specialty pharmacy: today’s prescription for a better tomorrow steve miller, md chief medical...
TRANSCRIPT
Specialty Pharmacy:Today’s Prescription for a
Better Tomorrow
Steve Miller, MDChief Medical Officer
2 2007 Express Scripts, Inc. All Rights Reserved.
What Are Specialty Medications?
• Injectable or non-injectable;
• Frequent dosing adjustments, or
• Intensive clinical monitoring, or
• Intensive patient training, or
• Limited or exclusive distribution, specialized handling or specialized administration, or
• Cost in excess of $500 for a 30-day supply
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Anemia
Cancer
Growth Deficiency
Hemophilia
Hepatitis
Infertility
Multiple Sclerosis
Pulmonary HTN
Rheumatoid Arthritis
Many others
Know Your Specialty Patients
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Specialty Growth Continues to Outpace Traditional Drug Market
Source: Express Scripts analysis of IMS data.
5 2007 Express Scripts, Inc. All Rights Reserved.
Relatively Few People Use Specialty Drugs
88%
10%2%
0%
20%
40%
60%
80%
100%
Pre
vale
nce
WellAcute condition
Low-grade chronic
Chronic conditions and/or
procedures
Rare Diseases, Acute Complex,
Multiple co-morbidities
Medical Care 41:1153, 2003
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Each Specialty Patient Has Large Annual Costs
1,000
10,000
50,000
$0
$20,000
$40,000
$60,000
Ann
ual C
ost /
pt
WellAcute condition
Low-grade chronic
Chronic conditions and/or
procedures
Rare Diseases, Acute Complex,
Multiple co-morbidities
Medical Care 41:1153, 2003
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Specialty Patients Remain With Their Health Plans
• Continuous eligibility from July 2003 through June 2006
• Members utilizing their Rx benefit for MS or RA vs. non-utilizers of Rx benefit
• GIC data
82.0%
70.9%
0% 25% 50% 75% 100%
Utilizers
Non-utilizers
Health Plan Retention Rate
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Overall Specialty Trend: 21%
$0
$20
$40
$60
$80
2005 2006
$60.02$72.58
PMPY
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New Drugs Have A Growing Impact in Specialty Trend
59%43%
39%
40%
17%
0%
25%
50%
75%
100%
Non-Specialty Specialty
New Drugs
Utilization
Cost/Rx
Contribution to Trend
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Top Six Specialty Therapy Classes2005:2006
$0 $5 $10 $15 $20
Hepatitis C
GrowthDeficiencies
Blood CellDeficiencies
Cancer
Multiple Sclerosis
InflammatoryConditions
20052006
PM
PY
+ 22.8%+ 22.8%
- 8.3%- 8.3%
+ 4.0%+ 4.0%
+ 39.5%+ 39.5%
+ 19.0%+ 19.0%
+ 22.7%+ 22.7%
PMPY
11 2007 Express Scripts, Inc. All Rights Reserved.
Top Six Specialty Therapy Classes2005:2006
$0 $5 $10 $15 $20
Hepatitis C
GrowthDeficiencies
Blood CellDeficiencies
Cancer
Multiple Sclerosis
InflammatoryConditions
20052006
PM
PY
+ 22.8%
- 8.3%- 8.3%
+ 4.0%+ 4.0%
+ 39.5%
+ 19.0%
+ 22.7%
PMPY
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A Common Disease Pathway
-1.5%
6.0%
1.4%
-1.8%
17.9%
0.1%
0.0%
-5% 0% 5% 10% 15% 20%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #1: Inflammatory Conditions
Units / Rx
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A Common Disease Pathway
-1.5%
6.0%
1.4%
-1.8%
17.9%
0.1%
0.0%
-5% 0% 5% 10% 15% 20%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #1: Inflammatory Conditions
Units / Rx
Fast Facts
Cost PMPY $19.04
Avg Cost/Rx
$1479
Rx/User/Yr 8.3
Class Trend 22.7%
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Price Increases Drove MS
0.4%
14.4%
0.2%
0.6%
2.7%
0.0%
0.0%
-5% 0% 5% 10% 15% 20%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #2: Multiple Sclerosis
Units / Rx
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Price Increases Drove MS
0.4%
14.4%
0.2%
0.6%
2.7%
0.0%
0.0%
-5% 0% 5% 10% 15% 20%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #2: Multiple Sclerosis
Units / RxFast Facts
Cost PMPY $13.60
Avg Cost/Rx
$1470
Rx/User/Yr 9.65
Class Trend 19.0%
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Cancer Pipeline Starts to Mature
0.2%
13.1%
-5.1%
-2.6%
8.3%
26.4%
-0.3%
-10% 0% 10% 20% 30%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #3: Cancer
Units / Rx
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Cancer Pipeline Starts to Mature
0.2%
13.1%
-5.1%
-2.6%
8.3%
26.4%
-0.3%
-10% 0% 10% 20% 30%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #3: Cancer
Units / Rx Fast Facts
Cost PMPY $10.44
Avg Cost/Rx
$1593
Rx/User/Yr 3.92
Class Trend 39.5%
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Cautious Use in More Patients
0.7%
1.8%
2.4%
-5.9%
5.3%
0.0%
0.0%
-10% 0% 10% 20%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #4: Blood Cell Deficiencies
Units / Rx
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Cautious Use in More Patients
0.7%
1.8%
2.4%
-5.9%
5.3%
0.0%
0.0%
-10% 0% 10% 20%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #4: Blood Cell Deficiencies
Units / Rx
Fast Facts
Cost PMPY $5.01
Avg Cost/Rx
$1683
Rx/User/Yr 4.54
Class Trend 4.0%
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Cautious Use in More Patients
Therapy Class #4: Blood Cell Deficiencies
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More Use and Higher Doses
10.7%
5.6%
1.9%
-3.2%
6.3%
0.3%
0.0%
-10% 0% 10% 20%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #5: Growth Deficiencies
Units / Rx
22 2007 Express Scripts, Inc. All Rights Reserved.
More Use and Higher Doses
10.7%
5.6%
1.9%
-3.2%
6.3%
0.3%
0.0%
-10% 0% 10% 20%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #5: Growth Deficiencies
Units / Rx
Fast Facts
Cost PMPY $4.59
Avg Cost/Rx
$2552
Rx/User/Yr 8.47
Class Trend22.8
%
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Growth Hormone Use Is Rapidly Moving Into Older
Patients
23%
25%
24%
20%
22%
24%
26%
2004 2005 2006
GH users above age 20
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Generic Drugs Impact Specialty
-0.1%
6.7%
1.7%
5.7%
-11.0%
0.0%
-10.1%
-15% -10% -5% 0% 5% 10%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #6: Hepatitis C
Units / Rx
25 2007 Express Scripts, Inc. All Rights Reserved.
Generic Drugs Impact Specialty
-0.1%
6.7%
1.7%
5.7%
-11.0%
0.0%
-10.1%
-15% -10% -5% 0% 5% 10%
New Drugs
Intensity
Prevalence
Therapeutic Mix
Brand / Generic Mix
Price
Therapy Class #6: Hepatitis C
Units / RxFast Facts
Cost PMPY $3.45
Avg Cost/Rx
$1133
Rx/User/Yr 10.17
Class Trend -8.3%
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What Have We Learned?Where Do We Go?
• Specialty drugs are an increasingly large part of the pharmacy spend
• Few patients are impacted today
• Programs can have a significant financial impact with little patient disruption
• Generic drugs can make a difference… even in specialty
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Biopharmaceutical Pipeline Continues To
Grow
Source:PhRMA, International Federation of Pharmaceutical Wholesalers & Biotech Industry Organization
10 2992
197
100
240
369
600
1990 1995 2000 2005
Biotech Drugs on the Market
Biotech Drugs in Development
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Most of the Specialty Pipeline Is for Common Illnesses
0 10 20 30 40 50 60 70 80
Oncology
Rheumatoid Arthritis
Crohn's Disease
Hepatitis C
Multiple Sclerosis
PsoriasisPhase 2
Phase 3
Applications Submitted
Number of Drugs
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New Indications Are Expanding Utilization
1 1
2
1
2
1
Alferon Campath Humira Rebif Rituxan Xolair
Number of Current FDA Indications
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New Indications Are Expanding Utilization
1 1
2
1
2
1
4
3
4
5
4
2
Alferon Campath Humira Rebif Rituxan Xolair
Number of Current FDA Indications Number of Indications Under Investigation
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The Routes of Administration Are
Growing More Complex
0
10
20
30
RA MS Hep C Crohn's Psoriasis
Unknown
IM
Sub Q
Intravenous
Injectable
Oral(Route
unknown)
ESI Pipeline Tracking database, Phase 2 or later
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What Do You Want?
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What Do You Want?
• Improved clinical outcomes
• Improved compliance
• Improved patient satisfaction
• Increased reliability of distribution channel
• Decreased acquisition costs
• Consultation on benefit design
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Superb Care Makes a Difference
82%
83%
86%
74%
72%
75%
65% 70% 75% 80% 85% 90%
More Satisfied
Rate staff asextremely skillful
Better Educated
Rheumatoid Arthritis Data
CuraScriptRetail0%
10%
20%
30%
40%
50%
42%42%33%33%
Self-ManagementSelf-Management
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CuraScript Patients Are More Adherent With Therapy
79%82%
84%87%
92% 92%
70%
75%
80%
85%
90%
95%
Rheumatoid Arthritis Multiple Sclerosis Hepatitis C
Retail CuraScript
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Natural History of HCV Infection High Level of Individual Variation
Reprinted with permission from Lauer GM, et al. N Engl JMed. 2001; 345:41-52. Copyright © 2001 Massachusetts Medical Society. All rights reserved.
NormalNormalliverliver
Acute Acute infectioninfection
Chronic Chronic infection infection develops develops in 80%in 80%
Chronic Chronic hepatitishepatitis
Cirrhosis Cirrhosis developdevelops in 20%s in 20%
Risk of Risk of carcinoma, carcinoma,
1-4% per 1-4% per yearyear
~20 years~20 yearsAlcohol use, co-infectionAlcohol use, co-infection
~30 years~30 yearsFemale sex, younger age at infectionFemale sex, younger age at infection
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Hepatitis C Impact On the Health System Today
Example: Liver Transplantation
• 1,000 per year in US
• $300,000-$900,000 each
Annual spend for HCV transplants in US is over $500,000,000
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Future Burden of HCV$830 Billion between 2010-
2019
190,000 additional deaths
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Compliance Is Critical To Clearing Hepatitis Virus
0%
20%
40%
60%
80%
Non-Compliant Compliant
% o
f Pat
ient
s wi
th S
usta
ined
Vira
l Res
pons
e
10%10%
75%75%
Hepatitis C Type 1
40 2007 Express Scripts, Inc. All Rights Reserved.
Value of Specialty Pharmacy
• More convenient
• Higher satisfaction
• Better educated
• More compliant
• Greater savings
• Safer
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Optimal Recommendations
Comprehensive Communications
for all programs
Clinical ProgramsClinical Programs•Prior AuthorizationPrior Authorization•Drug Quantity ManagementDrug Quantity Management
Co-PaymentsCo-Payments• $25 more for non-formulary$25 more for non-formulary• $30 more for Retail$30 more for Retail
CuraScript Exclusive•CuraScript for all fills•Courtesy fills for “stats” only
CuraScript Exclusive•CuraScript for all fills•Courtesy fills for “stats” only
42 2007 Express Scripts, Inc. All Rights Reserved.
Specialty Growth Continues to Outpace Traditional Drug Market
Source: Express Scripts analysis of IMS data.
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Access to Lifesaving Medications Act
•Introduced in 2007
•Bicameral, bipartisan
•Express Scripts supporting with research and analysis
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ESI Estimate of Biogeneric Savings
Opportunity•Studied four classes of medications
•Very conservative assumptions
Disease Category Drug Group
Patent Expiration
Multiple Sclerosis
Interferons 2003/2007
Anemia Erythropoietin 2004
Growth Failure Growth Hormone
2003
Diabetes Insulin 2004
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$3.5 Billion SavingsIn 1st Year Alone
$2,004
$797
$678
$28
$0 $500 $1,000 $1,500 $2,000 $2,500
Erythropoietins
Insulin
MultipleSclerosis
GrowthHormone
$ Millions
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In the first ten years:
$71 Billion Savings
$3.5 $4.0$4.6
$5.3$6.1
$7.0$8.1
$9.3$10.7
$12.3
$0
$2
$4
$6
$8
$10
$12
$14
Year1
Year2
Year3
Year4
Year5
Year6
Year7
Year8
Year9
Year10
$Bill
ions
Inflation and prevalence driving trend in this model
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An
nu
al S
ale
s $
Bill
ion
Biologic Drugs Losing Patent Protection
0
10
20
30
40
$11 $11.2 $11.4 $11.7 $12.1
$15.6
$20.1
$29.8
$33.5$35.4
$37.5
Residual New
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
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Contact Your Elected Officials
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Contact Your Elected Officials
www.therightprescription.org
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Contact Your Elected Officials
51 2007 Express Scripts, Inc. All Rights Reserved.
Contact Your Elected Officials
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It’s Easy.
Just visit the ESI Outcomes Website: http://www.express-scripts.com/
ourcompany/news/
outcomesconference
Follow the link to: http://www.therightprescription.org
53 2007 Express Scripts, Inc. All Rights Reserved.
Conclusions
• Specialty spend is increasing
• It is just not about covering the medication but assuring appropriate use
– Right drug, dose, route and care
• There is much you can do now
– Put in plan designs that support goals
– Support biogeneric legislation