Institute for Technology Assessment

Merrimac, MA, United States

Institute for Technology Assessment

Merrimac, MA, United States
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Use of the generic versions of directly-acting antiviral (DAA) drugs that are available in India to treat hepatitis C virus (HCV) infection is not only cost effective but actually saves lifetime costs for treating infected patients in that country. A report from an international research team appears in the open-access journal PLOS ONE and describes finding that the upfront costs of DAA are offset by the avoidance of costs incurred to treat late-stage disease. "More than 9 million people are infected with HCV in India, and more than 70 million worldwide," says Jagpreet Chhatwal, PhD, of the Institute for Technology Assessment at Massachusetts General Hospital (MGH), senior and corresponding author of the paper. "These persons are at risk of developing serious conditions such as cirrhosis and liver cancer, which can be fatal. However, only a fraction of them have been treated with these drugs so far." First introduced in 2011, DAAs such as sofosbuvir (Sovaldi) and ledipasvir (which is combined with sofosbuvir in Harvoni) have proven to be remarkably successful in the battle against HCV infection, with cure rates exceeding 95 percent. In developed countries, treatment with DAAs is very expensive -- reaching nearly $65,000 in the U.S. -- although it meets standards for cost effectiveness. In those countries the advent of these drugs has drastically changed the landscape of HCV infection. But other countries have lagged behind in their use. Through agreements with the pharmaceutical companies that developed these drugs, generic drug manufacturers in India are now able to produce versions that cost as little as $300 for the entire duration of treatment. But the absence of data on the cost effectiveness of these drugs in that country and low budgets for HCV treatment have meant that only a small proportion of people needing these drugs have received them. The research team -- including investigators from Sanjay Gandhi Postgraduate Institute of Medical Sciences in Lucknow, India, and the World Health Organization -- used a mathematical model to compare the outcomes of DAA treatment with those of no DAA treatment based on profiles of 30 hypothetical patients with characteristics typical of Indian patients with HCV infection. Factors incorporated into the model included the natural history of HCV disease, the costs of DAA administration, the costs of treating the adverse outcomes of HCV disease, and quality of life of individuals infected with HCV. The model indicated that, compared with no DAA treatment, use of the generic drugs in HCV-infected Indian patients would increase life expectancy by more than eight years while reducing lifetime health care costs by more than $1,300 per person. Payback for the upfront costs of DAA drugs would be achieved in an overall average of less than 10 years -- under 5 years for patients at advanced stages of HCV disease and almost 12 years if treatment begins at earlier stages. Even though there was wide variation in the factors -- such as patient age, disease stage, and viral genotype -- input to the model, results always indicated that generic DAA treatment reduced lifetime costs. "Our hypothesis was that treatment would be cost saving, given the low drug costs in India. However, we were pleasantly surprised to find that the full payback was achieved so soon after treatment," says Chhatwal, who is an assistant professor of Radiology at Harvard Medical School. "Our finding that treatment pays back its initial costs makes a very strong statement -- that investment in HCV screening and treatment should be a priority for public health agencies in India and other countries where generic DAAs are available. It could also be argued that generic DAAs should be made available in other low- and middle-income countries where HCV infection is common and budgets for treatment limited." Lead author Rakesh Aggarwal, MD, DM, of the Department of Gastroenterology at Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), a WHO Collaborating Center on Viral Hepatitis, says, "This is a win-win situation for the low- and low-middle-income countries where the generic DAAs can be sold. If these countries spend money on HCV treatment today, they will recoup it in the form of reduced health care expenditure within less than one decade. There is hardly any other health care intervention with such good return. Our results should show political leaders in those countries that they have a wonderful opportunity to make a difference for their constituents."


Use of the generic versions of directly-acting antiviral (DAA) drugs that are available in India to treat hepatitis C virus (HCV) infection is not only cost effective but actually saves lifetime costs for treating infected patients in that country. A report from an international research team appears in the open-access journal PLOS ONE and describes finding that the upfront costs of DAA are offset by the avoidance of costs incurred to treat late-stage disease. "More than 9 million people are infected with HCV in India, and more than 70 million worldwide," says Jagpreet Chhatwal, PhD, of the Institute for Technology Assessment at Massachusetts General Hospital (MGH), senior and corresponding author of the paper. "These persons are at risk of developing serious conditions such as cirrhosis and liver cancer, which can be fatal. However, only a fraction of them have been treated with these drugs so far." First introduced in 2011, DAAs such as sofosbuvir (Sovaldi) and ledipasvir (which is combined with sofosbuvir in Harvoni) have proven to be remarkably successful in the battle against HCV infection, with cure rates exceeding 95 percent. In developed countries, treatment with DAAs is very expensive -- reaching nearly $65,000 in the U.S. -- although it meets standards for cost effectiveness. In those countries the advent of these drugs has drastically changed the landscape of HCV infection. But other countries have lagged behind in their use. Through agreements with the pharmaceutical companies that developed these drugs, generic drug manufacturers in India are now able to produce versions that cost as little as $300 for the entire duration of treatment. But the absence of data on the cost effectiveness of these drugs in that country and low budgets for HCV treatment have meant that only a small proportion of people needing these drugs have received them. The research team -- including investigators from Sanjay Gandhi Postgraduate Institute of Medical Sciences in Lucknow, India, and the World Health Organization - used a mathematical model to compare the outcomes of DAA treatment with those of no DAA treatment based on profiles of 30 hypothetical patients with characteristics typical of Indian patients with HCV infection. Factors incorporated into the model included the natural history of HCV disease, the costs of DAA administration, the costs of treating the adverse outcomes of HCV disease, and quality of life of individuals infected with HCV. The model indicated that, compared with no DAA treatment, use of the generic drugs in HCV-infected Indian patients would increase life expectancy by more than eight years while reducing lifetime health care costs by more than $1,300 per person. Payback for the upfront costs of DAA drugs would be achieved in an overall average of less than 10 years - under 5 years for patients at advanced stages of HCV disease and almost 12 years if treatment begins at earlier stages. Even though there was wide variation in the factors -- such as patient age, disease stage, and viral genotype - input to the model, results always indicated that generic DAA treatment reduced lifetime costs. "Our hypothesis was that treatment would be cost saving, given the low drug costs in India. However, we were pleasantly surprised to find that the full payback was achieved so soon after treatment," says Chhatwal, who is an assistant professor of Radiology at Harvard Medical School. "Our finding that treatment pays back its initial costs makes a very strong statement - that investment in HCV screening and treatment should be a priority for public health agencies in India and other countries where generic DAAs are available. It could also be argued that generic DAAs should be made available in other low- and middle-income countries where HCV infection is common and budgets for treatment limited." Lead author Rakesh Aggarwal, MD, DM, of the Department of Gastroenterology at Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), a WHO Collaborating Center on Viral Hepatitis, says, "This is a win-win situation for the low- and low-middle-income countries where the generic DAAs can be sold. If these countries spend money on HCV treatment today, they will recoup it in the form of reduced health care expenditure within less than one decade. There is hardly any other health care intervention with such good return. Our results should show political leaders in those countries that they have a wonderful opportunity to make a difference for their constituents." Additional co-authors PLOS ONE paper are Qiushi Chen, PhD, MGH Institute of Technology Assessment; Amit Goel, MD, DM, SGPGIMS; Nicole Seguy, MD, MPH, and Razia Pendse, MD, MPH, World Health Organization; and Turgay Ayer, PhD, Georgia Institute of Technology. Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $800 million and major research centers in HIV/AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, genomic medicine, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, photomedicine and transplantation biology. The MGH topped the 2015 Nature Index list of health care organizations publishing in leading scientific journals and earned the prestigious 2015 Foster G. McGaw Prize for Excellence in Community Service. In August 2016 the MGH was once again named to the Honor Roll in the U.S. News & World Report list of "America's Best Hospitals."


News Article | November 21, 2016
Site: www.eurekalert.org

Adoption of novel oral targeted therapies for treatment of chronic lymphocytic leukemia (CLL) could raise the treatment costs for the blood-system cancer in the U.S. by almost 600 percent. In their analysis in the Journal of Clinical Oncology, a Massachusetts General Hospital (MGH)-led research team demonstrates how, at current prices, new targeted therapies for CLL - the most common form of leukemia in the western world - could financially burden patients and payers. "The rising cost of cancer care is a serious concern," says Jagpreet Chhatwal, PhD, of the MGH-based Institute for Technology Assessment, corresponding author of the paper that has been published online. "The average cost of annual cancer treatment, which was below $10,000 per patient before 2000 has now increased to more than $100,000. Such increasing trends can limit access to new therapies, potentially undermining their clinical effectiveness. These new drugs are highly effective, but their high costs motivated us to project their changing economic burden and affordability." In contrast to chemotherapy, which kills fast-growing cells throughout the body, targeted therapy drugs act by directly interfering with metabolic pathways driving cancer growth. As a result, they have fewer side effects, and they have shown to be better than chemotherapy-based approaches in clinical trials. Several targeted drugs have been approved for CLL treatment in recent years, initially for patients with specific gene mutation associated with poor survival outcomes or with relapsed diseases resistant to chemoimmunotherapies. Earlier this year oral targeted therapies became the first-line standard of care for CLL treatment in all patients. But since these drugs can cost around $130,000 per year and treatment may be continued indefinitely - compared with $60,000 to $100,000 for a single, six-month course of chemotherapy - the researchers investigated the potential financial impact of these drugs on payers' budgets, as well as on Medicare-enrolled patients, who represent the majority of CLL patients in the U.S. Based on both drug costs and the fact that patients receiving targeted treatment are likely to live longer, the researchers projected that: Qiushi Chen, PhD, co-lead author of the study and a research scientist at the Institute for Technology Assessment, explains, "Such substantial increases in the cost are mainly driven by high drug prices, prolonged treatment duration and the increase in the number of patients living with CLL." Whereas the standard measure used to determine the cost effectiveness of a medical intervention is whether it costs less than $100,000 for each additional year of life gained, the projected cost effectiveness ratio of oral targeted CLL therapy is $189,000 for each year gained. Chhatwal, who is an assistant professor of Radiology at Harvard Medical School, adds, "At the current average wholesale prices, oral targeted therapies for CLL are not cost effective, and prices would need to drop by 50 to 70 percent to become cost-effective. Studies also have shown that high out-of-pocket costs for cancer care not only cause financial hardships for patients but also reduce their quality of life through anxiety, stress and worry about paying those large bills. Lower-income patients may be unable to afford these therapies at all." Co-lead author, Nitin Jain, MD, an assistant professor at the University of Texas M.D. Anderson Cancer Center, stresses, "We are not recommending that clinicians choose less effective CLL management strategies that do not include oral targeted therapies. Instead we propose that the prices of these drugs need to be reduced to make the treatment cost-effective and more affordable, something we hope may happen with all cancer drugs. We also believe more research is needed to explore whether we can discontinue targeted treatment of patients who have responded well without risking worsening of their health." Additional co-authors of the Journal of Clinical Oncology paper are Turgay Ayer, PhD, MSc, Georgia Institute of Technology; William Wierda, MD, PhD, Michael Keating, MBBS, and Hagop Kantarjian, MD, University of Texas M.D. Anderson Cancer Center; Christopher Flowers, MD, Emory University; and Susan O'Brien, MD, University of California Irvine Medical Center. Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $800 million and major research centers in HIV/AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, photomedicine and transplantation biology. The MGH topped the 2015 Nature Index list of health care organizations publishing in leading scientific journals and earned the prestigious 2015 Foster G. McGaw Prize for Excellence in Community Service. In August 2016 the MGH was once again named to the Honor Roll in the U.S. News & World Report list of "America's Best Hospitals."


Zalis M.E.,Massachusetts General Hospital | Blake M.A.,Massachusetts General Hospital | Cai W.,Massachusetts General Hospital | Hahn P.F.,Massachusetts General Hospital | And 11 more authors.
Annals of Internal Medicine | Year: 2012

Background: Colon screening by optical colonoscopy (OC) or computed tomographic colonography (CTC) requires a laxative bowel preparation, which inhibits screening participation. Objective: To assess the performance of detecting adenomas 6 mm or larger and patient experience of laxative-free, computeraided CTC. Design: Prospective test comparison of laxative-free CTC and OC. The CTC included electronic cleansing and computer-aided detection. Optical colonoscopy examinations were initially blinded to CTC results, which were subsequently revealed during colonoscope withdrawal; this method permitted reexamination to resolve discrepant findings. Unblinded OC served as a reference standard. (ClinicalTrials.gov registration number: NCT01200303) Setting: Multicenter ambulatory imaging and endoscopy centers. Participants: 605 adults aged 50 to 85 years at average to moderate risk for colon cancer. Measurements: Per-patient sensitivity and specificity of CTC and first-pass OC for detecting adenomas at thresholds of 10 mm or greater, 8 mm or greater, and 6 mm or greater; per-lesion sensitivity and survey data describing patient experience with preparations and examinations. Results: For adenomas 10 mm or larger, per-patient sensitivity of CTC was 0.91 (95% CI, 0.71 to 0.99) and specificity was 0.85 (CI, 0.82 to 0.88); sensitivity of OC was 0.95 (CI, 0.77 to 1.00) and specificity was 0.89 (CI, 0.86 to 0.91). Sensitivity of CTC was 0.70 (CI, 0.53 to 0.83) for adenomas 8 mm or larger and 0.59 (CI, 0.47 to 0.70) for those 6 mm or larger; sensitivity of OC for adenomas 8 mm or larger was 0.88 (CI, 0.73 to 0.96) and 0.76 (CI, 0.64 to 0.85) for those 6 mm or larger. The specificity of OC at the threshold of 8 mm or larger was 0.91 and at 6 mm or larger was 0.94. Specificity for OC was greater than that for CTC, which was 0.86 at the threshold of 8 mm or larger and 0.88 at 6 mm or larger (P = 0.02). Reported participant experience for comfort and difficulty of examination preparation was better with CTC than OC. Limitations: There were 3 CTC readers. The survey instrument was not independently validated. Conclusion: Computed tomographic colonography was accurate in detecting adenomas 10 mm or larger but less so for smaller lesions. Patient experience was better with laxative-free CTC. These results suggest a possible role for laxative-free CTC as an alternate screening method. Primary Funding Source: GE Healthcare and the American Cancer Society. © 2012 American College of Physicians.


Bose-O'Reilly S.,UMIT University for Health Sciences, Medical Informatics and Technology | Drasch G.,Ludwig Maximilians University of Munich | Beinhoff C.,Gethsemanestr.4 | Rodrigues-Filho S.,University of Brasilia | And 8 more authors.
Science of the Total Environment | Year: 2010

Small scale miners use mercury to extract gold from ore in many countries. An environmental and health assessment was performed in Indonesia in two regions, Galangan in Central Kalimantan and Talawaan in Northern Sulawesi. The environmental assessment showed severe mercury contamination of the sediments, and increased mercury levels in local fish. For the health investigation 281 volunteers were recruited and examined by a standardized questionnaire, a neurological examination and neuro-psychological tests. A medical score was used consisting of significant factors of mercury intoxication. Mercury exposed workers showed typical symptoms of mercury intoxication, such as movement disorders (ataxia, tremor, dysdiadochokinesia, etc.). Blood, urine and hair samples were taken from any participant and analyzed for mercury. The mercury concentration in the biomonitors was high, partly extreme high in the working population, increased in the population living in the same habitat and low in the control group. By a standard protocol which includes a combination of threshold values of mercury in the biomonitors and a medical sum score the diagnosis of chronic mercury intoxication was made for highly burdened workers (amalgam smelters) in 55% in Sulawesi and in 62% in Kalimantan. Less exposed mineral processors and the general population in the mining areas were also intoxicated to a high percentage. © 2009 Elsevier B.V. All rights reserved.


Bose-O'Reilly S.,UMIT University for Health Sciences, Medical Informatics and Technology | Drasch G.,Ludwig Maximilians University of Munich | Beinhoff C.,Gethsemanestr.4 | Tesha A.,University of Dar es Salaam | And 7 more authors.
Science of the Total Environment | Year: 2010

In 2003 UNIDO (United Nations Industrial Development Organization) conducted an environmental and health assessment in a small-scale mining area in Tanzania. BGS (British Geological Survey) performed the environmental assessment. The Institute of Forensic Medicine - University of Munich performed the health assessment. The results of the medical, neurological and neuro-psychological examination of 180 participants from the affected area of Rwamagasa and 31 controls were analyzed. Urine, blood and hair samples were analyzed to detect the level of mercury body burden. Mercury concentrations in the bio-monitors urine, blood and hair were statistically significantly higher in the exposed population from Rwamagasa compared to the control group from Katoro. Only amalgam burners showed mercury levels above the toxicological threshold limits. A speciation of mercury in hair indicated that mainly elemental mercury vapor contributed to the high body burden of the artisanal miners. 104 amalgam-burners, the most exposed population group, were examined. 25 of these workers were found to be intoxicated. Small-scale mining is a serious health hazard for amalgam burners. Reduction of the exposure is essential to prevent further damage. © 2009 Elsevier B.V. All rights reserved.


Kong C.Y.,Institute for Technology Assessment | Kong C.Y.,Harvard University | Nattinger K.J.,Institute for Technology Assessment | Nattinger K.J.,Massachusetts General Hospital | And 12 more authors.
Cancer Epidemiology Biomarkers and Prevention | Year: 2011

Background: The United States has experienced an alarming and unexplained increase in the incidence of esophageal adenocarcinoma (EAC) since the 1970s. A concurrent increase in obesity has led some to suggest a relationship between the two trends. We explore the extent of this relationship. Methods: Using a previously validated disease simulation model of white males in the United States, we estimated EAC incidence 1973 to 2005 given constant obesity prevalence and low population progression rates consistent with the early 1970s. Introducing only the observed, rising obesity prevalence, we calculated the incremental incidence caused by obesity. We compared these with EAC incidence data from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) registry to determine obesity's contribution to the rise therein. Incidences were converted to absolute numbers of cases using U.S. population data. Results: Using constant obesity prevalence, we projected a total of 30,555 EAC cases cumulatively over 1973 to 2005 and 1,151 in 2005 alone. Incorporating the observed obesity trend resulted in 35,767 cumulative EACs and 1,608 in 2005. Estimates derived from SEER data showed 111,223 cumulative and 7,173 cases in 2005. We conclude that the rise in obesity accounted for 6.5% of the increase in EAC cases that occurred from 1973 to 2005 and 7.6% in the year 2005. Conclusion: Using published OR for EAC among obese individuals, we found that only a small percentage of the rise in EAC incidence is attributable to secular trends in obesity. Impact: Other factors, alone and in combination, should be explored as causes of the EAC epidemic. ©2011 AACR.


Hayes J.H.,Dana-Farber Cancer Institute | Ollendorf D.A.,Institute for Clinical and Economic Review | Pearson S.D.,Institute for Clinical and Economic Review | Barry M.J.,Massachusetts General Hospital | And 3 more authors.
Annals of Internal Medicine | Year: 2013

Background: Observation is underutilized among men with localized, low-risk prostate cancer. Objective: To assess the costs and benefits of observation versus initial treatment. Design: Decision analysis simulating treatment or observation. Data Sources: Medicare schedules, published literature. Target Population: Men aged 65 and 75 years who had newly diagnosed low-risk prostate cancer (prostate-specific antigen level 10<μg/L, stage ≤T2a, Gleason score ≤3+3). Time Horizon: Lifetime. Perspective: Societal. Intervention: Treatment (brachytherapy, intensity-modulated radiation therapy, or radical prostatectomy) or observation (active surveillance [AS] or watchful waiting [WW]). Outcome Measures: Quality-adjusted life expectancy and costs. Results of Base-Case Analysis: Observation was more effective and less costly than initial treatment. Compared with AS, WW provided 2 additional months of quality-adjusted life expectancy (9.02 vs. 8.85 years) at a savings of $15 374 ($24 520 vs. $39 894) in men aged 65 years and 2 additional months (6.14 vs. 5.98 years) at a savings of $11 746 ($18 302 vs. $30 048) in men aged 75 years. Brachytherapy was the most effective and least expensive initial treatment. Results of Sensitivity Analysis: Treatment became more effective than observation when it led to more dramatic reductions in prostate cancer death (hazard ratio, 0.47 vs. WW and 0.64 vs. AS). Active surveillance became as effective as WW in men aged 65 years when the probability of progressing to treatment on AS decreased below 63% or when the quality of life with AS versus WW was 4% higher in men aged 65 years or 1% higher in men aged 75 years. Watchful waiting remained least expensive in all analyses. Limitation: Results depend on outcomes reported in the published literature, which is limited. Conclusion: Among these men, observation is more effective and costs less than initial treatment, and WW is most effective and least expensive under a wide range of clinical scenarios. © 2013 American College of Physicians.


Choi S.E.,Institute for Technology Assessment | Hur C.,Institute for Technology Assessment | Hur C.,Massachusetts General Hospital | Hur C.,Harvard University
Current Opinion in Gastroenterology | Year: 2012

Purpose of review: Our article discusses the current understanding of screening and surveillance options for Barrett's esophagus and emerging concepts that have the potential to improve the effectiveness and cost-effectiveness of surveillance. Recent findings: Although endoscopic surveillance of patients with Barrett's esophagus is commonly practiced in order to detect high-grade dysplasia and early esophageal adenocarcinoma (EAC), the reported incidence of EAC in Barrett's esophagus patients varies widely. Recent studies found the risk of progression from Barrett's esophagus to EAC to be significantly lower than previously reported, raising concerns regarding the limitations of current surveillance strategies. Advances in imaging techniques and their enhanced diagnostic accuracy may improve the value of endoscopic surveillance. Additionally, various efforts are ongoing to identify biomarkers that identify individuals at higher risk of cancer, possibly allowing for individual risk stratification. Summary: These new data highlight some of the opportunities to revise and improve surveillance in patients with Barrett's esophagus. The incorporation of new advances such as imaging techniques and biomarkers has the potential to improve the effectiveness and cost-effectiveness of new surveillance regimens. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Carlos R.C.,University of Michigan | Buist D.S.M.,Group Health Research Institute | Buist D.S.M.,University of Washington | Wernli K.J.,Group Health Research Institute | And 4 more authors.
Journal of the American College of Radiology | Year: 2012

The Patient-Centered Outcomes Research Institute was created in response to a mandate to conduct comparative effectiveness research in clinical care to inform decision making. The institute will be funded by the Patient-Centered Outcomes Research Trust Fund, through congressional set-asides, and by Medicare and private health insurers, through a per beneficiary fee. The institute is governed by a board with a broad stakeholder constitution. Key committees set the national agenda for patient-centered outcomes research, the agenda for funding priorities, and communication and dissemination of the evidence with the goal of increasing the rate of implementation of the evidence into policy. In imaging, patient-centered outcomes go beyond the traditional metrics of patient satisfaction. Instead, these outcomes need to encompass the benefits and harms, focus on outcomes relevant to patients, and provide information to inform decision making. Therefore, radiologists need to be involved as stakeholders in the design, conduct, and dissemination of this research. © 2012 American College of Radiology.

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