2016 Market Access Update
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Inacomplexandchangingenvironmentitisbecomingcrucialtoimplement
marketaccessstrategyintheearlystagesofaproduct’s lifecycle
Accurateinformation oncountries toapply, pricing,legalleveragenotonly
optimise timeandbudgetattheimplementationstagebutalsoensurea
relevantcollectionofdataintheupstreamprocesses
ChristianHill
ManagingDirectorMAPBioPharma
[email protected]
Overview
• TopicselectionbyNICE:howtomakesureyou
areconsideredbyNICEandwhatmightthe
alternativesbe?
• NHSEngland- theevolutioncontinues- how
toplanfor2016andbeyond
• Challengingpricingandreimbursement
decisions
The NICE Process
Roles of NICE
TheroleofNICEisbecoming increasingly morediverseandnowincludesmorethan
evidencebasedguidance
Overview of Topic Selection Stages
Overview of Topic Selection Stages
Week 0
Receive topic filtration forms from
National Institute for Health Research
Horizon Scanning Centre at the
University of Birmingham
Filtering
Consultant Clinical Adviser considers
topics, seeks expert opinion and
eliminates unsuitable topics
Scoping
Prioritisation
Week 1
Any information that is published by
NICE about topic selection is with the
specific agreement of the company
Consultant Clinical Adviser seeks expert
opinion, including the relevant National
Clinical Directors in the request
Scopes are developed, content
considered and agreed internally, and
are released for consultation
Formal referral
Outcome of scoping consultation
considered, content of scopes finalised
and request to Minister for formal
referral of appropriate topics is made
Scoping
Week 4
Any information that is published by
NICE about topic selection is with the
specific agreement of the company
Internal
group consider
filtering
Scopes
are developed,
content
decisions
prioritisation
advice
considered
andand
agreed
internally,
and and
agree
list of potential
topics suitable for
are
released
for consultation
scope development
•
Formal referral
Week 7
List ofofpotential
are handed
Outcome
scoping topics
consultation
overcontent
to the technology
appraisal
considered,
of scopes finalised
scoping team for the scopes for
and request to Minister for formal
consultation to be developed
referral of appropriate topics is made
Copyright MAP BioPharma Limited 2015 - www.mapbiopharma.com
•
Copyright MAP BioPharma Limited 2015 - www.mapbiopharma.com
NICEdon’t reviewallhealthtechnologiesthat
cometotheUKmarket
Thosethatareshortlistedaresplitintoeithera
singleormultiplehealthtechnologyappraisalor
HST(ultraorphans)
Technology Appraisal Decisions
• Recommended– NHSlegallyobligedtofund
thehealthtechnologywhenNICEinclude
fundingguidance(almostalways)
• Optimised (effectivelyarestrictiontothe
patientpopulation)
• OnlyinResearch
• Notrecommended
NHS Structure
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•
SourcesandAllocationofFundingintheNHS
DecisionMakingProcessinSpecialised
Commissioning
Primary Responsibilities of Each Organisation
within the NHS
•
SecretaryofStateforHealth(SoSH):HasoverallresponsibilityforworkoftheDH
•
DepartmentofHealth(DH):Responsibleforstrategicleadershipandfundingforbothhealth
andsocialcareinEngland
•
NHSEngland(NHSE):MainroleinimprovinghealthoutcomesforpeopleinEngland
•
ClinicalCommissioningGroups(CCGs):Responsibleforplanningandcommissioningof
healthcareservicesintheirlocalarea(mainlysecondarycareservices)
•
HealthandWellbeingBoard(H&WB):Actsasaforumforlocalcommissionersacrossthe
NHS,socialcare,publichealthandotherservices
•
PublicHealthEngland(PHE):Providesnationalleadershipandexpertservicestosupport
publichealth,andalsoworkswithlocalgovernmentandtheNHStorespondtoemergencies
Routes to market access for specialised medicines in
England are varied and have many challenges
NICEHighly
Specialised
Technologies
(HST)Programme
Commissioning
Policy
©CanStockPhotoInc./RTimages
NICESingleor
Multiple
Technology
Appraisal
(STA/MTA)
Commissioning
Through
Evaluation
National
CancerDrugs
Fund(NCDF)
Individual
FundingRequests
(IFRs)
Appeals and Reviews of Pricing
and Reimbursement Decisions
WiththankstoPaulRanson for
material– seebio
EU and UK Level Controls
• Directive89/105– pricing/reimbursementtransparency
– Priceapproval,pricefreeze,approvalofpriceincreases,profit
control,productcoverage
– 90daytimeline
– Publishedobjectiveandverifiablecriteria
– Noticeofremediesandtimelimits
– Abandonedrevision
• NationalHealthServiceAct2006
– Voluntaryschemesandmembership
– Statutoryscheme
1
1
UK Remedies
•
•
•
•
•
•
•
PPRSdisputes
Statutoryschemeappeals
NICEappeals
CancerDrugsFundreviews
CCGcommissioning
UsingFOIA
Judicialreview
– Bypharmacompanies
– Bypatients
1
2
Judicial Review
•
Nofurtherappealavenues
•
Decisionmightbeunlawfulif:
–
thedecision-maker does nothavepowertomakethe
decision, orisusingtheirpowerimproperly
–
thedecision isirrational
–
theprocedurefollowed bythedecision-maker wasunfairor
biased
–
–
thedecision wasinbreachoftheHumanRightsAct
thedecision breachesEuropeanCommunity (EC)law
•
Challengesmustbewithin3monthsofdecision
•
CannotusuallyreviewthemeritsbutJRcansucceedfor
improperprocessormisunderstandingthemedical
evidenceorbeachofthepatient’shumanrights
Pre-action stage
Letter explaining
argument to Public
Body (PB); suggest
how they can remedy it
and set time limit
Satisfactory response
received and settlement
reached
No satisfactory response is
received from the PB
Permission Stage
Apply for permission to bring
a Judicial Review (JR) claim
against the public body
Defendant must file an
‘acknowledgement of
service’ & defence grounds
If no acknowledgement of
service is received, the
defendant may not take part
in the JR hearing
Judge reviews the papers
and either grants or denies
permission to continue
Grants
Denies
The Final Hearing
Public body files grounds for
defence. Judge makes
decision at trial, or reserves
judgement for a later date
Appeals
Unless case deemed totally
without merit
Within 7 days:
Appeal to have the JR
reviewed at an oral hearing
Granted
Denied
Your Lawyer can request for
an appeal to the Court of
Appeal
1
3
Appeal
Using FOIA
• FreedomofInformationAct2000
– appliestopublicauthoritiesatalllevels
– applytoanyrecordedinformationheldbyoronbehalfofan
authority
– requestshouldbeinwriting
– sendittotheauthority’sFOIofficer
– requirements
– 20daytimelimitandexceptions
– Costs
• Wayofgatheringevidenceforjudicialreview
• FOIAandjudicialreviewinparallel
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4
Accelerated Access Review
Don’tforgettorespondtokey
consultationsthroughout
Accelerated Access Review – Key Points
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RecommendationstoGovernmentonreformstoaccelerateaccessforNHSpatientsto
innovativemedicinesandmedicaltechnologies(includingdevicesanddiagnostics)
AkeyaimistodemonstratethattheUKisthebestplaceintheworldtodesign,developand
deployinnovativeproducts
Thescopeincludes
–
–
–
–
–
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Regulation,reimbursementanduptake
Identificationofkeypriorities foraction– bothstrategicandoperational– andsuggestpractical
improvements
Consideration ofthelongtermlandscapeforinnovation adoptionandhowschemesliketheCDF,
PPRSandValueBasedPricingmayfitintoanintegratedspecialist commissioning system
Cost-effectiveness andaffordability(BUTnottheICERthreshold ormethodology ofNICE)
useofdataandmeasurementtodriveevidencebaseddevelopment andcommissioning ofeffective
innovative medicines
ImplementationstepsbecomingclearoverQ1-22016includingsuccessmetrics
https://www.gov.uk/government/organisations/accelerated-access-review
Biography
ChristianHill
T+441480832360
M+447590197233
ChristianHillisManagingDirector atMAPBioPharmaLimitedandaDirectorofMAPMedTech
LimitedandMAPMarketAccessLimited.MAPprovide marketaccessguidanceforbiotech,
pharmaceutical,medicaldevice,diagnosticsandvaccinesbusinessesintheUKandEU.MAPoffer
anuptodate,validated,webbasedsubscriptionservice,whichactsasa‘virtual’experttohelp
companiesachievepricingandreimbursementacrossEurope. Ifwhatcompaniesneedisnot
alreadythere,theycompletetheadditionalwork,usuallyatno extracharge.Tosupplementthis,
theyofferproduct specific,one tooneexpertstrategicadviceonaconsultingbasisthroughout
theproduct lifecycle
Christianisaseasonedmarketaccessprofessionalwithover 15yearsofexperienceinthe
internationallifesciencesindustry. Hehasabroad rangeofexpertiseandexperience including
pricing,over50HTAsubmissionsandtheiroverallstrategyleadingtopositiveguidance,health
economicmodelingdevelopment,andrelationshipswithaccessandreimbursementbodiesand
theirinfluencersacrossEurope.
Hehasheldanumber ofseniormarket-access-relatedpositionsinindustry includingNationalHTA
andGovernmentAffairsManageratPfizer,HeadofMarketAccessandBusinessDevelopmentat
GileadSciencesandHeadofMarketAccessEuropeatInterMune. Heisalsoamemberofthe
boardatEUCOPE,atradebody inEurope representingMedtech andBioPharmacompanies;anda
member of thesteeringgroupofEMIG,aUKtradebody representingprimarilySMEs.
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Biography
PaulRanson
T+442032015565
F+442032015001
PaulRansonisaconsultantwhofocuseson theregulatoryandcommercialneedsofthe
pharmaceutical,biotechnology andmedicaldevicessectors.Paul’sregulatoryexpertisecoversboth
marketingauthorisation-relatedmattersandmarketaccess,pricing,andreimbursementissues.His
commercialworkisconcentrated ontransactionswithahighdegreeofindustry specificityincluding
collaborationsandoutsourcingtransactions.
Paulspenttheearlypartofhiscareerinin-houseroleswithSmithKline,Merck Sharp,andDohme,
andhassubsequentlymaintainedthisindustry focus.
PaulisthelegaladvisertotheUKtradeassociationforsmallerandmedium-sizedcompanies(Ethical
MedicinesIndustry Group)andtheprincipalauthor ofthelegalmoduleofanMSconpharmaceutical
licensing.Hehasalsobeenanon-executivedirector ofaspecialtypharmaceuticalcompany forsome
10yearsandwasamemberofanindependentethicscommitteeforsome5years.
AsaresultofhisexpertisePaulisafrequentspeakeratconferencesonavarietyoftopicsincluding
licensing,healthtechnology assessmentandvariousregulatorytopicsincludingduring2015 the
Informa EUPharmaceuticalLawForuminEuropeandBIOandISPOR intheUnitedStates.Hehas
writtensome10reportsonpharmaceuticalandmedicaldevice regulatoryissuesandhas
authored/co-authored numerousjournalarticles.
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