AmerisourceBergen (United States)

58 Background: The introduction of biosimilar colony-stimulating factors has led to the reduction in prices for these historically expensive therapies. To understand the impact of recent pricing trends on delivering efficient care, the cost-effectiveness of primary prophylaxis (PP) versus secondary prophylaxis (SP) using pegfilgrastim was assessed in patients with breast cancer, non–small-cell lung cancer (NSCLC), and non-Hodgkin lymphoma (NHL) receiving potentially curative chemotherapy at intermediate risk for febrile neutropenia per NCCN guidelines. Methods: A Markov decision analytic model was constructed from the US payer perspective over a lifetime horizon to evaluate pegfilgrastim PP versus SP in patients with breast cancer, NSCLC, and NHL receiving curative chemotherapy at intermediate risk of FN. Modeled chemotherapy regimens were adjuvant docetaxel (breast cancer), adjuvant carboplatin/paclitaxel (NSCLC), and R-CHOP (NHL) representing baseline FN risk of 16%, 18%, and 18%, respectively. Historical average sales prices (ASP) according to the Centers for Medicare and Medicaid Services of all pegfilgrastim products were obtained from January 2017 to April 2021. When more than one pegfilgrastim product was available, the average ASP was used as the cost input for the model. Cost-effectiveness for the base case scenario of each cancer type was evaluated over the range of years for cost per quality-adjusted life year (QALY) gained. Results: Pegfilgrastim as PP vs. SP provided an additional 0.069, 0.112, and 0.166 QALYs for breast cancer, NSCLC, and NHL, respectively. The peak ASP for pegfilgrastim was $4,554 per 6 mg during July 2018. Afterwards, a linear regression observed a declining ASP of approximately $134 dollars every 3 months to $3,024 per 6 mg during April 2021. At peak ASP, the incremental cost-effectiveness ratios (ICERs) for pegfilgrastim PP in patients with breast cancer, NSCLC, and NHL were $200,320, $113,942, and $103,495 per QALY, respectively. For April 2021, the ICERs were $124,845, $67,294, and $57,269 per QALY, respectively (Table). Conclusions: The trend of decreasing pegfilgrastim ASP improved the cost-effectiveness of PP vs. SP across intermediate risk breast cancer, NHL, and NSCLC indications between July 2018 to April 2021. For the most recent ASP, PP was cost-effective at a willingness-to-pay threshold of $100,000/QALY for NSCLC and NHL, and $150,000/QALY for breast cancer. This analysis provides support to expand the use of growth factor PP to intermediate risk patients. [Table: see text]

PURPOSE:Temporary COVID-19 guideline recommendations have recently been issued to expand the use of colony-stimulating factors in patients with cancer with intermediate to high risk for febrile neutropenia (FN). We evaluated the cost-effectiveness of primary prophylaxis (PP) with biosimilar filgrastim-sndz in patients with intermediate risk of FN compared with secondary prophylaxis (SP) over three different cancer types.METHODS:A Markov decision analytic model was constructed from the US payer perspective over a lifetime horizon to evaluate PP versus SP in patients with breast cancer, non–small-cell lung cancer (NSCLC), and non-Hodgkin lymphoma (NHL). Cost-effectiveness was evaluated over a range of willingness-to-pay thresholds for incremental cost per FN avoided, life year gained, and quality-adjusted life year (QALY) gained. Sensitivity analyses evaluated uncertainty.RESULTS:Compared with SP, PP provided an additional 0.102-0.144 LYs and 0.065-0.130 QALYs. The incremental cost-effectiveness ranged from $5,660 in US dollars (USD) to $20,806 USD per FN event avoided, $5,123 to $31,077 USD per life year gained, and $7,213 to $35,563 USD per QALY gained. Over 1,000 iterations, there were 73.6%, 99.4%, and 91.8% probabilities that PP was cost-effective at a willingness to pay of $50,000 USD per QALY gained for breast cancer, NSCLC, and NHL, respectively.CONCLUSION:PP with a biosimilar filgrastim (specifically filgrastim-sndz) is cost-effective in patients with intermediate risk for FN receiving curative chemotherapy regimens for breast cancer, NSCLC, and NHL. Expanding the use of colony-stimulating factors for patients may be valuable in reducing unnecessary health care visits for patients with cancer at risk of complications because of COVID-19 and should be considered for the indefinite future.

Melanoma and non-melanoma cutaneous malignancies are some of the leading causes of cancer-related death in the United States. Though melanoma is more known to have a high mortality rate, the total mortality per year is nearly equal for between melanoma and non-melanoma skin cancer. Moreover, the non-melanoma types of cutaneous malignancies have potential to become locally invasive and even metastasize with very little to no treatment options when advanced. The development of these malignancies involves various genetic pathways through the four hallmarks of cancer development: malignant cell growth, apoptosis evasion, the use of supporting stroma and vascularization, and modulating and promoting an inadequate immune response. The genetic signaling pathways of basal cell carcinoma, squamous cell carcinoma, verrucous carcinoma, basosquamous cell carcinoma, melanoma, and cutaneous T-cell lymphoma interact with each other through genetic predisposition as well as with environmental exposures. Furthermore, solar ultraviolet radiation and chronic inflammatory states are found to initiate the progression of many of these cutaneous malignancies. This paper includes validated models of genetic pathways, emerging pathways, and crosstalk between genetic pathways through the four hallmarks of cancer development. Moreover, unlike most reviews addressing oncogenetics of the well-recognized, as well as newly discovered, genetic pathway mutations, this review stresses that these pathways are not fixed but rather exist in dynamic, interrelated, interactive, complex, and adaptive flux states.

e21671 Background: Treating recurrences of non-small cell lung cancer (NSCLC) is increasingly expensive but still rarely curative. Disease free survival (DFS) among resected stage I-IIA patients remains only 50-70%. Guidelines advocate adjuvant therapy in “high-risk” patients in this population to reduce these costly and deadly recurrences, but recognize that conventional criteria have not been validated to stratify risk or predict benefit. A CLIA-certified, commercially available 14-gene expression risk profile (DetermaRx) has been extensively validated among stage I-IIA non-squamous NSCLC patients; prospective data now suggest that the test predicts improved DFS with adjuvant therapy. We therefore studied the potential economic impact of this molecular test on early stage NSCLC. Methods: Model variables included: relative increase in DFS with adjuvant treatment of molecular intermediate- and high-risk patients (25.5%; range 12.3-41.3%); cost of adjuvant ($8,760; $8,144-$9,376) or late-stage ($284,500; $224,900-345,200) treatment; and compliance with recommendations for adjuvant therapy (75%; 60-90%). Ranges were based on: historical trials and recent prospective data, published cost literature, and published survey data, respectively. Parameters were varied in a multifactorial, one-way sensitivity analysis to assess the impact of parameter uncertainty. Results: Reduction of recurrences with implementation of the 14-gene assay resulted in an average cost savings of $11,608/patient (potential systems savings of ~$450 million), even when including the cost of molecular risk stratification ($4000/patient) and of cisplatin-based adjuvant chemotherapy for molecular high- and intermediate-risk patients. Lower bound assumptions for relative improvement, cost of care, and compliance yielded persistent savings of $3,699, $8,091 and $8,486, respectively. Conclusions: Utilization of this predictive molecular risk stratification assay in the management of stage I-IIA non-squamous NSCLC has the potential to significantly reduce lung cancer costs in an era of targeted therapy and immunotherapy, while at the same time improving DFS and saving lives.

Following publication of the original article [1], the authors reported that one of the numbers within Fig. 6 contains a mistake.

13 Background: This study evaluated the shift in treatment patterns in Stage IV NSCLC following the approval of immune-oncology (IO) agents in the US. Methods: A retrospective cohort study was performed using structured data from a US community-based oncology electronic medical record (EMR) database for care received from Jan 2015-May 2018. The study sample included patients with Stage IV NSCLC, ≥18 years of age initiating first-line (1L) treatment with chemotherapy (chemo) or IO agents and classified into 3 groups: chemo alone, IO alone, or chemo+IO. Treatment patterns in 1L and treatment switch patterns in second-line (2L) are reported. A sub-group analysis of patients initiating 1L therapy during the last 6 months of the study period (Dec 2017-May 2018) was conducted to explore changes in 1L treatment patterns in the post-IO approval setting. Chart reviews were done for a subset of patients initiating 1L from Jan 2017-May 2018 to extract information on programmed cell death ligand 1 (PD-L1) testing and evaluate the association of PD-L1 expression levels with receipt of IO therapy. Results: Between Jan 2015-May 2018, 1,969 patients received 1L therapy with a chemo or IO agent. Mean age (SD) was 69.0 (10.1) years, with 44.7% female. The majority of patients (79%, n = 1570) initiated 1L therapy with chemo alone and 21% initiated IO (alone [14%, n = 271] or in combination with chemo [7%, n = 128]). Of 1L patients, 41% (n = 809) were treated with 2L therapy. Of the 1L chemo alone group, 37% (n = 580) received IO in 2L. The use of IO agents in 1L increased from 21% to 48% (n = 147) in the sub-group analysis of 305 patients initiating therapy Dec 2017-May 2018. In the subset of 62 patients whose charts were reviewed, 87% (n = 54) had their tumor tested for PD-L1, of which 37% (n = 20) had high (≥50%) expression values. The majority of high-PD-L1 patients were treated in 1L with IO alone (80%, n = 16), followed by chemo+IO (15%; n = 3), and only 5% (n = 1) received chemo alone. Conclusions: Initially, IO was used as 2L treatment for Stage IV NSCLC, but IO use shifted to 1L setting in the US by the end of 2017. The use of IO therapy alone or with chemotherapy in 1L was more likely in patients with ≥50% PD-L1 expression level.