The Government’s new strategy to support growth in the life sciences and innovation in healthcare aims to have industry working ‘hand-in-glove’ with the NHS to change care pathways and transform service delivery. Is this the new deal that the pharma industry has been waiting for – or just a sweetener for the medicine of NHS spending cuts?

The Government’s new strategy for the UK life sciences was presented by Prime Minister David Cameron to an audience of leaders from pharma and other life science sectors. Cameron announced measures to support early-stage research, make more NHS patient data available for clinical trials and improve the implementation of NICE guidance. He stated: “The endgame is for the NHS to be working hand-in-glove with industry as the fastest adopter of new ideas in the world.”

The background to the new strategy is complex. It builds on the ‘blueprint’ published in 2009 by the Office for Life Sciences, a ‘virtual department’ launched by the previous Government. The dissolution of the OLS and the abolition of the Regional Development Agencies had left a gap in the life science innovation landscape which the new strategy aims to fill.

In addition, the strategy is a response to calls from the Work Foundation and other expert sources for more investment in the ‘knowledge-based industries’ – and to a growing recognition of the clinical and commercial potential of ‘stratified medicine’: personalised drugs and companion diagnostics based on the new technology of genetic profiling.

Finally, the strategy seeks to improve the confidence of life science companies in the UK market at a time of upheaval and hardship. NHS spending will be subject to unprecedented constraints, and the envisaged growth of private healthcare will not rapidly counter the impact of this on the market for medical products. By promising a better commercial environment for life science companies in the UK, the Government hopes to stop the industry taking its business elsewhere.

From research to market
In December 2011, the Government published two closely related strategy documents: Strategy for UK Life Sciences and Innovation Health and Wealth: Accelerating adoption and diffusion in the NHS. The two documents came from different departments (the BIS and the DH respectively) and will be implemented through separate arrangements, but are two sides of the same coin.

The Strategy document speaks of the need to place the UK at the forefront of global medical R&D. Key measures announced include:

• In early 2012, MHRA will consult on proposals for a new Early Access Scheme to ease the route to market for ‘breakthrough therapies’.
• The Government will invest £180m in a new Biomedical Catalyst Fund to support early-stage research and a further £130m specifically to support R&D in stratified medicine.
• Pending consultation, the NHS constitution will be amended to allow companies conducting “approved research” to use anonymised NHS patient data, and to approach patients who may be eligible to participate in clinical trials.

The document notes that the UK life science industry (pharmaceuticals, biotechnology and medical technology) “is growing faster than the economy as a whole and is a key source of high-skill, high-tech jobs”. However, it comments that the time and cost of developing new treatments are increasing rapidly, and that the industry’s reliance on huge research establishments is not sustainable as products and their markets become more specialised.

Life science companies, the document promises, “will be able to operate in a streamlined regulatory framework, enabling quick entry to the market for new discoveries and innovations”. The Government will “nurture innovation through the translational funding gap,” and more generally will work to build “a life sciences ecosystem” that integrates the academic, industry and clinical sectors.  

Investments in clinical research infrastructure include the establishment of a new Cell Therapy Technology Innovation Centre in London; a new technical hub for bioinformatics in Cambridge; a number of academic health science networks across the country; and a national NIHR ‘Bioresource’ that builds on the existing facilities.

The £130m investment in stratified medicine by the Medical Research Council will consist of: £60m over three years to investigate disease mechanisms, particularly for chronic diseases; 60m over the next four years to support collaborations between academia, industry and clinicians to develop targeted treatments; and £10m to support work with AstraZeneca, who have made 22 compounds available to academic researchers.

The £180m Biomedical Catalyst Fund, invested by the MRC and the Technology Strategy Board, is intended to “nurture innovative technologies from the academic or commercial sector through to companies with products or technology platforms”. The document refers to the ‘open innovation’ model, whereby companies engage with partners in a wider R&D environment.

The Government will introduce a new Seed Enterprise Investment Scheme in 2012 offering 50% income tax relief on investments in small early-stage companies. In 2013, it will introduce an above the line R&D tax credit to attract large-scale investment in innovation.

The proposed new Early Access Scheme for ‘breakthrough’ drugs would typically be “available for drugs prior to authorisation but at the end of Phase III trials”, but could be extended to an earlier stage in some cases. The scheme would give patients access to drugs (and ensure reimbursement) where “there is a high unmet clinical need”, the likely benefits outweigh the known risks, the product is cost-effective for the NHS, and “the UK economy” will benefit.

In general, the measures outlined in the Strategy document shift the goalposts for the pharma industry only slightly, but could make a significant difference to some companies and R&D initiatives. They will promote the development of stratified and personalised medicine – and while the additional funding is very limited, the various measures could add up to a change in the innovation climate.

Changing patient pathways
The Strategy document argues that to facilitate innovation, the NHS needs to be “the ‘pull’ behind the industry ‘push’ for new therapeutic innovations”. The Innovation document expands on that statement, detailing measures to improve patient access to significant new therapies. It places more overt emphasis on medical devices than on drugs, but has major implications for the pharmaceutical sector.

The foreword by Sir David Nicholson, NHS Chief Executive, calls for a “commitment to innovation” in the NHS. He lists several opportunities open to the NHS to pioneer new treatments, including the “revolution in genome sequencing to monitor cancer and deliver personalised treatments; and to transform the detection, diagnosis and treatment of infectious diseases”.

The document states the economic case for innovation, both within healthcare (as a means of delivering care more cheaply and effectively) and in a wider context (by creating business growth and export opportunities). It emphasises the concept of the ‘value proposition’, whereby price is based on the value delivered by the product in use, including any changes it enables in the care pathway.

A number of priorities are identified for improving the climate for innovation in the NHS: reducing variation, compliance with NICE guidance, incentives, investment, procurement and adoption of ‘high impact innovations’. The document sums these up by saying: “We need an entirely new relationship with industry based on partnership, not just transactions.”

For the pharma industry, the most important changes outlined relate to NICE appraisals. The Government plans to:

• Introduce a NICE Compliance Regime to ensure rapid and consistent implementation of NICE guidance.
• Require that NICE technology appraisal recommendations are incorporated into relevant local NHS formularies in a planned way.
• Establish a NICE Implementation Collaborative, including industry representatives, to support prompt implementation of NICE guidance by helping NHS organisations to develop solutions and helping companies to optimise their value proposition to the NHS.

The Government will develop the tariff further in the direction of payment for outcomes. It will double its investment in the Small Business Research Initiative, and improve the protection of intellectual property. The NHS Confederation will work with the ABPI and the ABHI to establish an Innovation Pipeline Project that will drive “the adoption and diffusion of proven technologies in areas of high clinical need”. Finally, the new Clinical Commissioning Groups (CCGs) will have “a legal duty to promote innovation”.
The document concludes that having “a single model for driving transformation and change” will “avoid the problems of fragmentation and duplication that have previously beset the system”. Despite the impressive measures that precede it, this statement may give industry pause for thought. In an increasingly fragmented and diverse NHS, with Foundation Trusts competing for business and CCGs facing severe budgetary pressures, how can a single model for the adoption of innovation be either defined or enforced?

Deal or no deal?
Much of the Government’s life science strategy is aimed at emerging SMEs in the biotech and medtech sectors, rather than pharma companies (which tend to be larger and better-established). However, as drugs become more specialised and targeted, the dividing lines will blur – and what benefits a small biotech firm may benefit a pharmaceutical partner or parent company. Open innovation is the key to personalised medicine, and expertise is increasingly transferable between sectors.

The measures outlined in the Strategy document have less for the pharma industry than might at first appear, but the reverse is true of the Innovation document. In combination, they represent a significant initiative for the industry. There are opportunities for pharma companies in the stimulus offered to stratified medicine; in the emphasis on the value proposition and the patient pathway; in the prospect of early patient access to certain drugs; and in the more effective implementation of NICE guidance. The sharing of NHS clinical data with companies, which dominated press coverage of the new strategy, will also be of value.

What neither document explains is how the strategy will play out in a health system where private health providers play an increasingly major role, both in providing NHS care and in providing alternatives to what the funding-starved NHS can afford. A few days after launching the life science strategy, the Government passed legislation allowing NHS hospitals to allocate 49% of their beds to private patients. The new health providers may be crucial in determining whether the strategy is truly a new deal for industry or just a bribe.

Industry association Eucomed has proposed a new unified regulatory framework for medical devices across Europe.

The association’s position paper outlines six steps that will ensure patients have rapid access to innovative medical technologies that are value-based and safe.

Consistency, transparency and an integrated approach are the key themes identified by Eucomed as being in the shared interest of industry, healthcare providers and patients.

Eucomed’s position paper ‘A new EU regulatory framework for medical devices’ calls for enhanced member state engagement together with unified and science-based co-ordination of the regulatory system.

While prioritising delivery of high-quality healthcare, patient safety and rapid access to value-based medical technologies, the proposals also aim to encourage R&D and reduce the administrative burden on SMEs.

The association calls for a legal framework to provide a unified regulatory approach to the evaluation and certification of medical devices, with consistent and comprehensive implementation across all EU member states.

Existing bodies such as the European Commission, Competent Authorities and Notified Bodies can be used efficiently to provide a ‘smarter’ legal framework for medical devices, Eucomed says.

The six steps outlined are:

1. Only the best Notified Bodies – better control and monitoring of NBs are needed, including mandatory requirements for designation.

2. A single approach to vigilance and market surveillance – with a centralised reporting and surveillance system based on an EU portal.

3. Stronger harmonised standards – with greater engagement of international experts and earlier involvement of member states.

4. Consistent implementation of guidelines – to make medical device guidance more efficient and consistent across the EU, the current procedure must be revised (e.g. by commitment of member states to uniform implementation) and the European Commission’s current Medical Devices Expert Group (MDEG), which develops guidance, must be upgraded to a formal Advisory Committee.

5. Improved transparency – for better access to information for patients, consumers, healthcare professionals and manufacturers as well as regulatory and legislative bodies, it is critically important to establish a single EU database with information relating to such areas as market surveillance, vigilance and what products are available.

6. An integrated approach – better co-ordination and management, which could be supported by the Commission’s DG SANCO and Joint Research Centre (JRC). The JRC could play a crucial role in such areas as auditing Notified Bodies, co-ordinating vigilance, providing foresight intelligence on health issues, and giving scientific and policy advice to legislators.

John Brennan, Eucomed’s Director of Regulatory and Technical Affairs, commented: “By improving the regulatory framework for medical devices through the six solutions outlined in our position paper, we believe Europe will become stronger in many areas. We suggest many improvements that aid better management of the system by authorities and the Commission.

“In achieving this we think that the JRC is the natural partner for DG SANCO, member states and industry to shape and drive a smart EU medical technology legislative framework, as it is independent and experienced in the broad range of technologies that reflect the medical device industry.”

John Wilkinson (pictured), Chief Executive of Eucomed, has received a special Career award from the International Vascular and Endovascular Course (IVEC) in Milan.

The award recognises the medtech industry’s contribution to the development of vascular and endovascular surgery.

IVEC Chairman Giorgio Biasi presented the award to John Wilkinson to “honour the excellence of a distinguished scientist and eminent colleague who has contributed enormously in promoting, divulging and spreading culture, development and achievements in the field of vascular and endovascular techniques.”

Following the award presentation, Wilkinson gave the Edmondo Malan Lecture on ‘Development and Achievements in Endovascular Procedures as a Result of a Continuous and Ingenious Co-operation between Physicians and Industry’.

He discussed the long history of collaborative working between clinicians and industry over 200 years, with ideas from doctors and surgeons being developed by companies, culminating in such revolutionary devices as the drug-eluting stent.

Wilkinson also emphasised the need for innovation to be built on a platform of ethical interaction and transparency, and for industry to support education and training in the delivery of new therapies.

Finally, he drew attention to the demographic and economic challenges facing Europe’s health systems, and called for a collaborative approach between all stakeholders to support innovative solutions to these urgent problems.

Eucomed is the leading European medical technology industry association. It represents 4,500 designers, manufacturers and suppliers of medical technologies.

Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.

New funding for medical technology research by companies, clinicians and academics aims to promote innovative approaches to the prevention, diagnosis and treatment of diseases in the NHS.

The National Institute for Health Research (NIHR) Invention for Innovation (i4i) programme has allocated up to £13m for research projects, and has launched a call for proposals.

The NIHR i4i programme funds projects through prototype and commercial development until a technology is ready for clinical testing, bringing together academic or clinical researchers and technical experts from industry.

The programme has been updated in two ways:

• Research projects in Wales, as well as in England, are now eligible for i4i.
• Instead of being divided between early- and late-stage product development awards, applications will all be submitted through a single route.

As well as looking for technologies that will benefit NHS patients, the NIHR i4i programme supports collaboration between researchers in industry, the NHS and the academic field. Each approved proposal will bring together researchers from at least two of these sectors.

NIHR particularly welcomes proposals from SMEs and from teams that have previously succeeded in developing and commercialising new technologies.

Martin Hunt, NIHR i4i Programme Director, said: “In the present economic climate, it is becoming increasingly difficult for medtech companies to secure funding for new, innovative technologies. The NIHR i4i programme provides a valuable funding opportunity for the medtech sector.”

This year’s i4i funding covers a “much broader” range of projects than last year’s, he noted. “The amount of funding awarded is determined by the nature and scale of the proposed research activity and we are considering projects seeking larger funding amounts than before.”

Outline research proposals must be submitted by 5pm on Wednesday 7 December 2011. Further details are available at www.i4i.nihr.ac.uk.

The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.

The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.

Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”

He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.

Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.

Xience Prime received CE Mark Approval in 2009.

Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.

The FDA has approved Abbott Molecular’s genetic diagnostic, Vysis EGR1 FISH Probe Kit, to detect acute myeloid leukaemia (AML).

The new in vitro test is the third of Abbott’s FISH assays to be cleared for oncology applications in the US in the past two months.

Stafford O'Kelly, Head of Abbott's Molecular Diagnostics Business said that the medical technology “can identify which AML patients have the chromosomal abnormality upon diagnosis and provides physicians with another clinically validated tool to assess a patient's overall prognosis”.

The Kit’s technology detects chromosomal deletion in the bone marrow, and can be used in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of AML diagnosis to determine prognosis.

Each year, more than 12,000 people are diagnosed with AML, which is a rapidly progressive disease. Current standard procedure involves aggressive chemotherapy drugs, while some patients may require a stem-cell transplant to replace unhealthy bone marrow with leukaemia-free stem cells.  

Part of Abbott, Abbott Molecular is a leader in molecular diagnostics, analysing DNA and RNA at the molecular level. Abbott Molecular's tests aim for earlier detection or diagnosis, to provide information of appropriate treatment, and improve monitoring of disease progression.

Abbott is a global healthcare company, which discovers, develops, manufactures and markets pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and commercialises its products in more than 130 countries worldwide.

A new fluorescent imaging agent to assist detection of papillary cancer of the bladder has been adopted by Thomas Jefferson University Hospital in the USA.

Cysview (known in Europe as Hexvix) is licensed by GE Healthcare from Norwegian company Photocure ASA.

Used with patients who are known or suspected to have bladder cancer, it guides blue light fluorescence cytoscopy (pictured), which highlights cancerous lesions in the bladder.

The use of Cysview for cytoscopy has been shown to improve surgical outcomes relative to standard white light cytoscopy alone.

Bladder cancer, most commonly caused by smoking, is the fourth most common type of cancer in men and the eighth most common in women.

“Bladder cancer is difficult to detect,” said Dr Leonard Gomella, Associate Director for Clinical Affairs at the Kimmel Cancer Center at Thomas Jefferson University Hospital. “A missed diagnosis can result in delayed or incomplete treatment, which may lead to serious complications and a lower chance of survival.

“Cysview represents an important advance in diagnostic technology, enabling more accurate diagnosis of bladder tumours compared to the standard technique. By facilitating early diagnosis of bladder cancer, this innovative imaging agent can enable appropriate, timely treatment that may improve patients’ chances of survival.”

A new study of 350,000 mobile phone users has found no link between mobile use and incidence of brain cancer.

The Danish study, which follows months of argument over the possible risks of wireless communication devices, does not include people who use mobile phones in their work.

The National Radiological Protection Board (NRPB) in the UK has said the study “lacks statistical precision” and is not conclusive, though Cancer Research UK has noted that it provides “the strongest evidence yet” for the safety of mobile phones.

Mobile healthcare or mHealth is one of the fastest-growing areas of medical technology, and experts such as health consultant David Lee Scher have recognised its potential to enable ‘participatory medicine’.

Led by the Institute of Cancer Epidemiology in Denmark, the new study looked at 350,000 mobile phone users over 18 years. It found no increased incidence of gliomas and other brain cancers.

The researchers said their study could not rule out potential risks to children and to people whose work includes heavy mobile phone usage.

Hazel Nunn, Head of Evidence and Health Information at Cancer Research UK, said the Danish study provided “the strongest evidence yet that using a mobile phone does not seem to increase the risk of cancers of the brain in adults.”

However, the NRPB, which advises the government on radiation safety, said the study was not large enough to be conclusive.

Two specialists interviewed in a recent Panorama programme said their own studies indicated cause for concern. Dr Lennart Hardell (Sweden) reported finding a strong correlation between location of brain tumours and the side of the head used for mobile phone calls. Dr George Carlo (USA) said his study indicated an increased risk of a rare type of brain cancer.

Dr Carlo commented: “This is not black and white... we have moved now into a grey area that needs to be looked into very, very carefully.”

In May 2011, a Council of Europe committee declared mobile phone usage to be “potentially harmful” and called on governments to “take all reasonable measures” to reduce their use, particularly in schools.

Shortly afterwards, the World Health Organisation included mobile phones in the same “possibly carcinogenic” category as lead and car exhaust fumes, and called for further research. The Danish study is a major step in that process.

NICE has appointed a new external assessment centre to support its Medical Technologies Evaluation Programme.

The new assessment centre, developed by Newcastle upon Tyne Hospitals NHS Foundation Trust Medical Physics Department in partnership with York Health Economics Consortium, will provide independent assessment of the clinical and health economic evidence for medical technologies.

It will also develop and facilitate independent research to assist suppliers when NICE guidance recommends that further research should be carried out on a medical device or diagnostic.

The new assessment centres were selected for their knowledge and expertise in the evaluation of medical technologies.

To date, one more external assessment centre, CEDAR – part of Cardiff and Vale University Local Health Board – has been commissioned.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said: “We’re delighted to welcome the new joint external assessment centre based at Newcastle and York. Their input to the production of NICE medical technology guidance will be essential, providing independent assessment of the evidence available for devices going through the NICE evaluation process.

“Where the relevant NICE advisory committee identifies that a technology has considerable potential but insufficient evidence to support widespread adoption across the NHS, it may make recommendations for further research. In such cases, the external assessment centre will play a key role in facilitating the development of further relevant evidence.

“We look forward to working with the centre, and benefitting from their combined technical and economics expertise in supporting the development of robust guidance for the NHS.”

Established by NICE in 2009, the Medical Technologies Evaluation Programme is focused specifically on innovative medical technologies. Seven NICE medical technology guidance documents have been published to date.