Under the radar: This new Bill could change everything

by Alex Ledger 5. December 2016 09:44

 

 

Alex reminds us that there is political life beyond Trump

 

You would be forgiven for thinking that, unless a current story references either Brexit or the outcome of the U.S. presidential election, it is unimportant, not newsworthy or entirely irrelevant.

Gradually, however, a new piece of legislation is working its way through the House of Commons and it stands to make a significant impact on the life sciences industry. It doesn’t come with coiffured hair, or a catchy strapline like, ‘Brexit means Brexit’ and it doesn’t even come with a particularly appealing name.

What I’m referring to is the ‘Health Service Medical Supplies (Costs) Bill’. You need to know what it says, because it may well change the nature of the game when it comes to pharma in the UK and – quite possibly – it will arrive sooner than the UK’s departure from the European Union

So why care about this clumsily-titled piece of draft legislation? The Bill – rapidly becoming known as the ‘Costs of Medicines Bill’ – is designed to strengthen the Department of Health’s (DH) powers over the costs of medicines to the NHS.

It is currently being reviewed by a House of Commons committee, where amendments are being proposed. These will ultimately be voted upon, before being passed over to the Lords for further scrutiny.

And we’re not talking ‘Article 50, two-year exit period’ here – this legislation is on track to be passed in the coming months and would likely come into effect by spring 2017.

The idea behind the broad new powers for the DH is to prevent significant price rises for medicines, where a competitive market doesn't function properly. Although not considered a major problem in the UK, there have been several high-profile news stories in the U.S. recently, where unbranded, generic medicines – supplied by a single manufacturer – experienced significant price hikes. The Government wants to protect the NHS from that situation occurring here, although its new powers go some way beyond what would strictly be necessary.

This Bill will impact throughout all aspects of the life sciences industry that provides medicines to the NHS. Indeed, Keith Ridge, Chief Pharmaceutical Officer for NHS England, has already stated in front of the public bill committee, that provisions of the Bill will set the basis for future PPRS negotiations.

Ultimately, this is a clear indication that while chat rages on about Trump and Brexit, we must not overlook developments happening within our own, often quainter Parliamentary system.

 

 

Pill Bill Vol. 1: Key ingredients

 

The Bill has three vital provisions. Firstly, it introduces a ‘payment mechanism’ for companies whose medicines fall under the statutory pricing scheme, which applies to any manufacturer or supplier of branded medicines that is not a member of the voluntary Pharmaceutical Price Regulation Scheme (PPRS). It works by applying a 15% cut to the list price of medicines – whether branded or generic – and, according to ABPI figures, the statutory scheme covers about 20% of NHS spend on branded medicines, with the remainder covered by the PPRS.

The Bill proposes to replace the blanket 15% price cut with a system that would see companies paying a fee back to the DH, based on a percentage of their net sales. The exact level of this figure has not been disclosed in the Bill, but when the Government ran a consultation on the statutory scheme earlier in 2015, the level of the fee proposed was between 10% and 17% of net sales, including on sales of new products.

The rationale behind the proposed reforms to the statutory scheme are clear – the Government wants it to achieve at least the same level of savings as those delivered by the PPRS.

While the PPRS caps spend on medicines, the statutory scheme has grown over the last two years and the DH wants to balance its books and, in doing so, create some financial headroom for the rest of its stretched funding obligations. A consequence might be a migration of some statutory scheme companies into the PPRS, possibly increasing the level of fees required to be paid by PPRS member companies.

It is worth remembering that the PPRS is a voluntary agreement between Government and industry that places a cap on NHS spend for those branded medicines covered by the scheme. If the cap is exceeded, companies will reimburse the NHS for any additional spend it makes over the cap level. Such an arrangement ensures that the NHS spend on branded medicines is maintained within agreed limits and offers budgetary certainty to Government. The latest PPPRs came in force in 2014 and, since this time, the industry has paid £1.4bn to the DH in the form of a financial rebate.

The second key proposal from the Bill requires companies to provide additional information on how their medicines are priced. The draft legislation gives the DH power to require ‘any party in the medicines supply chain’ to provide profits data on a product-by-product basis. This is designed
to ensure that the reimbursement system and supply chain offers the NHS value for money, while also providing transparency.

It is expected that the Government will run a consultation with the industry on the scope of the information required by the Bill if it is passed into law. Further accompanying regulations will certainly be needed in any case. Companies currently provide data on medicines pricing and discounts to overall profitability, via existing systems, but not typically on a product basis. Supplying this degree of data is quite a step-change and is likely to be considered overly exacting by industry.

Finally, the Bill proposes new powers for the DH to decide upon acceptable prices of medicines where a competitive market is deemed to have broken down, including authorising a limit to the price of an unbranded generic medicine not covered by the PPRS.  

Alex Ledger is Deputy Managing Director at Decideum. Go to decideum.com. 

 

 

 

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Features

NHS uncovered: Revealing STP footprints

by John Pinching 25. November 2016 11:25

 

 

The NHS loves nothing more than a sub-plot, preferably nestled beneath an overarching narrative. Another acronym or abbreviation by the presiding administration is simply an additional layer on top of the most multi-tiered healthcare cake in the world – one that was lovingly prepared back in 1948, and has never stopped growing.

One of the latest strategies involves ‘Sustainability and Transformation Plans’ (STPs) – the kind of concept that keeps you up at night, as you try to decipher the ambiguity of its title. In reality, it deserved to be called something far more explicit like ‘Tailored Local Care Services’ (TLCs, if you will).

Indeed, STPs are part of a more tailored system, which focuses on the local populous and aims to help deliver the main objectives outlined in the ‘Five Year Forward View’ – a title which still makes you assume that whatever you’re targeting is perpetually five years away (the original paper was actually submitted in 2014).

Nevertheless, in NHS terms, STPs are pretty wild – they appear to encourage ambition, a results-driven culture, radical ideas and even calculated risk. Ultimately, the aim is to accelerate health and welbeing strategies in a specified zone.

A collection of 44 ‘footprints’ have been duly trodden into the turf of our beloved NHS landscape and, in January this year, local healthcare luminaries in each area convened to thrash out what the footprints would resemble – their heart and ‘sole’. Now it is about transforming the patient experience and the overall health of the nation across the board – using the sequence of footprints to reach the ‘Promised Land’.

Each region has also had a ‘leader’ appointed, who will act as a guardian, while the fledgling process starts to germinate within an already crowded infrastructure. The ‘footprints’ – while not possessing any real clout in terms of statutory authority or accountability – will have the ability to draw notable healthcare personnel for frank discussions on STP delivery.

The aspect of STPs that really sets them apart from other new NHS ventures – and, boy, there have been plenty since the 1950s – is the emphasis on local requirements and, encouragingly, a rejection of a one-size-fits-all nationwide ‘solution’. It is an acceptance that different areas of the country – through a range of reasons, such as alcoholism, unemployment, ethnicity, nutrition, mental health, heart disease and even the weather – have vastly contrasting needs.

The term ‘footprint’ itself is an intriguing and possibly deliberate one – there is a suggestion of the digital world in its use, while also indicating a forensic, personalised approach. Cynics may well assume, however, that ‘footprints’ – by virtue of their nature, may be brushed away at a moment’s notice.

 

There’s no place like home

STPs handle variables in a way that focuses on the specific needs of a demographic. This ‘new layer’ feels somewhat different – the cookie-cutter approach to healthcare appears to have been cast away, appreciating that there are fundamental differences between Bournemouth and Blackpool and Blyth.

Taken as an example, North West London’s STP has one of the highest population footprints in the UK, with two million people. Within that area there are several sub-regions, which all have very distinctive requirements. In Hillingdon there are only 20 rough sleepers, while 5.2% of registered patients above the age of 18 have depression, whereas a few miles down the road, in Westminster, the rate of depression drops to 3.9%, however, there is an explosion of rough sleepers, to the tune of 921.

Meanwhile, when you migrate upwards to Nottinghamshire in the East Midlands, there is a population footprint of one million, while an intimate and aspirational STP focuses on ‘what local people want’ including maintaining independence, quality care provision, joined-up services and healthcare set-ups which can offer a legacy to future generations.

Further up north, the Lancashire and South Cumbria STP – with a population footprint of 1.6 million – specifies needs across typical disease pathways. It states that control of hypertension, cholesterol and blood pressure are priorities, while noting that stroke patients’ time in the appropriate unit and patient access to psychological therapy completion must improve.

This all paints a picture of a very diverse Great Britain, which requires input from practitioners and demographic experts at 'street level', and STPs would appear to be a robust response to that. Identifying differences and homing in on solutions all seems like positive stuff.

Decideum’s Deputy Managing Director and Pf Magazine’s Political Correspondent, Alex Ledger, said: “STPs represent a practical invention by NHS England to unpick one of the changes, introduced by the Lansley reforms of 2012, by restructuring NHS commissioning and pooling budgets at a larger, regional level, rather than across 200+ CCGs. Critically, this nullifies the need to tinker with the statute book and introduce new legislation.

 

View from the expert

David Thorne is Chair, Washington Community Healthcare and Non-Executive Director, City and Vale GP Alliance

 

Thirty years of policy reversed in a year, suggests STPs matter more than you may think!

We now have one health economy joint plan for commissioners, providers and social care – the internal market has been abandoned and replaced by 'One Local Team NHS'. Integration, consolidation and collaboration will all be rewarded, but sanctions are applied to those not responding. Darwinian management has been enforced by NHS central control.

STPs have the ‘control total’ of local NHS virtual combined budgets. They can move money between NHS bodies, replacing ‘Payment by Results’, while funding is available to help CCGs join together. These major changes herald an imminent NHS with 44 integrated units along Accountable Care Organisations lines, so watch for changes to the named leads, as that will signal STPs evolving from planning to managing.

The absolute aim is financial balance and hitting ‘Key Performance Indicators’, so expect bullet-biting hospital rationalisation and intolerance of opposition to implementation and workforce reform. Stormy times ahead.

 

 

 

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Features

Are women about to become history?

by Amy Schofield 9. November 2016 09:15

 

Don’t believe the hype: health headlines dissected

 

THE STORY

The tabloids were beside themselves with joy recently at the news that scientists have discovered a way to create embryos, without the need for ‘sperm meets egg’, potentially doing away with women forever and ever.

The scientists appeared to have also vetoed God, society and even dating, as they apparently demonstrated that healthy offspring could be created from mere skin cells.

The story, needless to say, was not all it seemed, as it emerged from more judicious sources that babies can’t just be fashioned from dust.

 

THE RESEARCH

The study, conducted by researchers from the University of Bath, the Institute for Toxicology and Experimental Medicine (ITEM) and the University of Regensburg in Germany, used mice to observe if healthy offspring could be produced using a technique that bypasses the usual physical processes.

Chemicals which ‘tricked’ mouse eggs into developing into embryos, as though they had been fertilised, were used by the scientists. The ‘fake’ embryos – known as ‘parthenogenotes’ – were subsequently injected with sperm and implanted into female mice.

Despite the fact that the study relied on eggs taken from a female, and that the embryos were implanted into female mice, sections of the press surmised that the future – a female-free world, where all you need is a stash of skin cells and some sperm – is already here. It isn’t – women do have a future.

 

THE RESULTS

The scientists reported up to a 24% success rate in producing healthy mouse offspring using this technique. They also suggested that the process could be repeated in humans using cells other those from an egg.

 

THE DEAL

The success of these experiments on mice would not necessarily be translated successfully to humans. Then there’s the ethical minefield thrown up by the possibilities of this somewhat inhuman fertilisation technique.

As the scientists recognise, the study is speculative and simply demonstrates a principle. There is far more work to be done before women and their redundant wombs are consigned to the history books.

 

What the press said:

‘Fertility breakthrough means babies could be conceived from skin cells’ Daily Mirror

‘Ground-breaking fertilisation technique could allow gay couples to have babies with each other’ Independent

‘Scientists discover how to make embryos from skin cells instead of eggs, making women redundant’ MailOnline 

 

ONE BORN EVERY MINUTE

UNICEF estimates that, worldwide, 255 babies are born per minute

On average, women are born with 600,000 potential egg cells

Sperm release enzymes to ‘melt’ the surface of the female egg

At the age of 45, the average woman in Britain has had 1.9 children

 

 

 

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Features

Face Off: Traditional sales versus remote detailing

by Amy Schofield 31. October 2016 11:06

 

 

 

Industry has always evolved with the times, but being at the forefront of the digital realm has remained elusive. Remote or e-detailing, however, is changing the face of pharma sales − quite literally. The question is, can it really remove the human touch altogether? We ask some of the major players in this intriguing face off.

 

Ross MacPhee

Head of Integrated Multi–channel Engagement (Delivery), Europe, Quintiles

Industry reports consistently confirm that face–to–face sales representatives continue to be valued by physicians, and that their services remain important to their practices. Remote interactions such as e-detailing, however, are being increasingly adopted by pharma companies. The reasons range from, seeking out more efficient promotional models – through segmentation strategies – to customer engagement.

Our own market research* recently provided first–hand insight of healthcare professionals (HCPs), following a Quintiles’ delivered e–detailing service.

• 91% of physicians said they are likely to repeat an e–detail following their first experience

• 63% of physicians we surveyed think e-detailing is the future of promotional contact

• Physicians anticipate spending about half of their time on e–detailing interactions and half in face–to–face meetings.

 

We are all adopting more varied methods of communicating as the technology presents itself, and HCPs are proving to be no different. HCPs want choice to suit their mood or their circumstances; what counts is creating valued touchpoints and positive customer experiences through each touchpoint or channel.

*Research conducted by a third party with 101 physicians (GPs and specialists) covering four Quintiles–managed customer projects between July 2014 – August 2015.

 

Karen Bell

Business development director at Ashfield Commercial & Medical Services, part of UDG Healthcare

Sales techniques have evolved with advances in technology to include an increasing element of digital marketing, with the majority of pharma companies now using digital sales aids, and increasingly, an element of remote detailing.

Channel preference is the key here; there will always be healthcare professionals who want to have face–to–face interactions, but there are an increasing number of customers who are willing – and indeed prefer – to engage remotely, via either the telephone or on a digital platform such as WebEx.

Successful co–existence of face–to–face calling and remote detailing is dependent on selecting the preferred delivery method for that customer. Pharma companies need to be able to effectively map preference and deliver calls via the selected channel using a variety of digital tools and content.

Remote detailing can open up access to previously unseen customers, and provides more effective use of the representative’s time. This allows for vast geographies to be serviced by a relatively small team of people.

 

Lee Gittings

Sales Director, Boehringer Ingelheim

The technology we use to maximise the customer interaction and experience is evolving all the time, from sales representatives routinely using tablets, to a whole suite of multi-channel customer interactions. Both aspects complement one another and the research backs this up.

I still think the old adage that ‘people buy from people’ is very relevant, but this does not always have to be face-to-face. E-detailing can add that extra dimension of flexibility around the customer need.

It can also increase the reach of relevant data to customers, complementing the efforts of the face-to-face salesforce. Evolution will involve further use of more sophisticated and reliable technology, which may challenge the more traditional representatives to move

out of their comfort zone.

 

It will also inform and evolve the recruitment decision criteria in the future, while attracting and retaining generation X and Y talent.

 

Nick Lavery

Managing Partner, Republic M! Group

Personal selling remains one of the most powerful channels to influence behavioural change. Despite this, the environment has become extremely challenging with significant declines in market access for medicines, physical access to customers and increasing costs to deliver target activity.

Deployment of field teams has changed with less ‘blanket, total coverage’ teams and more focus on strategic account managers who develop local market access. Remote detailing is a growing element of personal selling, as it is highly-targeted and can be deployed according to specific environmental conditions in order to deliver a strong return on investment.

Although there is a spectrum of deployment models, there are two that are becoming most common in the UK.

1. Maintain reach with less investment

• Same activity levels with less total investment.

2. Increase reach and targeting in Primary and Secondary Care

• Increase activity levels with smaller budget increments

• Field team remains focused on access and remote detailing is deployed to accelerate adoption.

 

As companies move to the adoption of remote detailing, there are opportunities to amplify impact, and the evolution will include customer journeys. 

 


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Features

Pf Magazine: November issue out now! Read it here.

by John Pinching 31. October 2016 10:39

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Features

The price is right?

by John Pinching 24. October 2016 08:22


Pricing, access, transparency – the common denominators which draw the sectors together and often tear them apart

 

Pharma pricing, medicine access and data transparency are the tags subliminally graffitied across every medical institution, hospital and government building across the UK.

Indeed, I was at the Westminster Health Forum in Central London for a frank discussion on these three ubiquitous subjects.

Proceedings were reassuringly held together by a ‘Churchill’ – in this case, Jo, MP for Bury St Edmunds. She is a proper politician whose two battles with cancer inspired her to make a difference. “It is so important that patient outcomes lie at the heart of all decision-making,” she insisted.

Among the speakers was Nicole Mather – Director of the Office for Life Sciences. She seemed optimistic about the post-Brexit scene. “The UK is a magnet for life sciences and we are the best in the world in the area of genomics,” she said. “GSK is still investing £350m in their Cambridge development and the message we have to the world is ‘Britain is open for business’.”

She clearly stated that the Accelerated Access Review would not be changed as a result of leaving the EU and that it would be focussing on collaboration between the NHS and innovators to create a vision that works for patients. She also emphasised that the collection of data on patient outcomes would be the first step in building a new strategy.

On the subject of evolution, Dr Ian Hudson, Chief Executive, Medicines and Healthcare Products and Regulatory Agency, outlined some of the challenges: “We should be developing innovation appropriately to bring products to market, while maximising development opportunities.”

He also recommended the greater use of real world data monitoring, adding: “Early access should be weighed up against the risk and knowledge of a product.”

Meanwhile, Professor Gary Ford, Chief Executive, Oxford Academic Health Science Network, raised the subject of pricing. “We need to have another look at prescription charges. Why should a 20-year-old with asthma pay for a prescription, when a 61-year-old Chief Executive pays nothing?”

This was perhaps the best ‘counter’ argument I have ever heard.

“There is not much data on ‘appropriate prescriptions’ – are patients getting the right drugs?” he inquired. “More patients need to be involved in decision making.”

Professor Karl Claxton from the University of York is a sort of punk rock Professor of Economics, with an earring and a refreshingly defiant pro-pharma chorus. “There is a discrepancy between global changes and what the NHS is prepared to pay,” he rallied. “NICE does assessments well, but it is not enough. Innovative medicines are still rejected or thrown into the Cancer Drugs Fund.”

He was adamant that there was a solution: “Discounts impact on the global market and manufacturers must be protected. Early uptake should be incentivised, innovations should be rewarded and rebates removed. We have an opportunity to repair the system – patients, clinicians and pharma can all win.”

And Karl’s right – his argument strikes at the beatless heart of a ‘Poundland’ Britain where short term tat is preferred to long-term quality. Desperately bartering with pharma companies, even after a considerable discount, is not going to endear them to research and develop in the UK. In contrast, paying a fair price has long-term healthcare, but also socio-economic benefits, which – in the blur of austerity – politicians would do well to recognise.

 

 

A view from the expert

Julian Given is Chief Officer, Washington Community Health Care (GP federation) and Project Manager, City and Vale Alliance (CAVA, GP Federation)

Access to medicine has always been variable from CCG to CCG. Now there is a focus on what is termed ‘rationing’, which started with the failed attempt – by New Devon CCG in 2014 – to restrict surgery to smokers and the overweight, until patients had made health improvement gains.

This has now re-emerged with CCGs looking at areas that ‘can only be paid for by the local NHS in certain restricted circumstances’, which includes surgery for sleep apnoea and hysterectomy for heavy menstrual bleeding. Meanwhile, North Staffordshire CCG has decided not to routinely fund hearing aids for patients with 'mild' hearing loss.

As the 44 Sustainability and Transformation Plan (STP) footprints mature – with their planning documents being published this year – we are likely to see more uniformity across STP constituent CCGs in terms of medicine access.

One of the main objectives of the STPs is for all sectors of health and social care to work closer together, with the view of delivering cost savings and better care for patients and, if this is to be achieved, data transparency and sharing has to be key. Currently, patient data between secondary care, primary care, social care and other patient-facing services is not always routinely shared.

Although many remember the recent failure of Care.data, a successor – currently known as the new ‘digital services platform’ – is being taken forward with a view to bridging this gap of information continuity. With the phasing out of Read Codes, and the move across to the SnoMed coding system – which has the ability to be used by primary, secondary and social care – the direction of travel is only one way.

Meanwhile, with the change in focus moving to collaborative working between partner organisations, pharma pricing is going away from the old style view of ‘what is the cheapest product’ – which simply protected the medicines management budget – to now looking at the financial impact on the whole system. Therefore, a slightly more expensive product, which is more efficacious, easier for the patient to administer and supports improved patient compliance would, perhaps, be considered more favourably than it may have been in the past.

 

 

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Pf Magazine: October issue out now! Read it here.

by John Pinching 11. October 2016 10:29

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Can ancient needle therapy really turn back time?

by Emma 10. October 2016 08:34

 

Don’t believe the hype: health headlines dissected

 

THE STORY

 

When two researchers at Wuhan University in China were reviewing a couple of published studies – from 2012 and 2013 – which showed that people who had undergone acupuncture performed 10% better in mental tests, they hit upon a new hypothesis. If lower mental test scores are linked with earlier progression of dementia – and acupuncture improves those mental test scores – could the ancient Chinese treatment also slow down its progression?

 

THE RESEARCH

 

Researchers Min Deng and Xu-Feng Wang conducted a systematic review and meta-analysis of five earlier Chinese studies, which involved 568 patients. All of the trials involved subjects with mild cognitive impairment (MCI), a condition which leads to a decline in memory. Around one in 10 people with MCI will go on to develop a form of dementia within a year, usually Alzheimer’s disease.

The review’s aim was to collate the available evidence from previous randomised – or partially-randomised – controlled trials (RCTs), which addressed the safety and efficacy of acupuncture for treating MCI.

The trials compared a group who received acupuncture for MCI – on its own or with another treatment – with a control group, which was given another type of active treatment. A group of 288 received acupuncture and 280 people in control groups received nimodipine. Meanwhile, the acupuncture group in two of the trials were also given nimodipine.

 

THE RESULTS

 

The review and meta-analysis revealed that those in receipt of acupuncture scored better on two recognised cognition tests than those who took nimodipine alone.

Combining acupuncture and nimodipine also significantly improved scores when compared to the dementia drug alone.

The researchers concluded that acupuncture: ‘has a significant positive effective on cognitive and memory function’.

 

THE DEAL

 

Although the results of the review appear encouraging at first, there were a number of shortcomings which cast doubt on the Daily Mail headline that suggests acupuncture staves off dementia. Only five relatively small studies were included, all in China. No trials used placebo/sham acupuncture, so therefore it must be assumed that both subjects and scientists were aware of the treatment being given, which could introduce bias.

Furthermore, the trials only looked at changes in cognitive test scores, and did not assess whether an outcome of acupuncture treatment – combined with nimodipine or not – actually affected an outcome of diagnosed dementia.

Commenting on the research, Dr James Pickett, head of research at the Alzheimer’s Society, said: ‘The lack of strong and convincing evidence makes it difficult to reach any meaningful conclusions.’

 

What the press said:

‘Could acupuncture stave off dementia?’ MailOnline; ‘Acupuncture may stop memory loss that precedes dementia’ Telegraph.co.uk

‘Acupuncture prevents memory loss?’ World Report Now

 

 

 

 

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Features

In the balance: Looking into NHS’s dilapidated purse

by Claudia Rubin 6. October 2016 09:19

 

Claudia recklessly stares into the NHS’s dilapidated purse

Nearly 70 years ago when the NHS was established – principally as an urgent care service – the population of Britain was about 47 million. Life expectancy for men was 66 – it’s now 77, infant mortality was 24 per 1000 live births – now down to five, and there were three mass immunisation programmes – that figure is now more like 15.

Since then, starting with the rapid development of antibiotics from the 1940s, through to the advancing of scientific research, healthcare is almost beyond recognition today, as are the demands on the service that delivers it.

With more than half of people over 70 living with at least two long-term illnesses –  and a quarter with at least three – it is no surprise that 70% of NHS spending now goes on managing that situation.

As a reflection of this, the NHS that operates today is not the same as the one set up in 1948 – numerous ‘top-down reorganisations’ have tinkered with it, or attempted wholesale change. Some fundamentals do, however, remain – the key one being the NHS’s system of funding.

A taxpayer-funded system, entirely free at the point of use, is a core NHS principal. Few in Britain argue that we need abandon this model entirely, but as with any complex infrastructure, there are no black and white choices, but a range of options within. While we know the NHS lacks funds, and that it has experienced these crises before, it is entirely possible that we have now reached a new low. Nine out of 10 Trusts are spending beyond their budgets, with an overall NHS funding gap of £20bn beckoning, by 2020.

Since most people have some awareness of the current NHS finances, it is astonishing that there hasn’t been a fundamental discussion about what the NHS should provide, what the public’s expectations are of free specialist treatment, and whether it’s ever going to be acceptable to charge for some services.

Indeed, whenever a known treatment or service is not made universally available – the new meningitis B vaccine for example, or various chemotherapy treatments, or GP appointments made at the whim of patients – some feel outrage without hesitation. Evidently the public do have an opinion.

Headlines in recent weeks lamenting the ‘rationing in the NHS’ and implying that it is something new, highlights the paucity of debate and lack of public awareness. Specific issues do trigger discussion from time to time, such as the recent survey by the British Dental Association, which revealed that 600,000 people a year seek a free GP appointment for toothache – costing the NHS at least £26 million a year.

Broadly speaking, however, consumers of NHS services come armed with a culturally inbuilt sense of entitlement with little regard to resource rationing. The latest headlines were triggered by a survey of doctors that found that seven out of 10 had witnessed restriction in approved NHS services and treatments in the past year, mostly for financial reasons.

Rationing of NHS services is not new and takes place across the board. From laboratory to hospital bedside, clinically effective new treatments are often denied entirely to NHS patients or – as this survey found – as a necessary ad hoc reaction to a budget deficit. This is precisely why NICE was set up in 1999 – to reduce variation in the availability of services – and why it continues to regularly make decisions based on cost, denying patients access to potentially worthwhile treatments.

  

Nostalgia tip: Claudia consigns sentiment to clinical waste

To be clear – no amount of efficiency savings or structural reorganisations will cut it – more money is needed if we want the same service, let alone an improving one. Or instead, let’s agree that we don’t. But headlines decrying the NHS for ‘forcing’ people to re-mortgage their homes to pay for expensive cancer treatment, while the same paper’s readership consistently refuses to accept any tax increases to fund these treatments, smacks of hypocrisy.

If we are so fiercely protective of our NHS, regularly topping as it does the list of things that make us most proud to be British, then why is it so politically risky to put forward the case that we all need to pay more for it?

And what of the NHS being the envy of the world? True perhaps, for the fondness its customers feel for it, but not in its service delivery or outcomes. Though there are metrics of which the NHS can be proud – our vaccines rates for example – we still fall behind in cancer, stroke and heart disease survival rates.

When researchers make scientific breakthroughs, unearth new technologies and unlock genetic secrets with the aim of developing long sought after cures, they want to see them benefit patients, and we want them for our families.

So, if you were that researcher, that scientist striving for the next big discovery, would you want your industry to engage with this wide debate? When your operation is delayed or your wife/husband refused treatment, do you want your political representatives to lead in helping us to understand why the NHS makes these decisions and consider what alternatives there may be?

The pharmaceutical industry should absolutely be doing all it can to reduce the prices it charges for medicines and increase the value they deliver. But should pharma also drive forward the message that the incredible improvement in healthcare that has transformed our lives – and in which it has played no small part – can continue at an ever-increasing rate, only if we are willing to pay more for it?

The discovery of new vaccines, diagnostics, medical technologies and medicines is in all of our interest. If we want GP surgeries to be open at all hours, hospitals to offer operations at weekends and equal access to the best medicines when we fall ill, we might even conclude that we are willing to handover more of our personal and national wealth to help the NHS deliver it.

 

 

 

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Features

Welcome to the real world

by Amy Schofield 26. September 2016 08:42

 

 

The UK is poised at the rock face of real world data, but how successfully can it be mined?

 

Real world evidence (RWE – don’t try and say it) is transforming drug development. The use of large data sets – to determine how new drugs perform – beyond the limited reach of pre-approval clinical trials, helps pharmaceutical companies, healthcare providers and payers to determine the safety, efficacy and cost efficiency of a medicine. All this is can be achieved by extracting real world data from the records of many thousands of patients.

The evidence from data – generated through a range of resources across real life settings, including patient registries, electronic health records, insurance data, the web and social media – has the potential to accelerate the development of innovative medicines. This will transform the existing approach to health and healthcare, by finding out the cost of using a treatment in the real world, and establishing the real pattern of a product’s use during its lifecyle.

But what are the opportunities and benefits to be gained by RWE, what challenges remain, and what part is the UK playing?

 

ABPI view: Lead and others will follow

The UK is viewed as a rich mine of patient data for the collection of RWE. Shahid Hanif, ABPI Head of Health Data and Outcomes, believes the UK occupies a unique position: “As well as having an innovative and thriving research science base, and the internationally-renowned National Institute for Health and Care Excellence (NICE), the UK is regarded as a great source of patient data for real world evidence research,” he explained. “The NHS has a unique nationwide role in both providing care and collecting health data throughout patients’ lives, which – if used appropriately – could transform that care in the future.”

The report from a RWE workshop, held by the ABPI in partnership with the Academy of Medical Sciences, stated that the UK is at the vanguard of the future direction of RWE: ‘The UK has a very real opportunity to develop leadership in this field, and influence the development of a consistent approach across global regulators and other stakeholders.’

 

Home advantage

Consultant pharmaceutical physician Dr Martin Goldman, from Iatros Consulting, suggests that, despite the concerns about UK pharma post-Brexit, the move could actually consolidate its position as a global centre for the collection of data for RWE.

“The UK is the best territory set up for the collection of RWE. It has a number of pre-existing databases of healthcare that can yield retrospective information, for example the ‘Yellow Card’ system, and the General Practice Research Database (GPRD),” he said.

A wide range of UK and international organisations currently use or commission research from the GPRD, including the pharmaceutical industry, universities, charities, government departments and the NHS.

In addition – due to the nature of some RWE collection methods – this large amount of already-held data gives the UK an additional advantage: “Using more than one language makes for problems and it has always been the case that the ways of recording data in member states is heterogeneous,” added Dr Goldman. “I would envisage the UK becoming a power house for RWE studies, if sponsors have the appetite. Certainly RWE is far more easy to use for home markets. You would only need to deal with one language and one major platform for the delivery of healthcare.”

This mine of UK data is already being used to benefit the nation’s health. “We work closely in collaboration with the NHS, data providers – such as NHS Digital – government and academia to better understand the use of patient data, identifying how it can help improve understanding of the UK population’s health and improve access to the medicines they need,” said the ABPI’s Hanif.

“For the researchers in our companies, this data offers us three benefits; to help develop a greater understanding of a disease and its impact on a patient, identify how to improve the way patients receive their treatment, and show the effectiveness and safety of medicines over time,” he concluded.

In terms of how RWE is being utilised in the real world, Dr Goldman noted that many initiatives were trying to use real world and real time data to evaluate the management
of diabetes. “It fits very well with early access to medicines,” Dr Goldman said. “The drug regulators are interested in real world data on drug safety post-approval to evaluate the use of medicines that may have been approved on the basis of limited data.”

 

Getting real

One of the greatest challenges to optimising the use of RWE is acceptance – getting healthcare professionals to accept the validity of the information gathered and investigating whether it can be used for regulatory purposes.

According to Dr Goldman, one way to do this is by developing guidelines so that results are consistently credible to drug regulators and purchasers. “There needs to be more studies of different designs and more discussion with the purchasers of healthcare, advertising authorities and drug regulators.”

The ABPI, along with the European Medicines Agency and the Food and Drug Administration in the US, recognises the value of using more traditional data alongside RWE.

According to Hanif, it is also public confidence which is crucial to the future of RWE research: “None of this is possible without the support, understanding and trust of the public,” he insisted. “For the use of real world evidence to progress, patients need to have control over their data, understand its use, and be reassured that their data is protected, shared and used appropriately. Only then will patients feel confident that their health information has the power to improve healthcare and medicines for them and future generations.”

 

The views of Dr Martin Goldman are his own and do not necessarily reflect those of Iatros Consulting

 


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