ADULT MAJOR DEPRESSIVE DISORDER (MDD) - Free CE · PDF fileNursing Continuing Education ......

T R E A T M E N T T O O L B O X

ADULT MAJOR DEPRESSIVE DISORDER (MDD)

This activity is supported by an educational grant from This activity is jointly sponsored/co-provided by

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ADULT MDD TREATMENT TOOL BOX

Release date: October 13, 2011Expiration date: April 30, 2013Estimated time to complete activity: 1.0 hours

Intended Audience

This activity has been designed to meet the educational needs of:

• Psychiatrists,primarycarephysicians,andothercliniciansinvolved with the care of adult patients with major depressive disorder

• MedicalDirectorsandPharmacyDirectorsfromhealthplans,HMOs, integrated health systems, employers, quality organizations, public payer groups, and other managed care organizations and health insurers

• Managedcareaffiliatedcareteammembersinvolvedwithpatientevaluation, education, and follow-up for adult patients with MDD including: physicians, pharmacists, registered nurses, and care managers

Statement of Educational Need

Adult MDD is a serious medical illness affecting 15 million American adults, or approximately 5-8% of the adult population in a given year. Unlike normal emotional experiences of sadness, loss, or passing moodstates,MDDispersistentandcansignificantlyinterferewithan individual’s thoughts, behavior, mood, activity, and physical health. Over 50% of patients with adult MDD develop role impairment. There is no single cause of MDD—psychological, biological, and environmental factors may all contribute to its development.

AdultMDDhasalsobeenassociatedwithsignificantmedicalcomorbidity. In addition, adult MDD affects patients’ marital, parental, social, and vocational functioning. The disorder is unremitting in about 15% of patients and recurrent in another 35%. Compounding the problem is that treatment is often delayed. These factors highlight the need for changes in the delivery of mental health services to enhance timeliness and quality of care in adult MDD.

The economic toll associated with the treatment of depression is enormous—in 2000, the U.S. economic burden of depressive disorders was estimated to be $83.1 billion. More than 30% of these costs are attributable to direct medical expenses.

Educational Objectives

After completing this activity, the participant should be better able to:

• Implementevidence-basedsequencedmanagementstrategiesbased on the 2010 APA Practice Guideline to enhance clinical decision-making for adult patients with MDD

• Assesstheclinicalandeconomicvalueofatypicalantipsychoticsfor the treatment of adult patients with MDD who do not achieve full remission

• Explainhowthe2010APAPracticeGuidelinecanintegratewithamanaged care algorithm for optimal value of therapeutic options

• Applytheuseofdecisionsupporttools,suchascomparativeeffectiveness research (CER) and pharmacoeconomic (PE) models, that enable evidence-based treatment decisions for adult patients with MDD

• Implementasystem-wideapproachtocollaborativecare,stepped care, and medication therapy management

• Implementpatientscreeningandmonitoringthatleverageshealthinformation technology advances to improve outcomes for adult patients with MDD

• Provideappropriatecareandcounselforpatientsandtheirfamilies

• Provideaccurateandappropriatecounselaspartofthetreatment team

Physician Continuing Medical Education

Accreditation StatementThis activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Postgraduate Institute for Medicine and Impact Education, LLC. Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation StatementThe Postgraduate Institute for Medicine designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Pharmacist Continuing Education

Accreditation StatementPostgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Credit DesignationPostgraduate Institute for Medicine designates this continuing education activity for 1.0 contact hours (0.10 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - 0809-9999-11-132-H01-P)

Type of ActivityKnowledge-based

Nursing Continuing Education

Credit Designation StatementThis educational activity for 1.0 contact hours is provided by Postgraduate Institute for Medicine.

Accreditation StatementPostgraduate Institute for Medicine is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

A statement of credit will be issued only upon receipt of a completed activity evaluation form.

CME/CE information continued on page 4

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The purpose of the Adult Major Depressive Disorder (MDD) Treatment Tool Box is to provide examples of resources that have been used successfully by clinicians, educators, peer review organizations, managed care organizations and others to improve care of patients with MDD. This Tool Box does not specifically endorse any of the enclosed tools.

Table of ContentsIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6• BurdenofMDDinAdults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

• AnnualHealthcareCostsforPatientsWithMDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

• UnmetNeedsandMDDTreatmentChallenges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Management of MDD in Adults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9• GeneralApproachtoTreatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

• TimingofIntervention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

• AssessmentofTherapeuticFailure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

• AmericanPsychiatricAssociation(APA):RecommendedTreatmentApproaches. . . . . . . . . . . . 10

• Augmentation,Combination,andSwitching . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

• AugmentationStrategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

• TherapeuticOptionsinPatientsWithRefractoryDepression . . . . . . . . . . . . . . . . . . . . . . 12

Integrating Current MDD Practice Guidelines Into a Managed Care Treatment Algorithm . . . . . . . . 13• Guideline-recommendedStrategiesforTreatmentofRefractoryDepression. . . . . . . . . . . . . . 13

• MDDTreatmentStrategyandHEDISScores . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Decision Support Tools for Adult MDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14• ComparativeEffectivenessAnalysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

• PharmacoeconomicModeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

MDD Coverage Decision-making . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18• TreatmentAlgorithms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

• DecisionFactors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Benefit Design and MDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19• Value-basedInsuranceDesign . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Improving MDD Outcomes by Coordinating Care and Leveraging Technology . . . . . . . . . . . . . . . 21• PatientScreeningandMonitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

• CollaborativeCare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

• SteppedTherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

• MedicationTherapyManagement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

• LeveragingTechnology:ElectronicHealthRecords . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

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FacultyGeorge I. Papakostas, MDDirector,Treatment-resistantDepressionStudiesDepartmentofPsychiatryMassachusettsGeneralHospitalAssociateProfessorofPsychiatryHarvardMedicalSchool

Charles L. Raison, MDAssociateProfessorDepartmentofPsychiatryUniversityofArizonaSchoolofMedicineNortonSchoolofFamilyandConsumerSciencesUniversityofArizona

Carl V. Asche, PhD, MBAProfessor,Director,CenterforHealthOutcomesResearchUniversityofIllinoisCollegeofMedicine

David K. Nace, MDVicePresident,MedicalDirectorMcKessonCorporation/RelayHealthCo-chair,CenterforeHealthPatientCenteredPrimaryCareCollaborative

Disclosure of Conflicts of InterestPostgraduateInstituteforMedicine(PIM)requiresinstructors, planners, managers, and other individuals who are in a position to control the contentofCMEactivities.Allrelevantconflictsofinterest that are identified are thoroughly vetted byPIMforfairbalance,scientificobjectivityofstudies utilized in this activity, and patient care recommendations.PIMiscommittedtoprovidingitslearnerswithhighqualityCMEactivitiesandrelatedmaterialsthatpromoteimprovementsorqualityinhealthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CMEactivity:

George I. Papakostas, MD, is a consultant/advisorforCephalonInc.,DeyPharma,L.P.,OtsukaPharmaceuticals,PAMLABLLC,andRidgeDiagnostics(formerlyknownasPrecisionHumanBiolaboratories);receivedhonorariafromAstraZenecaPLC,BrainswayLtd.,Bristol-MyersSquibb,CephalonInc.,DeyPharma,L.P.,EliLillyCo.,GlaxoSmithKline,OtsukaPharmaceuticals,PAMLABLLC,andRidgeDiagnostics;andreceivedresearchsupportfromAstraZenecaPLC,ForestLaboratories,Inc.,theNationalInstituteofMentalHealth,PAMLABLLC,PfizerInc.,andRidgeDiagnostics(formerlyknownasPrecisionHumanBiolaboratories).

Charles L. Raison, MD, is a consultant/advisor for BiolexTherapeuticsandPAMLABLLC

Carl V. Asche, PhD, MBA, is a consultant/advisor for BayerAGandNovoNordisk,Inc.;andistheprincipleinvestigatorongrantstotheUniversityofUtahfromPfizerInc.andTakedaPharmaceuticalCompanyLimited.

David K. Nace, MD, has no relevant financial relationships to disclose.

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CMEactivity:

Steve Casebeer, MBA; Jan Hixon, RN, BSN, MA; Trace Hutchison, PharmD; Julia Kimball, RN, BSN; Samantha Mattiucci, PharmD; Jan Schultz, RN, MSN, CCMEP; and Patricia Staples, MSN, NP-C, CCRN hereby state that they or their spouse/life partner have not had any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

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Method of Participation and Request for CreditTherearenofeesforparticipatingandreceivingCEcreditforthisactivity.DuringtheperiodOctober13,2011throughApril30,2013,participantsmustreadthe learning objectives and faculty disclosures and study the educational activity.

PostgraduateInstituteforMedicinesupportsGreenCMEbyofferingyourRequestforCreditonline.Ifyouwishtoreceiveacknowledgmentforcompletingthis activity, please complete the posttest and evaluation on www.cmeuniversity.com.Onthenavigationmenu,clickon“FindPost-test/EvaluationbyCourse”andsearchbycourseID8262.Uponregistering and successfully completing the posttest with a score of 70% or better and the activity evaluation, your certificate will be made available immediately.Processingcreditrequestsonlinewillreduce the amount of paper used by nearly 100,000 sheets per year.

MediaInternet:PDF

Disclosure of Unlabeled UseThis educational activity may contain discussion of published and/or investigational uses of agents that arenotindicatedbytheFDA.PostgraduateInstituteforMedicine(PIM),ImpactEducation,LLC,andBristol-MyersSquibbdonotrecommendtheuseofany agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily representtheviewsofPIM,ImpactEducation,LLC,andBristol-MyersSquibb.Pleasereferto the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DisclaimerParticipantshaveanimpliedresponsibilitytousethenewlyacquiredinformationtoenhancepatient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patientmanagement.Anyprocedures,medications,or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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IntroductionBurden of Major Depressive Disorder (MDD) in Adults

• MDDaffects>18millionAmericans1,2

• ThelifetimeprevalenceofMDDis16.2%1,2

• Thediseaseprevalence,treatmentrate,anddegreeofimpairmentcontributetotheclinicalandeconomicburden of the disease3

• MDDpatientsachievingNationalCommitteeforQualityAssurance(NCQA)HealthcareEffectivenessDataandInformationSet(HEDIS)treatmentgoalscost>$3400lessinannualdirect(medicalanddrug)coststhan those not meeting these standards4

Annual Per-patient Healthcare Costs for Patients With MDD

1.GreenbergPE,etal.J Clin Psychiatry.2003;64:1465-1475;2.KesslerRC,etal.JAMA.2003;289:3095-3105;3.LuppaM,etal.J Affect Discord.2007;98:Epub2006Sep6; 4.GreenbergHG,etal.J Med Econ.2009;12:36-45.

0

5

10

15

20

25

30

Cost

($1,

000)

Depressed Non-depressed

Obesity Hypertension Diabetes Headache Joint Pain IVDD Asthma Back Pain Epilepsy CAD CHF

Median Annual Cost per Patient

Insuranceclaimsfor618,780patientsexaminedfortotalannualnon-mentalhealthcostofcarein11chronicdiseases.Ineachdiseasecohort,medianannualnon-mentalhealthcostwas calculated for individuals with and without depression.

CAD=coronaryarterydisease;CHF=congestiveheartfailure;IVDD=intervertebraldiscdisease.

WelchCA,et.al.Psychosomatics.2009:50;392-401.

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50%

25%

15%

35%

15%

0% 0%

20%

40%

60%

80%

100%

1st Treatment 2nd Treatment 3rd Treatment

Respond Remit

Perc

ent

Weeks to First Relapse Into Major Depressive Episode (MDE)

Odd

s Ra

tio

Median Weeks Well

231

68

(95% Con�dence Interval) (169-332)

(49-88)

Asymptomatic Recovery

Residual SSD Recovery

0.8

0.6

0.4

0.2

0

1

425 400 375 350 325 300 275 250 225 200 175 150 125 100 75 50 25 0 450 475 525 500

Asymptomatic Recovery (n=155)

Residual SSD Recovery (n=82)

Failure to Achieve Initial Remission Produces Poor Long-term Outcomes

SSD=sub-syndromaldepression;subthresoholddepressivesymptoms.

JuddLL,et.al.J Affect Disord. 1998:50;97-108.

RobinsonWD,etal.J Am Board Fam Pract.2005;18:79-86. FavaM,etal.Psychiatr Clin North Am.2003;26:457-494.

>20% of MDD Patients are Resistant to Treatment

Unmet Needs and MDD Treatment Challenges

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MDD Treatment Challenges

• Poorlydefinedconditionwhichisoftenmisdiagnosed

• Inadequatetreatment,under-treatment,delayedtreatment – Failuretoachieveremissionwithpriortherapy – “Pseudo-resistance”observedinpatientswhohavenotreceivedguideline-definedtreatment

• Failuretoaddresscomorbiddisorders – Substanceabuse – ConcurrentAxisIorIIdisorders – Othermedicalconditions

• Non-adherencetoprescribedtreatmentregimen – Prematurediscontinuationoftreatmentassociatedwithhigherratesofrelapse

GaynesB.J Clin Psychiatry.2009;70(suppl6):10-15;FavaM.Biol Psychiatry.2003;53:649–659.

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Management of Major Depressive Disorder (MDD) in Adults General Approach to Treatment

AmericanPsychiatricAssociation(APA).Am J Psychiatry.2010;167:1-152.

Timing of Intervention

• GoalofAcutePhaseoftherapyisremission1

• Measurement-basedcareiskey1

• Delayinachievingremissionofsymptomsischaracteristic2,3

– Discontinuingatreatmentprematurely(ie,<4weeks)duetolackofefficacyalonemaydeprivesome patients of a potentially effective therapy

– Waitingtoolonginthefaceofcompletenon-response(ie,>8weeks)mayunnecessarilyincrease patient’s exposure to an ineffective therapy and, ultimately, delay improvement

1.AmericanPsychiatricAssociation.Am J Psychiatry.2010;167:1-152;2.TrivediMH,etal.Am J Psychiatry.2006;163:28-40;3.QuitkinFM,etal.Am J Psychiatry.2003;160:734-740.

Assessment of Therapeutic Failure

• Adequacyoftreatment –Dose,duration,qualityoftherapy

• Appropriatenessofdiagnosis – Bipolar disorder, psychotic features

• Adequacyofdiagnosis –Psychiatric/medicalco-morbidity

• Complianceandtolerability

• Pharmacokineticfactors

AmericanPsychiatricAssociation.Am J Psychiatry.2010;167:1-152.

According to the APA Guidelines, the Goal of Treatment is Remission

Remission •  At least 3 weeks of the absence of both sad

mood and reduced interest •  No more than 3 remaining symptoms

Response •  ≥50% improvement in symptoms •  Allows for significant residual symptoms

Vs

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American Psychiatric Association (APA): Recommended Treatment Approaches

• Increasedosage

• Switching

• Augmentation –Additionofanon-antidepressantagenttoenhancetheeffectoftheantidepressant

• Combination –Additionofasecondantidepressantagenttoenhancetheeffectoftheoriginalantidepressant

Augmentation, Combination, and Switching

• Augmentationandcombination –Avoidlossofanytherapeuticbenefitsfromfirst-lineagent –Noriskofwithdrawalsymptoms – May target side effects of first-line treatment

• Switching – Better compliance –Lowerriskofdruginteractions –Resolutionofsideeffects –Costimplicationsmustbedetermined

• Partialresponse(vsnon-response) –Favorsretentionofinitialagent •Augmentation •Combination •Dose-increase

• Poortolerability(vsgoodtolerability) –Favorsdiscontinuationofinitialagent •Switching

• Knowledgeofrelativeefficacyandtolerabilityof2nd+linestrategieskeytoguidingtreatmentselection

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Antidepressant Therapy Augmentation Strategies

Drug Advantages Disadvantages (Varies by Agent & Dose)

Antipsychotics•aripiprazole5-15mg•olanzapine5-15mg•quetiapine150-300mg•risperidone0.5-2mg

•Beststudiedstrategy •Tolerability -Neuroendocrine - Metabolic -Extrapyramidalsymptoms•Efficacyassecond-linetreatmentnotwell-

described

Lithium•600-1200mg/d

•Pooledoddsratioofresponseduringlithiumaugmentationvsplacebo:3.31(95%CI,1.46-7.53)

•Marginofefficacyvsdoseincrease,other strategies•All“positive”placebo-controlledstudiesofshort

duration•Paucityofstudiesonneweragents•Riskoftoxicityandneedforbloodmonitoring

Mirtazapine/Mianserin•600-1200mgqs

•Strongefficacydata•Mayhelpwithinsomnia

•Weightgain•Sedation•Agranulocytosis(veryrare)

Pindolol•2.5-7.5mgtid

•Mayaccelerateresponsetoselectiveserotoninreuptakeinhibitors(SSRIs)

•Nodifferencefromplaceboin2largeststudies•Increasedirritability

Testosterone •Positiveresultsseeninonesmallstudy

•Nodifferencefromplaceboobservedinatleast3 larger studies

Omega-3FattyAcids •Tolerability•Acceptability•Maypossessotherhealth-promoting

benefits

•Optimaldoseunknown•Cost

Triodothyronine(T3)•600-1200mgqd

•Mayaccelerateclinicalresponse •Allplacebo-controlledstudiesinvolvedtricyclicantidepressants(TCAs)•Amongthe4randomizedcontrolledtrials(RCTs),pooledeffectedwerenotsignificant(p>0.05)

Modafinil•600-1200mgqd

•Efficacydemonstratedinpooledresults of 2 trials•Mayresolvesymptomsinpatients

who also present with residual somnolence and fatigue•Usefulforresidualsomnolence

•Unclearefficacyinpatientswithoutfatigueand sleepiness•Uncleareffectinpatientswithinsomnia

Buspirone•10-30mg

____ •Equivalenttoplaceboin2controlledstudies

Osmotic-releaseOralSystem(OROS)Methylphenidate•18-54mg/d

•Mayhelpwithfatigue,apathy,andsomnolence•Mayhelpwithcomorbidattention-deficit/hyperactivitydisorder(ADHD)

•2negativestudies•Potentialforabuse

L-methylfolate•7.5-15mg/d

•Significantlybetterthanmonotherapyat higher dose

•Nodifferencethanmonotherapyatlowerdose

S-adenosylMethionine(SAMe)

•PilotdataindicateSAMeisaneffective, well-tolerated, and safe adjunctivetreatmentstrategyforSRInonresponders

•Studywasunderpoweredandofshortduration

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Therapeutic Options in Patients With Refractory Depression

• Electroconvulsivetherapy

• Vagusnervestimulation

• Deepbrainstimulation

• Variabledataforefficacy

• Timingforintroductiondependingupon –RefractorinessofIllness –Useinpastepisodes –Patientpreference –Availability

Benefits of the Placebo Effect

• Psychotherapy,antidepressants,andsomatictherapiesareallpartofthereasonwhypatientsimprove

• Strategiesforplaceboenhancement –Assuagefears,worry,andembarrassmentaboutillness –Workonproblem-solvingskills –Planresumptionofpleasurableactivities –Providehope –Involvepatientsintreatmentdecisions–incorporatepatientpreferenceintothetreatmentregimen

• SupportivecomponentsofMDDcare – Team approach –Useofacasemanager –Assesstoapsychiatrist –Adherencemonitoringandsupport –Provideeducationtopatientandfamily

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Integrating Current Major Depressive Disorder (MDD) Practice Guidelines Into a Managed Care Treatment Algorithm• Identifyoptimal,cost-effectivetreatmentstrategies1

–Inadequatedoseordurationofantidepressanttherapycanpreventremission2,3

• Goaloftreatmentisremission3

–4-8weeksoftreatmentareneededbeforeconcludingthatapatientispartiallyresponsiveor unresponsive to a specific intervention

–Ifatleastamoderateimprovementinsymptomsisnotobservedwithin4-8weeksoftreatment initiation, the treatment plan should be adjusted

1.HoffmanL,etal.Am J Manag Care.2002;9:70-80;2.TierneyJG.J Manag Care Pharm.2007;13(supplS-a):S2-S7; 3.AmericanPsychiatricAssociation.Am J Psychiatry.2010;167:1-152.

Guideline-recommended Strategies for Treatment of Refractory Depression

• Optimizethemedicationdose

• Switchtoadifferentantidepressant –Withinclassordifferentclass

• Augmentthetreatmentregimenwithanon-depressantagent

• Combinetheinitialantidepressantwithasecondanti-depressantagentordepression-focusedpsychotherapy

AmericanPsychiatricAssociation.Am J Psychiatry.2010;167:1-152.

Implementation of MDD Sequenced Treatment Strategies May Improve Healthcare Effectiveness Data and Information Set (HEDIS) Scores*

NationalCommitteeforQualityAssurance.TheStateofHealthcareQuality.2010.

61.1% 62.9% 63.1% 62.9%

0%

20%

40%

60%

80%

100%

2006 2007 2008 2009

45.1% 46.1% 46.3% 46.2%

0%

20%

40%

60%

80%

100%

2006 2007 2008 2009

Patie

nts

Ach

ievi

ng H

EDIS

Mea

sure

(%)

Patie

nts

Ach

ievi

ng H

EDIS

Mea

sure

(%)

Acute Treatment Phase†

Continuation Phase Treatment‡

*HMOmeans.†Percentageofnewlydiagnosedandtreatedmemberswhoremainedonanantidepressantmedicationforatleast84days.‡Percentageofnewlydiagnosedandtreatedmemberswhoremainedonanantidepressantmedicationforatleast180days.

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Decision Support Tools for Adult Major Depressive Disorder (MDD)Decisionsupporttoolsaredesignedtointegrateamedicalknowledgebaseandpatientdatatoguideclinicaldecision-making.Componentsinclude:

1. Decision support • Supportingclinicaldiagnosisandtreatmentplanprocesses;promotinguseofbestpractices,condition-

specific guidelines, and population-based management

2. Managing clinical complexity and details • Adheringtotreatmentprotocols;trackingorders,referralsfollow-up,andpreventivecare

3. Costcontrol • Monitoringmedicationorders;avoidingduplicateorunnecessarytests

4. Administrative • Supportingclinicalcodinganddocumentation,authorizationofprocedures,andreferrals

Examplesinclude:

• ComparativeEffectivenessresearch(CER)

• Pharmacoeconomicanalysis

PerreaultL,MetzgerJ.J Healthcare Info Manag.1999;13:5-21.

Comparative Effectiveness Research

• Definition – Generationandsynthesisofevidencethatcomparesbenefitsandharmsofalternativemethodsto

prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care

• Goal – Toassistconsumers,clinicians,purchasers,andpolicymakerstomakeinformeddecisionsthatwill

improve healthcare at both the individual and population levels

• Drivers – Desiretoimprovethequalityofcarethroughevidence-basedmedicine

– Imperativetobemorecost-effective

– Needtoreflectpatients’andclinicians’real-worldexperiences

AgencyforHealthcareResearchandQuality.Availableat:http://www.effectivehealthcare.ahrq.gov/index.cfm/what-is-comparative-effectiveness-research1/.AccessedSeptember13,2011.

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Conducting Comparative Effectiveness Research (CER): Key Steps

1. Identifynewandemergingclinicalinterventions

2. Reviewandsynthesizecurrentmedicalresearch

3. Identifygapsbetweenexistingmedicalresearchandtheneedsofclinicalpractice

4. Promoteandgeneratenewscientificevidenceandanalytictools

5. Train and develop clinical researchers

6. Translateanddisseminateresearchfindingstodiversestakeholders

7. Reachouttostakeholdersviaacitizensforum

AgencyforHealthcareResearchandQuality.Availableat:http://www.effectivehealthcare.ahrq.gov/index.cfm/what-is-comparative-effectiveness-research1/.AccessedSeptember13,2011.

Comparative Effectiveness Research in MDD: Summary

• DepressiontreatmentisrankedbytheInstituteofMedicine(IOM)asthe6thhighestpriorityforCER

• Morethanhalfofmedicaltreatmentsprovidedlackclearevidenceofeffectiveness

• CERinvolvesarigorousevaluationof2ormoretreatmentoptionsforagivenmedicalcondition

• Usescurrent,unbiasedevidenceinmakinghead-to-headcomparisonstodeterminewhichinterventions: – Addvalue – Offerminimalbenefitabovecurrentchoices – Failtoreachtheirpotential – Workforsomepatients,butnotothers

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Pharmacoeconomic Analysis

Pharmacoeconomics Used to Identify, Measure, and Compare Costs and Outcomes of the Use of Pharmaceutical Products and Services

Perspective Influences the Costs Included in the Pharmacoeconomic Model

Identify

Measure

Compare

Resources Perspective

Time

Health Outcome & Economic Resources

Payers’ Perspective • Hospital costs • Physician costs • Lab costs • Rx costs (if covered)

Employers’ Perspective • Hospital costs • Physician costs • Lab costs • Rx costs (if covered) •  Indirect (productivity) costs

Patients’ Perspective • Deductible costs • Co-insurance costs • Co-pay costs • Out-of-pocket costs • Transportation costs

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Types of Pharmacoeconomic Analysis

Costs Included in a Pharmacoeconomic Analysis

*$,€,£,etc.;†Lifeyears,mg/dL,etc.

KatonWJ,etal.Arch Gen Psychiatry.2005;62:1313-1320.

Pharmacoeconomics: Summary

• Helpsdecision-makersin“optimizing”healthcareresourceuse

• Analysisrequiresdirectandindirectcostsandoutcomes

• Resultsonlyapplicablewheninterpretedwithintherelevantperspectiveoftheanalysis

• Typesofpharmacoeconomicanalyses –Cost-minimization –Cost-effectiveness –Cost-utility –Cost-benefit –Cost-consequence

Costs

Mental Health Collaborative Care Outpatient Inpatient

•  Antidepressant Rx

•  Specialty care

•  Collaborative care-speci�c

•  Care manager compensation

•  Specialty consultation/ supervision in excess of routine care

•  Educational materials

•  Sum of costs for outpatient mental healthcare and other medical, diagnostic, and testing costs

•  Sum of costs for all inpatient medical/surgical admissions

Analysis Cost Measurement Unit Outcome Unit

Cost-minimization Monetary units* Natural units†

Cost-effectiveness Monetary units* Natural units†

Cost-utility Monetary units* Quality-adjusted life years (QALYs)

Cost-benefit Monetary units* Monetary units*

Cost-consequence Monetary units* All the above*†

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Coverage Decision-makingWhenconsideringtheuseofcoveragedecision-makingtools,managedcareorganizationsmustbeawarethatregulatoryagenciesandgovernmentsmayrequirecoverageofmanyoralloncologyagentsincludingusefornon–FDA-approvedindicationsthatwouldbeconsideredinvestigationalorexperimentalandoutside of clinical trials. Therefore, nationally accepted guidelines and evidence-based compendia may not be applicable to coverage restrictions, prior authorization, or treatment algorithms based on local, state, or national coverage mandates.

Treatment Algorithms

Treatment algorithms and prior authorization guidelines can be based on national guidelines such as those fromtheAmericanPsychiatricAssociation.Thesealgorithmscanbeaccessedatthefollowingwebsite:

• http://www.psych.org/psych_pract/treatg/pg/prac_guide.cfm

However,duetoongoingadvancesintheidentificationanddevelopmentofnoveltherapies,treatmentguidelinesmaynotincludefindingsfromthelatestclinicaltrials.Ifaproposedtreatmentfallsoutsideofacceptedtreatmentguidelines,themanagedcareorganization(MCO)candirectproviderstoclinicaltrialsitessuch as www.clinicaltrial.gov.

Decision Factors

Whencomparingguidelinestoclinicalpractices,itshouldbestressedthatthechoiceoftreatmentisbasedonmultiplefactorsincluding:

• Presenceandtypeofriskfactors

• Patientcomorbidities

• Previousorcurrentadversedrugreactions

• Previoustherapies

• Routeandfrequencyofadministration

• Patientpreference(convenience;fearofpotentialtoxicities)

• Out-of-pocketexpense(co-payforoutpatientdrugsversusin-officedrugs)

• Medicalbenefit(maximumout-of-pocketperyear)versuspharmacybenefit

Itmustalsobestressedthattreatmentalgorithms,guidelines,andpriorauthorizationprocessesmustbecreated in cooperation with and be endorsed by clinicians associated with the plan. They must also be updatedfrequentlyasnewdataiscontinuallyemerging.

OrganizationscanalsouseCentersforMedicareandMedicaidServices(CMS)-approvedand-mandatedcompendia;AmericanHospitalFormularyService(AHFS)DrugInformation(www.ahfsdruginformation.com),GoldStandardClinicalPharmacology(www.clinicalpharmacology.com),andDrugDex(www.micromedex.com/products/drugdex),forcoveragedecisions.

Ifcoverageisunavailablethroughtheplan,membersmayfindahostofalternativecoveragesourcesfortheirdrugs.MCOsshouldmaintainafileofthesepotentialsourcestoprovidetheappropriatelevelofservicetomembers.OneexampleofaclearinghouseofpatientassistanceprogramsisIndiCare(www.indicare.com).

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Benefit Design and Major Depressive Disorder (MDD)Thebenefitdesigncanplayasignificantroleinchoiceoftherapy.Formemberswithcommercialinsurance,thecommondesignrequiredonlyamodestco-payfordrugsprovidedinaphysicianoffice,clinic.Asoutpatientprescriptionco-payshaveescalated,membersarechoosingin-officetherapies.Inaddition,ifmembersarerequiredtomeetadeductableorhaveamaximumout-of-pocket,choicecanbeinfluencedbasedontheallocationofmedical(in-officeinfusion)drugcostsand/orpharmacy(outpatientoral)drugcoststo the deductible or maximum. Medicare members less often face a differential co-pay based on place of service;however,theymustconsiderthatin-officeco-paysdonotaccumulateagainsttheirPartDbenefitandthereforeneverreachthecatastrophicPartDlimit.

Basic Tenets of Benefit Design

• Manage costs by restricting utilization of resources – MedicalandPharmacydesignsusuallyindependent

• Cost-sharingusedtoinfluenceutilizationpatterns – Patientcost-sharerelatedtoacquisitioncostofserviceorproduct – Assumesinelasticdemandorwillingnesstopay

WilleyVJ,etal.Am J Manag Care.2008;14:S252-S263.

Cost and Utilization Management in Benefit Design

Cost Management Utilization Management

Drug discounts Medical necessity review

Channelmanagement

Clinicalmanagementvia:• Treatment algorithms• Patienteligibility• Duration of therapy

Rebates Priorauthorization

Benefit design optionsFormularymanagement

• Tiers• Utilizationcaps

SternD,etal.J Manag Care Pharm.2008;14(supplS):S12-S16.

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Value-based Benefit Design Principles

• Focusonlong-termoutcomeofimprovedhealth • Assesstotalcostpictureincludingmedicalspendingandproductivity • The more beneficial the therapy, the lower the patient’s cost-share • Adjustout-of-pocketcostsforspecificservicesbasedonpatientcharacteristics

• Value-basedbenefitdesignsarebeingimplementedbysomeemployerplansponsorsinanefforttorestrain escalating costs

– Fullintegrationofmedicalandpharmacybenefits

– Uniformplandesign • Loweredcost-sharingifpatientusesthemosteffectiveresource • Highcost-sharingforutilizingnon-networkresources

• Typicallyinvolvesco-insurancewithanout-of-pocketlimit

• Datausedtoinvestinincentivesthatchangebehaviorstoimprovehealth,productivity,quality,andfinancial trends

Application of Value-based Benefit Design to MDD Therapy Management

• Primaryfocusisonoverallhealthoutcomes

• Out-of-pocketcostsmaybewaivedorreducedtoachievespecificgoals

• Prevention - Increaseuseofevidence-basedpreventivecare,services,and/orproducts

• Condition - Establishintegratedcaremanagement - Promotemedicationadherence(patients)andcompliancewithevidence-basedtreatment guidelines(providers)

• ServiceProvider(s) - Incentutilizationofaspecificproviderorservice(ie,conditionmanagement) - Incorporateoutcomes-basedcontracting

• Research - Useofcomparativeeffectiveresearch(CER)toguidetherapeuticselection

• Direct• Indirect

• Insurance• Incentives

• Health Information Technology (HIT)• Services• Communication

• Health/Productivity• Performance• Quality• Cost Trend Reduction

DIVIDENDS

DATA

DESIGN

DELIVERY

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Improving Major Depressive Disorder (MDD) Outcomes by Coordinating Care and Leveraging TechnologyGoals

• Implementasystem-wideapproachtocollaborativecare,steppedcare,andmedicationtherapymanagement

• Implementpatientscreeningandmonitoringthatleverageshealthinformationtechnologyadvancestoimprove outcomes for adult patients with MDD

Depression Screening in a Busy Practice

• Easeofadministrationandinterpretationarekey –Depressionscreeningshouldbeconsideredasa“vitalsign”(ie,aneasy-to-assessandreliablemarker ofdepression)

• Itisnotenoughtoknowthatformaldepressioncriteriaaremet;functioningmustbeassessed –Functioningshouldbe“clinically”assessed,evenwhenapatientmeetscriteriafordepression – Many patients may expect some form of intervention with a positive test, even though impairment may

be relatively mild –Certainotherpatientsmayresistanytreatmentatall,inspiteofclearfunctionalimpairmentandlikely

benefit of treatment

DeJesusRS,etal.Mayo Clin Proc.2007;82:1395-1402.

Screening Instruments

• Screeninginstruments – Diagnostic assessment – Functionalassessment

• Symptomcountinstruments(diagnostic)helpestablishwhetheraclinicalpicture“meetsthecriteria”foradepressiondiagnosis,butmaynotfullytakeintoaccountitsfunctionalimpact

• Assessmentinstruments(functional)provideasenseofseverityofsymptomsandtheirfunctionalimpact

• ThePersonalHealthQuestionnaire(PHQ-9)incorporatesthebestelementsofbothapproaches

ZuithoffNP,etal.BMC Family Practice.2010;11:98.

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Patient Health Questionnaire-9 (PHQ-9): Self-rating Depression Screening Tool

PHQ-9isadaptedfromPRIMEMDTODAY,developedbyRobertL.Spitzer,JanetB.W.Williams,K.Kroenke,andcolleagues,withaneducationalgrantfromPfizerInc.Forresearchinformation,contactDr.Spitzeratrls@columbia.edu.UseofthePHQ-9mayonlybemadeinaccordancewiththeTermsofUseavailableatwww.pfizer.com.Copyright©1999PfizerInc.Allrightsreserved.PRIMEMDTODAYisatrademarkofPfizerInc.

Over the last 2 weeks, how often have you been bothered by any of the following problems? (use “” to indicate your answer) Not at all Several days More than

half the days Nearly every

day 1. Little interest or pleasure in doing things 0 1 2 3 2. Feeling down, depressed, or hopeless 0 1 2 3 3. Trouble falling or staying asleep, or sleeping too much 0 1 2 3 4. Feeling tired or having little energy 0 1 2 3 5. Poor appetite or overeating 0 1 2 3 6. Feeling bad about yourself – or that you are a failure or have let

yourself or your family down 0 1 2 3

7. Trouble concentrating on things, such as reading the newspaper or watching television 0 1 2 3

8. Moving or speaking so slowly that other people could have noticed. Or the opposite – being so fidgety or restless that you have been moving around a lot more than usual

0 1 2 3

9. Thoughts that you would be better off dead, or of hurting yourself in some way 0 1 2 3

(Healthcare professional: For interpretation of TOTAL please refer to scoring card below)

add columns: + +

TOTAL:

10. If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?

Not difficult at all Somewhat difficult

Very difficult Extremely difficult

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Collaborative Care Models

• Coordinatedmodel:behavioralservicesavailableataseparateclinic/location – Accessandconvenienceislow;patientsmaynotshowupforreferral/follow-upcare,less-than-effective

communication

• Co-locatedmodel:behavioralservicesavailableatthesamemedicalcenter/clinic – More convenient for patients and providers

• Integrated:behavioralservicesarepartofthemedicaltreatmentwithintheclinicorpractice – Createsa“medicalhome”forthepatientwithbehavioralhealthservicesincorporatedintoasingle

primary care practice – Facilitatesmoreintegratedcommunication,patienttracking,andfollowup

Components Common to Successful Collaborative Models

• Componentsfoundinthemostsuccessfulcollaborativemodelsinclude – Validatedscreeningtoolsandevidence-basedtreatmentguidelines – Caremanagementgearedtowardincreasingpatientawarenessandself-management – Co-locationorintegratedservicedelivery – Integratedinformationtechnologysupportincludingappointmenttracking,charting,registry, riskstratification,evidence-basedmedicinesupport,andelectronicmedical records

– Robustadministrativeandfinancialsupportfromthehealthcaresystem

RobinsonPJ,StrosahlKD. J Clin Psychol Med Settings.2009;16:58-71.

Interaction Between Members of the Collaborative Care Team

UnutzerJ,etal. Med Care.2001;39:785-799.

Patient

Chooses treatment in consultation with providers

Consulting Psychiatrist Counselors/Therapists

Primary Care Physician

•  Refers to specialists •  Prescribes medications •  Manages comorbidities

Care Manager

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Stepped Care

• Inasteppedcaremodel,alleligiblepatientsstartwithlowintensityintervention –Progressismonitoredandpatientswhodonotrespondadequatelycan‘stepup’toasubsequent

treatment of higher intensity

• Allstepsarealignedwithrecognizedevidence-basedguidelines

• Caremanager(eg,nurseorsocialworker)monitorspatients,providesthefirsttreatments,andrefersthepatient to the appropriate mental healthcare specialist if necessary

BowersP,GilbodyS.BrJ Psychiatry.2005;186:11-17;SeeklesW,etal.Trials.2011;12:171.

Stepped Care: An Example

CBT=cognitive-behavioraltherapy

BowersP,GilbodyS.Br J Psychiatry.2005;186:11-17

Chronic, atypical, refractory, or recurrent

Severe depression

Moderate depression

Mild to moderate depression

Sub-clinical and patients who choose

not to have intervention

STEP5 Specialist treatment-resistant services

STEP4 Medication and case management or longer-term psychological therapy

STEP3 Medication and case management or longer-term psychological therapy

STEP2 Guided self-help, exercise prescription, psycho-education, signposting, or computerized CBT

STEP1 Watchful waiting

Assessment

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Use of Medication Therapy Management (MTM) in MDD

• MTMisagroupofservicesdesignedto – Ensureoptimumtherapeuticoutcomesthroughimprovedmedicationuse – Reducetheriskofadverseevents – Reducedrug-druginteractions

• CoreelementsofMTM – Medication therapy review – Personalmedicationrecord – Medication action plan – Educationandcoaching – Interventionand/orreferral – Documentation and follow upPatient-CenteredPrimaryCareCollaborative.IntegratingComprehensiveMedicationManagementtoOptimizePatientOutcomes.Availableat:http://www.pcpcc.net/medication-management.AccessedSeptember14,2011.

Characteristics of Patients Who May Benefit From MTM

• Patientswho – Havenotreachedorarenotmaintainingtheintendedtherapeuticgoal – Areexperiencingadverseeffectsfrommedications – Havedifficultyunderstandingandfollowingthemedicationregimen – Areinneedofpreventivetherapy

• ArefrequentlyadmittedtothehospitalPatient-CenteredPrimaryCareCollaborative.IntegratingComprehensiveMedicationManagementtoOptimizePatientOutcomes.Availableat:http://www.pcpcc.net/medication-management.AccessedSeptember14,2011.

MTM Design Considerations and Factors Associated With Success

• Eligibility – Targetedhigh-riskpatientsvsallbeneficiaries?

• Focus – Appropriatenessofmedicationtherapy

• Methodofdelivery/interaction – Face-to-face – Telephone – Email – Regularmail – Combination

• Factorsassociatedwithsuccessinclude – PharmacistswithdedicatedtimetoprovideMTMservices – PatienteducatorsandhealthcareproviderswhocaninformpatientsaboutthevalueofMTMservices – RiskstratificationmodelstodeterminepatientswhocouldbenefitmostfromMTMservices – Accesstopatienthealthinformation(eg,electronicmedicalrecords) – Consistent,efficientformatfordocumentationofMTMservices – OutcomesmeasurestoevaluatetheimpactofMTMservices

Patient-CenteredPrimaryCareCollaborative.IntegratingComprehensiveMedicationManagementtoOptimizePatientOutcomes.Availableat:http://www.pcpcc.net/medication-management.AccessedSeptember14,2011.

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Leveraging Technology: Electronic Health Records (EHR)

• Definition – Longitudinalcollectionofhealthinformationwithreal-timeaccesstoperson-andpopulation-leveldata – Providesknowledgeanddecision-supportsystemswhichenhancethequality,safety,andefficiencyof

patient care – Improvestheaccuracyandefficiencyofhealthcaredelivery

• AnEHRisNOTapaperrecordconvertedtoanelectronicformat

Core EHR Functions

• Healthinformationanddata

• Ordermanagement

• Resultsmanagement

• Decisionsupport

• Electroniccommunicationandconnectivity

• Patientsupport

• Administrativeprocesses

• Reportingandpopulationhealthmanagement

Why Implement an EHR?

• Timelyaccesstoaccurateandcompletepatientinformation

• Improvedpatientcareandsafety

• Enhancedoutcomes

• Minimize/avoidadversedrugevents

• Improvedqualitymeasures

• Increasedoperationalefficienciesandstaffproductivity

Features of the EHR That Promote Quality Care

• Patientcharttemplateswithbuilt-inguidelineprompts – Flowsheets,checklists,tables,summaries,etc.,asdecisionaids

• Internalmessagingandflagsforcoordination,collaboration,referral,andreminders

• Personalizedresultsforpatientdiscussion/education

• Labinterfaceforresultsreporting

• Schedulingtoolforfollowup

• Queriestoidentifypatientsneedingspecificcare

IOM.KeyCapabilitiesofanElectronicHealthRecordSystem.Availableat:http://www.providersedge.com/ehdocs/ehr_articles/Key_Capabilities_of_an_EHR_System.pdf. AccessedSeptember21,2011.

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Coordination of Care to Improve Major Depressive Disorder (MDD) Treatment Outcomes: Summary• >50%ofpatientswithdepressionaretreatedinprimarycare

• Earlyrecognitionandtreatmentinprimarycarecanminimizedepressionseverity

• Collaborationbetweenprimarycare,specialists,counselors/therapists,pharmacists,patients,andcaregivers can improve depression care

• Insteppedcare,allinterventionsarealignedwithrecognizedevidence-basedguidelines

• Medicationtherapymanagementensuresoptimumoutcomesthroughimprovedmedicationuse –Theelectronichealthrecord(EHR)provideshealthinformationwithreal-timeaccesstoperson-and

population-level data

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1 . What percentage of patients with Major Depressive Disorder (MDD) is estimated to be resistant to treatment?A. 35%B. <10%C. >20%D. 63%

2 . Failure to achieve initial remission has minimal effect on achieving beneficial long-term outcomes in patients with MDD .A. TrueB. False

3 . Sustained remission of MDD in adults is defined by the 2010 APA Guideline as:A. ≥50% improvement in symptomsB. At least 3 weeks of the absence of sad mood and

reduced interestC. <5 remaining symptomsD. Both B and C

4 . The addition of a second antidepressant medication to enhance the effect of a first-line agent is best defined as:A. AugmentationB. Stepped therapyC. Medication managementD. Combination

5 . All of the following are advantages of switching MDD therapies EXCEPT:A. Avoids risk of withdrawal symptomsB. Lower risk of drug interactionsC. May improve complianceD. May minimize adverse events

6 . Which of the following statements about atypical antipsychotic agents is FALSE?A. Many possess antidepressant propertiesB. They can be used to augment treatment with standard

antidepressantsC. They are effective adjunctive treatment for depression

that has failed to respond to standard therapyD. Theyareclassifiedasantidepressantdrugs

7 . The goal of comparative effectiveness research is to assist patients, physicians, payers, and policy makers in making informed decisions about the utilization of healthcare .A. TrueB. False

8 . The type of analysis used to identify, measure, and compare costs and outcomes associated with the use of a pharmaceutical product is called a ____ analysis .A. Health economicB. Cost-effectivenessC. Cost-benefitD. Pharmacoeconomic

9 . Which of the following screening tools provides an indication of the severity of depression symptoms and their functional impact?A. Depression assessment scalesB. Depression symptom count instrumentsC. Depression symptom surveyD. MDD evaluation scale

10 . Which of the following is NOT a feature of collaborative care?A. Delivers evidence-based treatment aligned with

recognized guidelinesB. Limits access to specialistsC. Includes a relapse-prevention planD. Provides integrated service delivery

Post-test

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