A Peek at the PEC: An Overview of Formulary Management at the Department of Defense (DoD) TRICARE Management Activity (TMA) Pharmacoeconomic Center (PEC)

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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

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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 PT
  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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Outline

• TRICARE Pharmacy Benefit
• Roles of the PEC
• Process Timeline
• Determining Clinical Effectiveness
• Determining Cost Effectiveness
• Functions of the PORT
• Implications of PTs decisions
• Conclusion
• Questions

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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
• PT Committee mandated by Congress

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TRICARE Formulary
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TRICAREPharmacy Benefit Points of ServiceFY09
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 Order 10,454,703 30,148,634 16 14 1.05 B
Normalized based on 30-day supply of medications
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The PEC Staff
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Responsibilities of the PEC

• Evaluate the clinical and cost effectiveness of
  drug therapy to support the DoD PT 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 PT Committee

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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 PT meeting
• Januvia and Onglyza
• Rationale
• Not previously reviewed
• Significant cost to the DoD
• Increased utilization
• Safety concerns
• Clinical guidelines

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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

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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 lt0.3
• Secondary endpoints
• of patients achieving A1c lt 6.5 and 7
• ? from baseline FPG, insulin, C-peptide,
  proinsulin, HOMA-2?

• Diabetes Metab Res Rev 201026540-549.

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Saxagliptin vs SitagliptinResults
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

• Diabetes Metab Res Rev 201026540-549.

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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 PT
  Committee
• Missing input from civilian network providers
• Januvia and Onglyza Email Invites gt 500,
  Responses 443

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• 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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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

• 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 patients 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

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CMA Results
Cost ()/Day
Weighted average cost for all 3 POS standardized
to drug A market share (46 MTF 30 RET 24
MAIL)
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Economic Analysis Decision Criteria
Rejection threshold
Cost
NO
MAYBE
Increase
Acceptance threshold
Worse
Better
Effect
Decrease
YES
MAYBE
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Process Timeline
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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 PT Committee and assess the
  effects of formulary changes on DoD beneficiaries

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First-line Use New Antidiabetic UsersNo
Antidiabetic Rxs Prior 12 Months, Combos w/
Parent Agents

• X12

July 10 Jul 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 No antidiabetic Rx 98 1176 23,053 5
TZD No antidiabetic Rx 460 5520 140,156 4
Insulin (any) No antidiabetic Rx 1177 14,124 159,665 9
SU No antidiabetic Rx 1449 17,388 222,537 8
Metformin No antidiabetic Rx 5959 71,508 423,224 17
Other antidiabetics No antidiabetic Rx 60 720 16,513 4

• New metformin users represent 17 of all
  metformin users

• 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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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 Pharmacy Outcomes Research Team

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Process Timeline
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DoD PT 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

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DPP-4 InhibitorsRelative Clinical Effectiveness

• DoD PT Committee Recommendation on the Relative
  Clinical Effectiveness (vote)
• Motion The DoD PT Committee agrees with the
  relative clinical effectiveness analysis of
  DPP-4s as presented

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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

• BCFBasic Core Formulary

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Medical Necessity vs Prior Authorization

• Medical Necessity
• Requirement when drugs are made Non-formulary
• Five criteria to meet medical necessity
• CI, ADRs, 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

• NFNon-formulary
• MTFMilitary Treatment Facility
• UFUniform Formulary

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Step Therapy

• Automated Prior Authorization Step Therapy
• Applies to Retail Network/Mail Order, where
  computer can look back at patients 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
Automated review of patient profile. Has the
patient previously received the preferred product?
Rx pays and is dispensed
YES
Prescription written
Pharmacy processes prescription
PDTS checks patient profile
NO
Rx does not pay
Prior Authorization required Or, Patient must try
the preferred product
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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

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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?

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Process Timeline
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TRICARE Management Activity (TMA) Director
Decision

• Reviews comments and approves the PT minutes
• After the minutes are approved, the decisions may
  be made public

• Dr. Jonathan Woodson
• Assistant Secretary of Defense for Health Affairs
• Director, TMA

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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

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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 PT Committee with
  recommendations that provide the greatest value
  to the Military Health System

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Questions
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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_at_amedd.army.mil