Health Technology Assessment in Pharma: A Review of Major Decisions
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:
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.
CHAPTER 1 INTRODUCTION
Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Analyst's Credentials
BCC Custom Research
Related BCC Research 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 santй (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
Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Analyst's Credentials
BCC Custom Research
Related BCC Research 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 santй (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
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
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
