Medical advisory body “NICE” should not spend too much time valuing drugs.

The UK National Institute for Health and Care Excellence (“NICE”) is currently holding a public consultation over its proposals for evaluating drugs. Drugs that are approved by NICE automatically become available for doctors to prescribe under the NHS throughout England and Wales, although local Clinical Commissioning Groups run largely by GPs are free to make other products available. In the light of the pricing scheme negotiated between the Department of Health and the drug industry (“2014 PPRS”) a strong case can be made for NICE to put more resources into focussing on which specific drugs represent the best medical option and less resources into complex economic assessments.

NICE should continue its present, very valuable, principal activities of evaluating non-drug medical procedures and products such as surgical operations and methods of diagnosis as well as making recommendations relevant to public health. The Institute’s work is internationally respected for the quality of its recommendations on a wide range of medical issues and plays a major and growing role in informing and educating doctors, other healthcare professionals and policymakers. Only a small proportion of NICE’s work relates to advice on drugs. However, well researched, unbiased opinions help to stimulate discussion, recognition and acceptance of medical advances amongst doctors. Such work is always welcome on both drugs and other treatments because of the limited amount of independent analysis.

Whilst most of NICE’s work is to be commended, the Institute is in danger of putting a lot of effort into assessing the value of drugs out of proportion to the benefit. My recommendations are:

  1. NICE should aim to avoid repeating work already carried out by regulatory bodies.

All newly marketed drugs are believed to be of potential benefit to someone. If they were not, they would not get approval through the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and from similar overseas bodies such as the FDA in the USA. There is no need therefore for NICE to give a medical opinion on whether a drug should be available for any particular use or not. The MHRA decides for what uses drugs are approved.

  1.  NICE’s proposed work on the financial value of drugs should be reduced because it will be of less importance under the 2014 PPRS.

NICE does not protect the NHS drug bill because this is effectively determined by a scheme (the”PPRS“) negotiated between the drug industry and the Department of Health. The scheme currently provides that the total NHS bill for branded medicines will grow as follows in each of the coming five years:

2014   2015   2016   2017    2018

0%      0%      1.8%   1.8%    1.9%

If sales exceed the above targets the industry will pay a full rebate with companies each contributing a proportion relating to their sales.

The only purpose served by NICE finding that a drug is too expensive is to protect the rest of the drug industry from having to pay an excessive rebate. This protection does not justify all the effort to which NICE proposes to go.

  1. Rebates received by the Government under the 2014 PPRS should be reflected in the budgets of Clinical Commissioning Groups so that they do not restrict the availability of drugs unnecessarily.

Clinical Commissioning Groups established under the Health and Social Care Act 2012 are the most important, direct controllers of NHS funds used to finance drugs. The benefit of having a national policy over drug prescribing and pricing is limited if the benefits are not passed on at a local level.

  1. The most important, general decisions to be taken over NICE’s methodology for assessing drugs are political, philosophical or ethical.

NICE’s evaluation of drugs involves looking at the difference between how much longer a patient would live with the drug compared with previously available therapy. An adjustment is made to reflect the quality of life in each year. This approach involves the concept of a “QALY” (Quality Adjusted Life Year). If, for example, a patient taking a drug was expected to be in perfect health for the rest of his life and to live ten years but without the drug he would live only six years with half the quality of life, the drug would cause an increase in QALY of (10 – 6/2) = 7. Academics and economists differ enormously about how much a QALY is worth and what adjustment factors should be applied for quality of life under different circumstances but the Government and the drug industry have agreed that for the coming five years a QALY will have a minimum value of £20,000. In the example earlier in this paragraph the gain in QALY is 7 and is therefore considered to be worth at least £140,000. Assuming that the drug has to be taken for the rest of the patient’s life, the product is therefore worth more than £14,000 per annum. The basic idea is that NICE would recommend against the drug if it was priced too far above £14,000 per annum.

The QALY system in its simplest form has had many drawbacks. The most obvious were a lack of consensus over how much a QALY is worth, how much adjustment is appropriate for quality of life in different circumstances and how much benefit a new drug really has. The MHRA will approve a drug when it is convinced that some patients will benefit from its availability and that it is sufficiently safe. The MHRA does not need to know exactly how great the benefit is and indeed may not find out the full picture until the drug has been in widespread use for several years.

Another disadvantage of the simplest QALY methodologies is the lack of allowance for benefits to people other than the patient, for example, carers, employers and health professionals. The value based on the basic QALY of £20,000 can be given a discretionary boost by a factor of up to 2.5 (i.e. to a maximum of £50,000 per QALY) to take account of factors not adequately represented in the basic £20,000 QALY.

The QALY system is perhaps the most honest way of valuing a drug intellectually but can only lead to controversy because of the unavoidable subjective element and variations between patients. The simplest systems also have a bias against the elderly and people with a short life expectancy because they have fewer remaining QALYs. NICE recommends considering a “Proportionate QALY” system, under which the value of a drug would be assessed not by the absolute increase in QALY but by the percentage increase. NICE would consider the position using both methods. This methodology helps the elderly and terminally ill but the two systems support a radically different list of recommended drugs.

Many other possible approaches involving QALYs exist. For example, a “Fair Innings QALY” has been considered where the increase in QALY is calculated as a percentage if the patient’s expected whole lifetime QALY.  A large number of alternative systems could easily be devised. Value-based assessment is not a precise science. Much of the published work is no more than a selection of subjective, fashionable opinions held by some influential health economists and academics who specialise in the area. The true decisions are political, ethical and philosophical and are largely a matter of personal belief and conscience.  Is the life of a convicted terrorist really worth the same as that of a young mother? Is the quality of life of someone with Alzheimer’s disease better or worse than for a person with terminal cancer? How much is an average human life worth? The media and politicians are paying less attention to such questions than is deserved. One reason is that much of the debate appears more complex than it is because of the language in which much of the material is expressed.

  1. The variation in the response of patients to drugs is too great for NICE to consider all possible circumstances.

Helping to consider the exact population of patients for which a drug is appropriate is certainly a useful activity for NICE to undertake. However, whilst discussion and debate is constructive, the final decision should rest with doctors in consultation where appropriate with patients. There are simply too many differences between patients and their illnesses for NICE to be able to cover every possibility. The wide variation makes any attempt to use a particular price as a cut-off point for a drug inherently unfair. The cost of giving a drug to a patient obviously depends on a number of variables such as the dose, which provides an example of one cause of widely varying costs. The optimum dosage for a patient may be affected by issues like the following;

i)    The weight of the patient.

ii)   How rapidly the patient excretes or uses up the drug.

iii)  The stage or severity of the disease

iv)  Limitations caused by side effects. Some drugs work best if used at the highest possible       dose with acceptable side effects. Different patients may experience different side                 effects and therefore be able to tolerate different doses.

v)    Combination use of drugs. Some patients may receive two or more drugs for the same         condition. Depending on whether there is synergy between the different drugs dose             may be affected.

In the real world the highest used dose of a drug can often be two to five times higher than the lowest. Variations of this magnitude make a mockery of any value-based assessment involving a single price target. In addition, a drug may be preferred because it is more effective or cheaper than alternatives, but this can be just pie in the sky to a patient who is allergic to it or for whom it is contraindicated.

  1. Some of NICE’s conclusions seem to be compromised by a focus on political correctness.

NICE has been partly motivated by a fear of becoming entangled in the forms of discrimination that are illegal or contrary to the ethos of the NHS. Nobody should be disadvantaged or held back on grounds of age, race, ethnic origin, gender, sexual orientation or religion. However, there is a danger that NICE will follow inconsistent and flawed systems in the name of equality by taking decisions that are unnecessary to avoid unacceptable biases. There are many circumstances where best medical practice for all requires the circumstances of different groups of people to affect treatment or screening policies. The following is just a few non-controversial examples.

a)    Women in the UK on average live longer than men.

b)    The incidence of many diseases such as cancer and most forms of dementia increase             with age and is the greatest in the elderly. Some complaints are quite different. For               example, lupus is most frequently diagnosed in women of childbearing age.                            Chickenpox is commonest in children. Any screening programme that does not focus on        the patients most at risk is absurd.

c)     Skin cancer occurs principally in fair, white people.

d)     Some drugs, for example certain blood pressure lowering products, work less well in patients of certain ethnic origins

e)      In the Ashkenazi Jewish population one in four individuals is thought to be a carrier             of one of a number of potentially harmful genetic conditions.

The efforts of NICE would be best directed at recommending what is medically and intellectually best rather than taking political decisions under cover of jargon and a methodology.

  1. Value-based assessments of drugs should be based on the best reasonable forecasts, not purely on hard facts.

When the MHRA is considering the approval of a drug, a very high burden of proof is rightly required. We do not want patients to suffer serious unexpected side effects because of the unproven views of regulators or other advocates. We also want to know that the drug does what the manufacturer claims. There is no room for shortcuts or unsubstantiated opinion, even from experts. Doctors need confidence that all the necessary tests have been carried out before launch.

The position with work done for economic or financial purposes is quite different. An economist, manager, politician or investment analyst is supposed to take account of what is expected to happen in the future.  He cannot say that he chooses to rely solely on what has been proven beyond reasonable doubt.

Some of the decisions by NICE to have received the most criticism have occurred because NICE has rejected expert opinion about the future owing to uncertainty or a lack of proof. As in the case of Alzheimer’s disease NICE has sometimes changed its mind after the necessary evidence has become available. If we accept that NICE’s forecasts would be better than random, patients would be better served if these forecasts were followed rather than by an assumption that the present state of knowledge will continue.

  1. There is insufficient emphasis on R&D and innovation.

The whole point about giving the pharmaceutical industry attractive UK prices is to encourage R&D for the long-term benefit of mankind and to make the UK a favoured country in which to invest. The aim is not to squabble about the financial value of individual drugs, a process which undermines confidence and creates ill feeling. Under the 2014 PPRS doctors could be allowed to prescribe all drugs that they wish. The total bill to the NHS would still be fixed with the risk being taken by the pharmaceutical industry.

Hopefully the present public consultation will see an appropriate level of public debate and will result in many of the issues being resolved or clarified without the need for further Government intervention.

Posted in Business, CCGs, Commissioning, Department of Health, Drugs, Elderly, equality, Genetics, GPs, Health and Wellbeing, Health Bill, Health reform, Inequality, Innovation, Jeremy Hunt, NHS, NHS reforms, Patients, Pharma, Policy, Public Health, Research, Technology, Uncategorized, Wellbeing | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

AIDS Today: The Facts, Figures, and Trajectory of a Global Illness

Ahead of a forthcoming report from 2020health on HIV and National Youth Aids awareness day on 10th April, here are some interesting statistics:

AIDS

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Why isn’t the NHS taking fraud more seriously?

It’s surely common knowledge now that the NHS is under massive cost pressures. This weekend saw the Royal College of GPs up its publicity campaign with alarming warnings that GPs will become ‘extinct’ if they don’t get a greater share of NHS funding – currently standing at 8.39% of the overall £110Bn NHS budget.

But did you know that estimates of NHS fraud across the whole system amount to over a third of the total amount that GPs receive? Some go further. Total losses of at least 3% are a reasonable assumption if the NHS is no worse or better protected than the best found international healthcare organisations, which equates to over £3 billion per year. Jim Gee who set up the original NHS Counter Fraud Service in the 1990′s now estimates fraud account for closer to the equivalent of 80% of what we spend on GPs, a whopping £7bn. Either way we are talking enormous sums, and it is the subject of tonight’s BBC Panorama programme.

The modus operandi of fraudsters are well known: stealing-money

A. Claiming for work that does not exist e.g.

Professionals creating ghost patients

Professionals working elsewhere while off sick

Managers making fake timesheet and payroll claims

Suppliers making bogus invoices

B. Claiming for higher value items e.g.

Professionals dispensing a cheaper product than claimed for

Professionals altering patient treatment details

doctors-prescriptionC. Securing materials/services on false premises e.g.

Community Professionals claiming for excess car mileage

Patients obtaining controlled drugs

D. Insider theft e.g.

Professionals theft of prescription forms

Professionals theft of inventory

E. Fraud and error e.g.

Patients wrongful claim of exemption from fees

Professionals over-prescribing, requested or administered

Since 2020health’s reports of 2011 highlighting the problems of fraud in the NHS (both alone and in partnership with the Centre for Counter Fraud Studies at the University of Portsmouth and the European Healthcare Fraud and Corruption Network), there appears to have been no systematic action taken to reduce fraud in the NHS. Indeed, since the 2012 Health Act, with more contracts being procured and an increase in transactions, the opportunities for fraud will have expanded. And whilst opportunities for fraud have increased, the workforce dedicated to reducing and detecting fraud in the NHS (NHS Protect) has been reduced by 21% and none of the recommendations we made three years ago have been acted on.

Quite simply what we previously called for is still required:

  1. An end to secrecy – Clarification of NHS Trust responsibility around reporting of counter fraud activity and spending to the public to enable transparency and accountability. Foundation Trusts can still hide behind ‘commercial sensitivity’ clauses and refuse to reveal data on losses.
  2. Outcomes not process – Change in the reporting requirements to provide clear and accurate outcomes information about how much losses are, to what extent they have been reduced, to what extent fraud losses have been recovered, and what preventative measures are in place. There is still no legal requirement for an NHS organisation to know or publish their financial losses. If they don’t know what they are, how can they start to tackle them?
  3. Consequences for concealment – Fine NHS Trusts who do not publish their counter fraud outcomes.

As demand on NHS services grow, we are perplexed as to why politicians have been so complacent about fraud. After we published our previous reports, Department of Health officials simply dismissed the numbers as being over inflated. Maybe so, but until NHS Trusts and now Clinical Commissioning Groups (CCGs) as well, start measuring their losses, we will never know how much money that should be being spent on patient care is actually ending up in the pockets of those in whom we are placing so much trust. GPs through their CCGs could lead the way by measuring their losses and showing the rest of the NHS that being accountable for your budget also includes making sure it is all spent on patients.

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The welfare reforms are having an impact on mental health and well being

Guest Blog by Councillor Sanchia Alasia, London Borough of Barking and Dagenham

The current cost of living crisis and the severe austerity measures have been felt quite strongly among our residents. Unemployment remains high in the borough where I live in Barking and Dagenham, and welfare reforms as well as the ‘bedroom tax’ means that households that were already struggling are finding it more difficult to manage their finances day to day.

The council’s Health and Adult Services Select Committee which I chair has recently concluded a six month in depth review, looking into the impact of the welfare reforms on mental health. The committee found that increased financial pressures have led to more people suffering from stress, anxiety and depression. Our resident’s mental wellbeing has been affected by continuing to live in hardship and uncertainty and we have seen increased numbers of people presenting to GPs and other health colleagues with stress-related symptoms.

The Committee has had a particular focus on what crucial support is available to our residents during these troubled times. Where do people suffering from emotional distress go to for help? How do our local services cope with increased demand when our council is being forced to make cuts to so many of our services? Because our review found that the recession has had a negative impact on our residents, it is imperative that we ensure that they receive the support they need at an early stage, so that they are able to cope. Early intervention is important and to that end our council is proactive one. We have done a significant amount of assertive outreach work to engage those already identified to experience cuts to their benefits and work, to establish early solutions such as gaining employment or downsizing their home. There are already in place a number of services that offer information guidance and advocacy to help inform residents of their options and provide guidance around financial hardship and benefits advice including practical support in the shape of our local credit union, which offers saving plans and a much cheaper way to borrow money. We are also delivering over the next few months a number of ‘mental health first aid’ training course, which provides increased awareness to professionals and residents across our borough, delivered by Mental Health First Aid England.

Our Committee’s review comes at a time where the government’s welfare reforms and the introduction of the spare room subsidy are having a severe impact on household incomes, both on those who are working and those who are unable to work for legitimate reasons. The Committee felt that it was important to understand the snowball effect of all the benefit changes coming into force in close proximity: the bedroom tax, housing benefit cap, universal credit and loss of disability allowance, so that we and our stakeholders could help residents deal with the changes in a holistic way.

We will continue to measure the needs of our population and the impact of the welfare reforms and the actions we have taken as well as continued monitoring of key local services to ensure that they remain fit for purpose including our specialist advocacy, local emergency support services and credit union.

Links:

Barking, Dagenham and Havering Credit Union www.lcu.org.uk
Mental health first aid course www.mhfaengland.org

 

 

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Another reason to see your physiotherapist

Guest Blog from Professor Karen Middleton, Chief Executive, Chartered Society of Physiotherapy.

The first physiotherapists have just completed the rigorous training to enable them to independently prescribe medicine to patients.

This is an important moment for our profession – recognition of the skills and expertise held by physiotherapists.

But more importantly, it represents a big step forward for patient care and will bring benefits for people with a whole range of conditions, including asthma, arthritis, stroke and chronic back pain.

The benefits for patients are clear.

It will remove the need for a return visit to their GP or consultant in order for them to get a prescription.

And speeding up access to their medication should mean they get more from their physiotherapy as, for example, the pain-killers allow greater movement of an injured joint.

Since 2005, some physiotherapists have already been able to complete training to become what is known as a supplementary prescriber.

This means they are able to prescribe medicines with the agreement of a doctor and the patient as part of a clinical management plan.

While physiotherapists have seen improvements to care from this work, many have been frustrated that their patients experienced delays in receiving medicines whilst waiting for a prescription to be counter-signed by a doctor.

The new system will remove those delays and improve patient care as a result.

Doctors recognise this, with both the Royal College of GPs and the British Medical Association welcoming the new responsibilities for physiotherapists.

And there will be broader benefits to the NHS as patients need fewer appointments to get their prescription and – through more effective treatment as a result – do not experience a deterioration in their condition that may require a hospital admission.

There will, of course, be strong safeguards in place to ensure patient safety.

The physiotherapists who take up this new responsibility will be experienced, advanced practitioners who can only prescribe medicines within their range of expertise – respiratory conditions, for instance.

They will have completed a training programme validated by their regulator, the Health and Care Professions Council.

And any prescribing decision will be communicated to the patient’s GP and any other clinicians involved in their care.

There is actually potential for new system to improve safety, as the person prescribing the medicine will be seeing the patient regularly so will be able to monitor progress, ensure compliance with the drug regime, and quickly identify any potential problems.

While training is underway in England, changes to regulations in Wales that will pave the way for independent prescribing are hoped for this year.

Scotland’s changes are expected soon but Northern Ireland has yet to make an announcement.

This new responsibility for physiotherapists is landmark in the development of our profession that will bring broad benefits for patients, doctors and the NHS as a whole.

For more information on independent prescribing, or physiotherapy in general, visit www.csp.org.uk

 

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Is section 119 wrong…

Having been submerged under Syria, floods and Sochi, Healthcare has emerged again like spring daffodils to be the talk of the news. Dorrell and Burnham slogged it out yesterday on Radio 4′s Today over section 119 and the vote was mentioned again today; genetic testing for Alzheimer’s was kicked back into touch (fabulous England win on Sunday by the way) as we were told not get excited by the latest research, and written press revealed (again) the black market growth in kidney sales.

Back to section 119 – the Commons vote on this section of the Care Bill today. I wonder whether reason and logic will prevail and we’ll have a frank debate about delivering quality and safe services from a NATIONAL Health Service, or whether localism wins (read local votes) and MPs default to protecting their ‘Neighbourhood’ Health Service as symbolised by bricks and mortar.

OK, I don’t wonder, we won’t. Because although section 119 will be rejected by those who say they will defend their local hospital to their dying day (which will probably be in the said hospital) and it must not be cut (and privatised, as if the two went together), the real reason to reject section 119 is because it represents another failure of communication and vision, of putting the stick in place before describing to the public what choices are before the NHS.

Maybe I am being idealistic, naïve, ignorant even, but we all want the same thing: a sustainable, safe NHS fit for the 21st century. It doesn’t take a genius to realise that a National service means that health economies are interconnected, but nor does it defy reason that people object when their local hospital is put in jeopardy by the failure of surrounding organisations, as happened in Lewisham.

We need national, political involvement when it comes to strategic planning of the expensive, specialised services; we need local engagement when it comes to improving the efficiency of neighbourhood services. The thinking behind Foundation Trusts public engagement was good, but unfortunately this cemented the NHS as a National Hospital Service as no one had the vision to describe where care should be best delivered in the future.

The Secretary of State is now looking for the power to make reconfiguration happen, but just like the recent care.data debacle, which crashed because of the total lack of narrative and disregard for public understanding, section 119 is putting the cart before the horse. The public deserve better. They deserve considered debate and consultation on the future of the NHS as a whole. A serious, large scale initiative to communicate the issues needs to be mapped and rolled out. It’s urgent but it mustn’t be rushed. That there is no one-size fits all solution must be clear. That to improve quality and safety, services mustn’t be cut but delivered differently. That there isn’t enough money to deliver everything, let alone everything everywhere must be broached. Anything else will simply result in more ‘save the NHS’ campaigns with no one working from the facts.

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Dementia….what’s in a word? by Dr Iseult Roche

Jeremy Hunt’s outstanding pledge to tackle Dementia in the UK at the international summit in Paris, is welcome news.

The exceptional step regarding the pledge to aid faster diagnosis times for those with suspected dementia, further funding, better awareness through partnerships with large businesses, leading the research agenda and also a dementia Tzar to promote the cause, must surely lead to progress and breaking down of barriers.

However, some sufferers, with early stage of the disease, fear a ‘one size fits all label ‘ could be created.

The majority of the UK referrals for an absolute diagnosis are already at the 6 week proposed time scale, although it can vary significantly and unacceptably in some areas – highlighted already as Sheffield and Cambridge and Peterborough (1)

However, at present, regardless of an absolute diagnosis, treatment is still very limited and although some medications may be beneficial and supportive management via memory clinics can be useful, there is no definitive cure or optimum treatment.

There are many forms of dementia and each can progress differently and will also vary in progression and impact from one person to the next. As such, from speaking to sufferers and their immediate families since the good news of this pledge was released, there has been slight caution from some – who fear stigmatization and preconceived ideas go hand in hand with the diagnosis.

There can be no doubt that the improvements outlined by Jeremy Hunt are welcome, however it may be important to remember that any term can have a double edged sword.

In an ideal world, a definite diagnosis would lead to optimum treatment, support and future planning for sufferers, families and carers… But in reality it will take considerable time and education for most people to gain better understanding and an equally long time for stigma ( both perceived and actual ) to fade. Perceived (self) stigma can be equally damaging and could also contribute to depression.

One early staged sufferer told me they did not want a “label” which would “mark them out” and continued that although their memory wasn’t what it was, once it was ‘labelled’ “you feel it takes over your personal identity” As they were still functioning well and were competent, I could see this was possibly a valid point (at least while the progression was still early).

However, my personal thought was that surely absolute diagnosis is useful, I was contemplating this, when I saw a patient, accompanied by their son.

This very elderly patient * had presented with a minor physical entirely non-dementia related issue, was functioning at home well, lived alone, was independent of daily needs (although had meals delivered ) and upon conversation was fully oriented and competent… They were due to move in with their son that week.

In their medical history was a diagnosis of early stage dementia

Their minor medical treatment was given. Physically all was stable and socially all was safe, however, from an emotional perspective this was the tip of an iceberg.

The patient’s son could not get passed the diagnosis of ‘early stage dementia’ and constantly questioned the validity of his parent’s opinion, behaviour, state of mind and coping ability.

He was paralyzed by the diagnosis and it had detrimentally impacted on their relationship and the way he perceived his parent…. He had ‘lost’ his parent and the person in front of him . In reality this was a very sad situation as his parent was very much there! Interlaced were also his personal fears of developing it too, which he mistakenly thought was a certainty.

This demonstrates the need for better education and support – and shows the dementia pledge is a huge step in the right direction, it will be down a down a long path. Society will undoubtedly change with this pledge and with an aging population this is an area which will become more dominant. However, social support factors to keep people in their own homes, and provide trusted home care and respite services for dementia sufferers and their families are vital and still need review and progress.

*NB patient details modified to ensure anonymity and confidentiality .

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