DoD/TMA Pharmacoeconomic Center Promoting high quality, cost effective drug therapy throughout the Military Health System A Peek at

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


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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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


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


The PEC Staff

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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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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


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


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.


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.


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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


•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

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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


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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


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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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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“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


“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


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


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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


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


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


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


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?


Process Timeline

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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


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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


Questions

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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]

Documents

DoD/TMA Pharmacoeconomic Center Promoting high quality, cost effective drug therapy throughout the Military Health System A Peek at