An Analysis of Stated Insurance Coverage and Estimated Patient-Incurred Costs of Treatments for Lower Urinary Tract Symptoms

WHY THIS MATTERS?

There is little understanding of the reasons for poor patient compliance for pharmacotherapies for lower urinary tract symptoms, such as overactive bladder, interstitial cystitis, and genitourinary syndrome of menopause. Although prescribing providers are aware of the indications, efficacy, and possible adverse effects for pharmacotherapies for lower urinary tract symptoms, they are often also aware of the financial burden such prescriptions place on patients. However, there is a lack of research on this topic to validate patient experiences. This study demonstrates poor overall coverage for female-predominant lower urinary tract symptoms, leading to substantial patient-incurred costs for those who seek treatment. The variable and inconsistent coverage by insurers for guideline-indicated therapies is likely to be contributing substantially to poor medication persistence and poor outcomes for patients with these conditions. Better information regarding the real cost burden on patients and how higher prices contribute to symptomatic outcomes is necessary to improving quality care. High deductibles combined with substantial monthly medication costs are likely to contribute to substantial inequities in women's health; better transparency about how such prices are determined is required to address these injustices in medical care.

Simply Stated

Lower urinary tract symptoms may manifest with urinary frequency, incontinence, pelvic pain, vaginal discomfort, nocturia, and sexual dysfunction in conditions such as overactive bladder, interstitial cystitis, and genitourinary syndrome of menopause. Overall, these conditions affect more than 75% of women across the lifespan, and each has available medications that can help to manage these symptoms. However, within 1 year of being prescribed one of these treatments, more than 90% of patients have stopped therapy. Although the effect of lack of efficacy and adverse effects is well documented, the contribution of the financial burden associated with obtaining these medications has not been examined for these genitourinary conditions. Review of the formularies for 5 low-cost and 5 high-cost insurance plans demonstrated poor and inconsistent coverage of medications for lower urinary tract symptoms, even when medications are U.S. Food and Drug Administration–approved, indicated by guidelines, and available as a generic alternative. Even covered by insurers, prices can still be prohibitive to patients. Better pricing transparency by insurers is needed to help improve equitable access to medical therapy for these female-predominant conditions.

Quantifying the adequacy of medication coverage and actual prices for the treatment of lower urinary tract symptoms (LUTSs) is difficult because of inadequate price transparency and high variability in coverage, even between plans offered by a single insurer.1 Anecdotally, physicians and patients perceive that LUTS medications are prohibitively expensive with or without insurance coverage.2 Many patients never seek care at all; 1 in 11 adults report delaying or avoiding care because of associated costs.3 In socioeconomically disadvantaged communities, fear of treatment prices influences choices to defer care.3–5 Medication coverage gaps or caps by insurers lead to worse outcomes for patients.6 Whereas other factors such as adverse effects and efficacy have a role in medication discontinuation for LUTS treatments,7,8 little information is available concerning the role medication prices play in the initiation and persistence of LUTS pharmacotherapies, particularly in women.

Lower urinary tract symptoms affect more than half of all adults, commonly manifesting as overactive bladder (OAB), interstitial cystitis/bladder pain syndrome (IC/BPS), and genitourinary syndrome of menopause (GSM).9 Prevalence of LUTSs increases to 75% in older adults,7 a population that has grown 34.2% during the past decade.10 Despite high prevalence, clinical care remains poor; fewer than 10% of patients remain on treatment within a year of seeking care.7 We compared existing coverage and out-of-pocket patient-incurred costs across a range of insurance providers for LUTS medications. Overactive bladder, IC/BPS, and GSM were chosen as conditions representative of LUTSs; these diagnoses have U.S. Food and Drug Administration (FDA)–approved medications that are available as generic alternatives and are backed by consensus treatment recommendations from physician societies.11–13 We sought to explore variability in patient expenses between common private insurance plans for evidence-based LUTS treatments.

MATERIALS AND METHODS

A total of 2,020 formularies for 1 low-cost and 1 high-cost plan for each of 5 major private nationwide insurance providers used in Southern California were reviewed for coverage of medications that treat LUTSs (Fig. 1). These insurers represented the most common plans for patients attending urogynecology clinics at 2 large health care systems in Los Angeles (University of California, Los Angeles and Cedars-Sinai). We selected the most common low-cost (Health Maintenance Organization [HMO]) and high-cost (Preferred Provider Organization [PPO]) plans for each insurer. Formularies available online denoted the level of insurance coverage provided, which was assigned a number or “tier” based on the coverage level described to normalize coverage between insurers. Tier 1 indicated medications with the lowest direct patient cost, typically designated as generic/preferred generic/low cost. Tier 2 defined nonpreferred generic/moderate-cost medications. Tier 3 was for preferred brand/intermediate-cost medications. Tier 4 specified nonpreferred brand/high-cost medications. Tier 5 was reserved for coverage of biologic drugs/specialty pharmacies. Tier 6 designates medications that are not covered. Prices after insurance for each drug tier were determined after speaking by telephone with insurer representatives. Individual medication costs or cost ranges were not disclosed.

F1FIGURE 1:

Heat map of coverage of medications for lower urinary tract symptom treatment by insurance plans. Colors in the figure are in the key (lower left) indicating the range of costs from lowest cost to no coverage. *Trade names were used only where necessary to distinguish coverage and associated cost for different formulations of equivalent medications.

When insurers specified patient payment as a proportion of overall medication cost, patient-incurred cost was estimated as a percentage of the average preinsurance cash price determined from GoodRx noncoupon prices for Los Angeles County.14 Preinsurance, noncoupon cash prices for New York City, Houston, and Chicago (the 3 largest U.S. population centers outside of Los Angeles)15 were included for comparison.

To compare overall coverage by insurance provider, numerical scores were calculated for each insurance plan by condition. Numeric tier designations, as defined previously, for individual medications for each condition were added to give a condition-specific coverage score, which were totaled to give an overall score for each insurance plan that compared diversity of coverage. Lower scores indicated that a broader range of guideline-supported medications was available under that plan, whereas higher scores indicated poorer overall coverage (fewer covered medications per condition).

RESULTS

Coverage of pharmacologic treatments for LUTS diagnoses varied widely across insurance plans (Fig. 1). Regardless of the availability of generic alternatives, no therapy recommended by clinical guidance documents from the American Urological Association12,13 or National American Menopause Society11 was covered by all insurance providers at low cost. The average price of medications across conditions ranged from $10 to $900 per month; most plans had deductibles of $200–$450 to meet before coverage begins (Fig. 2). Cash prices for these medications from GoodRx in Los Angeles represented possible uninsured patient-incurred costs and were similar across 3 additional large metropolitan areas (New York City, Houston, and Chicago) (Fig. 2).

F2FIGURE 2:

Average monthly patient cost of medications for LUTS treatment by insurance plan. Colors in the figure (key at lower left) form a spectrum of green to red indicating increasing cost ranges as specified. The second panel at the right indicates the noncoupon cash prices obtained for each of 4 metropolitan markets from GoodRx. *Trade names are used only where necessary to distinguish coverage and associated cost for different formulations of equivalent medications. LUTS, lower urinary tract symptom.

Coverage scores, determined as the sum of coverage tiers, compared the diversity of LUTS coverage provided by an insurer (Fig. 3). The low-cost plan of Cigna and the high-cost plan of Blue Cross/Blue Shield (BCBS) had the lowest coverage scores of 32. With a score of 81, Humana's low-cost plan demonstrated condition-specific scores more than double the lowest scores, correlating with less comprehensive coverage.

F3FIGURE 3:

Overall coverage of female lower urinary tract disorders by insurance plan. (A), An insurance provider score was generated as the sum of tier coverage for all drugs for lower urinary tract conditions (OAB, IC/BPS, GSM). (B), Ranking of the insurance provider coverage for lower urinary tract disorders from best to worst indicates inconsistent coverage even within insurers. Color gradients indicate coverage patterns for OAB (blue), IC/BPS (green), GSM (yellow), and lower urinary tract disorders overall (red), with the darker colors indicating worse coverage. (C), Box and whisker plots indicate the minimum, first quartile, median, third quartile, and maximum of the cost for all drugs examined in this analysis. The plans assessed included the Aetna Value Plan 2020 (low) and Premier Plus 2020 (high), BCBS Value (low) and Plus (high) plans, Cigna Legacy 3 Tier (low) and Advantage 3 Tier (high) plans, Humana Basic (low) and Premier (high) plans, and the UnitedHealthcare Traditional 4 Tier Plan (low) and Advantage 4 Tier Plan (high). L, Low-cost plan; (H), high-cost plan. BCBs, Blue Cross/Blue Shield; IC/BPS, interstitial cystitis/bladder pain syndrome; GSM, genitourinary syndrome of menopause; OAB, overactive bladder.

For medical management of OAB, oxybutynin was the only drug covered by all plans with a monthly patient cost under $10. Other antimuscarinic drugs, including tolterodine, darifenacin, and fesoterodine, were covered at a low/moderate cost by 4–5/10 plans but not covered by the remaining plans, despite generic alternatives. When uncovered, average monthly patient costs were greater than $300/month. Only 1 plan offered mirabegron for under $40/month, with a median price across plans of $349 (interquartile range [IQR], $47–$450) per month (Fig. 4A). Trospium, a quaternary amine antimuscarinic, is covered at low patient cost in 6/10 plans but was $148 per month ($1,800 yearly) in the 4 plans with no low-cost alternatives to oxybutynin (Fig. 2). Blue Cross/Blue Shield's high-cost and Cigna's low-cost plans exhibited the best coverage scores for OAB of 10, whereas the high- and low-cost plans from Humana and UnitedHealthcare had scores of 30 and 34, respectively (Fig. 3).

F4FIGURE 4:

Violin plots of average medication prices by condition. Plots indicate the median (white dot), IQR (dark bar), and distribution of cost for each drug used in the treatment of OAB (A), IC/BPS (B), and GSM (C).

The only FDA-approved oral medication for IC/BPS, pentosan polysulfate (PPS), is covered at a low price by 2/10 plans reviewed. For the remaining plans, average patient-incurred cost is more than $400/month. Medications with other indications used off-label for IC/BPS were covered by every plan; amitriptyline, a tricyclic antidepressant, and the antihistamines cimetidine and hydroxyzine were covered at under $10/month by 8/10 plans (Fig. 2). Overall, BCBS's high-cost and Cigna's low-cost plan had the lowest score of 5. The low- and high-cost plans from Aetna, BCBS, and Cigna exhibited similar coverage scores of 6, whereas the low- and high-cost plans from Humana and UnitedHealthcare had scores of 11–14 (Fig. 3).

The coverage and prices for vaginal estrogen formulations were inconsistent across plans (Fig. 4C). Despite multiple generics, 3/10 plans did not offer any low-cost option. The median price of vaginal estrogen across plans was more than $44/month (IQR, $12–$85) or $528 annually. Yuvafem, the generic for Vagifem, was the most affordable option, with a median patient cost of $9 (IQR, $8–$55) a month, but still costs more than $70/month in 3/10 plans. Estrace was covered by all insurance plans at or under $50/month. The median cost of $40/month (IQR, $31–$49) contrasted a cash price of Estrace without insurance of $33 per tube (IQR, $29–$37; $11/month). Coverage of Premarin, a second vaginal cream option, was more variable, costing $10–$11/month in 3 plans, $42–$47/month in 6 plans, and $180/month in the Humana low-cost plan. Imvexxy, a vaginal suppository, had a median price of $150/month (IQR, $44–$252). Ospemifene, the only oral medication indicated for GSM symptoms, costs the most across insurance plans at a monthly median of $160 (IQR, $44–$269). Estring, a continuously eluting vaginal estrogen ring, was variably covered, available for $10–$15/month from 4 insurers, but costing more than $300/month in the high- and low-cost Aetna and Humana plans (Fig. 2). The GSM-specific coverage scores ranged from 16 to 40. UnitedHealthcare's low-cost plan had the lowest coverage score of 16, whereas Humana's low-cost plan had highest score of 40 (Fig. 3).

DISCUSSION

There are significant discrepancies between insurance coverage and consensus practices in LUTSs, even when medications are FDA-approved and indicated by guidelines. Even when covered by insurers, patient costs for LUTS treatments can be prohibitive. Despite a high prevalence of LUTSs, several plans had no low-cost options for care. Because lack of care can have a profound impact on quality of life, ability to live independently, and overall morbidity, improved price transparency is required to understand the obstacles to equitable access to medications for women with LUTSs.

Inconsistency between insurers means that, even when low-cost options are available, specific coverage varies between plans. Providing each patient with an appropriate, inexpensive medication covered on their plan would require physicians to be familiar with each formulary, yearly changes in coverage, in-network pharmacies, and prescription durations needed to obtain maximal benefits. Given the difficulties experienced compiling the information for this study, such familiarity is challenging even for motivated health care providers. Thus, many patients are likely to encounter high costs obtaining LUTS medications, even when affordable alternatives exist. Although innovative solutions such as GoodRx coupons or Cost Plus Drug Company can provide medications at lower prices, they circumvent rather than solve these problems. Patients must be aware of these resources to take advantage of them; although health care providers may make efforts to communicate their availability, significant obstacles to navigating these alternatives still exist.

Antimuscarinics demonstrate treatment efficacy for OAB but have frequent adverse effects (dry mouth, constipation) that lower persistence. As OAB prevalence increases with age,16 recent studies detailing increased dementia risk17–19 and dose-dependent associations with brain atrophy, cognitive impairments, and clinical decline with anticholinergics are concerning.17 Oxybutynin, a nonselective anticholinergic, is the only option covered by all plans at low price, but many health care providers are reticent to prescribe it for fear of cognitive sequelae, particularly in older patients.20 Coverage of noncholinergic agents without these risks, such as mirabegron, is rare. For most, obtaining this medication without coverage is not possible and costs thousands of dollars per year.

If left untreated, IC/BPS, which affects 3.3–7.9 million women,21 can cause severe disability. Pentosan polysulfate, the only FDA-approved oral medication, came off patent in 2010 but remains prohibitively expensive on almost every plan. Other agents for IC/BPS, such as amitriptyline, cimetidine, and hydroxyzine, are used off-label but demonstrate poor efficacy and tolerability in IC/BPS.22 Whereas reports of progressive maculopathy associated with PPS have limited new prescriptions,23 the increasing prohibitive price of PPS has left many patients previously maintained on this therapy without options. This reality, in concert with the limited efficacy of affordable treatments, contributes to the devastating impact of IC/BPS on physical and psychological well-being.

Currently, improved life expectancy means that women are spending about 40% of their lifespan in the menopausal state; 50–70% of these women will have symptomatic GSM.24 Vaginal estrogen treatment is safe and effective for GSM management, supported by myriad clinical trials and consensus guidelines.25,26 Nonetheless, it continues to be costly, with unpredictable coverage across insurers. This coverage variability across plans was pronounced for vaginal estrogen and appeared unrelated to efficacy, history of use, or generic availability. Premarin, despite FDA approval in 1946, can cost $180/month ($2,160/year) with certain plans. Generic estradiol cream costs $40/month across plans but could be obtained without insurance for $33 per tube (approximately $11/month). Ospemifene, the only oral medication indicated for bone health, has a median cost of more than $1,900/year. Estring, the only option for patients who cannot self-administer vaginal estrogen (eg, because of mobility or cognitive limitations) is not covered by 40% of plans and would cost approximately $4,200/year. Claims-based analyses demonstrate that 50% of women prescribed vaginal estrogen will discontinue therapy within 1 year27; future studies will need to address the role of cost in that poor adherence.

Medication prices should be considered in the context of household income. The median household income for Los Angeles in 2020 was $5,440, with an average rent for a 1-bedroom (BR) apartment of $2,450. For reference, median household incomes in New York City, Houston, and Chicago were $5,783 (1-BR rent, $3,930), $4,467 (1-BR rent, $1,310), and $5,174 (1-BR rent, $1,830), respectively.28,29 A medication costing $450/month, such as Mirabegron on several insurance plans, would be approximately 10% of average monthly income. Once additional costs of living, such as rent, transportation, food, and taxes, are factored in, this sum is likely intractable for most. This analysis also did not consider plan premiums because these are variable by employer and insurer, which would contribute substantially to the financial hardship of obtaining LUTS treatment.

Opacity in drug pricing is a significant barrier to understanding the accessibility of pharmacotherapies for women with LUTSs. Across insurance providers, we observed significant variability between insurance companies in LUTS medication coverage with little relationship between the preinsurance cash prices and patient-incurred costs. These data suggest that forces independent of drug development and manufacturing costs are responsible for this variation. Lack of transparency in what determines patient-incurred cost makes it challenging to drive change toward affordable access to medications.

For medications where coverage is a percentage of the drug price, patient-incurred cost was calculated from the average noncoupon price on GoodRx; actual prices were not disclosed by either insurers or pharmacies. Thus, our price likely underestimates patient-incurred costs for higher tier medications. In addition, these costs assume that patients can access the full benefits of each formulary; use of out-of-network pharmacies or nonpreferred dosages may result in higher costs, which were also not disclosed by the insurers. For medications with poor coverage, there is the possibility that patients could obtain the medications after prior authorization. However, these costs are also not disclosed, and prior authorization presents additional hurdles to obtaining medications for both the patient and health care provider.

Both FDA indications and guideline recommendations can lag behind current safety and efficacy data. As mentioned previously, although oxybutynin is both FDA-approved for OAB and indicated by guidelines,13 many health care providers have significant concerns about cognitive adverse effects and would prefer β-3 adrenoreceptor agonists. However, these agents are not preferentially indicated in the guidelines. Insurance coverage, as with the FDA and guidelines, may be slow to adapt to new efficacy data or safety concerns that influence prescribing patterns. For each condition, not every treatment may be appropriate for every patient. We therefore generated coverage scores as a measure of coverage diversity, suggesting how capable a specific plan is at allowing patient-tailored treatment choices. High variability in these scores, however, suggests that coverage levels are determined by more than lagging adaptation to evidence. Transparency and accountability are needed to reveal the underlying forces driving coverage. More in-depth analysis of sex-based cost discrepancies may help to answer this question in the future. Although pharmacotherapies for LUTSs predominantly affecting women are inconsistently covered, medications for similar conditions affecting men, such as finasteride (indicated for benign prostatic hyperplasia), tamsulosin (indicted for benign prostatic hyperplasia), and sildenafil (indicated for sexual dysfunction), are more affordable with median preinsurance prices of under $10/month.14

Many questions remain. Are patients actually able to obtain these medications at the prices endorsed by insurer representatives? How many discontinue or never initiate prescribed treatments because of cost? How do health literacy and socioeconomic factors influence patients' abilities to access lower cost prescriptions? What are the implications of limited coverage on overall health-related quality of life for those experiencing LUTSs? Given the lack of price transparency, these questions will need to be addressed at the patient level to explore these experiences and provide avenues to improve LUTS care.

CONCLUSIONS

It can be challenging for patients to determine actual medications costs; variability between plans makes this landscape difficult to navigate. Even when medications are FDA-approved, evidence-backed, and indicated by guidelines, average prices may be prohibitive and prevent patients from obtaining appropriate care.

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