HEOR/ HTA/ PRO and Clinical Regulatory

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This document lists several drugs from different companies and the HEOR value proposition studies, HTA submissions, patient reported outcomes research, and regulatory work that has been conducted for each. Studies include US HCUP/Premier data, published studies in Australia and Canada, global health state utility valuations, EORTC trials, FDA/EMA submissions, and indirect economic analyses for conditions like CNS disorders, cardiovascular disease, endocrinology, oncology, rheumatology, and respiratory disease.

Dados e análise

SELECTED LIST OF DRUGS: HEOR VALUE PROPOSITION STUDIES/ HTA GLOBAL AND LOCAL PREPARATIONS/
PATIENT REPORTED OUTCOMES/ QOL AND CLINICAL /REGULATORY WORK
Company Drug HEOR Value
Propositions
HTA Submissions Patient Reported
Outcomes/
Quality of Life
NDA/ Regulatory CSR
CNS
Ortho-McNeil Tapentadol US HCUP/ Premier PRO
Janssen-Cilag Risperidone Australia/ published Canada/ Australia Health State
Utilities
Janssen-Cilag Risperidone Contra Australia Australia
AstraZeneca Quetiapine Canada/ UK Canada Health State
Utilities
QUEST Trial
Eisai Perampanel Global Global Health State
Utilities
GSK Lamotrigine US
BMS Aripiprazole US/ Pharmerit data
Cardiovascular
Sankyo Olmesartan US/ Managed care
data
US-AMCP CS866-306
Daichii-Sankyo Olmesartan US/ Germany/ EU-5 CS866-411
BMS Irbesartan Global Global Multiple Trials
Sanofi/BMS Irbesartan Europe
Nycomed Olmesartan Norway
Sanofi Ramapril Australia
Abbott Niacin Australia
Daichii-Sankyo Colesavelam US US AMCP
Servier Ivabradine Global Australia
Atherosclerosis
Sanofi/ BMS Clopidogrel Global Global CAPRIE
Sanofi/ BMS Clopidogrel Australia (ACS)

Endocrinology
Sanofi Insulin Glargine Australia Australia/ US
Sanofi U300 US/ UK
Daichii-Sankyo Colesavelam US WEL 301, 302, 303
Oncology
AstraZeneca Anastrozole Canada/ UK EORTC/ Health
State Utilities
AstraZeneca Zoladex Canada/ UK EORTC/ Health
State Utilities
AstraZeneca Faslodex Global EORTC
BMS Dasatinib US
Merck Pembrolizumab Global
Eisai Eribulin Global Global EORTC FDA/ EMA
Eisai Lenvatinib Global
Eisai Farlatuzamab EORTC FDA/ EMA
Sanofi Taxotere Australia Health State
Utilities
Rheumatology
BMS Abatacept US Indirect
Economics
Respiratory
AstraZeneca Zafirlukast Canada ASUI

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HEOR/ HTA/ PRO and Clinical Regulatory

1. SELECTED LIST OF DRUGS: HEOR VALUE PROPOSITION STUDIES/ HTA GLOBAL AND LOCAL PREPARATIONS/ PATIENT REPORTED OUTCOMES/ QOL AND CLINICAL /REGULATORY WORK Company Drug HEOR Value Propositions HTA Submissions Patient Reported Outcomes/ Quality of Life NDA/ Regulatory CSR CNS Ortho-McNeil Tapentadol US HCUP/ Premier PRO Janssen-Cilag Risperidone Australia/ published Canada/ Australia Health State Utilities Janssen-Cilag Risperidone Contra Australia Australia AstraZeneca Quetiapine Canada/ UK Canada Health State Utilities QUEST Trial Eisai Perampanel Global Global Health State Utilities GSK Lamotrigine US BMS Aripiprazole US/ Pharmerit data Cardiovascular Sankyo Olmesartan US/ Managed care data US-AMCP CS866-306 Daichii-Sankyo Olmesartan US/ Germany/ EU-5 CS866-411 BMS Irbesartan Global Global Multiple Trials Sanofi/BMS Irbesartan Europe Nycomed Olmesartan Norway Sanofi Ramapril Australia Abbott Niacin Australia Daichii-Sankyo Colesavelam US US AMCP Servier Ivabradine Global Australia Atherosclerosis Sanofi/ BMS Clopidogrel Global Global CAPRIE Sanofi/ BMS Clopidogrel Australia (ACS)

2. Endocrinology Sanofi Insulin Glargine Australia Australia/ US Sanofi U300 US/ UK Daichii-Sankyo Colesavelam US WEL 301, 302, 303 Oncology AstraZeneca Anastrozole Canada/ UK EORTC/ Health State Utilities AstraZeneca Zoladex Canada/ UK EORTC/ Health State Utilities AstraZeneca Faslodex Global EORTC BMS Dasatinib US Merck Pembrolizumab Global Eisai Eribulin Global Global EORTC FDA/ EMA Eisai Lenvatinib Global Eisai Farlatuzamab EORTC FDA/ EMA Sanofi Taxotere Australia Health State Utilities Rheumatology BMS Abatacept US Indirect Economics Respiratory AstraZeneca Zafirlukast Canada ASUI

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