Rebecca Burne

Dosing Patterns and Economic Burden of Palbociclib Drug Wastage in HR+/HER2− Metastatic Breast Cancer

IntroductionTargeted therapies have revolutionized the treatment of hormone receptor positive/human epidermal growth factor receptorxa02 negative (HR+/HER2−) metastatic breast cancer (mBC). However, as for many oncology drugs, the dose of targeted therapies may need to be adjusted over time, leading to drug wastage when a dose modification is needed but the dose cannot be split or saved. This has been shown to be the case for palbociclib and has led to concerns among payers. This study described palbociclib dosing patterns and estimated the economic burden of the drug wastage associated with palbociclib dose modifications in postmenopausal women with HR+/HER2− mBC.MethodsA large US claims database was used to identify postmenopausal women with HR+/HER2− mBC who received a palbociclib-based therapy during one of their first three lines of therapy for mBC between February 2015 (palbociclib approval) and December 2015. Dosing patterns (dosing modifications and sequences) were reported; a dose modification was defined as an increase/decrease of at least 25xa0mg daily compared to the preceding dose. Estimates of drug wastage costs were based on days with overlap in prescription fills for different palbociclib doses.ResultsA total of 473 postmenopausal palbociclib-treated women with HR+/HER2− mBC were included (first line 214; second line 157; third line 120). Over an average duration of line of therapy of approximately 4xa0months, dose modification was observed in 17.8%, 31.2%, and 35.0% of patients in first, second, and third line. Average overlap in prescription fills was 9.2, 9.9, and 5.4xa0days in first, second, and third line. This potential drug wastage resulted in an average cost of

Stage III melanoma incidence and impact of transitioning to the 8th AJCC staging system: a US population-based study

4376,

Healthcare resource utilization in patients with metastatic melanoma receiving first-line therapy with dabrafenib + trametinib versus nivolumab or pembrolizumab monotherapy

4740, and

Abstract 1209: Patterns of treatment with immune check point inhibitors and targeted therapy in patients with metastatic melanoma presumed BRAF V600 positive

2592 per patient in first, second, and third line.ConclusionsThis study showed that drug wastage due to palbociclib dose modification results in substantial costs. Treatment options with more flexible dosing may help reduce the costs of drug wastage.FundingNovartis Pharmaceuticals Corporation.

Abstract P5-20-15: Dosing patterns and economic burden of drug wastage among postmenopausal women with HR+/HER2- metastatic breast cancer receiving palbociclib

AIMnTo estimate incidence of stage III melanoma using the American Joint Committee on Cancer (AJCC) staging, 7th and 8th edition.nnnPATIENTS & METHODSnThe SEER US cancer registry was analyzed (2010-2014). AJCC7 stages were recorded in the data; AJCC8 stages were inferred.nnnRESULTSnOf 106,195 melanoma patients, 7669 and 7342 had stage III melanoma by AJCC7 and AJCC8, respectively (95% overlap). Nearly 30% of patients with AJCC7 stage III melanoma were reclassified in a higher stage III group by AJCC8 versus 7% in lower stage group. Regardless of the AJCC edition, incidence of stage III melanoma has increased from 2010 to 2014 both overall and within each stage III group.nnnCONCLUSIONnProviding appropriate management to this growing population of high-risk patients is a priority.

Economic Burden of HR+/HER2- Metastatic Breast Cancer Among Adult Premenopausal Women

Abstract Objective: To compare healthcare resource utilization (HRU) between patients with metastatic melanoma (MM) initiated on first-line (1L) combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib (Du2009+u2009T; oral) and those initiated on 1u2009L monotherapy with the anti-PD1 monoclonal antibodies nivolumab or pembrolizumab (N/P; intravenous). Methods: Patients with melanoma initiated on Du2009+u2009T or N/P from Q1/2014 to Q2/2016 (defined as 1u2009L treatment for MM) were identified in the Truven MarketScan database. Entropy balancing was used to reweight the N/P cohort in order to make it comparable to the Du2009+u2009T cohort with respect to the mean and variance of baseline covariates. HRU outcomes during 1u2009L therapy, reported per patient-year (PPY), were described and compared between the two cohorts post-weighting (i.e. independently of baseline covariates). Results: Of the 445 patients included, 202 and 243 were initiated on Du2009+u2009T and N/P, respectively. After weighting, patients initiated on N/P had more outpatient visits for drug administration during 1u2009L therapy than those initiated on Du2009+u2009T (differenceu2009=u200918.6 visits PPY [95% CIu2009=u200916.0–21.1]). Patients initiated on N/P also had more outpatient office visits for reasons other than drug administration (differenceu2009=u20098.1 visits PPY [95% CIu2009=u20091.9–13.7]). No significant differences were observed for other HRU parameters (i.e. inpatient admissions, inpatient days, and emergency department visits during 1u2009L therapy). Conclusions: HRU during 1u2009L therapy was generally similar between patients initiated on Du2009+u2009T and N/P. Nonetheless, patients initiated on N/P had more outpatient visits, including more outpatient visits for reasons unrelated to drug administration.

Treatment and Monitoring Patterns Among Premenopausal Women with HR+/HER2− Advanced Breast Cancer

Background: Immune check point inhibitors (I-O) and targeted therapies (TT) have changed the treatment landscape for patients with metastatic melanoma (MM), particularly for patients with BRAFV600 (BRAF) mutation who are eligible for both types of treatment after a diagnosis of MM. The aim of the current study was to describe patterns of treatment with I-O and TT in first line (1L) and subsequent lines of therapy for MM in a sample of patients presumed BRAF positive. Methods: Adults with MM initiated on I-O (ipilimumab, pembrolizumab, nivolumab) and TT (vemurafenib, dabrafenib, trametinib) therapies in 1L were identified in Symphony Health Solutions9 Integrated Dataverse (Q1/2014 - Q1/2017; n = 4,196), the largest pharmacy database in the US. Lines of pharmacological therapy were investigated from the first I-O/TT (index date) until the end of the observation period using an algorithm that relies on prescription/administration dates, days of supply and periods without any therapies. Patients were presumed BRAF positive if they received TT in at least one line of MM therapy. All patients in this analysis were required to have ≥ 2 lines of therapy for MM. Results: Of 366 presumed BRAF patients in the study sample, 110 (30%) and 256 (70%) were initiated on I-O and TT in 1L, respectively. The table below presents treatment patterns in 1L, 2L, and 3L for MM. The distribution of I-O vs TT was 30% vs. 70% in 1L, 25% vs. 57% in 2L, and 41% vs. 39% in 3L (table). Conclusions: This real-world data study showed dabrafenib+trametinib was the most common treatment for patients with MM presumed BRAF positive, even in the era of I-O availability. During the study period (years 2014-2017), ipilimumab continued to be the most common I-O therapy used in 1L and 2L among presumed BRAF patients. Citation Format: Sameer Ghate, Antonio Nakasato, Raluca Ionescu-Ittu, Sherry Shi, Briana Ndife, Rebecca Burne, Francois Laliberte, Mei Sheng Duh. Patterns of treatment with immune check point inhibitors and targeted therapy in patients with metastatic melanoma presumed BRAF V600 positive [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 1209.

Postsurgical treatment landscape and economic burden of locoregional and distant recurrence in patients with operable nonmetastatic melanoma

Background: Dose modification related to adverse event is common in the treatment of metastatic breast cancer (mBC). Based on the dosage form and strengths available, dose modification may lead to drug wastage when the dose cannot be split or saved for later use. This study aimed to describe dosing patterns and to estimate the economic burden of drug wastage associated with dose modifications in postmenopausal women with HR+/HER2- mBC receiving palbociclib. Methods: Postmenopausal adult women diagnosed with HR+/HER2- mBC were identified from the Truven administrative claims database (2006Q1–2015Q4). Regimens received following mBC diagnosis were identified – patients who received a palbociclib-based regimen during one of their first three lines of therapy for mBC were included in the study. Palbociclib starting daily dose, average daily dose, and dosing patterns (dosing modifications and sequences) were reported. A dose modification was defined as a change (decrease/increase) of ≥25mg daily compared to the preceding dose. The economic burden of drug wastage was estimated by multiplying the number of days with drug wastage (i.e., days with overlapping palbociclib prescriptions due to dosage change) by the average cost reimbursed by payers for one unit of palbociclib. Descriptive analyses were conducted separately by line of therapy for mBC. Results: A total of 473 patients received palbociclib in first (214), second (157), or third (120) line of therapy for mBC. Patients were observed to receive palbociclib for an average of 4.3 months in first line and 4.1 months in second and third line of therapy. The majority of patients started palbociclib on the recommended 125 mg dose and remained on that dose until the end of observation. Dosing patterns and sequences are summarized in Table 1. Among the 214 patients who used palbociclib in first line, 38 (17.8%) had a dose modification – among these, 6 (15.8%) patients had an overlap in prescription fills (average overlap of 9.2 days). This potential drug wastage resulted in an average cost of

Patterns of treatment and BRAF testing with immune checkpoint inhibitors and targeted therapy in patients with metastatic melanoma presumed to be BRAF positive

4,376 per patient over a period of approximately 4 months following treatment initiation. Results were consistent in second and third lines of therapy, with higher proportions of patients with drug wastage in later lines of therapy. Conclusion: Over a short observation period, dose modifications, mostly dose reductions, were relatively frequent, and potential resulting drug wastage was associated with a substantial economic burden. Citation Format: Dalal AA, Gagnon-Sanschagrin P, Burne R, Guerin A, Gauthier G, Small T, Niravath P. Dosing patterns and economic burden of drug wastage among postmenopausal women with HR+/HER2- metastatic breast cancer receiving palbociclib [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-20-15.

Time to first-line (1L) therapy discontinuation in metastatic melanoma (MM).

IntroductionPremenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) have complex treatment needs and may receive sequential combinations of endocrine therapy (ET) or chemotherapy. This study describes healthcare utilization (HRU) and costs among premenopausal women with HR+/HER2- mBC in real-world settings from a payer’s perspective.MethodsIn this retrospective cohort study, premenopausal women with HR+/HER2- mBC who received ET or chemotherapy were identified from the Truven Health Analytics MarketScan database (1 January 2006–31 December 2015). The main HRU outcomes per patient per 6xa0months (PPP6xa0M) were measured during each line of therapy and included number of days in inpatient (IP) and outpatient (OP) services. Healthcare costs per patient per month (PPPM) included medical and pharmacy costs.ResultsA total of 3203 patients received first-line, 2194 received second-line, and 1242 received third-line therapy for mBC. Mean number of IP days PPP6xa0M were 1.6, 1.3, and 1.5xa0days in the first, second, and third lines, respectively. Mean number of days with OP services PPP6xa0M was 31.4, 30.9, and 23.3 in the first, second, and third lines, respectively. Among patients receiving ET, mean total healthcare costs were