Transcript THE CHANGE

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Global Pharma Market:
Performance and Outlook to 2013
Paul Crotty
General Manager, IMS Health Canada
www.diahome.org
Agenda
•
•
•
•
Global Trends
US Trends
Canadian Trends
Harbingers of Change
www.diahome.org
Yesterday’s Model Will Not Deliver Tomorrow’s Growth
• The availability of good low-cost alternatives for most common conditions
combined with increasing payer control of prescribing drives irreversible
change
• R&D pipeline will not replace sales lost to generics - new products are
fewer and smaller
• Growth lies in new areas: specialist-driven therapies and emerging
markets
• Even in these areas, companies need to change their approach:
– Earlier preparation for launch to gain payer acceptance and physician
adoption
– Realignment of commercial models
– Leverage emerging markets to drive growth
– Re-think R&D
Surprisingly good performance in 2009 does nothing to alleviate the
need for significant change
Source: IMS Health Consulting 2009
www.diahome.org
Dependency on Specialty Products Declines as Primary Care Recovers
% CONTRIBUTION
TO GROWTH
5.4
Global Market
Biologics
7.5
23%
10.5
Oncologics
7.3
Specialist-driven
55%
14.2
Emerging Markets
(1)
13%
45%
8.5
Generics
0
5
10
% GROWTH CONSTANT US$
Source: IMS Health. MIDAS. MAT June 2009; (1) Market Segmentation 8 markets only
www.diahome.org
31%
15
20
25 to 30 NCE Launches Expected in 2009
60
43
45
44
43
41
40
37
37
28
30
30
30
29
25
Source: IMS Health. R&D Focus; Market Insights. June 2009
www.diahome.org
20
09
(f
)
20
08
20
07
20
06
25
20
05
20
04
20
02
20
01
20
00
19
99
19
95
0
19
98
10
34
Potential notable 2009 launches:
•Effient (Daiichi Sankyo antiplatelet agent)
•Menveo (Novartis meningococcal vaccine)
•Simponi (Centocor anti-TNF)
•Stelara (J&J anti-psoriasis MAb)
•Victoza (Novo Nordisk GLP-1 analogue)
19
97
20
34
20
03
50
49
19
96
NUMBER OF NCE LAUNCHES
2009 YTD: 13
Global NCE launches 1998-2008
45
NUMBER OF NCE LAUNCHES
40
35
21
25
30
22
17
7
23
25
13
19
14
14
20
12
15
10
23
18
19
23
20
14
5
21
15
14
15
7
13
6
0
1998
1999
2000
2001
2002
Specialist-driven
2003
2004
2005
2006
2007
Primary Care-driven
Source: IMS Health. Market Insights Team Analysis. June 2009
www.diahome.org
2008
2009
YTD
Global Outlook Through 2013 –
Continuing Challenges for Most Major Markets
• US new products will not fill the trough from the patent cliff
despite more positive recent signs
• Cost containment continues as a priority in major EU
markets though access begins to open for innovative
therapies, sometimes with risk-sharing agreements
• South Korea, Turkey and Russia respond to budget
pressure with significant reforms - outlook remains strong
• Japan looking at pricing system overhaul - major
implications for market performance and innovation
…Global growth 4% to 7%
www.diahome.org
Agenda
•
•
•
•
Global Trends
US Trends
Canadian Trends
Harbingers of Change
www.diahome.org
FDA Approvals Have Generally Slowed
And most are specialist-driven and niche therapies
New Molecular Entities
40
Therapeutic Biologics
35
30
2009 YTD: 18
21
25
20
15
2009 YTD: 5
10
5
5
0
1998
1999
2000
2001
2002
2003
2004
Source: IMS R&D Focus. FDA. September 2009
www.diahome.org
2005
2006
2007
2008
FDA approvals in 2008 are skewed towards specialist
driven and niche therapies
NUMBER OF NCE LAUNCHES
50
45
40
41
37
35
30
16
15
36
33
32
11
25
15
20
24
14
9
22
25
22
17
20
5
6
21
26
23
13
15
10
30
18
12
11
9
6
22
14
7
23
19
11
12
2006
2007
14
0
1998
1999
2000
2001
2002
Specialist-driven
2003
2004
2005
Primary Care-driven
Source: FDA. IMS Health. Market Insights Team Analysis. September 2009
www.diahome.org
2008
2009
YTD
FDA and EMEA decisions on new products since Jan 2007
generally coincide
EMEA
Approved
Approved
Pending or no
submission
Not approved
or delayed
44
15
5
FDA
Pending or no
submission
14
Not approved
or delayed
9
Source: IMS New Product Focus. FDA. EMEA. February 2009
www.diahome.org
5
7
R&D spending is growing while FDA approvals are
declining
PhRMA Member Global R&D Spending
FDA NCE and Biologic Approvals
R&D Spending Growth
60
$50
US$BN
$40
50
39
39
33
32
28
40
36
26
$30
26
20
22
18
$20
$10
15
11
8
$0
1998 1999 2000
20
15
10
11
4
2001 2002
30
7
8
2003 2004 2005
Source: FDA; PhRMA, Pharmaceutical Industry Profile, 2009, updated annually
www.diahome.org
9
10
5
2006 2007 2008
0
% R&D SPENDING GROWTH
$60
REMS in 2009 go hand in hand with major new product approvals
• 4 of the 18 NCE approvals in 2009 to date require REMS (Risk Evaluation
and Mitigation Strategies)
• Major new products are arriving to the market with REMS that mandate
MedGuide, communication plans, and more:
?
– Efient (prasugrel)
– Simponi (golimumab)
– Multaq (dronedarone)
• 24 REMS issued Apr-Dec 2008
• 31 REMS issued Jan-Jul 2009 already and counting
Source: IMS, Market Insights Research
www.diahome.org
FDA is actively managing product safety through REMS, a FDAAA
prerogative for the agency
• Risk Evaluation and Mitigation Strategies are becoming prominent in all of FDA’s safety-related
actions
• Unlike standard post-marketing studies demanded by FDA with specific scope and patient
populations, REMS are designed by companies and negotiated with FDA
• REMS components can include:
•
Medication guide (for new or previously approved products)
•
Communication plan
•
Elements to assure safe use (healthcare providers and patients registries)
•
Implementation system
?
• Medication guide-only REMS applied to multiple products in the following therapy classes:
• Antiepileptics
• TNF inhibitors
• Erythropoietin stimulating agents
• Fluoro-quinolones
• First formal class-wide REMS for opioids and botulinum toxin products pending FDA
implementation
Source: FDA, IMS Market Insights Research
www.diahome.org
FDA takes steps to improve its system for PMC design
and monitoring
• Deputy division director for safety - a position established under the agency's
Safety First initiative - has assumed the postmarketing study coordinator job,
and the safety regulatory manager will handle postmarketing study tracking;
will manage safety and postmarketing study portfolio for their division
• New policies and procedures are in place to "improve consistency in
developing" post-market requirements and commitments and lead to "better
designed studies and trials with effective and realistic time frames for initial
completion”; improved tracking and reviewing, including standardizing
policies and procedures across CDER review divisions and offices.
?
• New postmarketing study DB implemented July 2009 will increase capacity
for data capture, tracking and report generating
Source: IMS, Market Insights Research
www.diahome.org
Black box warnings have declined after a peak in 2007
COUNT OF BLACKBOX WARNINGS
80
73
Major boxed
warnings in 2009
70
58
60
50
49
50
40
28
30
22
21
20
16
10
0
2003
2004
2005
2006
2007
2008
Jul-08
Source: FDA MedWatch, Aug 2009
www.diahome.org
Jul-09
• Raptiva (withdrawn in EU
and US)
• Chantix, Wellbutrin for
smoking cessation
• Cimzia, Remicade for
autoimmune diseases
Black box warnings have declined after peak in 2007
COUNT OF BLACKBOX WARNINGS
REMS are becoming a prominent safety management tool
Major 2008 & 2009
NCEs with REMS
80
73
70
58
60
50
49
50
40
28
30
22
21
20
16
10
0
2003
2004
2005
2006
2007
2008
Jul-08
Source: FDA MedWatch, Aug 2009
www.diahome.org
Jul-09
• Cimzia
• Efient
• Entereg
• Multaq
• Promacta
• Simponi
• Vimpat
24 REMS Apr-Dec 2008
31 REMS Jan-Jul 2009
2008 FDA approvals of NCEs took place in a challenging
environment
Fewer new product submissions
24 in 2008* vs. 34 in 2007
Fewer “me-too” products
Delayed
or denied
market
access
36 complete
response or
not-approvable
letters
Restricted
market access
26 NCE approvals
Review delays
20% of PDUFA goals missed in 2008*
FDA staff shortage
Source: IMS, Market Insights Research. *Jan-Oct 2008.
www.diahome.org
21 Risk Evaluation
& Mitigation
Strategies
Patients are becoming increasingly active in
reporting adverse events to FDA or manufacturers
# ADVERSE EVENTS REPORTED TO FDA
300,000
250,000
200,000
150,000
100,000
50,000
0
1999
2000
2001
2002
2003
2004
Healthcare Provider
Source: FDA, Apr 2009
www.diahome.org
2005
2006
Consumer
2007
2008
Ongoing FDA activity on dissemination of medical
information to consumers
• Current system viewed as cumbersome and ineffective, according to study
of National Association of Boards of Pharmacy
• “Single patient document” considered as replacement of Consumer
Medication Information, Patient Package Information and Medication Guide
• Drug Facts Box REMS already tested in FDA pilot program
?
• Formatted like nutritional labels
• Quantify outcomes with and without the drug
• Improve consumers’ knowledge of benefits and side effects
• Elements to assure safe use (healthcare providers and patients
registries)
Source: FDA, IMS Market Insights Research
www.diahome.org
Agenda
•
•
•
•
Global Trends
US Trends
Canadian Trends
Harbingers of Change
www.diahome.org
Global economic slowdown has little impact on Canadian pharma market
Sales by drug store and hospital channels – MAT August 2009
$25.0
Purchases
($ Billions)
$20.0
$15.0
$10.0
$5.0
$0.0
MATJune
August
2009
MAT
2007
Purchases
Purchases
Growth (%)
Market
4 -Year
Share (%)
CAGR (%)
Total
$21.08 billion
+7.2
100
+7.1
Drug Stores
$18.76 billion
+7.5
89.0
+6.9
$2.32 billion
+4.9
11.0
+8.0
Hospitals
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 MAT
Aug
2009
Source: IMS Health. Canadian Drug Stores and Hospital Purchases. MAT August 2009.
www.diahome.org
Canadian market shows gradual slowdown in growth since 2001
Canadian market performance, total drug store and hospital purchases, August 2009
18%
16.7%
16%
14%
% Growth
12%
10%
13.6%
12.7%
11.5%
9.9%
12.8%
8.9%
9.6%
8%
7.1%
8.1%
6.3% 6.6%
7.2%
6.4%
6%
4%
2%
0%
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 MAT YTD
Aug. Aug.
2009 2009
Source: IMS Health. Canadian Drug Stores and Hospital Purchases. MAT and YTD August 2009
www.diahome.org
Canadian Market Performance Varies by Segment
Brands contribute 58.5% to absolute growth – YTD August 2009
4.8
Total Brand Market*
Total Branded Primary Care***
% CONTRIBUTION
TO GROWTH
6.4
Total Market
58.5%
1.0
16.0%
16.4
Biotech**
11.7
Generics
0.0
5.0
10.0
% GROWTH
* Brand market segment definition includes biotech and oncology segments
** Biotechnology market segment includes some oncology products
*** Branded primary care growth is based on MAT June 2009
Source: IMS Health. Canadian Drug Stores and Hospital Purchases. YTD August 2009.
www.diahome.org
27.5%
41.5%
15.0
20.0
CDR Performance through October 9, 2009
Number of Submissions* 172
– Withdrawn/Suspended
11
– Active (under review)
13
– Completed submissions** 148
• Positive recommendations
• Negative recommendations
70 (47%)
72 (49%)
*Includes resubmissions, withdrawn submissions and Advisory Committee on Pharmaceuticals Requests for Advice
**Includes 6 ACP Requests for Advice (No Final Recommendation issued)
Source: IMS Health. Provincial Reimbursement Advisor (PRA Weekly), October 14, 2009.
www.diahome.org
New Product Listings* Remain a Challenge – Especially Outside Quebec
June’ 07 to May’ 09 (n=94 products)
35.0
% Products
Listed
Restricted Listing
(Number of Products)
30.0
Full Listing (Number of
Products)
25.0
(20)
20.0
(14)
(16)
15.0
10.0
5.0
(8)
(10)
(10)
(4)
(6)
(4)
(11)
(10)
(7)
(5)
(8)
(7)
(8)
(8)
(8)
(7)
(3)
0.0
BC
(4)
(6)
AB
SK
MB
ON
Average TTL** (days)
Full
292
331
289
306
424
257
Restricted
458
301
382
418
399
293
*Listing status may not capture products covered by special drug programs
QC
585
466
NB
368
434
NS
273
431
PE
399
412
NL
NIHB
141
427
**TTL is calculated from the date the NOC was issued to the date the product was listed in a province. Products with launch delays of greater
than one year (NOC to launch date) are excluded.
Source: IMS Health. Provincial Reimbursement Advisor. FAME. August 2009.
www.diahome.org
Prescriber influence continues to shift to payers over the forecast
period - Takeholder influence on pharmaceutical product selection: 10-point scale
Stakeholder
Practitioners:
Physicians
Pharmacists1
Nurses
Payers/Managers:
2005
2009
2013
RNs, nurse practitioners
5.0
0.5
0.0
3.0
0.5
0.0
2.5
0.5
0.0
Government Drug Plans
Federal/provincial/territorial
3.0
3.0
3.5
Drug Approval/Advisory
Groups
Common Drug Review and other drug
expert groups
0.5
1.5
1.5
Regional Health Authorities
Different provincial models (e.g. Alberta
Health Services, LHINs2)
0.0
0.0
0.0
Private Drug Plans
Insurers, employers and other third parties3
1.0
1.0
1.0
Consumers:
Consumers at large, and organizations
(seniors’/women’s groups, disease
associations, consumer groups)
0.0
1.0
1.0
10.0
10.0
10.0
Consumers/Disease Groups
Description
FPs/GPs, specialists, residents
Hospital/community pharmacy
Total
1Pharmacists
can legally prescribe in several provinces, and more prescribing authority is expected in upcoming years. Nurse practitioners can also legally
prescribe in some provinces in limited circumstances.
2 Local Health Integration Networks in Ontario
3 Includes organizations set up to advise insurers/employers such as benefit managers, preferred-provider organizations
Source: IMS Health.
www.diahome.org
Harbingers of Change
Transforming events in the
pharmaceutical market
Global Pharmaceutical
Perspectives
March 31, 2016
www.diahome.org
Harbingers of Change: Transforming Events in
the Pharmaceutical Market
Primum Non Nocere…to the Cardiovascular
System:
FDA Raises Approval Hurdles for Diabetes
Medications
Coloring Outside the Lines:
R&D Companies Expand into Biosimilars
A Compromised Immune System:
Global Sourcing of API Overwhelms
the FDA
U.K. Gets Warm and Fuzzy:
Permits “Top-Up” Payments for Drugs
Not Covered by NHS
Trimming the Smorgasbord:
South Korea Mandates Economic Evaluation
for National Reimbursement of
Pharmaceuticals
The Comeback Biz:
Over-the-Counter Market Attractive to
Pharmaceutical Manufacturers, Once Again
All in One, One for All:
The Polypill to Prevent Cardiovascular Disease
among the Masses
Giving Up on Godot:
Shake Ups in R&D
Source: IMS INTELLIGENCE.360 (2008). http://www.imshealth.com/portal/site/imshealth
www.diahome.org
Trimming the Smorgasbord:
South Korea Mandates Economic Evaluation for
National Reimbursement of Pharmaceuticals
THE HARBINGER
In January 2008, new drugs became subject to a Health Technology
Assessment prior to being covered for reimbursement by
South Korea’s National Health Insurance System
IMS INTELLIGENCE.360 2008
www.diahome.org
South Korea follows in the footsteps of
developed markets
THE CHANGE
South Korea became the first Asian country to use health economic
data in determining reimbursement and pricing decisions
Ministry of Health hopes to promote rational use in this healthcare
paradise
•
IMS INTELLIGENCE.360 2008
www.diahome.org
Proving the value of medicines is
becoming a global requirement
THE IMPLICATIONS
Conducting HEOR is increasingly a global exercise that can be made
more efficient by adopting a core economic model to specific
countries
Companies will face greater price pressure in this growing market
Other Asian markets (China, Japan, and Taiwan) are watching
•
IMS INTELLIGENCE.360 2008
www.diahome.org
Primum Non Nocere...
to the Cardiovascular System:
FDA Raises Approval Hurdles for Diabetes Medications
THE HARBINGER
Following the recommendation of an advisory panel, the FDA
ruled that Type 2 Diabetes drugs in development must be shown
to not increase cardiovascular risk—even when there are no red
flags raised in Phase II and III trials.
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
FDA exercises greater caution
THE CHANGE
First time the FDA has been so prescriptive about what risks must be
ruled out
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
Companies must re-think their preapproval studies
THE IMPLICATIONS
Extreme regulatory caution seen in other therapeutic categories as
well
More robust, protracted trials the new reality, leading to higher costs
and market entry delays
Pre-approval studies must accommodate subpopulation analyses and
be powered for adverse events, not just efficacy
Developers should seek advice and guidance from FDA regularly
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
Coloring Outside the Lines:
R&D-Based Companies Expand into Biosimilars
THE HARBINGER
Merck & Co. announced that it was creating a new unit, Merck
Bioventures, to produce new and follow-on biologics.
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
Biosimilars hold promise of growth
THE CHANGE
Merck became the first major, pure-play R&D-based company to
venture into biosimilars
Other top-tier companies (Lilly, Pfizer, and AstraZeneca) also
expressed their interest in the area
Companies are open to exploring new avenues of growth, even if it
means altering their fundamental business model
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
Market will not mimic that of smallmolecule generics
THE IMPLICATIONS
Significant barriers to entry could limit competition, and uptake will be
dependent on substitution laws
The biosimilars market may be a good match for the skills inherent in
an R&D-based company
Development, production and marketing costs will limit the ability to
compete on price
Big pharma’s entrance into the market is a credibility boost for the
sector
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
Giving up on Godot
THE HARBINGER
During 2008, a number of “big pharma” companies shook up their
research and development units with bold moves designed to
spark innovation, improve productivity, and introduce a
commercial focus into the scientific realm. In fact, of the top ten
global pharmaceutical manufacturers, six announced major
changes to their R&D models, and nine have made changes
relating to the size, structure or focus of their R&D organizations.
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
It is futile to expect different results by
repeating the same approach
THE CHANGE
Many companies have come to the realization that:
•
Certain therapy areas hold no further commercial potential without the
(unlikely or very expensive) discovery of a major breakthrough
•
There is no longer room for a “build-it-and-they-will-come” mentality in
drug development
•
Most good ideas are easier to accomplish in smaller, more nimble
organizations
•
Small, entrepreneurial units are saleable
•
R&D is no longer a “sacred cow” when it comes to trimming expense
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
R&D in big pharma and biotech meeting
in the middle
THE IMPLICATIONS
Developers must be given incentives for not meeting payer criteria
Shareholders need to be conditioned to the fact that R&D projects
may have to take longer, cost more, and carry greater risk
Large pharmaceutical companies must foster greater flexibility and
openness within their research units
There will be no place to hide for the researcher who is not suited to
an entrepreneurial environment
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
R&D in big pharma and biotech meeting
in the middle
THE IMPLICATIONS
Companies must be open to new ways of working—including forming
partnerships at earlier phases of development
Biotechnology companies must look beyond their big pharma customers to
changing decision makers and their needs
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
A Compromised Immune System:
Global Sourcing of API Overwhelms the FDA
THE HARBINGER
Violations in Good Manufacturing Practices (GMP) at an API
producer in China claimed 149 lives and caused Baxter
Healthcare to recall its heparin sodium injection. Later in the year,
the FDA blocked more than 30 Ranbaxy products and APIs that
originated in India because of GMP violations.
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
Can the FDA be the “quality control” unit
for the world?
THE CHANGE
China and India are now the primary producers of API used in the US
The FDA is equipped to inspect only a smattering of the thousands of
foreign plants each year
Lawsuits in the heparin case are the first to involve Chinese
manufacturing defects in drugs
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
Some API suppliers “let the buyer beware”
THE IMPLICATIONS
US regulators’ efforts to inspect off-shore facilities will intensify
Greater collaboration will develop between regulatory agencies
Manufacturers must assume more of the burden for ensuring the
safety of their supply chain and weigh savings against risks
Source: IMS INTELLIGENCE.360 (2008)
www.diahome.org
Global Pharma Market:
Performance and Outlook to 2013
Paul Crotty
General Manager, IMS Health Canada
www.diahome.org