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4. Economic Modeling of the Combined Effects of HIV-Disease,Cholesterol and Lipoatrophy Based on ACTG 5142 Trial Data

Author

Simpson, Kit N, Dietz, Birgitta, Baran, Robert W, Garren, Kevin W, Riddler, Sharon A, Bhor, Menaka, and Haubrich, Richard H

Abstract

Abstract Background This study examines the cost and consequences of initiating an ARV regimen including Lopinavir/ritonavir (LPV/r) or Efavirenz (EFV), using data from a recent clinical trial in a previously published model of HIV-disease. Methods We populated the Markov model of HIV-disease with data from ACTG 5142 study to estimate the economic outcomes of starting ARV therapy with a PI-containing regimen as compared to an NNRTI-containing regimen, given their virologic and immunologic efficacy and effects on cholesterol and lipoatrophy. CNS toxicities and GI tolerability were not included in the model because of their transient nature or low cost remedies, and therefore lack of economic impact. CD4+ T-cell counts and the HIV-1 RNA (viral load) values from the study were used to assign a specific health state (HS) to each patient for each quarter year. The resulting frequencies used as "raw" data directly into the model obviate the reliance on statistical tests, and allow the model to reflect actual patient behavior in the clinical trial. An HS just below the last observed HS was used to replace a missing value. Results The modeled estimates (undiscounted) for the LPV/r-based regimen resulted in 1.41 quality-adjusted life months (QALMs) gained over a lifetime compared to the EFV-based regimen. The LPV/r-based regimen incurred $7,458 (1.8%) greater cost over a lifetime due to differences in drug costs and survival. The incremental cost effectiveness ratio using the discounted cost and QALYs was $88,829/QALY. Most of the higher costs accrue before the 7th year of treatment and were offset by subsequent savings. The estimates are highly sensitive to the effect of lipoatrophy on Health-related Quality of Life (HRQOL), but not to the effect of cholesterol levels. Conclusions The cost effectiveness of ARV regimens may be strongly affected by enduring AEs, such as lipoatrophy. It is important to consider specific AE effects from all drugs in a regimen when ARVs are compared. Trial registration (ClinicalTrials.gov number, NCT00050895 http://[ClinicalTrials.gov]).

Published
2011

5. Real-world upper endoscopy utilization patterns among patients with gastroesophageal reflux disease, Barrett esophagus, and Barrett esophagus-related esophageal neoplasia in the United States

Author

Sharma, Prateek, primary, Falk, Gary W., additional, Bhor, Menaka, additional, Ozbay, A. Burak, additional, Latremouille-Viau, Dominick, additional, Guérin, Annie, additional, Shi, Sherry, additional, Elvekrog, Margaret M., additional, and Limburg, Paul, additional

Published
2023
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6. Healthcare Resource Utilization and Costs Among Patients With Gastroesophageal Reflux Disease, Barrett’s Esophagus, and Barrett’s Esophagus-Related Neoplasia in the United States

Author

Sharma, Prateek, primary, Falk, Gary W., additional, Bhor, Menaka, additional, Ozbay, A. Burak, additional, Latremouille-Viau, Dominick, additional, Guerin, Annie, additional, Shi, Sherry, additional, Elvekrog, Margaret M., additional, and Limburg, Paul, additional

Published
2023
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15. Patient-Reported Outcomes and Economic Burden of Adults with Sickle Cell Disease in the United States: A Systematic Review

Author

Lee,Soyon, Vania,Diana K, Bhor,Menaka, Revicki,Dennis, Abogunrin,Seye, and Sarri,Grammati

Subjects
International Journal of General Medicine
Abstract

Soyon Lee,1 Diana K Vania,2 Menaka Bhor,1 Dennis Revicki,3 Seye Abogunrin,2 Grammati Sarri2 1Novartis, East Hanover, New Jersey, USA; 2Evidera, London W6 8BJ, UK; 3Evidera, Bethesda, MD 20814, USACorrespondence: Soyon LeeHealth Economics and Outcomes Research, US Oncology Medical, Novartis Pharmaceuticals Corporation, Building 345/2/2420E, East Hanover, NJ 07936-1080, Tel +1 862 217 7131Email soyon.lee@novartis.comPurpose: To systematically estimate the patient-reported outcomes (PROs) and economic burden of sickle cell disease (SCD) among adults in the United States (US).Patients and Methods: Two systematic literature reviews (SLRs), one each for the PROs and economic topics, were performed using MEDLINE and Embase to identify observational studies of adults with SCD. Included studies were published between 2007 and 2018 and evaluated health-related quality of life (HRQL), function, healthcare resource utilization (HCRU), or costs. Given the high degree of clinical and methodological heterogeneity, findings were summarized qualitatively.Results: The SLRs identified 7 studies evaluating the PROs and 15 studies evaluating the economic burden meeting the pre-specified selection criteria. The PRO evidence showed the prevalence of depression and anxiety to be 21– 33% and 7– 36%, respectively, in adults with SCD. The mean SF-36 physical summary scores ranged from 33.6 to 59.0 and from 46.3 to 61.5 for the mental summary scores. Overall HRQL for adults with SCD was poor and significantly worse in those with opioid use. Adult SCD patients were found to have varying rates of emergency department (ED) utilization (0.3– 3.5 annual ED visits), hospitalizations (0.5– 27.9 per patient per year), and/or readmission (12– 41%). Key factors associated with significant HCRU were age, dental infection, and SCD-related complications. SCD specialized care settings and SCD intensive management strategy were reported to significantly decrease the number of hospitalizations.Conclusion: This systematic evidence synthesis found that disease burden measured by PROs and economic burden of SCD on adults in the US are substantial despite the availability of approved SCD treatments during 2007– 2018. The use of hydroxyurea, optimal management with opioids, and employing intensive treatment strategies may help decrease the overall burden to patients and healthcare systems. Published data on costs associated with SCD are limited and highlight the need for more economic studies to characterize the full burden of the disease.Keywords: sickle cell disease, patient-reported outcomes, health-related quality of life, economic burden

Published
2020

18. Vaso-occlusive crises and costs of sickle cell disease in patients with commercial, Medicaid, and Medicare insurance – the perspective of private and public payers

Author

Shah, Nirmish R., primary, Bhor, Menaka, additional, Latremouille-Viau, Dominick, additional, Kumar Sharma, Vikash, additional, Puckrein, Gary A., additional, Gagnon-Sanschagrin, Patrick, additional, Khare, Ankur, additional, Kumar Singh, Mukesh, additional, Serra, Elizabeth, additional, Davidson, Mikhaïl, additional, Xu, Liou, additional, and Guerin, Annie, additional

Published
2020
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29. Economic modeling of the combined effects of HIV-disease, cholesterol and lipoatrophy based on ACTG 5142 trial data

Author

Garren Kevin W, Baran Robert W, Dietz Birgitta, Simpson Kit N, Riddler Sharon A, Bhor Menaka, and Haubrich Richard H

Subjects
lopinavir/ritonavir, efavirenz, antiretroviral therapy, HIV, AIDS, Markov model, economics, Medicine (General), R5-920
Abstract

Abstract Background This study examines the cost and consequences of initiating an ARV regimen including Lopinavir/ritonavir (LPV/r) or Efavirenz (EFV), using data from a recent clinical trial in a previously published model of HIV-disease. Methods We populated the Markov model of HIV-disease with data from ACTG 5142 study to estimate the economic outcomes of starting ARV therapy with a PI-containing regimen as compared to an NNRTI-containing regimen, given their virologic and immunologic efficacy and effects on cholesterol and lipoatrophy. CNS toxicities and GI tolerability were not included in the model because of their transient nature or low cost remedies, and therefore lack of economic impact. CD4+ T-cell counts and the HIV-1 RNA (viral load) values from the study were used to assign a specific health state (HS) to each patient for each quarter year. The resulting frequencies used as "raw" data directly into the model obviate the reliance on statistical tests, and allow the model to reflect actual patient behavior in the clinical trial. An HS just below the last observed HS was used to replace a missing value. Results The modeled estimates (undiscounted) for the LPV/r-based regimen resulted in 1.41 quality-adjusted life months (QALMs) gained over a lifetime compared to the EFV-based regimen. The LPV/r-based regimen incurred $7,458 (1.8%) greater cost over a lifetime due to differences in drug costs and survival. The incremental cost effectiveness ratio using the discounted cost and QALYs was $88,829/QALY. Most of the higher costs accrue before the 7th year of treatment and were offset by subsequent savings. The estimates are highly sensitive to the effect of lipoatrophy on Health-related Quality of Life (HRQOL), but not to the effect of cholesterol levels. Conclusions The cost effectiveness of ARV regimens may be strongly affected by enduring AEs, such as lipoatrophy. It is important to consider specific AE effects from all drugs in a regimen when ARVs are compared. Trial registration (ClinicalTrials.gov number, NCT00050895http://[ClinicalTrials.gov]).

Published
2011
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32. Cost-consequence model comparing eltrombopag and romiplostim in pediatric patients with chronic immune thrombocytopenia

Author

Tremblay,Gabriel, Dolph,Mike, Bhor,Menaka, Said,Qayyim, Roy,Anuja, Elliott,Brian, Briggs,Andrew, Tremblay,Gabriel, Dolph,Mike, Bhor,Menaka, Said,Qayyim, Roy,Anuja, Elliott,Brian, and Briggs,Andrew

Abstract

Gabriel Tremblay,1 Mike Dolph,1 Menaka Bhor,2 Qayyim Said,2 Anuja Roy,2 Brian Elliott,3 Andrew Briggs4 1Health Economics, Purple Squirrel Economics, New York, NY, USA; 2Health Economics and Outcomes Research, Novartis Pharmaceuticals, East Hanover, NJ, USA; 3Hematology, Novartis Pharmaceuticals, East Hanover, NJ, USA; 4Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, Scotland, UK Background: Immune thrombocytopenia (ITP) is an auto-immune disorder characterized by enhanced platelet destruction and, subsequently, the potential for increased bleeding. Thrombopoietin receptor (TPO-R) agonists have recently emerged as promising therapies for ITP patients who are refractory to other treatments. While eltrombopag (EPAG) is the only TPO-R agonist US Food and Drug Administration approved for use in pediatric patients, romiplostin (ROMI) has been used in Phase III clinical studies. Methods: A cost-consequence model (CCM) was developed to evaluate the costs of EPAG, ROMI, and watch-and-rescue (W&R) in relation to their respective treatment outcomes in previously-treated pediatric chronic ITP (cITP) over a 26-week time horizon. The costs of drugs, administration, routine care, rescue medications, adverse events, and mortality were included. Data on platelet count response rate, bleeding events, and adverse events were derived from all relevant identified Phase III-registered clinical trials, health outcomes were compared via indirect treatment comparison. Results: The overall estimated cost of EPAG per patient was US$66,550, compared to US$101,056 for ROMI and US$32,720 for W&R. EPAG’s lower cost compared to ROMI was largely due to lower drug costs (US$62,202 vs US$84,396), administration costs (US$0 vs US$1,955), and significantly lower costs due to severe bleeding (US$354 vs US$10,191). When assessing cost per severe bleeding event avoided, EPAG was dominant over ROMI (less expens

Published
2018

33. Cost-consequence model comparing eltrombopag versus romiplostim for adult patients with chronic immune thrombocytopenia

Author

Tremblay,Gabriel, Dolph,Mike, Bhor,Menaka, Said,Qayyim, Elliott,Brian, Briggs,Andrew, Tremblay,Gabriel, Dolph,Mike, Bhor,Menaka, Said,Qayyim, Elliott,Brian, and Briggs,Andrew

Abstract

Gabriel Tremblay,1 Mike Dolph,1 Menaka Bhor,2 Qayyim Said,2 Brian Elliott,2 Andrew Briggs3 1Department of Health Economics, Purple Squirrel Economics, New York, NY, USA; 2Department of Health Economics and Outcomes Research, Novartis Pharmaceuticals, East Hanover, NJ, USA; 3William R. Lindsay Chair of Health Economics, University of Glasgow, Glasgow, Scotland, UK Background: Thrombopoietin-receptor agonists eltrombopag (EPAG) and romiplostim (ROMI) are treatment options for adults with chronic immune thrombocytopenia (cITP) who have had an insufficient response to corticosteroids or immunoglobulins. Methods: A cost-consequence model was developed to evaluate the costs relative to treatment success of EPAG, ROMI, and watch and rescue (W&R) in previously treated patients. The primary endpoint assessed was severe bleeding, derived from all identified phase III registered clinical trials. Health outcomes were compared via indirect treatment comparison. Costs incorporated in the model included drug and administration, routine care, rescue medications, bleeding-related adverse events, other adverse events, and mortality costs. A trial (26-week) time horizon was used, as certain endpoints used in the model were bound to within-trial results. Results: In the intent-to-treat (ITT) population, the overall estimated cost per patient for EPAG was US$66,560 compared to US$91,039 for ROMI and US$30,099 for W&R. Compared to the ITT population, the difference in cost between EPAG and ROMI was slightly greater in splenectomized patients (US$65,998 for EPAG compared to US$91,485 for ROMI) and slightly less in non-splenectomized patients (US$67,151 for EPAG compared to US$91,455 for ROMI), though the overall trend remained the same. When assessing cost per severe bleeding event avoided in the ITT population, EPAG dominated (less expensive, more effective) ROMI. Sensitivity analyses confirmed these results. Conclusion: EPAG was preferred over ROMI in the treatment of cI

Published
2018

36. Obstacles and proposed solutions to effective antiretroviral therapy in resource-limited settings

Author

Bartlett, John A., Hornberger, John, Shewade, Ashwini, Bhor, Menaka, and Rajagopalan, Rukmini

Subjects
HIV (Viruses) -- Drug therapy, HIV (Viruses) -- Patient outcomes, HIV (Viruses) -- Prevention, Antiviral agents -- Usage, Antiviral agents -- Health aspects, Highly active antiretroviral therapy -- Usage, Highly active antiretroviral therapy -- Patient outcomes, Health
Published
2009

38. Impact of lipoatrophy on patient-reported outcomes in antiretroviral-experienced patients

Author

Doward, Lynda C., Dietz, Birgitta, Wilburn, Jeanette, McKenna, Stephen P., Bhor, Menaka, and Rajagopalan, Rukmini

Subjects
HIV patients -- Health aspects, HIV patients -- Medical examination, Antiviral agents -- Dosage and administration, Antiviral agents -- Patient outcomes, Connective tissue diseases -- Risk factors, Connective tissue diseases -- Influence, Quality of life -- Research, Health
Abstract

Lipoatrophy is a noteworthy adverse effect of antiretroviral therapy. A 2-part literature review was conducted to assess the impact of lipoatrophy in HIV-infected persons: the first reviewed the qualitative studies [...]

Published
2008

43. Dose Delays, Dose Reductions, and Relative Dose Intensity in Patients With Cancer Who Received Adjuvant or Neoadjuvant Chemotherapy in Community Oncology Practices

Author

Denduluri, Neelima, primary, Patt, Debra A., additional, Wang, Yunfei, additional, Bhor, Menaka, additional, Li, Xiaoyan, additional, Favret, Anne M., additional, Morrow, Phuong Khanh, additional, Barron, Richard L., additional, Asmar, Lina, additional, Saravanan, Shanmugapriya, additional, Li, Yanli, additional, Garcia, Jacob, additional, and Lyman, Gary H., additional

Published
2015
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46. An analysis of early molecular testing, time to treatment initiation, and medical resource use in metastatic NSCLC.

Author

Reynolds, Craig H., primary, Smith, David A., additional, Patt, Debra A., additional, Smith, Gregory, additional, Bhor, Menaka, additional, Horblyuk, Ruslan, additional, Rembert, Debra, additional, Sollano, Josephine A., additional, Bhowmik, Debajyoti, additional, Mardekian, Jack, additional, Yap, Mark, additional, and James, Leonard Philip, additional

Published
2014
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47. Dose delays, dose reductions, and relative dose intensity in patients with cancer who received (neo)adjuvant chemotherapy in community oncology practices.

Author

Bhor, Menaka, primary, Li, Xiaoyan, additional, Favret, Anne, additional, Morrow, Phuong Khanh H., additional, Denduluri, Neelima, additional, Barron, Richard L., additional, Saravanan, Shanmugapriya, additional, Girardi, Vincent, additional, Patt, Debra A., additional, Li, Yanli, additional, and Lyman, Gary H., additional

Published
2014
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50. Association Between Treatment Adherence and Response Among Patients With Chronic Myeloid Leukemia (CML) Receiving First-Line TKIs In The Community Setting

Author

Di Bella, Nicholas J., primary, Bhowmik, Debajyoti, additional, Bhor, Menaka, additional, Yap, Mark, additional, Middlebrook, Brooke, additional, Rembert, Debra, additional, Dhanda, Rahul, additional, Cain, Zachary, additional, Okoro, Tony, additional, Bolinder, Bjorn, additional, and Jabbour, Elias J., additional

Published
2013
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