PCN164 Impact of Treatment and Patient Attributes on Oncologists Decision-Making in First-line Chronic Lymphocytic Leukemia (CLL) in the United States (US)

2021 ◽  
Vol 24 ◽  
pp. S50
Author(s):  
D. Sharma ◽  
K. Deering ◽  
M. Sundaram ◽  
K. Daly ◽  
Q. Huang
Keyword(s):  
United States ◽  
Decision Making ◽  
Chronic Lymphocytic Leukemia ◽  
The United States ◽  
Lymphocytic Leukemia ◽  
First Line

scholarly journals Economic Burden of Chronic Lymphocytic Leukemia in the Era of Oral Targeted Therapies in the United States

2017 ◽  
Vol 35 (2) ◽  
pp. 166-174 ◽  
Author(s):  
Qiushi Chen ◽  
Nitin Jain ◽  
Turgay Ayer ◽  
William G. Wierda ◽  
Christopher R. Flowers ◽  
...  
Keyword(s):  
United States ◽  
Chronic Lymphocytic Leukemia ◽  
Targeted Therapies ◽  
Standard Of Care ◽  
The United States ◽  
Lymphocytic Leukemia ◽  
Significant Advance ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Purpose Oral targeted therapies represent a significant advance for the treatment of patients with chronic lymphocytic leukemia (CLL); however, their high cost has raised concerns about affordability and the economic impact on society. Our objective was to project the future prevalence and cost burden of CLL in the era of oral targeted therapies in the United States. Methods We developed a simulation model that evaluated the evolving management of CLL from 2011 to 2025: chemoimmunotherapy (CIT) as the standard of care before 2014, oral targeted therapies for patients with del(17p) and relapsed CLL from 2014, and for first-line treatment from 2016 onward. A comparator scenario also was simulated where CIT remained the standard of care throughout. Disease progression and survival parameters for each therapy were based on published clinical trials. Results The number of people living with CLL in the United States is projected to increase from 128,000 in 2011 to 199,000 by 2025 (55% increase) due to improved survival; meanwhile, the annual cost of CLL management will increase from $0.74 billion to $5.13 billion (590% increase). The per-patient lifetime cost of CLL treatment will increase from $147,000 to $604,000 (310% increase) as oral targeted therapies become the first-line treatment. For patients enrolled in Medicare, the corresponding total out-of-pocket cost will increase from $9,200 to $57,000 (520% increase). Compared with the CIT scenario, oral targeted therapies resulted in an incremental cost-effectiveness ratio of $189,000 per quality-adjusted life-year. Conclusion The increased benefit and cost of oral targeted therapies is projected to enhance CLL survivorship but can impose a substantial financial burden on both patients and payers. More sustainable pricing strategies for targeted therapies are needed to avoid financial toxicity to patients.

scholarly journals Chronic Lymphocytic Leukemia in Hiroshima and Nagasaki, Japan

Blood ◽  
1969 ◽  
Vol 33 (1) ◽  
pp. 79-86 ◽  
Author(s):  
STUART C. FINCH ◽  
TAKASHI HOSHINO ◽  
TAKASHI ITOGA ◽  
MICHITO ICHIMARU ◽  
ROLAND H. INGRAM
Keyword(s):  
United States ◽  
Chronic Lymphocytic Leukemia ◽  
The United States ◽  
Lymphocytic Leukemia ◽  
Hiroshima City

Abstract In Hiroshima and Nagasaki chronic lymphocytic leukemia is rare in comparison to the United States. No patient with this disorder was identified among the residents of Hiroshima City during a 20 year period of study. The incidence of chronic lymphocytic leukemia in Nagasaki City, however, was similar to that for all Japan. There is no evidence that the development of chronic lymphocytic leukemia in these cities was related to exposure to the atomic detonations of 1945.

How Many Life Years Have Been Saved In The United States From Using Rituximab Plus Chemotherapy Compared To Chemotherapy Alone From 1998-2013

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2937-2937
Author(s):  
Mark Danese ◽  
Michelle Gleeson ◽  
Marc Halperin ◽  
Sandra Skettino ◽  
Carolina Reyes
Keyword(s):  
United States ◽  
Research Funding ◽  
B Cell Lymphoma ◽  
The United States ◽  
Incidence Rates ◽  
Lymphocytic Leukemia ◽  
Age Group ◽  
First Line ◽  
Medicare Data ◽  
Life Years

Abstract Introduction Rituximab was approved in December 1997 and has since become the standard of care in diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). Clinical trials have shown statistically significant improvements in progression-free and overall survival. The objective of this study was to estimate the real-world effectiveness of first-line rituximab plus chemotherapy (R+Chemo) relative to chemotherapy alone (Chemo Alone) in the United States (US) from 1998 to 2013. Methods For each cancer, we constructed a population effectiveness model from 1998-2013 comprised of 3 modules: epidemiology, utilization and survival. The epidemiology module included age group, gender, and year-specific incidence rates for each cancer from the Surveillance, Epidemiology, and End Results (SEER) program from 2000-2010. Published SEER-based join-point estimates were used to extrapolate to other years. Census population data using the same age group, gender, and year strata were combined with incidence rates to project total diagnosed patient counts. The utilization module was based on SEER-Medicare linked data from 1999-2009. Drug utilization (defined as first infusion within 180 days of diagnosis for each cancer) for R+Chemo and for Chemo Alone was estimated as a proportion of all diagnosed patients, and stratified by age group, gender, and calendar year of diagnosis in the SEER-Medicare data. Utilization proportions were then multiplied by the diagnosed population counts to estimate treated patient counts for each cancer, by age group, gender, and calendar year. The survival module was calculated using SEER-Medicare data, starting from 30-days after first infusion, with follow up through 12/31/2010. For each cancer, flexible parametric (Royston-Parmar) survival models were applied to estimate restricted (10-year) mean survival times for each person, adjusted for individual patient covariates. These estimates were averaged across patients within strata defined by age group, gender and treatment. Life years lived were estimated for patients receiving R+Chemo, first by using mean survival for treatment with R+Chemo, and then by using mean survival estimates for Chemo Alone. The incremental life years saved were calculated as the difference between the projected survival from using R+Chemo and from using Chemo Alone. These differences were summed over age group, gender, and calendar year for each cancer. Monte Carlo sampling was used to estimate the 95% uncertainty intervals (UI). Results Across all three cancers, there were 289,793 cumulative life years saved (95% UI, 248,300-330,618; see Figure) from 1998 to 2013. For DLBCL, an estimated 177,952 patients were treated with R+Chemo. In these patients, an estimated 199,323 (95% UI 169,534-231,214) additional life years were lived compared to what might have occurred if Chemo Alone had been used instead. For FL, an estimated 84,303 patients were treated with R+Chemo, and an additional 80,338 (95% UI 53,876-106,709) life years were lived compared to Chemo Alone. For CLL, an estimated 14,398 patients were treated with R+Chemo, and an additional 10,132 (95% UI 4,469-15,998) life years were lived compared to Chemo Alone. Conclusions For DLBCL, FL and CLL patients treated with first-line therapy within 180 days of diagnosis in the US, approximately 290,000 cumulative life years were saved by adding rituximab to chemotherapy between 1998 and 2013. Next generation therapies may be able to extend these survival gains for patients with CLL, FL and DLBCL. Disclosures: Danese: Amgen: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; Medimmune: Consultancy, Research Funding. Gleeson:Amgen, Inc.: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; MedImmune: Consultancy, Research Funding. Halperin:Genentech: Consultancy, Research Funding; Medimmune: Consultancy, Research Funding; Amgen: Consultancy, Research Funding. Skettino:Genentech: Employment, stock Other. Reyes:Genentech, inc: Employment, Equity Ownership.

Study of VH3-21 in a Large Cohort of Chronic Lymphocytic Leukemia Patients Reveals Evidence for Antigen Selection and Confirms Its Predictive Value for Early Disease Progression.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2774-2774
Author(s):  
Emanuela M. Ghia ◽  
Laura Z. Rassenti ◽  
George F. Widhopf ◽  
Donna S. Neuberg ◽  
Michael J. Keating ◽  
...  
Keyword(s):  
United States ◽  
Amino Acid ◽  
Chronic Lymphocytic Leukemia ◽  
Disease Progression ◽  
Heavy Chain ◽  
The United States ◽  
Lymphocytic Leukemia ◽  
Light Chains ◽  
Early Disease ◽  
Ig Heavy Chain

Abstract The use frequency of the immunoglobulin (Ig) heavy chain variable region gene (VH) 3–21 in chronic lymphocytic leukemia (CLL) varies among studies on various cohorts of European patients, ranging from 0.9%–10%. Such variation could be due to geographic/population differences and/or sample-size limitations. We examined a large cohort (N=2,190) of CLL patients evaluated in the United States by the CLL Research Consortium (CRC) and found 56 (2.6%) used IgVH3-21. Thirty-five of the 56 cases (63%) expressed Ig light chains, whereas only 821 (38%) of the 2,134 cases that used IgVH other than IgVH3-21 used light chains, a difference that was highly significant (P < 0.001). Cases that used IgVH3-21 and light chains had significantly fewer amino acid residues in Ig heavy chain third complementarity determining region (CDR3) (m = 11.5 ± 5.3, S.D.) than did VH3-21 cases with light chains (m = 18.4 ± 4.8) (P<0.001). Twenty-eight of the 56 cases (50%) used unmutated IgVH3-21, defined as having >98% homology to germline VH3-21. Twenty (43%) or 18 (38%) of the 47 cases examined by flow cytometry expressed ZAP-70 or high-level CD38, respectively. Although there was frequent concordant expression of ZAP-70 and/or CD38 with unmutated IgVH3-21, such associations were not absolute, as had been noted for CLL cases that did not use IgVH3-21. Thirty-two percent (18/56) of the cases had a previously described common amino-acid motif (ARDANGMDV) in the otherwise highly variable Ig heavy-chain CDR3. Seventeen (94%) of such cases used light chains typically encoded by V3-21/J3. In addition, we identified a novel amino-acid consensus motif (DPSFYSSSWTLFDY) in the Ig heavy chain CDR3 for 3 of the 56 cases (5.4%). We examined the time from diagnosis to initiation of therapy as per established NCI-Working Group guidelines in 40 patients for whom complete clinical data were available. With a median follow-up of 4.2 years from the date of diagnosis, 25 of the 40 patients had received therapy at the time of this analysis. The median time to treatment (TTT) for all 40 patients was 3.5 years, which was significantly shorter than the median TTT of 6.6 years noted for a previously-described CRC cohort of 307 patients that were not selected for use of IgVH3-21 (NEJM2004; 351: 893–901) (P<0.001). The median TTT of 19 patients that used unmutated IgVH3-21 in this subset (3.0 years) appeared shorter than that noted for the 21 patients that had mutated IgVH3-21 (5.4 years), but this difference did not reach statistical significance. We conclude that a small proportion of patients studied in the United States by the CRC use IgVH3-21, which encodes Ig heavy chains that frequently have canonical motifs in the CDR3 and that typically are paired with certain Ig light chains, providing strong evidence for Ig selection by antigen(s). Finally, patients with IgVH3-21-expressing CLL have a higher risk for early disease progression than do patients with CLL not selected for use of IgVH3-21.

Variation in health-related quality of life (HRQOL) by line of therapy, age, and gender among patients with chronic lymphocytic leukemia.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7086-7086
Author(s):  
Christopher Flowers ◽  
Charles Michael Farber ◽  
Ian Flinn ◽  
David L. Grinblatt ◽  
Neil E. Kay ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Statistical Significance ◽  
The United States ◽  
Lymphocytic Leukemia ◽  
Age Group ◽  
First Line ◽  
Hrqol Score ◽  
Age And Gender ◽  
And Gender ◽  
Line Of Therapy

7086 Background: The HRQOL of patients (pts) with chronic lymphocytic leukemia (CLL) has not been adequately delineated across patient, disease and treatment characteristics. We evaluated HRQOL of CLL pts undergoing treatment in the United States (US) by age, gender and line of therapy. Methods: Data were collected in Connect CLL, a prospective observational US registry. Physicians provided data on demographics, clinical characteristics and line of therapy at enrollment. HRQOL was self-reported by pts at enrollment using the Functional Assessment of Cancer Therapy-Leukemia, an instrument that yields a leukemia-specific total HRQOL score (FACT-Leu) and a cancer-specific total HRQOL score (FACT-G). Mean total scores were analyzed by line of therapy, age and gender. Statistical significance was ascertained by ANOVA using SAS 9.2. Multivariate analyses were conducted to assess the relative association of line of therapy, age and gender with HRQOL. Results: Among 1,252 pts enrolled from 161 geographically diverse centers (90% community, 8% academic, 2% veterans/military), pts were predominantly male (63%), white (89%) with mean age 69 yrs. Pts were categorized by line of therapy at enrollment: First 61%, Second 18%, Third 11%, Higher 9%; and by age group: <65 33%, 65-74 35%, 75+ 32%. Univariate analyses suggested that the total FACT-Leu score was significantly better in men than women (P=0.004); in pts aged 65-74 vs younger or older pts (P=0.033); and in pts initiating first-line treatment vs pts receiving subsequent treatments (P=0.0002). Similar results were found with the FACT-G score except that gender differences were not statistically significant. Multivariate analysis confirmed that line of therapy (P=0.007), gender (P<0.0001), and age group (P=0.039) were each associated with significant differences in the FACT-Leu total score. Conclusions: Results from the Connect CLL Registry indicate that HRQOL is better among pts initiating first-line therapy compared to pts initiating subsequent treatments, and that this remains true when age and gender are considered. Future analyses should determine how HRQOL may change over time relative to treatment and treatment response.

scholarly journals Comparison of Access to Novel Drugs for Lymphoma and Chronic Lymphocytic Leukemia Between India and the United States

2020 ◽  
pp. 1124-1133
Author(s):  
Vishwanath Sathyanarayanan ◽  
Christopher R. Flowers ◽  
Swaminathan P. Iyer
Keyword(s):  
United States ◽  
Chronic Lymphocytic Leukemia ◽  
Hematologic Malignancies ◽  
The United States ◽  
Lymphocytic Leukemia ◽  
Compulsory Licensing ◽  
Development Costs ◽  
Novel Drugs ◽  
New Treatments ◽  
Compare And Contrast

This review will compare and contrast the costs and access to novel drugs for treating chronic lymphocytic leukemia (CLL) and lymphoma in the United States and India during the last 5 years. Clinical outcomes for patients with hematologic malignancies have improved significantly since the approval of immunotherapeutic and targeted therapies. These new treatments have had an impact on overall outcomes and have helped determine the design for translational research and future trials. Although most of these novel drugs called “innovators” are initially approved and marketed in the United States, several have also become available in countries such as India. With the expiration of patents, generic versions of innovator drugs have increased and accessibility has improved for patients. The advent of biosimilars is another route for expanding access to biologic compounds. As a result, the development costs for developing these drugs are lower, and consequently, the costs for the patient are often lower. Although the delivery of cancer care is not the same in India as it is in the United States, the introduction of biosimilars and generics has helped bridge the gap. This has made treatment of CLL and lymphoma similar in both countries and has had the same impact on patient outcomes and quality of life. Compulsory licensing for essential medications, as stipulated by the Doha Declaration, and capping of drug prices could improve global access to treatments for CLL and lymphoma.

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