scholarly journals Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe

2020 ◽  
Vol 108 (2) ◽  
pp. 350-357 ◽  
Author(s):  
Rick A. Vreman ◽  
Huseyin Naci ◽  
Wim G. Goettsch ◽  
Aukje K. Mantel‐Teeuwisse ◽  
Sebastian G. Schneeweiss ◽  
...  
Keyword(s):  
United States ◽  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
The United States ◽  
Decision Making Under Uncertainty

PERSPECTIVE: SOME CONCLUSIONS FROM MY LIFE IN HEALTH TECHNOLOGY ASSESSMENT

2018 ◽  
Vol 34 (2) ◽  
pp. 131-133 ◽  
Author(s):  
H. David Banta
Keyword(s):  
United States ◽  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Cost Effective ◽  
Health Technology ◽  
The United States ◽  
Main Concern ◽  
United States Congress ◽  
Healthcare Interventions

I have worked in health technology assessment (HTA) since 1975, beginning in the United States Congress Office of Technology Assessment (OTA), where we were charged with defining “medical technology assessment”. My main concern in HTA has always been efficacy of healthcare interventions. After years in OTA, I was invited to the Netherlands in 1985, where the Dutch government invited me to head a special commission concerning future healthcare technology and HTA. From there, I became involved in over forty countries, beginning in Europe and then throughout the world. My most intense involvements, outside the United States and Europe, have been in Brazil, China, and Malaysia. During these 40-plus years, I have seen HTA grow from its earliest beginnings to a worldwide force for better health care for everyone. I have also had some growing concerns, outlined in this Perspective article. Within HTA, I am most disappointed by a narrow perspective of cost-effective analysis, which tends to ignore considerations of culture, society, ethics, and organizational and legal issues. In the general environment affecting HTA and health care, I am most concerned about the need to protect the independence of HTA activities from influences of the healthcare industries.

scholarly journals Health Technology Assessment in Health-Care Decisions in the United States

2009 ◽  
Vol 12 ◽  
pp. S39-S44 ◽  
Author(s):  
Sean D. Sullivan ◽  
John Watkins ◽  
Brian Sweet ◽  
Scott D. Ramsey
Keyword(s):  
United States ◽  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
The United States ◽  
Health Care Decisions

scholarly journals Health technology assessment in the United States

2009 ◽  
Vol 25 (S1) ◽  
pp. 33-41 ◽  
Author(s):  
Bryan Luce ◽  
Rebecca Singer Cohen
Keyword(s):  
United States ◽  
Private Sector ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Reform ◽  
Health Technology ◽  
The United States ◽  
Current Health ◽  
Personal Experiences ◽  
The Us

Objectives: To describe and explore the reasons for the current health technology assessment (HTA) landscape in the United States.Methods: Relying on multiple historical literature and other documents as well as drawing on personal experiences and observations, we describe, evaluate, and explain the evolving and dynamic HTA-related evidence landscape.Results: The present HTA-related landscape is a product of a dynamic, somewhat turbulent path in the United States. Many early aggressive federal efforts beginning in the 1970s were rejected in the 1980s only to be revived by the mid-1990s and continue to strengthen today, likely due to diffusing private sector political opposition from de-linking HTA from policy decisions (e.g., coverage, clinical guidelines) and omitting economic evaluation. Meanwhile, private sector HTA efforts have remained active during the entire period.Conclusions: The current HTA-related landscape is at least as dynamic as it has been at any point in its turbulent 30-year history and is likely to continue as health reform in the US is debated once again.

VP157 What Is The Response To Immuno-Oncology By Health Technology Assessment Agencies?

2017 ◽  
Vol 33 (S1) ◽  
pp. 220-221
Author(s):  
Judith Rubinstein ◽  
Boaz Adler ◽  
Jake Blumenthal ◽  
Ruth Chang ◽  
S. Yin Ho ◽  
...  
Keyword(s):  
United States ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Data Model ◽  
Health Technology ◽  
The United States ◽  
Economic Evaluations ◽  
Gemeinsamer Bundesausschuss ◽  
Chi Squared ◽  
Drug Review

INTRODUCTION:Immunotherapies are a relatively new innovative class of drug that have garnered excitement in the fight against cancer. In 2011, the immunotherapy drug, ipilimumab, was approved. Since then, four additional drugs have gained approval. This analysis evaluates the initial reception of immunotherapies by Health Technology Assessment (HTA) agencies.METHODS:The Context Matters Data Model was used to evaluate the regulatory and HTA agency decisions surrounding the five approved immunotherapies through November 2016: atezolizumab, elotuzumab, ipilimumab, nivolumab, and pembrolizumab. Thirty-three labels from Australia, Canada, Europe, and the United States, and ninety-two assessments from Agenzia Italiana del Farmaco (AIFA), Gemeinsamer Bundesausschuss (Federal Joint Committee; G-BA), Haute Autorité de Santé (French National Authority for Health; HAS), Institute for Clinical and Economic Review (ICER), Institute for Quality and Efficiency in Health Care (IQWiG), National Institute for Health and Care Excellence (NICE), Pharmaceutical Benefits Advisory Committee (PBAC), pan-Canadian Oncology Drug Review (pCODR), and Scottish Medicines Consortium (SMC) were found. Using a sample t-test and a chi-squared test, reimbursement agencies’ decisions were evaluated, and the clinical and economic factors that went into these decisions were examined.RESULTS:Of the evaluated reviews: sixty-four were for melanoma indications, fourteen were for non-small-cell lung cancer (NSCLC) indications, and seven were for kidney cancer indications. Many of the reviews did not reach any decision, but 75 percent of HTA decisions (n = 72; p = .0000) reached were positive. Elotuzumab, approved for multiple myeloma, received a positive decision from G-BA and a negative one from SMC. There was an association between different disease conditions or drugs and the rate of positive decisions.For reviews that had clinical reasons for their decisions, 72.9 percent (n = 59; p = .0000) had positive clinical rationales that were associated with positive decisions (p = .000). Economic rationales for decisions were more mixed, with only 48.4 percent (n = 31; p = .0000) receiving positive decisions. Positive economic evaluations were also associated with positive decisions (p = .000). Atezolizumab, approved only in the United States at the time of this writing, has yet to be reviewed by any of the HTA agencies.CONCLUSIONS:Immunotherapies are promising new options for the treatment of cancer. Thus far, reception by HTA agencies has generally been positive.

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