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BioTheranostics Publishes BCI Cost Study; Suggests Benefit of Optimizing Extended Hormonal Therapy

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Originally published Sept. 22.

NEW YORK (GenomeWeb) – A cost-effective analysis of BioTheranostics' Breast Cancer Index test published in the The American Journal of Managed Care shows the molecular diagnostic lowers healthcare spending in women with estrogen-receptor positive disease when used at the time of diagnosis or five years after diagnosis.

This is the first study funded by BioTheranostics that gauges the health economic impact of BCI. The gene expression test assesses a woman's risk of early breast cancer recurrence in the first five years following diagnosis, late recurrence beyond five years post-diagnosis, and overall 10-year risk.

Additionally, retrospective BCI testing of breast cancer patients who as part of a previously conducted trial received five years of the hormonal therapy letrozole after the usual tamoxifen regimen, found that more than 16 percent of patients with a high BCI score had a reduction in risk of recurrence with extended letrozole treatment, while those with a low score didn't have a statistically significant benefit. As such, BioTheranostics believes that BCI may also be used to predict whether women will benefit from five years or more of hormonal therapy.

BCI algorithmically combines molecular grade index, which factors in information about tumor grade and proliferation status, and the so-called HOXB13:IL17BR ratio, which characterizes estrogen signaling pathways. In this study, researchers led by Haythem Ali, a medical oncologist at the Henry Ford Heath System, employed an economic model where they used a hypothetical patient cohort and tracked their outcomes and associated costs in various scenarios — such as when they received adjuvant chemo, when they go on hormonal therapy, and when they experienced health complications, recurrence, or died — over a 10 year follow-up period.

The analysis found BCI test results can help doctors optimize the use of adjuvant chemotherapy at the time of diagnosis and predict benefit from additional hormonal therapy use in those who are recurrence-free after five years. Using standard clinical and pathological patient data to gauge risk of recurrence and make treatment decisions resulted in mean costs of $45,437. When BCI was used to gauge recurrence risk and guide treatment strategies, mean per-patient costs were $41,634, resulting in average savings of approximately $3,800 per patient after factoring in the cost of performing the test.

For patients tested with BCI five years after diagnosis, the base case yielded mean per-patient costs of $22,708, while with the use of BCI the cost came down to $20,904. The savings in this setting were approximately $1,800 per patient. "The cost benefit was predominantly driven by targeted use of extended hormonal therapy ($5,194 savings per patient)," the study authors wrote in the paper. The study involved other researchers from BioTheranostics and the healthcare consulting firm Health Advances.

The publication comes just a few months after Medicare contractor Palmetto GBA issued a draft local coverage determination in its North Carolina jurisdiction, extending coverage of BCI for post-menopausal women with ER-positive breast cancer completing five years of tamoxifen treatment; when the doctor or patient is concerned about toxicities related to anti-hormonal therapy; and after test results, the risk and benefits of testing and treatment guidelines are discussed with the patient. The contractor warns in the proposed LCD that BCI cannot be used by itself, and that doctors must consider patients' clinical factors when gauging their recurrence risk after five years.

Moreover, the test has not shown convincingly in studies that it can pick out low recurrence risk patients who can forgo hormone therapy completely, according to Palmetto. "A significant concern exists as to whether the assay can identify any group at such a low risk that it is safe to depart from a strong expert recommendation and safely stop therapy," the contractor states.

The National Comprehensive Cancer Network recommends that patients should be treated with adjuvant hormonal treatment with tamoxifen for five years, in addition to standard-of-care regimens, to reduce late recurrences. According to BioTheranostics, oncologists are mostly ordering BCI in the situations that Palemetto described in the LCD – when the patient approaches the five-year recurrence-free mark to figure out whether they should receive additional years of hormonal therapy, or when patients are having adverse side effects to existing therapy in the post-five year period to the extent that the physician is thinking about stopping that treatment.

BioTheranostics conducted the latest economic impact study to "alleviate concerns that BCI might be cost additive to our healthcare delivery system and confirm its cost-effectiveness," a company spokesperson told PGx Reporter last week. Additionally, the spokesperson noted that following the issuance of the draft LCD, the company has provided Palmetto information about the test that will help establish a reimbursement rate for the diagnostic. The list price of the test is around $3,000.

The spokesperson noted that the firm is building its own salesforce to reach out to oncologists and address the early stage and metastatic breast cancer markets. According to BioTheranostics, it has seen growth in first-time and repeat physician orders for BCI since the test's commercial launch in February. The company didn't provide specific numbers in this regard.

Ultimately, one of the main benefits with a next-generation breast cancer assay such as BCI is its ability to predict the likelihood that a patient will benefit from extended endocrine therapy, not just whether they are likely to benefit from adjuvant chemotherapy as first-generation breast cancer diagnostics, are able to predict, according to the study authors. The cost savings reported in the study are "primarily driven by a reduction in adjuvant chemotherapy in patients unlikely to derive benefit and an increase in extended endocrine therapy utilization in patients likely to receive substantial benefit," Ali and colleagues concluded. The study showed that with these added capabilities BCI could save an extra $2,644 per patient above the savings associated with optimizing adjuvant chemotherapy alone.

However, since predicting late recurrences in breast cancer is a valuable capability in the recurrence testing market, that is something that has gained interest among developers of first-generation assays. At ASCO, Genomic Health presented data from a study showing that the Oncotype DX breast cancer test could predict late recurrences in early stage patients, five to 15 years after receiving initial tamoxifen therapy. This suggests, "that the test results may help identify which patients have greater potential to benefit from extended hormonal therapy beyond five years," Steve Shak, Genomic Health executive VP of R&D, said during a recent earnings call. Oncotype DX is a first generation test, but it is the only test recommended in multiple treatment guidelines as a tool doctors can use to gauge recurrence risk and predict chemotherapy benefit.

A newer player in the space, NanoString Technologies, also published a study earlier this year demonstrating that the PAM50 gene signature, on which its Prosigna breast cancer prognostic is based, accurately determined the risk of late distant recurrence up to 15 years after diagnosis in postmenopausal women with estrogen receptor-positive, early stage breast cancer, regardless of nodal status. However, Prosigna isn't indicated as a test that can predict chemo benefit.

Meanwhile, there are a number of weaknesses with this economic analysis for BCI, mainly that it models hypothetical scenarios based on published literature and expert interviews rather than real world data. For example, since there is no data showing that BCI predicts whether patients will benefit from adjuvant (post-surgery) chemo, the study authors modeled data from published studies, such as one that shows BCI can predict which patients will respond to neoadjuvant (pre-surgery) chemotherapy.

"Future studies must assess the impact of the assay in collaboration with third-party payers to illustrate cost savings in a real-world setting," the study authors wrote in the paper.

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