimbursement for one BTX-A injection and AC was $2,946.83 and $25,041.53, respectively. BTX-A treatment was less expensive over 5 years, costing $28,065. The model was only sensitive within a reasonable clinical range for Botox durability. BTX-A was more cost-effective over 5 years if the effect lasted for >5.1 months. The model was based on an AC complication rate of 40%. If the PAC complication rate<14%, AC was cheaper over 5 years. The model was sensitive to surgeons costs of BTX-A ($3,027) and facility costs of BTX-A ($1,004) and AC ($17,100). CONCLUSIONS: This is the first cost analysis of BTX-A and AC. BTX-A is cheaper at durations>5.1 months and AC was cheaper when the cost of BTX-A increases or the AC complication rate dropped below 14%.

Total endoscopic and anal irrigation management approach to noncompliant neuropathic bladder in children: a good alternative.

PURPOSE: We prospectively evaluated the efficacy and durability of combined intradetrusor botulinum-A toxin and endoscopic treatment for vesicoureteral reflux with anal irrigation as a total endoscopic and anal irrigation management approach. This minimally invasive protocol is used to manage myelomeningocele and noncompliant bladder in children who do not respond to standard conservative therapy and have urine and stool incontinence. MATERIALS AND METHODS: Ten females and 3 males with a mean +/- SD age of 5.3 +/- 2.5 years with myelomeningocele and vesicoureteral reflux who did not respond to standard conservative treatment were prospectively included in this study. All had at least 1 year of followup. All patients received a cystoscopic intradetrusor injection of 12 U/kg (maximum 300 U) botulinum-A toxin into an infection-free bladder. Vesicoureteral reflux in a total of 20 refluxing ureters, including bilateral vesicoureteral reflux in 7 patients, showed no resolution on pretreatment voiding cystourethrogram. Thus, we administered a submucosal Deflux injection. Since most patients were still diaper dependent due to stool incontinence, we extended management to include complete bowel rehabilitation with the new Peristeen anal irrigation system to manage stool incontinence. RESULTS: Mean maximum bladder capacity increased significantly from 75 +/- 35 to 150 +/- 45 ml after 1 month (p <0.02), to 151 +/- 48 after 6 months (p <0.002) and to 136 +/- 32 after 1 year (p <000). Maximum detrusor pressure decreased significantly from 58 +/- 14 to 36 +/- 9 cm H(2)O after 1 month (p <0.001), to 39 +/- 9 after 6 months (p <0.001) and to 38 +/- 6 after 1 year (p = 000). Of 20 refluxing ureters (95%) completely resolved, including 1 after attempt 2, and 1 with grade V vesicoureteral reflux remained unchanged despite 2 attempts. Seven of 8 urinary incontinent patients (87.5%) attained complete dryness between catheterizations and 1 partially improved. Ten of 13 patients achieved stool dryness with anal irrigation 1 to 2 times weekly. Three patients who were stool continent on standard enemas did not require this irrigation system. CONCLUSIONS: This new total endoscopic and anal irrigation management approach is a comprehensive, minimally invasive, safe, simple, effective way to achieve most goals when treating these patients by protecting the upper tract, maintaining the bladder at safe pressure and providing a satisfactory social life with satisfactory urine and stool continence.

The use of botulinum toxin type A in urological procedures.

Botox is a sterile, vacuum-dried, purified BoNT-A produced from fermentation of Clostridium botulinum. There is an abundance of literature to support the use of Botox in urology, and its off-label use continues to grow. While there are no FDA-approved clinical indications, there are ongoing phase II and III studies to approve Botox for use in some urological conditions. This article will explore the use of Botox in urology and provide a brief review of the literature supporting its use.

How much are patients willing to pay to avoid postoperative muscle pain associated with succinylcholine?

STUDY OBJECTIVE: To determine how much money patients are willing to pay to avoid postoperative muscle pains associated with succinylcholine. DESIGN: Observational study with survey instrument. SETTING: University-affiliated metropolitan hospital. PATIENTS: Eighty-eight adult patients, 43 men and 45 women, who were scheduled to undergo surgery with general anesthesia and who completed a preoperative questionnaire (median age range, 41-50 y; median income, US$45,000-60,000). INTERVENTIONS AND MEASUREMENTS: Patients completed a computerized, interactive questionnaire preoperatively. They were asked about demographics and previous experiences with muscle pain and postoperative myalgia. With the use of the willingness-to-pay model, the value that they would be willing to pay for a hypothetical muscle relaxant that avoided postoperative myalgia was determined. MAIN RESULTS: Eighty-nine percent of patients considered avoiding postoperative myalgia as important. Patients were willing to pay a median (interquartile range) of $33 ($19-$50) out of pocket for a muscle relaxant that was not associated with postoperative myalgia, a figure that increased to $40 if the insurance company paid for the drug (P < 0.0001). Willingness to pay was influenced by patients' income but not by prior experience with postoperative myalgia. CONCLUSION: Patients consider avoidance of postoperative myalgia important and are willing to pay $33 out of pocket for a muscle relaxant that is not associated with this side effect.

Cost-effectiveness of botulinum toxin type a in the treatment of post-stroke spasticity.

OBJECTIVE: Treatment strategies for post-stroke spasticity include oral anti-spastic drugs, surgery, physiotherapy and botulinum toxin type A injection. The objective of this study was to compare the cost-effectiveness and outcomes of oral therapy vs. botulinum toxin type A treatment strategies in patients with flexed wrist/clenched fist spasticity. METHODS: Treatment outcome and resource use data were collected from an expert panel experienced in the treatment of post-stroke spasticity. A decision tree model was developed to analyse the data. RESULTS: Thirty-five percent of patients receiving oral therapy showed an improvement in pre-treatment functional targets which would warrant continuation of therapy, compared with 73% and 68% of patients treated with botulinum toxin type A first- and second-line therapy, respectively. Botulinum toxin type A treatment was also more cost-effective than oral therapy with the "cost-per-successfully-treated month" being 942 pounds, 1387 pounds and 1697 pounds for botulinum toxin type A first-line, botulinum toxin type A second-line and oral therapy, respectively. CONCLUSION: In conclusion, botulinum toxin type A is a cost-effective treatment for post-stroke spasticity.

Costs and consequences of botulinum toxin type A use. Management of children with cerebral palsy in Germany.

This study was a retrospective survey of the management of a cohort of children with cerebral palsy at Seepark Hospital, Germany, who did (cases; n=107) and did not (controls; n=107) receive botulinum toxin injections. Data on healthcare resource use and clinical outcomes over 12 months were collected from the date cases received their first injection and from the date controls were first admitted into hospital. Botulinum toxin use led to an 85% reduction in the number of children requiring surgery. Additionally, controls used significantly more healthcare resources than cases, particularly hospital bed days (69.2+/-34.1 vs. 27.5+/-27.9 days; p <0.0001). The total cost of managing cases and controls was 16,700 and 33,800, respectively. In conclusion, use of botulinum toxin released resources for alternative use during the first year following treatment, without any loss of clinical improvement. However, it is unknown how botulinum toxin affected the need for surgery and associated outcomes in subsequent years.

Pneumatic dilation versus intrasphincteric botulinum toxin injection in the treatment of achalasia cardia in India: an economic analysis.

BACKGROUND: Pneumatic dilation (PD) is an established therapeutic option for achalasia cardia. Recently, intrasphincteric botulinum toxin (BT) has been used to treat achalasia cardia in view of its simplicity and safety. However, it is likely to be a costly treatment as repeated injections are often needed due to its short-lasting effect. No economic analysis of PD and BT strategies has been done in India. METHODS: A decision tree was constructed using decision analysis software (DATA 4.0; TreeAge Software, Williamstown, MA, USA). Probability estimates for BT injection and PD (and, in case of failure, surgery) were obtained from published literature, preferably from India. Direct "out-of-pocket" costs (in Indian rupees; currently US$ 1 = 49 rupees approximately) for baseline analysis were obtained from our hospital and from some private hospitals. Sensitivity analysis was done using a wide range of probability and cost estimates. RESULTS: Intrasphincteric BT injection strategy was more costly at 18,520 rupees per patient than PD strategy (4,568 rupees), yielding an incremental cost of 13,952 rupees per patient successfully treated. Sensitivity analysis supported the conclusions of the baseline analysis. CONCLUSION: Primary intrasphincteric BT injection strategy was costlier than primary PD strategy in the treatment of achalasia cardia in India, and therefore cannot be justified despite its efficacy, relative ease of administration and safety.

Comparison and cost analysis of different treatment strategies in achalasia.

Currently there are three acceptable long-term treatments of achalasia: pneumatic dilatation, laparoscopic Heller myotomy, and botulinum toxin injection. Primarily retrospective studies suggest equal efficacy of pneumatic dilatation and surgical myotomy, especially in centers with expertise in both treatments. Randomized prospective studies find pneumatic dilatation superior to botulinum toxin because of the need for serial frequent treatments with the latter therapy. All cost analysis studies support the superiority of pneumatic dilatation over the two other treatments.

Effects of a low-cost protocol on outcome and cost in a group practice setting.

STUDY OBJECTIVE: To investigate, in a group practice setting, the effects of combining information about drug costs with adoption of a voluntary low-cost protocol. DESIGN: Prospective before-and-after intervention comparison study. SETTING: Private practice anesthesiology group (certified registered nurse-anesthetists and anesthesiologists) of a large midwestern for-profit hospital. MEASUREMENTS AND MAIN RESULTS: Clinical outcome and anesthesia-related drug cost were examined for coronary artery bypass grafts (CABG), laparoscopic cholecystectomy (LC), and lumbar laminectomy (LL). There were no restrictions on the use of any drug if warranted by the patient's condition. 135 consecutive prospective (P) cases performed by the anesthesiology group after the intervention were retrospectively matched by surgery type and surgeon to cases done 9 months prior to the protocol to form the retrospective control group (R) resulting in a total sample of 270 subjects. Significant cost reductions were seen in LC-(57%), LL-(42%), and CABG-(37%). The largest cost reductions were opioids (78%), induction drugs (50%), and muscle relaxants (41%). There were no differences in pain, nausea, or hypertension scores between the P and R groups, but there were minor differences in recovery room, oxygen therapy, and dismissal times between the R and P groups of LC and LL patients. There were no differences in anesthetic outcome for CABG patients between the P and R groups. A follow-up survey completed 4 months after the study demonstrated that muscle relaxant costs and fresh gas flow rates and costs had returned to preintervention levels, while opioid and induction drug savings were maintained. CONCLUSIONS: A private practice anesthesia group that followed a voluntary protocol could significantly reduce drug cost with little change in clinical outcome. However, the savings may not be completely maintained after the monitoring period.