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INTRODUCTION An increasing body of evidence demonstrates that the COVID-19 pandemic of 2020 saw large reductions in the number of US patients being diagnosed with a variety of conditions, including cancer. A previous real world evidence study based upon analysis of CMS claims data showed a large drop in cancer diagnoses across multiple solid tumor diseases and evidence suggesting changes in testing behaviors for these patients over the period of maximal lockdown measures to mitigate spread of infection. Further, the drop in patient numbers had not returned to normal once these measures were relaxed by the end of June. Therefore, we decided to examine CMS data for the entire year of 2020 and focus on a single sub-group in breast cancer, TNBC. These patients have poor prognosis and are relatively intensively managed;it was reasoned that changes in management, especially testing behavior, might be more apparent in this group than in breast cancer patients as a whole. METHODS CMS data for 2019-20 were queried using a proprietary business rule for identifying TNBC cases and then subdivided into 2 groups: those who received a treatment under a "J" HCPCS code and those who had not. Office visits, Level IV surgical pathology (SP) and immunohistochemistry (IHC) were defined by appropriate HCPCS codes. Since all PD-L1 testing is covered by HCPCS code 88360, a claim for 88360 was considered indicative of a PD-L1 test. A decrease in the number of patients during the COVID-19 pandemic Swas defined as a ≥ 10% drop for the value in a given month in 2020 compared to the same month in 2019, as a percentage of the 2019 median value. This is termed the "COVID-Dip". RESULTS Data were gathered from a total of 68, 018 patients, 8, 131 with a J code treatment and 59, 887 without. Results of COVID dip analysis are presented in Table 1. Trastuzumab administration showed an overall decline across the entire study period. While IHC for 88360 showed a COVID dip, administration of atezolizumab and pembrolizumab increased across the study period with administration of nivolumab (collectively immuno-oncology, IO, drugs) remaining relatively constant. 47% of patients receiving IO therapy received a presumed PD-L1 test. There was longitudinal variation in the use of chemotherapy agents but no apparent COVID dip in their use. DISCUSSION There were declines both in patient presentation to doctors' offices, as well as diagnostic testing among TNBC patients during the COVID-19 pandemic of 2020 with differences between those receiving chemotherapy under J codes and those not. There was no evidence of decline in use of chemotherapy under J codes. Increased IO use but declines in IHC testing suggest a greater use of off-label prescribing of these drugs during the pandemic. The decline in presentation to doctors' offices and in testing of patients not receiving J code drugs suggests that these patients may experience significant delays in management of their condition with concomitant increases in morbidity and mortality.
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Introduction Measures taken to mitigate infection spread during the 2020 COVID-19 pandemic are considered to have caused significant unintended consequences on other diseases. Large decreases in the numbers of symptomatic and asymptomatic people presenting for diagnosis of heart disease, diabetes and cancer have been observed. A recent analysis of solid tumors showed up to 70% reduction in the number of patients presenting for diagnosis. The potential exists for significantly increased morbidity and mortality for these missed or delayed presenting patients. Further, it is important to determine whether infection spread mitigation measures affected the diagnostic testing and treatment decisions for these patients. This study aimed to determine whether pandemic control measures affected presentation, testing and treatment of patients across eight different hematologic cancers. Methods CMS claims data were analyzed for the presence of diagnostic (DX) ICD 10 codes indicative of hematologic cancer. Patients with a DX code first appearing in 2019 or in 2020 were selected to provide newly diagnosed pre-COVID-19 and during COVID-19 cohorts for comparison, with unique patient counts being calculated for each month. A “COVID-19 dip” i.e. a decrease in the number of patients was calculated as the change in number of patients diagnosed in a given month relative to the number for JAN2020. Dip duration was calculated only when the decrease was >10% of the JAN2020 figure. Patients who received treatment via a “J” code Healthcare Common Procedure Coding System (HCPCS) code were extracted from the cohorts and the time taken from initial diagnosis to first treatment calculated. Results Eight hematologic cancers: AML, CLL, CML, HEME (a group of different hematologic cancers), Hodgkins (HOG), Myelodysplasia (MDS), Non-Follicular Lymphomas (NFL), and Non-Hodgkins Lymphoma (NHL) showed a decrease in the number of patients being diagnosed during the early part of 2020 (Fig.1) Fig.1. Change in new patient diagnoses for selected hematologic cancers as a proportion of their JAN2020 value There was some variation in the depth and duration of the COVID-19 dip (Table 1) with MDS having both the longest and deepest dip. Median depth and duration of the dip was 33% and 3.5 months, respectively, with all dips starting either in FEB or MAR2020. Table 1. Duration and depth of COVID-19 dips for selected hematological cancers The proportions of patients receiving therapy via J HCPCS code (JRX) are shown in Table 2 Table 2. Proportions of patients receiving J code therapy Conclusions The decline in new patient diagnoses for heme cancers during the period when COVID-19 control measures were implemented is similar to that seen with solid tumors, although the depth of the COVID-19 dip was generally larger in the latter. There is no evidence of “catch up” diagnosis occurring i.e. patients missing from Q2 2020 are not reappearing en masse in subsequent quarters. The decline for MDS patients has, except for SEP to OCT2020, remained. Collectively, (depending on the calculation method), the COVID-19 dip for these eight heme cancers represents 16,584-33,671 patients who will likely have significantly increased rates of morbidity and mortality due to delayed diagnosis. Analysis of J code treatments show little difference between the proportions of patients receiving these treatments in 2020 compared to 2019 suggesting that at least some aspects of treatment e.g. infused chemotherapy, IO drugs for these patients was relatively unchanged by pandemic control measures. It also suggests that the main cause for decreased patient numbers treated is due to decreased testing for diagnosis, rather than not being treated once diagnosed. This aligns with findings from studies in the US and UK. The results of this study indicate that there may be a “backlog” of tens of thousands of people with cancer whose diagnosis has been significantly delayed and who urgently need to be identified in order to get on proper treatment to lessen the impact of that delay. [F rmula presented] Disclosures: No relevant conflicts of interest to declare.
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Introduction: Various rare driver genomic variants have been investigated in metastatic non-squamous non-small cell lung cancer (mNSCLC). Individually they are considered rare (<3% prevalence), however, studies have shown collectively they represent up to 14.5% of the mNSCLC mutation profile. While multiple targeted therapies for rare variants such as NTRK fusions, MET exon14 skipping and RET fusions have been approved in the US for 1st line therapy in mNSCLC, other variants such as HER2 exon20ins, EGFR exon20ins, and FGFR-alterations are also gaining traction. This ever-growing number of actionable biomarkers is driving the need to use multi-gene testing such as NGS to ensure that actionable variants are tested prior to 1st line treatment. Here, we assessed US laboratory real-world NGS testing adoption and readiness that enables comprehensive genomic testing required to identify mNSCLC patients harboring any of these emerging actionable biomarkers. Methods: US NGS testing landscape in mNSCLC was assessed utilizing our Diagnostic Network for Precision Medicine (DXRX) data solution. Real-world data from 186,971 patients diagnosed with mNSCLC from Q12019 through Q32020 was used to calculate the NGS testing rate for these patients. NGS testing readiness and adoption for the top 25 US laboratories representing 70% of the overall US mNSCLC patient testing volume in 2019 was also assessed. Results: Overall, NGS testing rates in mNSCLC in the US dropped slightly from 58% in 2019, to an average of 53% in 2020 despite new targeted therapy approvals and changes in recommendations as described in ASCO/CAP and NCCN guidelines supporting NGS testing for mNSCLC patients. 84% of the top 25 labs offer in-house NGS testing for mNSCLC, accounting for 64% of the NSCLC testing volume. 55% offer NGS testing capable of identifying common and rare mutations such as HER2 ex20ins and EGFRex20ins. Additionally, 79% of these labs also offer RNA-based NGS panels, more suitable for detecting any fusions involving FGFR and NTRK genes. 24% of these NGS testing labs can test liquid biopsy samples, useful for tissue limited scenarios. Conclusion: Non-pharmaceutical interventions such as lockdowns to limit spread of COVID-19 infection are likely linked to the drop in testing rate observed in 2020 versus 2019. NGS is the desirable method that enables simultaneous, comprehensive testing to identify any actionable driver genomic variants present. However, adoption of NGS is still limited and highly centralized in the US. Today, only a small number of top labs can identify patients harboring any of this new wave of biomarkers for appropriate management. Barriers to NGS testing readiness and/or adoption include low demand due to lack of physician awareness and entrenched testing practices and conditions favoring sequential, single biomarker testing such as lab logistics, cost and reimbursement factors. Increasing awareness of clinical utility for broader genomic testing, which includes increasing involvement and effective use of tumor boards inclusive of pathologists to manage all mNSCLC patients will help establish the need and drive for use of NGS to ensure patients harboring common or rare actionable variants are identified. Keywords: Next Generation Sequencing, precision medicine, rare mutation
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Background: The COVID-19 pandemic has caused >400,000 infection related deaths in the US to January 2021. Actions taken to limit COVID-19 infection and mortality could potentially lead to unintended consequences, precipitating excess mortality due to other causes. One such cause is delayed cancer diagnosis. Significant decreases in presentation for cancer diagnosis at the primary care level have been noted in the UK. This study aimed to look for evidence of a similar effect in the US. Methods: CMS claims data from JAN18-JUN20 associated with primary diagnosis across 11 cancers (bladder, breast, cervical, colorectal, endometrial, lung, ovarian, pancreatic, prostate, sarcoma and thyroid) were analyzed for use of surgical pathology (SP), a procedure associated with initial diagnosis, and immunohistochemistry (IHC). Test volumes varied widely by test and cancer so were normalized to enable comparison across indications. This was done by dividing the month-on-month difference for the period JAN19-JUN19 vs JAN20-JUN20 by the median monthly test volume for the period JAN18-DEC19 (“pre-COVID period”). Extent and duration of declines in test rates and number of missing patients as the sum of these declines were then determined. The ratio of IHC to SP testing was taken to determine any decline in likely post-initial diagnosis testing. Results: There were significant (>10%) declines in test volumes for SP for all 11 cancers at some time in Q1- Q2 2020. Table. Extent, duration and return to preCOVID levels for SP testing across 11 cancers Median extent and duration of the decline was 56% (range 41.1%-80.4%) and 2 months (range 1- >4). This equates to 32,192 missing diagnoses across all cancers. SP test volumes for all cancers except lung and breast had returned to around pre-COVID levels by JUN20. There was no significant (>10%) increase in normalized SP test volume after the COVID dip for any cancer. While SP showed decreased test volumes across all cancers at some point during the first half of 2020, test volume ratios of IHC to SP showed increases for most cancers in the same time period. Conclusions: These data highlight that the decline in patients presenting to their primary care physicians with suspicion of cancer for diagnostic investigation was linked to COVID-19 prevention strategies. No evidence for increased, “catch up” testing to address presentational/diagnostic backlog was observed. Thus, it is predicted that these patients may subsequently present with a more advanced cancer. Potential excess morbidity, mortality and cost associated with absent or delayed diagnosis should be factored into cancer control programs going forward. (Table Presented).