Bristol-Myers Squibb (BMS) has entered into a broad framework agreement with Dako on the development of pharmacodiagnostic tests.

The agreement, which builds on a collaboration begun in 2008, aims to develop diagnostics to identify patients more likely to benefit from treatment with BMS investigational drug candidates.

Pharmacodiagnostics (or companion diagnostics) are an important feature of the growing personalised medicine approach, which can improve outcomes and reduce healthcare costs by identifying individuals who are more likely to benefit from specific therapies.

Dako, a global leader in tissue-based diagnostics, has a history of developing clinical diagnostics in collaboration with pharmaceutical companies that are used in conjunction with drugs.

“It is a great pleasure for me to announce Dako’s new collaboration with Bristol-Myers Squibb,” said Lars Holmkvist, CEO of Dako. “This alliance heralds the intentions of both companies to work closely together to develop new diagnostic tests linked to drugs for the higher purpose of identifying the patients most likely to respond to treatment.”

“It is part of Dako’s long-term strategy to collaborate with pharma companies on the development of companion diagnostic tests.”

Based in Denmark, Dako produces reagents, instruments and software used by hospitals and clinics in more than 80 countries worldwide in the diagnosis of cancer and the planning of its treatment.

Healthcare corporation 3M has lost its dispute with representatives of the British Government over the company’s failure to market a diagnostic for MRSA developed within the Ministry of Defence.

The complainants have won $1.3 million in damages, whereas they were seeking $40 million – an outcome claimed by both sides as a success.

The BacLite medical device, which uses photoluminescence to detect MRSA bacteria, was purchased by 3M in 2007 and then abandoned as having failed the necessary clinical trials to support its marketing in the EU and the US.

The MoD, its spin-out company Ploughshare Innovations and private equity firm the Porton Group together claimed that 3M had deliberately mismanaged the BacLite trials in order to protect its rival (and more expensive) Fastman device.

The High Court in London found that 3M was in material breach of its obligation “actively to market” BacLite in the EU, the US, Canada and Australia, including its obligation to seek regulatory approval in the US.

However, it did not find that 3M had “intended” a breach of contract and thereby conducted the clinical trials dishonestly.

3M has announced its intention to pursue charges in the US against the Porton Group for alleged attempts to “extort” an out-of-court settlement by threatening to use political influence.

While the arguments rage on, the question of whether BacLite has the potential to improve worldwide treatment of MRSA remains unresolved.

A new technology for point of care diagnosis of carpal tunnel syndrome (CTS) is about to be become available to GPs through leading UK healthcare distributor Williams Medical Supplies.

Williams has an exclusive agreement with Finnish company Mediracer to make this groundbreaking diagnostic tool available to UK primary care.

CTS, often linked to typing or driving, is a pressure on the median nerve in the wrist that can lead to numbness, tingling, weakness or muscle damage in the hand.

The use of Mediracer’s NCS test is claimed to reduce the CTS screening cost per patient from £270 in secondary care to £67 in primary care.

The Mediracer NCS technology identifies nerve entrapments in the hand using disposable surface electrodes. The results can be used to diagnose CTS and grade its severity.

Steve Dunn, CEO of Williams Medical Supplies, said: “We have a strong presence in the primary care market, but we want to strengthen our position to help suppliers and manufacturers – like Mediracer – to win more business.

“By offering exclusivity on key products to Williams, these companies will benefit from our unparalleled market penetration and business support.”

“CTS is a high-incidence condition and our tool provides consultant interpretation within minutes, allowing GPs to do work which is normally confined to hospitals and which saves the NHS money,” commented Pasi Karsikas, Mediracer’s Sales Director.

“We chose to partner with Williams for a number of reasons – they are the UK’s leading GP supplier, with excellent customer support and unrivalled market penetration – so we are looking forward to a bright future in this marketplace.”

Based in Gwent, Williams Medical Supplies is the UK’s leading provider of medical supplies and services, used by around 9,000 of the 10,500 GP surgeries.

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.

Despite the ongoing criticism of the Health Bill as it passes through the House of Lords, structural changes are still happening at ground level. Dr Thoreya Swage outlines the timescale for changes as PCT clusters switch responsibilities to CCGs.

The momentum of reform of the National Health Service in England continues to gather pace. Following a four month hiatus while the wise and the good of the NHS Future Forum pondered and produced recommendations for the adjustment of the Bill, the DH published further guidance on the developing role of the Primary Care Trust (PCT) clusters.

Although the 151 PCTs have been squeezed into fifty-one PCT clusters in preparation for their demise in April 2013, it seems that they have a vital part to play in the development of the emerging Clinical Commissioning Groups (CCGs).

This guidance or ‘shared operating model for PCT clusters’ has been produced by the mandarins at the DH to ensure that the commissioning landscape is as consistent and smooth as possible in time for the takeover by the CCGs. This is so that the nascent NHS Commissioning Board inherits a robust enough system to take account of further developments and improvements in healthcare in early 2013.

 

A shared model

There are six main functions or ways of working for the shared operating model for the clusters. These have been identified where consistency of approach is considered to be of importance and they are listed as commissioning development, financial and operational issues, ensuring quality, emergency planning, development of providers as Foundation Trusts and communications.

 

CCG development

The most important function is the preparation of CCGs for authorisation as soon as possible following the successful passage of the Health Bill through Parliament. The process of authorisation to become fully fledged commissioners is due to begin in the second half of 2012.

Although this is a year away, CCGs can commence their preparations now using a self diagnostic tool – an interactive computer-based assessment that helps them to determine their capability in six domains and identify their development needs.

The areas covered include:

• A clear clinical focus of the CCG commissioning plans to include tackling health inequalities and improving primary care
• Demonstration of meaningful involvement of patients and the wider community
• A plan for development that is clear and credible which, in particular, delivers the QIPP (quality, innovation, productivity and prevention) agenda
• Capacity and capability of the CCG, i.e. robust constitutional and governance arrangements which enable the CCG to commission care effectively and ensure financial control
• Collaborative arrangements for working with other CCGs, local authorities and the NHS Commissioning Board
• Capacity and capability of the CCG leadership which ensures effective working.

The tool helps the CCGs identify priority development areas which form the basis of the developmental plan paving the way to full authorisation.

To support all this work CCGs will receive £2 per head from the PCT clusters as well as extra management resource to help the groups hone their commissioning skills and capability.

CCGs experiencing difficulty in defining their boundaries will have guidance from PCT clusters on how to resolve this. PCT clusters also have the unenviable task of engaging the reluctant practices that so far have not participated in their local CCG discussions, with the aim of being part of a viable commissioning group by October.

 

Separating commissioning functions

All through the last quarter of this year a very detailed exercise is being carried out by PCT clusters to identify and segregate the service areas that CCGs and the NHS Commissioning Board will be responsible for. Although CCGs will be commissioning acute, mental health, community and ambulance care there are other services that PCTs currently commission which will need to be transferred to the Board.

Services such as GP and other primary care contractor groups – primary dental care, pharmacy and optical services – secondary dental care, prison, specialised and military health services are set to go under the umbrella of the NHS Commissioning Board. Even though the contracts for GP services are held by another body, the CCGs are expected to have an input into primary care development and improvement.

 

Quality assurance

A vital component of the commissioning process is ensuring the quality of healthcare. Practices may have been involved to a greater or lesser degree in various quality assurance processes in the past. However, CCGs are required to take on board these responsibilities seriously.

There is a whole raft of procedures and measures including delivery of better health outcomes for patients, meeting the Care Quality Commission (CQC) requirements for safety and quality of services, standard contracts, the NHS Operating Framework, professional guidance and other relevant requirements that CCGs need to get to grips with.

This could potentially be a vulnerable time for the development of the CCGs if attention wanders and serious patient safety incidents are not acted on promptly. Clinical governance processes must therefore be extra secure.

 

Budgets and responsibilities

Over the next year or so there will be a period of dual functioning and handover as the CCGs mature and the PCT clusters delegate more and more responsibilities until April 2013. The handing over of the baton has started now with PCT clusters having identified a “clear percentage of budgets” to CCG pioneers or pathfinders in August and plans for future delegation of budgets set by October.

Sandwiched in between will be the agreement on which mental health and community services will be subject to ‘Any Qualified Provider’ (AQP). This policy is set to be implemented from April next year when GPs can refer to providers of certain services eligible for AQP from a list of approved organisations, including the private sector, drawn up by the DH.

A review of commissioning support required by CCGs has already been undertaken in July with clear arrangements agreed by the end of the year.

In March next year, CCGs will be required to enable the development of the local health and wellbeing boards supported by their PCT clusters – health and wellbeing boards being the mechanism for joint health and social care planning and commissioning locally.

Meanwhile, individual PCTs will continue to carry out their statutory functions through the clusters until their abolition in April 2013. The statutory functions include contract monitoring, ensuring that providers meet their QIPP obligations and other statutory requirements, for example, safeguarding children and vulnerable adults.

The big challenge for CCGs will begin when they will be required to lead the next planning round for 2012/13. This begins in the latter part of this year and is a function previously undertaken by the PCTs.

This will involve doing a needs analysis, identifying local inequalities, understanding demand and activity for local services, negotiating and setting priorities with partners and developing the local strategic vision. Handover of commissioning functions will continue with CCGs being an active participant in the subsequent contract negotiations and agreement.

 

The outside world

It is apparent that despite the pause for reflection on the proposed changes in the NHS earlier this year, the momentum for restructuring and dissolving healthcare organisations continues. The picture remains a little confusing however, as CCGs are in varying stages of development and maturity and it is not clear that all will be truly viable by the tight deadline set for October.

What is clear is that that work of commissioning and delivering healthcare has to go on and now is a good time to find out who the key movers are within the CCGs.

It is at this point in time when the developmental needs of CCGs will be uppermost and it is here that pharma can provide some input. Skills and knowledge in leadership development and highlighting therapeutic areas where evidence-based care really works are two such possibilities.

CCGs will be keen to smooth patient pathways across primary and secondary care and nowhere is this more pertinent than in prescribing effectively. Delegated prescribing budgets are now very real for CCGs and they will be keen to ensure value for money and improvements in care for their patients. This provides a good opportunity for pharma companies to demonstrate the effectiveness of their drugs in specific disease areas.

On the commissioning front, by December of this year, CCGs and PCT clusters will have had to agree what commissioning support they need to carry out this function. Given the requirement to reduce costs, commissioning skills and expertise may actually be thin on the ground within CCGs.

Bearing in mind that effective commissioning will be judged by outcomes achieved as outlined in the NHS Outcomes Framework, pharma is well placed to demonstrate how their products can meet the requirements of domain 1: preventing premature deaths, domain 2: enhancing the quality of life of people with long-term conditions and domain 3: aiding the recovery of people who have an acute illness or injury.

The next few months will be busy while the NHS sorts itself out structurally. Once the picture begins to clear, pharma will need to engage with the new clinically skilled commissioners who now have the financial responsibility for making decisions about healthcare.

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.

France is Europe’s biggest importer and exporter of medical devices. However, current reforms are driving cost reduction and efficiencies. Medtech Business in association with Espicom takes a look at the French market for medical technologies.

France is one of the top five medical device markets in the world, accounting for around 3.9% of the global market.* Within Europe, the market ranks behind Germany and is a similar size to that of the UK.

The country has a well-developed healthcare system, combining public hospitals with commercial clinics that are the main providers of elective surgical treatment. While the public sector is the largest purchaser of most diagnostic and therapeutic equipment, the private sector is the dominant purchaser of surgical equipment and supplies.

The high level of healthcare expenditure (11.8% of GDP) and the substantial health deficit are major concerns that have prompted various reform programmes aimed at curtailing costs and improving efficiency in the healthcare system. For this reason, the medical market is only likely to see moderate growth, rising from US$8.3 billion in 2011 to US$9.8 billion by 2016.

Despite several high-profile investment programmes, France continues to lag behind its European neighbours in some high-technology fields, most notably imaging and radiotherapy equipment. A second five-year cancer plan has now been launched which aims to increase the numbers of scanners.

With flagging domestic production in several sectors the French medical device market is increasingly reliant upon imports, which now account for around 80% of consumption. However, many imported products are re-exported to other countries.

 

The market in 2011

In 2011, the French medical device market (see Figure 1) is valued at US$8,280 million. Consumables is the largest product category, accounting for 20.9% of the overall market, followed by diagnostic imaging (19.8%).

Espicom estimates that the medical device market will grow at an average annual growth rate of 3.5% between 2011 and 2016 – bringing the total market value to US$9.8 billion by 2016.

Orthopaedic and prosthetic devices are expected to continue to be the most dynamic sector of the market, with growth forecast to be more than double the rate for the overall market. Conversely, diagnostic imaging is forecast to have the lowest growth during the 2011–16 period.

 

Predictions for market segments

Figure 2 shows Espicom’s predictions for the major segments of the medical device market.

1. Consumables. The market for medical consumables is estimated at US$1,729 million. The consumables market grew at an annual rate of 5.1% in US dollar terms between 2006 and 2010. Imports supply the greater part of the market. Espicom estimates the consumables market will continue to grow by an average of 3.5% over the next few years.

The wound care products market is forecast to grow at an average annual rate of 2.9% in US dollar terms during the 2011–16 period. Syringes, needles & catheters has been the fastest growing sector of the consumables market and will continue to be, with a CAGR of 4.1% to 2016.

2. Diagnostic imaging apparatus. The market for diagnostic imaging is estimated at US$1,636 million. The market grew at an annual rate of 2.8% between 2006 and 2010. France lags behind its European neighbours in the diagnostic imaging field, though the second cancer plan aims to increase provision of MRI, CT and PET scanners.

Imports supply the greater part of the market, though their market share is lower for radiation apparatus due to the strength of the domestic manufacturing industry. The USA and Germany are the major sources of supply. Espicom estimates that the imaging market will grow by an average of 2.1% between 2011 and 2016.

3. Dental products. The market for dental products is estimated at US$859 million, equal to 10.4% of the total medical device market. The dental products market grew at an annual rate of 4.2% between 2006 and 2010. It is forecast to grow at an annual rate of 3.5% over the next few years, taking the total to US$1,020 million by 2016.

4. Orthopaedic & prosthetic devices. The market for orthopaedic & prosthetic devices is estimated at US$1,336 million, equal to 16.1% of the total medical device market. The orthopaedic & prosthetic devices market grew at an annual rate of 9.2% between 2006 and 2010.

Imports have seen particularly high growth in recent years, though a corresponding increase in exports in this sector indicates that not all imported products are destined for the domestic market. The majority of orthopaedic imports are supplied by Switzerland and the USA.

The orthopaedic & prosthetic devices market is forecast to grow at an annual rate of 6.1% in US dollars over the next few years, taking the total to US$1,794 million by 2016.

5. Patient aids. The market for patient aids is estimated at US$1,131 million, equal to 13.7% of the total medical device market. The patient aids market grew at an annual rate of 4.5% between 2006 and 2010.

French imports of patient aids far exceed the value of the domestic market due to a high level of re-export activity, particularly for pacemakers. Switzerland and the USA are the leading suppliers of portable aids, whilst the USA and China are the major sources of supply for therapeutic appliances.

The patient aids market is forecast to grow at an annual rate of 3.9% over the next few years, taking the total to US$1,367 million by 2016.

 

Imports

The value of French medical device imports has recorded a steady rise over the past decade, reaching US$10.4 billion in 2008 before falling back to US$10.3 billion in 2009.

Imports of consumable items amounted to US$1,780.6 million in 2009. Imports fell by 1.0% over 2008 in US dollar terms (though they increased in euro terms). Syringes, needles, catheters & cannulae are the largest subcategory.

Diagnostic imaging imports totalled US$1,564.0 million in 2009, equal to 15.2% of the total. This was the weakest performing category in 2009, with a fall of 16.4%.

Imports of orthopaedic & prosthetic devices were worth US$1,549.1 million in 2009, equal to 15.1% of total medical device imports. This was the fastest growing category in 2009, with a rise of 26.6%. All three subcategories – artificial joints, orthopaedic appliances and other artificial body parts – recorded strong growth.

Patient aids are the largest import category, with imports worth US$2,624.1 million in 2009, equal to 25.5% of total medical device imports. Pacemakers accounted for 54.7% of imports in this category in 2009, but also accounted for more than half of patient aid exports.

The leading suppliers of French medical imports in 2009 were the USA, Switzerland and Belgium, with the UK ranking eighth as a supplier with imports worth US$288,964 (2.8% of the total).

 

Exports

In 2009, medical device exports registered a 3.0% fall in value to US$9.2 billion, having recorded steady growth in previous years with a CAGR of 6.8% for the 2005–2009 period.

In 2009, 69.5% of all French medical device exports were sent to the rest of the EU, with the Netherlands taking a 17.6% share, followed by Germany with 14.4%. The UK took 6.6% of French medical device exports.

Outside Europe, the leading destination is the USA, which accounted for 9.1% of exports. The USA is the leading destination for French exports of diagnostic imaging apparatus.

Next month, Medtech Business will look at the medical technologies market in Germany.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence. *All figures are in US $. For further details of the 66 markets covered, please visit www.espicom.com/outlookm1

Life Technologies is to join GlaxoSmithKline (GSK) Biologicals in developing a diagnostic to be used with a GSK cancer immunotherapy.

Life will develop a multi-gene qPCR-based molecular in vitro diagnostic assay for GSK’s MAGE-A3 cancer immunotherapy candidate designed to identify patients likely to benefit from the treatment.

Kim Caple, Head of Molecular Diagnostics at Life Technologies, said: “Life Technologies' platform technologies, such as qPCR, are allowing biological knowledge to be applied in multiple markets, including companion diagnostics.”

MAGE-A3 is currently being evaluated in two clinical trials, MAGRIT and DERMA, evaluating safety for patients with non-small cell lung cancer whose melanoma has invaded lymph nodes.

Under the terms of the agreement, Life Technologies and GSK will develop and commercialise the qPCR-based test to detect MAGE-A3 positive patients most likely to benefit from MAGE-A3 ASCI. 

Based in California, Life Technologies is a global biotechnology company that manufactures both molecular diagnostic and research use only 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.

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.

Roche has posted solid sales performance in the first nine months of 2011 with overall group activity up 2% to 31.5bn Swiss francs.

Sales in the pharmaceutical division grew 1% after growth of key medicines and markets, particularly in the international region where a 6% increase was recorded.

Severin Schwan, Roche CEO, says the Group is “on track to achieve our targets for 2011” after recording results in line with expectations.

The Group confirmed it is expecting low single digit growth this year and is still targeting Core EPS growth of approximately 10% despite a challenging environment and global health reforms.

US pharmaceutical sales were up 1% and driven mainly by demand for Lucentis, Rituxan and Actemra. But the company suffered an expected negative impact in sales of Avastin (pictured) after the uncertainty around the metastatic breast cancer indication in the US.

Sales were down 4% in West Europe, primarily due to government austerity measures, and 2% in Japan after the affects of the earthquake in the country in March, the company said. Although an increasing demand for products in China (+28%), Venezuela (+88%) and Brazil (+16%) helped boost figures internationally.

In the same period, Roche also reported positive data from seven clinical studies, a number of which have already formed the basis for regulatory filings and approval in Q3; including the launch of skin cancer medication Zelboraf and companion diagnostic cobas BRAF Mutation Test following FDA approvals in August and Tarceva (pictured) in the EU for EGFR-mutated non-small cell lung cancer.

“The successful US launch of our new melanoma medicine Zelboraf and the diagnostic cobas BRAF test has strengthened our leading position in personalised healthcare,” said Severin Schwan. “The good results we have achieved with new medicines in seven late-stage clinical trials so far this year further enhance our prospects for future growth.”