NICE has published guidance supporting the use of a patient warming mattress from a Yorkshire company to prevent hypothermia during surgery.

The Medical Technologies Advisory Committee (MTAC) assessed the use of the Inditherm mattress (pictured) from Inditherm Medical, which is designed for use with patients having surgery involving an anaesthetic.

The evidence considered suggests that the device is as effective in maintaining a patient core body temperature above 36°C as forced air warming, which NICE continues to recommend.

MTAC also estimated that the Inditherm mattress offers the NHS an average annual cost saving of £9,800 compared with forced air warming (where heated air is blown into a specially designed blanket).

In addition, MTAC concludes, the Inditherm mattress may have further practical advantages: it is re-usable and can be cleaned in the same way as a normal operating table mattress, as well as minimising waste of energy.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “We are very pleased to publish guidance today advising that the Inditherm patient warming mattress should be considered for use in patients at risk of inadvertent hypothermia. The evidence examined indicates that as well as benefiting patients by reducing a range of serious complications associated with inadvertent hypothermia, it also benefits the NHS by saving money.”

Longson also noted that the new guidance did not supersede the recommendation of forced air warming – rather, it suggested “that when considering new investment in warming devices, consideration should be given to whether use of Inditherm would be beneficial with respect to local circumstances.”

NICE estimates that there are 2700 theatres in England not currently using any type of patient warming, of which 40% might be expected to purchase the Inditherm mattress.

Inditherm Medical is based in Rotherham.

A new imaging technique enables scientists to trace individual cancer cells as the growth of a tumour spreads through the brain.

Researchers at the Case Western Reserve University School of Medicine used cryo-imaging to look at a mouse model of glioblastoma multiforme, an aggressive cancer with no treatments to stop it spreading.

Susann M. Brady-Kalnay, Professor of Molecular Biology and Microbiology at the Case Western Reserve School of Medicine said: “We're able to see things we couldn't before, and we can use these images to understand how tumour cells invade and disperse”.

The cryoimaging system consisted of a fluorescence microscope, robotic imaging positioner, customized cryostat, PC-based control system, and visualization/analysis software. The technique alternates between sectioning and imaging, collecting colour brightfield and fluorescent blockface image volumes.

The scientists used a model that included four different cell lines of brain cancers at various stages of tumor development and dispersion. The cancer cells were modified with fluorescent markers and implanted in the model's brain.

Researchers found that two cell lines, a human brain cancer LN229, and a rodent cancer CNS-1, best resembled the actions of glioblastoma multiforme in human patients.

The ability to produce clear and detailed images will be invaluable when evaluating the potency of drugs and other therapies designed to block dispersal of glioblastoma multiforme cells.

Joerns Healthcare, a leading specialist in patient handling solutions, has signed a partnership agreement with Acorns Children’s Hospice, which cares for seriously ill children across the Midlands in England.

The partnership shows Joerns investing in the local community by supporting a regional charity, following its own move to Worcestershire at the beginning of 2011.

Acorns will receive support from Joerns in the form of patient handling equipment, specialist moving and handling training, staff fundraising activities, onsite voluntary work and collaborative PR and marketing activity.

In partnering with Acorns, Joerns Healthcare joins such organisations as Aston Villa FC and Birmingham Airport.

Joerns Healthcare’s Managing Director, Nathan McWattie, said: “It is a real privilege for Joerns to be involved with this amazing organisation and the wonderful people who work for them.

“With our specialist skills and knowledge of the acute and community healthcare markets, we look forward to helping Acorns improve the lives of these children and their families.”

According to Acorns Corporate and Partnership Manager Elinor Eustace (pictured with Nathan McWattie), this agreement “marks an important first for Acorns, the first time we have teamed up with a healthcare-related partner.”

Joerns Healthcare has offices in the UK, the US, Canada and the Netherlands. Its UK operation, now based in Pershore, Worcestershire, is best known for its Oxford range of patient lifts.

Acorns Children's Hospice provides care and support for children and young people who have life-limiting or life-threatening conditions.

Valeant Pharmaceuticals has bought cold remedy manufacturer Afexa Life Sciences in a deal worth 76million Canadian dollars.

Afexa, based in Edmonton, Alberta, sells Cold-FX and Coldsore-FXT, totalling annual revenue of approximately C$40million.

Michael Pearson, Chairman and CEO of Valeant, said that the combination of both companies’ products “will provide the critical mass we need in the OTC market and should provide Valeant Canada with another platform for growth”.

Valeant stated that Afexa's board unanimously approved the deal and recommended that the company's shareholders tender their shares, who will receive C$0.71 per share in cash.

Canada-based Valeant is a manufacturer and marketer of a range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.

US patients with late-stage, non-small cell lung cancers (NSCLC) could receive Pfizer’s recently approved Xalkori (crizotinib) for free, instead of paying $115,000 per year.

The expensive drug has proved to extend patients’ lives with the rare form of cancer, but Pfizer is making efforts to ensure patients don’t have to pay the entire cost. The company has stated it will cover insurance copayments that are more than $100, and in some cases give the drug away for free to patients who are either uninsured or underinsured.

Geno Germano, who runs Pfizer’s specialty-care and cancer businesses, told Wall Street Journal: “The results may not achieve multi-billion-dollar sales, but whether that yields a product for tens of millions of patients or 10,000 patients, we're interested”.

In clinical trials, the average duration of treatment was between 22 and 32 weeks, but because the drug appears to extend patients’ lives, many may be on it for far longer than that, totaling a potentially hefty bill. One study reported that 60% of patients on Xalkori stayed alive after two years of the treatment.

The drug has been approved with a companion diagnostic test that will determine if a patient has the abnormal anaplastic lymphoma kinase (ALK) gene. These genes are responsible for cancer growth and development and are specifically targeted by the drug.

Dr Richard Pazdur, Director of the Office of Oncology Drug Products for the FDA, said: “The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug”.

Between 1% and 7% of those with NSCLC have the ALK gene abnormality, those of which are typically non-smokers.

Ian Read, CEO of Pfizer, stated: “Xalkori is an advance in the treatment of this devastating illness, providing a new therapeutic option for a subset of patients with the disease.”

The safety and effectiveness of the medication were tested in two multi-centre, single-arm trials involving 255 patients with late-stage ALK-positive NSCLC.

In one study, the objective response rate was 50% with an average response duration of 42 weeks. In another, the same statistic was 61% with an average response of 48 weeks.

Xalkori is the second drug approved by the FDA this year to benefit cancer patients with specific mutations. The first was Zelboraf, developed and manufactured by Daiichi Sankyo and Roche.

Alberto Gutierrez, Director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA, commented: “The trend in oncology research continues towards targeted therapies”.

Pfizer has also applied for approval of Xalkori with the European Medicines Agency.

Ipsen has filled all the positions in the Group’s Executive Committee after making two new appointments.

Nathalie Joannes has been appointed Executive Vice President, General Counsel, and Susheel Surpal has joined as Executive Vice President, Chief Financial Officer.

Mr Surpal had been a member of the Executive Committee and Financial Director of LABCO since 2009 and will commence his new role in the coming weeks. Nathalie Joannes joins from Genzyme where she served as Senior Vice President and Chief European Counsel for the past three years. She will begin her role on 1st October 2011.

The company has also entered into a strategic partnership agreement with Inspiration Biopharmaceuticals to launch Inspiration’s haemophilia product portfolio in Europe.

Inspiration aims to file a Marketing Authorisation Application with the EMA for its intravenous recombinant factor IX, IB1001, for the treatment and prevention of bleeding in individuals with haemophilia B by the end of this year.

Astellas will move its base of UK operations from its premises in Stains, Middlesex, to a new facility in Chertsey, Surrey.

The pharma company is believed to have paid around £17 million for the 90,000 square foot building, which is currently occupied by software company EA Games.

The agreement will also include an adjacent 100,000 square foot office development and will house the workforce which currently stands at more than 250 employees.

The company has also sold a research centre in Tokyo for more than 10bn YEN, excluding tax, to improve asset efficiency through reduction and liquidation of assets, the company says.

Several large pharmaceutical companies have paid US physicians nearly $150m this year, according to analysis by the Financial Times.

Industry data into the controversial marketing and support practices found that $148m has been given to 165,000 doctors so far, including $48m from Eli Lilly and $42m from Pfizer.

A spokesperson for Lilly said the “collaboration with healthcare providers is essential” to improve outcomes for patients and to provide innovative medicines.

In the UK, the ABPI recently changed its Code of Practice meaning companies now have to declare payments to healthcare professionals for their services from 2013 in an attempt to increase transparency. Government agencies in the US are currently finalising similar guidelines as part of the healthcare reforms.

The analysis by the Financial Times, in conjunction with PharmaShine, is designed to allow health authorities, medical institutions and patients better scrutinise and understand the links between doctors and pharma.

But the way current disclosures are made and presented varies and makes comparisons and analysis difficult for both authorities and patients alike.

Allan Coukell, Head of the Pew Prescription Project – a US drug safety watchdog – says that healthcare professionals and the industry needs to work together for research purposes, “but the marketing model is problematic”.

“The first step is transparency and we are not even there yet,” he added.

Research found that collectively the industry paid $437m to 262,000 doctors in 2010. Among the physicians who received the highest level of support was Dr Zale Bernstein, an Associate Professor from the Roswell Park Cancer Institute in Buffalo, New York. Dr Bernstein received $234,000 in 2010 from Cephalon, Eli Lilly and Pfizer and has already received more than $57,000 already this year.

Although the majority of doctors received smaller sums, studies have suggested even modest support by pharma can affect prescribing practices.

Pharma’s Account Management model is built on the principle that frontline professionals develop and deliver brand value propositions that align with the key priorities of key customers. But in a changing market where new customers are emerging, how well do you understand those priorities? Omar Ali pens Part I of a typical day in the life of a Formulary Pharmacist.

Despite consumers’ apparent lust for TV medical dramas and gruesome surgical documentaries, it’s unlikely that the viewing public would find a biopic centring on the work of a Formulary Pharmacist particularly enticing. But, for an audience of pharmaceutical sales professionals charged with understanding its customer-base, gaining an insight into the breadth and depth – and far-reaching implications – of a typical week in the life of NHS prescribing advisers, medicines management and formulary pharmacists should provide much food for thought.

Pharma appears desperate to establish the ‘key priorities’ of its many customers. This article, based on typical encounters with medical sales professionals, is a genuine attempt to outline mine.

A MONDAY MORNING, SOMEWHERE IN SURREY
8.10am: GI CONSULTANT / IBD.
(Discussion in the corridor)
Arrived at my NHS base camp. Stopped in the corridor by one of the GI Consultants who wants to set up a GPC/CCG commissioning group on GI Inflammatory Disease with one of the local Consortia - we ran one with Rheumatology framed around an osteoporosis brand. We put a date in the diary to discuss. I will be coordinating an IBD lunch event to facilitate joined-up working. Bringing in the GPCs is easy - I can text most of the GPs on the Commissioning Board of our local clusters, such is the relationship required for joined-up thinking. He’s very committed to his cause – and has very recently impressed significant knowledge and application of commissioning processes involved. Needless to say, many of his choice agents are either off-license or difficult to source from community pharmacies. He also has a whole stack of biologics he’s keen to use – but without some PCT discussions (and now outreaching to GPCs) he won’t get very far.

Thoughts for pharma

GI/IBD has become very noisy and in certain areas very controversial. Biologics are testing the very essence of ‘affordability’ in the NHS. We also know that by using them correctly, we can prevent signi­cant morbidity – surgery/admissions/etc. However, joined-up thinking doesn’t occur by magic – and you have a signifi­cant role in making this happen. When we coordinate this GPC/Hospital IBD lunch event, I am certain I will be discussing with various stakeholders, including pharma. NICE in principle supports a number of products but there are complexities. For example, bringing patients in for an IV infusion will generate income for the Trust – which funds a nurse who provides additional services. Patients treated at home may be a preferred option – there is no VAT. Home healthcare is not without its headaches around delivery, months’ supply ordered and administrative burden.

I am still disappointed at the level of pharma support I have seen here. There is far more that can be done to bring a clinical context into a financial framework. I call this the ‘Mortgage Principle’ – translating falling in love with a house into a financial framework with a defined loan: value and %APR with monthly repayments – see previous Matrix Revolutions. There seems to be a vast gap in understanding NHS processes – not just from pharma, but also from consultants – so improved process mapping from chronic disease to A&E through to post-discharge is essential. It also brings out the ‘true-cost’ of the disease in IBD – not just the ‘drug’s cost’. If our consultant doesn’t move ahead and advance his prescribing base, he will end up referring more patients to tertiary centres (which will only increase PCT costs) – so it’s important to put things into context here. Process Map the patient and the money will follow. If this is not tackled by pharma, I foresee the future of managed care entering here very neatly. Looking after the whole pathway and pushing pharma out to bystanders – look at companies like IHP, United Healthcare & Medco, it’s happening.

8.40am: Pharmacy Base.
(Discussion with the boss)
Arrived to my desk – finally. This time it’s the Chief waiting with an IFR/one-off-request that needs sorting. It’s the usual story: this time it’s a urology product that a GP is refusing to prescribe. We are having to push through the IFR/one-off-request – and also liaise with the GP for a medium-term solution (the patient is travelling significant distances to obtain this). This means some research, PCT discussions, GP emails and a phone call to the patient. I will also try and perch on the urology consultant’s shoulders (he runs a clinic this afternoon) and coordinate future D&T processes. Most of all, we need to ensure that the patient is central to this whole system – which is easier said than done. It’s good timing though – I have been in discussions with urology, working through the top-ten spend on the drug list to see where we have efficiency savings (something which is occurring across the whole trust in conjunction with PCTs & GPCs). This product initially came up as ‘not-on-the-radar’ but clearly needs some attention. I have our medicines information pharmacist conducting background research – I have emailed the specialist commissioning pharmacist at the PCT and CCd the prescribing adviser who has just evaluated a recent APC paper on overactive bladder prescribing (which we are discussing at our next D&T).

Thoughts for pharma

Urology is big on the radar. Many prescribing items are specialist, while there are significant prescribing efficiency savings aimed at ‘overactive bladder’ and linked into a more encompassing discussion with endocrinologists, and the ongoing story behind testosterone. I am sure I am sitting on a business card of a testosterone brand, but which company it was I cannot recall. Thumbing through my cards – the stack waiting for a call back is big – I can’t really see through the thick fog of various companies/pharma/sub-companies/take-overs. Note to self: request all staff to ensure reps write their brands on their business cards when they call at the pharmacy. Key priorities around urology that are high on the radar across primary/secondary care are as follows:

• Urinary retention/BPH
  Is it just me or has Combodart lost its way? I remember some very exciting joined up thinking on preventing unnecessary referrals and bringing consultants out to primary care. Given urology consultants admit themselves that DREs to exclude prostate Ca is not easy, liability and governance for getting GPs to this was always heading into a cul-de-sac. I think there is a ‘new campaign’, though I’m not sure what it is. We have both finasteride and dutasteride on our joint formulary – but I’m not seeing the right financial framework on the ground. I can see NHS PCOs moving backwards, lifting finasteride back on the pedestal and not even considering the Combodart story. If there is a value proposition around this brand someone better get this moving within commissioning circles fast. To add to this, tamsulosin’s patent expiry further hastens the need for the value story here. If the last D&T rejection we had is anything to go by this is either off the radar or must be a third drop-down detail on someone’s bonus scheme.
• Urinary incontinence
  We have NICE, LUTS and SMC. HTA is all important. Most of pharma focuses on product differentiation. They need to, NICE is an open forum for prescribing. But I don’t see a commissioning story or a decent value proposition for payers. Please don’t state you want to run me through a cost model – that is not a ‘value proposition’. I have yet to see a company come to me and talk about QIPP. Where are you guys? Please don’t moan at the NHS for using generic oxybuytnin first-line – we get the opposition, what we don’t get is a Payer ‘QIPP Value Proposition’ around your brand. Too much n=1 for my liking. The only brand working the NHS has to some extent are the solifenacin crowd – they certainly have significant clinician/KOL buy-in if the Payers are left somewhat ‘wanting’. I’m unsure where exactly duloxetine & fesoteradine are heading, or what their value story is – despite SMC approval. Maybe it’s just me.
• Bladder instillation
  This is hotting up big time. Why? Because there are costs to both primary and secondary care – and furthermore, despite numerous products – some without a license – for conditions such as interstitial cystitis there is significant unmet need on cure rates, relapse rates and hospitalisations. Someone, somewhere will win big when they map out to us what already suspect – hospitalisation costs here are huge, and process mapping will show how these are sectored into various health economies. At the moment, everyone is walking and talking product – bag of saline/infuse like this/lovely twisty connector/etc. Just waiting for someone like United or Medco to come and show us the path to the land of milk and honey. It appears no-one else will.
• Testosterone
  It’s back! The story has become interesting all over again, and all credit to pharma. The link with diabetes is moving this higher and higher up the agenda. It is fraught with issues. Everything from best mode of delivery to patient/compliance and desired effect, through to overlap with specialties – is this endocrine or urology or both, same pathway or different pathway? The pharmaceutical arguments in testosterone are worthy but having no coat hanger to hang your outcomes on makes for difficulty in pulling out the cheque book. There is a ‘gap-effect’ in situ – from academic niceties to clinical practice. I’m not sure the pull is there yet – and again, I return to my translation into a financial argument. Furthermore, there are cost savings and efficiencies to be had and this is where a product-matrix weighted with Payer Related Priorities would assist a brand in its Payer Value Proposition – if it indeed cares to invest in one.

It goes a bit like this:

1. What’s important to payers with a view to testosterone replacement?
2. Rank this list in a weighted manner so that they all add up to 100% (ie they may say evidence w%, compliance x%, safety y%, cost z% – w+x+y+z must all add up to 100%
3. Now you have your weighting, get the payers to allocate the numbers for each of the testosterone brands
4. Now you have not just who is the winner, but also how and why
5. So if, for instance, compliance is 25% weighting of the whole game, then if you spend 80% of your time talking about compliance, this may not be effecting your exposure time with payers to maximum benefit –remember the clinicians will have a different matrix. You may have the best compliance story – well done, that’s 25/25 but you will never score higher than this. There is another 75 points in this exam that you haven’t answered yet. You need to find out ‘what is the % weight that formulary/prescribing advisers give to the ‘testosterone story’ – once you have this value, you know how important it is.

9.30am: Meeting with Obs & Gynae Consultant / re: Formulary Application
This should be quick. We’ve recently put on some pessaries to our formulary. Obs and gynae want to use them in difficult/pre-specified labour/delivery situations. Now the company has whipped over a freezer to their unit. Yes, they are stored in the freezer, and no, before you ask, I don’t know whether we defrost before use or just pop them into our patients freezing cold. Have had a discussion about this with my wife over dinner, she is also a pharmacist – not a good move. Anyway, I’ve been firm but clear. The pharmacy doesn’t have a freezer, we need to discuss with the company about a freezer. There will be no prescribing of this new product within the Trust until we resolve the ‘freezer’ issue. All credit to the company, supportive they are, quick to respond they have been and, as I write, and you read, one of my staff is coordinating logistics around this. This is a classic example of simple supportive strategy. I looked back at the minutes of our D&T Form and smiled to myself… “accepted onto formulary, pending freezer.”

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

A new brain scan can detect if healthy individuals may be at risk from developing Alzheimer’s, claims a recent study.

Results published in Neurology state that the advanced imaging technique – proton MR spectroscopy – can determine any abnormalities in various brain metabolites that may be Alzheimer’s biomarkers.

Dr Jonathan M. Schott, from the Dementia Research Centre, University College London, said: “There is increasing evidence that Alzheimer disease is associated with changes in the brain that start many years before symptoms develop.”

PET scans assessed amyloid-beta deposits (plaques) in the brain, which are one of the initial signs of Alzheimer’s onset. Volunteers’ language, memory and other skills were also tested.

The study involved 311 participants aged over 70 from the Mayo Clinic Study of Aging, Rochester, USA. One third of participants tested with considerably high levels of amyloid-beta deposits. The same people had high levels of the brain metabolites choline/creatine and myoinositol/creatine, which also tend to correlate with poor scores.

Dr Schott, commented: “If we could identify people in whom the disease process has started but symptoms have not yet developed, we would have a potential window of opportunity for new treatments to prevent or delay the start of memory loss and cognitive decline.”

Dr Kejal Kantarci, who carried out the study, said: “This relationship between amyloid-beta deposits and these metabolic changes in the brain are evidence that some of these people may be in the earliest stages of the disease.

“More research is needed that follows people over a period of years to determine which of these individuals will actually develop the disease and what the relationship is between the amyloid deposits and the metabolites.”