With the Government aiming to increase innovation within the NHS, pharma has been tasked with helping to meet the challenge. Omar Ali, in his Matrix Revolutions series, focuses on the means to help the industry find the next big thing.  

With so many documents to read – white papers, NHS initiatives and DH directives – keeping tabs on the direction of travel of the NHS, as well as the pace of change, makes life difficult; and that’s not including the latest clinical trials, review publications and NICE guidance. In this issue of the Matrix Revolutions, I want to review one of the most important and potentially game changing documents to have
crossed my desk: Innovation, Health and Wealth.

The document comes under ‘improvement and efficiency’ from the DH and has an impressive circulation list. However, if the cascade didn’t get past those at directorship level, the average GP and healthcare professional may not have received what is a very important document. It also goes hand-in-hand with a story from NICE in February – Improving access to NICE-approved drugs – which provided the NHS with a best-practice guide on the implementation of local formularies in accordance with national guidance.

Innovation, Health and Wealth calls for all NHS organisations to come to ‘action’ by starting planning processes for the implementation of innovative new treatments approved by NICE.

“…while the NHS is recognised as a world leader in invention, the spread of those inventions within the NHS has often been too slow, and sometimes even the best of them fail to achieve widespread use”

I think we would all recognise this symptom of the NHS and list numerous examples. The UK is well known in being conservative with its adoption and prescribing of new drugs. But when NICE makes deep probing evaluations of new treatments it may be disturbing to find such variation in the implementation of best practice and subsequent availability of new medicines for patients.

It’s well known that when HTA agencies reject drugs the NHS is very good at implementing rapid ‘decommissioned’ formularies, which make general prescribing and availability very limited. However, when NICE does approve a new treatment, the variable uptake observed within the NHS as a whole has resulted in this new initiative.

“The challenge both for the NHS and for its industry partners is to pursue innovations that genuinely add value but not cost”

This is interesting how it adds up… I’m supposed to work with you to find innovations that don’t add cost… The problem with documents is rhetoric and direction. In reality, implementation will come down to precise and specific details. There are not many new drugs that ‘don’t add cost’ – they all add cost! The modelling comes in finding those that may offset some of the costs (QIPP).

“This report has been developed as part of the Prime Minister’s UK Strategy for Health Innovation and Life Sciences. The aim of this strategy is to ensure that the UK maintains and builds on its world leading position for life sciences, that the potential of life sciences to contribute to UK growth is realised, and that the UK remains and grows as an attractive location for investment now and in the future”

The flavour of the document paints a clear picture of investment from pharma which will potentially deteriorate within the UK due to poor uptake/diffusion by the NHS. The difficulty lays in that ‘uptake’ criteria for the NHS doesn’t have ‘investment’ as part of the decision process. For example, if a company invests millions into UK R&D and produces a poor, non-innovative and non-cost effective drug, should we put it on formulary due to the fact they have invested in the UK economy? If the answer is ‘yes’, we all need to change the paradigm and throw QIPP out of the window. I guess the alternative is how long can pharma keep resourcing UK investment and see no return? Not long in this climate. Surely then the answer is as seen above: the challenge of making new, innovative drugs cost effective.

Having helped bring NHS payers, CCG commissioners and pharma together, it brings some common ground on market access. I have found that with all of the details, some dedicated quality time with stakeholders and some flexibility from pharma, we can always find some manner of value-added to the product and/or a financial/value proposition that changes the paradigm. The truth is we don’t spend enough quality time talking together about the real issues. We tend to spend poorly co-ordinated NHS/pharma interactions looking at insane cost-models and budget impacts that are largely irrelevant. Add to that ABPI/compliance and internal concordance issues, and the NHS and pharma are often dancing around the tables instead of having decent commercial business discussions that pave the way to a healthier, wealthier future for both.

Potential barriers
“Poor access to evidence, data and metrics”

I have been impressed with some of the data informatics I have seen that actually represent data handling with a view to Secondary Uses Service (SUS) information, hospital episodes and prescribing by the CCG sector or a PCT. Here, pharma is beginning to excel themselves and it does have an influence on working together. This approach is far better than those companies who have a black-box approach to health economics.

“Insufficient recognition and celebration of innovation and innovators”

It’s hard for NHS innovators to ‘step out’ and stick their heads above the parapets when those around them are stuck in the same old ways. Far from recognition or reward, one can expect pushing uphill and against the grain. The only way to succeed here is to believe in the cause of innovation and true improvement. My feeling is those ‘beacons of light’ are beginning to shine in healthcare – and love it or hate it – one of the strengths of the Health Bill is bringing those leaders to the forefront through sheer necessity. My observation is that the pharma culture celebrates innovation from the core – it’s what you do and what you believe in. Being an optimist, I believe pharma has a role on the ground in bringing some of that innovation to ‘rub-off’ on your NHS customers.

“Financial levers do not reward innovators and can act as a disincentive to adoption and diffusion”

You may have read my previous Matrix Revolutions ‘case’ on Prolia (denosumab) – it had a NICE TAG but saw variable uptake, even a year after its recommendation. This case clearly outlined how micro-economics and financial levers can stall the introduction of new innovative therapies. But getting the tariffs to match, commissioning to fund and finding the code to unlock prescribing took a long time… why? Partly because our own informatics is poor – an example of the NHS barrier – and partly because dealing with payer issues doesn’t come first-hand to most brand teams.
Other financial levers that will inhibit uptake include:

• Enhanced LES & DES warfarin payments to GPs which will be a threatened source of income with new oral anticoagulants.
• QoF cholesterol targets of 5mmol/l in the face of innovative agents which may achieve lower cholesterol targets and reduced outcomes.
• QIPP Indicators aiming for a percentage of metformin and sulphonylurea when newer agents for type 2 diabetes reduce incidence of hypoglycaemic episodes and save money on blood glucose testing strips.

In the next issue of Matrix Revolutions, Omar Ali continues to review the DH’s modernisation plans and also focuses on what makes the diffusion of innovation happen. 

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He can be reached at omar.ali@sash.nhs.uk.

Together with its health reforms, the UK Government has developed a programme to accelerate the uptake of innovative therapies in the NHS that is not only ambitious but concrete and immediate. Thoreya Swage examines the new innovation agenda and what it offers to the pharma industry.

Although the main focus of Government health policy is reform, the development of new commissioning processes and structures and saving £20bn of annual NHS spend, the powers that be at the top at the NHS are still keen on accelerating the adoption of innovation in healthcare.

With that in mind a document, Innovation Health and Wealth, was published in December 2011 by the DH to speed up the process by establishing a set of measures to support change in the practice of healthcare and to identify a timetable for implementation. Unlike similar exhortations in the past to ‘speed up innovation’, this document has a sense of urgency, with a requirement to start immediately and build the actions set out in the report in the planning cycle for 2012–13.

The document recognises that by adopting innovation, the NHS can improve its own productivity – essential for achieving QIPP. It can also provide much-needed support to the life sciences industry at home and abroad through exporting new ideas and expertise, working in partnership with UK industry and generating new business for UK-based companies.

Of course, the ultimate outcome is to improve patient care.

What’s in store?

Innovation is defined in the document as “an idea, service or product, new to the NHS or applied in a way that is new to the NHS, which significantly improves the quality of health and care wherever it is applied”. The term covers a wide range of processes, technologies and uses of pharmaceutical products. The main thrust of the document is to ensure that change is disseminated throughout the NHS, and does not remain in isolated pockets in the more progressive parts of the healthcare system.

The listed barriers to the dissemination of new ideas are probably familiar to all in the pharma industry. They include:

• limited access to data and information

• lack of recognition of those who innovate

• inflexible financial levers that oppose change

• commissioners not having the tools or capability to drive innovation

• lack of consistent leadership to support change

• poor structure and processes to drive innovation.

The actions are highlighted to overcome these barriers are listed below.

1. Ensuring compliance with new ideas

In addition to introducing a value-based pricing structure for new medicines from 2014 – to ensure that patients can access effective treatments that reflect their value, the Government plans to set out in statutory form a NICE Compliance Regime that attaches funding to NICE Technology Appraisals in order to ensure rapid and consistent implementation throughout the NHS, so that patients receive the clinically and cost-effective technologies and medicines their doctors believe they need.

There will also be a requirement for all NICE Technology Appraisals to be added to relevant local NHS formularies, and a NICE Implementation Collaborative (NIC) will support timely implementation of NICE guidance. The NIC will be made up of the NHS Commissioning Board, NICE, the Chief Pharmaceutical Officer, the NHS Confederation, the Clinical Commissioning Coalition, the Royal Colleges and the life sciences industry. It will identify areas that require support and develop implementation guidance and solutions for the NHS, as well as helping pharma companies to improve their value propositions to NICE.

2. Improving information

There will be a single comprehensive web portal for innovation in the NHS, which, among other things, will ‘showcase’ and exchange ideas, and an ‘innovation scorecard’ to track compliance with NICE Technology Appraisals. Both of these will be available publicly.

The web portal will hold a database of case studies, implementation guides and tools, and e-learning programmes for clinical staff to support the introduction of new practice.

A later development will be the inclusion of the existing database of current clinical trials for drugs and medical technologies, which permits patients to participate in clinical studies. The aim will be to encourage more patients to get involved in research and so generate better data for new interventions.

Public awareness of innovations will be driven by consumer campaigns – developed by Which? – to promote effective new ideas in health.

A secure data linkage service will be set up by the Health and Social Care Information Centre by September 2012. ­ This will provide data extracts based on information generated by primary and secondary care and other sources, permitting an improved understanding of which interventions work best, when and why. A complementary secure data service, the Clinical Practice Research Datalink (CPRD) will be set up by the MHRA to support the needs of life science researchers.

3. Architecture for delivery of innovation

­This is a key action through which more robust relationships will be developed between academia, science and industry to develop solutions to healthcare problems and ensure the dissemination of ideas. A designated number of Academic Health Science Networks (AHSNs) will be established nationally, with the first to go live during 2012–13. Every NHS organisation will be affiliated to its local AHSN, which will act as a gateway for NHS professionals requiring help with innovation and provide industry with a point of access to the NHS. Details of the designation process will be published this spring.

The many existing organisations that have been set up to support innovation will be rationalised in a review of all DH/NHS-funded or sponsored bodies.

4. Incentivising innovation

­The funding structure of the NHS will be altered to allow savings yielded to be used for innovation, to prevent ‘silo budgeting’ and to permit cross-boundary working. Tariffs for healthcare will continue to be developed on the basis of outcomes, thereby promoting cost-effective approaches. At the local level, there will be opportunities to use existing tariffs flexibilities to improve care through the development of ‘Best Practice’ tariffs.

NICE will be responsible for stating which activities and tariffs should be decommissioned or reduced as a consequence of new and improved practice or medicines being introduced.

Achieving change will be slow – however, a few high-impact innovations are identified to kick-start this process. Most of these interventions are technologies, but the management of dementia in accordance with NICESCIE guidelines is highlighted.

From 2013, compliance with high impact innovations will be incorporated into the CQUIN requirements.

5. Procurement

Procurement processes will be smartened up, beginning with a procurement strategy that will be produced shortly to enable delivery of about £1.2bn of the £20bn savings required of the NHS. Among other priorities, there will be a focus on innovation and the emphasis will be on building partnerships with industry that deliver mutual value rather than just transactions.

6. Education and leadership

Innovation will be established as an integral part of clinical and managerial education, training programmes, continuous professional development and competency frameworks in the NHS.

A jointly funded industry and NHS training and education programme will be established to enable senior NHS managers and clinicians to work and train with their industry counterparts, together with a new industry and NHS CEO network.

An NHS Innovation Fellowship Scheme, drawing experts from different sectors including industry, will provide coaching and mentoring for senior NHS staff, conduct master classes and provide advice and support on innovation strategies.

An Innovation Pipeline Project to accelerate the adoption and dissemination of proven interventions will be established by the ABPI, the ABHI and the NHS Confederation. Between 15 and 20 joint working projects will be up and running by December 2013.

Chief executives of Clinical Commissioning Groups (CCGs) and the NHS Commissioning Board will be personally responsible for ensuring that research, innovation and adoption are taken up and are part of commissioning plans. This will be reinforced by a statutory duty on CCGs to seek out and adopt best practice.

What’s new for pharma?

Although much of the Innovation document is focused on medical technologies, there are a few key actions for the pharmaceutical industry.

A few more details are still required, but the action is starting now, with NHS commissioners prioritising the adoption and spread of innovation and good practice using the CQUIN mechanism of payment.

­The Government appears quite serious about forging closer links with the industry through joint training and joint working projects with the NHS, and this is a good a time as any to take the initiative.

At all levels pharma has an opportunity to engage with NHS colleagues to demonstrate how their products could streamline care and improve efficiency. The breaking down of budgetary barriers will make it easier to develop a business case, for example, for a particular medicine in primary care reducing the need for a service or intervention in secondary care.

For the first time, encouraging innovation will be put on a statutory footing for commissioners, and this will develop further as commissioning for outcomes becomes the norm. Another opportunity presents itself for the industry to put forward the argument that their products can improve outcomes, and to provide examples of excellence using the local best practice tariffs.

One greatly encouraging feature is the attention given to raising awareness of innovations among patients and the public. They can be the best advocates for the uptake of new interventions, and perhaps will be more willing to support research undertaken by the industry by getting involved in clinical trials.

This document provides the best direction so far on how the NHS and the pharmaceutical industry can work together for mutual benefit.

Dr Thoreya Swage was formerly an NHS clinician and a senior manager in various NHS organisations covering acute and primary care. She has expertise in commissioning health services and is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare.