A Peek at the PEC:
An Overview of Formulary Management at the
Department of Defense (DoD) TRICARE
Management Activity (TMA) Pharmacoeconomic
Center (PEC)
LCDR Marisol Martinez, PharmD
Fort Sam Houston, TX
DoD/TMA
Pharmacoeconomic
Center
Promoting
high quality, cost
effective drug therapy throughout the Military Health System
www.pec.ha.osd.mil
Objectives
• Discuss the Department of Defense (DoD) TRICARE
pharmacy benefit and the role and responsibility of the
PEC in formulary management
• Discuss the lessons learned from the DoD P&T process
for conducting drug class reviews to determine clinical
and cost effectiveness
• Review the functions of the Pharmacoeconomic
Outcomes Research Team (PORT) and the implications
of formulary decisions on military treatment facilities
(MTF)
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
2
Outline
•
•
•
•
•
•
•
•
•
TRICARE Pharmacy Benefit
Roles of the PEC
Process Timeline
Determining Clinical Effectiveness
Determining Cost Effectiveness
Functions of the PORT
Implications of P&T’s decisions
Conclusion
Questions
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
3
TRICARE
Pharmacy Benefit Background
•
Points of service
–
–
–
•
Population – 9.7 million beneficiaries
–
•
•
MTF
Retail
Mail Order
Active duty, retired Uniformed Service members, and
family members
Expenditures – $7.5 billion dollars
Uniform Formulary Rule
–
P&T Committee mandated by Congress
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
4
TRICARE Formulary
Basic Core
Formulary
Uniform
Formulary
Non
Formulary
Extended
Core
Formulary
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
5
TRICARE
Pharmacy Benefit – Points of Service
FY09
POS
Rxs
30-day Rxs*
30-day
Rxs (%)*
%
Dollars
Total
Dollars
MTF
48,101,964
80,252,540
44%
19%
$1.43 B
Retail 71,414,850
73,753,775
40%
67%
$5.06 B
Mail
10,454,703
Order
30,148,634
16%
14%
$1.05 B
*Normalized based on 30-day supply of medications
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
6
The PEC Staff
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
7
Responsibilities of the PEC
• Evaluate the clinical and cost effectiveness of
drug therapy to support the DoD P&T Committee
formulary decision-making process
• Implement and maintain the DoD pharmacy
benefit
• Assess the outcomes of drug therapy to improve
patient care and provide a feed-back loop for the
DoD P&T Committee
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
8
Process Timeline
Implementation
TMA Director
Decision
Drug Class
Selection
PEC completes Clinical and
Economic Analysis
Beneficiary
Advisory
Panel
Consult
with
PORT
DoD
P&T
Meeting
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
9
Drug Class Selection
• High expenditures across Military Health System
(MHS)
– “20/80 Rule”: 20% of the drugs comprise 80% of the
expenditures
•
•
•
•
Market competition within a class
Expiration of existing DoD or DoD/VA contracts
Impending generic competition
Newly approved drug likely to impact existing
class
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
10
Drug Class Selection
• November 2010 P&T meeting
– Januvia and Onglyza
• Rationale
–
–
–
–
–
Not previously reviewed
Significant cost to the DoD
Increased utilization
Safety concerns
Clinical guidelines
JANUVIA
JANUMET
ONGLYZA
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
11
Process Timeline
Implementation
TMA Director
Decision
Drug Class
Selection
PEC completes Clinical and
Economic Analysis
Beneficiary
Advisory
Panel
Consult
with
PORT
DoD
P&T
Meeting
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
12
• Team Approach
Clinical Analysis
Review Process
• Drug Class Review
–
–
–
–
–
–
Key Questions
Background
Efficacy
Safety
Tolerability
Other Factors
• Formal Presentation
– Utilization and Spend
– PEC Recommendations
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
13
Clinical Analysis
Evidence Based Medicine
• Goal
– Use the best quality evidence when determining differences
within the drug class
Meta-analyses and Systematic Reviews
Randomized Controlled Trials
Non-randomized Trials
Cohort and Case
Control Studies
Poster
Presentations
Reps
14
Clinical Analysis
Evidence Based Medicine
• Januvia and Onglyza Evidence
– No meta-analysis or systematic reviews
– Relied on randomized controlled trials for
efficacy and safety
– Head-to-Head trial
DoD/TMA Pharmacoeconomic Center
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15
Head-to-Head Trial
Saxagliptin vs Sitagliptin
•
•
•
•
18 week, Phase 3b, MC, DB, non-inferiority trial
Saxagliptin 5mg OR Sitagliptin 100mg
Stable metformin doses (1500-3000mg/day)
Primary endpoint
–  from baseline A1c
– Non-inferiority concluded if upper limit of 2-sided 95% CI of the
A1c difference between treatments was <0.3%
• Secondary endpoints
– % of patients achieving A1c < 6.5% and 7%
–  from baseline FPG, insulin, C-peptide, proinsulin, HOMA-2
DoD/TMA Pharmacoeconomic Center
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16
•Diabetes Metab Res Rev 2010;26;540-549.
Saxagliptin vs Sitagliptin
Results
SAXA + Met
N = 334
SITA + Met
N = 343
Mean (SE) A1c at baseline (%)
7.68 (0.052)
7.69 (0.047)
Mean (SE) A1c at week 18 (%)
7.16 (0.052)
7.07 (0.051)
Adjusted change from baseline A1c
(%)
Mean (SE)
Two-sided 95% CI
-0.52 (0.039)
-0.60, -0.45
-0.62 (0.038)
-0.69, -0.54
Difference in adjusted change from
baseline A1c vs sitagliptin + met (%)
Mean (SE)
Two-sided 95% CI
0.09 (0.055)
-0.01, 0.20
-
SE = standard error
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
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•Diabetes Metab Res Rev 2010;26;540-549.
Clinical Analysis
Provider Input
• Developed by the clinical evaluation team
• Sent via email using web survey tool
• Questionnaire
– Physicians
– Pharmacists
– Other healthcare providers
• Summarized responses presented to the P&T
Committee
• Missing input from civilian network providers
• Januvia and Onglyza: Email Invites > 500,
Responses 443
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
18
•Survey: Non-Insulin Anti-Diabetic Agents: To what extent do you agree or disagree with this statement: "In order to treat the majority of y ...
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
19
Economic Analysis
Relative Cost-Effectiveness
• Two broad types of economic analyses
– Pharmacoeconomic Analysis
• Evaluates the outcomes and costs of interventions
designed to improve health
• 4 types
– Budget Impact Analysis (BIA)
• Accounts for costs associated with a decision
• Estimates the likely impact (use and cost) of a
formulary decision over 2-3 years
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
20
Types of Pharmacoeconomic Analysis
• Cost-Minimization Analysis (CMA)
– Treatments are equally effective
– Cost is only factor
• Cost-Effectiveness Analysis (CEA)
– Outcomes vary but can be expressed in a common unit
– Combines clinical benefits with cost efficiency
• Cost-Utility Analysis (CUA)
– Costs and consequences of different interventions in terms of the
patient’s health-related quality of life and survival time
• Cost-Benefit Analysis (CBA)
– Compares the net costs of a health care intervention with the
benefits as a result of applying that intervention
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
21
CMA Results
$3.00
Retail
$2.50
Retail
Retail
Cost ($)/Day
Retail
$2.00
$2.00
$1.75
$1.50
MTF
MTF
$1.00
$1.00
$0.50
MTF
MTF
Weighted average cost for all 3 POS standardized to
drug A market share (46% MTF; 30% RET; 24% MAIL)
$0.00
Drug B
Drug B
Drug B
(1 of 1 UF)
(1 of 2 UF)
(1 of 2 UF/BCF)
Drug A
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
$1.55
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Economic Analysis
Decision Criteria
Cost
NO
Rejection
threshold
Increase
Worse
MAYBE
Better
Acceptance
threshold
Effect
MAYBE
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
Decrease
YES
23
Process Timeline
Implementation
TMA Director
Decision
Drug Class
Selection
PEC completes Clinical and
Economic Analysis
Beneficiary
Advisory
Panel
Consult
with
PORT
DoD
P&T
Meeting
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
24
Pharmacy Outcomes Research Team
(PORT)
• Co-located in DC and San Antonio
–
–
–
–
3 pharmacists
2 pharmacoeconomists
Data analyst
Technical writer
• Improve the outcomes of drug therapy and
enhance the quality of the TRICARE pharmacy
benefit
• Support the DoD P&T Committee and assess
the effects of formulary changes on DoD
beneficiaries
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
25
“First-line Use”: New Antidiabetic Users
No Antidiabetic Rxs Prior 12 Months, Combos w/ Parent Agents
•X12
Jul 09 –
Jun 10
New users
Jul10
Estimated new
users/year
Total unique
utilizers/yr
Jul09-Jun10
No
antidiab
etic Rx
495
5940
93,661
6
98
1176
23,053
5
460
5520
140,156
4
Insulin (any)
1177
14,124
159,665
9
SU
1449
17,388
222,537
8
Metformin
5959
71,508
423,224
17
July 10
DPP-4
GLP-1
TZD
% new
users
•New metformin users represent 17% of all metformin users
Other
antidiabetics
60
720
16,513
4
•Note: This method counts individuals who received an Rx for a given drug or drug
class during a given month (e.g., Jul10) but NOT during the previous 12-month
period (e.g., Jul 09 to Jun10); all POS
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
26
“First-Line” Use of DPP-4s
• 93,661 unique users Jul 09 – Jun 10
• Estimated new users per year (n)
– No antidiabetics at all, last 12 months = 5940
– No DPP-4 last 12 months = 35,364
– No DPP-4, had Met or SU, last 12 months = 27,636
• ~22% of new DPP-4 users had no Met or SU last 12
months
• Of these, about 1/3 (1788) had antidiabetics other than
Met or SU prior to DPP-4s
• So, the percent of new DPP-4 users with no prior
antidiabetic use is ~17%
DoD/TMA Pharmacoeconomic
•DoD Pharmacy Outcomes
Center
www.pec.ha.osd.mil
Research Team
27
Process Timeline
Implementation
TMA Director
Decision
Drug Class
Selection
PEC completes Clinical and
Economic Analysis
Beneficiary
Advisory
Panel
Consult
with
PORT
DoD
P&T
Meeting
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
28
DoD P&T Meeting
•
•
•
•
•
•
Uniform Formulary placement
Basic Core Formulary (BCF) additions
Medical necessity criteria for NF drugs
Prior authorization requirements
Quantity limits
Minutes of each meeting include
recommendation summaries and supporting
documentation
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
29
DPP-4 Inhibitors
Relative Clinical Effectiveness
• DoD P&T Committee Recommendation on the
Relative Clinical Effectiveness (vote)
– Motion: The DoD P&T Committee agrees with the
relative clinical effectiveness analysis of DPP-4s as
presented
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
30
BCF Decision
PEC Recommendation
• Recommendation
– Januvia and Janumet BCF
• Justification
– Budget impact analysis showed more cost effective
when placed on the BCF
– Questionnaire results showed preference for a BCF
agent
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
•BCF=Basic Core Formulary
31
Medical Necessity vs Prior Authorization
• Medical Necessity
– Requirement when drugs are made Non-formulary
– Five criteria to meet medical necessity
• CI, ADR’s, Tx failure, stable patient and unacceptable risk if
change to UF drug, no UF alternative
– Retail/Mail Order: Fulfilling MN reduces co-pay from
$22 (NF) to $9 (UF)
– MTF: Fulfilling MN allows pt to receive NF drug at MTF
• Prior Authorization
– Drug with PA can be in a UF-reviewed class (PDE-5s,
biologics for RA), or class not previously reviewed
– Assist with ensuring appropriate use
•NF=Non-formulary
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
•MTF=Military Treatment Facility
•UF=Uniform Formulary
32
Step Therapy
• Automated Prior Authorization = Step Therapy
– Applies to Retail Network/Mail Order, where computer
can look back at patient’s profile
– Requires use of preferred agent first, then can try
others in the class that are UF
– PPIs , BPH drugs, Insomnia
• Manual Prior Authorization
– When automated PA fails
– Physician initiates a call or fills out form
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
33
Step Therapy
Automated
review of
patient profile.
Has the patient
previously
received the
preferred
product?
Prescription
written
Pharmacy
processes
prescription
PDTS checks patient
profile
Rx pays
YES and is
dispensed
NO
Rx does not
pay
Prior Authorization required
Or, Patient must try the preferred product
34
Process Timeline
Implementation
TMA Director
Decision
Drug Class
Selection
PEC completes Clinical and
Economic Analysis
Beneficiary
Advisory
Panel
Consult
with
PORT
DoD
P&T
Meeting
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
35
The Beneficiary Advisory Panel (BAP)
Washington DC
• Congress established
• Focus on implementation of UF decisions
– Enhance transparency to beneficiaries
• Members
–
–
–
–
–
Active duty family members
Retirees and their family members
2 clinical experts outside of the DoD
Pharmacist from the US Family Health Plan
Physicians or pharmacists from the TRICARE
regional contractors
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
36
The BAP
• Concerns regarding Januvia and Onglyza
– Does the Committee consider the mechanism of
action when deciding where to place an agent?
– Does a patient need to go through step therapy to use
metformin in combination?
– Can a patient get Janumet without trying a
sulfonylurea or metformin first?
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
37
Process Timeline
Implementation
TMA Director
Decision
Drug Class
Selection
PEC completes Clinical and
Economic Analysis
Beneficiary
Advisory
Panel
Consult
with
PORT
DoD
P&T
Meeting
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
38
TRICARE Management Activity (TMA)
Director Decision
• Dr. Jonathan Woodson
• Assistant Secretary of
Defense for Health Affairs
• Director, TMA
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
• Reviews comments and
approves the P&T
minutes
• After the minutes are
approved, the decisions
may be made public
39
TRICARE Management Activity (TMA)
Signed Minutes
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
40
Process Timeline
Implementation
TMA Director
Decision
Drug Class
Selection
PEC completes Clinical and
Economic Analysis
Beneficiary
Advisory
Panel
Consult
with
PORT
DoD
P&T
Meeting
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
41
Implementation
• 30, 60, 90, up to 180 day implementation
– Based on level of effort and awareness necessary to
make the change
• Several things happen
–
–
–
–
–
Education
Operations
Prior Authorization edits-testing
Formulary search tool and Epocrates
Monitoring
• DPP-4 Inhibitors - 60 day implementation
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
42
Summary
• Review of the TRICARE formulary is important to
help manage a $7.5 billion dollar pharmacy
benefit
• Formulary management is accomplished through
a thorough evaluation of efficacy, safety, and cost
• The PEC staff assists the DoD P&T Committee
with recommendations that provide the greatest
value to the Military Health System
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
43
Questions
DoD/TMA Pharmacoeconomic Center
www.pec.ha.osd.mil
44
A Peek at the PEC:
An Overview of Formulary Management at the
TRICARE Management Activity (TMA)
Pharmacoeconomic Center (PEC)
LCDR Marisol Martinez, PharmD
Email: marisol.martinez@amedd.army.mil
DoD/TMA
Pharmacoeconomic
Center
Promoting
high quality, cost
effective drug therapy throughout the Military Health System
www.pec.ha.osd.mil