+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)
Sale

Health Technology Assessment in Pharma: A Review of Major Decisions

  • PDF Icon

    Report

  • 82 Pages
  • April 2020
  • Region: Global
  • BCC Research
  • ID: 5014081
UP TO OFF until Aug 31st 2033

Report Scope:

The current report provides details about HTA processes in countries such as U.S., Canada and U.K. This report highlights information and insights on the molecules which were recently approved in terms of regulatory and reimbursement decisions. The report includes policies, country-specific HTA activities, drug overviews, mechanisms of action, disease backgrounds, clinical evidence on safety and efficacy, regulatory scenarios, and HTA evaluation details.

Report Includes:


  • 45 tables
  • A detailed outlook on the HTA process and its approvals in major pharma industries
  • Insights into the recent HTA submissions to HTA agencies by top pharmaceutical manufacturers
  • Discussion on how HTA helps in the development of safe, and effective health policies, thereby benefitting both patient and health care providers
  • Information about the medical, social, economic and ethical issues related to the use of a health technology
  • Company profiles of market-leading players, including Janssen Pharmaceuticals Inc., Merck & Co. Inc., AstraZeneca PLC, Eli Lilly and Co., and Hofmann-La Roche Inc.

Table of Contents

Chapter 1 Introduction
  • Introduction
  • Study Goals and Objectives
  • Reasons for Doing This Study
  • Scope of Report
  • Information Sources
  • Methodology
  • Analyst's Credentials
  • Custom Research
  • Related Reports


Chapter 2 Introduction to Health Technology Assessment
  • Introduction
  • Origins of Technology Assessment
  • Fundamental Concepts
  • Health Technology
  • Health Technology Categories
  • Purpose or Application
  • Stage of Diffusion
  • Health Technology Assessment
  • Purposes of HTA


Chapter 3 Pharmaceutical Industry’s Perspective on HTA
  • HTA and Efficiency
  • HTA: A Cost Driver
  • Implementation Barriers


Chapter 4 Overview of Global HTA Organizations
  • HTA in Europe
  • United Kingdom (England and Wales)
  • Scotland
  • Germany
  • France
  • Italy
  • HTA in North America
  • U.S.
  • Canada
  • HTA in the Asia-Pacific Region
  • Japan
  • China
  • Australia


Chapter 5 Daratumumab (Darzalex)
  • Overview of Daratumumab
  • Scientific Summary
  • Pharmacodynamics and Mechanism of Action
  • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
  • Multiple Myeloma: Disease Overview
  • Staging and Prognosis
  • Signs and Symptoms
  • Regulatory Milestones
  • Technology Assessment Decisions
  • NICE U.K.
  • SMC Scotland
  • Haute de santé (HAS) France
  • CADTH (pCODR) Canada
  • Company Profile
  • Janssen Pharmaceuticals Inc.


Chapter 6 Tildrakizumab (Ilumya)
  • Overview of Tildrakizumab
  • Scientific Summary
  • Pharmacodynamics and Mechanism of Action
  • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
  • Psoriasis: Disease Overview
  • Regulatory Milestones
  • Technology Assessment Decisions
  • NICE U.K.
  • SMC Scotland
  • Company Profile
  • Merck And Co. Inc.


Chapter 7 Durvalumab (Imfinzi)
  • Overview of Durvalumab
  • Scientific Summary
  • Pharmacodynamics and Mechanism of Action
  • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
  • Non-small Cell Lung Cancer: Disease Overview
  • Regulatory Milestones
  • Technology Assessment Decisions
  • NICE U.K.
  • SMC Scotland
  • CADTH (pCODR) Canada
  • HAS France
  • Company Profile
  • Astrazeneca Plc


Chapter 8 Abemaciclib (Verzenio)
  • Overview of Abemaciclib
  • Scientific Summary
  • Pharmacodynamics and Mechanism of Action
  • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
  • Breast Cancer: Disease Overview
  • Regulatory Milestones
  • Technology Assessment Decisions
  • NICE U.K.
  • SMC Scotland
  • CADTH (pCODR) Canada
  • HAS France
  • Company Profile
  • Eli Lilly and Co.


Chapter 9 Ocrelizumab (Ocrevus)
  • Overview of Ocrelizumab
  • Scientific Summary
  • Pharmacodynamics and Mechanism of Action
  • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
  • Multiple Sclerosis: Disease Overview
  • Regulatory Milestones
  • Technology Assessment Decisions
  • NICE U.K.
  • SMC Scotland
  • CADTH Canada
  • HAS France
  • Company Profile
  • Hoffmann-La Roche Inc.


Chapter 10 Conclusion
List of Tables
Table 1: Types of Health Technologies, by Category
Table 2: Types of Health Technologies, by Application
Table 3: Types of Health Technologies, by Stage of Diffusion
Table 4: National Healthcare Spending in Germany, by Sector/ Services, 2015-2017
Table 5: Key Organizations Involved in the Reimbursement of Pharmaceuticals and Medical Devices in France
Table 6: Key Organizations Involved in the Reimbursement of Pharmaceuticals in the U.S.
Table 7: Public Health Insurance Programs in the U.S.
Table 8: National Healthcare Expenditures in Canada, 2010-2019
Table 9: National Healthcare Expenditures of Canada, by Sector/Service, 2017
Table 10: Trends in Japanese Healthcare Expenditures, 1995-2016
Table 11: National Healthcare Expenditures in Japan, by Sector/Service, 1995-2014
Table 12: Distribution Shares of Healthcare Spending on Pharmaceuticals in China, 2017
Table 13: Trends in the Number of Medicines Included in Previous National Essential Medicines Lists, 1982-2009
Table 14: National Health Expenditures in Australia, by Sector/Service, 2017-2018
Table 15: Key U.S. Clinical Trials on Daratumumab
Table 16: Multiple Myeloma International Staging System
Table 17: Regulatory Milestones of Daratumumab, 2013-2015
Table 18: NICE Technology Assessment of Daratumumab
Table 19: SMC Technology Assessment of Daratumumab
Table 20: HAS Technology Assessment of Daratumumab
Table 21: CADTH-pCODR Technology Assessment of Daratumumab
Table 22: Key U.S. Clinical Trials on Tildrakizumab
Table 23: Tildrakizumab Regulatory Milestones
Table 24: NICE Technology Assessment of Tildrakizumab
Table 25: SMC Technology Assessment of Tildrakizumab
Table 26: Key U.S. Clinical Trials on Tildrakizumab
Table 27: Regulatory Milestones of Durvalumab
Table 28: NICE Technology Assessment of Durvalumab
Table 29: SMC Technology Assessment of Durvalumab
Table 30: CADTH-pCODR Technology Assessment of Durvalumab
Table 31: HAS Technology Assessment of Durvalumab
Table 32: Key U.S. Clinical Trials on Abemaciclib
Table 33: Regulatory Milestones of Abemaciclib
Table 34: NICE Technology Assessment of Abemaciclib
Table 35: SMC Technology Assessment of Abemaciclib
Table 36: CADTH-pCODR Technology Assessment of Abemaciclib
Table 37: HAS Technology Assessment of Abemaciclib
Table 38: Key U.S. Clinical Trials on Ocrelizumab
Table 39: Incidence and Prevalence of Multiple Sclerosis Cases, by Country, 2016
Table 40: Regulatory Milestones of Ocrelizumab
Table 41: NICE Technology Assessment of Ocrelizumab
Table 42: SMC Technology Assessment of Ocrelizumab
Table 43: CADTH Technology Assessment of Ocrelizumab
Table 44: HAS Technology Assessment of Ocrelizumab
List of Figures
Figure 1: Shares of Healthcare Expenditures in the U.K., by Sector, 2017
Figure 2: IQWiG Technology Assessment Process
Figure 3: IQWiG Conclusions on the Benefits of Assessments
Figure 4: Shares of National Healthcare Expenditures in the U.S., by Sector, 2018
Figure 5: Schematic of the Reimbursement Process in the U.S.
Figure 6: Features of the Asia-Pacific Market
Figure 7: Shares of Drugs Listed in the National Formulary of China, by Therapeutic Area, 2017
Figure 8: Management of Advanced Non-small Cell Lung Cancer and Expected Outcomes

Samples

Loading
LOADING...

Executive Summary

Since the 1900s, a continuous and rapid generation, innovation and improvement of medical technologies has been observed in the healthcare industries. Not all research and development in innovation results in overall health benefits, however, nor does their application lead to improved cost-effective solutions.

Global health systems need to achieve productivity and show value for money, and when combined with financial demands and resource constraints, they create a challenging decisionmaking environment for investing in health technology. To address these challenges, all technologies need to be assessed; those that are obsolete and not cost-effective, and that have been superseded, need to be eliminated. Technologies or innovations are evaluated by considering the availability of resources and to societal, economic, legal and ethical issues pertaining to the country or local setting.


Companies Mentioned

  • Astrazeneca Plc
  • CADTH Canada
  • Eli Lilly and Co.
  • HAS France
  • Hoffmann-La Roche Inc.
  • Janssen Pharmaceuticals Inc.
  • Merck and Co. Inc.
  • NICE U.K.
  • SMC Scotland