Financial conflicts of interest among the National Comprehensive Cancer Network (NCCN) Clinical Practice Guideline (CPG) Panelists in 2019.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 15-15
Author(s):  
Aakash Desai ◽  
Madhuri Chengappa ◽  
Ronald S. Go ◽  
Thejaswi Poonacha
Keyword(s):  
Expert Witness ◽  
Conflicts Of Interest ◽  
Standard Of Care ◽  
Nccn Guidelines ◽  
Non Hodgkin Lymphoma ◽  
Advisory Boards ◽  
The Us ◽  
Financial Conflicts Of Interest ◽  
Cancer Network ◽  
The Impact

15 Background: CPG are evidence-based guidelines, which serve as a standard of care in practice, quality improvement, and reimbursement. The extent of financial conflicts of Interest (FCOI) in NCCN guidelines has not been recently evaluated. Our study evaluated the extent of FCOI in the NCCN CPG among the 10 most common malignancies in the US. Methods: We examined the latest 2019 version of the NCCN CPG for the 10 most common cancers by incidence in the US. Using disclosure lists, we catalogued the FCOIs for the panelists under various categories outlined in the CPG. We also tabulated the companies/institutions involved in each disclosure. An “episode” describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. “Affiliation” describes a commercial, industry, or institute affiliation reported by a panelist in each episode. Results: Of the 491 panelists on the CPG, 483 (98.3%) completed FCOI disclosures. 224 (46.38%) reported at least 1 FCOI. A total of 1,103 episodes were disclosed with an average of 4.9 episodes per panelist with FCOI. Being a part of scientific advisory boards, consultant, or expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1,103 episodes of FCOI. The top companies were Bristol Myers Squibb, Merck, Genentech and AstraZeneca. Among the top 10 cancers, the prevalence of FCOI were lung (56%), bladder (52%), pancreatic (52%), non-Hodgkin lymphoma (50%), kidney (49%), colorectal (43%), breast (42%), melanoma (40%), prostate (38%), and uterine (32%). Among the panelists with FCOI, 26%, 17%, and 57% reported 1, 2, and > 3 episodes, respectively. There were 127 episodes among the CPG chairs/vice chairs who reported FCOI (mean 6.4). The chairs/vice chairs of uterine, pancreatic, melanoma, and prostate cancer CPG did not have any FCOI. Conclusions: FCOI are very prevalent among the top 10 NCCN CPG panelists. In almost half of the CPG, the majority of the panelists had at least 1 FCOI. Over half of the CPG chairs/vice chairs reported multiple FCOI. Further studies are necessary to determine the impact of these FCOI.

Nature and extent of financial conflicts of interest among National Comprehensive Cancer Network (NCCN) clinical practice guidelines panel members.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16555-e16555
Author(s):  
Anusha Reddy Madadi ◽  
Ronald S. Go
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Expert Witness ◽  
Conflicts Of Interest ◽  
Research Support ◽  
Expert Opinions ◽  
Non Hodgkin Lymphoma ◽  
Financial Conflicts Of Interest ◽  
Cancer Network

e16555 Background: NCCN Clinical Practice Guidelines are the most widely recognized and comprehensive clinical policies used in oncology written by multidisciplinary panels of expert physicians from NCCN member institutions. However, the recommendations are largely developed from lower levels of evidence or expert opinions, and therefore, potentially vulnerable to influence by financial conflicts of interest (FCOIs) (Poonacha T, et al. J Clin Oncol 2011;29:186-191). Objective: We performed this study to describe the nature and extent of self-reported FCOIs of NCCN panel members among the 10 most common cancers in the US. Methods: We obtained the disclosures from the NCCN website (accessed December 1, 2011). FCOIs are reported under 4 categories: clinical research support (research), advisory board/speaker bureau/expert witness/consultant (honoraria), patent/equity/royalty (equity), and other remunerations. Results: There are 330 panel members with a mean of 33 per panel. Most (94%), but not all, disclosures are up to date as of 2011. 141 (43%) panel members reported FCOIs. The extent of FCOIs among panel members according to disease sites are as follows: non-Hodgkin lymphoma (60%), breast (52%), kidney (49%), colorectal (48%), lung (47%), prostate (41%), bladder (40%), melanoma (29%), thyroid (28%), and uterine (25%) cancers. 74% (n=23) of writing committee members and 83% of panel chairs have FCOIs. Among the panel members with FCOIs, 51%, 48 %, 1%, and 1% of the FCOIs are related to research, honoraria, equity, and other remunerations, respectively. Of those with non-research FCOIs (n=109), 38%, 29%, and 33%, reported 1, 2-3, and >4 disclosures, respectively Conclusions: ASubstantial proportions of NCCN panel members as well as the majority of panel chairs and writing committee members have FCOIs. Nearly half of the FCOIs are unrelated to research support. While the actual impact of FCOIs on the NCCN recommendations cannot be determined from our study, the potential for such influence can be considerable.

Conflicts of interest (COI) among the UpToDate oncology management authors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13573-e13573
Author(s):  
Madhuri Chengappa ◽  
Aakash Desai ◽  
Ronald S. Go ◽  
Thejaswi K. Poonacha
Keyword(s):  
Clinical Practice ◽  
Clinical Management ◽  
Expert Witness ◽  
Conflicts Of Interest ◽  
Utilization Distribution ◽  
Potential Conflict ◽  
Advisory Boards ◽  
Clinical Resource ◽  
Management Recommendations ◽  
The Impact

e13573 Background: UpToDate is an evidence based clinical resource designed to provide current clinical information. It is a widely used clinical practice tool providing evidenced based recommendations for diagnosis, management, and therapy. The extent of COI among the UpToDate authors has not been well studied. Our study evaluated the extent of COI of UpToDate authors involved in medical management recommendations for the 10 most common cancers in United States. Methods: We examined the latest November 2020 version of the UpToDate clinical management recommendations for 10 most common cancers. Using disclosure lists, we catalogued COIs for participants in each work group. The categories included: Category I- Grant/Research/Clinical Trial Support; Category II- Consultant/Scientific Advisory Boards/Expert witness; Category III- Speakers Bureau; Category IV- Equity Ownership/Stock Options/Patent holder/Employment/Other Financial Interest; and Category V- Spouse/Domestic Partner/Dependent Potential Conflict. We cataloged the companies/institutions involved in each disclosure. An “episode” describes 1 instance of participation of an individual in 1 company in 1 category for each cancer section. Results: There was a total of 207 authors including section and deputy editors of oncology management section. All authors completed their COI disclosures (100%). 128 (62%) of a total of 207 individuals reported COIs. A total of 1343 episodes were disclosed. We found that each author had an average of 10.49 episodes overall. Authors involved in Category I, II, III, IV & V were 6.3%, 13.5%, 3.2%, 4.7% and 1.6% respectively. 29.36% authors were involved both in Category I and II. A total of 672 company affiliations were associated with COI disclosure. AstraZeneca (6.10%), Merck (4.31%) and Novartis (2.68%) were the companies most frequently reported. The guideline with the maximum episodes (223) was prostate cancer. Conclusions: COIs are prevalent among authors of UpToDate clinical management recommendations. More than ½ of the participants disclosed at least 1 COI, but there appears to be a substantial number of experienced experts without COIs. Further research studies are necessary to determine the impact of these COIs on clinical practice patterns and resource utilization. Distribution of COI and total episodes.[Table: see text]

scholarly journals P.013 Conflicts of interest in neurosurgical research - comparing voluntary physician disclosure to mandatory company data

2016 ◽  
Vol 43 (S2) ◽  
pp. S24-S24 ◽  
Author(s):  
PJ McDonald ◽  
ER Shon ◽  
AV Kulkarni
Keyword(s):  
Voluntary Disclosure ◽  
Conflicts Of Interest ◽  
Average Rate ◽  
Industry Data ◽  
Ethical Implications ◽  
The Us ◽  
Financial Conflicts Of Interest ◽  
Author Disclosure ◽  
Open Payments

Background: Industry involvement in neurosurgical research is common, creating financial conflicts of interest (COIs). Most journals require voluntary disclosure of financial COIs. In 2013, the Sunshine Act (SA) was passed in the US, mandating industry disclosure of all payments to physicians. The accuracy of voluntary disclosure can now be determined by comparing voluntary author disclosure with industry data. Methods: We reviewed disclosure statements and calculated rates of voluntary disclosure in major neurosurgical journals before (2011) and after (2013) the Sunshine Act to determine if voluntary disclosure increased after its implementation. We then determined the accuracy of voluntary disclosure in 2013, comparing voluntary disclosure with industry disclosure on the Open Payments Database (OPD). Mean, median and range of industry payments to neurosurgeons were calculated Results: Voluntary disclosure significantly increased in JNS-Spine only (10.7% to 35.4%,p<0.001) after implementation of the SA. The average rate of non-disclosure in all journals studied was 38.3% (Range 33.8%-42.2%)$32,598,522.97 of industry payments were provided to 656 authors in the five-month period studied (Average $49,692.87/author) Conclusions: Voluntary COI disclosure in JNS- Spine increased after implementation of the Sunshine Act. Industry payments to physicians publishing in neurosurgery journals are common and rates of non-disclosure of COIs are high. The ethical implications of COIs and non-disclosure are discussed.

Outcome of Patients with Relapsed/Refractory AIDS-Related Lymphoma In the AIDS Malignancy Consortium (AMC) 1997–2008

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3569-3569
Author(s):  
Ariela Noy ◽  
Ulas Darda Bayraktar ◽  
Neel Gupta ◽  
Adam M. Petrich ◽  
Page Moore ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Infectious Complications ◽  
High Dose ◽  
Hiv Diagnosis ◽  
Curative Intent ◽  
Hematopoietic Stem ◽  
The Impact ◽  
Aids Related Lymphoma

Abstract Abstract 3569 Introduction: High dose therapy (tx) with autologous hematopoietic stem cell transplantation (AHSCT) in (rel/rfr) lymphoma is the standard of care in the general population with chemosensitive disease. The feasibility of second line therapies (Tx) and AHSCT in (rel/rfr) AIDS related lymphoma (ARL) has been shown in a number of trials. However, the true impact of 2nd line tx and AHSCT is unknown, as nearly all studies focus on those already with disease sensitive to 2nd therapy going onto transplantation. The only recent study capturing patients (n=50) before 2nd line tx showed 49% progression-free survival (Re et al. Blood 2009). Here, we retrospectively analyzed the outcome of patients (pts) presenting at 13 US AIDS Malignancy Consortium sites with (rel/rfr) ARL in the HAART era. Patients and Methods: HIV-positive pts initiating tx for (rel/rfr) ARL between 1997–2008 were included. Overall survival (OS) was calculated from the initiation of 2nd line tx. Results: A total of 126 pts received 2nd line tx. Only those 88 pts who received 2nd line with curative intent to treat (ITT) were included in the analysis. Baseline and selected clinical characteristics are summarized in the table. Median CD4 at HIV diagnosis was 110 (n=37) with a range of 12 to 1000. At ARL dx, median CD4 was 152 (5-803). 47% had an opportunistic infection (OI) prior to ARL. 2nd line tx were: ICE (n=34), EPOCH (n=16), ESHAP (n=11), High-dose MTX variants (n=10), Hodgkin's specific tx (n=5), DHAP (n=4) and others (n=8). Thirty-two (36%) had a response to 2nd line tx (CR, n=21; PR, n=11). Of 50 pts with grade ≥3 toxicities, the most common were thrombocytopenia (46%) and neutropenic fever (44%). Six pts died during 2nd line tx due to infectious complications, with 1 aspergillosis. Best response to 2nd line tx: Thus, CR/PR was 32/88 (36%) in ITT analysis. Only 10/32 CR/PR pts went onto AHSCT due to availability and changing treatment paradigms. Conditioning was BEAM (n=9) and Bu/Cy (n=7). No pt went onto allotransplant. At AHSCT day +90, 10 pts were in CR. For all pts, median follow-up was 122 weeks (range, 8–597), median OS was 38 weeks (95% CI, 27–63). Reflecting the 65% prevalence of pts refractory to 2nd line tx in the non-AHSCT group, OS was longer in pts who underwent AHSCT compared to those who did not (2-year OS: 55.3% vs. 31.0%). Surprisingly, 1-year OS in the CR/PR pts was 87.5±12.5% for AHSCT and 81.8±8.2% for non-AHSCT. One Burkitt pt survived a year without AHSCT. Discussion: Rel/rfr ARL was treated aggressively in this largest ever reported cohort, but CR/PR was only 32/88 (36%) in ITT analysis. Not all CR/PR pts went onto AHSCT due to changing treatment paradigms and regional availability. Aggressive 2nd line tx and ASHCT was feasible despite prior low CD4 and OI, but DFS may be possible without transplant. We cannot draw conclusions about the impact of AHSCT from this retrospective cohort. Similarly, it is not known whether survival in (rel/rfr) ARLs is equivalent to the HIV negative population. The current paradigm is to offer pts with rel/rfr ARLs AHSCT if disease is chemosensitive and no contraindication exist. New strategies are needed for 2nd line therapy, particularly in rel/rfr BL. Disclosures: No relevant conflicts of interest to declare.

Bendamustine-Rituximab (BR) Replaces R-CHOP As “Standard of Care” in the Treatment of Indolent Non-Hodgkin Lymphoma in German Hematology Outpatient Centres

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3666-3666 ◽  
Author(s):  
Wolfgang Ulrich Knauf ◽  
Wolfgang Abenhardt ◽  
Arnd Nusch ◽  
Renate Grugel ◽  
Norbert Marschner
Keyword(s):  
Hodgkin Lymphoma ◽  
Real Life ◽  
Stage Iv ◽  
Standard Of Care ◽  
Low Grade ◽  
Line Treatment ◽  
Clinical Registry ◽  
Non Hodgkin Lymphoma ◽  
Systemic Treatments ◽  
The Impact

Abstract Abstract 3666 Introduction With the FDA and EMA approval of Bendamustine a new treatment option has recently become available to patients (pts) with indolent (low-grade) non-Hodgkin lymphoma (iNHL). Clinical registries provide insight into real-life treatment of pts. They can help to answer the question whether patients may benefit from new research findings. Methods The clinical registry on lymphoid neoplasms (TLN Registry), conducted by iOMEDICO in collaboration with the Arbeitskreis Klinische Studien (AKS) and the Kompetenznetz Maligne Lymphome (KML), prospectively collects data on the treatment of pts with lymphoid B-cell neoplasms as administered in hematology outpatient centres in Germany. Pts are followed for 5 years. A broad set of data regarding patient and tumor characteristics, comorbidities, all systemic treatments, response rates, progression-free survival and overall survival are recorded. Since May 2009, 106 sites have actively recruited a total of 2579 pts. Results From the overall sample, 645 pts received systemic 1st-line treatment for indolent Non-Hodgkin lymphoma (iNHL). 53% of pts are male, mean age at time of primary diagnosis was 65 years (yrs) and at start of therapy 66 yrs. Tumor stage was 7% Stage I, 15% Stage II, 25% Stage III and 54% Stage IV. 61% of pts (n=387) were diagnosed with at least one comorbidity, mainly hypertension (33%) or diabetes (12%); the average Charlson Comorbity Index of 0.6 indicates that pts have few comorbities. Rituximab is part of the 1st-line treatment in 94% (n=606) of pts with iNHL. Bendamustine is part of the 1st-line treatment in 71% (n=455) of pts with iNHL. It is mostly applied in combination with Rituximab (BR, 66%, n=428). Further 2% (n=10) receive Bendamustin as monotherapy. Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone (R-CHOP) as 1st-line treatment is applied in 16% (n=105) of pts with iNHL. Pts receiving BR or R-CHOP differ. Pts characteristics indicate that BR is applied preferably in elderly pts (mean 67.3 vs. 60.9 yrs). However, BR is the preferred treatment also in pts younger than 66 yrs (60% vs. 23%). The use of BR has increased from 62% in 2009 to 68% in 2011, whereas the rate of R-CHOP has decreased from 19% in 2009 to 15% in 2011. Of all pts with iNHL, 121 have received 2nd-line treatment. Rituximab is part of the 2nd-line treatment in 84% (n=102) of pts with iNHL. Bendamustine is part of the 2nd-line treatment in 68% (n=82) of pts with iNHL. It is mostly applied in combination with Rituximab (BR, 60%, n=72). Further 7% (n=9) receive Bendamustin as monotherapy. R-CHOP as 2nd-line treatment is applied in 7% (n=9) of pts with iNHL. Conclusion BR is the most frequently used systemic treatment for pts with iNHL in German hematology outpatient centres. The use of BR has continuously increased since 2009. In contrast, the use of R-CHOP has decreased. This indicates that in Germany R-CHOP can no longer be considered as “standard of care” for pts with iNHL. These data also show that results from clinical trials are quickly implemented into daily practice. The impact of BR on quality of life and survival remains to be of central interest in the future. Disclosures: Knauf: Mundipharma GmbH: Honoraria, Membership on an entity's Board of Directors or advisory committees.

Impact Of Dose-Density Delays In Diffuse Large B-Cell Lymphoma (DLBCL) Treated With R-CHOP21 Or R-CHOP14

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4374-4374
Author(s):  
Antonio Gutierrez ◽  
Antonia M Bautista-Gili ◽  
Leyre Bento ◽  
Ines Herraez ◽  
Lucia Garcia ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
University Hospital ◽  
Aggressive Lymphoma ◽  
High Dose ◽  
Prognostic Impact ◽  
Non Hodgkin Lymphoma ◽  
Ann Arbor ◽  
The Impact

Abstract Background DLBCL is the more common non Hodgkin lymphoma. This is an aggressive lymphoma that is treated with a standard chemotherapy regimen: R-CHOP. In the last years attempts have been done to improve the outcome both increasing dose-density (DD) (CHOP14) or intensity (CHOEP, ACVBP, frontline high dose therapy followed by autologous stem cell transplantation). Although phase 2 studies of these interventions suggested promising results, when randomized phase 3 trials have been conducted, there is no demonstrated benefit of these higher toxicity approaches when compared with R-CHOP alone. Only addition of rituximab to CHOP has proved a survival advantage. This has allowed setting R-CHOP administered every 21 days (R-CHOP21) as the standard treatment for DLBCL patients. The purpose of this study is further analyzing the prognostic impact of DD delays in two cohorts of DLBCL patients treated with R-CHOP21 or R-CHOP14. Methods All patients diagnosed between 1999 and 2013 of DLBCL in University Hospital Son Espases were identified from Pathology Department registry. Only patients treated with R-CHOP21 or R-CHOP14 +/- radiotherapy were included. Patients receiving other chemotherapy regimens or consolidations were excluded. DD delay was calculated as follows: DD delay = real number of days from first to last cycle of chemotherapy / expected number of days from first to last cycle in every regimen. Results A total of 166 cases were identified: considering inclusion and exclusion criteria finally 111 cases were selected (71 in the R-CHOP21 cohort and 40 in the R-CHOP14 cohort). Respectively for R-CHOP21 and R-CHOP14, 61% and 37% were older than 60 years (p=0.02), 26% and 35% had an ECOG PS higher than 1 (p=0.3), 49% and 62% had an Ann Arbor stage III-IV (p=0.09), 44% and 51% an a-IPI higher than 1 (p=0.47). Median DD delay was 2% versus 14% for R-CHOP21 and R-CHOP14 groups (p<0.001). Clinically significant DD delay was considered those patients with DD delay higher than the median of the R-CHOP14 group. Complete response (CR) rate in patients with or without DD delay higher than 14% was 50% versus 85% in the R-CHOP21 group (p=0.004) and 80% versus 78% for R-CHOP14 group (p=0.87). Median follow-up was 60 months (4-169). OS and PFS were not significantly different in patients treated with R-CHOP21 or R-CHOP14: respectively 5y-OS of 73% vs 82% (p=0.97) and 5y-PFS 78% vs 70% (p=0.46). However, DD delay higher than 14% influenced OS and PFS only in the R-CHOP21 group (5y-OS of 39% vs 82% with or without DD delay; p=0.002 and 5y-PFS of 61% versus 81%; p=0.024) but not in the R-CHOP14 group (5y-OS of 78% vs 84% with or without DD delay; p=0.24 and 5y-PFS of 57% versus 72%; p=0.56). Conclusions Overall in our series there were no differences in terms of response or survival between patients treated with R-CHOP21 or R-CHOP14. Significantly higher rates of DD delay were observed in the R-CHOP14 group. However, the impact of DD delays on response and survival was only observed in the R-CHOP21 group but not in patients treated with R-CHOP14. We can conclude that R-CHOP21 and R-CHOP14 are equivalent regimens in terms of response and survival only if DD delays are avoided. For patients receiving R-CHOP21 we recommend using clinical and support measures in order to avoid DD delays. Disclosures: No relevant conflicts of interest to declare.

Compliance with National Comprehensive Cancer Network guidelines for antiemesis in cisplatin regimens.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 280-280
Author(s):  
Terri P. Wolf ◽  
Dana Ann Little
Keyword(s):  
National Comprehensive Cancer Network ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cancer Center ◽  
Adherence Rate ◽  
Cancer Centers ◽  
Nccn Guidelines ◽  
Guideline Compliance ◽  
Cancer Network ◽  
The Impact

280 Background: The members of a network of community cancer centers affiliated with an academic medical center report following National Comprehensive Cancer Network (NCCN) guidelines. To determine guideline compliance, cisplatin regimens were audited. Cisplatin was selected because of its wide use, high emetic potential, and the impact on QOL for patients with unmanaged nausea and vomiting.The community cancer centers affiliated with an academic medical center report following National Comprehensive Cancer Network (NCCN) guidelines for treatment plans. To determine guideline compliance rates, cisplatin regimens were audited. Cisplatin was selected because of its wide use, high emetic potential, and the impact on QOL for patients with unmanaged nausea and vomiting. Methods: Prior to a chart audit, medical oncologists were surveyed on their knowledge of NCCN antiemesis guidelines, frequency of prescribing based on guidelines, and reasons for not using guidelines. Auditors identified patient charts through billing records and reviewed cycle 1 day 1 orders of cisplatin regimens. Secondary data was collected on hydration orders and home medications for antiemesis. Results: Guideline adherence varied from 0% to 76% with overall adherence at 28%. Dexamethasone doses ranged from 2-20 mg (guideline 12 mg) as did serotonin antagonists (5HT3) ordered at higher IV doses of 24-32 mg (guideline 8-16 mg). Conclusions: Although cancer centers report following the guidelines, this study did not find consistent adherence. The cancer center with the highest adherence rate works closely with a pharmacist and has built order sets with the guidelines. One cancer center had wide variances among practitioners. The variances increase the potential for error. The cancer center with lowest adherence rate used 10 mg doses of dexamethasone because the drug is delivered in 10 mg vials. This study identified multiple systems issues impacting guideline compliance. Managing nausea and vomiting is important for patient QOL and to manage costs by decreasing hospitalizations, treatment delays, and nutritional deficits. Understanding prescribing habits relative to guidelines provides an opportunity to change practice and reduce variability.

Elevating the standard of care: Impact of a regimen-level prior authorization tool on provider adherence to clinical guidelines.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19235-e19235
Author(s):  
Rogelio Alberto Brito ◽  
Geri Kuklinski ◽  
Patricia Angelica ◽  
Anne Claussen ◽  
Diana Fischer ◽  
...  
Keyword(s):  
Treatment Guidelines ◽  
Quality Care ◽  
Standard Of Care ◽  
Clinical Decision ◽  
Cost Of Care ◽  
Evidence Based ◽  
Prior Authorization ◽  
Total Cost ◽  
Nccn Guidelines ◽  
The Impact

e19235 Background: New developments in oncology therapy continue to grow in complexity, fueling a dramatically rising cost of care. Traditional care models present opportunities to streamline plan sponsor management efforts, expedite therapy, and improve health outcomes. Studies suggest adherence to evidence-based standards results in higher quality care. Current plan sponsor management platforms match medical policy to individual drugs, not to combination therapy regimens and lack real-time access to standard treatment guidelines. 70% of precertification requests are submitted via antiquated, cumbersome methods such as paper and fax. Methods: CVS Health/Aetna developed a comprehensive oncology solution featuring an enterprise web-based clinical decision support prior authorization tool (Novologix) at the regimen level to reduce administrative burden and support quality care. Novologix regimens were updated via collaboration with the National Comprehensive Cancer Network (NCCN) evidence-based guidelines. Groups also entered a value-based payment (VBP) model to help support quality of care by promoting adherence to NCCN guidelines when clinically appropriate and tool utilization. Eligible members were Commercial, fully-insured members newly diagnosed with breast, colorectal, or lung cancer. Providers were offered dedicated, individual training sessions to provide education on the Novologix tool. NCCN-aligned regimens requested through the platform were automatically certified. Any non-NCCN aligned regimens received accelerated medical review by a board-certified medical oncologist with the option for an external peer-to-peer review upon denial. Providers received ongoing quality and cost of care reporting. Results: Primary in progress. N of precertification requests submitted via Novologix ( 28 requests as of 1/23/2020) - (will include graph displaying N of requests by month). N of regimens submitted via Novologix that were automatically certified (46% as of 1/23). Avg turnaround times for modified regimen requests requiring clinical review (TBD). Avg % adherence to NCCN guidelines (100% as of 1/23/20) Secondary: Total cost of care (preliminary/other leading indicator). Conclusions: By engaging oncology practices through an enhanced payer-provider collaboration and implementing an automated regimen-level precertification process we can facilitate higher-quality oncology care. Future studies will be needed to measure the impact of this program on total cost of care.

scholarly journals Profiling COVID-19 pneumonia progressing into the cytokine storm syndrome: results from a single Italian Centre study on tocilizumab versus standard of care

2020 ◽  
Author(s):  
Luca Quartuccio ◽  
Arianna Sonaglia ◽  
Dennis McGonagle ◽  
Martina Fabris ◽  
Maddalena Peghin ◽  
...  
Keyword(s):  
Inflammatory Markers ◽  
Conflicts Of Interest ◽  
Standard Of Care ◽  
Good Prognosis ◽  
Care Group ◽  
List Type ◽  
Cytokine Storm ◽  
Prognostic Features ◽  
The Impact ◽  
Bacterial Superinfection

AbstractObjectiveApproximately 5% of patients with coronavirus disease 2019 (COVID-19) develop a life-threatening pneumonia that often occurs in the setting of increased inflammation or “cytokine storm”. Anti-cytokine treatments are being evaluated but optimal patient selection remains unclear, and the aim of our study is to address this point.MethodsBetween February 29 to April 6, 2020, 111 consecutive hospitalized patients with COVID-19 pneumonia were evaluated in a single centre retrospective study. Patients were divided in two groups: 42 severe cases (TOCI) with adverse prognostic features including raised CRP and IL-6 levels, who underwent anti-cytokine treatments, mostly tocilizumab, and 69 standard of care patients (SOC).ResultsIn the TOCI group, all received anti-viral therapy and 40% also received glucocorticoids. In TOCI, 62% of cases were ventilated and there were 3 deaths (17.8±10.6 days, mean follow up) with 7/26 cases remaining on ventilators, without improvement, and 17/26 developed bacterial superinfection. One fatality occurred in the 15 TOCI cases treated on noninvasive ventilation and 1 serious bacterial superinfection. Of the 69 cases in SOC, there was no fatalities and no bacterial complications. The TOCI group had higher baseline CRP and IL-6 elevations (p<0.0001 for both) and higher neutrophils and lower lymphocyte levels (p= 0.04 and p=0.001, respectively) with the TOCI ventilated patients having higher markers than non-ventilated TOCI patients.ConclusionHigher inflammatory markers, more infections and worse outcomes characterized ventilated TOCI cases compared to ward based TOCI. Despite the confounding factors, this suggests that therapy time in anti-cytokine randomized trials will be key.FundingThis research received no external funding.Conflicts of Interest“The authors declare no conflict of interest.”HighlightsThere is an urgent need for markers of prognosis in COVID-19.Higher inflammatory markers best select tocilizumab treatment.The ward based tocilizumab group showed better responses and less infections than ICU tocilizumab group.The former group may be the best for evaluating the impact of anti-cytokine therapy in COVID-19.The known poor risk factors for COVID-19 infection were present in the TOCI treated rather than in the good prognosis standard of care group.

Racial disparities in treatment and outcomes of colorectal cancer in young adults.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6559-6559
Author(s):  
Olatunji Boladale Alese ◽  
Renjian Jiang ◽  
Walid Labib Shaib ◽  
Christina Sing-Ying Wu ◽  
Madhusmita Behera ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Young Adults ◽  
Proportional Hazards ◽  
Standard Of Care ◽  
Cox Proportional Hazards ◽  
Care Utilization ◽  
Nccn Guidelines ◽  
Rectal Cancers ◽  
The Impact

6559 Background: The incidence of colorectal cancer (CRC) in young adults is increasing. Minority populations with CRC are known to have worse outcome. The objective of this study is to evaluate the impact of race on the outcome of young adults with CRC. Methods: Data were obtained from all US hospitals that contributed to the National Cancer Database (NCDB) between 2004 and 2013. Univariate and multivariate testing was done to identify factors associated with patient outcome. Kaplan-Meier analysis and Cox proportional hazards models were used for association between patient characteristics and survival. Results: A total of 83,449 patients between 18 and 50 years of age were identified. The mean age was 43.6 years (SD±6), with a male preponderance (53.9%). About 72% were non-Hispanic Whites (NHW) while African Americans (AA) made up 15.1%. Distribution across stages I-IV was 15.6%, 22.4%, 33.9% and 27% consecutively, similar among the races. 41.8% of NHW and 28.4% of AA had rectal cancers (p<0.001). Despite equally receiving standard of care (SOC) as per NCCN guidelines, AA had significantly lower 5year survival rates (58.8%) compared to Hispanics (64.8%) and NHW (66.9%; HR 1.42; 1.38-1.46; p<0.001). Patients with colon cancer had worse outcome compared to rectal cancer (HR 1.21; 1.18-1.24; P<0.001). In terms of survival, NHW (HR 0.85; 0.81-0.88; p<0.001) and Hispanics (HR 0.75; 0.70-0.79; p<0.001) were more likely to benefit from chemotherapy compared to AA. As expected, SOC utilization was associated with improved survival across all racial groups, especially in AA with HR of 0.64 (0.60 – 0.69; p<0.001). Conclusions: Despite comparable rates of standard of care utilization, AA young adults with CRC had worse outcomes compared to other races. Colon cancer was significantly more common in AA than rectal cancers, which may have contributed to their worse outcomes. [Table: see text]

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