QIPP is trumping NICE as the driver of local prescribing decisions, with price ranked above value, the parliamentary Health Select Committee has been told.

Witnesses representing healthcare providers, patients and the pharmaceutical industry told the MPs that local commissioners are still restricting patient access to NICE-recommended treatments.

The ‘grey area’ between two conflicting agendas, cost-cutting and innovation, was highlighted as a cause of confusion among decision-makers.

Laura Weir, chairwoman of the patient coalition group Patients Involved in NICE, noted that despite patients’ legal right to receive drugs approved by NICE, the implementation of guidance was often blocked or delayed at local level.

“Currently there is no scrutiny or monitoring of NICE approved medicines, and there’s no one body that is responsible,” she said, arguing that the Care Quality Commission (perhaps together with Monitor) could help the NHS Commissioning Board to monitor that aspect of CCG work.

Stephen Whitehead (pictured), ABPI Chief Executive, pointed to the conflict of priorities: “Although often there will be medicines that go on the formulary, there is often not the freedom of the healthcare professional to prescribe the most appropriate medicine for that patient.

“This has been explicitly recognised by government through the publication of Innovation, Health and Wealth, which says the uptake of NICE medicines is a problem in the UK.”

Linda Patterson, Clinical Vice President of the Royal College of Physicians, highlighted the key issue: “There is an issue about implementation, which is partly about practice and the clinical decision maker implementing the guidance or not.

“On wider implementation, that is a debate about how we encourage good practice to be implemented across the country without variation. At the moment, there is a rather grey area as to who is responsible.”

The new NHS Mandate, presented to Parliament by Health Secretary Jeremy Hunt, has replaced the draft version’s outcome targets with requirements for “measurable progress”.

The final Mandate, which establishes the strategic objectives for the NHS Commissioning Board (NHS CB), maintains the broad goals of the draft version but is lighter on specific commitments.

Positive responses from the NHS CB and the BMA suggest that criticisms of the draft version as being over-prescriptive have been addressed.

Significant changes include the loss of definite overarching commitments to reduce premature death and increase quality of life for the chronically ill.

More generally, where quantitative outcome targets were set with the numbers pending consultation, there is now only a requirement to improve.

The Mandate states that improvements should be measurable by March 2015, the end of the Board’s first term of office.

As before, it notes the duty of the Board and the DH to promote “the autonomy of local clinical commissioners”, and identifies this is the means by which outcomes will be improved.

Key priorities for improvement include: standards of treatment for older patients; diagnosis, treatment and care of people with dementia; support for people with multiple physical and mental long-term conditions; and preventing premature deaths from major diseases.

The section on premature deaths notes the importance of “tackling risk factors such as high blood pressure and cholesterol”, as well as ensuring that patients have access to NICE-approved drugs.

The section on long-term conditions places emphasis on integration of care and on patient choice. Personalised care plans and personal health budgets are promised, as well as online access for patients to their care records and the means to book appointments and repeat prescriptions.

Dementia is highlighted as a priority, with progress towards “timely diagnosis and the best available treatment” set as an objective. A further aim is “to put mental health on a par with physical health” and address poor access to healthcare among the mentally ill.

A section on innovation repeats the previous commitment to introducing the controversial “quality premium” for GPs, as well as establishing a “fair playing field” for competing providers from all sectors.

The Mandate stresses the need for “redesigning services, open procurement and contracting for outcomes” – which reaffirms the Government’s commitment to the NHS innovation agenda as well as the role of the private sector.

Sir David Nicholson, Chief Executive of the NHS CB, commented: “The Mandate avoids the danger of excessively prescribing the actions of health professionals. Our role will be to work closely with local clinical leaders and provide the support they need. Our role is not to tell them what to do.”

Dr Mark Porter, Chair of BMA Council, praised the “welcome reduction in targets, objectives and micromanaging” from the draft Mandate, but noted: “If the NHSCB’s strategic vision is to be delivered, ministers must ensure there is genuine clinical involvement and adequate resourcing.”

Commenting on the Government’s innovation agenda, ABPI Chief Executive Stephen Whitehead said: “The NHS Mandate must work hand-in-hand with Innovation, Health and Wealth to help break down barriers to innovation in the NHS and to ensure that new medicines reach patients.”

Incivo, Victrelis and Mepact win recognition at the 2012 UK Prix Galien Awards.

Two new medicines for the treatment of Hepatitis C have won the 2012 UK Prix Galien Innovative Product
Award. Incivo (Janssen) and Victrelis (MSD) fought of stiff competition to win the prestigious prize at London’s House of Commons. The chairman of the judging panel, Professor Sir Michael Rawlins, said the treatments provided a perfect example of how the pharmaceutical industry can “demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world.”

The ceremony also saw Takeda become only the third winners of a Prix Galien Award for orphan drug development. Mepact – for the treatment of osteosarcoma, a rare malignant bone tumour – won the Orphan Drug Award.

UK Prix Galien 2012
The UK Prix Galien, organised and managed by the specialist market access consultancy WG Consulting – which owns the UK franchise – is held every two years. The 2012 awards were hosted by former shadow Minister for Health Kevin Barron MP, who was the event’s Parliamentary Sponsor. Barron, who is currently co-Chair of the Associate Parliamentary Health Group, said: “It’s a privilege to be able to witness, at first hand, just a glimpse of the deep volumes of medical innovations being developed here in the UK. As an MP, I’ve had a long-standing professional acquaintance with UK pharma. I know and recognise the many
benefits UK medicines have brought – and continue to bring – to patients all over the world. The sector’s continued commitment to the development of medicines to tackle disease, improve health outcomes and extend life is both remarkable and humbling.”

Barron said there was political consensus that driving improvements in health outcomes across all major diseases is a key priority for the NHS – and this focus had been reflected in the 2012 finalists. “It’s interesting to note that the shortlisted entrants for the 2012 UK Prix Galien show that pharmaceutical innovation is aligned with many of the priority needs identified in the NHS Outcomes Framework. Finalists include innovations for the treatment of diseases in cardiovascular, hepatology, mental health, neurology, gastroenterology and oncology. In addition, Prix Galien’s recognition of the industry’s attempts to treat rare, orphan diseases, once again underlines the very human value of R&D.”

Value-based message
The architect of the NHS Outcomes Framework, former Health Secretary Andrew Lansley, also addressed the audience. Attending his fourth consecutive UK Prix Galien, Lansley said: “Every time I come to this event I hear about fascinating innovations that I know are going to be at the heart of the health service for years to come. I’ve met – and continue to meet – patients that have benefited directly from innovations that I’ve previously heard about at Prix Galien. The HPV vaccination programme we have been able to roll out is just one example of that. So it’s a privilege to be here.”

Lansley said that recognising and rewarding innovation is a key Government priority – and that the publication of Innovation Health and Wealth last December was part of a consistent value-based message
it wanted to send to the NHS. “That message is that as you, the pharmaceutical industry, bring forward new treatments that will clearly add value and improve the quality of healthcare for patients then the NHS should be at the forefront, internationally, of demonstrating that value. Our health service can be an exemplar and inspiration to people around the world because of its capacity to demonstrate the effectiveness of new treatments when they are used within the NHS.”

Lansley praised the UK pharma industry, highlighting the value its innovations bring both to the economy and to patients worldwide. “What you are doing is part of how this country will pay its way in the future,” he said. “And it has the added value of knowing that, in the process, we can give patients in this country access to the very best healthcare anywhere in the world.”

The recognition of innovation that can lead to improved health outcomes is a core aim of Prix Galien, as outlined by Professor Sir Michael Rawlins, who announced the winners. “Prix Galien is about honouring excellence in pharmaceutical research and development,” said Professor Sir Michael. “It is about recognising the contribution that new medicines can make to the lives of people with life-threatening conditions. It is about celebrating the achievements of all those individuals – working as teams – upon whom we rely for the discovery and development of new medicines. Most will be unknown to us – but we all owe them a huge debt of gratitude.”

Innovative Product Award
The prestigious Prix Galien medal for innovation was jointly awarded to Janssen and MSD for their respective hepatitis C treatments Incivo and Victrelis. In the UK, it is estimated that there are between 200,000 and 400,000 people chronically infected with hepatitis C virus. This may lead to liver cancer as well as other serious liver diseases. Infection with the hepatitis C virus poses a substantial global health burden, and is responsible for 40% of all cases of end-stage cirrhosis, 60% of hepatocellular carcinoma and 30% of liver transplants.

Professor Sir Michael Rawlins said: “Hepatitis C virus has become an enormous area of need globally, with many patients unaware that they are infected. The consequences of this virus are considerable and burdensome to both patients and the healthcare system; current treatments remain ineffective in a significant number of cases whilst being unpleasant and poorly tolerated by patients themselves.

“Hepatitis C infection is a perfect example of where the pharmaceutical industry can demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world. It is for this reason that the panel felt that both Janssen and MSD should be celebrated and congratulated for their part in addressing the ongoing challenge in managing HCV and its associated complications.”

Brilique (AZ) and Resolor (Shire) both received commendations. Gilenya (Novartis), Xarelto (Bayer), Xeplion (Janssen), Xgeva (Amgen), Yervoy (Bristol-Myers Squibb), Zelboraf (Roche) and Zytiga (Janssen) were all shortlisted.

Orphan Drug Award
The Orphan Drug Award was introduced as a dedicated category at 2008 UK Prix Galien. There had previously been a special award for orphan products in 2006. The term ‘orphan condition’ is used to describe conditions that affect a very small number of patients in a given population – many of which are either untreatable or treated very inadequately. It is estimated that there are 6,000 orphan diseases – which, in total, affect about 30 million EU citizens.

“For orphan diseases that are potentially treatable with medicines, pharmaceutical manufacturers face a number of hurdles – including concerns about the size of the market and difficulties because of the small numbers of patients – in their development,” said Professor Sir Michael.

The 2012 Orphan Drug Award was won by Mepact from Takeda. Mepact (mifamurtide) is for the treatment of osteosarcoma, a rare malignant bone tumour – mainly of children and adolescents – that affects fewer than 1 per 10,000 individuals in the EU. This is equivalent to 150 children and young adults each year in the UK. Tumours most frequently occur in the long bones and are highly aggressive with a propensity to metastasise, particularly to the lung. If left untreated, the primary tumour will undergo local and systemic progression, leading to death within months.

“To investigate the role of this immune modulator in osteosarcoma required extensive and complex trial design with careful implementation of the study programme,” said Professor Sir Michael. “Apart from its novel mechanism of action – and clear evidence of its clinical effectiveness – the jury were also extremely impressed that such an advance in the management of osteosarcoma represents the first significant change in outcomes in 10–20 years of managing this disease. That Takeda managed to undertake the clinical development of this product – in such a niche indication – is hugely to their credit.”

Stephen Whitehead outlines the ABPI’s latest initiatives to facilitate collaboration – and how sales professionals have a key part to play .

This year the ABPI is launching a Regional Partnership team to help the industry establish and develop sustainable relationships with the NHS at a regional level. The team, deploying experienced industry professionals in each of the four regional SHA clusters, aims to promote and facilitate collaborative working as a means to improve patient outcomes. Its key objectives are to identify and remove existing barriers to accessing innovative medicines, to help develop regional partnership projects and to share best practice across the country. The initiative reflects the growing recognition that improving patient health in a constrained financial environment will be best achieved by adopting a more collaborative approach. And there is an increasing consensus across both parties that, after years of developing adversarial relationships, the direction of travel towards NHS/industry partnerships is the right one for patient care.

But progress is an incremental process. The perceived cultural barriers that have historically plagued the relationship and impacted access will not be overcome overnight. “Trust and reputation has widely been acknowledged as an issue for industry – but it’s getting better,” says Stephen Whitehead, CEO at the ABPI. “In fact, it has dramatically improved. You can 12 see that from the Innovation, Health & Wealth (IHW) review: the NHS really wants to partner with pharma. In turn, as an industry we know that we are operating within restricted NHS budgets, and that we need to make it clear that we are not always there to sell something. Joint working is not about developing something that can help companies achieve a sales target on a quarterly basis, it’s about establishing a new way of working that will redefine the relationship between us and the customer. That will take time.”

In an evolutionary process, the ABPI appears determined to take the lead – to trail-blaze the concept of partnership working from a top-line strategic position and help ease the concerns of more anxious NHS customers. “The driving platform for joint working from the side of the industry should be the ABPI,” says Stephen. “We established the joint working protocol with the DH, and have developed the code of practice and regulatory infrastructure to enable it to happen. We’ve therefore created the headroom to allow partnerships to be established. Most parts of the NHS have understood and grasped this. It’s now up to us to lead, and for companies to take the opportunities within that.”

IMPROVING ACCESS

With access to NHS customers a perennial problem for UK pharma, the battle to develop the joint working agenda is a challenging one for individual companies. Medical sales professionals are tasked with advancing discussions, but attempts are often stymied due to diminishing levels of customer access. The ABPI believes its NHS Partnerships initiative will play a major part in raising awareness of partnership working, and overcoming access issues on an industry-wide basis. “NHS Partnerships will help industry
engage with key NHS stakeholders in England and ensure partnership conversations happen at a regional level. It’s not about individual products – we will not be talking about those – but we will be a facilitator of dialogue around joint working, aligned with the partnership principles set out by David Nicholson. We will be looking closely at the national issues on uptake and access, and any policy that emerges around that – and reinforcing it locally. Critically, NHS Partnerships isn’t the creation of ‘talking shops’, it’s about being able to facilitate on the key issues – which are fundamentally about access and uptake of innovation.”

NHS Partnerships has already been welcomed by the Department of Health, whose Director of Innovation & Service Improvement, Miles Ayling, said: “The ABPI partnership team will help build stronger links between industry and the NHS, as described in IHW. Beyond medicines, we are also looking at how all concerned can share skills, expertise and knowledge to improve the health of UK patients and help transform lives.”

REPUTATION

The long-standing issue of industry mistrust does, at long last, seem to be fading within the NHS. This was reflected in the ABPI’s seat at the top table of discussions around IHW last year, and has been reinforced by Stephen Whitehead’s involvement on the IHW Implementation Board. In addition to the partnerships initiative, the ABPI (along with ABHI) has also established a series of pilot projects with the NHS Confederation to look at how joint working can make a difference in selected disease areas. Pilots are already underway in mental health, circulatory diseases, diabetes and long-term conditions. “This is about providing examples of best practice within the NHS so customers can understand what we mean and establish that there is nothing for them to be worried about,” says Stephen.

“We have a strong status, but we’ve not yet fully utilised it in the context of joint working capability. That’s what these initiatives have been set up to do. This is a whole new world and a very exciting one – ten years ago we could never have had these relationships. But now that we are here, we need to approach customers gently and appropriately, and work with the NHS collaboratively and co-operatively to ensure that we dispel any of those old misunderstandings.”

And so, in the new environment, what role will sales professionals and Key Account Management play in NHS engagement? “The role of sales is evolving quite rapidly,” says Stephen. “Sales engagement is increasingly about liaison, as well as detailing around a product. It’s about facilitating collaborative working – and the salesforce has a key role to play in this.”

Selling medicines in today’s marketplace should be built on partnership principles. ABPI CEO Stephen Whitehead talks exclusively to Pharmaceutical Field about the importance of NHS/industry partnerships.

Back in 2009, Chris Brinsmead – then President of the ABPI – told Pharmaceutical Field that the future role of the pharma field force would be to facilitate partnerships between the NHS and industry. Three years later and the partnership agenda is slowly inching forward. Progress has been made, but adoption of a more collaborative approach across the country has been variable. As ever, there are early adopters, and those that wait. Last month, Pf led with an ABPI announcement that predicted the NHS and industry would ‘become partners within 3-5 years’. Why not now, came the familiar cry? Why not, indeed. The ABPI seems determined to address this.

This month, Pf spoke exclusively to Stephen Whitehead as he approached the first anniversary of his tenure as CEO at the ABPI. It is clear that, in challenging times for the UK industry as it battles to ensure that patients gain access to life-changing medical innovations, partnership sits at the heart of the ABPI agenda.

“There is a currently a big commitment to move the joint working agenda forward,” says Stephen. “Strategically, over the past 15 years there has been the emergence of many different influences on prescribing – NICE, local commissioning and local formularies are obvious examples. The industry now has to work with a wide variety of stakeholders to demonstrate the value of its medicines. And traditional sales representatives have to work with many different and more complex audiences than they used to when they were purely detailing. Increasingly, I think joint working is the vehicle best suited to satisfy these varying demands.”

Innovation Health and Wealth
The environment for a more collaborative approach is certainly improving. The Innovation Health and Wealth review last December reiterated the need for greater partnership working to help accelerate the adoption and diffusion of innovation in the UK. Crucially, it said that the NHS needed to be ‘open for business’ on partnership. As such, advocates from both parties are working hard to raise the profile (and the benefits) of the approach. But resistance and misunderstandings around joint working remain.

“One of the problems is that there are variable definitions and understandings of what joint working is,” says Stephen. “In simple terms, joint working is a partnership approach focused on solving a patient-driven issue. The industry has disease expertise, it knows how to manage conditions and has developed medicines in those areas. Joint working is about bringing that expertise together with the providers and focusing on patient outcomes. And often we can find cost savings in delivering those outcomes as well.”

Importantly, says Stephen, joint working is not sponsorship. “This is not about industry paying for something. Historically we have funded a lot of things and sometimes there is a real benefit to us bringing money to the table. But this is about changing that perception. Partnership is where two parties, with different strengths and weaknesses, come together to focus on a shared goal. In this case, that has to be patient care.

“The fundamental issue is about recognising the value of innovation and its implications for a pathway of care. By working together to find out how these medicines can be used appropriately, we can save money in the system, we can prevent unnecessary and costly hospitalisation and we can improve patient care.”

Medicines in the middle
In recent years, discussion has focused on whether UK pharma companies should reconsider their product-centric approach to customer engagement, and concentrate instead on developing services with the NHS. The caveat being that a specific medicine would form the core part of any service. But joint working is not an exact science. There is no one-size-fits-all solution – it’s simply about working together to establish the most appropriate approach in a given disease area. “It’s about products and services,” says Stephen. “Some of our members do offer services. But the way I look at joint working is that there is always a medicine in the middle of it – because that’s what we discover, develop and sell. In today’s environment, the only way that the value of that medicine can be truly realised is through joint working that reengineers the pathway of care.”

At present, most joint working initiatives are being built around new innovations – and are being used to redesign services and improve the care pathway. A good example of this is in the field of anticoagulants, where a number of new brands are coming to market. “The new class of drugs have gone through NICE have been recommended and should therefore be utilised,” says Stephen. “Old warfarin clinics should now be closing as patients move onto the new drugs. But to achieve that, and to free up the funds to be able to use the new innovations, we need to take other measures. And you can only do that, in my view, through joint working.

“It is my passionate belief that in most cases, innovative medicines will save money in the system – in the short, medium and long term. We simply need to work together to deliver it.”

Implications for pharma sales
The implications for pharmaceutical sales professionals are significant. While joint working is not always appropriate – aspects such as disease area or where a particular product is along its lifecycle are key factors in whether the approach is applicable – adopting a partnership approach most certainly is. “Joint working is a natural evolution of partnership principles,” says Stephen. “Industry engagement has changed from being a simple seller/buyer transaction, into seeking to work in partnership with customers to ensure the NHS properly maximises the value of medicines. The UK has a low price and a slow uptake of medicine – and as a consequence, the UK system is not as efficient as it could be. It would be more efficient if it adopted innovation more quickly. And if it did, we would certainly have better patient outcomes.

“Joint working is best used when you want to coax the system into innovation. It is not always the most appropriate approach. But whatever you have in your medicine chest, partnership is always applicable. In today’s marketplace, how you approach selling that medicine should always be built upon partnership principles.”

New innovations from ten of the world’s leading drug companies will compete for the most prestigious distinction in pharmaceutical research later this year – a globally revered Prix Galien medal.

Twelve medicines have made the shortlist for the final of UK Prix Galien, which will return to the House of Commons this coming September.

The shortlist reflects the strength and diversity of pharmaceutical innovation, with treatments for a broad range of disease areas set to be assessed by Prix Galien’s esteemed judging panel – led by NICE Chairman Professor Sir Michael Rawlins. Medicines developed to treat schizophrenia, hepatitis C, MS, DVT, constipation, coronary disease and a variety of cancers will battle it out for the Innovative Drug Award. A treatment for the rare bone cancer in adolescents, osteosarcoma, will be considered for the Orphan Drug Award. All shortlisted products were launched or granted a new indication in the UK between 1 January 2010 and March 31 2012.

The 2012 ceremony comes at a time when the value of medical innovation finds itself under great scrutiny in the UK. The Innovation Health and Wealth Review, published at the end of 2011, outlined the growing need to accelerate the adoption and diffusion of innovation in the NHS – setting out a blueprint designed to ensure innovations that can improve health outcomes actually reach their target patients.

“The challenge for the UK pharmaceutical industry is to demonstrate that its medicines truly add value, and can help the NHS meet its quality and productivity goals. The ethos of Prix Galien is very much aligned with the aspirations of both QIPP and Innovation Health and Wealth. It provides the perfect platform for the UK industry to promote its position as world leaders in pharmaceutical research and development,” says Karen Westaway, Joint Chief Executive at WG Consulting, which has owned the UK Prix Galien franchise for eight years and managed the process since 1996.

UK Prix Galien takes place every two years and is judged by a highly respected panel of influential, eminent and experienced NHS professionals. Alongside Professor Sir Michael Rawlins, the judging team includes experts such as Professor Dame Carol Black, Professor Parveen Kumar, Professor Gordon Duff and the current National Cancer Director, Professor Sir Michael Richards.

“The judges are all high-achieving, influential stakeholders who have shaped, and are still shaping, healthcare,” says Karen Westaway. “Their continued commitment to Prix Galien is itself an endorsement of the process.”

UK Prix Galien 2012

The 2012 ceremony will take place on Wednesday 26 September at the House of Commons, London. The Rt. Hon. Kevin Barron, MP, a former shadow health minister and chair of several all-party parliamentary groups including those relating to the pharmaceutical industry and health, takes over from Lord Walton of Detchant as the Parliamentary Sponsor. Current Secretary of State for Health, Andrew Lansley, is a long-standing supporter of UK Prix Galien and was the Parliamentary Sponsor for many years. The Health Secretary presented the most recent UK Prix Galien awards in 2010, describing them as a ‘fascinating occasion’ that allows people to acknowledge ‘the volume of innovation and new medicines that have been coming through.’

The 2010 Prix Galien medal for innovation was won by Xarelto (rivaroxaban), Bayer Healthcare’s revolutionary treatment for the prevention of venous thromboemolism (VTE). Shire Pharmaceuticals’ Firazyr (icatibant), a treatment for hereditary angioedema, won the Orphan Drug Award.

Prix Galien around the world

Prix Galien is internationally renowned, with a further ten national franchises conducting ceremonies around the globe, as well as an International Prix Galien every two years. The award has been described as ‘the highest distinction which may honour a pharmaceutical product’, and ‘a prestigious testimony and acknowledgement of the vitality of our pharmaceutical research.’ In 2008, US President Barack Obama said: “The Prix Galien is a welcome initiative to stimulate creative research and promote excellence.”

For more information about UK Prix Galien, please visit www.prixgalien.co.uk

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.

The ABPI and the NHS Confederation are to partner with Communiqué to share best practice in healthcare communications.

The new Communiqué Awards workshops will share experience and expertise for the benefit of industry and the NHS.

The agreement reflects recent steps by both organisations to develop closer industry-NHS partnership in order to promote the uptake of innovative therapies.

At its recent conference, the ABPI launched a new team to promote regional collaboration with the NHS through the sharing of best practice.

The NHS Confederation has since appointed Sir Keith Pearson as Chair of Health Education England, which will lead healthcare education and training from June 2012.

The new initiative takes its lead from the DH report Innovation Health and Wealth: Accelerating Adoption and Diffusion in the NHS, which said: “We need to get the brightest and best innovators to share their knowledge, learning and expertise with the NHS.”

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.

This month’s Pharmaceutical Field looks at some of the major issues affecting UK pharma at present; the evolution of its customer-base, an increased focus on compliance, the developing training needs of medical sales professionals and pharma companies’ ongoing challenge to attract and, crucially, retain talent.

The DH’s Innovation Health and Wealth document, published at the tail end of 2011, seeks to address the most significant challenge for UK healthcare – accelerating the adoption of innovation within the NHS. There is much that pharma can do to help enable innovative medicines reach patients more quickly.

Regulatory compliance remains a key priority for pharma as recent and impending global legislation puts pharma’s engagement with customers under increased scrutiny. In the process, the changing legislative landscape is having a significant impact on the training needs of medical sales professionals in the UK. This, in turn, is having a domino-effect on the pharmaceutical employment market, where a notable ‘skills gap’ is having a huge impact on recruitment and the quality of applicants for commercial roles.

Faced with an apparent dearth of quality candidates for sales positions, companies are needing to work hard to create the best working environment to retain their most talented employees. Pf’s annual attitudinal survey of the UK sales force reveals that, in some parts of the industry, there remains much to be done to ensure that the company culture advertised in the corporate brochure matches that experienced by employees in the workplace.