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The American Journal of Managed Care May 2012
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Economic Benefits of BIS-Aided Assessment of Post-BC Lymphedema in the United States
Sara P. Bilir, MS; Mitchell P. DeKoven, MHSA; and Juliet Munakata, MS
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Economic Benefits of BIS-Aided Assessment of Post-BC Lymphedema in the United States

Sara P. Bilir, MS; Mitchell P. DeKoven, MHSA; and Juliet Munakata, MS
Use of bioimpedance spectroscopy to aid in post“breast cancer assessments for lymphedema can be cost saving for healthcare organizations in the United States.
Based on these rates, associated treatment costs (eg, hospitalizations, antibiotics) are incorporated into the results via sensitivity analysis. Costs align with the following resource use: 90% of patients visit their physician, in an outpatient setting, prior to admission; antibiotic administration (3 days in hospital, 7 additional days of oral vancomycin). The remaining 10% of patients are assumed to visit an emergency department prior to admission for antibiotic administration, a conservative estimate informed by general skin infection ambulatory care data.34

Shih reports in her medical claims analysis that 6% of those diagnosed with lymphedema require mental health resources as compared with post-BC patients without lymphedema.11 In sensitivity analysis incorporating sequelae, an average depression treatment cost is applied based on total national depression rates/expenditures.35

Healthcare Costs

Healthcare costs were derived from publicly available fee schedules, and where possible, reflect Medicare national average reimbursement rates.36-38 No discount rate was applied to these costs due to the 1-year time horizon (Table 2).

RESULTS

Base-Case Analysis

For the 627 newly treated post-surgery BC patients, based upon the CTCAE v3.0 definition of lymphedema and other base-case model input values, the total 1-year budget impact, from the payer perspective, is $1,984,529 for CS assessment and $1,668,818 for BIS-aided early detection, for a savings of $315,711, or $0.03 per member per month (PMPM) (Table 3). Because of the default assumption that patients pay for sleeves, this result reflects no treatment costs for the BIS-aided assessment model arm. Treatments comprise the largest source of CS-assessment model arm costs, while the BIS-aided assessment costs can be attributed to assessments.

Sensitivity Analyses—Univariate

Univariate sensitivity analyses were performed for each model parameter, as well as specific scenarios and multivariate combinations. Where data fail to indicate a range, ±25% is used to evaluate model sensitivity to parameters. Univariate results for the most sensitive parameters are presented in Table 4.

The budget impact varies importantly according to the proportion inappropriately diagnosed and treated post–CS assessments, characterized by the specificity of CS assessments. If CS assessment specificity is 25% over the default value, then BIS-aided assessment is no longer cost saving, and total budget impact becomes $649,475, or $0.08 PMPM; cost savings is lost at specificity >85%. If CDT is likewise 25% less expensive than the default, cost savings of BIS-aided assessment

is lost, for a budget impact of $26,270 (negligible PMPM); the cost-savings threshold is just over $2260 per CDT course. Alternatively, if CS assessment is less specific than the default value, or CDT costs significantly more, as has been suggested by clinical experts, then cost savings of BIS-aided detection more than doubles (to $754,975 and $657,692, respectively, for upper-range values in Table 2). Cost savings due to BISaided detection is robust to ±25% changes even in other sensitive variables, including proportion/cost of pneumatic pump use, assessment rate, and CS assessment sensitivity, as well as the more conservative set of annual lymphedema incidence rates.

Scenario Analyses

Compression Sleeve Coverage

Payers may incur additional costs if they reimburse for compression sleeves. With all other inputs set to base-case values, 1-year budget impact of BIS-aided assessment grows to a savings of $685,741 from the base case of $315,711, due to greater use of expensive custom sleeves among the more severe cases found by CS-assessment methods. Savings slightly decrease if custom sleeves are covered but patients pay for\ off-the-shelf sleeves (cost savings of $673,636). Savings decrease further if the proportion of patients requiring custom sleeves following BIS-aided assessment increases by 25%, or if the proportion of patients using custom sleeves following the CS-assessment method decreases by 25%. Even eliminating sleeve use entirely from treatment following CS assessment and requiring all patients following BIS-aided assessment to use custom sleeves results in cost savings, although minimal at only $4843 for the population. Other post-CS-assessment costs, such as CDT and pneumatic pumps, outweigh the costs of covering compression sleeves.

Pneumatic Pump Use

As pneumatic pumps are used by only a proportion of patients (modeled as adjunct to CDT for severe patients), the budget impact may differ based upon practice patterns. If pumps are eliminated entirely, budget impact becomes positive at $136,259, but still a minimal $0.01 PMPM. The cost savings return if more than 5% of patients found at clinically evident volumes use pumps as part of lymphedema therapy.

Higher Treatment Costs for BIS-Detected Cases

Although lymphedema detected at pre-clinical stages has been shown to be reversible, a scenario in which a portion of these cases progress and require CDT within the year is worth examining. If 25% of cases found with BIS ultimately receive treatment according to the treatment pattern modeled following CS detection, there is still a cost saving of $125,596 for the BIS arm. This cost saving is retained until >42% require the same treatment as CS-detected patients.

Low-/High-risk Populations Only

If BIS is used for only a subset of post-BC patients, according to risk group, the cost savings falls to represent only a portion of the base-case cost savings. Following SNB for localized BC, 382 at-risk patients result in savings of just under $150,000, and savings following post-regional BC (194 patients) are higher, at over $160,000.

Sequelae Inclusion

Infection prevention may be a significant benefit of early detection of lymphedema and may interest payers. With all other base-case values, the inclusion of sequelae-related costs nearly doubles the cost savings from BIS-aided assessment ($630,319, or $0.05 PMPM). If infection rates are significantly lower than the base-case values (with 0 infections/ year for healthy patients or those with excess fluid volume under 5% and only 0.1/year for those who have more than savings of $408,100 due to early detection.

Extreme Value Multivariate Analyses

The model also explored the most/least favorable scenarios for the intervention under consideration while holding assessment sensitivity/specificity at default values, using the sensitivity ranges found in Table 2. When costs of treatments following diagnosis at the more severe stage are all less expensive, and a smaller proportion of CS-assessment patients require the pneumatic pump, cost savings from BIS-aided early detection disappears: CS assessment accrues total costs of $1,300,702, compared with BIS-aided assessment costs of $1,627,528. However, the budget impact of $326,827 is still relatively low, at only $0.03 PMPM.

In contrast, when these variables are altered to their higher ranges, with high costs for treatment and more pneumatic pump users, routine BIS use saves significantly more money for the covered population than the default. The BIS-aided assessment total costs remain the same, but CS-assessment total costs rise to $3,049,779 per year. The difference of $1,422,250 translates into a savings of $0.12 PMPM.

DISCUSSION

The model demonstrates that, over a 1-year time horizon, using BIS-aided lymphedema assessment in post-surgery BC patients is cost saving by $0.03 PMPM for a payer with a nationally representative population when compared with CS assessment, due to earlier detection. The savings are primarily due to the more costly interventions required to treat this condition when it is found, on average (in our model cohort), at more severe stages associated with CS assessment methods. Additional savings result from the higher specificity of BIS, leading to fewer non-lymphedema patients being treated unnecessarily. Detecting lymphedema when average excess fluid volume is reversible allows compression sleeve use to control the condition, whereas at clinically evident volumes, the lymphedema is treated with CDT and compression sleeves, with some patients using pneumatic pumps as well.

These results are robust to varying parameter values, including lower incidence of lymphedema and different resource- use patterns. Although the base-case analysis excludes any cost offsets due to improved downstream health from early detection and treatment, the model results only become more favorable if serious and costly sequelae are prevented.

Limitations

Despite robust results, this study is limited by a number of elements. Foremost is the lack of a clear natural history of lymphedema (and associated incidence) and severity at the time of detection and associated resource use (eg, sequelae). Much of the peer-reviewed epidemiological literature is based upon circumference measurements or contralateral arm volume comparisons to define degree of swelling; this can poorly represent the presence of lymphedema given natural volume/ circumference differences by arm dominance. In particular, risk-stratified incidence data are lacking. Although Herd- Smith present longitudinal data, it is not stratified by risk group, which impacts our assumptions and associated incidence rates; we applied the proportion of total cases found in the first year from Herd-Smith to both SNB and ALND when calculating 1-year values from alternate length studies. Similarly, our use of an equal incidence for BIS and CS detection is a simplification, as the literature-based incidence values reflect clinically evident disease and thus may underestimate BIS detections. Despite this assumption, base-case results remain unchanged. Using extensive sensitivity analyses, our study addresses the previously mentioned literature gaps around key parameter values to show changes to budget impact based upon this potential parameter variability.

Another limitation is noted around the lack of variability in population lymphedema characteristics, due to cohort modeling with population averages (standard modeling practice) and data limitations. In order to account for this, sensitivity analysis is applied to demonstrate the possible variation around average budget impact. A 1-year time horizon, of particular interest to payers, is utilized, though there may be additional costs or savings if BIS is continued beyond that.

Finally, there may be non-economic benefits to routine BIS testing as well,43 if patients experience a quality of life improvement or if use of compression sleeves, rather than CDT, allows patients to miss fewer days of work. Improved data around these parameters, establishing firm lymphedema definitions to clarify natural history and associated clinical assumptions, and research to verify causal relationships with downstream sequelae will allow a more detailed and longerterm picture of budget impact in the future.

Author Affiliations: From IMS Health, Inc, Health Economics and Outcomes Research (SPB, MPD, JM), Falls Church, VA.


Funding Source: ImpediMed, Inc.


Author Disclosures: Ms Bilir, Mr Dekoven, and Ms Munakata report employment with IMS Health, Inc, and report receiving payment for involvement in the preparation of this manuscript.


Authorship Information: Concept and design (SPB, MPD, JM); acquisition of data (SPB); analysis and interpretation of data (SPB, MPD, JM); drafting of the manuscript (SPB, MPD); critical revision of the manuscript for important intellectual content (SPB, JM); obtaining funding (MPD); administrative, technical, or logistic support (MPD, JM); and supervision (MPD, JM).


Address correspondence to: Sara P. Bilir, MS, Health Economics and Outcomes Research, IMS Health, 3 Lagoon Dr, Ste 230, Redwood City, CA. E-mail: pbilir@us.imshealth.com.
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