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

by John Pinching 27. September 2016 14:29

 

 

 

 

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Modelling could set trends in drug development

by Edmundo Muniz 20. September 2016 08:41

 

The game changer: Modelling and simulation in drug development could change the commercial and regulatory landscape forever

It could easily be said that the current drug development process is broken. Tufts Center for the Study of Drug Development reports that the average cost to develop and gain marketing approval for a new drug is more than $2.5 billion. Furthermore, only 10% of drugs entering clinical trials achieve regulatory success. The current approach to developing new drugs, employed by most biopharmaceutical companies, clearly requires an overhaul.

Sponsors need to be able to determine a new drug candidate’s likelihood of success, at important milestones, throughout its development, so they can ‘course correct’ if necessary. They have to better understand the probability of success for everything, from proof-of-concept studies, to interactions with regulatory agencies and acceptance on formularies. By increasing those odds, using proper scientific approaches and technologies, they can intelligently inform core decisions.

 

Enhanced decision-making

In the quest to improve drug development’s return on investment (ROI), biopharmaceutical companies have sought methods, technologies and operational programmes to reduce costs and increase efficiency. Most of those approaches, however, have focused on improving clinical trial management, rather than systematically enhancing the research and development (R&D) decision-making process, especially in early-phase development.

Modelling and simulation (M&S) – also known as biosimulation, or ‘model-informed drug discovery and development’ (MID3) – can deliver significant business and scientific value to companies that fully integrate it into their drug development strategy. M&S combines two transformative and constantly-evolving technologies: computer-aided mathematical simulation and biological sciences. It uses pre-clinical and clinical data, combined with published industry data, to determine the relationships between drug exposure, drug response and patient outcomes.

M&S can influence every phase of the drug development process, including commercial decisions around the benefits of bringing a specific drug to market. It can also be used to compare the safety and efficacy of drug candidates; select dose and dose regimen to be used in clinical trials; and identify potential drug-drug and drug-food interactions. Knowledge of drug-drug interactions is particularly important for patients who are being treated for multiple conditions, and M&S is increasingly enabling that information to be included on drug labels.

In addition, M&S can be used to investigate how a new drug candidate will behave in patient populations which, for practical or ethical reasons, have traditionally been considered untestable. This includes paediatric patients, pregnant women and patients with rare diseases.

Certara has developed specific models of those patient populations within the Simcyp® Population-based Simulator. This simulator integrates knowledge of the physiochemistry of a drug with human biology, anatomy, physiology and genetics to simulate how that drug will behave in virtual patient populations.

Proprietary databases enable Certara to create virtual patient populations, which also consider different environmental circumstances, and adjust enzyme levels to reflect genetic differences.

The simulator combines that knowledge with pre-clinical and clinical data to predict differences in pharmacokinetic and pharmacodynamic response between individuals. Pharmacokinetics describes how a drug moves through the body during absorption, distribution, metabolism and excretion, while pharmacodynamics looks at the relationship between drug concentration and effect.

 

Working with global regulators

Like the tortoise and the hare, M&S has slowly and steadily impacted both the efficiency and effectiveness of drug development. It does this by informing a myriad of crucial decisions along the development path, imbuing them with more reliability and predictability.

Furthermore, M&S is now encouraged by global regulators, who have referred to M&S as ‘a regulatory necessity.’ The US Food and Drug Administration (FDA), the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) all use the Simcyp Simulator to inform drug label language. In 2015 alone, Certara leveraged its M&S technology and expertise on nine of 21 orphan drugs and four of the 10 breakthrough drugs approved by the US FDA.

Using M&S, Certara was able to advise the drugs’ sponsors regarding trial design, helping them to develop the smallest and most targeted trials possible, and assisting them in identifying the correct drug dose to use from a safety and efficacy standpoint.

In many cases, Certara was able to eliminate the need for specific studies by simulating how particular drugs would interact in virtual patient populations. This provides more precision and ultimately reduced risk for patients. Dosing a virtual patient, after all, will always be less risky than dosing a real patient.

 

The results business

M&S informs biopharmaceutical companies’ most crucial drug development decisions, while optimising the data available for their crucial go/no-go drug and portfolio decisions. Ultimately, it permits a much larger number of potential drug-drug interactions to be investigated than could ever be undertaken in a clinical setting. All this additional high-quality data reduces the risks associated with bringing a new drug to market to the benefit of sponsors, payers and patients alike.

 

Edmundo Muniz, MD, PhD is Chief Executive Officer at Certara, a leading provider of decision support technology and consulting services for optimising drug development and improving health outcomes. Go to certara.com

 

 

 

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

by Hazel Lodge 5. September 2016 10:46

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Precision medicine set to revolutionise outcomes

by Amy Schofield 4. September 2016 09:30


Currently, many available drugs are used to treat patients under the assumption that ‘one-size-fits-all’, but drugs don’t work the same way for every patient. The precision – or personalised – medicine approach, based on comprehensive diagnostic and clinical characterisation, ensures that the right patient gets the right treatment at the right time. 

Precision medicine involves using various technologies including genomics, diagnostics and data analytics. Diagnoses are subsequently adapted to the detailed information that is emerging about our specific genetic make-up. Pharmaceutical solutions tailored to our DNA – rather than one-size-fits-all medicines aimed at the mass-market – are the future of medical treatment, which treats the person, not the disease.

Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, says: “The confluence of new medicines, sophisticated diagnostics and advanced technologies has created an unprecedented opportunity to improve outcomes for patients today and in the future.”

 

Accelerating the process

As people live longer and diagnosis and treatments improve, the prevalence of non-communicable diseases, such as cancer and diabetes, present a significant challenge as lifestyle choices act together with the genetic make-up of a patient. The need to treat the individual, rather than the group of individuals with the condition, is the catalyst for the personalised medicine approach.

Is the pace of development able to keep up with the evolving needs of the patient population?

Steven Shak, MD and chief scientific officer, Genomic Health, told Pf Magazine: “There is no question that innovations and new discoveries are being made at an accelerated pace today, compared with the past. As researchers and caregivers in the world of cancer, we know that patients have an incredible urgency for us to move even faster to make sure that we identify both drugs and tests that really work, and make sure they are used appropriately in clinical practice.”

NHS England’s National Director Sir Bruce Keogh announced the transition, to a personalised approach, in September last year, while outlining his emerging strategy for personalised medicine in the health service. He called it “the future of the NHS”.

He said that the work already being done, through the NHS’s contribution to the 100,000 Genomes Project, must be capitalised on, and fast.

“The shift to personalised medicine is already underway – our role as a system leader and commissioning organisation is to consider how this transformation can be accelerated,” he said. Embracing technology and innovation is clearly key to the success of this shift. 

An example of this comes from Genomic Health, which has developed the Oncotype DX® Breast Recurrence Score™. The therapy has now been used in over 600,000 patients around the world, to help them decide whether they need chemotherapy or not, when they’re first diagnosed with breast cancer.

“With new technologies we can now look at tens of thousands of genes and at their expression. We used a very innovative and creative approach to find and identify the genes that mattered,” said Shak. “In precision medicine it’s incredibly important that innovations are developed, used appropriately and reimbursed and paid for, so patients can benefit.”

 

Gene genie

Scientists cracked the human genome code thirteen years ago, resulting in the evolution of genomics. This discipline studies each individual’s complete set of DNA which, in turn, helps in the understanding of the person’s predisposition towards genetic diseases, and helps to inform the personalised treatment that is best for that patient.

Chief Scientific Officer for England, Professor Sue Hill, recently delivered an overview on how genomics and personalised medicine is set to transform the NHS. With the knowledge gained from the project, researchers are learning how inherited differences in genes affect the body’s response to medicines. These differences will then be used to predict whether a medication will be effective for an individual and help to prevent adverse drug reactions.

Shak points out, however, that innovations take time to reach those who need them: “Healthcare innovations can take 10 to 20 years to disseminate into actual practice. One of the things that’s going to be very important for bringing innovation into clinical practice in the future is to better take advantage of technology.”

 

Catapulting innovation

The Precision Medicine Catapult’s (PMC) aim is to make precision medicine a reality in the UK. It has six regional centres of excellence, all working on locally driven programmes, using the PMC network to harness the breadth of UK expertise, while developing innovative technologies and solutions for broader use across the UK’s healthcare sector.

It is headquartered in Cambridge, where AstraZeneca is creating a new research centre, led by Dr Menelas Pangalos, Executive Vice President of AstraZeneca’s Innovative Medicines and Early Development Biotech Unit.

Earlier this year the PMC announced a strategic partnership with the UK Pharmacogenetics and Stratified Medicine Network to drive the growth of the UK industry and accelerate the delivery of precision medicine to patients. It has over 400 individual members drawn from academia, medicine, industry, regulatory authorities and patient groups across the UK and elsewhere.

Meanwhile, pharma pipelines that include precision medicine-based targeted therapies are continuing to grow, with the added benefit of the maximisation of patient populations, for clinical trials, by the use of genomic information as an integral part of trial enrolment.

Precision medicine is gaining momentum, which has the potential to reshape how therapies are developed in the future, and industry is perfectly placed to capitalise on incorporating huge amounts of genomic and clinical data in their R&D processes, creating greater success in drug development and the understanding of disease. 

 


 

 

 

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

by Hazel Lodge 14. August 2016 08:22

 

 

 

 

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Dangerous liaisons: GPs are failing transgender patients

by Admin 8. August 2016 09:41

 

GPs are failing transgender patients with a lack of compassion and understanding that must change, according to Dr Helen Webberley

The recent massacre in Orlando served as a grim reminder that discrimination against minority groups continues to play a very real part in our so-called ‘modern society’.

Of course, these episodes are extreme, but while this degree of hatred is mercifully rare, members of the LGBT community have come to accept prejudice as an everyday occurrence. Nowhere is that more true than if you are a trans man or a trans woman.

Every day I hear stories through my online clinic – GenderGP – from members of the trans community, about the battles of bigotry, prejudice and humiliation they face. But what shocks me most, is when that sentiment comes from members of the health profession.

Following significant concerns raised by the House of Commons Women and Equalities Committee in their recent report on Transgender Equality – specifically in relation to the lack of awareness and consideration shown by a great many doctors in treating transgender patients – I was delighted to see the General Medical Council (GMC) publish guidelines on managing transgender patients.

The guidelines state that GPs can prescribe hormones to patients suffering with gender identity disorder, under the following ‘exceptional circumstances’:

 

 

  • The patient is self-prescribing with hormones from an unregulated source 
  • The bridging prescriptions are intended to mitigate risk of self-harm or suicide
  • The GP has sought the advice of a gender specialist and prescribed the lowest acceptable dose

 

 

This was met with a variety of concerns from NHS GPs, and I am disappointed at the reluctance to openly embrace the news that we can now do more to help our trans patients.

Dr Chaand Nagpaul, CBE Chair of the BMA General Practitioners Committee, penned his concerns to the GMC, raising a number of emotive points. His main uneasiness being that specialist prescribing would place GPs in a difficult position, forcing them to prescribe outside the limits of their competence.

In response, Susan Goldsmith, acting chief executive of the GMC, provided reassurances, which included the point that GPs would be expected to ‘acquire the knowledge and skills to be able to deliver a good service to their patient population’. This, she explained, may mean undertaking training. It was clear that the GMC does not consider care for patients with gender dysphoria as a highly specialised treatment area requiring specific expertise.

Goldsmith goes on to endorse a firm view of mine: that these patients actually require very simple care and well-known medication.

The medication for transgender care includes oestrogen therapy used for treating female menopause (estradiol), injections that are typically given to women with endometriosis or men with prostate cancer (GNRH analogues) and a diuretic used for heart failure (spironolactone). Furthermore, anti-androgens used in contraceptives (cyproterone acetate), medication for benign prostate hyperplasia (finasteride) and testosterone replacement therapy, generally used for the management of the male menopause, can also be prescribed.

These are medications that are well known to GPs, and we are well versed in their potential side effects and effective monitoring.

So why is it that GPs are reluctant to take this on? There have been some well-publicised legal cases of doctors trying to help transgender patients – Dr Russell Reid was criticised for a lack of caution in initiating hormonal and surgical gender reassignment treatment, without more careful and thorough investigation and assessment. Meanwhile, his successor, Dr Richard Curtis, was also subjected to a lengthy investigation.

Fear of litigation is at the forefront of any doctors’ mind, but should this impair our duty to help our patients in the best way we can? GPs prescribe hormone patches for menopausal symptoms regularly, but if a trans man asks you to do the same, the response he experiences is often one of horror.

Not all trans people want to go through lengthy assessments, procedures, hoops and surgery – they just want the right hormones to suit their true gender.

These are actually very safe treatments, and delays in receiving care from GPs and NHS gender clinics mean that people are turning to illegal sources and unsafe forms of medication. In the very worst cases, death appears to be the only answer.

The other essential aspect of transgender care is listening, hearing, caring, educating, protecting – bread and butter to GPs. Often the key healthcare provider for the transgender patient, however, is an endocrinologist. Experts in their field yes, but have they honed their patient skills to the same extent as a GP? I would argue not.

So many of my patients tell me about the long journey they have to take, before even feeling brave enough to confide with their GP that they are suffering from gender variance, only to have their feelings dismissed or told that they will ‘grow out of it.’ 

 

Carry On Doctor

 

I have the following simple advice for GPs, which might just help any transgender patients they may come into contact with.

 

  • If you don’t know, look it up. There are many training resources and literature sources on gender care. Go to elearning.rcgp.org.uk/gendervariance
  • Listen to your patients, they are not mentally ill, they are gender incongruent
  • Their medical needs are often very simple – some hormone replacement therapy and a listening ear
  • The treatments are those that we use every day – put any prejudice aside and, if you think your patient is suffering from gender variance, get your prescription pad out
  • The cost of treating these patients is far less than the loss of life and distress caused by refusing them very simple, basic care

 

 

Dr Helen Webberley MBChB MRCGP MFSRH is a GP specialising in the treatment of transgender patients on the NHS and via her private online clinic. Go to gendergp.co.uk

 

 

An online petition calling for a reduction in waiting times for appointments at Gender Identity Clinics currently stands at over 5000 signatures. Add your signature to the petition.


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Making a packet: What would make you take drugs?

by John Pinching 7. August 2016 14:23

 

Why the human spirit must be reflected by pharmaceutical drug packaging

There is a suggestion of communism in the way prescription drugs are packaged. Apart from the odd conservative flourish, like a coloured line, our life-saving pharmaceuticals arrive in steadfastly plain and, invariably, white boxes.

Whether it’s Erythrocin, Viagra, Tenormin or Pioglitazone, you will always get roughly the same container – the blandness only punctuated by the product’s name and a smattering of Braille. In a way, it is a corner of our lives that will forever remain ‘East Germany’, where eggs and shoes and Beatles’ albums were packaged in much the same way.

This stripped back style even became the focus of a Damien Hirst series of artworks. These were created by exponentially increasing the dimensions of the package facade, replacing the product names with items of food such as ‘Chicken’ and exhibiting the results on a gallery wall.

Perhaps this was a clever study of how pharma products have become so omnipresent in our lives that we barely notice them, or that drugs are now as readily consumable as everyday groceries. Alas, I think this was simply an example of Hirst’s own addiction to selling arbitrary art for obscene sums of money  – somewhat ironically in this case, given the criticism aimed at pharma.

Curiously, the design situation in terms of prescription therapies is in stark contrast to ‘off the shelf’ medication, which appears to have licence to use all manner of glowing organs and pain-expunging go-faster stripes on which friendly headache-crusading capsules glide.

One might suggest that the more useless the product, the broader the brush strokes on the associated container. I defy anyone to have experienced relief from a cough medicine, and yet these are among the most flamboyant vessels on the high street – according to the label your windpipe will be draped in a phlegm-consuming ultraviolet blanket and your hack will soon be history. Hogwash – quite literally.

I do think, however, that pharma companies have – through a rather complex set of moral and regulatory reasons – resisted the opportunity to make their products excite, interact or even talk to consumers. I do, however, understand why classic simplicity has been the chosen exterior for so long – in the UK there has been a reticence when it comes to celebrating drugs, as accusations of illicit glorifying hang over pharma like a guillotine. Consequently, industry has had to retreat into an extreme Britishness where cutting edge, disease-curing science is condemned to a white box for eternity.

 

Between the Lines

In spite of pharma’s cautiousness, the government’s stance on how pharma should be presented, could be navigated.

I’m not expecting pharmacists to fire antibiotics out of a cannon, or your dose to be announced by the voice of Tom Hanks, but surely, the appearance of boxes could at least engender hope or excitement or even human spirit.

All the scientific wizardry and creative zeal that goes into the development of a drug grinds to a halt at the packaging treadmill. This habit is unique to our industry – theoretically nothing needs to have a glorious exterior. Cars and buildings could all finish up as white boxes  – but the architects of those products want their invention to uplift consumers. So why are the same principles not applied to pharmaceuticals?

The government document which provides guidance on the packaging of medicines is called Best Practice Guidance on the Labelling and Packaging of Medicines. How plain a box should be is not as dominating as you might think. It appears in item 4.3, thus: ‘Consideration should be given to the line-spacing and use of white space to enhance the legibility’.

The point made in 4.5, however, hints at the reason for pharma’s reticence: ‘The labelling of packs intended for supply against a prescription should include space for the placement of the dispensing label. It is recommended that this should be a blank white space.’

‘Recommended’ – that doesn’t constitute a direct order. You don’t cure cancer because you listen to every recommendation.

The point I am keenest to digest, however, is the tuna mayo, the BLT, the – if you will – cheese and pickle between 4.3 and 4.5. Yes, I’m talking about 4.4 – the optimistic filling between two slices of white. It states: ‘Innovative pack design that may incorporate the judicious use of colour is to be encouraged to ensure accurate identification of the medicine.’

Woah! If that’s not a blatant invitation for pharma marketers to somersault into a loop hole, I don’t know what is. It continues: ‘The primary aim of innovative design of packaging is to aid in the identification and selection of the medicine.’

I would venture to suggest that almost all drug packages are entirely indistinguishable, and that the opportunities clearly stipulated in 4.4 have been ignored due to the ‘insurmountable’ obstacles posed by 4.3 and 4.5.

We’re talking about multi-national companies, surely with a little reinterpretation, some origami and the drive to optimise patient experience, drug companies can waltz confidently into 4.4’s unchartered pastures.

I am convinced that drug boxes featuring scenes from Star Wars would considerably enhance the mission of picking up a prescription. And, if you don’t think George Lucas would be up for that – think again. The whole Jedi ethos is about combining technology with the possibilities of the mind. It could even yield an interactive online  game featuring our favourite characters attacking disease.

How about using album covers to decorate boxes or linking them to a sporting event. Perhaps every time a patient punctures a blister pack it could activate ‘crowds cheering.’ The possibilities are endless.

If I was ill and I went to pick up a box saying ‘may the force be with you’, would I feel motivated – hell yeah!

Tackling illness doesn’t have to be about ‘get drug, take drug, get better’ – it has to involve the human spirit and, if that results in a 1% increase in efficacy, it has to be worth it.

It’s time to start thinking outside the white box. 

 

Illustration by Alex Buccheri

 

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Not nice

by John Pinching 19. July 2016 10:24

Kevin Grogan is in Chicago as delegates launch fierce attacks on their drug pricing systems while kicking ours straight out of the park

The American Society of Clinical Oncology (ASCO) meeting in Chicago once again provided a fascinating insight into the leading research being carried out into tackling cancer but, unsurprisingly, the price of
drugs was a debate that rang around the halls of McCormick Place.

ASCO itself presented a modified version of its ‘Value Framework’ – originally published in June last year – which represents an attempt by the Society’s ‘Value in Cancer Care Task Force’ to develop a methodology which defines the currency of treatment within the context of rising costs, when applied to new and novel therapies.

Development of a software tool to aid cancer therapy decision-making will continue toward a pilot study by the end of the year, with the aim of conjuring up something much simpler for doctors to use while in conversation with patients.

Ah yes, patients. Fair play to ASCO, it is trying to address the problem of patient involvement – but are they a significant part of the discussion? No, I don’t think so.

With this in mind, I ventured out of the congress centre to actually speak to some American patients, and gauge their views on the cost of medicines. They have much to say and about one group in particular – the Institute for Clinical and Economic Research (ICER).

ICER is a Boston, USA-headquartered group, which describes itself as “a trusted non-profit organisation”, and has been in the headlines for a number of analyses. These studies have concluded that drugs are too highly priced and, in May, it focussed on myeloma treatments, stating that the price of some should be cut by as much as 94% to justify their true value.

The methodology used by ICER uses the quality adjusted life year (QALY) measure, which has some similarity to the equation used by the National Institute for Health and Care Excellence (NICE) in England and Wales. In terms of myeloma, its methodology has been slammed by Amgen and Bristol-Myers Squibb and the latter has said that its limitations could set up “arbitrary barriers to patient access.”

B-MS acknowledges that while “assessments of cost-effectiveness may prove useful in comparing treatments,
they have significant limitations”. It added that ICER’s assessments should “not be used for decision-making that determines access to innovative medicines”.

The problem is that they are being used for decision-making, according to Bob Goldberg of the Center for Medicine in the Public Interest. He told Pf Magazine that the NICE comparison is not particularly accurate, as the process in the UK is open and involves robust science-based dialogue. “What ICER wants to do is limit the spending on medicines to pay for roads, bridges and police. I find that to be offensive – I can’t get my mind around it”.

He also stresses that the headline list prices of products give a false picture, and further negates ICER’s flawed models. Discounts of 30%–50% are commonplace, because of rebates that drug companies provide. These rebates, however, worth billions of dollars, and are arguably being trousered by insurers and pharmacy benefit managers. Meanwhile, patients in the USA are being forced to pay 30% of the list price out of their own pockets.

Mr Goldberg believes that ICER sees healthcare in terms of cost – he essentially sees it as an investment. He acknowledges that cancer costs are increasing, but that is mainly because people are living longer, thanks to increased survival rates.

Is ICER therefore saying that survival is a problem? Quite the opposite, as it means that more people are alive to pay taxes.

At an event held at the home of the Chicago Symphony – concurrent with the ASCO conference – Jonathan Wilcox, co-founder and policy director of Patients Rising, said “the so-called ‘value-frameworks’ by ICER, and others, could re-shape the future of healthcare”.

He added that they “use complicated mathematical formulas to put arbitrary limits on the cost of new treatments.”

“The proposals could potentially harm the health and well-being of the millions of Americans with cancer and other life-threatening diseases,” he concluded.

 

We are not worthy

 

Would following the example of NICE be better for our friends across the Atlantic? No thanks, says the brilliantly-named Stacey Worthy, director of public policy for the Aimed Alliance, who was also at the Chicago Symphony event.

She has authored a report claiming that under NICE’s model, “priority in the UK has changed from providing healthcare to all consumers, to dividing up the care that is available, and distributing it equitably, regardless of individual circumstances and needs – the institutional rationing of healthcare. The same can be expected in the USA if insurers implement ICER’s price controls”.

Worthy believes NICE has led to “decreased quality of care, delays in treatment, increased mortality rates and a stifling of innovation”. Arguing that NICE has not approved a single breast cancer drug in the last seven years, she said, “England is a decade behind the other countries in Europe in terms of cancer survival rates”.

At present, England’s cancer survival rates are 15% lower than the USA’s rates. “We cannot afford that to happen here”, she added.

Worthy thinks that if the US healthcare system moves closer to the model on our side of the Atlantic, it will lead to higher mortality rates and poorer quality of care for patients. This may yield a short-term budget impact, but the long-term cost would be terrible for patients, Worthy insists.

Scorching words, but one thing is clear, the patient’s voice in the USA is getting louder and resistance to drug rationing will be ferocious.

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Head start: The mental health challenge has begun

by Claudia Rubin 18. July 2016 08:02

Mind matters: Claudia considers one of the greatest challenges of the modern age

 

There are some things we all know – healthcare costs rising, is one of them. Total healthcare expenditure in the UK from public and private sectors was £150.6 billion in 2013, having been only £54.9 billion in 1997. This equates to a ‘per person’ spend of £2,350 in 2013, more than two and a half times the level in 1997, when £941 was spent for each UK resident, according to ONS data.

Obvious explanations for these rises – like the ageing population, medical advances and patients’ greater expectation of their health – are not offset by technological change which, unlike in manufacturing for example, can only marginally reduce health costs.

It’s not often that a whole new area of health emerges that has the potential to impact healthcare services, and shape the thinking of policy-makers, across the board. The focus, however, that is now given to mental health is markedly greater than just five years ago, and has the potential to disrupt established healthcare norms.

As an indicator of its growing political capital, the term ‘mental health’ was mentioned 162 times in House of Commons debates from June 2005 to June 2010, compared to 847 times from June 2011 to June 2016. A massive achievement for those campaigning to get recognition and critical exposure for mental health sufferers.

It is also delivering results. There has been a near-universal acknowledgment of some basic requirements and a commitment to increasing services. 

In 2011, the government set an ambition that mental health would be valued as much as physical health. In October 2014, the Department of Health and NHS England set out standards for access to mental health services that people should expect, and how long they should have to wait for treatment. The government has also committed £1bn extra a year by 2020, which should help one million extra people a year to receive treatment.

Despite government pledges to establish parity with physical health, however, the amount actually spent on mental health by the NHS last year, was just 11.9% of overall NHS spending.

It is also the case that, although standards have been set, and a plethora of policy goals delivered from the highest level, not least the ‘Five Year Forward View for Mental Health’ earlier this year, the full cost of meeting these standards is not well understood.

This is why parliament’s Public Accounts Committee (PAC) – chaired by Labour MP Meg Hillier – has opened a new inquiry into the funding of mental health services. They note that full data does not exist to measure how far the NHS is from meeting the new access and waiting time standards, but it is clear that achieving the standards will be a very significant challenge.

Despite seemingly never ending increases in funding for healthcare, there are massive gaps in funding at almost every level. The Kings Fund offers a good explanation; “Between 2009/10 and 2020/21, spending on the NHS in England will rise by nearly £35 billion in cash terms – an increase of 35%. But much of this increase will be swallowed by rising prices. In fact, around £24 billion will be absorbed by inflation, leaving a real increase of just £11 billion [a 10% rise over eleven years; equivalent to an average annual increase of just 0.9 %].”

So we can see how significantly this new, quite proper, commitment to treating mental health may increase the pressure on budgets. One in four adults reports being diagnosed with a mental illness at some point in their lives. Government has committed to providing additional money, but there will be competition for this funding. CCGs will have impossible decisions in terms of delivering mental health commitments without sacrificing other services.

This is where the developing field will impact upon everyone invested in healthcare delivery in this country. Since the Commons PAC inquiry opened in May, almost 100,000 testimonies have been submitted by the public, emphatically highlighting the lack of NHS services.

Where cancer funding once had to compete with heart disease, and then with huge levels of spending on dementia, into the mix comes the realisation that mental disorders are not restricted to the ageing population, but of critical importance through school years and beyond.

 

Dual complications

There is no mutual exclusivity at play with mental health. Chronic pain, illness or weight problems; these physical conditions may be complicated by associated mental health concerns, and successful treatment of the former can be impossible without addressing the latter.

In 2014-15, 3.3 million people were known to be suffering from depression. Building the mental health workforce is a challenge, and an expensive one. Evidence from past initiatives indicates that it takes years to embed change successfully across the health system.

Typically the pharmaceutical industry has had a smaller stake in mental than physical health, though there are a range of medications available for its treatment, such as anti-psychotic drugs, anti-depressants and mood stabilisers. 

Many of these have attracted controversy for prescribers and manufacturers, with growing levels of addiction to opiates and benzodiazepines adding another dimension for policy-makers. As the government pushes the NHS to deliver higher standards, the Prescribing Observatory for Mental Health (POMH-UK) – which aims to help specialist mental health Trusts improve their prescribing practice – will also grow in importance.

It is likely that the pressure on NHS funding will necessitate greater engagement with mental health from across industry and its partners. 

Though the ABPI’s Pharmaceutical Mental Health Initiative (PMHI) currently comprises just three companies, its description as “a group of ABPI member companies with an interest in mental health” suggests it ought to be larger. Policy-making in the health sector must increasingly take a holistic view from across health and social care, and it is advisable that we all engage better with how the NHS delivers vastly improved mental health outcomes.

 

Claudia Rubin is a Government Affairs Strategist at Decideum. Go to decideum.com

 

 


 

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

by Hazel Lodge 12. July 2016 14:06

 

 

 

 

 

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