Merck appoints new head of HR

by emma 29. July 2011 11:49

Pf industry news

Merck has appointed Piotr Bednarczuk as the new Head of Corporate Human Resources (HR).

Mr Bednarczuk will lead the company’s current reorganisation to consolidate HR globally across the Merck Group.

Kai Beckmann, Executive Board member of Merck, stated: “Piotr’s extensive professional experience and international background make him a perfect candidate for this task.”

Mr Bednarczuk will succeed Gregor Wehner, who will retire from the role in September.

Merck is the oldest global pharmaceutical and chemical company in the world, dating back to 1668.

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Appointments

The deepest cut: rationing of NHS surgery

by Joel 28. July 2011 17:02

MB NHS news

Two-thirds of NHS Trusts are rationing operations in accordance with the Audit Commission’s recommendations, reducing access to hip replacement, cataract, varicose vein and tonsil surgery to the most severe cases.

Most Trusts are restricting bariatric surgery to the worst cases – a policy that a surgeon has described as encouraging obese people to gain weight.

The denial of common operations to ‘non-urgent’ cases is part of a national drive to reduce the NHS budget by £20bn over the next four years.

A survey of 111 PCTs by the health service magazine GP found that the controversial ‘Croydon list’ of procedures to be rationed has become prevalent in the NHS, despite protests from industry, clinicians and patient groups.

The prevalent cuts in surgery provision include:

• No hip and knee replacements unless the patient is in severe pain.

• No cataract operations until sight loss ‘substantially’ affects the patient’s ability to work.

• No varicose vein surgery unless the patient is suffering ‘chronic continuous pain’, ulceration or bleeding.

• No tonsillectomy unless the child has suffered from tonsillitis seven or more times in the previous year.

Two-thirds of NHS Trusts are either not providing bariatric surgery or restricting it to patients with a BMI of 50 or even 60. NICE guidelines say it should be available to patients with a BMI over 40 (or over 35 where there is a co-morbidity). The recommendation followed studies showing that weight loss surgery reduced the overall cost of healthcare for these patients.

Professor Mike Larvin, a bariatric surgeon and Director of Education at the Royal College of Surgeons, commented: “In many regions the threshold criteria are being raised to save money in the short term, meaning patients are being denied life-saving and cost-effective treatments and effectively encouraged to eat more in order to gain a more risky operation further down the line.”

Chris Naylor, a senior researcher at the King's Fund, criticised the use of rationing to save short-term costs without regard to patients’ needs and the overall cost of their care: “Blunt approaches like seeking an overall reduction in local referral rates may backfire, by reducing necessary referrals – which is not good for patients and may fail to save money in the long run.”

Chaand Nagpaul of the BMA’s GPs committee argued that Trusts rationing access to treatments on the basis of local policies meant a return to the ‘postcode lottery’. “Patients and the public recognise that with limited resources we need to make the maximum health gains and so there needs to be prioritisation,” he said. “What is inequitable is that different PCTs are applying different thresholds and criteria.”

However, a DH spokesman defended the principle of local control: “Decisions on the appropriate treatments should be made by clinicians in the local NHS in line with the best available clinical evidence and NICE guidance. What is suitable for one patient may not be suitable for another.”

Lost in Translation

by emma 28. July 2011 16:59

omar_small

The frustrations that pharma – and clinicians – face when trying to secure a drug on formulary have been well documented. But Omar Ali (pictured) explains that understanding the Payer’s ‘language’ can greatly increase the chances of success.

The NHS changes over the last decade have shifted power away from secondary care to varying degrees in different specialties. These new NHS changes are further exaggerating this. Pharma has a significant role in facilitating consultants in keeping in step with these changes, supporting them through the brave new world, and ensuring that they learn a second language – the language of the Payer.

A very good friend of mine – she is a Consultant Cardiologist – said to me not so long ago: “Omar, I don’t see why I have to justify my prescribing to you. This is the drug I want, just give it to me.” This was a delicate discussion. I needed to handle myself carefully but be firm to the point. There were also two pharma representatives at the table. Basically my reply went something like this: “Dear Dr, regardless of what you feel about justifying your prescribing decisions to me, this is the process, this is the financial framework for the managed entry of new drugs into the health economy – so get with the programme.” I also added that I could help her if she’s interested in how to best go about this. Within the next
three months I was indeed requested to present at a mandatory briefing for all consultants within the Trust on the current financial position and the future of our organisation with the new financial framework for commissioning new products onto formulary – my presentation was sandwiched in between our CEO and the Department of Finance!

So what can pharma do to assist my Consultant Cardiologist colleague to better ‘frame’ her positional argument to me? There are five key factors to consider:

1. Understand the Health Bill and commissioning: secondary care is somewhat hidden from much of these changes. Pharma needs to pull these influential clinicians out of their comfort zones and brief them on the changing NHS.

2. Understanding the Drug and Therapeutic (D&T) processes/ APC Formularies: many clinicians are frustrated with the system, do not understand and speak the ‘Payer language’ and so disengage from the process as a result. Pharma needs to bring them back to the table and empower them in a new way.

3. How to get a drug ‘through the D&T’: – it’s a simple workshop and a skill that can be learned with clinical and geo-political factors brought in. Use your brand as a ‘case example’, but the principles are the same. Many consultants will echo the discussion I had
with my consultant – frustration at the barriers to access, pointing accusingly at cost savings, and not prepared for the Payer’s rigorous Q&A. In a way, these KOLs need to be briefed in a secure environment as to what they may face when in front of the firing line
of the PCT/D&T Committee.

4. What makes a good D&T Application: streams of new drugs fail at the first hurdle. Quality of submissions are often poor and do not resonate with the Payer’s audience. They still resound of “I’m professor of cardiology, if I bang my fist on the table I will get my drug funded”. You have a role, duty and responsibility in assisting one of your most valuable
support mechanisms. Without KOL support the Payer’s influence is actually irrelevant.

5. Understand the difference between ‘being on formulary’ and ‘commissioning a new drug
into a pathway’: most consultants don’t fully understand how their own activity is reimbursed; issues around expensive drugs, tariffs for admissions/outpatients – and related trim-points – and implications of red/amber/green prescribing guidance. The subsequent generation of a shared care guidance is critical for your brand. Without this will mean a lack of prescribing which results in a reduction of sales.

We currently have at least eight new brands which have passed D&T application, have passed PCT APC, and are on formulary; but do NOT have a shared care guidance in place. This means they are in ‘limbo’. They are in ‘hyper-space’. A consultant simply won’t be able to prescribe it. The GP won’t be able to continue. This is about joint working, bringing
stakeholders around the table, bringing examples of best practice from around the country, and bringing your agenda so that it becomes higher on my own.

The KOL ‘demand’ factor

It’s one thing for a Payer having to deal with a well prepared consultant who understands the financial process and has made a convincing positional QIPP framework for your brand. It’s quite another when the KOL has not even turned up and has disengaged from the application and support process. That speaks volumes to the Payer. Please don’t confuse ‘KOL demand’ for a treatment option with a ‘KOL demanding a brand’.

Payers look for and make a judgement on ‘KOL demand’ for a product. It is critical when deciding on an initial interest level. Remember that Payers are often ‘fighting off’ consultants from various disciplines and specialties wanting new products. The silence from KOLs with reference to your brand can be deafening in what it spells out: “this product holds no value to us”. Make sure they are knocking on my door with ‘demand’. Now once we have engaged, what I don’t want is your KOL simply ‘demanding the product’. What I want now is a financial QIPP framework focusing on how we redesign our services around a new intervention, in both clinical and commissioning terms.

What disappoints me is that the majority of D&T support to consultant KOLs I see today from pharma falls under two main themes:

1. Pharma translates ‘the need for evidence’ into dumping ream after ream of largely irrelevant clinical papers onto the desk of the consultant – which further makes them want to disengage.

2. Pharma translates ‘the need for a better quality application’ into taking the D&T form
and having their medical departments complete them on the behalf of the consultant.
Trust me, when these come to D&T you can see them a mile away!

Given pharma is always touting joint working why don’t you work together on this issue? Coordinate your timetable of formulary applications, enrol your KOLs into a D&T workshop where they receive some skills set training and ‘mock D&T’, and empower them in the ways of the new NHS. And have your executive teams keep them abreast of local payer
influencers and mechanisms with underlying framework for prescribing pathways.

Falling in love

Some of you will know I’m currently in the process of moving house. We have just gone in to the market and indeed have fallen in love with a house in Guildford. Now here’s the thing. We fell in love with the house when we first saw it and this continued throughout
our viewing. We have pictured it becoming our home, almost living out the years. The garden is perfect, the rooms all fit with what we want and, although it’s not quite the ‘moon’, it sure as hell is a good way towards it.

Now, to get into the house – our new home – we need to go and see the bank. It wasn’t a great first meeting, I can tell you. All of a sudden we found ourselves wrestling with APRs,
2yr/3yr/5yr fixed plans, repayment versus interest only, deposit amounts, indicative financial re-payments and limitations on loan to value thresholds that have unsettled us somewhat. We came out of that meeting a little dizzy, somewhat dejected and unsure now of what and where we want to go. We still don’t relish the idea of going back. We won’t say it out loud, but we are slowly losing this house.

The discussion at the bank was a far cry from the romantic notion of what was to be our home. The bank was not really interested in the lovely garden, wonderful residential location and how we could see our children growing up in the various rooms within the property. No, it seems the meeting with the bank revolved around a very different language. It was a financial framework. It was a requirement we have to prepare for adequately to get us into our next home. I now know we could have been better prepared
and that poor preparation may have cost us our ‘moon’. I learned that I had to get with the programme, regardless of my views of bankers’ bonuses, financial hurdles and an annoyance at justifying our income/expenses to a third party.

There is no way I will get into my dream home without getting to grips with the financial framework that is required to proceed the dream into reality. Many of your KOL consultants have already done the first part. They see the USP of your product, the
clinical need is palpable, they have patients waiting to reap the benefits of your drug. In essence they’ve fallen in love with the brand. But here’s the thing, are they prepared for meeting with the bank? Are they prepared to entangle with the financial framework
to get them their gold standard product? Or are they in danger of losing their dream home because they have not got with the financial framework?

Think about it.

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

Getting the message across

by emma 28. July 2011 16:54

xavier louyot

Talking business isn’t restricted to exclusively speaking English. Xavier Louyot (pictured), Dolce Hotels and Resorts, explains how multilingual content can create global opportunities for your business.

Generating content for global markets and communicating to a multilingual audience is a challenge that comes part and parcel of a global position or organisation, especially given the pressure to standardise and comply with internal and international standards.

A common risk is to see the meaning in your messages either lost or altered because of these language differences. Culture, translation, writing, and design always interweave in curious ways when presenting to a multilingual audience; so keeping it simple is often the key to avoid misinterpretation and to keep communication lines clear and concise.

By putting some simple techniques into practice you can ensure that you get your message across effectively and accurately to your associates and clients, not just in their language, but in ways that show that you value and respect their culture.

Keeping it simple

Start by keeping sentences short and, where possible, use bullet points. This is good practice in any presentation; but is even more important if you are communicating to audiences in a language that is not their mother tongue. Bullet points allow a speaker to identify clear key points and keep audiences focused on the most important or relevant elements of the presentation.

In the same way that sentences should be short, the vocabulary and grammar chosen should be as easy and simple as possible for audiences to understand. Sticking to plain words and sentence structures will ensure the audience is focussed on the presentation and not pre-occupied by a word they cannot translate or understand.

Of course, there will always be times when it’s hard to avoid certain words or expressions that do not translate. Perhaps you need to use a colloquial term or a reference to the local dialect, either way, in this instance it is useful and completely appropriate to give audiences an explanation or definition of the word or expression. This enables you to put it within the intended context and avoids any confusion or the message being diluted.

A common interest

It’s often hard with multilingual audiences to find a shared interest but it’s this common ground that helps communities come together and can really make or break a conference. Including references or giving examples that resonate across cultures is an effective way to develop a rapport with your audience and, at the same time, bring delegates together. Building this sense of camaraderie amongst audiences can often lead to more productive breakout sessions and networking around a conference or event.

Finally, it’s useful to remember that it’s best to use formal language when addressing a multilingual audience. Informal vocabulary is very specific to each culture and is not always learnt when a language is being taught at school or university. Sticking to formal language ensures you don’t alienate your audience or worse still, offend them.

The above are just a small amount of tips and hints to put into practice when communicating to a multilingual audience; but most of all, the best tool you have is your smile. A person who smiles exudes friendliness, openness and approachability.

Even if audiences don’t understand everything you have said, say it with a smile and they will feel comfortable enough to approach you with a question. For something that is universally understood and costs nothing to give, the value of a smile cannot be underestimated when it comes to breaking down language barriers and engaging international audiences.

Xavier Louyot is Global Director, Marketing and PR for Dolce Hotels and Resorts.

Brain surgery device installed in UK

by Joel 28. July 2011 16:53

A new device introduced to the UK can destroy tumours in the brain or the spine without the need for invasive surgery.

The Novalis Tx radiosurgery system, developed by Varian Medical Systems and Brainlab, has been installed in the Christie at Salford Royal Hospital: a new radiotherapy centre for the North West.

The launch of this therapy coincides with the release of new guidelines from the NHS National Cancer Action Team stating that radiosurgery should be available to all suitable cancer patients in England.

Radiosurgery can treat previously inoperable cancers in a single 20-minute session, using beams of radiation shaped to fit the tumour. The short treatment time means that many patients can attend the clinic as outpatients.

The frameless radiosurgery of the Novalis Tx is more patient-friendly than existing radiosurgery systems that require immobilisation of the head by a ring fastened to the skull.

Malignant primary brain tumours reduce life expectancy more than any other cancer, and are the most significant cause of cancer death among young men and women.

Ms Tina Karabatsou, Consultant Neurosurgeon at the Salford Royal NHS Foundation Trust, said: “One of the fantastic advantages of the new Novalis Tx treatment is we will be able to treat brain conditions we were previously unable to treat, such as tumours really deep in the brain.

“Equally important is the non-invasive nature of treatment, which means treatment sessions can be performed as an outpatient day-case and with significantly less side effects.”

“The launch of the Novalis Tx system is a huge stride towards modernising cancer care in the UK,” said Helen Bulbeck, Director of charity Brainstrust. “This is a great achievement for brain tumour treatment.”

US company Varian Medical Systems is a leading manufacturer of radiotherapy and radiosurgery systems. German company Brainlab produces software-driven medical technologies to support less-invasive treatment.

By the end of 2011, three UK centres will be using the Novalis Tx.

Novalis-Banner 
Novalis Tx

Shire appoints new board member

by emma 28. July 2011 16:05

Shire has appointed Susan Kilsby as a member of their Board of Directors.

Ms Kilsby will become a member of the company’s Audit, Compliance and Risk Committee on 1st September.

She currently works as a non-executive director at global skincare company, L’Occitane International.

Matt Emmens, Chairman at Shire commented: “Susan’s impressive experience of investment banking and finance across global markets will be a welcome addition to our Board.”

Ms Kilsby has distinguished a global career in investment banking having held senior positions with Barclays and Credit Suisse.

She stated that she is looking forward to joining “such a strong team with diverse backgrounds and knowledge.”

Shire is a global biopharmaceutical specialist focused on enabling those with life-altering conditions to lead better lives. These include Fabry disease, Hunter syndrome, Gaucher disease, hereditary angioedema, and metachromatic leukodytrophy.

Prescription drugs up 70%

by emma 28. July 2011 15:53

The number of prescribed drugs has risen by almost 70% over the past decade, according to a new report.

Prescriptions Dispensed in the Community; England, Statistics for 2000 to 2010 found that a total of £9bn was spent on medicines dispensed to patients this year.

Tim Straughan, Chief Executive, NHS Information Centre, says the report highlights the “significant cost” of prescription drugs to the NHS.

An average of 17.8 prescription items were dispensed per person last year, compared to 11.2 ten years before.

There were 927 million prescriptions issued in 2010, compared to 552 million items given out in 2000, with the average cost per head rising from £113 in 2000 to £169 in 2010.

Cardiovascular drugs, such as statins that lower cholesterol, and ACE inhibitors to lower blood pressure are the most frequently prescribed.

The rising number of people with diabetes – up 75% in four years – is the most expensive condition to treat, resulting in more than £713million worth of medicine last year.

Reasons for the increase could lie in longer life-expectancy, as well as the growth in obesity causing more people to develop diabetes.

These new figures were released a day after the Family Doctor Association alleged that four in five GPs were prescribing drugs to patients suspected to be addicted to them.

‘Solid’ Q2 results at Merck

by emma 28. July 2011 15:14

Merck KGaA posted healthy profits in Q2, despite being hit by a number of ‘one-time adjustments’.

Revenues increased by 16% to €2.6 billion following the acquisition of the Millipore Corporation, but integration costs and increased operating expenses hit profits.

Karl-Ludwig Kley, Chairman of the Executive Board of Merck KGaA, says the “solid” figures “give us a healthy basis on which our new management team can build”.

Profits were helped by global sales of multiple sclerosis treatment Rebif which increased by 5.2% to €423 million. The group’s divisions also enjoyed an increase in revenues with Merck Serono’s profits up 2% to €1.4bn; the Consumer Health Care division up 3.9% to €118m; with Merck Millipore amounting revenues of €584m.

But operating expenses more than doubled in the quarter to €270m from €109m in the same period a year ago. An impairment loss of €161m due to overcapacity at the Corsier-sur-Vevey Large Scale Biotech (LSB) production plant in Switzerland was also suffered, as well as a provision of €20 million after the FDA and EMA rejected its MS cladribine tablets.

Merck says it realises it needs to make improvements to its pharma pipeline, as well as internal processes and structures, if it is to meet future financial targets.

“We are striving for leaner processes and we are reviewing our cost structures,” said Mr Kley. “Generating attractive returns on invested capital and cost management continue to be the top priorities on our agenda. The first steps have already been taken this year. These include the changes in the Merck Executive Board, in Merck Serono and Consumer Health Care as well as decisions resulting from our pipeline review.”

The company’s Executive Board now believes the total revenue for 2011 for the Group will increase between €10bn and €10.4bn.

Pfizer completes Icagen merger

by emma 28. July 2011 12:52

Pfizer has entered into a definitive merger agreement with Icagen in deal worth $56 million.

The pharma giant already owns approximately 11% of the global leader in pain research and will now acquire the remaining 8.3 million shares.

Ruth McKernan, Senior Vice President, Pfizer's Pain & Sensory Disorders and Regenerative Medicine unit, says the deal will strengthen “our innovative core”.

The two entered into a worldwide collaboration to research and develop new potential treatments for pain and related disorders in 2007.

Kay Wagoner, CEO, Icagen says the company is delighted to have signed an agreement with Pfizer. “During the nearly four years since the initiation of our collaboration, each side has developed a mutual appreciation of the expertise and capabilities of the other,” she said.

“By joining forces in a more integrated manner, we believe that our joint efforts towards the identification and development of novel pharmaceuticals targeting specific ion channels will be significantly enhanced.”

The companies hope to finalise the deal before the end of the year.

Trobalt advised by NICE

by emma 28. July 2011 12:47

Trobalt (retigabine) has joined the options available to the NHS for the treatment of controlling seizures in adults who have epilepsy.

NICE has advised that the drug be used as an add-on treatment option if several other recommended medicines have been ineffective or produced unmanageable side effects.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE says the Institute is pleased to offer final guidance “so soon after retigabine’s regulatory approval”.

The GSK drug was licensed by the EMA back in March.

Epilepsy is a common neurological disorder characterised by recurring seizures, which affects between 260,000 and 416,000 people in England and Wales – more than half will experience partial onset seizures.

Sufferers of the condition usually need to take a combination of drugs to control their seizures. In the guidance, NICE recommends Trobalt as an add-on treatment for those who have not responded to the following: Tegretol (carbamazepine), Frisium (clobazam), Neurontin (gabapentin), Lamictal (lamotrigine), Keppra (levetiracetam), Trileptal (oxcarbazepine), Epilim (sodium valproate) and Topamax (topiramate).

“Seizures can be extremely debilitating as they can interfere with a person’s social life, employment and other daily activities,” said Professor Longson.

“While there are a number of effective anti-epileptic drugs already widely available on the NHS, people can have different responses to them. It’s therefore very important for doctors to have a broad range of options so that they can find the right combination for their patients.”

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