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5/31/2017

HistoryoftheAMCPFormat
1990s
AMCPFormatforFormulary PROBLEM
Growingrecognitionthatinformation(FormularyKits)onnewproductsprovidedby
Submissions PhRMAtohealthplansandotherpayerswaspromotionalandinsufficienttoinform
evidencebaseddecisionmaking
RiseofHEORunitswithinPhRMAtogenerateevidenceofproductvalue.But,this
informationwasnotincludedinproductlabelsdespitesystematicattempts(FDMASEC
114,etc.)
DDMACregulatescontentofinformationfrommanufacturertohealthcare
PresentationDevelopedforthe professionalsandhealthplans Relativelylittledatabeyondwhatisincludedinthe
label.
AcademyofManagedCarePharmacy RESPONSE
Regionaleffortstoimproveaccesstobetterandmorecompleteevidencebyspecifying
February2015 informationneeds.
RegenceBlueShield(WAState) RegenceGuidelines
BCBSColoradoGuidelines

HistoryoftheAMCPFormat AMCP&AMCPFoundationCollaboration
1999 TheAMCPFoundationsupportstheFormat
AcademyofManagedCarePharmacy(AMCP) 3Revisions(v3.1addendaaddedinDecember2012)
Committeeorganizedtodraftstandardunsolicitedrequestforevidencetosupport FormatExecutiveCommittee
formularydeliberations EducationandTraining:
2000 AMCPFormat Version1.0 TheAMCPFoundationsupportsprogramstoeducatemanagedcare
AMCPBoardofDirectorsapprovesAMCPFormat asageneralizedunsolicitedrequest
pharmacistsabouttheFormat anduseofevidenceinformulary
decisionmaking
AMCPBoardmandatesevaluationoftheAMCPFormat
>45programsto>1400attendeesfrom>300organizations
2002 AMCPFormat Version2.0 2005 2008:
2005 AMCPFormat Version2.1 TheAMCPFoundationsupportscomprehensiveevaluationofthe
Format
2005 WellPointHealthTechnologyAssessmentGuidelines Auditofthequalityandcompletenessofdossierinformation
Version5.1 SurveyofhealthplansuseandvalueoftheFormat

2009 AMCPFormat Version3.0


2012 AMCPFormat Version3.1

Version3.1 UpdatesinVersion3.1
Changestothisversionarelimitedtothe
inclusionofthreeaddenda:
CompanionDiagnosticTests
ComparativeEffectivenessResearch
SpecialtyPharmaceuticals

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TheAMCPFormatis: RoleoftheFormat
Supportinformedselectionof
pharmaceuticals,biologics,andvaccinesby:
Standardizingandcommunicatingproductand
a processtoobtainastandardizedsetofdata supportingprograminformationrequirements
andinformationaboutadrugfromits Requiringprojectionsofproductimpactonboth
theorganizationanditsenrolledpatient
manufacturertosupportreimbursementand/or population
formularyplacementconsideration Requestinginformationonthevalueofproducts
Makingevidenceandrationalesupportingall
choice(s)moreclear,transparentandevaluableby
decisionmakers

GoalsoftheFormat Process AMCPFormat:ImplicationsforthePharmaceuticalIndustry

Improvethetimeliness,quality,scope,and Increasedresponsibilityforprovidinga
relevanceofinformationavailableto completedataset,includingeconomicimpact
healthcaresystemevaluators(P&T information
Committeesorothertechnologyassessment
Providestheopportunitytoestablishthe
committees)
value ofanewproductwithevidence
Streamlinethedataacquisitionandreview
processforhealthcaresystemstaff(eg, Anewcompetitiveenvironment
pharmacists)

AMCPFormat:ImplicationsforHealthPlans TheAMCPFormatis:
Mustevaluatethequalityandcontentof Aroadmaptoasoundclinicalevaluation
submissionsreceived
Willincorporateoutcomesandeconomic
evaluationdataintoformularydecisions
MustgetclinicalstaffandP&TCommittee
memberseducatedonPEstudiesorbringin
outsideconsultants
Good Clinical Evaluations Scientific Evidence Healthy People

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TheAMCPFormat Whatdossiersdo(ifdonewell)
Atemplateorguide,notamandate Putyour(neworold)productonalevel
playingfieldwithotherdrugs
Identifiescoreinformationalandanalytical OpendoortofullP&Treview
needsforformularysubmissions
Showthevalueofyourproduct infullor
Focusesformularydecisionsonsystemwide subpopulation
impact Showscientificcredibility
Adaptabletoindividualplanneeds Includebothonlabelandofflabelscientific
data
Neitherstaticoroverlyprescriptive Helpguidedevelopmentofclinicalguidelines

PotentialBenefits SpecificIssues
Improvedcommunicationandcooperation Confidentiality
Requestvsrequirement
Explicitevidentiaryrequirements
Dossiersforallproductsorjustnew
Standardizedprocess Criteriafordeterminingadequacyofdossier
Allowsplantofocus Sharingdatawithmanufacturers
lessonacquisitioncostandrebates Relevancevsstandardization
AMCPFormat sectionsimplylargedegreeof
moreonoutcomesandvalue customizationforindividualplans
Outcomesmodelsshould offerflexibilitytomeet Manufacturersneedreasonablestandardizationto
supportFormat
theneedsofindividualhealthplans

CurrentEnvironment AMCPeDossierSystem
>150millionmembersinhealthplansand Acentralized,secure,webbasedplatformthatprovides
qualifiedHeathCareDecisionMakers(HCDMs)the
PBMsusingtheAMCPFormat opportunitytoeasilyaccess,review,andevaluateresearchto
MCOsindifferentstagesofAMCPFormat makeinformed,evidencebaseddecisions.
implementation Itcombinesthefamiliarstructureofpaperbaseddossiers
withwebtechnologiesthatareflexibleandinteractive,while
Wideacceptancebypharmaceutical remainingincompliancewithregulatorystandardsfor
companies unsolicitedrequests.
RegistrationontheAMCPeDossierSystemisfreetoqualifiedHCDMs
Dossiersareapartofoverallmarketingplanning (i.e.,thoseindividualswhoaredirectlyinvolvedinmakingformulary
and/orbenefitdesigndecisionsonbehalfofahealthorganizationor
Similarsubmissionrequirementsinother system).
countries
GreatBritain,Australia,Canada,othercountries

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AMCPeDossierSystem HealthSystemGuidelinesforManufacturers
Forinterestedmanufacturers,theAMCPeDossierSystem
TeamwillconvertproductdossiersintoeDossiersandmake
themaccessible,viatheSystem.Manufacturerspaya
subscriptionfeefordisseminatingproductdossiersviathe
System.
AccesstoanyproducteDossierrequiresanunsolicited EvidentiaryRequirementsforFormulary
requestbyaHCDManddirectauthorizationbytheproducts
manufacturer. Submission
Amongseveralbenefits,theAMCPeDossierSystem:
Providestheopportunitytomoreefficientlyevaluatecritical
informationneededtodetermineproductvalue;
Streamlinestheoverallprocessesofrequesting,reviewing,and
applyingscientificevidenceinthedecisionmakingprocess;
Offersaninnovativedeliverymethodtoimprovetheuseofdossiers;
and
Adherestocriticallyimportantregulatoryrequirements

1.0EXECUTIVESUMMARY 1.0EXECUTIVESUMMARY
Justifythevalueoftheproduct CLINICALANDECONOMICVALUEOFTHEPRODUCT
ReplacesSection4ofthepreviousversion(Version2.1)oftheAMCP 1.1ClinicalBenefits
FormatforFormularySubmissions andrepresentstheprincipal
opportunityforamanufacturertobrieflysummarizethevalueofits 1.2EconomicBenefits
product.
1.3Conclusions
Themanufacturershouldbrieflydescribetheclinicalandeconomic
informationpresentedinthedossierusingthelayoutprescribedin
Sections1.1and1.2andstatetheexpectedperunitproductcost.
Basedonthisinformation,themanufacturershouldarticulateavalue
argumenttojustifytheseexpectedexpendituresforthisproductinthe
contextofitsanticipatedeffectsontheclinicalevidence,health
outcomes,andtheeconomicconsequencesforthehealthcaresystem.

1.1CLINICALBENEFITS 1.2ECONOMICBENEFITS
BeginwiththeFDAapprovedindicationforthedruganda Summarize(Nomorethan1page)theeconomicbenefitsof
short(1to2paragraph)synopsisoftheefficacyandsafety thePROPOSEDTHERAPY,intermsof:
information(fromtheprescribinginformationandclinical Costperunit
trials). Contextoftheproposedcost:potentialclinicalbenefitsprovided
(includingqualityoflifebenefits)andpotentialeconomicbenefits
Summarize(Nomorethan1page)theclinicalbenefitsofthe (includingsavingsorcostoffsets)
PROPOSEDTHERAPY,intermsof: Shortcomingsofothertherapies
EfficacyandEffectiveness Brieflypresentresultsofanyobservationalresearchor
economicdata,withinclusionofthePMPM(permemberper
Safety/tolerability month)orICER(internationalcosteffectivenessratio)result
Shortcomingsofcurrenttreatmentandtheunmetmedical atminimum.
needthatthePROPOSEDTHERAPYaddresses Brieflysummarizeotherpublishedinformationonthecostor
economicimpactoftheproduct(suchasimpactofresource
utilizationorothercostoffsets).

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1.3CONCLUSIONS 2.0PRODUCTINFORMATION&DISEASEDESCRIPTION

SummarizethevalueofthePROPOSEDTHERAPYin1 2.1ProductDescription
to2paragraphs(Nomorethanpage). 2.2PlaceoftheProductinTherapy
Highlightkeypointsregardingtheclinicaland 2.2.1DiseaseDescription
economicadvantagesanduniquenessoftheproduct 2.2.2ApproachestoTreatment
arehighlighted. 2.2.3RelevantTreatmentGuidelinesandConsensusStatements
BasedontheinformationpresentedinSections2to fromNationaland/orInternationalBodies
5thatfollow,conclusionsshouldincludeastatement 2.3EvidenceforPharmacogenomicTestsandDrugs
regardingtheexpectedimpactoftheproduct
relativetootheravailabletreatmentoptionsboth
pharmaceuticalandnonpharmaceutical.

2.1PRODUCTDESCRIPTION 2.1PRODUCTDESCRIPTION
Manufacturersarerequiredtoprovidedetailedinformationabout Componentsthatshouldbesupplied:
theirproduct.Theyshouldcomparethenewproductwithother Generic,brandnameandtherapeutic i.Contraindications/Warnings
classoftheproduct, Precautions/AdverseEffects
agentscommonlyusedtotreatthecondition,whetherornotthese
b.Alldosageforms,includingstrengths j.Interactions(withsuggestionsonhowto
productsarecurrentlyonthehealthcaresystemsformulary.The andpackagesizes, avoidthem)
productdescriptionconsistsofinformationthattraditionallyhasbeen c.TheNationalDrugCode(NDC)forall Drug/Drug
formulations, Drug/Food
incorporatedinaproductmonograph,PackageInsert(PI)orformulary Drug/Disease
kitasdescribedbelow.Italsocontainsinformationthatgoesbeyond d.TheASPandWACcostperunitsize.
(Thepayerscontractprice,ifavailable, k.DosingandAdministration
thescopeofthepackageinsert,monographandformularykitthatcan shouldbeincludedaswell). l.Access,e.g.restrictionsondistribution,
onlybeprovidedpursuanttoanunsolicitedrequest. (20pagesmax) e.AHFSorotherDrugClassification supplylimitations,anticipatedshortages,
and/orprescribingrestrictions.
f.FDAapprovedindication(s)andthedate
approvalwasgranted(orisexpectedtobe m.CoPrescribed/ConcomitantTherapies,
granted). includingdosages,andrecommendeduse
NEWEVIDENCEGUIDELINES:Ifthetechnologyunderconsiderationis ofotheragentsortreatmentswiththe
aCompanionDiagnosticTestorSpecialtyPharmaceuticaland/or Alsoothersignificantofflabelusesand product.
potentialnewindicationsbeingstudied.
evidencefromComparativeEffectivenessResearchisincludedinthe ConcisecomparisonofPIinformationwith
g.Pharmacology theprimarycomparatorproductsinthe
dossierfollownewADDENDUMguidelines h.Pharmacokinetic/Pharmacodynamic sametherapeuticarea.

2.2PLACEOFTHEPRODUCTINTHERAPY 2.3EVIDENCEFORPHARMACOGENOMICTESTS&DRUGS
Thisshouldbeprovidedforeachindication(iftherearemultiple)
2.2.1DiseaseDescription(12pagesperindication/disease) Thefollowingevidenceshouldbepresented:
Overallreviewofthediseaseandcharacteristicsofpatientswhoneedtreatment,as AnalyticValidity(geneticstatus)
wellasanysubpopulationdata. Accuracywithwhichaparticulargeneticcharacteristiccanbe
Briefliteraturesummaryshouldbeprovidedforeach. identifiedusingagenetictestinrelationtoprofessionalstandardsand
2.2.2ApproachesToTreatment(12pagesperdisease) federalregulationrequirements.
Howthediseaseiscurrentlytreated,howtheproductfitsintoexistingtherapy. ClinicalValidity(clinicalstatus)
Anypostmarketingobligations(i.e.RiskEvaluationMitigationStrategies Strengthoftheassociationbetweenthegeneticvariant(s)andclinical
(REMS),patientregistries,etc) outcome(s)(e.g.,efficacy,adversedrugreaction)
Expectedprevalenceofgeneticvariant(s)intargetpopulation;
2.2.3ReleventTreatmentGuidelinesAndConsensusStatementsFrom positivepredictivevalue(PPV)andnegativepredictivevalue(NPV)of
NationalOrInternationalBodies test
Anytreatmentguidelinesortoolsavailableregardingtherapy. ClinicalUtility(risksandbenefitsresultingfromtestuse)
Discussionondifferencesinguidelines Effectivenessandsafetyoftheclinicalinterventionimplementedasa
resultofthegenetictest
NEWEVIDENCEGUIDELINES:IfthetechnologyunderconsiderationisaCompanion CostEffectiveness(differencestousualcare)
DiagnosticTestorSpecialtyPharmaceuticaland/orevidencefromComparative
Expecteddifferenceincostsandoutcomeswithpharmacogenomic
EffectivenessResearchisincludedinthedossier,Formatusersshouldfollowthe testingcomparedtousualcare
evidenceinclusionguidelinesintheappropriateaddendum

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3.0SUPPORTINGCLINICALEVIDENCE 3.1SUMMARIZINGKEYCLINICALSTUDIES
3.1SummarizingKeyClinicalStudies Submitdetailedsummariesofallrelevantclinicalstudiesthathave
beenconducted(2pagesmaximumperstudy)
3.1.1RelevantPublishedAndUnpublishedClinicalStudies
3.1.1IncludeAllRelevantPublishedAndUnpublishedClinicalStudies
SupportingLabeledIndications SupportingLabeledIndications
3.1.2RelevantPublishedAndUnpublishedClinicalStudies Placebocontrolledsafetyandefficacytrials
SupportingOfflabelIndications
Prospectiveeffectivenessandcomparativeeffectivenesstrials,
3.1.3ClinicalEvidenceSpreadsheetsOfAllPublishedAnd includingpragmatictrials
UnpublishedTrials Openlabelsafetyextensionstudies
3.1.4SummaryOfEvidenceFromSecondarySources Prospectivestudiesexaminingothernoneconomicendpointssuch
ashealthstatusmeasurespatientreportedoutcomes.Ifthe
instrumentsutilizedinthesestudiesaresupportedbyprevious
validationandreliabilitystudies,alsoreferencethesestudies
Unpublisheddata:Provideasmuchdetailascanbedisclosed

3.1SUMMARIZINGKEYCLINICALSTUDIES 3.1SUMMARIZINGKEYCLINICALSTUDIES
Submitdetailedsummariesofallrelevantclinicalstudiesthathave Informationfromallrelevantstudiesontheproductshouldbe
beenconducted(2pagesmaximumperstudy) summarizedinevidencetablesinthedesignrequestedbythehealthcare
system
3.1.2IncludeAllPublishedAndUnpublishedDataAndClinical
StudiesSupportingOfflabelIndications 3.1.3ClinicalEvidenceSpreadsheetsOfAllPublishedAndUnpublishedTrials
Evidencetablesshouldincludethefollowingdataelements:
Includeallrelevantstudiesofthetypeslistedin3.1.1.
Citation,(ifunpublished,giveabstractinformationorindicatedataonfile)
Includeofflabelindicationsthatarereasonablylikelytobe Treatments
consideredbypractitioners,basedontheavailablesupporting Samplesizeandlengthoffollowup
evidence.Providecontactinformationforquestionsaboutother Inclusion/exclusioncriteria
uses. Design
Unpublisheddata:Provideasmuchdetailascanbedisclosed PrimaryEndpoints
SecondaryEndpoints
ThisconstitutesanunsolicitedrequestforALLrelevantstudies Results:Provideanexplicitstatementofeffectsize,notjustrelativeriskreduction
supportingofflabelusesoftheproduct and/orstatisticalsignificance.WithintheResultscolumn,includeatableofkey
results
Statisticalsignificance

3.1SUMMARIZINGKEYCLINICALSTUDIES 3.1SUMMARIZINGKEYCLINICALSTUDIES
3.1.4SummaryOfEvidenceFromSecondarySources(1page Componentsthatshouldbesupplied:
maximum) a.Nameoftheclinicaltrialorstudyand i.Otheroutcomemeasures(e.g.,patient
publicationcitation(s) reportedoutcomes)
Relevantevidencemaybeavailablefromavarietyofsecondarysources. Principalfindings
b.Objective,locationandstudydate
Thefollowingmaybesubmitted.Summariesshouldbeconcise,focusing j.Statisticalsignificanceofoutcomesand
onlyonthemajorconclusions c.Trialdesign,randomizationand
blindingprocedures powercalculations
CochraneCollaborationsystematicreviews d.Setting,inclusionandexclusioncriteria k.Validationofoutcomesinstruments(if
Formal,publishedsystematicreviewsfrompeerreviewedjournals applicable)
e.Samplecharacteristics(demographics,
AgencyforHealthcareResearchandQuality(AHRQ)evidence numberstudied,diseaseseverity,co l.Generalizabilityofthepopulation
morbidities) treated
summaries
f.Dropoutratesandproceduresfor m.Studylimitations,asstatedbythe
Healthtechnologyassessmentsfromotherrecognizedagencies,public authors
orprivate,includingreviewsfromothercountries. handlingdropouts(ITT,perprotocol,
etc.) n.Publicationcitation(s)/referencesused
Evidencebasedclinicalpracticeguidelines,medicalsocietyposition g.Treatment:dosageregimens,washout includingfundingsourceofthestudy
statements,etc.Thesedocumentsshouldincludeexplicitevidence period,etc
gradingcriteria h.Clinicaloutcome(s)measures
CompendiaofficiallyrecognizedbytheSecretaryofHealthandHuman Outcomesevaluated
Servicesthatlistthedrug.Ifthesereferencesareavailableonlyby Delineateprimaryvs.secondarystudy
subscription,providePDFdocumentsorreprintsoftherelevant endpointsandtheircorrespondingresults
content.

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4.0ECONOMICVALUEANDMODELINGREPORT 4.1MODELINGOVERVIEW
4.1ModelingOverview Thissectionpresentsanoverviewoftherationale,
4.1.1UtilityofModelingforDecisionmaking approach,andsuggestedmethodsfordevelopinga
4.1.2TypesofModels decisionanalyticbasedcosteffectivenessmodel.The
4.1.3OtherConsiderations
intentofthemodelistoquantifyforthehealthcare
systemtheriskbenefittradeoffoftheproduct,andits
4.2ModelingApproachesandMethods economicvalue.
4.2.1ApproachandFramework
4.2.2DataSources
NEWEVIDENCEGUIDELINES:Ifthetechnologyunder
4.2.3Analysis considerationisaCompanionDiagnosticTestorSpecialty
4.3ModelingReportandInteractiveModel Pharmaceuticaland/orevidencefromComparative
4.2.1Transparency EffectivenessResearchisincludedinthedossier,Format
4.2.2ModelingReportFormat usersshouldfollowtheevidenceinclusionguidelinesin
4.2.3InteractiveModel theappropriateaddendum

4.1MODELINGOVERVIEW 4.2MODELINGAPPROACHESANDMETHODS
4.1.1UtilityOfModelingForDecisionmaking 4.2.1ApproachandFramework
TheAMCPFormathasbeendevelopedtohelpaddressthese Guidelines
ConsiderrecommendationspublishedbythePanelonCostEffectivenessin
limitationsbyprovidingaconsistentformatforconducting HealthandMedicineconvenedbytheU.S.PublicHealthService, andthe
andreportingcosteffectivenessmodelstoimprovetheir modelshouldfollowtheguidanceprovidedbytheInternationalSocietyfor
transparencyandacceptability. PharmacoeconomicsandOutcomesResearch(ISPOR)GoodPracticeModeling
Principles.
4.1.2TypesOfModels AnalyticFramework
CosteffectivenessModels Thegeneralcategoryofcosteffectivenessmodelsincludesanalysesthat
valueoutcomesbyassessingclinicalevents,lifeexpectancy,and/orquality
BudgetImpactModels adjustedlifeyears(QALYs).
FinancialModels ModelingTechnique
Thereareseveraldecisionanalyticbasedapproachestoconstructingdisease
4.1.3OtherConsiderations basedcosteffectivenessmodels,primarily:1)decisiontrees,2)Markov
(cohort)models,and3)patientlevel simulation (discreteeventsimulation).
Whenaproductisintendedfortreatmentofmorethanone
PerspectiveandTimeframe
diseaseorindication,itsimpactshouldbemodeledforeach, Thepayerperspectiveisrecommendedfortheprimaryanalysis,withoptional
unlessareasonablecasecanbemadeforasinglemodel,such perspectives(i.e.,societal,employer)conductedassecondaryevaluations.The
asmaybethecaseforbudgetimpactmodels. modelshouldconsideratimehorizonthatisappropriatetothediseasebeing
studiedandreflectthedecisionmakingandfinancialandbudgetconstraints
ofthehealthcaresystem.

4.2MODELINGAPPROACHESANDMETHODS 4.2MODELINGAPPROACHESANDMETHODS

4.2.2DataSources 4.2.3Analysis
DrugEffectiveness Basecaseestimates
Theexpected(average)clinicalandeconomicoutcomes
DrugSafetydata shouldbecalculatedforeachstrategyevaluated,as
Economicdata wellasincrementalcosts,effectiveness,andcost
effectiveness
Utilities
SensitivityAnalysis
Demographicandpracticepatterndata Comprehensiveonewaysensitivityanalysisofall
Surrogatemarkers parametersinthemodelisstronglyrecommended,
includingassessmentofimpactsonbothincremental
Expertopinion effectiveness(e.g.,QALYs)andcosteffectiveness
Efficacyvs.Effectiveness

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4.3MODELINGREPORTANDINTERACTIVEMODEL 5.0OTHERSUPPORTINGEVIDENCE
4.3.1 Transparency 5.1SummarizingOtherRelevantEvidence (2
Transparencyandclarityofpresentationareanecessity. pagemaximumperstudy)
5.1.1IncludePublishedAndUnpublishedStudies
4.3.2ModelingReportFormat SupportingLabeledAndOfflabelIndications
Introduction/Background,Methods,Results,Limitations, RefertoSection3.1and3.1.1foritemstobeincludedinthe
Discussion.A500wordabstractfollowingthissameformat studysummariesandforrelevanceandgradingcriteria.
shouldbeprovidedonthefirstpageofthemodelingreport,and 5.1.2EvidenceTableSpreadsheets
includeanexplicitdescriptionofthekeydriversofthemodel Informationfromallstudiesdescribedinthissectionshould
resultsidentifiedinsensitivityandscenarioanalyses. besummarizedinevidencetablesspreadsheetformat
4.3.3InteractiveModel
NEW EVIDENCE GUIDELINES: If the technology under consideration is a
ModelCharacteristics
Companion Diagnostic Test or Specialty Pharmaceutical and/or evidence
ModelAccessibility from Comparative Effectiveness Research is included in the dossier, Format
users should follow the evidence inclusion guidelines in the appropriate
addendum

6.0SUPPORTINGINFORMATION COMPANIONDIAGNOSTICTESTS(CDT)ADDENDUM

6.1ReferencesContainedInDossiers Theobjectivesofthisaddendumareto:
Providedrugandcompaniondiagnostictest(CDT)developerswith
Includecitationsforallknownpublishedclinical guidancefortheprovisionofclinicalandeconomicevidencein
andeconomicstudiesinthebibliographysection. healthtechnologyassessments,and
InformdrugandCDTmanufacturers,P&Tcommittees,Medical
6.2DossiersAndEconomicModels TechnologyAssessmentcommittees,andothercoverageand
reimbursementdecisionmakersaboutappropriatetypesof
evidenceforaCDTsothatwellinformedevaluationscanbe
performed.
TheinformationcomplementsexistinginformationintheAMCP
FormatforFormularySubmissions,Version3.1.Thefollowingsections
providebackgroundinformationonCDTsandrecommendationsfor
thedevelopmentandcontentofboth:
EvidencedossiersfordrugswithCDTsand
StandaloneevidencedossiersforCDTs

COMPANIONDIAGNOSTICTESTS(CDT)ADDENDUM COMPANIONDIAGNOSTICTESTS(CDT)ADDENDUM

ImplementationofdossierrequestsforCDTsusingtheFormat RecommendationswhendevelopingdossiersforCDTs
1. TheCDTiscodevelopedwiththedrugorbiologic:
maybecomplicatedbythevarietyofpotentialrelationships Theevidenceforthesafety,efficacy,andvalueofthedrug/biologicwillbe
betweenadrug/biologicmanufacturerandCDT inherentlylinkedtotheCDT.Thedrug/biologicmanufacturershouldprovide
thesedataaspartofthedrug/biologicdossierintheAMCPFormat.
manufacturer/provider.ThefollowingarepossibleCDT 2. TheCDTisdevelopedindependentlyofthedrugorbiologic:
developmentscenarios(innoorderofpreference): IftheCDTisrequiredinthedrug/biologiclabel,thedrug/biologic
manufacturershouldprovidedataontheclinicalvalidity,clinicalutility,and
CDTcodevelopedwithdrug,andFDAapprovedtogether economicvalueofboththeCDTandthedrug/biologicinthedrug/biologic
withdrug dossierdevelopedintheFormat.Informationontheanalyticvalidityofthe
testshouldbeprovidedinthedossierasfeasible.
CDTdevelopedindependentlyofdrug,typicallyafterdrug IftheCDTisnotrequiredinthedrug/biologiclabel,thentheCDTdeveloper
shouldprovideaCDTdossierthatprovidesEvidenceRequirementsFor
approval DiagnosticTests.
CDTdevelopedindependentlyandtargetedforclassof 3. TheCDTisdevelopedindependentlyandistargetedforaclassof
medications.
medications TheCDTdevelopershouldprovideaCDTdossierthatprovidesinformation
asoutlinedinSectionIVbelowspecifictodrugsinthetargeteddrugclass.

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COMPARATIVEEFFECTIVENESSRESEARCH(CER)ADDENDUM COMPARATIVEEFFECTIVENESSRESEARCH(CER)ADDENDUM

SectionI:
This addendum provides a brief introduction to the evolving field Background
and method related to comparative effectiveness research and FocusandEmphasisofCER
its importance to the format. Federal initiatives have stimulated
SectionII:
interest among stakeholders in the development and use of
ComparativeEffectivenessResearchUsewithintheFormat
comparative evidence to support clinical decision making. The
BriefOverviewofSelectedMajorTypesofCERStudyDesign
AMCP format makes clear that comparative evidence is a
BayesianandAdaptiveTrialDesign
necessary component of a comprehensive product dossier, PragmaticClinicalTrials
regardless of the methodology used to generate the evidence ProspectiveObservationalStudies
(eg., Systematic reviews or modeling studies). RetrospectiveObservationalStudies
SystematicEvidenceReviews
ModelingStudies
RelatedCERActivities
Conclusion

SPECIALTYPHARMACEUTICALSADDENDUM SPECIALTYPHARMACEUTICALSADDENDUM
SectionI:
Background
SpecialtyPharmaceuticalsDefinitionsforUsewithintheFormat
This section intends to explain where the particular SectionII:
ApplicationoftheFormat forSpecialtyPharmaceuticals
characteristics of these drugs fit into the existing 1.2EconomicBenefits
2.1ProductDescription
Format, and where special considerations, if any, are

2.1.c.TheNationalDrugCode(NDC)forallformulations
2.1.d.TheASPandWACcostperunitsize
2.1.k.DosingandAdministration
needed. This current framework for sharing evidence

2.1.l.Access(eg,RestrictionsonDistribution,SupplyLimitations,AnticipatedShortages,and/orPrescribingRestrictions
2.1.m.Coprescribed/ConcomitantTherapies
2.1.n.ConciseComparisonofPIInformationwithPrimaryComparatorProducts
has been designed to communicate clinical and 2.2PlaceofProductinTherapy
2.2.1DiseaseDescription

economic value for most technologies and is flexible

2.2.2.c.ThePlaceandAnticipatedUsesoftheProposedTherapyinTreatment
2.2.2.d.ProposedAncillaryDiseaseorCareManagementInterventionStrategies
2.2.2.f.DescriptionofOtherDrugDevelopmentorPostMarketingObligations
3.1SummarizingKeyClinicalStudies
enough to cover both traditional and specialty drugs 3.1.4SummaryofEvidencefromSecondarySources
4.2ModelingapproachesandMethods
4.2.2DataSources
4.3ModelingReportandInteractiveModel
4.3.2ModelingReportFormat
Biologicals,BiosimilarsandtheAMCPFormat

Formulary(New)DrugEvaluationTool
RealityCheck TheFormat ShortForm

Does: A.Evidenceofneed
Istherecompellingevidenceofaneedtoaddthisdrugtoourformulary?
Identifyevidenceneeded B.Efficacy
Definehowitshouldbepresented Whatistheevidencetosupporttheclaimsforthisdrug?
C.Safety
Provide morecompletedataforasoundP&Tdecision
Whatsafetyissuesneedtobeconsidered?
Doesnot: D.Misuseimpactpotential
Provideapreciseanswer Ifplacedontheformulary,whatisthepotentialformisuseoroveruse?
E.CostIssues
Definethedecisionmakingprocess Canwejustifythecostofthisdrug?
Guaranteebetterdecisions F.Decisionmakinginformation,calculations,timingandprocess
Whatisthestrengthandqualityofevidenceandinformationavailabletothe
Guaranteelowerhealthcareexpenditures Committee?Whatisstatusandqualityofthereviewprocessatour
institution?

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FinalNote: Reference
AMCPFoundation.TheAMCPFormatforFormularySubmissions.Version
TheAMCPFormat hasthepotentialtoserveas 3.1.AFormatForSubmissionOfClinicalAndEconomicEvidenceOf
anational,unifyingtemplateforP&T PharmaceuticalsInSupportOfTheFormularyConsideration. Alexandria,
VA:AcademyofManagedCarePharmacy;December2012.Availableat:
committeestoconsiderclinicalandeconomic http://www.amcp.org/practiceresources/amcpformatformulary
informationinasystematicandrigorous submisions.pdf
fashion.Itisawelcomedevelopmentfora
U.S.healthsystemthatisinneedofmore
rigorousevaluationofevidence.
PeterJ.Neumann,ScD,ForewordtotheAMCPFormatforFormularySubmissions,Version2.1,
April2005.

ThankyoutoAMCPmemberJay
Jacksonforcreatingthisslide
deckfor2015.

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