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6. Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study

Author

Dummer, Reinhard, Prince, Henry M, Whittaker, Sean, Horwitz, Steven M, Kim, Youn H, Scarisbrick, Julia, Quaglino, Pietro, Zinzani, Pier Luigi, Wolter, Pascal, Eradat, Herbert, Pinter-Brown, Lauren, Sanches, Jose A, Ortiz-Romero, Pablo L, Akilov, Oleg E, Geskin, Larisa; https://orcid.org/0000-0001-7348-2571, Huen, Auris, Walewski, Jan, Wang, Yinghui, Lisano, Julie; https://orcid.org/0000-0003-2454-2800, Richhariya, Akshara, Feliciano, Joseph, Zhu, Yanyan, Bunn, Veronica, Little, Meredith, Zagadailov, Erin; https://orcid.org/0000-0002-4903-2762, Dalal, Mehul R, Duvic, Madeleine, Dummer, Reinhard, Prince, Henry M, Whittaker, Sean, Horwitz, Steven M, Kim, Youn H, Scarisbrick, Julia, Quaglino, Pietro, Zinzani, Pier Luigi, Wolter, Pascal, Eradat, Herbert, Pinter-Brown, Lauren, Sanches, Jose A, Ortiz-Romero, Pablo L, Akilov, Oleg E, Geskin, Larisa; https://orcid.org/0000-0001-7348-2571, Huen, Auris, Walewski, Jan, Wang, Yinghui, Lisano, Julie; https://orcid.org/0000-0003-2454-2800, Richhariya, Akshara, Feliciano, Joseph, Zhu, Yanyan, Bunn, Veronica, Little, Meredith, Zagadailov, Erin; https://orcid.org/0000-0002-4903-2762, Dalal, Mehul R, and Duvic, Madeleine

Abstract

Background: Brentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/kg once every 3 weeks; ≤16 cycles) versus physician's choice (methotrexate/bexarotene; ≤48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined. Methods: QoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires. Results: Mean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (-27.96 versus -8.62); the difference, -18.9 (95% confidence interval -26.6, -11.2; adjusted p < 0.001), exceeded the study-defined minimally important difference (9.0-12.3). Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29). EQ-5D changes were also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was -35.54 versus -11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores. Conclusions: In summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients. Clinical trial registration: NCT01578499.

Published
2020

7. Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study

Author

Dummer, Reinhard, primary, Prince, Henry M., additional, Whittaker, Sean, additional, Horwitz, Steven M., additional, Kim, Youn H., additional, Scarisbrick, Julia, additional, Quaglino, Pietro, additional, Zinzani, Pier Luigi, additional, Wolter, Pascal, additional, Eradat, Herbert, additional, Pinter-Brown, Lauren, additional, Sanches, Jose A., additional, Ortiz-Romero, Pablo L., additional, Akilov, Oleg E., additional, Geskin, Larisa, additional, Huen, Auris, additional, Walewski, Jan, additional, Wang, Yinghui, additional, Lisano, Julie, additional, Richhariya, Akshara, additional, Feliciano, Joseph, additional, Zhu, Yanyan, additional, Bunn, Veronica, additional, Little, Meredith, additional, Zagadailov, Erin, additional, Dalal, Mehul R., additional, and Duvic, Madeleine, additional

Published
2020
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10. Real-world analysis of cost, health care resource utilization, and supportive care in Hodgkin lymphoma patients with frontline failure

Author

Bonafede,Machaon, Feliciano,Joseph, Cai,Qian, Noxon,Virginia, Princic,Nicole, Richhariya,Akshara, Straus,David J, Bonafede,Machaon, Feliciano,Joseph, Cai,Qian, Noxon,Virginia, Princic,Nicole, Richhariya,Akshara, and Straus,David J

Abstract

Machaon Bonafede,1 Joseph Feliciano,2 Qian Cai,1 Virginia Noxon,1 Nicole Princic,1 Akshara Richhariya,2 David J Straus3,4 1IBM Watson Health, Cambridge, MA, USA; 2Seattle Genetics, Inc., Bothell, WA, USA; 3Memorial Sloan Kettering Cancer Center, New York, NY, USA; 4John P Leonard Department of Medicine, Weill Cornell Medicine, New York, NY, USA Purpose: The purpose of this study was to evaluate the economic burden of frontline failure (FLF) among classical Hodgkin lymphoma (HL) patients during and after treatment.Patients and methods: The population consisted of adult HL patients identified from January 2010 through September 2015 without any other primary cancer prior to HL diagnosis, who also had a frontline (FL) regimen indicative of curative intent. Patients were characterized as FLF (those who restart, switch to any chemotherapy; had a hematopoietic stem cell transplant; or newly initiated radiation therapy [RT] after discontinuing FL) or non-FLF (those not considered as FLF). Direct health care utilization and expenditures were measured over both fixed and variable length follow-up periods and during FL therapy.Results: There were 77 FLF and 602 non-FLF patients who met the final inclusion criteria. FLF and non-FLF patients were demographically similar with mean age 38.5 years and 47.5% females. Average per patient per month (PPPM) costs were significantly higher for FLF patients during all follow-up (US$20,266 vs US$7,772, P<0.05). Annual total expenditures were significantly higher among FLF patients (US$198,388) vs non-FLF patients (US$37,549). FLF (vs non-FLF) patients had a significantly shorter duration of FL therapy (116 vs 131 days, P=0.024) and higher total PPPM expenditures during FL (US$29,040 vs US$16,369, P<0.05). Annual cost varied by failure type with those who failed due to restart incurring the highest cost (US$269,189) and those who switched incurring the lowest cost (US$46,951). FLF patients had a significantly greater utilizat

Published
2018

21. Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma

Author

Ramsey, Scott D., primary, Nademanee, Auayporn, additional, Masszi, Tamas, additional, Holowiecki, Jerzy, additional, Abidi, Muneer, additional, Chen, Andy, additional, Stiff, Patrick, additional, Viviani, Simonetta, additional, Sweetenham, John W., additional, Radford, John, additional, Zhu, Yanyan, additional, Bonthapally, Vijayveer, additional, Thomas, Elizabeth, additional, Richhariya, Akshara, additional, Hunder, Naomi N., additional, Walewski, Jan, additional, and Moskowitz, Craig H., additional

Published
2016
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25. Brentuximab vedotin in relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant: A cost-effectiveness analysis updated with 5-year follow-up data from the pivotal trial.

Author

Parker, Christopher, primary, Kay, Gemma, additional, Ma, Esprit, additional, Woods, Beth, additional, Eaton, James, additional, Sajosi, Peter, additional, Engstrom, Andreas, additional, Selby, Ross, additional, Benson, Eugene, additional, Teasell, Jeremy, additional, Richhariya, Akshara, additional, Briggs, Andrew, additional, and Bonthapally, Vijayveer, additional

Published
2016
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27. Brentuximab vedotin (BV) consolidation post-autologous stem cell transplant (ASCT) in patients (pts) with Hodgkin lymphoma (HL) at risk of residual disease: Number needed to treat (NNT) analysis.

Author

Gautam, Ashish, primary, Huebner, Dirk, additional, Zhu, Yanyan, additional, Ma, Esprit, additional, Lee, Shih-Yuan, additional, Zagadailov, Erin, additional, Teasell, Jeremy, additional, Richhariya, Akshara, additional, and Bonthapally, Vijayveer, additional

Published
2016
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28. Medical costs associated with cardiovascular events among high-risk patients with hyperlipidemia

Author

Bonafede,Machaon, Johnson,Barbara, Richhariya,Akshara, Gandra,Shravanthi, Bonafede,Machaon, Johnson,Barbara, Richhariya,Akshara, and Gandra,Shravanthi

Abstract

Machaon M Bonafede,1 Barbara H Johnson,1 Akshara Richhariya,2 Shravanthi R Gandra2 1Outcomes Research, Truven Health Analytics, Cambridge, MA, USA; 2Global Health Economics, Amgen, Thousand Oaks, CA, USA Objectives: This study descriptively examined acute and longer term direct medical costs associated with a major cardiovascular (CV) event among high-risk coronary heart disease risk-equivalent (CHD-RE) patients. It also gives a firsthand look at fatal versus nonfatal CV events. Methods: The MarketScan® Commercial Claims and Encounters Database was used to identify adults with a CV event in 2006–2012 with hyperlipidemia or lipid-lowering therapy use in the 18 months prior to one of the following inpatient CV events: myocardial infarction, ischemic stroke, unstable angina, transient ischemic attack, percutaneous coronary intervention, or coronary artery bypass graft (CABG). Patients were required to have a preindex diagnosis of at least one of the following: peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease, or diabetes. A subset analysis was conducted with patients with data linkable to the Social Security Administration Master Death File. Direct medical costs were reported for each quarter following a CV event, for up to 36 months after the first CV event. Results: In total, 38,609 CHD-RE patients were included, mean age 57 years, 31% female. CABG, myocardial infarction, and percutaneous coronary intervention were the most frequent and most expensive first CV events, accounting for >75% of all first CV events with mean first quarter costs ranging from $17,454 (nonfatal transient ischemic attack) to $125,690 (fatal CABG). Overall, 15% of those with a first CV event went on to have a second event during the 36-month study period with mean first quarter nonfatal and fatal costs similar to first event levels. Third CV events were rare, happening in less than 3% of patients. Conclusion: CV events among CHD-RE patient

Published
2015

29. Brentuximab vedotin consolidation post-autologous stem cell transplant in Hodgkin lymphoma patients at risk of residual disease: number needed to treat.

Author

Gautam, Ashish, Zhu, Yanyan, Ma, Esprit, Lee, Shih-Yuan, Zagadailov, Erin, Teasell, Jeremy, Richhariya, Akshara, Bonthapally, Vijayveer, and Huebner, Dirk

Subjects
HODGKIN'S disease, HODGKIN'S disease treatment, DRUG efficacy, STEM cell transplantation, PREVENTION of disease progression, PATIENTS
Abstract

The number needed to treat (NNT) with brentuximab vedotin consolidation therapy post-autologous stem cell transplant (ASCT) versus placebo in the phase 3 AETHERA trial to avoid one additional event of disease progression/death was evaluated. AETHERA included 329 Hodgkin lymphoma patients at increased risk of progression post-ASCT who received brentuximab vedotin 1.8 mg/kg (n = 165) or placebo (n = 164) on day 1 of each 21-d cycle (up to 16 cycles). Over 60 months, the NNT with brentuximab vedotin ranged from 4.08 to 7.79 for the intent-to-treat population, 3.18–6.07 for patients with ≥2 risk factors, and 2.98–5.65 for patients with ≥3 risk factors. At various time points, and dependent on the risk group, 3–8 patients would need to be treated with brentuximab vedotin consolidation therapy to prevent a disease progression/death, compared with placebo. Patients with increased risk of relapse may benefit most from brentuximab vedotin. [ABSTRACT FROM AUTHOR]

Published
2018
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38. Trends in use of intravenous bisphosphonates in patients with prostate cancer and newly diagnosed metastases to bone in two large U.S. integrated health systems.

Author

Lamerato, Lois, primary, Glass, Andrew, additional, Richert-Boe, Kathryn E., additional, Edelsberg, John, additional, Wolff, Greg G., additional, Czapski, Natalie, additional, Dodge, Tracy, additional, Lopez, Andrea, additional, Chung, Karen, additional, Richhariya, Akshara, additional, and Oster, Gerry, additional

Published
2013
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45. Clinical Profiles, Treatment Characteristics and Outcomes Among Newly Diagnosed Hodgkin Lymphoma Patients Presenting with Unfavorable and Advanced Disease within a US Community Oncology Setting

Author

Yasenchak, Christopher A., Feliciano, Joseph, Aguilar, Kathleen M., Clark, Jamyia, Amirian, E Susan, and Richhariya, Akshara

Abstract

The intent of treating newly diagnosed Hodgkin lymphoma (HL) patients is to achieve a complete remission that can eventually translate into a cure. Treatment decisions for HL are guided by several factors, including sub-type, stage, disease symptomatology, laboratory results, radiologic imaging, age and overall health. Understanding patient profiles and treatment characteristics is important as there is a demographic difference between patients treated in community and academic settings. The intent of this study was to improve understanding of the HL patient population and treatment trends among unfavorable-/advanced-stage HL patients receiving care within the US community oncology setting. METHODS: This was a retrospective, observational cohort study of adult HL patients with Stage IIB-IV disease who initiated first-line chemotherapy within the US Oncology Network between 1/1/09 - 6/30/12. Patients were followed until 6/30/16. Most data were captured from structured fields of the electronic healthcare record, with a targeted chart review performed to provide additional detail on select study variables for a subset of the study population. Descriptive analyses were performed to assess patient and treatment characteristics, while the Kaplan Meier method was used to calculate the duration of therapy (DOT), time to next treatment (TTNT) and time to stem cell transplantation (SCT). RESULTS: In total, 565 patients met eligibility criteria and were included in the analysis. The mean age of the patient population was 44.3 years (standard deviation [SD] 18.2), 55.0% were male and 69.2% were Caucasian. Most patients (90.4%) received the ABVD regimen (doxorubicin, bleomycin, vinblastine and dacarbazine) or a variant of the ABVD regimen in the first-line setting (LOT1). Seventy-four (13.1%) patients were as assumed to have relapsed/refractory disease, as evidenced by advancement to second-line (LOT2) therapy. Among these patients, 44.6% received an etoposide-containing regimen, 17.6% received a brentuximab vedotin-containing regimen and 9.5% GVD (gemcitabine, vinorelbine, doxorubicin). Nearly 30% of LOT2 patients received a regimen classified into an “other” category because it was received by less than 5 patients in the study. Following LOT1, the median TTNT was 67.9 weeks (95% confidence interval [CI] 50.8,104.5). Among the 511 patients who received ABVD/ABVD variant regimens in LOT1, the median TTNT was 67.9 weeks (95%CI 49.0,90.9). Compared to LOT1, the median DOT of LOT2 was shorter (22.1 weeks [95%CI not reached] vs. 7.6 [95%CI 6.3, 10.1] weeks). The median DOTs of ABVD/ABVD variants and AVD in LOT1 were 22.1 (95%CI not reached) and 20.1 (95%CI 7.1, 22.1) weeks, respectively. Only 32 patients advanced to LOT3 and 7 to LOT4. Among patients selected for chart review, 31.2% reported symptoms associated with peripheral neuropathy during LOT1. Data pertaining to radiologic imaging and SCT were only available among patients selected for chart review. These results indicated that positron emission tomography (PET) scans were most frequently performed at diagnosis (74.9% of records reviewed) and/or after LOT1 (55.3% of records reviewed). At diagnosis, all PET scan results were positive (Deauville score 4-5); after LOT1 71.7% were negative (Deauville score 1-3). Treatment changes explicitly attributed to PET scan results were infrequently documented. Among the 29 patients observed to have undergone SCT, the median time to SCT was 41.1 weeks (95%CI 32.7, 56.8). CONCLUSIONS: These findings provide insight into the patient profiles and treatment progression in a US community oncology setting. In particular, ABVD/ABVD variant regimens were observed to be the predominate therapy in the front-line setting. Intensive salvage therapy and consolidative SCT were uncommon in the second-line setting, with most patients receiving etoposide- and brentuximab vedotin-containing regimens. Utilization of PET imaging at diagnosis, for interim response assessment and at completion of therapy was not universal. The apparent difference in use of imaging observed in this community oncology setting compared to what is reported by academic centers may be due variation treatment practices across these organizations or underlying differences in their patient populations. Future research should explore how patient profiles influence use of imaging and associated treatment decisions.

Published
2017
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46. Factors influencing patient adherence and persistence to hormonal therapy drugs in treatment of breast cancer

Author

Richhariya, Akshara

Subjects
Hormonal therapy, Adherence, Persistence, Breast cancer
Abstract

The purpose of this study was to investigate the relationship between patient out-of-pocket costs and adherence and persistence to hormonal therapy (HT) used in treatment of breast cancer. A retrospective analysis of medical and prescription drug claims for patients with breast cancer (N=6,504) was conducted to estimate the medication possession ratio; adherence; days of persistence; persistence; HT out-of-pocket costs, and total out-of-pocket costs, over 12 months after index HT and over the study period. The multivariate linear regression, logistic regression, and the Cox proportional hazard regression were employed to evaluate the association. The mean (SD) MPR over the 12 months and the study period was 85.6 (23.5) and 89.3 (16.1) percent, respectively. The MPR was positively related to HT out-of-pocket costs and not related to total out-of-pocket costs. Of the study sample, 75.1 percent of the patients were adherent (MPR≥80 percent) to HT over the 12 months period and 82.0 percent were adherent over the study period. The adherence to HT was positively related to HT out-of-pocket costs but not related to total out-of-pocket costs. The mean (SD) days of persistence over the 12 months and the study period were 313.3 (97.8) and 826.8 (583.7) days, respectively. HT out-of-pocket costs and total out-of-pocket costs were inversely related to risk of discontinuation over the 12 months period. The HT out-of-pocket costs and risk of discontinuation were inversely related over the study period. No relationship was observed between total-out-of-pocket costs and risk of discontinuation over the study period. A total of 68.2 percent of the patients were persistent to their therapy for the 12 months and 30.9 percent were persistent (gap of 60 days or less in continuous therapy) for the study period. A positive relationship was observed between HT out-of-pocket and total out-of-pocket costs and persistence during the 12 months period. The study period analyses showed positive relationship between HT out-of-pocket costs and persistence and no relationship between total out-of-pocket costs and persistence. The results show that patient HT adherence and persistence is poor; however, patient HT and total out-of-pocket costs do not have an adverse effect on adherence and persistence.

Published
2015

47. Impact of Medicare part D on adherence and persistence to statin medications for Texas dual-eligible beneficiaries

Author

Richhariya, Akshara

Subjects
MPR, Medication possession ratio, Persistence, Adherence, Dual-eligible beneficiaries
Abstract

Statins are commonly used for treating the elevation of lipids in the blood stream, also known as hyperlipidemia. Statins are considered to be an economical and effective way to achieve desirable long-term health outcomes for hyperlipdemic patients, however, ensuring adequate adherence to statin medications is often difficult as hyperlipidemia is an asymptomatic condition and patients sometimes fail to recognize the importance of being adherent to their statin medications. The purpose of this study was to evaluate impact of enrollment under Medicaid and Medicare Part D and patient out-of-pocket costs on patient statin adherence, persistence, and mean number of gap days per claim. A retrospective claims database was used in this study to conduct repeated measures analyses on statin prescription claims from independent community pharmacies in Texas. The pre-period in this study extended from January 1, 2005 to September 30, 2005 (Medicaid period) and the post-period extended from January 1, 2006 to September 30, 2006 (Medicare period). The study population consisted of dual-eligible beneficiaries in Texas who had at least two stain claims in the pre and post-periods each. The final study population comprised of 1734 Texas dual-eligible beneficiaries with 6064 statin claims during the pre-period and 7956 claims during the post-period. Patients had an average of 3.49 statin claims during the pre-period and 4.58 statin claims during the post-period. Patients were dispensed an average of 57.34 days of drug supply per claim during the pre-period and 42.02 days of drug supply per claim during the post-period. The results from this study showed that out-of-pocket costs for patients increased from $0.39 per claim under Medicaid to $13.36 per claim under Medicare Part D. Patient adherence to statins was assessed by calculating medication possession ratio (MPR). The results showed that mean patient MPR increased from 75.71 percent under Medicaid to 79.37 percent under Medicare. Results from generalized estimating equations showed that odds of being adherent (i.e., MPR ≥ 80 percent) to statins increased by 36 percent when patients were covered under Medicare Part D. Linear mixed model analysis showed that MPR increased by 3.66 percent when patients were covered under Medicare Part D compared to Medicaid. Also, patient MPR was found to increase by 0.13 percent when patient out-of-pocket payment increased by $1.00. Patient persistence was calculated by measuring gaps in therapy and patients with a gap of 60 or more days were considered to have discontinued therapy. Patients were found to be persistent to their drug therapy for an average of 151.76 days under Medicaid and 159.75 days under Medicare. Linear mixed model analysis showed that patient persistence increased by 7.99 days when patients were enrolled under Medicare Part D compared to Medicaid. Days of persistence was also found to increase by 0.41 days when patient out-of-pocket costs increased by $1.00. Mean number of gap days per claim during the Medicaid period was 11.91 days and decreased to 8.38 days during the Medicare period. Linear mixed model analysis showed that mean number of gap days per claim decreased by 3.52 days when patients were enrolled under Medicare Part D compared to Medicaid. Mean number of gap days in therapy were found to decrease by 0.10 days when patient out-of-pocket costs increased by $1.00. The results of this study showed that implementation of Medicare Part D resulted in an increase in MPR and persistence and a decrease in mean number of gap days per claim for Texas dual-eligible beneficiaries. The results also suggest that increased out-of-pocket costs under Medicare Part D may not have had a negative impact on statin drug utilization by dual-eligible beneficiaries in Texas.

Published
2010

48. Patient-level costs of major cardiovascular conditions: a review of the international literature.

Author

Nicholson G, Gandra SR, Halbert RJ, Richhariya A, and Nordyke RJ

Abstract

Objective: Robust cost estimates of cardiovascular (CV) events are required for assessing health care interventions aimed at reducing the economic burden of major adverse CV events. This review synthesizes international cost estimates of CV events., Methods: MEDLINE database was searched electronically for English language studies published during 2007-2012, with cost estimates for CV events of interest - unstable angina, myocardial infarction, heart failure, stroke, and CV revascularization. Included studies provided at least one estimate of patient-level direct costs in adults for any identified country. Information on study characteristics and cost estimates were collected. All costs were adjusted for inflation to 2013 values., Results: Across the 114 studies included, the average cost was US $6,466 for unstable angina, $11,664 for acute myocardial infarction, $11,686 for acute heart failure, $11,635 for acute ischemic stroke, $37,611 for coronary artery bypass graft, and $13,501 for percutaneous coronary intervention. The ranges for cost estimates varied widely across countries with US cost estimate being at least twice as high as European Union costs for some conditions. Few studies were found on populations outside the US and European Union., Conclusion: This review showed wide variation in the cost of CV events within and across countries, while showcasing the continuing economic burden of CV disease. The variability in costs was primarily attributable to differences in study population, costing methodologies, and reporting differences. Reliable cost estimates for assessing economic value of interventions in CV disease are needed.

Published
2016
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