Gregory Smith

New Anticancer Drugs Associated With Large Increases In Costs And Life Expectancy

Spending on anticancer drugs has risen rapidly over the past two decades. A key policy question is whether new anticancer drugs offer value, given their high cost. Using data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we assessed the value of new cancer treatments in routine clinical practice for patients with metastatic breast, lung, or kidney cancer or chronic myeloid leukemia in the periods 1996-2000 and 2007-11. We found that there were large increases in medical costs, but also large gains in life expectancy. For example, among patients with breast cancer who received physician-administered drugs, lifetime costs-including costs for outpatient and inpatient care-increased by

Clinical and economic outcomes by first-line treatment among women with HR+/HER2– metastatic breast cancer in a large US health plan database

72,000 and life expectancy increased by thirteen months. Changes in life expectancy and costs were much smaller among patients who did not receive these drugs.

Abstract P3-07-23: Patient characteristics, clinical and economic outcomes of women with first-line therapy for HR+/HER2- metastatic breast cancer in a large US managed care health plan: Chemotherapy first vs. no chemotherapy first

Abstract Background: Guidelines recommend that women with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (mBC) initiate hormonal therapy before chemotherapy. This study compared outcomes of women with mBC who received chemotherapy first vs hormonal therapy. Methods: A retrospective cohort study of women with mBC was conducted using a large US commercial health plan database between January 1, 2008–April 30, 2013. Subjects had evidence of a HR+/HER2– tumor sub-type in a cancer registry and use of chemotherapy or hormonal therapy in claims. Subjects were continuously enrolled for ≥6 months after metastasis and assigned to cohorts for receiving chemotherapy only or hormonal therapy only during first-line (CT-1L vs HT-1L). Adjusted incidence rates of clinically significant events were compared using a negative binomial model, and adjusted healthcare costs were compared using a generalized linear model. Results: Three hundred and twenty-four women with HR+/HER2– mBC met the selection criteria; 179 (55%) received CT-1L and 145 (45%) received HT-1L. Mortality rates did not differ between cohorts (unadjusted incidence rate ratio (IRR) = 1.67, 95% CI = 0.82–3.46; adjusted IRR = 0.64, 95% CI = 0.32–1.27). Adjusted average total all-cause healthcare costs were

Abstract P3-07-24: Clinical characteristics and treatment utilization by tumor subtype among metastatic breast cancer patients in a large US managed care health plan

11 090 for women with CT-1L and

First-, second- and third-line lung cancer treatment patterns and associated costs in a US healthcare claims database

6743 for women with HT-1L (cost ratio =1.64, 95% CI =1.36–1.99). Conclusions: Observed use of first-line chemotherapy (>50%) was higher than expected given the HR + molecular profile of the tumors. Chemotherapy use during first-line did not appear to be associated with a survival benefit, but was associated with significantly higher costs compared with the use of hormonal therapy during first-line; however, this comparison is limited by demographic and baseline characteristic differences between the two cohorts. This study contributes to understanding real-world treatment patterns and the associated clinical and economic outcomes of using chemotherapy vs hormonal therapy as a first-line treatment option for the HR+/HER2– mBC population.

The Value of New Anticancer Drugs

BACKGROUND: NCCN guidelines clearly identify when chemotherapy may be an appropriate therapeutic approach for metastatic breast cancer (mBC). This study compared patient characteristics, mortality rates, and health care costs by initial chemotherapy (CT) use among women with HR+/HER2- mBC. METHODS: A retrospective cohort study design was used to analyze administrative claims data linked to clinical information for commercial health plan enrollees with evidence of mBC between 1/2008 and 4/2013. Clinical status at diagnosis was obtained from physician reports, including date of diagnosis, hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status. Women with known HR+/HER2- subtype and diagnosed initially with Stage IV or Stages I-III with evidence of progression later to metastatic disease were evaluated for at least 6 months after their Stage IV diagnosis or first metastatic claim, or until death if sooner. Clinical characteristics were compared descriptively between women who initiated therapy with/without chemotherapy (CT 1st vs. no CT 1st, respectively) using t-test for continuous and chi-square test for categorical variables. Mortality was compared using the incidence rate ratio (IRR) and 95% confidence interval (CI) from a negative binomial distribution. Total average per-member-per-month (PMPM) health care costs were compared using a generalized linear model. Both the mortality rates and costs were adjusted for age, geographic region, stage at diagnosis, initial metastatic site(s), and initial use of CT. RESULTS: Of 349 women with HR+/HER2- mBC, 204 (58%) had CT 1st and 145 (42%) had no CT 1st. Median follow-up was 17 months, and median length of the first-line of therapy (1st LOT) was 4 months (including censored LOTs). The mean age of women with CT 1st was slightly lower than those without CT 1st (52 vs. 55 years, p CONCLUSION: In this study of commercially insured women with HR+/HER2- mBC, use of CT 1st (>50%) was higher than expected. While there were minor cohort differences in patient characteristics, CT 1st does not appear to be associated with a survival benefit, but was associated with significantly higher costs when compared to no CT 1st. Additional research is needed to determine subset(s) of mBC women with CT 1st likely to benefit from initial HT. Citation Format: Tanya Burton, Stacey DaCosta Byfield, Ying Fan, Yiyu Fang, Feng Cao, Gregory L Smith, Giovanni Zanotti, Timothy J Bell, Julia J Perkins, Ruslan Horblyuk, April Teitlebaum. Patient characteristics, clinical and economic outcomes of women with first-line therapy for HR+/HER2- metastatic breast cancer in a large US managed care health plan: Chemotherapy first vs. no chemotherapy first [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-07-23.

PCN50 First and Second Line Lung Cancer Treatment Utilization Patterns and associated Costs in A United States Health Care Claims Database

BACKGROUND: Breast cancer is the second most common cause of cancer death among US women. Molecular profiling of breast cancer tumors is important for assessing prognosis and optimizing treatment. This study compared clinical characteristics and treatment utilization by tumor subtype among women with metastatic breast cancer (mBC). METHODS: A retrospective cohort study design was used to analyze administrative claims data linked to clinical information for commercial health plan enrollees with evidence of mBC between 1/2008 and 4/2013. Clinical status at diagnosis was obtained from physician reports, including date of diagnosis, hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status. Women with known HR/HER2 subtypes and diagnosed initially with Stage IV or Stages I-III with evidence of progression later to metastatic disease were evaluated for at least 6 months after their Stage IV diagnosis or first metastatic claim, or until death if sooner. Lines of therapy (LOTs) were identified based on the timing of claims for NCCN-recommended chemotherapy (CT), hormonal therapy (HT), and biologics (BIO). Clinical characteristics and treatments were compared descriptively across the HR/HER2 subtypes using t-test for continuous and chi-square test for categorical variables. RESULTS: Table 1 presents study results by tumor subtype. There were 657 women identified (72% HR+ and 28% HR-). Median age was 53 years, and median follow-up was 16 months. Overall, 93% initiated therapy; of which, 48% started a 2nd LOT, 4% died, 28% discontinued or had a ≥90-day gap in therapy, and 20% had their 1st LOT censored due to disenrollment or end of study (EOS) period. More than half received CT during the 1st LOT, regardless of tumor subtype. Less than half of HR+ women initiated HT, and among HER2+ patients, most initiated a BIO agent. CONCLUSION: In this study of commercially insured mBC women, initial therapy choices were generally consistent with NCCN guidelines for three of the four subtypes, while the largest subtype of HR+/HER2- women had a higher than expected utilization of CT. Future analyses of study data will investigate appropriateness of these initial treatments and their impact on clinical and economic outcomes. Citation Format: Tanya Burton, Stacey DaCosta Byfield, Ying Fan, Yiyu Fang, Feng Cao, Gregory L Smith, Giovanni Zanotti, Timothy J Bell, Julia J Perkins, Ruslan Horblyuk, April Teitlebaum. Clinical characteristics and treatment utilization by tumor subtype among metastatic breast cancer patients in a large US managed care health plan [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-07-24.