Penny-wise but Pound-foolish: The Hidden Costs of Step Therapy for Overactive Bladder

Open AccessJournal of UrologyJU Forum1 Jun 2023Penny-wise but Pound-foolish: The Hidden Costs of Step Therapy for Overactive Bladder A. Lenore Ackerman A. Lenore AckermanA. Lenore Ackerman *Correspondence: David Geffen School of Medicine, 10833 Le Conte Ave, Box 951738, Los Angeles, CA 90095-1738 telephone: 310-794-0206; E-mail Address: [email protected] https://orcid.org/0000-0003-4192-7649 Department of Urology and Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California View All Author Informationhttps://doi.org/10.1097/JU.0000000000003430AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Overactive bladder, including symptoms of increased urinary frequency, urgency, and incontinence, is more prevalent than diabetes, affecting 1 in 6 adults in the United States.1,2 Occurring more commonly among women and older adults, untreated overactive bladder is associated with reduced quality of life, increased incidence of depression and anxiety, increased risk of experiencing falls/fractures, and increased institutionalization. The American Urological Association treatment guidelines for overactive bladder recommend pharmacological treatment with anticholinergics or β3-adrenergic receptor agonists in combination with behavioral therapy as first-line treatment or pharmacological treatment alone as second-line treatment.1 Anticholinergic medications, which have been used to treat overactive bladder for decades, may be effective for some patients but have long been recognized to result in bothersome and persistence-limiting side effects such as constipation and dry mouth. More concerning, however, are a recent study reporting an increased incidence of falls/fractures3 and a meta-analysis of 6 studies that suggests an increase in dementia risk4 with these medications. To avoid these risks of confusion, dry mouth, constipation, and other anticholinergic-related effects, the American Geriatrics Society Beers Criteria recommend reducing or avoiding unnecessary anticholinergics in older adults.5 β3-adrenergic receptor agonists provide an effective, nonanticholinergic oral treatment option for overactive bladder. However, many national health plans have implemented step-therapy protocols that require patients to try one or more anticholinergic medications, typically low-cost generics, before other treatments will be approved. Step-therapy requirements may be implemented at the pharmacy, with a request sent to the prescriber to substitute a β3-adrenergic receptor agonist with a lower-cost anticholinergic. While medication substitutions require provider approval, substitutions can result in anticholinergics being dispensed to patients despite the physician's initial intent to prescribe a different treatment class because anticholinergics may have been inappropriate due to age or potential for cognitive dysfunction or falls. The substitution may also occur without an opportunity for the provider to discuss the risks and benefits of anticholinergics with the patient. While step therapy may provide short-term savings to insurers, there are no data on how it impacts patient health outcomes in overactive bladder. Step-therapy protocols may contribute to hidden long-term costs for patients, health care providers, and even payers. Anticholinergic step therapy may increase the number of patients who live with untreated overactive bladder. Patients who experience insufficient efficacy or intolerable side effects with first-line overactive bladder treatment may stop taking their medication rather than seek an alternative treatment. When untreated, patients living with overactive bladder may withdraw socially, which can lead to reduced quality of life and poor relationships, as well as anxiety and depression, which may require medical treatment. Some may experience falls and fractures while rushing to the bathroom. Particularly for patients with mobility impairments, overactive bladder–associated incontinence places a substantial physical and psychological burden on caregivers. Constant attention to patient hygiene may interfere with caregivers' ability to work, sleep, and attend to their own health and ultimately contribute to institutionalization of these dependent older adults. If health care providers were able to choose overactive bladder treatments based on a patient's individualized needs, without the requirement for step therapy, persistence might improve, reducing the burden of untreated overactive bladder. Step therapy with anticholinergics may also increase the number of patients who experience anticholinergic side effects and associated increases in health care resource utilization. While generally viewed as a benign side effect, constipation alone can impart a significant burden on the health care system, with over 3.7 million office and immediate care visits each year centering on the evaluation and management of constipation (including constipation unrelated to anticholinergic use).6 In addition, constipation may impair productivity, increase psychological distress, and degrade overall quality of life. Particularly in older patients with overactive bladder, anticholinergic use may exacerbate an already heightened risk of falls/fractures with associated potential for hospitalization and/or institutionalization. Most concerning, however, is the risk for cognitive effects in patients receiving anticholinergics. Evidence from a systematic literature review and meta-analysis supports a heightened risk of Alzheimer disease, incident mild cognitive impairment, and cognitive impairment/decreased performance, in addition to an increased risk of dementia with anticholinergic administration.4 Step-therapy protocols may require patients to trial specific anticholinergics (eg, oxybutynin and tolterodine) that have an association with cognitive decline7 for anywhere from a month to a year before they can receive treatments (eg, β3-adrenergic receptor agonists) that have not been associated with adverse cognitive effects. The aforementioned meta-analysis identified heightened cognitive risk in a population that included patients with as little as 3 months of anticholinergic exposure.4 Dementia-related health care costs are estimated at >$28,000 per person annually, not including societal costs (eg, >$13,000 per year in lost caregiver wages).8 Anticholinergic-related increases in incident dementia may further add to the hidden health care costs of current overactive bladder care, adding to the already high burden dementia poses on the health care system and on payers. Although further evidence is needed on the potential cognitive effects of short-term anticholinergic exposure, providers and payers must begin to ask themselves whether requiring anticholinergics as a first step in overactive bladder treatment could constitute a harm to patients. Beyond the potential for medical consequences, step-therapy requirements impose broader, less-tangible costs on patients, providers, and the health care system. It is typical for a patient with overactive bladder to try multiple treatments before finding a tolerable and efficacious therapy. Implementing step therapy may increase the number of treatments a patient must try, resulting in additional physician appointments and associated costs (eg, co-pays, travel and parking costs, lost time at work), as well as costs associated with managing overactive bladder, such as incontinence and skin care products. Meanwhile, health care providers and their staff must spend time completing prior authorization forms and annual reauthorizations rather than treating patients. The administrative burden may lead to underuse of newer therapies, particularly in patients at high risk of adverse events. Many of these costs could be averted if patients and health care providers were able to choose an initial overactive bladder therapy based on a patient's individualized needs rather than insurance requirements. Although step-therapy requirements are meant to save money for patients and payers, it is unclear whether they do so when all of these costs are considered. Untreated overactive bladder may lead to unanticipated costs, including increased health care utilization for unresolved symptoms, depression, or anxiety, as well as caregiver burden and heightened risk of falls/fractures, both of which can lead to institutionalization. Treatment with anticholinergics, although effective, may result in adverse effects that are themselves costly, such as constipation, enhanced fall/fracture risk, and increased rates of dementia, with the potential need for long-term care. A recent systematic review found that increasing anticholinergic use or burden, low persistence, and potentially inappropriate anticholinergic use (as defined by Beers Criteria) were all associated with increased health care utilization and costs to the payer.9 In addition, a cost-effectiveness model that considered anticholinergic-related adverse events found that a β3-adrenergic receptor agonist can be cost-effective compared with anticholinergics from a commercial and Medicare payer perspective.10 Health plans should reevaluate, and consider abandoning, requirements to trial anticholinergic treatments before other treatment options for overactive bladder. While anticholinergic step therapy is likely associated with a modest, short-term cost reduction for patients and payers, this should not supersede the ability of health care providers to select the most appropriate treatments for overactive bladder for each individual patient. Although step therapy may provide initial savings, it ultimately may result in long-term financial costs far in excess of any savings. The burden of step therapy could also be alleviated, in part, by policy changes such as enactment of the Safe Step Act (S 464/HR 2163), which would require group health plans to allow exceptions to step therapy through a transparent and standardized process. Health care providers and professional societies should continue to advocate for policy changes that will enable providers and patients to choose safe and effective therapies that fit their unique care needs. Acknowledgments I thank Joseph Kruempel, PhD, CMPP, of The Curry Rockefeller Group, LLC (Tarrytown, New York), for writing the first draft of the manuscript and providing editorial support. REFERENCES 1. Diagnosis and Treatment of Non-neurogenic Overactive Bladder (OAB) in Adults: AUA/SUFU Guideline (2019). https://www.auanet.org/guidelines-and-quality/guidelines/overactive-bladder-(oab)-guideline. Google Scholar 2. . Prevalence and burden of overactive bladder in the United States. World J Urol. 2003; 20(6):327-336. Crossref, Medline, Google Scholar 3. . Assessing risks of polypharmacy involving medications with anticholinergic properties. Ann Fam Med. 2020; 18(2):148-155. Crossref, Medline, Google Scholar 4. . Increased risk of incident dementia following use of anticholinergic agents: a systematic literature review and meta-analysis. Neurourol Urodyn. 2021; 40(1):28-37. Crossref, Medline, Google Scholar 5. 2019 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2019 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019; 67(4):674-694. Medline, Google Scholar 6. . Burden of gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology. 2015; 149(7):1731-1741.e3. Crossref, Medline, Google Scholar 7. . A systematic review of neurocognitive dysfunction with overactive bladder medications. Int Urogynecol J. 2021; 32(10):2693-2702. Crossref, Medline, Google Scholar 8. . Monetary costs of dementia in the United States. N Engl J Med. 2013; 368(14):1326-1334. Crossref, Medline, Google Scholar 9. . Healthcare and economic burden of anticholinergic use in adults with overactive bladder: a systematic literature review. J Comp Eff Res. 2022; 11(18):1375-1394. Crossref, Medline, Google Scholar 10. . Cost-effectiveness of vibegron for the treatment of overactive bladder in the United States. J Med Econ. 2022; 25(1):1092-1100. Crossref, Medline, Google Scholar Support: Medical writing and editorial support for the preparation of this manuscript were funded by Urovant Sciences (Irvine, California). Conflict of Interest: The Author receives research support from MicrogenDx and Medtronic, Inc, and is a consultant for Watershed Medical and Abbvie. Ethics Statement: This paper was exempt from Institutional Review Board review. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.© 2023 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue 6June 2023Page: 1045-1047 Advertisement Copyright & Permissions© 2023 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.AcknowledgmentsI thank Joseph Kruempel, PhD, CMPP, of The Curry Rockefeller Group, LLC (Tarrytown, New York), for writing the first draft of the manuscript and providing editorial support.MetricsAuthor Information A. Lenore Ackerman Department of Urology and Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California *Correspondence: David Geffen School of Medicine, 10833 Le Conte Ave, Box 951738, Los Angeles, CA 90095-1738 telephone: 310-794-0206; E-mail Address: [email protected] More articles by this author Expand All Support: Medical writing and editorial support for the preparation of this manuscript were funded by Urovant Sciences (Irvine, California). Conflict of Interest: The Author receives research support from MicrogenDx and Medtronic, Inc, and is a consultant for Watershed Medical and Abbvie. Ethics Statement: This paper was exempt from Institutional Review Board review. Advertisement Advertisement PDF downloadLoading ...