This document summarizes a presentation given by Dr. Richard Greville on the value partnership between the NHS, pharmaceutical industry, and other healthcare providers in the UK. It discusses several challenges facing the NHS, including the important role of medicines, issues with medicines optimization, and the Pharmaceutical Price Regulation Scheme (PPRS). It outlines efforts through the PPRS and a medicines optimization program between NHS England and the industry group ABPI to improve patient outcomes and extract more value from healthcare spending. Specific initiatives discussed include implementing safety features like serialization and tamper evidence on medicines to protect the supply chain.

1. Dr Richard Greville, Director Wales and Director Distribution & Supply, ABPI
The value partnership between NHS, industry and other
providers
12 April 2016

2. The Value Partnership between
NHS, Industry andother Providers
April 2016
2
Dr Rick Greville,
ABPI Director, Distributionand Supply

3. ABPI- a voice forindustry
3
The ABPI represents
innovative research-
based
biopharmaceutical
companies, small,
medium and large.
Our members supply
90% of all medicines
used by the NHS,
and are researching
and developing over
two thirds of the
current medicines
pipeline, ensuring
that the UK remains
at the forefront of
helping patients
prevent and
overcome diseases.
The ABPI is
recognised by
government as the
industry body
negotiating on behalf
of our members and
the branded
pharmaceutical
industry in relation to
the Pharmaceutical
Price Regulation
Scheme. The ABPI is
also consulted on
content and changes
to the statutory
scheme alternative.
Working together with
members we provide
a strong voice,
ensuring that members
and industry are heard
through advocacy
and engagement with
key stakeholders
including policy
makers, government
and regulators to
ensure that the
pharmaceutical
industry is recognised
as a key sector for the
UK economy and
positioned as a partner
in the wider healthcare
system.
We keep members
informed and up to
date with policy
briefings and
updates, supporting
engagement at the
highest levels on all
the key issues.

4. •Challenges
•Role of medicines
•Issues
•PPRS
•Medicines Optimisation
•FMD and serialisation
•Questions
ValuedPartnerships?
4

5. Given the growing demand formedicinesthat comeswith an ageing population and budget
constraints, it is more important than ever that the NHS and patients get the best value,in terms of
money and outcomes, from the tax-payersinvestment in medicines.
Currentchallenges facingtheNHS

6. Medicines:
• Prevent life-threatening diseases
• Help to changepreviously life-threateningillnessestolong-term conditionse.g.HIV,cancer, Hepatitis C
• Improve thequalityoflife for peoplewithlong-term conditions
• Reducemortality acrossa widerangeofdiseasesand thereby helpincrease lifeexpectancy
They are the most common therapeutic intervention - NHS spends£14.4 billion each year on them
– 15% of its annualbudget.
Medicines continueto havea vital roleto play

7. But thereareissues…
•Patients report having
insufficient supporting
information
•Poor adherence:30 - 50% of
medicines not taken as
intended
•Medicines wastage in primary
care: £300M pa with £150M pa
avoidable
•UK literature suggests5% - 8%
of hospitaladmissions due to
preventable adverse effectsof
medicines

8. In addition…
•Inadequate reviewand monitoring
of medicines outcomes
•Polypharmacy
•Uptake of newer medicines can be
patchy
– Unwarrantedvariationin useof medicines
across UK
•Realthreat of antimicrobial
resistance
•Unacceptable levelof medication
error

9. We need to help improve patient outcomes, qualityand value fromallmedicines useby:
• Findingnew andinnovativeways todeliver services topatients.
• Extractingmorevalue from themoney spent in theNHS, includingfrom medicines
• Tacklingvariatione.g. InnovationScorecard
Tacklingthesechallenges

10. •To address persistentlow levels ofpatientaccessto modern medicines,industry has
agreed to keepgrowth in the branded medicines bill flatfor 2 years andbelow2% for a
further 3 years
•This presents the NHS witha uniqueopportunity to ensurepatients are gettingthe right
medicinesatthe righttime,lessconstrained by cost
•It gives the NHS the flexibility to actbasedon the full long-term valueofmedicines rather
than using short-term costcontainmentmeasures
PPRS–ValuePartnership

11. Previous PPRS havefeatured price
cuts
The 2014 scheme underwrites the
overall growth in spend by the
NHS on branded medicines
within the scheme
• Industry is a committed partnerwith NHS England
• Supports patientsand cliniciansaccessto newermedicines
• Five-yearagreementcovering 2014-2018
• Commitments to dialogue on NICE and uptake
• Vast majority (93%)of brandedmedicinesincluded in the scheme
UnderstandingthePPRSfortheNHS,taxpayersandpatients

12. Pharmaceutical PriceRegulationScheme
Unique dealunderwritesbranded
medicines growth, through direct
industry paymentsto DH
£800m
Estimatedthat industry will payintothe
NHS budget in 15/16
Agreed growth rates

13. •PPRS payments are centrally factored into NHS England’soverallMandate budget fromthe DH,
and are part of the funding growth provided
•The additional£2bn funding announced for2015/16took account of revised PPRS forecastsand
reprioritisation byDH and NHS England.
•This is a simple and effective approach whichenablesadditionalfundsto be factored into
allocations up front, and used to benefit the whole of the NHS.
•A significant element of the 2015/16 funding wasallocatedto CCGs, with those below target
benefiting the most.
•A centralmechanism to directly link payments from industrydirectlyto individualCCGswould be
very complexand bureaucratic to operate. It would also reduce the scope forthis strategic
approach to allocation decisions.
PPRSandNHSfunding

14. •For patients and clinicians, PPRS providesan opportunityto find the right levelof usage of
branded medicines, based on clinicalfactorsrather than cost
•For the NHS, medicines billgrowth hasbeen underwritten, socommissionerscan remove barriers
to clinicians choosingwhich medicinesto use
•For industry,PPRS gives stability and supportsinnovativecompanies, but there is a levelof risk
driven by austerity issues
•For Government and the taxpayer, PPRS achievespredictability on the branded medicines bill
through this period
PPRSprovides aone-offopportunity

15. Harnessingthisopportunity
The Rt Hon Jeremy HuntMP,the Secretary ofState for
Health wrote to ABPI& NHS England and asked thatthey
work together….
“to agree and carry through a solution for accelerating uptake of
clinically and cost effective medicines which maximisesthe
benefits of the PPRS within the current financialsituation. This
means an end to cost containment measureson branded
medicines which will not in the long run save the NHS any money.
It also means creating a realclinical pull for innovative and cost
effective medicines, replacing costly non drug treatmentsby a
programme of culturalchange led jointly by NHS England and the
industry using all the management levers available”.

16. NHSE andABPI
Medicines Optimisation– ValuePartnership
NHS England and ABPI developed a
joint programme of work,guided by the
Principles of Medicines Optimisation
that were published by the Royal
PharmaceuticalSocietyin May 2013.

17. “Medicines optimisationis about ensuring
the right patients,get the right choiceof
medicine at the right time”
RPS, Medicines Optimisation: Helping patients
to make
the most of medicines, May 2013

18. Medicines optimisationlooksbeyond the cost of medicinesto the value theydeliverand recognises
medicines as an investmentin patient outcomes.
The goal is to help patients to:
• Improve their outcomes,includingbetter monitoringand metrics
• Have accesstoanevidence-basedchoiceof medicine
• Improve adherenceandtakemedicinescorrectly
• Avoid takingunnecessarymedicines
• Reducewastageofmedicines
• And improvemedicinessafety
Thegoalofmedicinesoptimisation
“Where a
medicine or
technology is
clinically sound
and cost effective
for the NHS,
patients should
have access to it
– no question, no
qualification.”
Baroness Barbara Young, Chair,
Diabetes UK

19. •Localsystemredesign and integratedcare
•A move from the ‘cost’to the ‘value’discussion
•A new approach of value in systemredesign rather than doing thingsas theyhave been done for
the past 20 years
•Commissioning of innovative medicineswhere theyshowoverallvalue
•But…..
•Dominated by contribution to £22bn systemefficienciesoverthe 5year Forward View
WhatdoesthePPRS/MOValuePartnershipfacilitate?

20. •A considerable amount of falsified medicines reach the patient through illicit on-line pharmacies,
however the threatof falsified medicinespenetrating the legalsupply chain is also very real.
•The branded bio-pharmaceuticalindustry is committedto ensure patient safetyand is actively
engaged in helping secure the legalsupply chain for medicines
•Pharmaceuticalcompanieshavecommitted to adding tamperevidencedeviceson allof its
prescribable medicines from 2019, sothat patientscan have confidence in their medicines.
•In addition, pharmaceuticalcompanieswillplace a serialisation code on eachpackof medicines,
so that each pack maybe uniquely identified by healthcare digitalsystemse.g. enablerof e-
Procurement Strategy
•To fully utilise the benefits of tamper evidence devices and serialisation, the industrywillinvest a
further estimated 100 million Euros a year acrossEurope to build and manage a software system
which willallow medicines to be authenticated before theyare dispensed to patients.
ValuePartnershipinPatientSafety

21. Objective
Protectionof patients from falsifiedmedicines in thelegal distributionchain
Content
Additionof Safety Features (Serialisation and Tamper EvidenceDevice) anddevelopPan-European
system to verifytheauthenticity ofmedicinal products
2011
2019 (2016+3)
Complete
Implementation
9th Feb 2016
Publication of
Delegated Regulation
July 2011
Publication of FMD
36
Mon.
20192016
Non-compliance puts sales at risk
Implementation oftheFalsifiedMedicinesDirective(FMD)required
byFeb2019

22. ÞTamper Evidence Device
Requirementsforsafetyfeatures
Þ Unique identifier
Þ Data-Matrix Code
Þ Randomised serialnumber
Product #: 09876543210982
Batch: A1C2E3G4I5
Expiry: 140531
S/N: 12345AZRQF1234567890

23. Common BasicConcept–‘PointofDispenseVerification’
In line with
expectations
of Delegated
Regulation

24. Pan-Europeanarchitecture:The“NationalBlueprintSystem“approach
National
System
Pharmacy
Wholesaler
Pharmaceutical
Manufacturer
Parallel
Distributor
National
System
National
System
European
Hub
National Blueprint
System
National Blueprint
System
National Blueprint
System
National Blueprint
System

25. Whowillhavetopay?
National system cost estimate
Pharmacists, wholesalers, …
Installations for
pack verification
Marketing Authorisation
Holders
Installations for pack coding
and tamper evidence
Marketing Authorisation
Holders
Repository system
(Hub & national systems)
Pharmacy Wholesaler
Pharmaceutical
Manufacturer
Parallel
Distributor
European
Hub
MAHs selling products in a Member Statepay for respectivenational
system anda share of theEuropeanHub

26. UK Stakeholdersin distributionchainareobligedto buildthe
UK verificationsystem
System set up and
governed by
stakeholders under
supervision of national
competentauthorities
Healthcare
Distribution
Association (HDA
UK)

27. Q1
Incorporation of
UKMVO
Finalise UKMVO
Business Plan
(Funding, Articles,
Selection Criteria)
Stakeholder
assent of
Framework MoU
Q2 Q3 Q4
Consultation
with
Stakeholders
Finalise UK URS and
Selection of IT
Provider
20162016
2016 Key Milestones – UK
Start IT System
Build
ValuePartnership- RoadMap2016