THERAPEUTIC CLASS REPORT: WILL NEXT GENERATION ORAL ANTICOAGULANTS REPLACE WARFARIN AS MAINSTAY THERAPY
WILL WARFARIN CONTINUE AS A MAINSTAY TREATMENT IN THE ERA OF NEXT GENERATION ORAL ANTICOAGULANTS
Pradaxa: With first mover advantage, Will it be the Leader in SPAF?
Xarelto: Is it the future mainstay anticoagulant therapy?
Eliquis and Edoxaban: Would they be able to differentiate enough?
In the coming months, there are major regulatory and clinical milestones with regard to the new generation of oral anticoagulants (Pradaxa, Xarelto, Eliquis and Edoxaban), which will have wide ranging impact on the treatment paradigm in several therapeutic areas encompassing - stroke prevention in atrial fibrillation / DVT Treatment / VTE prevention in medically ill patients and Acute coronary syndrome.
This therapy class report analyses the practical issues in the adoption of new generation anticoagulants, major upcoming milestones, clinical trial design/data and cost-effectiveness of recently launched and upcoming molecules. This report will provide insightful information about the performance of molecules in oral anticoagulation arena in all the indications (SPAF, VTE, ACS) and the way these newer drugs will be positioned to garner the benefits against Aspirin/Warfarin/Lovenox are discussed.
Pradaxa: With first mover advantage, Will it be the Leader in SPAF?
Xarelto: Is it the future mainstay anticoagulant therapy?
Eliquis and Edoxaban: Would they be able to differentiate enough?
In the coming months, there are major regulatory and clinical milestones with regard to the new generation of oral anticoagulants (Pradaxa, Xarelto, Eliquis and Edoxaban), which will have wide ranging impact on the treatment paradigm in several therapeutic areas encompassing - stroke prevention in atrial fibrillation / DVT Treatment / VTE prevention in medically ill patients and Acute coronary syndrome.
This therapy class report analyses the practical issues in the adoption of new generation anticoagulants, major upcoming milestones, clinical trial design/data and cost-effectiveness of recently launched and upcoming molecules. This report will provide insightful information about the performance of molecules in oral anticoagulation arena in all the indications (SPAF, VTE, ACS) and the way these newer drugs will be positioned to garner the benefits against Aspirin/Warfarin/Lovenox are discussed.
1. ANTICOAGULANTS MARKET
Market size and Segmentation – By Drugs and Indications
Goals (Duration) of Current anticoagulant therapy in different indications
New generation anticoagulants pipeline
Major Upcoming Milestones
Estimated launch timelines for new generation anticoagulants– Indication wise
Characteristic of Ideal anticoagulant
Factor Xa Vs. Direct Thrombin inhibitor
2. STROKE PREVENTION IN ATRIAL FIBRILLATION
The Current Market Dynamics- Geography wise prevalence of SPAF and treatment paradigm of anticoagulation therapy in SPAF
The need for new generation anticoagulants
Does higher unmet need prevail in high risk (CHADS2 score) patients or low risk patients?
Experts view on the hurdles to the adoption of new generation anticoagulants in SPAF
Factors that will influence the choice of anticoagulation therapy in Atrial Fibrillation – Regulatory and Clinical
Patient’s history of stroke and bleeding risk factors impacting treatment decision
Regulatory Scenario – Medicare Shared Saving program to be implemented in 2012
Reimbursement status of PT/INR monitoring for warfarin in major countries
Physician’s Experience and cost effectiveness
Warfarin Genotype testing, its regulatory approval and its reimbursement
Warfarin continues to hold itself strong against Pradaxa – Will the entry of Xarelto / Eliquis / Edoxaban change the scenario?
Clinical data comparision of AVERROES, RELY and ROCKET AF Studies and our analysis on each clinical data
Baseline and Trial Design comparisons – RELY, ROCKET AF AND ARISTOTLE
Overall Efficacy and Safety comparison – ROCKET, RELY AND AVERROES
Efficacy and safety comparison in high risk patient’s population
Clinical data analysis from ROCKET- AF detail data
AVERROES trial rationale and results – No commercial implications
What to expect from the detailed data of ARISTOTLE (Eliquis) at ESC?
FDA Advisory Committee’s – The Key Questions on Xarelto for approval in SPAF - Will the Label be comparable to Pradaxa?
Universal antidote for novel oral anticoagulants
The Future Mainstay Treatment In SPAF - Xarelto Or Pradaxa Or Eliquis
3. ROLE OF NEW GENERATION ORAL ANTICOAGULANTS IN VTE PREVENTION IN ORTHOPEDIC SURGERY
Prevalence of VTE after Total Hip Replacement Surgery / Total Knee Replacement Surgery
The need and importance for extended prophylaxis and current limitations
Clinical data comparison – Xarelto, Eliquis and Pradaxa
4. ROLE OF NEW GENERATION ORAL ANTICOAGULANTS IN VTE PREVENTION IN MEDICALLY ILL PATIENTS
Market segmentation based on Illness
Risk/Incidence of DVT and Fatal PE in different categories of Medically Ill Patients
Incidence Of DVT In Orthopedic Surgery Vs. Acute Medically Ill Patients
VTE Prevention in Cancer Patients – VTE incidence rates in different types of cancer
Ongoing clinical studies
Xarelto – Review of MAGELLAN study
Semuloparin - Clinical data comparison Of VTE prophylaxis in cancer Patients
5. ROLE OF NEW GENERATION ORAL ANTICOAGULANTS - VTE TREATMENT
New Generation anticoagulants will expand the DVT treatment opportunity manifold
Pradaxa - RECOVER study
Eliquis - BOTTICELLI Study and AMPLIFY study
Xarelto – EINSTEIN DVT study
Xarelto – EINSTEIN EXT study
Xarelto – Other Ongoing studies
Edoxaban – HOKUSAI study
Clinical data comparison from DVT treatment studies
6. FACTOR XA INHIBITORS- DO THEY HAVE POTENTIAL TO BE AN IDEAL ANTICOAGULANT FOR SECONDARY PREVENTION OF ACS?
Historically anticoagulant have failed to show a positive risk-reward profile in ACS - Xarelto is likely to be an exception
Clinical data comparison of Anticoagulant as add on to current ACS treatment vs. Newer Antiplatelets agent
Upcoming clinical data newsflow which has potential to change market dynamics
7. WHO IS BETTER POSITIONED IN EARLY STAGE FACTOR Xa INHIBITORS? – YM150
LY517717
Eribaxaban
Betrixaban
TAK-442
8. HOW THE NEXT GENERATION ORAL ANTICOAGULANTS WOULD STACK UP?
ANNEXURES
Goals of Anticoagulation therapy
Current Anticoagulation - Market Segmentation by drugs and Indication
Characteristics of an Ideal Anticoagulant
New Generation Anticoagulant Pipeline
Clinical profile
a) Rivaroxaban
b) Dabigatran
c) Apixaban
d) Edoxaban
e) Betrixaban
f) Other Early Stage Compounds- YM 150, TAK 442
Preclinical profile of Eliquis, Pradaxa and Xarelto
Pharmacokinetic/dynamic comparison of Factor Xa inhibitors/direct Thrombin inhibitor vs. Warfarin
Clinical Data comparison of major anticoagulants in VTE prevention
Prevalence of VTE after Total Hip Replacement Surgery / Total Knee Replacement Surgery
VTE Incidence in patients taking prophylaxis Vs. Those not taking Prophylaxis post Discharge
Rate of Fatal PE Emboli and DVT In different categories of Medically Ill Patients
Reported VTE incidences In Various types of Cancer
Comparison of Clinical data from Trials – Prevention of VTE in cancer Patients
Clinical Data comparison major anticoagulants in DVT treatment
Clinical Data comparison major anticoagulants in ACS Liver Toxicity
Long term safety concern: Liver Toxicity
Assessment of Bleeding Risk
Clinical Data comparison - Stroke Prevention In AF Studies (Edoxaban, Betrixaban, Pradaxa, Exanta, Warfarin, aspirin, Eliquis, Xarelto)
Stroke Prevention in Atrial Fibrillation – Market segmentation by drug usage srosivdA PMNext Generation Oral Anticoagulants / 05
Baseline Characteristics Comparison Of Pivotal Trials In SPAF – ROCKET, RELY, ARISTOTLE and AVERROES
Reimbursement status of PT/INR monitoring for warfarin in major countries
Estimated launch timelines for new generation anticoagulants– Indication wise
PhIII Trial Design of late stage Factor Xa Inhibitors for Stroke Prevention in AF
Mortality Rate in Atrial Fibrillation – By Gender and Age
Stroke Rate Per 100 Patient Years Increases Substantially With CHADS2 Score
Reported VTE Incidences In Various Cancer
Incidence Of DVT In Orthopedic Surgery Vs. Acute Medically Ill Patients
Risk / Incidence of DVT and Fatal PE in different categories of Medically Ill Patients
Ongoing Clinical trials in ACS, whose outcome will have significant implications on the treatment paradigm and market potential
Clinical data comparison – VTE Prevention in Medically Ill Patients
Upcoming Milestones – New Generation Anticoagulants
Market size and Segmentation – By Drugs and Indications
Goals (Duration) of Current anticoagulant therapy in different indications
New generation anticoagulants pipeline
Major Upcoming Milestones
Estimated launch timelines for new generation anticoagulants– Indication wise
Characteristic of Ideal anticoagulant
Factor Xa Vs. Direct Thrombin inhibitor
2. STROKE PREVENTION IN ATRIAL FIBRILLATION
The Current Market Dynamics- Geography wise prevalence of SPAF and treatment paradigm of anticoagulation therapy in SPAF
The need for new generation anticoagulants
Does higher unmet need prevail in high risk (CHADS2 score) patients or low risk patients?
Experts view on the hurdles to the adoption of new generation anticoagulants in SPAF
Factors that will influence the choice of anticoagulation therapy in Atrial Fibrillation – Regulatory and Clinical
Patient’s history of stroke and bleeding risk factors impacting treatment decision
Regulatory Scenario – Medicare Shared Saving program to be implemented in 2012
Reimbursement status of PT/INR monitoring for warfarin in major countries
Physician’s Experience and cost effectiveness
Warfarin Genotype testing, its regulatory approval and its reimbursement
Warfarin continues to hold itself strong against Pradaxa – Will the entry of Xarelto / Eliquis / Edoxaban change the scenario?
Clinical data comparision of AVERROES, RELY and ROCKET AF Studies and our analysis on each clinical data
Baseline and Trial Design comparisons – RELY, ROCKET AF AND ARISTOTLE
Overall Efficacy and Safety comparison – ROCKET, RELY AND AVERROES
Efficacy and safety comparison in high risk patient’s population
Clinical data analysis from ROCKET- AF detail data
AVERROES trial rationale and results – No commercial implications
What to expect from the detailed data of ARISTOTLE (Eliquis) at ESC?
FDA Advisory Committee’s – The Key Questions on Xarelto for approval in SPAF - Will the Label be comparable to Pradaxa?
Universal antidote for novel oral anticoagulants
The Future Mainstay Treatment In SPAF - Xarelto Or Pradaxa Or Eliquis
3. ROLE OF NEW GENERATION ORAL ANTICOAGULANTS IN VTE PREVENTION IN ORTHOPEDIC SURGERY
Prevalence of VTE after Total Hip Replacement Surgery / Total Knee Replacement Surgery
The need and importance for extended prophylaxis and current limitations
Clinical data comparison – Xarelto, Eliquis and Pradaxa
4. ROLE OF NEW GENERATION ORAL ANTICOAGULANTS IN VTE PREVENTION IN MEDICALLY ILL PATIENTS
Market segmentation based on Illness
Risk/Incidence of DVT and Fatal PE in different categories of Medically Ill Patients
Incidence Of DVT In Orthopedic Surgery Vs. Acute Medically Ill Patients
VTE Prevention in Cancer Patients – VTE incidence rates in different types of cancer
Ongoing clinical studies
Xarelto – Review of MAGELLAN study
Semuloparin - Clinical data comparison Of VTE prophylaxis in cancer Patients
5. ROLE OF NEW GENERATION ORAL ANTICOAGULANTS - VTE TREATMENT
New Generation anticoagulants will expand the DVT treatment opportunity manifold
Pradaxa - RECOVER study
Eliquis - BOTTICELLI Study and AMPLIFY study
Xarelto – EINSTEIN DVT study
Xarelto – EINSTEIN EXT study
Xarelto – Other Ongoing studies
Edoxaban – HOKUSAI study
Clinical data comparison from DVT treatment studies
6. FACTOR XA INHIBITORS- DO THEY HAVE POTENTIAL TO BE AN IDEAL ANTICOAGULANT FOR SECONDARY PREVENTION OF ACS?
Historically anticoagulant have failed to show a positive risk-reward profile in ACS - Xarelto is likely to be an exception
Clinical data comparison of Anticoagulant as add on to current ACS treatment vs. Newer Antiplatelets agent
Upcoming clinical data newsflow which has potential to change market dynamics
7. WHO IS BETTER POSITIONED IN EARLY STAGE FACTOR Xa INHIBITORS? – YM150
LY517717
Eribaxaban
Betrixaban
TAK-442
8. HOW THE NEXT GENERATION ORAL ANTICOAGULANTS WOULD STACK UP?
ANNEXURES
Goals of Anticoagulation therapy
Current Anticoagulation - Market Segmentation by drugs and Indication
Characteristics of an Ideal Anticoagulant
New Generation Anticoagulant Pipeline
Clinical profile
a) Rivaroxaban
b) Dabigatran
c) Apixaban
d) Edoxaban
e) Betrixaban
f) Other Early Stage Compounds- YM 150, TAK 442
Preclinical profile of Eliquis, Pradaxa and Xarelto
Pharmacokinetic/dynamic comparison of Factor Xa inhibitors/direct Thrombin inhibitor vs. Warfarin
Clinical Data comparison of major anticoagulants in VTE prevention
Prevalence of VTE after Total Hip Replacement Surgery / Total Knee Replacement Surgery
VTE Incidence in patients taking prophylaxis Vs. Those not taking Prophylaxis post Discharge
Rate of Fatal PE Emboli and DVT In different categories of Medically Ill Patients
Reported VTE incidences In Various types of Cancer
Comparison of Clinical data from Trials – Prevention of VTE in cancer Patients
Clinical Data comparison major anticoagulants in DVT treatment
Clinical Data comparison major anticoagulants in ACS Liver Toxicity
Long term safety concern: Liver Toxicity
Assessment of Bleeding Risk
Clinical Data comparison - Stroke Prevention In AF Studies (Edoxaban, Betrixaban, Pradaxa, Exanta, Warfarin, aspirin, Eliquis, Xarelto)
Stroke Prevention in Atrial Fibrillation – Market segmentation by drug usage srosivdA PMNext Generation Oral Anticoagulants / 05
Baseline Characteristics Comparison Of Pivotal Trials In SPAF – ROCKET, RELY, ARISTOTLE and AVERROES
Reimbursement status of PT/INR monitoring for warfarin in major countries
Estimated launch timelines for new generation anticoagulants– Indication wise
PhIII Trial Design of late stage Factor Xa Inhibitors for Stroke Prevention in AF
Mortality Rate in Atrial Fibrillation – By Gender and Age
Stroke Rate Per 100 Patient Years Increases Substantially With CHADS2 Score
Reported VTE Incidences In Various Cancer
Incidence Of DVT In Orthopedic Surgery Vs. Acute Medically Ill Patients
Risk / Incidence of DVT and Fatal PE in different categories of Medically Ill Patients
Ongoing Clinical trials in ACS, whose outcome will have significant implications on the treatment paradigm and market potential
Clinical data comparison – VTE Prevention in Medically Ill Patients
Upcoming Milestones – New Generation Anticoagulants
