Update from the ABPI

Procurement and Distribution

Interest Group6 November 2014Carol Blount NHS Partnerships Director

PPRS context

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Since the 1950s, PPRS has been negotiated between Department of Health

(DH) on behalf of all 4 nations and the ABPI, on behalf of the UK research-

based industry

• For DH as the primary negotiator on medicines in the UK, DH needs to ensure medicines are available at reasonable prices whilst the environment remains positive for the biopharmaceutical industry

• For Industry, the scheme recognises the need to ensure patients have access to the medicines they need and that the Industry remains profitable to enable on going investment in research and development

2014 PPRS Context

At the time of negotiation of PPRS, both sides recognised the challenge

UK austerity, debt and rising healthcare costs

Low and slow uptake of newer medicines, but

lowest prices in Europe

Importance of life sciences industry and

R&D to the UK economy

Stability required for the longer term for both

industry and Government

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Previous PPRS have featured price cuts, so NHS benefits from lower

prices but spend increased

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 across the UK

Supports patients and clinicians access to newer medicines

Five-year agreement covering 2014-2018

Commitments to dialogue on NICE and uptake

Vast majority (90%+) of branded medicines included in the scheme

Understanding the PPRS

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PPRS includes 93% of UK branded medicines by value (Jan 2014 data):

It doesn’t include..

• Exceptional central procurements (national stockpiles, pandemic preparation)

• Procurements of centrally supplied vaccines

• Parallel imports or exports

Majority of Branded products are in PPRS

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98% of all Branded medicines spend in Primary Care

87% of Branded medicines spend in Secondary Care

New five year pricing agreement caps the medicines bill for the first time

“This agreement ensures NHS patients will receive the best and most advanced medicines in the world while managing the cost. UK pharmaceutical companies have responded to the challenges we face as a country, both in terms of the increased demand for medicines and pressure on public spending.”Jeremy Hunt, Health Secretary, Department of Health press release, 6th November 2013

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c£4bThe deal Estimated

payments

Q2 data published by DH

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£000's

Aggregate Net Sales Subject to Medicines Bill Growth Calculation

(Measured Spend)

Aggregate Net Sales Covered by the PPRS

payment

Aggregate Payment

received by DH YTD Q1 YTD Q2Q1 2013 1,865,113 1,865,113 1,865,113 Q2 2013 1,943,105 1,943,105 Q3 2013 2,012,318 2,012,318 Q4 2013 2,151,675 2,151,675 Q1 2014 1,985,170 1,982,636 74,000 1,985,170 Q2 2014 2,033,106 2,024,576 76,000Growth 6.44% 5.52%

3,808,218

4,018,276

New products launched after the start of the scheme account for

0.275% of measured spend YTD, vs forecast of 0.47%.

Q2 alone 4.63%

Q2 Payment: £76M, YTD Growth: 5.52%

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2014 2015 2016 2017 2018

Initial forecast Growth Rate of Measured Spend (F%)

3.87% 3.52% 3.86% 2.14% 3.09%

Allowed Growth Rate of Measured Spend (AGR)

0% 0% 1.8% 1.8% 1.9%

Initial forecast of New Products Share of Measured Spend (NP%)

0.47% 1.85% 3.37% 5.13% 7.01%

Initial annual payment percentage (P%1)

3.74%

Estimated future annual payment percentages (2015-2018) (FP%2, FP%3, FP%4, FP%5)

7.13% 9.92% 9.92% 9.92%

PPRS Forecast and payments

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Timelines:

2014

30 Apr 14 2014 Q1 Sales Report + Payment

18 June 14 Q1 data published

31 July 14 2014 Q2 Sales Report + Payment

12 Sept 14 Q2 data published

31 Oct 14 2014 Q3 Sales Report + Payment

Early Dec 14Q3 data published + 2015 % Payment set & communicated

2015

31 Jan 15 2014 Q4 Sales Report + Payment

30 Apr 15 2015 Q1 Sales Report + Payment

31 July 15 2015 Q2 Sales Report+ Payment

30 Sept 15 2014 Annual Sales Report submitted

31 Oct 15 2015 Q3 Sales Report + Payment

Nov 15 2016 % Payment set & communicated

NHS communication on PPRS:

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“The NHS and pharmaceutical industry have a mutual interest to ensure patients can access cost and clinically effective innovative medicines and can optimise the use of these medicines to achieve better outcomes”

“NHS England, DH and the ABPI are continuing to work collaboratively to ensure that the NHS maximises the opportunities offered by the Agreement”

Committed to improving access for patients across the UK through this deal and through negotiated access schemes

Significant payments made, industry commitment to the NHS

New joint NHS England /ABPI PPRS/Medicines Optimisation programme to drive change

Supporting Innovation, Health and Wealth

Industry and NHS England partnership

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What is industry doing?

• Could PPRS payments go directly to commissioners / budget holders to support uptake of new medicines?

• How can PPRS encourage an end to rationing of innovative medicines?

• How to improve transparency and accountability on the use of new medicines via one set of metrics?

• How to focus on value and outcomes, not on short term costs alone

Unanswered questions

Patients and clinicians the 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 a level of stability and supports innovative companies, but need to change access and uptake of innovative medicines

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

PPRS provides a one-off

opportunity

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PPRS/Medicines Optimisation programme

ABPI: NHSE joint programme aims:1. To improve patient outcomes, quality and value of care from medicines use2. To maximise the benefits of the PPRS through a joint programme of action3. To accelerate uptake of innovative, clinically effective and cost effective medicines4. To create clinical pull for patient access to these medicines

Medicines optimisationMO dashboard joint venture,

patient panel

Access and uptake of innovationincluding IHW commitments , a

combined national metrics report, Pilot of 90 day tariff

Specialised commissioningImpact of MO on specialised commissioning, joint work on

Commissioning through Evaluation

Communications and engagementNHSE/ABPI regional road shows,

joint communications, ABPI Therapy Groups working with NCDs

Governance: PPRS/MO steering group: NHSE, ABPI, AHSNs, RPS, RCN, CCGs, BGMA, DH 13

Medicines Optimisation Guidance

Medicines Optimisation – intended outcomes

Principle 1Aim to understand the patient’s experience

Patients are more engaged, understand more about their medicines and are able to make choices, including choices about prevention and healthy living

Patients’ beliefs and preferences about medicines are understood to enable a shared decision about treatment

Patients are able to take/use their medicines as agreed Patients feel confident enough to share openly their experiences of taking or not taking medicines,

their views about what medicines mean to them, and how medicines impact on their daily life

Principle 2Evidence based choice of medicines

Optimal patient outcomes are obtained from choosing a medicine using best evidence (for example, following NICE guidance, local formularies etc) and these outcomes are measured

Treatments of limited clinical value are not used and medicines no longer required are stopped Decisions about access to medicines are transparent and ain accordance with the NHS Constitution

Medicines Optimisation – intended outcomes

Principle 3Ensure Medicines use is as safe as possible

Incidents of avoidable harm from medicines are reduced Patients have more confidence in taking their medicines Patients feel able to ask healthcare professionals when they have a query or difficulty with their

medicines Patients remain well and there is a deduction in admissions and readmissions to hospitals related

to medicines usage Patients discuss potential side-effects are there is an increase in reporting to the Medicines and

Healthcare products Regulatory Agency (MHRA) Patients take unused medicines to community pharmacies for safe disposal

Principle 4Make medicines optimisation part of routine practice

Patients feel able to discuss and review their medicines with anyone involved in their care Patients receive consistent messages about medicines because the healthcare team liaise

effectively It becomes routine practice to signpost patients to further help with their medicines wand to local

patient support groups Inter-professional and inter-agency communication about patients’ medicines is improved Medicines wastage is reduced The NHS achieves greater value for money invested in medicines The impact of medicines optimisation is routinely measured.

ABPI Regional Partnership Managers

RPM Purpose:•To be the regional face of Industry and position Industry as a partner to the NHS and an integral part of the solution•Responsible for shaping and improving the regional environment for Industry, to improve patient outcomes by enabling patient access to and optimum usage of innovative medicines •Develop and establish strong, sustainable relationships with key regional NHS stakeholders and member companies

RPM Primary focus 2015 :Implementation of nationally agreed policies at a regional level (eg IHW, MO)Delivery of the joint PPRS/Medicines optimisation programme at a regional level to:

• Improve patient outcomes, quality and value of care from appropriate medicines use• Maximise the benefits of the new PPRS scheme through a joint programme of action• Accelerate uptake of clinically effective and cost effective branded medicines • Create clinical pull for patient access to these medicines

Team • 4 Regional Partnership Managers aligned to the 4 regions in England• Harriet Lewis (North); Andy Riley (Midlands and East); Hasseena Winter (London)• Diana Vegh (South)

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NHS Organisation description Projected Outcomes / Measures of SuccessNENC AHSN communication transfer at interface, medicines

review in care homes /improve use of Respiratory COPD medicines

Reduction of medication errors for vulnerable patientsImproved outcomes for patients with respiratory conditions

NENC AHSN Programme of work led by NE Quality Observatory. adoption of NICE TAs without barriers

Y&H AHSN Diabetes care pathway review adoption of NICE TAs

Y&H AHSN Anticoagulation service redesign improved anticoagulation provision and access to appropriate medicines in accordance with NICE

GMAHSN Adoption of integrated framework for rapid and effective implementation of NICE TAs

Validation and roll out of framework developed by Oldham CCG

Oxford AHSN Stroke prevention/ adoption of NICE guidance for NOACs

To work with IMS on using the most effective treatment for patients with AF and change prescribing behaviour

Southampton FT/ Wessex AHSN

Reducing harm from alcohol Linking clinical services and commissioners to reduce alcohol related harm

WM AHSN Flo tele-health – including adherence support package STARTBACK – stratified care model for back pain

Improvements in patient adherence to medicines

Eastern AHSN (PRESCQIPP)

Build MO programme and IHW work streams Insights into factors which contribute to medicines waste and what can be done to improve adherence and enhance treatment outcome

Nottingham Uni Rushcliff CCG / EM AHSN

Roll out of PINCER across all the practices in East Midlands

working in partnership with the steering group at East Midlands AHSN and support the development of medicines safety infra-structure in primary care

Current Industry : AHSN Medicines Optimisation

collaborations

Innovation Health and Wealth

“NHS England is committed to delivering the recommendations in the Innovation, Health and Wealth Report to improve outcomes for individuals, carers and families”

NHS Mandate chapter 7 ‘The broader role of the NHS in society’

“NHS England is committed to ongoing implementation of IHW, which seeks to improve NHS use of innovative treatments for the benefit of patients..”

PPRS 2014 chapter 4

The overall expectation is that the IHW refresh would continue to build the strategic direction , update progress and set out next steps, supported by a series of actions and timelines for the next 2-3 years as the next stage in the longer term strategy.

Innovation Health and Wealth RefreshIndustry proposals

1.Reducing variation and strengthening compliance – continued commitment to the NICE compliance regime•Rapid and consistent implementation of NICE TAs•NICE TA recommendations are incorporated automatically included into relevant local NHS formularies and formularies are published•Continued commitment to and resourcing of the NICE Implementation Collaborative to overcome system wide barriers to implementation of NICE TAs•Development of the Innovation Scorecard into the new combined metrics report

2.AHSNs – continued commitment to fund AHSNs and greater clarity in their role in improving the adoption of innovative medicines is needed

3.Aligning financial , operational and performance incentives – financial incentives should work to encourage early adoption of NICE TAs.

•Introduction of an integrated national incentive for improved access and uptake of NICE TAs with sanctions/penalties for organisations found to be blocking or restricting patient access to those medicines. •Align existing incentive schemes•Regular audit of NICE TA implementation and publication of annual Innovation Returns at organisational level•Include IHW as a national priority for inclusion in Quality accounts

Innovation Health and Wealth RefreshIndustry proposals

4.Increasing responsibility and accountability for IHW from national to local level within the NHS

•NHS clinical, operational and financial accountability for IHW delivery needs to be considerably strengthened, from the NHSE Board , through the operational directorate to local levels•Innovation plans and objectives should be set at every level and audited•The IHW Implementation Board should be reconstituted and reinstated including senior level representation of NHSE clinical , operations and finance