Transcript Slide - Express Scripts

Can the Specialty Beast
Be Tamed?
Steven B. Miller, MD
Express Scripts
Specialty Growth Continues to
Outpace Traditional Drug Market
•
21%
2007
• Specialty: $59 billion
(Actual) • Non-Specialty: $227 billion
Source: Express Scripts analysis of IMS data.
2
Specialty Growth Continues to
Outpace Traditional Drug Market
•
27%
21%
2007
• Specialty: $59 billion
(Actual) • Non-Specialty: $227 billion
Source: Express Scripts analysis of IMS data.
3
Specialty Growth Continues to
Outpace Traditional Drug Market
2011 • Specialty: $98 billion
(Projected) • Non-Specialty: $ 267 billion
27%
21%
2007
• Specialty: $59 billion
(Actual) • Non-Specialty: $227 billion
Source: Express Scripts analysis of IMS data.
4
Agenda
Drivers of specialty spend
Progress for Follow-on Biologics
Questions and answers
5
What Are Specialty Medications?
Anemia
Cancer
Growth Deficiency
Frequent
dosing
adjustments
Intensive
clinical
monitoring
Intensive
patient
training
Limited or Hemophilia
Specialized
exclusive
handling and
Hepatitis
distribution
administration
Cost
>$500 per
30 days
Infertility
Multiple Sclerosis
Pulmonary Hypertension
Rheumatoid Arthritis
Many others
6
Overall Specialty Trend: 14%
PMPY
7
“Specialty”:
Now the #1 Therapy Class
PMPY
8
Utilization Drove Trend
More Than Last Year
PMPY
9
Key Specialty Therapy Classes
2006:2007
+ 18%
PMPY
+ 16%
+ 20%
- 10%
+ 6%
+ 17%
+ 1%
PMPY
10
Key Specialty Therapy Classes
2006:2007
+ 18%
PMPY
+ 16%
+ 20%
- 10%
+ 6%
+ 17%
+ 1%
PMPY
11
Inflammatory Conditions
Expanded and Earlier Use
Fast Facts
Class Trend
18.1%
Cost PMPY
$22.96
Cost/Rx
$1,548
Rx/User/Yr
8.17
12
Inflammatory Conditions
Expanded and Earlier Use
Fast Facts
Class Trend
18.1%
Cost PMPY
$22.96
Cost/Rx
$1,548
Rx/User/Yr
8.17
13
Multiple Sclerosis
Price Drove Trend
Fast Facts
Class Trend
15.7%
Cost PMPY
$16.02
Cost/Rx
$1,647
Rx/User/Yr
9.53
14
Multiple Sclerosis
Price Drove Trend
Fast Facts
Class Trend
15.7%
Cost PMPY
$16.02
Cost/Rx
$1,647
Rx/User/Yr
9.53
15
Multiple Sclerosis
Price Drove Trend
16
Cancer
Price, Place and Product
Fast Facts
Class Trend
19.7%
Cost PMPY $12.96
Cost/Rx $1,816
Rx/User/Yr
4.17
17
Cancer
Price, Place and Product
Fast Facts
Class Trend
19.7%
Cost PMPY $12.96
Cost/Rx $1,816
Rx/User/Yr
4.17
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Cancer
Price, Place and Product
Price
• Temodar: 3 – 11%
• Xeloda: 15.6%
• Revlimid: 3 – 9.9%
Mix
• Market share decreased for Lupron ($792/Rx)
• Market share increased for Gleevec ($3109/Rx)
New
Drugs
•Tykerb most meaningful (1.4% of cancer market)
•Several others, much smaller
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Blood Cell Deficiency
Safety Changed the Landscape
Fast Facts
Class Trend
-9.7%
Cost PMPY
$4.86
Cost/Rx
$1,725
Rx/User/Yr
4.51
20
Blood Cell Deficiency
Safety Changed the Landscape
Fast Facts
Class Trend
-9.7%
Cost PMPY
$4.86
Cost/Rx
$1,725
Rx/User/Yr
4.51
21
Growth Hormone
Prevalence and Price
Overwhelmed Mix
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Growth Hormone
Prevalence and Price
Overwhelmed Mix
Fast Facts
Class Trend
6.3%
Cost PMPY
$4.62
Cost/Rx
$2,569
Rx/User/Yr
8.23
23
Growth Hormone Use Is Rapidly
Moving Into Older Patients
Users
above
age 20
24
Anticoagulants
Medical Shifted to Pharmacy
Fast Facts
Class Trend
17.3%
Cost PMPY
$4.18
Cost/Rx
$887
Rx/User/Yr
1.85
25
Anticoagulants
Medical Shifted to Pharmacy
Fast Facts
Class Trend
17.3%
Cost PMPY
$4.18
Cost/Rx
$887
Rx/User/Yr
1.85
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Hepatitis C
Where are the Patients Going?
Fast Facts
Class Trend
0.6%
Cost PMPY
$3.34
Cost/Rx
$1,174
Rx/User/Yr
10.20
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Hepatitis C
Where are the Patients Going?
Fast Facts
Class Trend
0.6%
Cost PMPY
$3.34
Cost/Rx
$1,174
Rx/User/Yr
10.20
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Hepatitis C Prevention Is Working
US has 3.2 Million Chronically Infected and 10,000 Annual Deaths
http://www.cdc.gov/ncidod/diseases/hepatitis/resource/PDFs/disease_burden.pdf
accessed March 24, 2008
Hepatitis C Prevention Is Working
US has 3.2 Million Chronically Infected and 10,000 Annual Deaths
http://www.cdc.gov/ncidod/diseases/hepatitis/resource/PDFs/disease_burden.pdf
accessed March 24, 2008
Specialty Growth Continues to
Outpace Traditional Drug Market
2011 • Specialty: $98 billion
(Projected) • Non-Specialty: $ 267 billion
27%
21%
2007
• Specialty: $59 billion
(Actual) • Non-Specialty: $227 billion
Source: Express Scripts analysis of IMS data.
31
Follow-on Biologic
Savings Opportunity
ESI studied four classes of specialty drugs
Disease
Category
Drug
Group
Key Patent
Expirations
Multiple Sclerosis
Interferons
2003-2007
Anemia
Erythropoietin
2004
Growth Failure
Growth Hormone
2003
Diabetes
Insulin
2004
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Follow-on Biologic
Savings Opportunity
ESI studied four classes of specialty drugs
Disease
Category
Drug
Group
Multiple Sclerosis
Interferons
Key Patent
Expirations
2003-2007
Current
Biogeneric
Anemia
Erythropoietin
2004
Experience
Assumption
Growth Failure
Growth
HormoneNon-biologics:
2003 60-90%
Generic
discounts
25%
Diabetes
Insulin
2004
Generic switchs
Non-biologics: 96%
83%
Therapeutic switchs
Non-biologics: 49%
49%
Impact of new drugs
Biologics: 3.5%
0%
Specialty trend
Biologics: 21%
15%
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In the first ten years:
$71 Billion Savings
$ Billions
Inflation and prevalence
drive trend in this model
34
Every Study Says “Billions”
ESI
Avalere
PCMA
10-year
Savings
$71 Billion
$3.6 Billion
$14 Billion
$67-108 Billion
Population
Entire US
Federal Govt.
Med. B Benefic.
Entire US
Drugs
Erythro.,
insulin, GH,
interferon
Non-specific;
excluded
erythropoietin
Part B drugs
within the
PHS Act
12 classes
Assumptions
(samples)
Evidencebased
model
10% go off
patent each
year; discounts
10-30%
Single
competitors;
savings at 30%
in 10 years
35% reduction
for “high value”
classes
Key Issues
Safety
Savings
Impact on
Industry
36
2007 Was An Active Legislative
Year for Follow-On Biologics
S 623 & HR 1038
Access to Lifesaving
Medicine Act
HR 1956
Patient Protection and
Innovation Act
S 1695
Biologics Price
Competition and
Innovation Act of 2007
• Repeat clinical trials and interchangeability at FDA’s
direction
• Critics concerned about inadequate market exclusivity
for innovator
• Requires clinical testing, risk management, surveillance
• Prohibits interchangeability; provides data exclusivity
• Provides >14 years of market exclusivity for innovator
• Passed in Senate H.E.L.P. committee in June 2007
• Requires proof in switching or alternating agents
• Provides >12 years of market exclusivity for innovator
High-level excerpts of selected issues; not a
complete description of legislative proposals.
2008 Biogenerics Legislation
Bush’s new
budget
• Mentions creating an FDA regulatory pathway.
• Suggest BIO wants to deal with this under Bush.
• Clinton, Obama, and McCain all are viewed as
more pro-generic than the current Administration.
Good
legislation is
needed
• Clear FDA approval pathway
• Reasonable number of years of market exclusivity
Coming this
summer
• Expect a deal on the table, but unclear which
constituents it will favor.
Conclusions
Specialty pharmacy spend will
continue to be a challenge
Today’s tools are effective at reigning in cost
New tools will be needed
Lay tomorrow’s groundwork today
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