dod/tma pharmacoeconomic center promoting high quality, cost effective drug therapy throughout the...
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DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Promoting high quality, cost effective drug therapy throughout the Military Health System
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 Centerwww.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)
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DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Outline
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• 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 Centerwww.pec.ha.osd.mil
TRICARE Pharmacy Benefit Background
• Points of service– MTF– Retail– Mail Order
• Population – 9.7 million beneficiaries– Active duty, retired Uniformed Service members, and
family members• Expenditures – $7.5 billion dollars• Uniform Formulary Rule
– P&T Committee mandated by Congress
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TRICARE Formulary
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TRICAREPharmacy Benefit – Points of Service
FY09
POS Rxs 30-day Rxs*30-day
Rxs (%)*%
DollarsTotal
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 Order
10,454,703 30,148,634 16% 14% $1.05 B
*Normalized based on 30-day supply of medications
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
The PEC Staff
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DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
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
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DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Process Timeline
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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
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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
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Process Timeline
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Clinical AnalysisReview Process
• Team Approach
• Drug Class Review– Key Questions– Background– Efficacy– Safety – Tolerability– Other Factors
• Formal Presentation– Utilization and Spend– PEC Recommendations
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Clinical AnalysisEvidence Based Medicine
• Goal – Use the best quality evidence when determining differences
within the drug class
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Clinical AnalysisEvidence 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 Centerwww.pec.ha.osd.mil
Head-to-Head TrialSaxagliptin 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
16•Diabetes Metab Res Rev 2010;26;540-549.
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Saxagliptin vs SitagliptinResults
SAXA + MetN = 334
SITA + MetN = 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
--
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SE = standard error
•Diabetes Metab Res Rev 2010;26;540-549.
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
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Clinical AnalysisProvider 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 Centerwww.pec.ha.osd.mil
•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 ...
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DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
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
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Types of Pharmacoeconomic Analysis
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• 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 Centerwww.pec.ha.osd.mil
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CMA Results
Weighted average cost for all 3 POS standardized to drug A market share (46% MTF; 30% RET; 24% MAIL)MTF
MTF
MTFMTF
Retail
Retail
Retail Retail
$1.00
$2.00
$1.75$1.55
$0.00
$0.50
$1.00
$1.50
$2.00
$2.50
$3.00
Drug A Drug B
(1 of 1 UF)
Drug B
(1 of 2 UF)
Drug B
(1 of 2 UF/BCF)
Co
st (
$)/D
ay
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Economic Analysis Decision Criteria
Cost
Effect
Worse
Better
Increase
Decrease
Rejectionthreshold
Acceptancethreshold
NO
YES
MAYBE
MAYBE
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Process Timeline
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DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
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
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DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
“First-line Use”: New Antidiabetic UsersNo Antidiabetic Rxs Prior 12 Months, Combos w/ Parent Agents
July 10Jul 09 – Jun 10
New users Jul10
Estimated new users/year
Total unique utilizers/yr
Jul09-Jun10% new users
DPP-4 No antidiabetic Rx
495 5940 93,661 6
GLP-1 98 1176 23,053 5
TZD 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
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
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•New metformin users represent 17% of all metformin users
•X12
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
“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%
27•DoD Pharmacy Outcomes Research Team
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Process Timeline
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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 Centerwww.pec.ha.osd.mil
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DPP-4 InhibitorsRelative 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 Centerwww.pec.ha.osd.mil
BCF DecisionPEC 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
31•BCF=Basic Core Formulary
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
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
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•NF=Non-formulary
•MTF=Military Treatment Facility
•UF=Uniform Formulary
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
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
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Step Therapy
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Prescription written
Pharmacy processes prescription
PDTS checks patient profile
Automated review of patient profile. Has the patient previously received the preferred product?
Prior Authorization requiredOr, Patient must try the preferred product
Rx pays and is dispensed
Rx does not pay
NO
YES
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Process Timeline
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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 Centerwww.pec.ha.osd.mil
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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 Centerwww.pec.ha.osd.mil
Process Timeline
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DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
TRICARE Management Activity (TMA) Director Decision
• Dr. Jonathan Woodson• Assistant Secretary of
Defense for Health Affairs• Director, TMA
• Reviews comments and approves the P&T minutes
• After the minutes are approved, the decisions may be made public
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TRICARE Management Activity (TMA)Signed Minutes
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Process Timeline
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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 Centerwww.pec.ha.osd.mil
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• 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
Summary
DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Questions
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DoD/TMA Pharmacoeconomic Centerwww.pec.ha.osd.mil
Promoting high quality, cost effective drug therapy throughout the Military Health System
A Peek at the PEC: An Overview of Formulary Management at the
TRICARE Management Activity (TMA) Pharmacoeconomic Center (PEC)
LCDR Marisol Martinez, PharmD
Email: [email protected]