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ORIGINAL RESEARCH |
From the School of Professional Studies in Business and Education, Johns Hopkins University, Baltimore, Maryland; Robert Wood Johnson Clinical Scholars Program, Johns Hopkins Medical Institutions, Baltimore, Maryland; and Department of Obstetrics/Gynecology, Johns Hopkins Medical Institutions, Baltimore, Maryland and Department of Obstetrics/Gynecology, Union Memorial Hospital, MedStar Health, Baltimore, Maryland
Address reprint requests to: Andrew M. London, MD, 6 Old Lyme Road, Lutherville, MD 21093; E-mail: alondon{at}comcast.net.
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ABSTRACT |
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 ABSTRACT METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: We created three economic models, with each model representing a unique cost perspective (societal, private third party, and patient), to estimate the incremental annual costs associated with women taking trimonthly-cycle rather than standard-cycle OCP. Direct costs considered were costs for OCP prescriptions, female hygiene products, generic over-the-counter pain relievers and iron tablets, home pregnancy tests, and physician visits for menstrual-related concerns. Indirect costs considered were lost wages due to menstruation-related disability and opportunity costs of physician visits. We derived base-case and sensitivity range estimates from prior literature, public use data, expert opinion, and cross-sectional survey data that we collected from 59 adult women taking standard-cycle OCP visiting a large, community-based gynecology office. All costs were adjusted to 2002 US dollars.
RESULTS: Under base-case assumptions that both regimens were equivalently priced ($1.16/pill) and trimonthly OCP reduces hygiene product use by 50%, annual societal costs per person were $460 for trimonthly OCP and $501 for standard OCP (incremental cost savings = $41). Assuming no difference in monthly drug copayment costs between the two regimens ($5.00), annual private third-party costs were nearly identical at $365 per regimen. Annual patient costs were $95 for trimonthly OCP and $136 for standard OCP. Trimonthly OCP remained cost saving to society as long its price remained below a 9% premium to standard OCP prices. The degree to which trimonthly OCP reduces hygiene product use also significantly influenced the cost difference between the two regimens.
CONCLUSION: Compared with standard-cycle OCP, tri-monthly-cycle OCP appears to be associated with significant societal and patient cost savings. These savings are highly conditional upon trimonthly OCP being priced similarly to standard OCP.
Monthly hormonal fluctuations and withdrawal bleeding are associated with significant adverse health measures, short-term disability, and negative economic consequences. In the United States, 2.5 million women aged 18–50 years have debilitating symptoms from menstrual disorders.1 These symptoms, which include menorrhagia, menstrual migraines, dysmenorrhea, and breast tenderness, cause two thirds of affected women to contact a health care professional at least once a year for ailment relief, and one third to have an average of 9.6 days of bed confinement and lost work productivity annually.1 Heavy menstrual bleeding, alone, contributes to an estimated $1692 in expected lost wages per affected woman and a 6.9% reduction in total employment per year.2
Combination oral contraceptive pill (OCP) therapy, prescribed in a monthly cyclical fashion (21 days of estrogen-progestin followed by 7 days of pill-free interval), is the typical approach to controlling menstrual-related disorders while also affording effective contraception. A new concept OCP continuous dosing regimen, however, which consists of 84 days of estrogen-progestin followed by 7 days of pill-free interval and reduces the yearly number of withdrawal bleeding episodes from 12 to four, is currently under advanced clinical phase testing in the US. Although the formulation and packaging of the proposed trimonthly OCP is proprietary (Seasonale, Barr Laboratories, Pomona, NY) various forms of extended OCP regimens have been the topic of six observational4–9 and four randomized controlled trials (Anderson FD. Poster presented at American College of Obstetricians and Gynecologists 50th Annual Clinical Meeting, May 4–8, 2002, Los Angeles, CA)10–12 since 1977 (Table 1
). Compared with standard OCP regimens, extended OCP regimens provide similar contraceptive effectiveness (Anderson FD. Poster presented at American College of Obstetricians and Gynecologists 50th Annual Clinical Meeting, May 4–8, 2002, Los Angeles, CA)3 fewer total days of withdrawal bleeding,11,12 and similar or reduced rates of other menstrual-related symptoms, such as weight gain, nausea, and headache.10–12 These benefits, however, appear to occur at the expense of increased breakthrough bleeding or spotting events and possibly more frequent pregnancy concerns with extended OCP regimens, which negatively influence some individuals’ opinions about long-term use of such therapies (Table 1).
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METHODS |
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ABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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We conducted a base-case analysis, which measured costs using estimates presumed to be most realistic for each variable in the model. Given the uncertainty of our estimates, we also performed one-way sensitivity analyses to evaluate the effect of altering the values of each variable across a reasonable range. Variables influential to the cost estimates based on the results of one-way analyses were studied in two-way and multiway analyses. These analyses identify the economic consequences across a range of circumstances that are favorable and unfavorable for trimonthly OCP usage.
All probabilities, costs, and units of product or service use were estimated from one or more of the following sources: a thorough review of the medical literature, survey responses from a sample of 59 adult women visiting a single-center, community-based, high-volume gynecology office, public use data, and expert gynecologic opinion.
Using MEDLINE, we searched the medical literature between January 1, 1966, and November 15, 2002, to identify prospective observational or randomized controlled trials involving extended OCP regimens. Studies were identified using the medical subject search heading term "contraceptives, oral" and the key search term "extended," while limiting the search to clinical trials and articles written in English. Other PubMed search keywords were "extended oral contraceptives," "trimonthly," and "continuous oral contraceptives." References were also obtained from key article bibliographies, discussions with local opinion leaders, and data presented at recent conference proceedings (Table 1
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To complement estimates from the literature, we also constructed a brief cross-sectional survey to gather annual cost estimates on menstruation, probability estimates on product and health service use, and consumption patterns among women using standard OCP. Because trimonthly OCP is not yet in widespread use, we were unable to gather such data for that strategy. Given our belief that the number of female hygiene products used monthly would be among the most important factors to estimate accurately in our cost models, we determined our need to survey at least 43 women to have 95% confidence that we were detecting, within a three-unit margin of error, the true mean number of hygiene products used by women taking standard OCP (assumed standard deviation = 10). Thus, we sampled 59 consecutive adult women (age 
18 years) already taking standard OCP presenting to see a single provider (AL) in a high-volume, community gynecology office during December 2002 and January 2003 (Table 2). All women approached agreed to complete the self-administered survey while in the office. The local institutional review board approved the survey design and allowed women to provide oral consent for study participation.
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. Direct costs included the average wholesale price of standard OCP based on an average wholesale price of the three most highly prescribed OCP therapies during 2000 (Ortho Tri-Cyclen, Triphasil, and Ortho-Novum 7/7/7)14; the average wholesale price of tri-monthly OCP conservatively defined by estimates based on the average wholesale price of standard OCP14; the cost of hygienic products determined by the average price of all sanitary pads (per pad mean $0.17, range $0.08–$0.37, n = 116) and tampons (per tampon mean $0.20, range $0.10–$0.38, n = 191) currently marketed by three large online pharmacies (Drugstore.com,15 Walgreens.com,16 and CVS.com17); the cost of home pregnancy tests defined by the average price and range of all pregnancy tests (per test mean $9.29, range $5.00–$15.00, n = 40) marketed by the same three online pharmacies15–17; the average wholesale price of acetaminophen and ferrous sulfate as the major forms of pain relief and iron replacement therapy, respectively, for treating menstrual pains and anemia14; and the costs of a physician visit for menstrual-related concerns based on a 99212 current procedural terminology code of physician visit as defined by the American Medical Association’s 2003 National Physician Fee Schedules Relative Value Scale (established outpatient visit for a self-limited or minor condition).18 Because tampon and sanitary napkin costs were nearly identically priced,15–17 we combined these costs into one estimate. We also combined the costs of acetaminophen and iron replacement therapy into one estimate because of their negligible and identical average unit prices ($0.04).14 Indirect costs included daily wage losses from women staying home from work to manage menstruation-related symptoms and the opportunity costs of physician visits. Estimates of these indirect costs were based on average hourly US wage figures for women aged 15–64 years19 and the assumption that women spend 2 hours in travel and visit time when seeing their physicians for a routine office visit.
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). In estimating the number of products and services used, we conservatively assumed that women taking trimonthly OCP compared with those on standard OCP would use 50% fewer female hygiene products,10,11 use slightly fewer pain relievers and iron tablets (Anderson FD. Poster presented at American College of Obstetricians and Gynecologists 50th Annual Clinical Meeting, May 4–8, 2002, Los Angeles, CA)3,10–12,20 have fewer days of lost work, and slightly more home pregnancy tests and physician visits because of mild increases in breakthrough bleeding and spotting.11 Three separate cost models were constructed to compare the economic consequences of the two OCP treatment strategies (21 days of active estrogen-progestin followed by 7 days of placebo (standard therapy) versus 84 days of active estrogen-progestin followed by 7 days of placebo [trimonthly therapy]). Model 1 assumed the societal perspective and accounted for both direct and indirect annual expenditures of OCP use. The difference in annual cost (C) between the two OCP regimens from Model 1 was determined by the following formula:
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Using this formula, trimonthly OCP is deemed cost saving to standard OCP when the result is positive and cost spending when the result is negative.
Model 2 assumed the private third-party perspective and accounted for only the direct prescription costs for OCP therapies less copayment and reimbursement rates for physician visits less copayment. Rates of private insurance coverage for OCP therapy range from 60% (conventional plans) to 87% (health maintenance organizations),21 and we assumed a fixed drug copayment amount of $5.00 per month (range $0.00–$25.00). For physician visits, we assumed the copayment to be a standard 20% out-of-pocket patient expense ($4.71) and have a range between $0.00 and $10.00.
Model 3 assumed the patient perspective and accounted for the copayment amounts required for OCP prescriptions and physician visits, all direct costs associated with other product use, and lost productivity costs. For women without private insurance who are responsible for all OCP and physician visit costs, results from model 3 would be the same as results from model 1.
Finally, we calculated all annual OCP costs using the intention-to-treat assumption, where all women are compliant throughout the entire year with a single therapy. All costs were calibrated to 2002 US dollars, and historic and 2003 costs were inflated and deflated, respectively, using either the general (for wage data) or medical care portion of the consumer price index. DATA 3.5 (Tree-Age Software Inc, Williamstown, MA) and Stata 7.0 (Stata Corporation, College Station, TX) were used to perform all analyses.
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RESULTS |
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ABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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). After excluding a $15 copayment on 3 months of either standard or trimonthly OCP and a 20% copayment on all physicians’ visits, and considering only direct OCP and physician visit costs, the annual private third-party payer costs were the same for both OCP regimens ($365 versus $364 for standard and trimonthly OCP, respectively). Under the patient perspective, where women were responsible for copayment OCP and visit costs and other direct out-of-pocket and indirect expenditures related to menstruation, $41 in annual savings was realized from trimonthly OCP (Table 4).
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shows the range of expected annual societal costs under varied tri-monthly OCP prices. The break-even point, where the expected costs of standard OCP and trimonthly OCP are equal, is $1.27 per trimonthly pill, which reflects a 9% premium to currently priced standard OCP. For private third party payers, the break-even point is $1.16 per trimonthly pill, which reflects a 0% premium to currently priced OCP therapies. Given the assumption that women have fixed-dollar, out-of-pocket expenditures associated with taking insurance-covered OCP therapies, the average wholesale price of trimonthly OCP has no bearing on annual patient costs. Under all price ranges, it is cost saving for a woman to use trimonthly OCP (Figure 1C).
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Table 5 shows the results of a two-way sensitivity analysis, where the two most influential variables on cost under the societal perspective are varied across reasonable ranges. Societal cost savings are most significant if the trimonthly OCP is priced at a discount to the current price of leading standard OCP regimens and if the trimonthly OCP significantly reduces the total number of hygienic products used monthly. Alternatively, societal losses are greatest if the trimonthly OCP is priced at a notable premium to current prices of leading standard OCP regimens and the trimonthly OCP does not significantly reduce the number of female hygiene products used monthly.
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represents multiway sensitivity analyses using the variables that account for the greatest uncertainty in the models. Two circumstances, one unfavorable and one favorable to using trimonthly OCP, are represented. In the unfavorable circumstance, the cost of trimonthly OCP increases from a base-case of $1.16 to $2.32 per pill, cost of standard OCP decreases from $1.16 to $1.00 per pill, number of total female hygiene products used monthly with trimonthly OCP increases from nine to 14, and monthly copayment for OCP therapy increases from $5.00 to $10.00. In the favorable circumstance, cost of trimonthly OCP decreases from $1.16 to $1.00 per pill, cost of standard OCP remains fixed at $1.16, number of total female hygiene products decreases from nine to five, and monthly copayment for OCP therapy decreases from $5.00 to zero. As observed, subtle changes from base-case assumptions can have a significant impact on annual costs and the ability to determine the optimal cost saving OCP strategy.
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DISCUSSION |
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ABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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Using base-case assumptions, the annual cost to society in 2002 US dollars for trimonthly OCP use was $460 per person compared with $501 per person for standard OCP use. This amount corresponded to $41 in savings for every patient using trimonthly OCP. The validity of our base-case estimates is a necessary determinant to our suggestion that trimonthly OCP use is cost saving. Although we cannot be certain of the predicted societal costs for trimonthly OCP because of a lack of suggestions from the literature, our estimates of the total societal costs for standard OCP are supported from prior data. Trussell et al22 calculated the 5-year direct costs of standard OCP after taking into account pills, side effects, and unintended pregnancies. Five years of standard OCP use was $1784 in 1991 terms, which when inflated to 2002 terms and annualized, equals $590 per year. Subtle differences between that value and ours ($501) may be partly due to the fact that we considered indirect costs and neglected unintended pregnancy costs, whereas Trussell et al considered unintended pregnancies and neglected indirect costs.
Our data suggest that annual savings of $41 per woman who takes trimonthly OCP over standard OCP is contingent on the trimonthly OCP being priced competitively with branded standard OCPs. When we varied the price of trimonthly OCP between 50% and 300% of the lowest and highest prices, respectively, for the standard OCPs we studied, annual societal costs of trimonthly OCP changed substantially, ranging from $219 (incremental savings = $282) for a $0.50 per pill price to $1460 (incremental losses = $959) for a $3.90 per pill price. Trimonthly OCP use appears to be cost saving if the pill is priced anywhere below a 9% premium ($1.27 per pill) to the current price of standard OCP use.
Two evolving trends in the oral contraceptive market currently pose the greatest threats to branded trimonthly OCP being cost saving. The first is an increase in the use of generic formulations of standard OCP regimens. Generic medications comprised approximately 50% of the total number of prescriptions filled in the United States during 1999,23 and this percentage will likely increase in the future as pharmaceutical costs escalate, public and private payers further pressure providers to prescribe generic formulations, and patients assume higher out-of-pocket expenses for new prescription drugs that have uncertain health benefits over older drugs. In the oral contraceptive market, generic OCP formulation prescriptions increased from 3.6% of the total in 1990 to 18% of the total in 2001.24
The second trend that could dissuade widespread adoption of branded trimonthly OCP, particularly from the perspective of third-party payers, is downward price pressure being placed on branded, standard OCP regimens because of competition among themselves or with generic substitutes. In our study, when we used base-case assumptions, any premium placed on trimonthly OCP relative to the price of standard OCP made the trimonthly regimen economically undesirable from the private insurer’s perspective. From the patient’s perspective, however, assuming that insurers do not require patients to pay different monthly copayments based on their choice of treatment, trimonthly OCP appears cost saving regardless of its price. These savings are largely attributable to reduced use of fewer numbers of female hygiene products and reduced lost work time from menstrual-related disability with trimonthly OCP.
Schwartz et al13 performed a cost analysis on trimonthly OCP use by using a simplified model based only on the patient perspective. Accounting for only the costs and number of hygiene products used and costs of oral contraceptives, they concluded that the trimonthly regimen was not cost effective for the average woman who uses approximately 18 hygiene products per withdrawal bleed unless oral contraceptive costs are less than $9.45 per cycle. These conclusions are limited by the fact that the authors assumed the cost of one cycle of trimonthly OCP to be three times the cost of one cycle of standard OCP without performing sensitivity analysis around this assumption. They also failed to consider other potential cost savings afforded by trimonthly OCP, such as reductions in analgesic and iron replacement therapy and improvements in work-related productivity. When we considered these savings, even after discounting the fact that trimonthly OCP is possibly associated with a slight increase in pregnancy testing and physician visits, trimonthly OCP use saved patients $41 per year.
Our study has several limitations. The major limitation was that we constructed economic models without considering the health benefits or harms that trimonthly OCP may afford over standard OCP. Although it would be ideal to calculate an incremental effectiveness difference between trimonthly OCP and standard OCP, the evidence we had available for review was insufficient to draw reliable claims about differences in major health outcomes, quality of life, and patient preferences. In addition, none of the four randomized controlled trials performed to date between trimonthly OCP and standard OCP have discerned differences in contraceptive efficacy (Anderson FD. Poster presented at American College of Obstetricians and Gynecologists 50th Annual Clinical Meeting, May 4–8, 2002, Los Angeles, CA).3,10–12 Still, trimonthly OCP may have some important health benefits that we did not consider, which would make trimonthly OCP even more cost saving than our estimates suggest. Particularly among women who have significant menstruation-related morbidity, reducing the frequency of menstruation by a factor of three may reduce anemia, dysmenorrhea, symptoms related to endometriosis, menstrual migraines, epilepsy, premenstrual syndrome, and menorrhagia.25 Our analysis also neglected the potential risks of trimonthly OCP, which appear largely limited to increases in breakthrough bleeding that decrease over time.3 Other limitations include the fact that we narrowed our analysis to a 1-year time frame and used an intention-to-treat assumption. We studied 1 year of OCP use because there are no long-term published data comparing these two OCP regimens; thus, we had no way to externally validate our models beyond 1 year. Finally, it is unlikely that we accounted for all costs pertinent to OCP treatment. For instance, the cost of unintended pregnancies could influence our results if one OCP regimen proves to have higher contraceptive efficacy than the other.
In conclusion, under an appropriate drug pricing policy, trimonthly OCP may hold considerable promise for adding value over existing standard OCP, particularly for women with medical indications for delaying menstruation. Considering that an estimated 2.5 million women in the United States currently have significant menstrual-related disorders, annual savings to society from using the trimonthly regimen over standard regimens could be on the order $100 million in direct costs and improvements in work productivity. These numbers are likely to be substantially larger if a percentage of normally menstruating women begin using trimonthly OCP as their preferred method of contraception. Many women are likely to embrace this therapy, as 49% to 92% of all women studied thus far provided favorable approval ratings over standard OCP regimens.
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Footnotes |
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Received May 2, 2003. Received in revised form June 13, 2003. Accepted June 19, 2003.
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REFERENCES |
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2. Cote I, Jacobs P, Cumming D. Work loss associated with increased menstrual loss in the United States. Obstet Gynecol 2002;100:683–7.
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27. Archer DF, Maheux R, DelConte A, O’Brien FB. A new low-dose monophasic combination oral contraceptive (Alesse) with levonorgestrel 100 micrograms and ethinyl estradiol 20 micrograms. North American Levonorgestrel Study Group (NALSG). Contraception 1997;55:139–44.[Medline]
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