The value partnership between NHS, industry and other providers

Size: px
Start display at page:

Download "The value partnership between NHS, industry and other providers"

Transcription

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

2 The Value Partnership between NHS, Industry and other Providers April 2016 Dr Rick Greville, ABPI Director, Distribution and Supply 2

3 ABPI - a voice for industry The ABPI represents innovative researchbased 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. 3

4 Valued Partnerships? Challenges Role of medicines Issues PPRS Medicines Optimisation FMD and serialisation Questions 4

5 Current challenges facing the NHS 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.

6 Medicines continue to have a vital role to play 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.

7 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

8 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

9 Tackling these challenges 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

10 PPRS Value Partnership 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

11 Understanding the PPRS for the NHS, taxpayers and patients 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 Commitments to dialogue on NICE and uptake Vast majority (93%) of branded medicines included in the scheme

12 Pharmaceutical Price Regulation Scheme Unique deal underwrites branded medicines growth, through direct industry payments to DH Agreed growth rates 800m Estimated that industry will pay into the NHS budget in 15/16

13 PPRS and NHS funding 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.

14 PPRS provides a one-off opportunity 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

15 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.

16 NHSE and ABPI Medicines 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.

17 Medicines optimisation is about ensuring the right patients, get the right choice of medicine at the right time RPS, Medicines Optimisation: Helping patients to make the most of medicines, May 2013

18 The goal of medicines optimisation 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 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 What does the PPRS/MO Value Partnership facilitate? 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

20 Value Partnership in Patient Safety 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.

21 Implementation of the Falsified Medicines Directive (FMD) required by Feb 2019 Objective Protection of patients from falsified medicines in the legal distribution chain Content Addition of Safety Features (Serialisation and Tamper Evidence Device) and develop Pan-European system to verify the authenticity of medicinal products July 2011 Publication of FMD 9 th Feb 2016 Publication of Delegated Regulation 36 Mon (2016+3) Complete Implementation Non-compliance puts sales at risk

22 Requirements for safety features Þ Unique identifier Þ Data-Matrix Code Þ Randomised serial number ÞTamper Evidence Device Product #: Batch: A1C2E3G4I5 Expiry: S/N: 12345AZRQF

23 Common Basic Concept Point of Dispense Verification In line with expectations of Delegated Regulation

24 Pan-European architecture: The National Blueprint System approach National Blueprint System National System National Blueprint System National Blueprint System Pharmaceutical Manufacturer European Hub Parallel Distributor National National Blueprint System National System Pharmacy Wholesaler

25 Who will have to pay? Installations for pack coding and tamper evidence Installations for pack verification Repository system (Hub & national systems) Pharmaceutical Manufacturer European Hub Parallel Distributor Pharmacy Wholesaler Marketing Authorisation Holders Pharmacists, wholesalers, Marketing Authorisation Holders MAHs selling products in a Member State pay for respective national system and a share of the European Hub National system cost estimate

26 UK Stakeholders in distribution chain are obliged to build the UK verification system Healthcare Distribution Association (HDA UK) System set up and governed by stakeholders under supervision of national competent authorities

27 Value Partnership - Road Map 2016 Finalise UKMVO Business Plan (Funding, Articles, Selection Criteria) Consultation with Stakeholders Start IT System Build 2016 Q1 Q2 Q3 Q Stakeholder assent of Framework MoU Incorporation of UKMVO Finalise UK URS and Selection of IT Provider 2016 Key Milestones UK