Dr Richard Greville, Director Wales and Director Distribution & Supply, ABPI

The value partnership between NHS, industry and other providers

12 April 2016

The Value Partnership between NHS, Industry and other Providers

April 2016

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Dr Rick Greville,ABPI Director, Distribution and Supply

ABPI - a voice for industry

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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.

•Challenges

•Role of medicines

•Issues

•PPRS

•Medicines Optimisation

•FMD and serialisation

•Questions

Valued Partnerships?

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Given the growing demand for medicines that comes with 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-payers investment in medicines.

Current challenges facing the NHS

Medicines:

• Prevent life-threatening diseases

• Help to change previously life-threatening illnesses to long-term conditions e.g. HIV, cancer, Hepatitis C

• Improve the quality of life for people with long-term conditions

• Reduce mortality across a wide range of diseases and thereby help increase life expectancy

They are the most common therapeutic intervention - NHS spends £14.4 billion each year on them – 15% of its annual budget.

Medicines continue to have a vital role to play

But there are issues …

•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 suggests 5% - 8% of hospital admissions due to preventable adverse effects of medicines

In addition…

• Inadequate review and monitoring of medicines outcomes

•Polypharmacy

•Uptake of newer medicines can be patchy

– Unwarranted variation in use of medicines across UK

•Real threat of antimicrobial resistance

•Unacceptable level of medication error

We need to help improve patient outcomes, quality and value from all medicines use by:

• Finding new and innovative ways to deliver services to patients.

• Extracting more value from the money spent in the NHS, including from medicines

• Tackling variation e.g. Innovation Scorecard

Tackling these challenges

•To address persistent low levels of patient access to modern medicines, industry has agreed to keep growth in the branded medicines bill flat for 2 years and below 2% for a further 3 years

•This presents the NHS with a unique opportunity to ensure patients are getting the right medicines at the right time, less constrained by cost

•It gives the NHS the flexibility to act based on the full long-term value of medicines rather than using short-term cost containment measures

PPRS – Value Partnership

Previous PPRS have featured price cuts

The 2014 scheme underwrites the overall growth in spend by the

NHS on branded medicines within the scheme

• Industry is a committed partner with NHS England• Supports patients and clinicians access to newer medicines• Five-year agreement covering 2014-2018• Commitments to dialogue on NICE and uptake• Vast majority (93%) of branded medicines included in the scheme

Understanding the PPRS for the NHS, taxpayers and patients

Pharmaceutical Price Regulation Scheme

Unique deal underwrites branded medicines growth, through direct

industry payments to DH

£800mEstimated that industry will pay into the

NHS budget in 15/16

Agreed growth rates

•PPRS payments are centrally factored into NHS England’s overall Mandate budget from the DH, and are part of the funding growth provided

•The additional £2bn funding announced for 2015/16 took account of revised PPRS forecasts and reprioritisation by DH and NHS England.

•This is a simple and effective approach which enables additional funds to be factored into allocations up front, and used to benefit the whole of the NHS.

•A significant element of the 2015/16 funding was allocated to CCGs, with those below target benefiting the most.

•A central mechanism to directly link payments from industry directly to individual CCGs would be very complex and bureaucratic to operate. It would also reduce the scope for this strategic approach to allocation decisions.

PPRS and NHS funding

•For patients and clinicians, PPRS provides an opportunity to find the right level of usage of branded medicines, based on clinical factors rather than cost

•For the NHS, medicines bill growth has been underwritten, so commissioners can remove barriers to clinicians choosing which medicines to use

•For industry, PPRS gives stability and supports innovative companies, but there is a level of risk driven by austerity issues

•For Government and the taxpayer, PPRS achieves predictability on the branded medicines bill through this period

PPRS provides a one-off opportunity

Harnessing this opportunity

The Rt Hon Jeremy Hunt MP, the Secretary of State for Health wrote to ABPI & NHS England and asked that they work together….

“to agree and carry through a solution for accelerating uptake of clinically and cost effective medicines which maximises the benefits of the PPRS within the current financial situation. This means an end to cost containment measures on branded medicines which will not in the long run save the NHS any money. It also means creating a real clinical pull for innovative and cost effective medicines, replacing costly non drug treatments by a programme of cultural change led jointly by NHS England and the industry using all the management levers available”.

NHSE and ABPIMedicines Optimisation – Value Partnership

NHS England and ABPI developed a joint programme of work, guided by the Principles of Medicines Optimisation that were published by the Royal Pharmaceutical Society in May 2013.

“Medicines optimisation is about ensuringthe right patients, get the right choice of medicine at the right time”

RPS, Medicines Optimisation: Helping patients to makethe most of medicines, May 2013

Medicines optimisation looks beyond the cost of medicines to the value they deliver and recognises medicines as an investment in patient outcomes.

The goal is to help patients to:

• Improve their outcomes, including better monitoring and metrics

• Have access to an evidence-based choice of medicine

• Improve adherence and take medicines correctly

• Avoid taking unnecessary medicines

• Reduce wastage of medicines

• And improve medicines safety

The goal of medicines optimisation

“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

•Local system redesign and integrated care

•A move from the ‘cost’ to the ‘value’ discussion

•A new approach of value in system redesign rather than doing things as they have been done for the past 20 years

•Commissioning of innovative medicines where they show overall value

•But…..

•Dominated by contribution to £22bn system efficiencies over the 5year Forward View

What does the PPRS/MO Value Partnership facilitate?

•A considerable amount of falsified medicines reach the patient through illicit on-line pharmacies, however the threat of falsified medicines penetrating the legal supply chain is also very real.

•The branded bio-pharmaceutical industry is committed to ensure patient safety and is actively engaged in helping secure the legal supply chain for medicines

•Pharmaceutical companies have committed to adding tamper evidence devices on all of its prescribable medicines from 2019, so that patients can have confidence in their medicines .

• In addition, pharmaceutical companies will place a serialisation code on each pack of medicines, so that each pack may be uniquely identified by healthcare digital systems e.g. enabler of e-Procurement Strategy

•To fully utilise the benefits of tamper evidence devices and serialisation, the industry will invest a further estimated 100 million Euros a year across Europe to build and manage a software system which will allow medicines to be authenticated before they are dispensed to patients.

Value Partnership in Patient Safety

ObjectiveProtection of patients from falsified medicines in the legal distribution chain

ContentAddition of Safety Features (Serialisation and Tamper Evidence Device) and develop Pan-European system to verify the authenticity of medicinal products

2011

2019(2016+3)CompleteImplementation

9th Feb2016

PublicationofDelegatedRegulation

July2011PublicationofFMD

36Mon.

20192016

Non-compliance puts sales at risk

Implementation of the Falsified Medicines Directive (FMD) required by Feb 2019

ÞTamper Evidence Device

Requirements for safety features

ÞUnique identifierÞ Data-Matrix CodeÞ Randomised serial number

Product #: 09876543210982Batch: A1C2E3G4I5Expiry: 140531S/N: 12345AZRQF1234567890

Common Basic Concept – ‘Point of Dispense Verification’

In line with expectations of Delegated Regulation

Pan-European architecture: The “National Blueprint System“ approach

NationalSystem

PharmacyWholesaler

PharmaceuticalManufacturer

ParallelDistributor

NationalSystem

NationalSystem

EuropeanHub

National BlueprintSystem

National BlueprintSystem

National BlueprintSystem

National BlueprintSystem

Who will have to pay ?

National system cost estimate

Pharmacists, wholesalers, …

Installations for pack verification

Marketing AuthorisationHolders

Installations for pack coding and tamper evidence

Marketing AuthorisationHolders

Repository system (Hub & national systems)

Pharmacy Wholesaler

Pharmaceutical Manufacturer Parallel

Distributor

EuropeanHub

MAHs selling products in a Member State pay for respective national system and a share of the European Hub

UK Stakeholders in distribution chain are obliged to build the UK verification system

System set up and governed by stakeholders under supervision of national competent authorities

Healthcare Distribution Association (HDA UK)

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 SystemBuild

Value Partnership - Road Map 2016