2. Tasigna’sTasigna’s
Glivec established
as a preferred 1st
line drug and has
a significant
market share
Glivec established
as a preferred 1st
line drug and has
a significant
market share
Aemulus enjoys
70% market share
as 2nd line
treatment against
30% for Tasigna
Aemulus enjoys
70% market share
as 2nd line
treatment against
30% for Tasigna
Tasigna has first to
market advantage
Tasigna has first to
market advantage
Current CML Market in Spain
Launch
Strategy
for Tasigna
Launch
Strategy
for Tasigna
Tasigna’s
approved as 1st
line drug
Tasigna’s
approved as 1st
line drug
market advantage
as 1st line over
Aemulus by 5
months
market advantage
as 1st line over
Aemulus by 5
months
3. Recommendations
Short-Term Strategy
Timeline: July 2011 – Dec 2012
Promotion - Tasigna as first-line
treatment for CML
Positioning – “Fastest Response
to CML”
Long-Term Strategy
Timeline: January 2013 and
beyond
Consolidate Tasigna’s Position in
the CML value chain
Active stakeholder engagement
to CML”
Market Access – “Payment-by-
performance” model
Penetration – Region-based
Pre-emptive market access
strategy for pipeline drugs
Active stakeholder engagement
Push pipeline products as 2nd
Line Treatment
Development of “preventive”
medication such as vaccines
6. The market – Spanish Pharmaceutical Industry
Central Government Health Administration
- Basic Legislation & Budget Allocation
- General Coordination of the Spanish National Health System
(SNS)
- Pharmaceutical Policy
17 Autonomous Community Health Administrations
- Regional Health Legislation
- Health Insurance
- Health Service Planning, Management & Provision- Health Service Planning, Management & Provision
- Decentralization Policies
Health Areas (provincial and municipality)
- Max. Population: 200,000-250,000
- Sanitation provision
- Direct Management of Public Health and Community Services
The legislation changes to the statutory SNS in 2009, have handed greater autonomy
and importance to the role of the 17 autonomous communities (AC’s)
7. The market – Spanish Pharmaceutical Industry
Present
• Key Opinion Leaders – Critical Stakeholders
• Visibility to payer (Regional government) essential
• Payment mechanisms controlled by regional governments
• Efficacy – still the most important parameter for payer
• Increased importance to cost
Future
• Increased importance to cost
• ‘Prevention’ preferred to cure
• Private Insurance companies
• Prospective healthcare privatisation
9. Efficacy comparison
Parameter Best Efficacy Displayed
Estimated overall rate of survival Tasigna
CCyR Tasigna / Aemulus *
MMR Tasigna
MR Tasigna
Progression to AP/BC Tasigna
Number of Deaths TasignaNumber of Deaths Tasigna
Dosage Guidelines Aemulus / Glivec **
*Tasigna better over 24 months; Aemulus better over 12 months
** Displayed here due to relevance
Key results in favour of Tasigna:
•1 year MMR 4% higher than Glivec and 11 percent higher than Aemulus
• Estimated rate of overall survival 99.3% (highest among all)
• Lowest rate of AP/BC progression
• CML related of deaths - 38% lower than Aemulus and 50% lower than Glivec
10. Safety comparison
• Nausea, diarrhoea, rash, myalgias, fluid retention
• Low adverse side effects with all three drugs
• Glivec shows best safety parameters, followed by Tasigna
Non-haematological
side-effects
•Anaemia, Neutropenia
•Tasigna displays best safety factor
•Observed in less than 50% of patients taking Tasigna than with those
Haematological side-
effects •Observed in less than 50% of patients taking Tasigna than with those
taking Aemulus
effects
Conclusions from Trials:
•Tasigna is superior to Glivec and Aemulus in both the primary end point (MMR) and key
secondary end point (CCyR)
•Disease progression to AP/BC was significantly lower in Tasigna than the other two
•Tasigna has better side-effects profile and better compliance
12. Stakeholder Management
Stakeholder Relevance
(Current)
Relevance
future trend
How to approach
Payer/ government High Very High Key account managers
KOLs High Slight
decrease
Medical Scientific Liaisons
Hospital management Moderate
to High
Constant Sales Representatives
to High
Physicians Low to
Moderate
Slight
Increase
Sales Representatives / Medical
Scientific Liaisons
Patient Low Slight
Increase
Patient Advocacy Group /
Social Media / Cancer Centers
Private
Insurance/Hospitals
Low Slight
increase
Sales Representatives
13. The key stakeholders
Payer
• Reimbursement plan finalization - We
recommend payment by performance
model
• Build on Glivec trust factor
• Educate them about pipeline drugs and
Novartis’ commitment to Oncology
portfolio
KOL’s
• Short term - Aggressive marketing to
KOL’s by Medical Liaisons team through
medical conferences, medical journals,
research data publications and direct
contact
• Long term - Educate them about pipeline
drugs
Hospitals/Physicians
• Short term - Identification and urgent
targeting of early adopters
• First contact through Medical Liaison
team
• Long term - Target late adopters and
laggards through mix of sales and medical
liaison team
Patient
• Social Media Marketing
• Patient Advocacy Groups
• Cancer Centers
14. The market entry strategy - Reimbursement
Cost sharing strategy
• Price discount
Risk Sharing Strategy
• Price discount based on disease progression
“Payment by Performance” Strategy
• Complete price waiver if first cycle of treatment produces no
response
The aggressive “payment by performance” strategy is preferred due to
the ease of market access through it and the optimistic efficacy results.
16. Resource Allocation
Region Autonomous
Communities
Population
North-
Western
Galicia, Asturias,
Cantabria, Castilla
Leon, Basque
Country
9,213,100
North-Eastern La Rioja, Navarre,
Aragon, Catalonia
9,850,900
Eastern Valencia, Murcia,
Castilla La Mancha
8,702,600
Castilla La Mancha
Southern Extremadura,
Andalucia, Ceuta,
Melilla
9,694,300
Capital Region
& Islands
Madrid, Canary
Islands, Balearic
Islands
9,729,600
We propose to assign 3 sales representatives (SMR) and one medical science liaison (MSL)
for every region. This would imply additionally hiring or training 1 SMR and 1 MSL this year.
17. Projected Sales Revenue
50.0
100.0
150.0
200.0
250.0
300.0
Revenues(inmillionEuros)
Others
Tasigna
Glivec
Glivec sales
heavily
cannibalized
Glivec sales
heavily
cannibalized
Expected share of
Aemulus, generics and
new entrants: 12.28%
market share
Expected share of
Aemulus, generics and
new entrants: 12.28%
market share
Glivec expected
revenues: € 0.8
Million
Glivec expected
revenues: € 0.8
Million
Tasigna expected sales:
€ 215.7 Million, CAGR
from 2010: 148.33%
Tasigna expected sales:
€ 215.7 Million, CAGR
from 2010: 148.33%
New Entrants Glivec Generics Introduced
0.0
50.0
2010 2011 2012 2013 2014 2015 2016 2017
Projections for 2017
18. Risk Assessment and Mitigation Plan
Description Explanation Mitigation Plan
Post Launch
R&D failure
Post launch trial results:
- Tasigna does not cure CML completely
- CML remerges after stopping dosage.
Expedite development of pipeline
drugs (LBH 589 & Bcr-Abl
Inhibitors)
Industry
Competition
CML drugs introduced by competitors in
the next five years show better efficacy
results as first line such as Pipsutinib
(Miler) and Ginytinib (Smaul)
- Enhance Novartis’ oncology
brand among physicians before
replacement drugs become
available
- Expedite pipeline drugs.- Expedite pipeline drugs.
Regulation
change
Budget cap by Payer on Pharmaceutical
expenditures
Create demand for Tasigna so that
future price caps do not affect
revenues
Spanish
Economy Risk
Delayed reimbursement receivables from
government
-Due to high uncertainty, manage
finances efficiently and work with
payer to design new payment
terms.
-Make the payment terms strict
