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Comparing Direct Medical Costs of OnabotulinumtoxinA With Other Common Overactive Bladder Interventions

This cost analysis demonstrated that onabotulinumtoxinA is one of the least-costly treatment options for inadequately managed overactive bladder syndrome.
Published Online: Feb 02,2018
Alon Yehoshua, PharmD, MS; Brian P. Murray, MD; Sandip P. Vasavada, MD; and Peter K. Sand, MD
Abstract

Objectives: To compare the estimated direct costs of onabotulinumtoxinA with other overactive bladder syndrome (OAB) interventions for patients inadequately managed by an anticholinergic.
Study Design: A cost analysis compared the direct annual costs of 12 common pharmaceutical treatments, including branded and generic anticholinergics, and mirabegron; 1 injection procedure (intravesical injection of onabotulinumtoxinA); and 2 devices (sacral nerve stimulation [SNS] device implantation and percutaneous tibial nerve stimulation [PTNS]).
Methods: Direct medical treatment costs were assessed from a United States payer perspective and included costs of drugs and/or procedures, administration (if applicable), and routine follow-up care. Drug acquisition costs were based on average wholesale price minus 15% and maximum allowable cost.
Results: During year 1, costs of pharmaceutical treatment ranged from $500 (oxybutynin) to $3472 (Detrol LA [long acting]); the cost for an injection procedure was $1892 (onabotulinumtoxinA); and costs for devices were $3395 (PTNS) and $19,443 (SNS). At years 5 and 10, respectively, costs were $2500 to $17,360 (oxybutynin) and $5000 to $34,720 (Detrol LA) for pharmaceutical treatments; $9458 to $18,916 for onabotulinumtoxinA; $11,849 to $21,316 for PTNS; and $21,316 to $33,801 for SNS.
Conclusions: This analysis suggests that short- and long-term costs of OAB treatment vary considerably. Pharmaceutical therapies were not necessarily less costly than injection procedures or devices. Among the injection procedure and device treatments, onabotulinumtoxinA was the least costly option at all time points. Although cost is an important component when comparing these treatments, aspects such as efficacy and safety must be considered when deciding on an appropriate treatment for OAB.

                                                                                          Am J Pharm Benefits. 2018;10(1):11-17

The International Urogynecological Association and the International Continence Society define overactive bladder syndrome (OAB) as a constellation of urinary symptoms, characterized by urinary urgency, and usually accompanied by frequency and nocturia, in the absence of urinary tract infection (UTI) or other obvious pathology.1 OAB may occur with or without urinary incontinence (UI). OAB is among the most common disorders among older adults, affecting approximately 16.0% of men and 16.9% of women in the United States.2 The prevalence of OAB peaks around age 60 for both men and women; however, increasing age is associated with higher prevalence of OAB among men but not women.3,4

Owing to its high prevalence, OAB places a substantial cost burden on society and payers, in particular. The total societal cost of OAB with UI in the United States was projected to be $76.2 billion in 2015, and is expected to increase as the population ages.5 The majority of the total cost of OAB (75%) is attributable to direct medical costs of treatment, such as pharmacotherapy or surgical procedures.

Much of the treatment cost is due to the need to try multiple agents or procedures. Although behavioral therapy, such as fluid restriction, or bladder or pelvic floor muscle training, are recommended as first-line therapy in OAB by the American Urological Association, most patients will require pharmacological treatment and are usually initiated on generic anticholinergic agents.6 However, a retrospective claims analysis of 103,250 patients diagnosed with OAB who were prescribed an anticholinergic found that 92% of patients failed their anticholinergic treatment.7 Published OAB patient surveys have described poor treatment efficacy and intolerable adverse effects (AEs) as the main reasons for anticholinergic discontinuation.8,9 Patients who fail initially prescribed anticholinergic therapy still have a variety of treatment options. These include long-acting branded anticholinergics; topical anticholinergic formulations; beta-3 adrenergics, such as mirabegron; bladder chemodenervation with onabotulinumtoxinA injection; and implantable devices, such as sacral neuromodulation (ie, sacral nerve stimulation [SNS]) or peripheral tibial nerve stimulation [PTNS]).6 As healthcare costs rise in the United States, combined with the anticipated increase in the prevalence of OAB with the aging population, the cost of new therapies is a key driver of payers’ reimbursement and access decisions. The main objective of this study is to compare, from a payer perspective, the cost of onabotulinumtoxinA injection with the costs of other OAB treatment in patients who are inadequately managed on an anticholinergic.

METHODS
An Excel-based cost model was developed to compare the annual costs of onabotulinumtoxinA 100 units (U) injection with 12 commonly used pharmaceutical treatments and 2 medical devices for OAB. Pharmaceutical treatments included Enablex (darifenacin) 7.5 mg daily; Toviaz (fesoterodine fumarate) 4 mg or 8 mg once daily; Myrbetriq (mirabegron) 50 mg once daily; oxybutynin chloride IR (immediate release) 5 mg twice daily; Ditropan XL (oxybutynin chloride extended release) 10 mg once daily; Gelnique (oxybutynin chloride) 10% gel once daily; Vesicare (solifenacin) 5 mg or 10 mg daily; tolterodine IR (immediate release) 2 mg twice daily; tolterodine LA (long acting) 4 mg once daily; Detrol LA (tolterodine long-acting) 4 mg once daily; trospium chloride IR 20 mg twice daily; and Sanctura XR (trospium chloride extended release) 60 mg once daily. Additional treatments for OAB included 2 medical devices, SNS device implantation and PTNS. These treatments were selected to reflect all of the FDA approved treatments (branded and generic) available to patients with OAB.

The analysis took the perspective of a commercial US payer and estimated the direct healthcare costs of each intervention. Direct healthcare costs included costs of the drug, procedural costs (where applicable), follow-up care, and AE costs (Table 1). Although each intervention is associated with a specific set of AEs, for the base case, only AE costs attributable to onabotulinumtoxinA were included. Drug acquisition cost for generic pharmaceutical medications were estimated using maximum allowable cost, a payer-specific negotiated rate. The maximum allowable cost rates were obtained from a survey of multiple insurers to provide an estimated national average (unpublished data). Cost for branded pharmaceutical medications was estimated to be 85% of the 2015 average wholesale price. The total cost of using pharmaceutical medications included drug costs and 2 annual physician visits for follow-up. Additionally, for mirabegron, it was assumed that 13% of patients would be prescribed metoprolol based on an analysis of MarketScan claims data, and these patients would require 1 additional physician visit to assess interactions with metoprolol (unpublished data on file). Medicare reimbursement rates were used to estimate costs associated with procedures, follow-up office visits, and office visits for management of AEs. Commercial costs were based on the estimation that private payer rates would be 122% of Medicare rates, based on a Medicare Payment Advisory Commission report in which Medicare rates averaged 82% of private payer rates in 2011.10 Costs were evaluated over a 1-, 5-, and 10-year time horizon. For onabotulinumtoxinA compared with SNS and PTNS, the 5- and 10-year time horizon was of particular interest to ensure appropriate characterization of the introductory and maintenance phase costs of SNS and PTNS.




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