Walgreens TrendReport_2009

Transcription

>>
outlook | trend report
2009
©2009 Walgreens Health Initiatives, Inc., a wholly owned subsidiary of
Walgreen Co. All rights reserved.
Material from this publication may not be reprinted or reproduced
without advance written permission from Walgreens Health Initiatives, Inc.
Brand names are the property of their respective owners.
Claims made in this publication about the efficacy of the medications
referenced have been made by the medication manufacturers.The
inclusion of a medication in this publication is not deemed an endorsement
by Walgreen Co., or its subsidiaries or affiliates.
Numbers in this report may not total as expected due to rounding.
contents
>>
Welcom e
A nalysis: forces d r iving t h e tr end S olut ion s : s t r at egies for m anaging d rug spend La n ds c a p e : pr escr ip tion d rug d e v elopm ents
Append ix : m e t h od ology
2
3
14
20
28
>>contents
01
Welcome to the Walgreens Health Initiatives Outlook Trend Report.
In this report, we highlight our pharmacy benefit trend management
performance for 2008, share case studies that demonstrate the
significant results of our work with—and for—our clients, and present
forecasts for pharmacy benefit costs in 2009 and beyond.
In 2008, our Walgreens Health Initiatives team produced its fifth
consecutive year of single-digit trends for our clients. The average total
prescription drug cost increase, or trend, was a low 4.1%, excluding specialty drugs. Our overall
trend, including specialty drugs, was 5.6%. Our highly managed clients realized even greater
savings with an incredible negative trend of -0.5%. We scored another impressive increase in
generic utilization with a money-saving overall generic dispensing rate (GDR) of 65.6%, among the
highest in the industry. And our highly managed clients achieved an even higher GDR—67.1%.
One of our case studies demonstrates the powerful results that our uniquely integrated
approach to pharmacy benefits produced for a large employer. Our proactive plan-management
strategies helped this client achieve a lower overall drug trend, higher GDR, impressive step
care therapy results, return on investment that exceeded expectations for their Walgreensmanaged worksite clinics, and increased overall member satisfaction.
With the recent addition to our portfolio of a new 90-day option for members, we expect to
deliver even greater savings in 2009. Walgreens90™ gives members the added convenience
and flexibility to obtain a 90-day supply of maintenance medications at more than 6,500
Walgreens community pharmacies or through mail service with the same pricing discounts.
Walgreens Health Initiatives projects prescription drug expenditures increasing at a rate of
5.0% to 6.5% in 2009, and 4.0% to 6.0% in 2010. Also, we anticipate that approximately
75.0% of all prescriptions, including specialty medications, may be dispensed as generics
by 2011. Our integrated approach—and all of the services Walgreens and our healthcare
subsidiaries provide—will deliver more value than ever in helping our clients manage prescription
drug expenditures in the coming years.
Thanks for reading this report. I hope you’ll contact me with any questions or comments—
or to ask how we can help you achieve greater success with your pharmacy benefit program.
Michael A. Nameth, RPh, MBA
Executive Vice President
Pharmacy Benefit Management and Specialty Pharmacy
Walgreens Health Services
02
analysis
Fo r c e s d r i v i n g t h e t r e n d
Every year, Walgreens Health Initiatives analyzes changes in clients’ prescription
drug expenditures to identify cost drivers and opportunity areas for savings. Our
findings are described in this section of the report. A brief discussion of selected
national prescription drug trends sets the stage.
National Prescription Drug Expenditure Trends
Prescription drug spending, like most
sectors of the U.S. economy, has been affected by the economic recession that began in December 2007 and
accelerated during 2008. The economic downturn is affecting consumers’ use of prescription drugs. The number
of prescriptions dispensed nationwide dropped slightly in the first eight months of 2008, according to an analysis
of data from IMS Health. Although the overall decline was less than 1%, it was the first downturn after more than
10 years of steady increases in prescription volume. According to a study conducted by the Center for Studying
Health System Change, a nonprofit research group, one in seven Americans went without prescribed medications
in 2007 because of cost-related concerns. Although uninsured people were more likely to forgo a prescription,
one in 10 working-age adults surveyed with private, employer-sponsored health insurance also went without a
prescription drug.1 The current figures may be even higher because of the worsening economic downturn,
according to the lead author of the study.2 Consumers may also be attempting to cut costs by splitting pills
or taking their medication less frequently than prescribed, without their doctors’ knowledge or consent.3
1 Felland
LE, Reschovsky JD. More nonelderly Americans face problems affording prescription drugs. Tracking Report. January 2009; vol 22. Center for Studying Health System Change.
http://www.hschange.com/CONTENT/1039/1039.pdf. Accessed February 2009.
2 Rabin CR. More Americans skipping necessary prescriptions, survey finds. The New York Times. January 23, 2009. http://www.nytimes.com/2009/01/23/health/23drug.
html?scp=1&sq=skipping%20prescription&st=cse. Accessed February 2009.
3 Saul S. In sour economy, some scale back on medications. The New York Times. October 22, 2008. http://www.nytimes.com/2008/10/22/business/22drug.html?sq=prescription&st=cse&
scp=9&pagewanted=print. Accessed February 2009.
>>analysis
03
Lower adherence to medication for chronic conditions has
been linked to accelerated disease progression and higher
rates of disease complications, which in turn lead to higher
healthcare costs.
$400
$200
$0
Including
Specialty
Figure 2: Components of Overall Trend
Figu
8%
5.6%
7%
6%
5%
4%
3%
0.1%
1%
0%
-1%
-2%
-1.9%
Trend was influenced by changes in drug prices, utilization,
product mix and the introduction of new medications.
Price was the main trend driver in 2008—boosting
expenditures by 6.2% (see Figure 2). Changes in
quantities of medication dispensed, or utilization, added
2008
2007
2%
Average per member per year (PMPY) costs for 2007 and
2008 were compared to calculate the trend. As shown
in Figure 1, PMPY prescription drug costs increased by
$49 (including specialty drugs) to $912 in 2008; excluding
specialty drugs, PMPY was $812 in 2008, up $32.
Excluding
Specialty
1.2%
To provide a complete picture of trend and performance,
Walgreens Health Initiatives reports trend data for all
medications that are managed or covered under our
clients’ prescription benefit programs, including specialty
and limited-distribution drugs.
$600
6.2%
We are also pleased to report that Walgreens Health
Initiatives has delivered a single-digit trend for clients for
the fifth consecutive year. Average total prescription drug
costs, excluding specialty drugs, increased by 4.1% in
2008 for clients of Walgreens Health Initiatives.4 This
compares favorably with the 2007 trend of 4.8%. When
specialty drugs are included, the 2008 trend was 5.6%.
These results were achieved in part through increases in
the generic dispensing rate (GDR) and effective clinical
management in highly utilized therapeutic classes.
$800
$812
Against the national backdrop, the Walgreens Health
Initiatives trend data analyzed in this report offer some
reassuring findings. For example, the proportion of
members who use prescription medications did not fall;
it actually edged up slightly while the average number of
prescriptions dispensed per utilizing member remained
constant. And utilization of medications for treatment of
high cholesterol, high blood pressure and diabetes among
Walgreens Health Initiatives members increased in 2008.
These metrics suggest that our members are making good
choices and not putting their health at risk by curtailing
their prescription utilization.
$780
Walgreens Health Initiatives Trend Results
$863
$1,000
$912
Figure 1: Change in PMPY Costs
-3%
Price
Utilization
Product
Mix
New
Medications
Total
2008
Figure 2
4 Clients
04
who had less than full-year 2007 and 2008 data were excluded from this analysis. For other selection criteria, see the Appendix.
another 1.2%. Cost-saving shifts in product mix—changes to less costly medications such as generics—reduced trend
by 1.9%. New medications added only 0.1% to the trend, reflecting the relatively small number and low impact of new
FDA drug approvals.
The Impact of Price
Average wholesale prices (AWPs) for brands rose 12.2% in 2008; brand ingredient
costs increased 11.8%. For generic drugs, AWP increased 10.4% while ingredient costs edged upward by 1.3%.
(Price inflation was calculated based on the products common to 2007 and 2008. Products that were converted from
brand to generic in 2008 were excluded from the analysis.) Walgreens Health Initiatives minimizes the impact of AWP
inflation by negotiating aggressive pricing and discounts while maximizing generic utilization.
The Impact of Utilization Utilization is defined as the change in the number of units dispensed per covered life.
Three factors contributed to changes in utilization between 2007 and 2008 (see Table 1).
Table 1: impact of utilization changes on trend
Factor
Change
Percentage of members taking prescription medications
Increase
Average number of prescriptions dispensed per utilizing member
No change
Impact on
Utilization
Notes
•Increased from 77.9% to 78.1%
Low
•Remained constant at 13.6
None
Quantities dispensed per prescription
Increase
•Increased 1.2% from 58.8 to 59.5 units
•Partially driven by an increase from 33.9 to
34.4 average days supply, due to growth in
90-day dispensing
Moderate
Percentage of members age 60 and older
Increase
•Increased from 13.5% to 14.2%
Moderate
Ratio of prescriptions per utilizing member over age 60
No change
None
•In 2007 and 2008, members age 60 years and
older used 2.6 times as many prescriptions as
younger members.
Of the top 25 therapeutic classes in 2008, utilization increased in 20 and decreased in the remaining five between 2007
and 2008. The classes with the greatest changes in utilization are shown in Table 2.
Table 2: most dynamic therapeutic classes
Therapeutic Class
Change
Factors Affecting Utilization
Classes With Largest Utilization Increases
Hematological agents
16.8% increase
•Depletion of supplies of generic clopidogrel (Plavix®) that were available prior to successful
patent litigation
•Ongoing increase in use of clopidogrel for patients with coronary artery stents for longer
treatment durations
Antivirals
8.3% increase
•U tilization of new HIV/AIDS agents such as Isentress® and Selzentry™, likely due to increasing
resistance to older agents
•Direct-to-consumer advertising campaign for Valtrex®, which is used in the treatment of genital herpes
Analgesics/narcotics
7.2% increase
•Interruption of supply of generic extended-release oxycodone during 2007 and 2008 due to patent
litigation, resulting in increased utilization of OxyContin®
table continued on next page
>>analysis
05
Table 2: most dynamic therapeutic classes (continued)
Therapeutic Class
Change
Factors Affecting Utilization
Classes With Largest Utilization Decreases
Migraine agents
6.4% decrease
•Effectiveness of Walgreens Health Initiatives clinical prior authorizations in limiting quantities dispensed
•F DA action to pull unapproved drugs containing ergotamine from the market
Antiasthmatic agents
2.1% decrease
•Effectiveness of Walgreens Health Initiatives step care therapy programs
•Safety concerns with certain asthma medications used for long-term asthma control
•Regulatory requirements to adopt an environmentally friendly but costly propellant in
albuterol inhalers
Analgesics/
anti-inflammatories
1.4% decrease
•Ongoing cardiovascular safety-related issues with nonsteroidal anti-inflammatory drugs (NSAIDs)
The Impact of Product Mix
Shifting from high-cost to low-cost drugs, such as generics, lowered the trend in
20 of the top 25 therapeutic classes in 2008. The four classes with the greatest reductions in product mix are shown in
Table 3. All of these classes, with the exception of hypnotics, ranked in the top five by total spend in 2008 (see Table 6).
Table 3: classes with notable changes in product mix and generic utilization
Therapeutic Class
Hypnotics
Blood pressure lowering
Decrease in
Product Mix
Increase in Generic
Utilization
19.8%
19.8%
9.9%
11.6%
Recent FDA-Approved Generics
FDA Approval Date
zaleplon (Sonata®)
05/08
zolpidem (Ambien®)
04/07
ramipril (Altace®)
01/08
metoprolol extended release (Toprol-XL®)
05/07
amlodipine and benazepril (Lotrel®)
05/07
Cholesterol lowering
6.8%
7.9%
simvastatin (Zocor ®)
06/06
Ulcer medications
6.1%
13.8%
pantoprazole (Protonix®)
12/07
The Impact of New Medications
Continuing a trend in recent years, few medications launched in 2008
had a significant impact on trend (see Table 14 for a list of selected new drugs approved in 2008.) The impact of
new medications is calculated by dividing their total cost in 2008 by the total increase in expenditures that year.
Analysis of Brand and Generic Expenditures
The Walgreens Health Initiatives GDR climbed from
61.3% in 2007 to 65.6% in 2008 (see Figure 3). For every 1.0% increase in generic utilization, our clients realize
approximately 2.0% savings in total spend. Generics are a high-yield strategy for many reasons.
• Brands cost 5.4 times more than their generic counterparts in 2008.
• The gap in average ingredient cost between brands and generics widened from $100 in 2007 to $120 in 2008
(see Figure 4). Average brand ingredient costs increased from $126 in 2007 to $146 in 2008; generic ingredient costs
were unchanged. (Costs shown in Figure 4 include all drugs used in 2007 or 2008.)
• Generics represented nearly two-thirds of prescriptions dispensed but little more than one-fifth of total spend
in 2008.
• Even with the decline in the proportion of brands dispensed (from 38.7% in 2007 to 34.4% in 2008), dollar expenditures
on brands still increased 4.2% PMPY, primarily as a result of manufacturer price inflation.
06
Figure 3: Proportion of Brand and Generic
Prescriptions in Total Dispensing
Figure 4: Average Ingredient Cost for
Brand and Generic Prescriptions
$180
70%
$120
34.4%
30%
$90
$60
$26
20%
$30
10%
0%
2007
2008
$26
40%
38.7%
60%
50%
$150
$126
61.3%
65.6%
80%
$146
90%
$0
2007
2008
Brand
Generic
Brand
Generic
Walgreens Health Initiatives continually promotes generic utilization through appropriate plan design, formulary and
clinical programs such as the following:
• Step care therapy programs, which help ensure appropriate and cost-effective medication utilization and promote the
use of clinically effective, alternative medications
Figure
• MedMonitor® Complete, which integrates and monitors prescription
and3medical histories to help ensure safe,
appropriate medication therapy
• Informed Prescribing®, which recommends formulary alternatives to physicians; educates members about the safety,
efficacy and cost savings of generic drugs; and encourages formulary compliance through a team of dedicated and
specially trained pharmacy professionals
A growing number of clients are adopting these and other cost-saving clinical management programs and plan design
solutions, including shifting coverage from the medical benefit to the pharmacy benefit. In addition, as many highly
utilized medications lose patent protection in the next few years (see Table 10), there will be opportunities to increase
GDR and decrease costs in classes that previously had few generic options, such as ulcer medications and
anticonvulsants. As a result of the synergies between these trends, Walgreens Health Initiatives anticipates that
approximately 75.0% of all our clients’ prescriptions may be dispensed as generics by 2011.
Changes in Plan and Member Cost Sharing
Plan costs increased by 7.2% in 2008, while member
costs decreased by 0.4%. This represents a slight decrease in average annual member cost from $179.20 in 2007
to $178.40 in 2008, likely due to shifting from brands with higher copays to generics with lower copays. As shown
in Table 4, plans paid a higher proportion of the costs for brands (83.4%) than they did for generics (70.2%).
Walgreens Health Initiatives recommends that clients re-evaluate their copay structure every year to ensure that target
cost sharing levels are achieved. To assist clients with this analysis, our proprietary Web-based system allows modeling
of alternative plan designs using historical or forecasted drug utilization. With this insight, clients can make informed
decisions about alternative copays and other plan design change scenarios.
>>analysis
07
Table 4: cost sharing for brand and generic medications
2008
2007
Plan Share
Member Share
Plan Share
Member Share
Brand
83.4%
16.6%
81.8%
18.2%
Generic
70.2%
29.8%
69.6%
30.4%
Overall
80.4%
19.6%
79.3%
20.7%
Growth in 90-Day Dispensing
Ninety-day fills save money for plans through deeper discounts and reduced
dispensing and administrative fees. Members typically save on copays, as compared with three 30-day fills.
A total of 37.4% of all prescriptions were filled through 90-day channels when calculations are normalized for
30-day supplies, up from 36.0% in 2007. Walgreens Health Initiatives continues to be among the industry leaders in
90-day dispensing.
• Approximately 10.2% of all prescriptions were filled through the Walgreens Health Initiatives Advantage90® program
in 2008, up from 8.8% the previous year. Advantage90 offers members the option of obtaining their maintenance
medications in 90-day supplies at more than 41,000 participating network pharmacies.
• Many members also choose to fill their maintenance medication prescriptions through Walgreens Mail Service.
Approximately 16.5% of all prescriptions were dispensed in 90-day supplies through mail service and Advantage90
in 2008, up from 15.7% in 2007.
A New 90-Day Option for Members: Walgreens90™
Launched in late 2008, Walgreens90™ allows members the flexibility
of obtaining a 90-day supply of maintenance medications at more than
6,500 Walgreens community pharmacies or through mail service. Using
Walgreens90™, plans and their members can realize the same pricing for
their 90-day maintenance medications at retail or mail. Members pay the same
copay as they would for mail service and plan sponsors benefit from lower
pharmacy benefit costs.
90-day options
Feature
08
Walgreens90™
Advantage90®
Retail network
More than 6,500 pharmacies
More than 41,000 pharmacies
Plan rate
Same as mail
More aggressive than 30-day retail; less aggressive than mail
Member copay
Same as mail
Lower than three 30-day fills; generally more than mail
Trend and Share of Spend for Top 20 Brands
The top 20 brands accounted for 28.0% of total spend in
2008, as compared with 27.4% in 2007 (see Table 5). All of the top 10 brands in 2008 were also in the top 10 in 2007,
although rank order changed slightly.
• Lipitor®, a statin used in the treatment of high cholesterol, was the No. 1-dispensed brand for the sixth consecutive
year, although it represented a lower share of total spend this year (3.4% in 2008 versus 3.8% in 2007).
• The brands with an increase in spend of 25% or more in 2008 included Humira® (44.0%), Copaxone® (31.6%)
and Plavix® (26.0%).
Biologic response modifiers (BRMs) continued to be approved for new indications. Humira received approval for
moderately to severely active Crohn’s disease in adults in 2007.
Trend for Copaxone was driven by an increase in manufacturer prices.
Spend increased for Plavix as supplies of generic clopidogrel were depleted following patent litigation. Additionally,
spend reflects the growing use of Plavix for patients with coronary artery stents for longer treatment durations.
• There was a notable decrease in trend for Vytorin®, likely due to safety and effectiveness concerns.
Table 5: trend and share of spend for top 20 brands
Brand
Lipitor ®
Prevacid
Enbrel
®
®
Nexium
®
Advair Diskus
Singulair
®
Effexor XR
Plavix
Actos
®
®
Lexapro
Crestor
®
®
Cymbalta
Humira
Valtrex
®
®
Topamax
®
®
Celebrex
Vytorin
Tricor
®
®
®
®
Imitrex
®
Copaxone
®
Rank, 2008
Share of Total
Spend, 2008
Rank, 2007
Share of Total
Spend, 2007
Trend
1
3.4%
1
3.8%
-4.6%
Ulcer medications
2
2.3%
2
2.4%
3.5%
Biologic response modifiers
3
1.8%
4
1.7%
10.2%
Ulcer medications
4
1.7%
3
1.8%
-0.1%
Antiasthmatics
5
1.6%
6
1.6%
0.5%
Antiasthmatics
6
1.6%
5
1.7%
-0.2%
Antidepressants
7
1.6%
7
1.5%
8.3%
Platelet inhibitors
8
1.5%
10
1.2%
26.0%
Antidiabetics
9
1.3%
9
1.3%
8.7%
Antidepressants
10
1.3%
8
1.3%
6.6%
11
1.2%
12
1.0%
21.3%
Antidepressants
12
1.2%
13
1.0%
24.5%
13
1.2%
17
0.9%
44.0%
Anticonvulsants
14
1.1%
14
1.0%
16.2%
Antivirals
15
1.1%
16
0.9%
23.2%
Analgesics/anti-inflammatories
16
0.9%
15
0.9%
8.9%
17
0.9%
11
1.2%
-17.9%
18
0.9%
21
0.8%
15.0%
Migraine
19
0.7%
20
0.8%
-1.4%
Multiple sclerosis
20
0.7%
26
0.6%
31.6%
Therapeutic Class
®
>>analysis
09
Trend and Share of Spend for Top 10 Therapeutic Classes
The top 10 therapeutic classes
accounted for 57.3% of the total drug spend in 2008, as shown in Table 6. Changes among classes may be
influenced by the following factors:
• Manufacturer price changes
• Increased utilization of generic drugs and over-the-counter products
• Availability of new drugs
• Additional indications for currently available drugs
• Increased implementation of proven clinical management programs
The impact of price, utilization and product mix on trend is shown in Table 6. In addition, new medications (not shown in
Table 6) had a small impact on trend in three of the top 10 classes—antivirals
and antidepressants (0.5% in each class)
and blood pressure-lowering medications (0.2%).
Table 6: trend and share of spend for top 10 therapeutic classes
Rank by
Spend
Share of Total
Spend
Trend
Rank by No.
of Rxs
Impact of
Price
Impact of
Utilization
1
9.4%
1.2%
2
3.2%
4.9%
-6.8%
2
7.6%
-3.6%
1
3.1%
3.0%
-9.9%
Antidepressants
3
6.4%
1.9%
3
1.1%
1.6%
-1.3%
Ulcer medications
4
6.3%
0.8%
7
4.3%
2.6%
-6.1%
Antidiabetics
5
6.3%
13.9%
5
8.4%
3.2%
2.3%
Antiasthmatics
6
5.6%
6.6%
6
7.0%
-2.1%
1.6%
Analgesics/
anti-inflammatories
7
4.5%
15.3%
12
8.3%
-1.4%
8.5%
Anticonvulsants
8
4.1%
16.8%
14
12.8%
7.1%
-3.1%
Antivirals
9
3.9%
19.6%
30
9.6%
8.3%
1.3%
Analgesics/narcotics
10
3.2%
8.3%
4
-3.3%
7.2%
4.4%
Therapeutic Class
Impact of
Product Mix
Significant trend increases occurred in the following three classes:
• Antivirals: 19.6%. Trend in this class was driven by increases in price (9.6%) and utilization (8.3%). The utilization
increase may reflect the use of new HIV/AIDS treatment agents, likely due to increasing resistance to older agents,
and a consumer advertising campaign conducted by the manufacturer of the herpes drug Valtrex®.
• Anticonvulsants: 16.8%. A 12.8% price increase and a 7.1% increase in utilization factored into this trend increase,
tempered by a 3.1% decrease in product mix. Off-label use of drugs such as Topamax® and Lyrica® has contributed
to utilization increases in this class.
• Analgesics/anti-inflammatories: 15.3%. Price and product mix increases in this class (8.3% and 8.5%, respectively)
were moderated by a 1.4% decrease in utilization. Ongoing cardiovascular safety-related concerns about nonsteroidal
anti-inflammatory drugs (NSAIDs) continued to affect utilization in this class.
Walgreens Health Initiatives clinical management programs reduced product mix in several classes, thereby minimizing
the potential trend impact of price and utilization increases. For example, the trend for blood pressure-lowering agents
dropped to -3.6% in 2008, despite a 3.1% price increase, reflecting the benefit of a 9.9% decrease in product mix.
The blood pressure-lowering class ranked No. 1 in prescription volume for Walgreens Health Initiatives clients so this
negative trend was particularly impactful in terms of overall trend management.
10
Analysis of Specialty Drugs Specialty drugs had a substantial impact on trend in 2008. The volume of
specialty drugs dispensed is relatively low but their high cost results in a disproportionate impact on trend. It should be
noted that Walgreens Health Initiatives included oral chemotherapy drugs in the specialty category for the first time in
2008. In general, specialty drugs include those manufactured through a biotech or traditional drug development process.
In the specialty pharmacy industry, the terms “biotech” and “specialty” are often used interchangeably.
• Specialty drugs accounted for just 0.5% of total prescriptions dispensed for Walgreens Health Initiatives clients but
10.9% of total spend.
• The average cost for a specialty drug was $2,032 in 2008, approximately 26.4 times more than the average cost for a
nonspecialty drug.
• When specialty drugs are included in the overall trend, it rises from 4.1% to 5.6%.
The number of members using specialty drugs increased 7.7% in 2008, as compared with only a 2.0% increase in the
number of members using nonspecialty drugs. Furthermore, the quantity dispensed per specialty utilizer increased 2.3%
in 2008, as compared with a 1.0% increase in the quantity dispensed per nonspecialty utilizer.
The top five specialty drugs accounted for 42.9% of total specialty spend in 2008. Rankings for the top five specialty
drugs were unchanged in 2007 and 2008 (see Table 7).
Table 7: share of total specialty spend for top five specialty medications
Brand
Therapeutic Class
Rank, 2008
Share of Total
Specialty Spend,
2008
Rank, 2007
Share of Total
Specialty Spend,
2007
Enbrel®
1
16.2%
1
17.7%
Humira®
2
10.8%
2
9.0%
Copaxone®
Multiple sclerosis
3
6.5%
3
5.9%
Avonex®
Multiple sclerosis
4
5.3%
4
5.4%
Lovenox®
Anticoagulants
5
4.1%
5
4.4%
The No. 1- and No. 2-ranking specialty drugs in 2008 were the BRMs Enbrel® and Humira. BRMs are used for
conditions such as Crohn’s disease, psoriasis, psoriatic arthritis and rheumatoid arthritis.
• Enbrel and Humira alone represented 27.0% of total specialty spend in 2008.
• The trend for Humira increased 44.0% in 2008 (see Table 5). One factor contributing to the increase is the new
indication Humira received in 2007 for treatment of moderately to severely active Crohn’s disease in adults.
Two of the top five specialty drugs—Copaxone and Avonex®—are used in the treatment of multiple sclerosis.
The first drugs in a new class of oral immunosuppressants for this condition are currently in FDA phase III studies.
All current multiple sclerosis treatments are injectables.
>>analysis
11
Share of Total Spend for Top Five Specialty Classes
For the fourth year in a row, BRMs were the
leading specialty class by total spend, increasing to 3.1% of total spend from 2.7% in 2007 (see Table 8).
Table 8: share of total spend for top five specialty classes
Therapeutic Class
Rank, 2008
1
Multiple sclerosis
Share of Total Spend, 2008
Rank, 2007
Share of Total Spend, 2007
3.1%
1
2.7%
2
2.1%
2
1.8%
Oral chemotherapy
3
1.5%
3
1.3%
Growth hormone
4
0.6%
4
0.5%
Anticoagulants
5
0.5%
7
0.5%
• The BRM class maintained its No. 1 status in 2008 because of continued high utilization as new indications were added
for selected drugs.
• Price increases drove the increase in share of total spend for multiple sclerosis drugs.
Trend Projections, 2009-2011
Drug spending growth is expected to rebound as economic conditions
improve, new specialty drugs come onto the market and existing medications receive new indications.5 Walgreens
Health Initiatives projects that overall prescription drug expenditures will increase at a rate of 5.0% to 6.5% in 2009
(see Table 9).6 In 2010, the rate of growth is likely to slow to the 4.0% to 6.0% range. Looking ahead to 2011, little
change in trend projections is expected overall. (These projections include specialty drugs.)
Table 9: walgreens health initiatives drug trend projections, 2009-2011
Year
Overall Trend
Utilization Component
Price/Mix Components
2009
5.0%-6.5%
2.5%-3.0%
2.5%-3.5%
2010
4.0%-6.0%
2.5%-3.0%
1.5%-3.0%
2011
4.5%-6.5%
2.5%-3.0%
2.0%-3.5%
Utilization
Utilization is expected to remain fairly stable over the 2009-2011 period. Generic utilization will likely
grow faster than utilization of brands. The actual number of prescriptions dispensed per member, including retail,
mail and specialty fulfillment channels, is reflected in these utilization projections.
Price/Mix Generics are expected to save 0.9% to 2.4% in drug costs annually over the next three years, with
the larger increases occurring in 2010 and 2011. Price reflects the impact of competitive markets on AWP discounting
and rebating, as well as manufacturer AWP increases. Brand inflation will likely outpace inflation in generic prices by
a three-to-one margin, driven largely by specialty drugs and hefty price increases on brands that are nearing
patent expiration. Loss of patent protection and availability of first-time generics for a host of widely utilized drugs is
expected to save plans 0.9% to 1.0% in 2009; 2.0% to 2.4% in 2010; and 1.4% to 2.2% in 2011.
5 Sisko
A, Truffer C, Smith S et al. Health spending projections through 2018: recession effects add uncertainty to the outlook. Health Affairs. 2009; vol 28. doi:10.1377/hlthaff.28.2.w346.
projections are calculated at the gross ingredient cost level, after discounts and dispensing fees but before administrative fees, rebates or member cost share. Actual client performance
will vary based on level of clinical management, member cost sharing provisions and other plan design and demographic attributes.
6 Trend
12
Projected savings attributable to specific patent expirations during this period are shown in Table 10. These projections
take into account the 180-day exclusivity period for first-time generics, when applicable. (Late-year patent expirations
may shift savings to the following calendar year.) Aggressive clinical management to drive generic utilization can yield
even greater savings.
Table 10: projected cost savings attributable to selected patent expirations
Year of Patent Expiration
Projected Aggregate Savings
Brand
2009
0.9%-1.0%
Adderall XR®, Depakote ER®, Imitrex®, Topamax®, Valtrex®
2010
2.0%-2.4%
Aricept®, Cozaar ®, Effexor XR®, Flomax®, Hyzaar ®, Prevacid®
2011
1.4%-2.2%
Actos®, Levaquin®, Lipitor ®, Plavix®, Seroquel®
>>analysis
13
solutions
Strategies for managing drug spend
This section of the report presents highlights of four case studies that document
the impressive results achieved by clients who take advantage of the cost-saving
programs offered by Walgreens Health Initiatives.
The first case study highlights dramatic differences in trend and GDR between
selected groups of clients with different levels of plan management. Patient safety
and cost management results that clients can realize by adopting clinical prior
authorizations for specialty medications are demonstrated in the second case study.
The third case study presents examples of cost savings generated by Walgreens
Health Initiatives step care therapy programs. The fourth and final case study
profiles a client who achieved a negative trend and significant prescription and
medical cost savings during their first two years with Walgreens Health Initiatives.
To view the complete case studies, please visit WalgreensHealth.com/casestudies.
14
Case study 1
the impact of plan management
Walgreens Health Initiatives offers a wide variety of plan design solutions and clinical
programs to help clients manage prescription costs and utilization. Clients make choices
based on their financial goals and benefits philosophy. Prudent plan management and
implementation of new programs every year can yield a prescription cost increase that is
significantly less than the average trend for the Walgreens Health Initiatives book of
business. Conversely, clients who choose a lower level of plan management may
experience an above-average increase in trend. Table 11 and Figure 5 show the results
achieved in 2008 by groups of clients with varying plan management strategies.
Experience shows that clients who implement the right mix of Walgreens Health Initiatives’
benefit and clinical management programs achieve a lower trend.
Table 11: management strategies used by selected clients
Level of
Management
Total Number of
Step Care or Clinical
Prior Authorization
Programs
Number of Step Care
or Clinical Prior
Authorization
Programs Added in
2008
Plan
Share of
Cost
High
Three-tier
differentiala
Yes
9 or more
2 or more
≤ 75%
Low
Two tier
No
4 or fewer
0
> 75%
Three-tier high-differential formularies have a copay difference of $15 or more between tiers 2 and 3.
Our Results
Figure 5: Trend by Level
of Management
• Highly managed plans actually
12%
16%
12%
8%
4%
0%
-0.5%
reduced their overall prescription
costs, achieving a negative trend
of -0.5%, significantly lower than the
overall trend of 5.6%.
• Clients with few plan management
strategies had a much higher
trend: 12.0%.
• The GDR for highly managed plans
was 67.1%, more than five percentage
points higher than the GDR for plans
with a low level of management.
5.6%
a
Formulary
Walgreens
Specialty
Pharmacy
-4%
Overall
High
Low
Figu
>>solutions
15
Case study 2
specialty prior authorizations: managing costs and
enhancing medication safety
Complex treatment regimens are a defining characteristic of many specialty drugs. If clinical guidelines for the use of
these drugs are not followed, clients and members may incur additional prescription expenses and members may be
exposed to unnecessary health risks. Clinical management is needed to help ensure safe, cost-effective specialty
medication therapy.
Specialty prior authorization (SPA) programs encourage clinically appropriate and cost-effective use of medications
by allowing coverage when certain conditions are met. Walgreens Health Initiatives currently offers 17 SPAs to help
ensure that evidence-based clinical guidelines for patient selection, treatment initiation, dosing and discontinuation
in various specialty drug classes are followed.
Two new Walgreens Health Initiatives SPAs were introduced in 2008. One SPA covers hepatitis C medication therapy with
interferon and ribavirin. The other provides guidelines for using anemia-fighting drugs known as erythropoietic agents, or
red blood cell stimulators. These drugs are prescribed for patients who are receiving chemotherapy treatment for cancer
and those who have been diagnosed with chronic renal failure, among others.
Our Results Providing medication therapy in accordance with national guidelines was a cost-saving strategy for
several clients who implemented SPAs for hepatitis C and erythropoietic agents in 2008.
$3
$2
$2
$1
$1
$0
$0
Pre
Control
Post
$1.68
$4
$3
Study
$4.44
$5
$4.80
$6
$3.96
$3.19
$5
$4
Figure 7: Total PMPY Costs for
Erythropoietic Agents
$7
$3.93
$6
$4.02
$7
$5.64
Figure 6: Total PMPY Costs for
Hepatitis C
Study
Pre
Control
Post
• As shown in Figure 6, total PMPY costs for hepatitis C medications fell by $2.45 for clients who implemented the
Walgreens Health Initiatives Hepatitis C SPA. This represents PMPY savings of 43.4%. PMPY costs decreased $0.09,
or 2.2%, in the control group during the same period.
• As shown in Figure 7, total PMPY costs for erythropoietic agents for clients who implemented our SPA in this
therapeutic class decreased by $2.28 following SPA implementation. This represents PMPY savings of 57.6%.
PMPY costs decreased $0.36, or 7.5%, in the control group
during
Figure
Figure
6 the study period.
A client with 100,000 covered lives could achieve savings of $473,000 by implementing these two SPA programs.
In light of the rapidly growing cost of specialty drugs, SPAs are becoming an increasingly important cost management
strategy for our clients.
16
7
Case study 3
moving brands to the third tier: a comparison with
step care therapy
Walgreens Health Initiatives advises clients that step care therapy programs are a high-yield approach to managing costs
and utilization in a wide array of drug classes. Step care therapy requires that one or more prerequisite medications be
tried before a “step therapy” drug will be covered, unless medical exception authorization is received.
The client profiled in this case study preferred a different approach to managing nonsedating antihistamine (NSA) costs.
(NSAs are widely prescribed for treatment of allergy symptoms such as sneezing, itching, watery eyes and runny nose.)
Due to concerns about potential member disruption associated with step care, the client chose to move all brands in
the NSA class to the third tier. After this change was made, the copay for brand medications in this class was $50
or $65 for a 30-day supply at retail, depending on whether or not the prescription was filled at a network pharmacy.
(Several widely utilized generic prescription and over-the-counter NSA products are available for $15 or less for a 30-day
supply at many retail pharmacies.)
Walgreens Health Initiatives provided benchmarking data to the client to determine whether the copay change increased
GDR and reduced costs to target levels. We compared deidentified NSA prescription claims data for this client with
those of a control group and a select group of step care clients. The study period began one year prior to implementation
of the plan design change and ended one year afterward.
Figure 8: Total PMPY
NSA Cost Savings
69.6%
90%
70%
60%
50%
52.3%
80%
48.1%
Our Results Step care therapy offers a clinical solution to help
ensure the appropriate use of prescription medications in many highly
utilized classes. Our benchmarking data confirm that step care therapy
in the NSA class remains the best option for cost savings (see Figure 8).
• Total PMPY NSA costs for this client decreased 52.3% during
the year after the copay change, substantially less than the 69.6%
cost savings realized by clients using the Walgreens Health
Initiatives NSA Step Care Therapy Program but more than the
48.1% savings in the control group. The control group savings
are attributable in part to the availability of generic Zyrtec®
(cetirizine) starting in January 2008.
• Total PMPY savings attributable to NSA step care in this study
were $16.20. For a group with 100,000 covered lives, this
represents a savings of $1.62 million per year. In comparison,
total PMPY savings resulting from the copay change were $8.04,
the equivalent of $804,000 annually for a group with 100,000
covered lives.
40%
30%
20%
10%
0%
Control
Client
Step
Care
Fig
>>solutions
17
Case study 4
new client achieves noteworthy results
The client profiled in this case study, a large employer with more than 130,000 covered lives, switched from another major
PBM to Walgreens Health Initiatives to find excellent customer service and member-friendly clinical management options.
Like most clients who are concerned about escalating healthcare costs, this client was also seeking proactive strategies
for managing pharmacy benefit costs while minimizing disruptions for their employees.
Our Results The healthcare solution delivered by Walgreens Health Initiatives included a lower prescription trend,
higher GDR, impressive step care therapy results and a return on their investment in Walgreens-managed worksite clinics
that exceeded expectations.
Trend This client posted a lower overall trend of -0.41% from 2006 to 2008, after their second full year with
Walgreens Health Initiatives. Only a select few highly managed clients achieve a negative trend for multiple years.
The client’s trend performance is attributable to steady, substantial growth in generic utilization in 2007 and 2008
along with Walgreens Health Initiatives’ highly effective clinical programs and formulary management.
GDR
Generic dispensing increased by nearly 10 percentage points over the two-year period, representing an estimated
savings of approximately $12.4 million to the client.
• In 2006, the client’s GDR with another PBM was 60.0%. It has increased steadily since becoming a Walgreens Health
Initiatives client, reaching 69.8% in 2008.
• With the client’s previous PBM, mail service was mandatory for maintenance medications and generic utilization for mail
service pharmacy was only 44.6%. Offering Walgreens Health Initiatives’ Advantage90 in addition to mail service gave
members freedom of choice between mail service and retail for their 90-day prescriptions. In addition, it provided the
client with significant cost savings through a 60.2% Advantage90 GDR in 2008.
Clinical management
The client implemented a number of Walgreens Health Initiatives step care therapy and
clinical medication management programs. Cost savings for three of the most impactful clinical programs are shown
in Table 12.
Table 12: selected step care therapy program results
Step Care Therapy Program
Therapeutic Use
Trend, 2006-2008
Proton pump inhibitors
Gastroesophageal reflux disease and ulcers
-13.3%
Selective serotonin reuptake inhibitors
Depression
-9.7%
Leukotriene antagonists
Asthma or allergy
-2.5%
Worksite clinics
During 2006 and 2007, Take Care Health Employer Solutions, a wholly owned subsidiary of
Walgreens, launched worksite clinics at client locations in two states. Take Care Health Employer Solutions manages
primary care, health and wellness, occupational health, pharmacy and fitness centers at large employer campuses.
The worksite clinics are staffed by board-certified advanced practitioners.
• Data compiled by Take Care Health Systems™ showed that more than $2.7 million in direct value was delivered in 2008
alone as a result of the medical care provided at the client’s two worksite Take Care Clinic locations. These estimated
savings resulted from the medical care that was provided and reductions in urgent care/emergency room visits,
specialist office visits and inpatient admissions.
18
• Productivity gains associated with the proximity of the worksite clinics generated more than $1.3 million in additional
savings for the client in 2008. Combined with almost $500,000 in savings attributed to health risk avoidance and
risk reduction, the total indirect value delivered by the worksite clinics and other health and wellness programs was
more than $1.8 million in 2008. The total direct and indirect value was more than $4.5 million.7
• After deducting program operating costs, the net value on investment for the worksite clinics—which includes the
direct and indirect value received—was $1.40 for every dollar spent in 2008. This represented a net value of nearly
$1.3 million.
Data on prescribing patterns revealed that worksite clinicians who provided patient care at these clinics had
substantially higher generic utilization and formulary compliance rates than those who did not practice at the
worksite clinics (see Table 13). Higher generic utilization and formulary compliance yielded substantial savings for
the client.
Table 13: prescribing patterns for worksite and off-site clinicians
Prescriptions Written by Worksite Clinicians
(n = 14,284)
Prescriptions Written by Off-Site Clinicians
(n = 1,719,647)
Generic utilization
90.4%
63.9%
Formulary compliance
97.9%
90.4%
Taking direct and indirect savings into consideration, the benefits of the Walgreens total healthcare solution for this client
extended far beyond prescription drug expenditures and utilization.
7 If
reduced sick time costs were factored into the analysis, an additional $2.2 million in savings could be generated.
>>solutions
19
landscape
Prescription drug developments
Walgreens Health Initiatives tracks changes in prescription drug research and
marketplace availability on a daily basis. Key industry developments, including new
medication approvals, first-time generics and patent expirations, are summarized in
this section of the report.
Selected New Medication Approvals A total of 24 new drugs were approved by the FDA in 2008,
the most since 2004. However, few of these new medications are expected to have a significant impact on future
trends. Selected new medications approved by the FDA in 2008 are listed in Table 14. Some of the more impactful
new medications include the following:
• TriLipix™, a new formulation of Tricor®, is the first fibric acid derivative to receive FDA approval for use in
combination with statins. Concurrent therapy with fibric acid derivatives and statins has traditionally been
avoided because of potential drug interaction.
• In the antidepressant class, Pristiq™ is a derivative of Effexor®.
• Banzel™ and Vimpat® expand the treatment options for different seizure disorders. They are approved as
add-on therapies to other seizure medications.
• In the specialty medication category, Cimzia® offers a new treatment option for Crohn’s disease, especially for
patients who are unsuccessful with other currently available medication therapies. Cimzia is a limited-distribution
medication and is therefore available only through select providers, including Walgreens Specialty Pharmacy.
New medications represented approximately 0.05% of total prescription volume for Walgreens Health Initiatives
clients and 0.12% of their total spend in 2008.
20
Table 14: selected new medication approvals, 2008a,b,c
Therapeutic Use
Brand Name
(Manufacturer)
Generic Name
FDA Approval
Datec
Projected
Impactd
Coste
Nonspecialty Medications
Benign prostatic hyperplasia
Rapaflo (Watson)
silodosin
10/08
Medium
$$
TriLipix (Abbott)
fenofibric acid
12/08
Medium
$$
Depression
Pristiq (Wyeth)
desvenlafaxine
02/08
Medium
$$
HIV/AIDS
Intelence (Tibotec)
etravirine
01/08
Medium
$$$$
Overactive bladder
Toviaz (Pfizer)
fesoterodine
10/08
Medium
$$
Seizure disorders
Banzel (Eisai)
rufinamide
11/08
Medium
$$
Vimpat (Schwarz)
lacosamide
10/08
Medium
$$
04/08
Low
$$$$$
™
™
™
™
™
™
®
Specialty Medications
Cimzia (UCB)
®
certolizumab
Drugs approved by the FDA (2008). CenterWatch Clinical Trials Listing Service . http://www.centerwatch.com/patient/drugs/druglist.html.
Accessed December 2008.
a
SM
TM
b
New drugs approved by the FDA in 2008. Pharmacist’s Letter. http://www.pharmacistsletter.com. Accessed December 2008.
c
Drugs@FDA. U.S. Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cder/drugsatfda. Accessed December 2008.
d
Range is based on cost of the medication and expected number of prescriptions.
Cost is for 30-day supply: Average wholesale price (AWP) X DACON X 30; DACON = daily average consumption = average quantity
dispensed/average days supply; $ = < $100, $$ = $100 to $249, $$$ = $250 to $499, $$$$ = $500 to $1,000, $$$$$ = > $1,000.
e
Selected New Combination Medication Approvals Combination
medications offer the convenience of two medications commonly prescribed together
in a single dosage form. They reduce the number of pills taken per day and decrease the
number of member copays. In addition, they may improve adherence to therapy. Among
the combination medications approved in 2008 (see Table 15) are the following:
• Treximet® is the first combination of a triptan with an NSAID, for the treatment
of migraines.
• Prandimet™ is a combination medication for the treatment of diabetes, a condition that
often requires multiple agents to achieve treatment goals.
>>landscape
21
Table 15: selected new combination medication approvalsa,b
Brand Name
(Manufacturer)
Therapeutic Use
Generic Name
FDA Approval Dateb
Projected Impactc
Costd
Blood pressure
lowering
Tekturna HCT® (Novartis)
aliskiren and
hydrochlorothiazide
01/08
Medium
$$
Simcor ® (Abbott)
niacin and simvastatin
02/08
Medium
$$
Diabetes
Prandimet (Novo Nordisk)
repaglinide and metformin
06/08
Medium
$$
Migraine
Treximet (GlaxoSmithKline)
sumatriptan and naproxen
04/08
Medium
$$$
™
®
a
b
c
Range is based on cost of the medication and expected number of prescriptions. Medications with low impact have been omitted as their effect on trend is minimal.
Cost is for 30-day supply: Average wholesale price (AWP) X DACON X 30; DACON = daily average consumption = average quantity dispensed/average days supply; $ = < $100, $$ = $100 to $249,
$$$ = $250 to $499, $$$$ = $500 to $1,000, $$$$$ = > $1,000.
d
Selected New Indications and Dosage Forms
Several medications received new indications in 2008
(see Table 16). Some, such as Vyvanse® and Concerta®, received indications that expanded the age range for use.
Others received indications for treatment of additional health conditions, including the antidepressant Cymbalta® for
fibromyalgia, the cholesterol-lowering medication WelChol® for blood glucose control for patients with type 2 diabetes
and the BRM Humira for juvenile rheumatoid arthritis. Medications with new dosage forms include Keppra XR™ for
once-daily dosing for seizure disorders.
Table 16: selected new indications and dosage formsa,b
Therapeutic Use
Brand Name
(Manufacturer)
Generic Name
New Indication or Dosage Form
Projected
Impactc
Costd
Antiviral
Valtrex
(GlaxoSmithKline)
valacyclovir
New indication for treatment of chickenpox
in ages 2 to 17
Medium
$$$
Attention deficit
hyperactivity
disorder (ADHD)
Concerta®
(Ortho-McNeil and
Janssen)
methylphenidate
New indication for ADHD in adults
Medium
$$
Vyvanse®
(Shire/New River)
lisdexamfetamine
New indication for ADHD in adults
Medium
$$
Cardiovascular
disease
Ranexa®
(CV Therapeutics)
ranolazine
New indication for first-line treatment of chronic angina
(chest pain)
Medium
$$$
Cholesterol
lowering
Crestor ®
(AstraZeneca)
rosuvastatin
New indication for certain lipid disorders
Medium
$$
WelChol®
(Daiichi-Sankyo)
colesevelam
New indication to improve blood glucose control in
type 2 diabetes
Medium
$$$
Depression
Cymbalta® (Lilly)
duloxetine
New indication for fibromyalgia
Medium
$$$
Erectile
dysfunction
Cialis (Lilly)
tadalafil
Once-daily dosage form
Medium
$$
Osteoporosis
Actonel®
(Proctor & Gamble)
risedronate
Once-monthly formulation
Medium
$$
®
®
22
Table 16: selected new indications and dosage formsa,b (continued)
Brand Name
(Manufacturer)
Therapeutic Use
Generic Name
New Indication or Dosage Form
Projected
Impactc
Costd
Seizure disorders
Keppra XR (UCB)
levetiracetam
Once-daily, extended-release formulation
Medium
$$$
Seroquel XR
(AstraZeneca)
quetiapine
New indication for treatment and maintenance therapy
for bipolar mania and bipolar depression
Medium
$$$
™
®
Biologic response
modifiers
Humira (Abbott)
adalimumab
New indication for polyarticular juvenile rheumatoid
arthritis
Medium
$$$$$
Tysabri® (Biogen Idex
and Elan)
natalizumab
New indication for moderately to severely active
Crohn’s disease
Medium
$$$$$
®
a
b
c
Cost is for 30-day supply: Average wholesale price (AWP) X DACON X 30; DACON = daily average consumption = average quantity dispensed/average days supply; $ = < $100, $$ = $100 to $249,
$$$ = $250 to $499, $$$$ = $500 to $1,000, $$$$$ = > $1,000.
d
Selected First-Time Generic Approvals
Various generic medications for treatment of a wide range of
health conditions were approved by the FDA in 2008 (see Table 17). First-time generics are a major source of cost
savings, especially when a medication is the first available generic in its class. Imitrex® (sumatriptan), a highly utilized
medication for treatment of migraines, was the first in the triptan class to become available as a generic. Fosamax®
(alendronate) was highly utilized for the treatment of osteoporosis; the introduction of a generic version in 2008
decreased spending in that drug class. New generics represented approximately 0.9% of total prescription volume
for Walgreens Health Initiatives clients in 2008 and 0.8% of their total drug spend.
Table 17: selected new generics approved in 2008a,b
Therapeutic Use
Brand Name (Manufacturer)
Generic Name
FDA Approval Dateb
Antipsychotic
Risperdal® (Ortho McNeil and Janssen)
risperidone
07/08
Altace (Monarch)
ramipril
01/08
Depression
Paxil CR (GlaxoSmithKline)
paroxetine extended release
05/08
Glaucoma
Trusopt (Merck)
dorzolamide
11/08
Cosopt (Merck)
dorzolamide and timolol
11/08
Insomnia
Sonata (King)
zaleplon
05/08
Migraine
Imitrex (GlaxoSmithKline)
sumatriptan
12/08
Oral contraceptives
Yasmin (Bayer and Schering)
drospirenone and ethinyl estradiol
07/08
Osteoporosis
Fosamax (Merck)
alendronate
02/08
Parkinson’s disease
Requip (GlaxoSmithKline)
ropinirole
05/08
Seizure disorders
Depakote (Abbott)
divalproex delayed release
07/08
Keppra (UCB)
levetiracetam
11/08
Lamictal (GlaxoSmithKline)
lamotrigine
07/08
®
®
®
®
®
®
®
®
®
®
®
®
a
First-time generic drug approvals 2008. U.S. Food and Drug Administration. http://www.fda.gov/cder/ogd/approvals/default.htm. Accessed December 2008.
b
>>landscape
23
Selected Patent Expirations, 2009-2013
A number of highly utilized medications will become available as
generics in the next few years (see Table 18), continuing a recent trend. In 2009, these will likely include Prevacid® for
gastroesophageal reflux disease and ulcers; Valtrex for genital herpes; and Topamax, a medication used for seizures,
migraines and other off-label indications with significant utilization. Other notable agents such as Flomax® for benign
prostatic hyperplasia will likely become available as generics in 2010. (It is important to note that the availability of generics
may be delayed by patent litigation.) The projected impact of new generic medications is based on an assessment of
factors such as disease prevalence, availability of other brand-name and generic medications for a given indication, and
utilization, where applicable. (See Table 10 for projected cost savings attributable to selected patent expirations.)
Table 18: selected patent expirations, 2009-2013a
Therapeutic Use
Generic Nameb
Anticipated
Availabilityc
Projected
Impactd
2009
Antiviral
Valtrex® (GlaxoSmithKIine)
valacyclovir
12/09
High
Attention deficit
hyperactivity disorder
Adderall XR (Shire)
amphetamine and
dextroamphetamine salts
04/09
High
Diabetes
Starlix® (Novartis)
nateglinide
09/09
Medium
Glaucoma
Xalatan (Pharmacia)
latanoprost
09/09
Medium
Seizure disorders
Depakote ER (Abbott)
divalproex extended release
02/09
Medium
Topamax (Johnson & Johnson)
topiramate
03/09
High
Ulcer medications
Prevacid (Takeda)
lansoprazole
11/09
High
Alzheimer’s disease
Aricept (Eisai)
donepezil
11/10
Medium
Flomax (Boehringer Ingelheim)
tamsulosin
04/10
High
Cozaar (Merck)
losartan
09/10
High
Hyzaar (Merck)
losartan and hydrochlorothiazide
09/10
High
Depression
Effexor XR (Wyeth)
venlafaxine extended release
07/10
High
Oncology
Arimidex (AstraZeneca)
anastrazole
06/10
Medium
Anti-infective
Avelox (Bayer)
moxifloxacin
12/11
Medium
Levaquin (Ortho-McNeil)
levofloxacin
06/11
Medium
Antipsychotic
Seroquel (AstraZeneca)
quetiapine
09/11
High
Uroxatral (Sanofi-Aventis)
alfuzosin
01/11
Medium
Atacand (AstraZeneca)
candesartan
04/11
Medium
Atacand HCT (AstraZeneca)
candesartan and hydrochlorothiazide
04/11
Medium
TriCor (Abbott)
fenofibrate
01/11
High
Lipitor (Pfizer)
atorvastatin
11/11
High
Diabetes
Actos (Takeda)
pioglitazone
01/11
High
Platelet inhibitors
Plavix (Bristol-Myers Squibb and
Sanofi-Aventis)
clopidogrel
11/11
High
®
®
®
®
®
2010
®
®
®
®
®
®
2011
®
®
®
®
®
®
®
®
®
®
24
Table 18: selected patent expirations, 2009-2013a (continued)
Therapeutic Use
Generic Nameb
Anticipated
Availabilityc
Projected
Impactd
2012
Clarinex (Schering-Plough)
desloratidine
07/12
Medium
Xyzal (UCB)
levocetirizine
09/12
Medium
Asthma
Singulair (Merck)
montelukast
08/12
High
Avapro (Bristol-Myers Squibb and
Sanofi-Aventis)
irbesartan
03/12
Medium
Avalide® (Bristol-Myers Squibb and
Sanofi-Aventis)
irbesartan and hydrochlorothiazide
03/12
Medium
Diovan® (Novartis)
valsartan
09/12
High
Diovan HCT (Novartis)
valsartan and hydrochlorothiazide
09/12
High
Depression
Lexapro (Forest)
escitalopram
03/12
High
Diabetes
Avandia (GlaxoSmithKline)
rosiglitazone
03/12
Medium
Avandaryl (GlaxoSmithKline)
rosiglitazone and glimepiride
03/12
Medium
Avandamet (GlaxoSmithKline)
rosiglitazone and metformin
03/12
Medium
Erectile dysfunction
Viagra (Pfizer)
sildenafil
03/12
Medium
Insomnia
Lunesta (Sepracor)
eszopiclone
01/12
Medium
Migraine
Maxalt (Merck)
rizatriptan
06/12
Medium
Osteoporosis
Boniva (Roche)
ibandronate
03/12
Medium
Evista (Lilly)
raloxifene
07/12
Medium
Overactive bladder
Detrol LA (Pfizer)
tolterodine extended release
09/12
Medium
Avodart (GlaxoSmithKline)
dutasteride
09/13
Medium
Niaspan (Kos)
niacin extended release
09/13
High
Depression
Cymbalta (Lilly)
duloxetine
06/13
High
Ulcer medications
AcipHex (Eisai)
rabeprazole
05/13
High
Allergy
®
®
®
®
®
®
®
™
®
®
®
®
®
®
®
2013
®
®
®
®
FDA Electronic Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA Center for Drug Evaluation and Research. http://www.fda.gov/cder/ob/default.htm.
Accessed December 2008.
a
b
Generic medications have manufacturers with approval or tentative approval to market the generic version of the medication.
c
Generic availability is subject to change due to pending litigations and patent exclusivities.
d
Selected Medications in the Pipeline Selected pipeline agents that are expected to impact prescription
costs over the next few years, if approved, are listed in Table 19.
• New anticoagulation agents, such as Xarelto® and dabigatran will likely not require the close monitoring that is required
for warfarin therapy, and may replace it as standard therapy in some indications.
• Saxagliptin and alogliptin are new additions to the DPP-4 class of diabetes treatments, of which Januvia® is currently
the only marketed agent.
• Almorexant and eplivanserin are new agents being evaluated for the treatment of insomnia.
• Anacetrapib increases HDL, the healthy form of cholesterol that helps clear LDL cholesterol from the body. Currently
available cholesterol medications have little effect on HDL.
>>landscape
25
Specialty medications expected to enter the market within the next few years include albinterferon alfa-2b for the
treatment of hepatitis C, and fingolimod and teriflunomide—agents which would be the first oral treatments for
multiple sclerosis. Oncology agents such as phenoxodiol and vandetanib are being developed to treat resistant
cancers. Denosumab is being developed as a twice-yearly self-injectable therapy for osteoporosis.
Table 19: selected medications in the pipeline 2009 and 2010a, b
Therapeutic Use
Brand Name
(Manufacturer)
Generic Name
Comments
Statusc
Projected
Impactd
Effient (Daiichi
Sankyo and Lilly)
prasugrel
Oral antiplatelet agent for management of
acute coronary syndrome
Under FDA
review
High
Xarelto® (Bayer)
rivaroxaban
A once-daily, oral anticoagulant expected
to decrease need for monitoring
In phase III
studies
High
N/A (Boehringer
Ingelheim)
dabigatran
An oral direct thrombin inhibitor
In phase III
studies
Medium
N/A (Sanofi-Aventis)
idrabiotaparinux
Once-weekly injectable anticoagulant
In phase III
studies
Medium
Asthma and chronic
obstructive pulmonary
disease (COPD)
Daxas (Nycomed)
roflumilast
Oral agent for treatment of COPD
In phase III
studies
Medium
N/A (Novartis)
indacaterol
Inhaled treatment for asthma and COPD
In phase III
studies
Medium
N/A (Merck)
anacetrapib
Primary mode of action is increase of HDL
cholesterol
In phase III
studies
High
Depression
Valdoxan (Novartis)
agomelatine
First of a new class of medications for
treatment of depression
In phase III
studies
Medium
saredutant
First of a new class of medications for
treatment of depression
In phase III
studies
Medium
Onglyza
(AstraZeneca
and Bristol-Myers
Squibb)
saxagliptin
Oral DPP-4 inhibitor
Under FDA
review
Medium
Victoza®
(Novo Nordisk)
liraglutide
Once-daily self-injectable for the treatment
of type 2 diabetes
Under FDA
review
Medium
N/A (Roche, Ipsen)
taspoglutide
Once-weekly self-injectable for the
treatment of type 2 diabetes
In phase III
studies
Medium
N/A (Takeda)
alogliptin
Oral DPP-4 inhibitor
Under FDA
review
Medium
Fibromyalgia
Savella™ (Forest)
milnacipran
Serotonin norepinephrine reuptake
inhibitor
FDA approved;
launch expected
March 2009
Medium
Insomnia
N/A (Actelion)
almorexant
May improve sleep without negative
next-day effects
In phase III
studies
Medium
N/A (Neurocrine)
indiplon
Non-benzodiazepine treatment for insomnia
Under FDA
review
Medium
eplivanserin
Oral 5-HT2 antagonist for the treatment
of insomnia
In phase III
studies
Medium
Anticoagulation and
platelet inhibitors
Diabetes
™
26
Table 19: selected medications in the pipeline 2009 and 2010a, b (continued)
Therapeutic Use
Brand Name
(Manufacturer)
Generic Name
Comments
Statusc
Projected
Impactd
Migraine
N/A (Merck)
telcagepant
New class of oral antimigraine agents
In phase III
studies
Medium
Osteoporosis
Fablyn (Ligand)
lasofoxifene
Oral treatment for osteoporosis
Under FDA
review
Medium
Viviant (Wyeth)
bazedoxifene
Oral treatment for osteoporosis
Under FDA
review
Medium
N/A (Merck)
odanacatib
Once-weekly treatment for osteoporosis
In phase III
studies
Medium
Seizure disorders
N/A (UCB Pharma)
brivaracetam
Oral treatment for partial seizures
In phase III
studies
Medium
Ulcer medications
Kapidex™ (Takeda)
dexlansoprazole
Oral, once-daily PPI for treatment of
acid-related disorders
FDA approved;
launch expected
mid-2009.
Medium
N/A (Centocor and
Schering-Plough)
golimumab
Anti-tumor necrosis factor-alpha
monoclonal antibody for treatment of
rheumatoid arthritis, psoriatic arthritis
and ankylosing spondylitis
Under FDA
review
Medium
N/A (Centocor)
ustekinumab
Injectable agent to treat plaque psoriasis
Under FDA
review
Medium
Hepatitis C
Albuferon (Novartis)
albinterferon
alfa-2b
Long-acting form of interferon alfa-2b;
may be easier to tolerate than current
standard therapy
In phase III
studies
Medium
Multiple sclerosis
N/A (Novartis)
fingolimod
Oral therapy
In phase III
studies
Medium
teriflunomide
Oral therapy
In phase III
studies
Medium
Zactima®
(AstraZeneca)
vandetanib
Treatment of advanced or metastatic
non-small cell lung cancer
In phase III
studies
Medium
N/A
(GlaxoSmithKline)
pazopanib
Oral therapy for renal cell carcinoma,
soft tissue sarcoma and ovarian cancer
In phase III
studies
Medium
N/A (Marshall
Edwards)
phenoxodiol
Currently being studied in prostate,
ovarian, cervical and vaginal cancers
In phase III
studies
Medium
N/A (Amgen)
denosumab
Twice-yearly self-injectable therapy
for osteoporosis
Under FDA
review
Medium
Oncology
Osteoporosis
a
Projecting future drug expenditures—2009. American Journal of Health System Pharmacy. 2009; vol 66: pp. 237-257.
b
New drug application submissions. Drugs.com. http://www.drugs.com/new-drug-applications.html. Accessed January 2009.
Status as of February 2009. Phase II = intermediate phase of drug development; involves testing for safety and preliminary evidence of beneficial effects. These studies may involve several hundred
patients and take about a year to complete. Phase III = last phase of drug development; involves safety and efficacy trials of the new drug. These studies usually include several hundred to several
thousand patients and can take years to complete. Under FDA review = application has been filed with the FDA.
c
d
N/A = not available.
>>landscape
27
Ap p e n di x : me t h o d o l og y
Client Selection Criteria
The following criteria were applied to ensure that data represent a
typical Walgreens Health Initiatives client base and that the observed trend is indeed the result of
the efforts of Walgreens Health Initiatives, rather than a change in cost that occurred due to the
addition or omission of clients during the trend period studied.
The trend number is based on all data from clients who met the selection criteria. It is not based on
data sampling.
All clients of Walgreens Health Initiatives for the full years 2007 and 2008 were included.
Clients were excluded if:
• Their member population was entirely or primarily located in Puerto Rico
• They were managed care organizations, Medicare Part D clients or 340B clients
• They offered only 100% copay or mail service-only programs
• They used a custom formulary
• Their eligibility changed suddenly or significantly in 2008
Overall Trend Calculation
• Trends were calculated based on the change in total cost per eligible member per year from
2007 to 2008.
• AWP was not used as a unit of analysis because it does not reflect the true price. Total cost of a
medication to our clients is usually lower than its AWP. Total cost accounts for a discounted AWP,
but does not account for manufacturer rebates.
= AWP – discount + dispensing fee
Total cost
= client cost + member cost
Note: Overall trend is based on all the prescription medications dispensed to eligible plan members in
2007 and 2008, including specialty products.
This methodology is consistent with the methodology used in our 2006, 2007 and 2008 reports.
28
thank you
To Our Clients
We extend our sincere gratitude to our
clients for their business. Our clients are the foundation upon
which our business has grown over the years and will always
be the inspiration for the development of our ideals, programs
and services. We would especially like to thank the clients who
adopted our recommendations, achieved cost savings and
contributed to another year of single-digit trend performance.
To Our Employees
Your service to—and important work
for—our clients and their members contributes to their trend
and benefit management success. Thank you.
Walgreens Health Initiatives wishes to acknowledge the
professionals from the departments that contributed to
this report: Clinical Services, Health Outcomes, Marketing
and Communications, Analytics and Provider Services, and
Sales and Client Services.
800-926-6779 | WalgreensHealth.com/pbm
PBM10333-0409

Walgreens TrendReport_2009

Transcription

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