Maintaining cost-effective access to antiretroviral drug therapy through a collaborative approach to drug procurement, consensus treatment guidelines and regular audit: the experience of London HIV commissioners and providers.

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by  Foreman, Claire

Service models
Maintaining cost-effective access to antiretroviral
drug therapy through a collaborative approach to drug
procurement, consensus treatment guidelines and
regular audit: the experience of London HIV
commissioners and providers
Claire Foreman,1 Brian Gazzard,2 Margaret Johnson,3 Peter Sharott,1
Simon Collins4
1LondonSpecialised ABSTRACT Currently, the Department of Health makes
CommissioningGroup,London, BackgroundIntheUK,meetingthe£20billionefficiency recurrent funding allocations directly to PCTs on
UK challengeintheNHSrequiresnewapproachestoprotect the basis of the relative needs of their populations
2HIV/GUUnit,Chelseaand
quality and improve productivity. In London, clinicians, and in line with relevant policy. A weighted capi-
WestminsterHospitalNHS
FoundationTrust,London,UK people living with HIV and commissioners are tation formula determines each PCT’s target share
3IanCharlesonDayCentre, collaboratingtoreducethecostofantiretroviralsaspart of available resources to enable them to commis-
RoyalFreeHampsteadNHS of the Quality Innovation Productivity and Prevention sionsimilarlevelsofhealthservicesforpopulations
Trust,London,UK
4HIVi-Base,London,UK agenda. in similar need and to reduce avoidable health
Objectives To describe how collaboration in inequalities. In turn, PCTs work with Specialised
Correspondenceto antiretroviral procurement in 2011/2012 aimed to CommissioningGroupstoagreeannualbudgetsfor
ClaireForeman,Senior significantlyreducedrugacquisitioncosts,ensureequity the commissioning of specialised services on their
CommissioningManager, of prescribing and protect the quality and experience of behalf.
LondonSpecialised
care and treatment for patients. As a result of the wider economic climate and
CommissioningGroup,Portland
House,StagPlace,London Methods Greater clinical leadership and engagement rising costs of care, NHS budgets are under
SW1E5RS,UK;claire. and involvement of patient representatives enabled an unprecedented financial pressure. The Operating
[email protected] approach to drug procurement focused on clinical Framework fortheNHS2setsout therequirement
outcomes at a patient and population level while todeliver upto£20billionofefficiencysavingsby
Accepted4January2012
reducing cost. Consensus guidelines for implementation 2014/2015. In response to this challenge, the NHS
weredevelopedandagreedbyallLondonleadclinicians is developing Quality Innovation Productivity and
while people living with HIV produced a patient Preventionplanswhichaimtoimprovequalityand
information leaflet to explain the tender process and cost through innovation and effective prevention
outcomes.Aplannedauditisunderwayatallservicesto strategies.
monitorprescribing changesand outcomesforthoseon
treatment. The challenge of commissioning for HIV care and
Results HIV clinicians, pharmacists and patient treatment in the UK
representatives were directly involved in this novel The epidemiology of HIV poses significant
therapeutic tendering approach to antiretroviral drug commissioning challenges in the context of finan-
procurement. Modelling indicates that £8e£10 million cial constraint. According to the Health Protection
savings will be released through the process over Agency, an estimated 91500 people were living
2years. withHIVintheUKin2010,ofwhom69400were
Conclusions Clinically led therapeutic tendering of in care and treatment. By the end of 2012, the
antiretroviral drugs provides an opportunity to protect number of people living with HIVinfection (diag-
quality and improve productivity in HIV. The approach nosedandundiagnosed)intheUKwaspredictedto
is novel in HIV in the UK, and the emergent learning havereached100000.Inadditiontoincreasesinthe
has implications for quality and cost improvement number of people living with HIV, commissioning
in HIV spending in the UK and potentially in other intentions need to take account of the increasing
countries. proportion of patients taking antiretrovirals. HIV
surveillancedataindicatethatin2010,aroundhalf
ofthosediagnosedashavingHIVinfectionsinthe
UK had a CD4 count of <350, below the recom-
INTRODUCTION mended threshold for beginning HIV treatment.3
Commissioning health services in the UK Current debate about the role of treatment as
In the UK, Primary Care Trusts (PCTs) are the prevention is likely to increase the proportion of
statutory bodies with responsibility for commis- people ontreatment further.
sioning health services for their patient popula- Additional commissioning challenges included
Thispaperisfreelyavailable tions. Specialised services are defined in law as lackofaccesstopatientidentifiabledata,planning
onlineundertheBMJJournals those services with a planning population of >1 foropenaccesstoHIVservicesandensuringequity
unlockedscheme,seehttp://sti.
bmj.com/site/about/unlocked. million people and typically include services deliv- in the context of highly individualised treatments,
xhtml eredbyfewerthan 50providers inEngland.1 including theuse ofoff-licencetreatment.
112 SexTransmInfect2012;88:112e115.doi:10.1136/sextrans-2011-050438
Service models
The London experience of commissioning for HIV care and appropriate alternatives is reasonable in order to balance the
treatment needs of individuals and populations in a resource-constrained
In London, HIV care and treatment is collaboratively commis- environment.
sioned by the London Specialised Commissioning Group on The Drugs and Treatment Sub Group delegated a multidisci-
behalf of 31 PCTs. An engagement structure with clinically led plinary panel involving doctors, commissioners, specialist phar-
subgroups for Drugs and Treatment and Audit and Outcomes macy,publichealthandpatientrepresentativestotakeforward
bring together commissioners, clinicians and patient represen- theprocess.Meetingswereheldwithpharmaceuticalcompanies
tatives to plan, deliver and evaluate HIV care and treatment toexplaintheprocess, andinvitations totender were placedin
services. Twenty-three HIV-specialised service providers are the Official Journal of the European Union. Pharmaceutical
commissionedtodelivercareandtreatmentservicesonanopen companieswereinvitedtotenderbasedonbothcontinuationof
access basis. existing prescribing volumes and on a cost and volume matrix.
Commissioning for improvements in quality and cost has Theprocurementprocess wassupportedbytheDepartment of
been underway for a number of years. London HIV care and Health’sCommercial Medicines Unit.
treatment contracts include four clinical outcome measures In December 2010, tenders were reviewed by the panel and
relatedtoaccesstocare,effectivenessoftreatment,effectiveness recommendations for accepting tenders were referred to all
ofcareandmortality.Outcomesaremonitoredforeachprovider clinicalleadsfordiscussionandapproval.Consensusprescribing
using Health Protection Agency surveillance data. Commis- messages were developed and agreed by lead HIV clinicians for
sioning for clinical outcomes in this way is novel and probably clinically appropriate use of the least expensive nucleoside
unique, and the standard of clinical care achieved is interna- analoguereversetranscriptaseinhibitorsandproteaseinhibitors
tionallyrenowned.By2010,thequalityofHIVcarereceivedin (PIs).
Londonwashigh:80%ofnewlydiagnosedpatientswereseenin
a HIV clinic within 1month of diagnosis, 90% had an unde-
tectable viral load(<50copies/ml) 1year afterstarting therapy RESULTS
and93%ofthoseincareformorethanayearhadaCD4count Clinical considerations in therapeutic tendering
above 200cells/mm3.4 HIV clinicians, commissioners and patient representatives
In 2011/2012, the budget available to commission HIV care reviewed the submitted tenders in the context of evidence and
and treatment in London for approximately 30000 people was existing treatment guidelines, taking account of toxicity, toler-
the same as the previous year at around £250 million. The ability and convenience. Following the review of the tenders,
number of people living with HIV and accessing care and thereweretwoareaswherepotentialchangesintreatmentwere
treatmentinLondonhasalmostdoubledinthelastdecadeand agreed.
increases annually by approximately 1800 new patients. By Consideration would be given first to the use of Kivexa(cid:1)
2010, 83%ofthose incarewere onantiretroviral treatment.5 (abacavir and lamivudine fixed-dose combination) before teno-
fovir in the fixed-dose combinations with emtricitabine
Anewapproachtoantiretroviraldrugprocurement:therapeutic (Truvada(cid:1)) or with emtricitabine and efavirenz (Atripla(cid:1)) or
tendering other Nucleoside analogue Reverse Transcriptase Inhibitor
London NHS Trusts spend around approximately £170 million backbone combinations in patients starting antiretroviral
per annum on antiretroviral drugs, representing almost 20% of therapy for the first time or where a switch of treatment was
their total drugs expenditure. Antiretroviral procurement on being considered. As in the current routine clinical practice,
a collaborative pan-London basis has successfully secured equi- a negative HLA-B*5701 test would be required. Additional
tableaccesstotherapyforpatientsatthebest-negotiatedprices exclusioncriteriaforusingabacavirwouldincludehighbaseline
for a number of years. With base case funding, commissioners viral load (>100000 copies) because of the results of the
asked the clinically led Drugs and Treatment Sub Group to ACTG5202 clinical trial. A high Framingham risk score for
consider opportunities to secure further reductions in drug cardiovascular disease (>10% over 10years) would also consti-
acquisition costs. tute an exclusion due to potential concerns about possible
cardiovascular riskwith abacavir.ArecentACTGreviewfound
METHODS no signal of enhanced cardiovascular events in individuals with
In October 2010, the London HIV Drugs and Treatment Sub alowcardiovascularriskinrandomisedclinicaltrials.Theadvice
Group agreed to include a therapeutic tender approach in the alsomadeclearthatthereisarangeofpre-existingabnormalities
antiretroviral procurement process for 2011/2012. The aim of inadditiontocardiovascularriskwhereonenucleosideanalogue
thetherapeutictenderwastoidentifythepotentialforagreeing backbone might be preferred over another. While there is no
first-line drug choices which would stimulate volume growth definitive data that tenofovir should not be used in individuals
and significantly reduce acquisition costs while protecting clin- withahighriskofdevelopmentofrenalinsufficiency,abacaviris
ical care and outcomes for all HIV-infected individuals. often the preferred option. These recommendations are for
Outcomes of the tender process would need to demonstrate people starting treatment. The outcome of the tender did not
evidence-based use of antiretroviral drugs, in line with current includeafinancialincentivetochangenucleosidetreatmentfor
treatmentguidelines,andensurecontinuedperformanceonthe patients currently on stabletreatment.
London clinical outcome measures. In addition, the process Second,withregardtoPIs,anumberofhead-to-headstudies
would need to support the primacy of the clinical consultation havedemonstratedthatmanyoftheroutinelyuseddrugshave
betweenHIVdoctorandpatient.Thefreedomoftheindividual very similar efficacy profiles but can have different toxicity
clinician to prescribe the most appropriate drug for the patient profiles.Therefore,whenchoosingaPIforuseinfirstPItherapy,
andfullinvolvementofthepersonlivingwithHIVintreatment itisagainreasonabletotakecostintoaccount.Asaresultofthe
decision-making processes were confirmed as fundamental tendering process, atazanavir/ritonavir offered the opportunity
principles. On this basis, the clinicians and patient representa- for considerable cost saving if considered first compared with
tives involved agreed that using least expensive clinically using other once-daily andtwice-daily PIs.
SexTransmInfect2012;88:112e115.doi:10.1136/sextrans-2011-050438 113
Service models
With PIs, the tender outcome included a financial incentive of saving years of good quality life and compares favourably
ifsomepatientscurrentlyonPI-basedtreatmentweretoswitch with the treatment for many other chronic diseases. Where
to atazanavir/ritonavir. Therapy would be reviewed for drugshaveequivalentefficacyandtoxicity,prescribingtheleast
switching treatment but it was agreed that this would only be expensive alternative can deliver individual and public health
considered when clinically appropriate and with the patient’s benefit forthose living with HIV.
consent. This work has highlighted consensus on the principle that
The most recent edition of the UK (BHIVA) treatment cost is a reasonable consideration for individual clinicians and
guidelineswaspublishedin2008andthereforedoesnotcapture patientstotakeintoaccountwhenselectingtreatmentoptions
all current clinical practice. Clinicians involved in the process ofsimilarefficacy.Concernshavebeenexpressedabouthowthe
discussed existing evidence in relation to clinical efficacy and changes may affect the doctorepatient relationship. It is
adherence in agreeing the outcome of the tender and the essential that there is always a full discussion of treatment
guidelines to support implementation. As >100 physicians are optionsincludingefficacy,risksandcostrationalewithpatients,
involved across London in initiating or changing antiretroviral andthishasbeenemphasisedthroughoutLondonHIVservices.
treatment for HIV patients, the clinical guidelines were devel- Thereisastrongtraditionofpatientengagementandadvocacy
oped to ensure consistent approaches across all services. These in HIV care in London and the UK which means patients,
werewidelydisseminatedthroughHIVservices,thePatientand doctors and commissioners have a history of working together
PublicEngagementSubGroupandviacommunityinformation to protect quality while challenging and addressing inefficien-
websites including Aidsmap andHIVi-Base.6 cies.InmanyLondonservices,patientsandtreatmentadvocates
Patient information to support the process was been crucial. have led the way in developing or supporting improvements
The HIV Patient and Public Engagement Sub Group developed suchasincreasedpeersupport,moreflexibleclinicarrangements
a leaflet explaining the context for the tender and the implica- and homedeliveryof medicines.
tions of the outcomes on patient care. Leaflets have been The tender resulted in guidelines for use of preferred anti-
disseminated via clinicsand advocacy organisations.7 retrovirals that would deliver considerable cost reduction
without negatively impacting on the likely efficacy or tolera-
Implementation and audit
bilityoftreatment,aslongastheguidelineswerefollowed.For
Modelling suggests that the agreed contractsdwhich cover many patients, the newer guidelines represented potential
a2-yearperiodfromApril2011dwilldeliver£8e£10millionof improvements over their previous care, often with reduced pill
savingsifthevolumesandpricesfortheantiretroviraldrugsare burden.Theoutcomelimitedtheimpactonpatientswhowere
achieved for London as a whole. Monitoring of drug usage is already stable on treatment and ensured access to the highest
undertakenonamonthlybasisandreportedtocliniciansateach qualitycarewithminimaldisruptiontopatients.Infuture,itis
provideraswellasbeingreviewedbytheDrugsandTreatment possible that such processes could result in tenders where less
SubGroup. potent antiretroviral drugs were substantially less expensive or
Of paramount importance to commissioners, clinicians and where savings could only be realised through more widespread
patients is ensuring that clinical quality of care is maintained switching of patients currently on stable treatment. Both of
and clinical outcomes protected. Equity in implementation of theseissuesneedtobeconsideredaspartoffutureprocurement
the clinical guidelines isalso criticaltosuccess. processes in order that quality of treatment continues to be
Providing assurance that guidelines are being implemented optimised, disruption to patients is minimised and drug acqui-
and clinical outcomes protected requiresa programme ofaudit. sition costscontinue toimprove.
All services in London are participating in an audit to track all ForLondon,animportantquestioniswhatwillhappenatthe
patientsaffectedbythechangestomonitorimplementationand endofthistenderperiod.Someantiretroviraldrugshavepatents
the clinical outcomes. The clinically led Audit and Outcomes duetoexpire.Therewillbenewdataonefficacyandtoxicityof
Sub Group will be reviewing the audit findings over the next existingantiretroviraldrugsandnewdrugswillbelicensed.The
2years. commissioning landscape too is in a process of change which
will impact on the way in which procurement exercises are
DISCUSSION AND CONCLUSIONS likelytobeundertaken.Anongoingprocessofhorizonscanning
Thechallengeforeveryhealthcaresystemishowtopayforthe will be required to inform future recommendations for drug
careitwishestoprovide.ThesuccessofHIVcareandtreatment procurement and to continue to develop creative solutions to
means more people are living longer and healthier lives. The manage increased demand within existing resources. While we
continuedsuccesswilldependontheseandmorepeoplehaving continuetoadvocateformoreresourcesforHIVprevention,care
continued access to effective therapy, which must be paid for. andtreatment,weneedtocontinuetoidentifyopportunitiesfor
Everyone involveddfrom commissioners, clinical practitioners, cost improvement, so that freed up resources can be reinvested
public health specialists, patients and their representativesd inHIV services, anditcanbeshown thatthecurrentexcellent
agree on the importance of securing access to effective therapy clinical care of HIV is being maintained despite financial
for the future. Finding solutions to this challenge must be constraints.
a collaborative process. This year’s work on extending the
approach to procurement of antiretrovirals is proving Learning points
successfulinthisregard.Modellingsuggeststhattheworkison A major challenge to the tendering process was how to engage
target to deliver the savings required and engagement of clini- with all stakeholders. The commercially confidential nature of
cians and patients in procurement has been significantly tenderingrestrictsopportunitiesforconsultationorthesharing
enhanced. of specific details during the procurement process in order that
Oneoftheimportanttenetsofmedicalethicsrequiresconsid- the outcome is not prejudiced or subject to legal challenge.
erationofthecostsofdrugsprescribedandthepotentialimpactof DespitetheengagementachievedintheHIVtherapeutictender
prescribing in a cost-constrained system. Suppressive HIV treat- throughtheuseofclinicalleadsandpatientrepresentatives,the
mentdwhatever the drug useddremains a cost-effective way announcement of the completed process raised some concerns
114 SexTransmInfect2012;88:112e115.doi:10.1136/sextrans-2011-050438
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from community advocates who were not directly involved in equitableprescribingpractice,qualityclinicaloutcomesandcost
the process. reductions.Thisdependsonamanagedprocessthatcanachieve
As well as ensuring procurements continue to be Official clinicalleadershipandextensiveclinicalandpatientengagement
Journal of the European Union compliant, future collaborative in a commercially confidential context. Learning from and
tendering will need to do more to communicate and reassure buildingontheseprocesseswillbecriticalifHIVisabletomeet
stakeholdersoftherobustnessandtransparencyofcommercially the Quality Innovation Productivity and Prevention challenge
confidential processes. For example, there would be benefit in over thecoming years.
greater discussion prior to procurements on the key objectives
and acceptability of potential outcomes. Approaches will need AcknowledgementsThankstoallcontributors,toallLondonHIVClinicalLeads,
to explore how to achieve greater involvement in the prepara- HIVPPESubGroupandLondonHIVPharmacists.
tionphase,howtosharenon-confidentialinformationwithkey CompetinginterestsNone.
groups and how outcomes can be widely publicised. Delivering
PatientconsentObtained.
broader and deeper engagement in the context of procurement
ContributorsCFistheLeadCommissionerforHIVandleadsonensuringclinicaland
rules requires clear structures for involvement and for decision
patientengagementinplanning.CFistheleadauthorforthisarticle.BGistheChairof
making, andthese will needtoevolve further. theDrugs&TreatmentSubGroup,whichledtheprocurementprocessandproduced
In summary, reflections on the process so far indicate theconsensusguidelines.BGhasco-authoredthisarticle.MJistheViceChairofthe
a number of learningpoints, summarised intheboxbelow. Drugs&TreatmentSubGroup.MJhasco-authoredthisarticle.PSleadsthe
negotiationsonantiretroviralsonbehalfofLondon.PShasco-authoredthisarticle.SC
AlthoughthelearningandoutcomesforLondonareemergent,
actedasoneofthetreatmentadvocaterepresentativesintheprocurement.SChas
indications are that collaborative approaches can secure
co-authoredthisarticle.ThisarticlesetsouttheexperienceofLondoncommissioners,
providersandpatientsintherapeutictenderofARVS.
ProvenanceandpeerreviewCommissioned;externallypeerreviewed.
Key messages
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