Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Improving NICE
- John A Stapleton (24 November 2006)
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NICE isn't doing it's job
- Jonathan Bensley (24 November 2006)
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The "fourth hurdle" downunder - still there
- Ruth Lopert (24 November 2006)
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NICE guidance on dementia treatments
- Kallur Suresh (25 November 2006)
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Cost and cost-effectiveness
- Roger A Chalmers (27 November 2006)
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Re: Cost and cost-effectiveness
- Phil Miller (29 November 2006)
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Australian PBS is under pressure from American companies
- David A Henry (4 December 2006)
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Flexibility and Psychological impact
- Munir E Nassar (7 December 2006)
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Support for NICE
- David N Griffith (23 December 2006)
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John A Stapleton, Medical Statistician Kings College London
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Articles in this weeks BMJ imply that NICE governs the use of NHS drugs. It does not. NICE offers only guidance to clinicians and their funding Trusts. The suggestion that the role of NICE could be improved by also offering guidance on which treatments should be cut whenever they recommended a new technology is totally unworkable. NHS funding is organised locally to meet local needs, and one rule could never apply to all situations. However, NICE could be improved if it were asked to producing league tables of the most effective and the most cost effective treatments for each condition, rather than simply offering guidance on which treatments are sufficiently cost effective within the current NHS budget. Effectiveness must be considered separately when making decisions about which treatment to use because increasingly there will be situations where the most cost effective treatment is also the least effective. The seriousness and projected course of a disorder might often necessitate the use of a less cost effective, but far more effective treatment, as the first option. Competing interests: None declared |
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Jonathan Bensley, Biomeical Sciences Student Monash University, Australia
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I would contend that NICE isn't doing it's job adequately. The total fixation on cost, with almost total exclusion of anything else (such as quality of life) is inappropriate and doesn't provide what I think most people would think would be a correct judgement on the value versus cost of drugs and interventions. I can only imagine the scenario of the healthcare economist needing a very expensive drug and not being able to get it. Would he/she lay back and say... 'well... the cost effectiveness is over 60,000 pounds so it really would be better for me to die sooner', or would they scream and yell for the drug despite the cost? What's even more bizzare is that the NHS constantly complains it doesn't have enough money, whilst blowing over 10 billion pounds on an IT system that doesn't work. There is obviously a place for rationing healthcare, resources are not unlimited. However, the NHS has time and time again shown it is incapable of spending taxpayers money wisely and in a manner focused on patients, rather than a fanatical concern for cost and love of administration/IT. With things like the rejection of carmustine and temozolomide (except performance score of 0), it took on the abusrd. The total cost to the NHS would have been very small and whilst neither are curative, do extend life. These patients currently have very few treatment options, and both these agents do work. Then there is the rejection of pemetrexed. NICE rejected the only drug currently approved for the treatment of malignant pleural mesothelioma, suggesting that patients be given other drugs not approved for this indication, but used anyways. Bizzarely however, Imatinib was rapidly given funding by NICE, as was Trastuzumab. Both of these were pushed by the press very heavily. If only temozolomide and pemetrexed got such public attention... Competing interests: None declared |
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Ruth Lopert, 2006-07 Harkness Fellow in Health Care Policy Department of Health Policy, George Washington University, 2021 K St NW, Washington DC 20006
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The statement that "Australia's groundbreaking initiative to establish such a "fourth hurdle" crumbled under pressure from the US drug industry. An unholy deal was struck that allowed Australia access to US markets in exchange for unrestricted access to Australia's pharmaceutical market" simply cannot go unchallenged. The listing and pricing processes which mandate assessment of cost effectiveness as a prerequisite for formulary listing on the Australian Pharmaceutical Benefits Scheme have not "crumbled under pressure". There have been no changes in the degree of access US Pharmaceutical companies have to the Australian market as a result of the Australia US Free Trade Agreement. The pharmaceutical provisions of the AUSFTA are largely process related, impacting on the timing, transparency and consultation of the PBS processes. The FTA provisions have not altered the fundamentals of the PBS listing and pricing processes, but if anything have strengthened these by facilitating a greater degree of transparency than was hitherto the case. Australia’s “fourth hurdle” remains very much intact. Competing interests: None declared |
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Kallur Suresh, Consultant in old age psychiatry and honorary senior lecturer Derwent Centre, Princess Alexandra Hospital, Harlow, Essex CM20 1QX
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Dear Editor I understand your point that NICE has a job to do in looking at which interventions are evidence-based and effective and then recommend them (or not) for general use in the NHS based on their appraisal of such treatments. The work of NICE has so far been commendable in validating a lot of what clinicians were doing when treating patients and providing a framework for good practice. However, its latest guidance on the use of cholinesterase inhibitors in Alzheimer's disease is a 'restrictive' guidance rather than an 'enabling' one like its previous 2001 guidance on the same drugs. The problems with the new guidance are manifold. The most fundamental difficulty for individual clinicians trying to implement it is this - to give patients the bad news that not only have they got Alzheimer's disease but also that they can not be treated with medication until they reach the stage of 'moderate severity'. It conflicts with a doctor's duty of care to patients as set out in the GMC's 'Duties of a Doctor'. How will we be able to justify withholding a treatment, that is acknowledged to be effective (even by NICE)? The validity of the definition of stages of dementia based on the Mini-Mental State Examination (MMSE) scores is questionable. MMSE scores only act as a guide and vary considerably from one occasion to the next. They are infuenced not just by cognitive abilities but also by several other unrelated factors. It is worth remembering that these stages of dementia are our conventions rather than validated entities. They merge imperceptibly into each other, with considerable overlap. So patients and families may not accept the clinician's judgment on the staging of dementia. To take such unreliable scores as the yardstick by which to determine whether someone gets treatment or not is not only inaccurate but unethical. There has to be a degree of flexibility which will allow clinical judgment to be part of the decision making process as well. Patients can of course obtain these drugs privately. It increases inequalities in access to treatment based on ability to pay. The new guidance also deprives those patients who are likely to deteriorate rapidly, of the chance of slowing down the progression of their disease, as it is difficult to predict which patients will have an aggressive course of disease. For the carers, who are the real victims of dementia, the burden of caring may increase from the early stages of diagnosis. In the long term, the guidance is likely to have a negative impact on research into treatments for dementias. With the population of older people predicted to increase rapidly in the coming years and decades, there will be more patients than ever with Alzheimer's disease who will need treatment. How can we ensure that we support them to live active, healthy and independent lives for as long as possible, as set out out in the National Service Framework for older people? Competing interests: I have received sponsorship to attend a conference from a company that makes one of the drugs in question. |
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Roger A Chalmers, GP locum Many GP practices in East Anglia
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When considering which treatments should be funded by health services, I find it staggering that the market price of a new drug is almost invariably treated by both scientific and populat press as an absolute, non-negotiable quantity. In a free market, which is what the drug industry claims it wants, the cost of the product should be the starting point of any negotiation. Naively, many of us have assumed that market prices of new drugs reflect the cost of developing that particular agent, even though the industry is transparent about the fact that this is not the case and price is purely a commercial decision based on what the market may take. Obviously a non-profitable drug is not going to be marketed, but the simple facts - trumpeted regularly in media business reports - are that the pharmaceutical industry generates astronomical profit to investment ratios, far exceeding those of most other major industries. Thus there is clearly room for manouevre on product prices even for new agents while still generating fat profits and hansom 'shareholder value'. Why do public, medical, and political campaigns, for specifc drugs like Herceptin not address product price at all while bringing huge pressure to bear on local specialists and funding authorities, and on NICE? Until this is done, we are certainly not operating in the free market conditions that drug companies claim they want. Indeed, as recent US pressures on the NHS and German health services have shown, commercial interests are increasingly hiding behind a fig leaf of free market ideology (as they have long done in such areas as agriculture, to the massive detriment of world health). As for recent claims that a 'free market' will drive down drugs costs in the NHS (voiced by US Health secretary Azar) - why then are so mnay drugs (especially generics) more expensive in the US than in the supposedly restricted markets of Canada and UK? (And why did the Bush Administration - self-styled champions of the free market - do all it could to stop their own people accessing cheaper Canadian drugs?). As with so much that is happening to our own health service, appeals to the free market are so often merely ideological spin, cloaking politically protected commercial interests and based on no evidence at all. Not surprisingly industry is always ready to lend its support to emotive calls for specific drugs from desperate patients - gaining massive free advertising into the bargain - while treating their astronomical profits as sacrosanct. Until the role of big pharma in this problem is addressed, as it has not been even in otherwise excellent BMJ editorials, and until doctors stop colluding with the illusion that it is merely an issue for NICE, cash strapped PCTs, or hard pressed local clinicians, patients will continue to be the losers - whether due to lack of access to unnecessarily expensive new treatments or through cuts in other services needed to fund them. Competing interests: None declared |
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Phil Miller, Research Nurse Queens Medical Centre, Nottingham UNiversity Hospitals, Nottingham NG7 2UH
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Chalmers' (rapid responses) contribution suggests an interesting potential addition to NICE guidance. In future, NICE reports should include a price for each drug regime at which it would, ceteris paribus, deliver cost effectiveness for the NHS. That would rebalance the argument (I hesitate to say nicely) between the drug industry and the NHS. NICE would continue justifying its guidance on the basis of the available evidence. The drug industry could then be encouraged to give a breakdown of the difference in the two figures in terms of their expected return on investment in development and marketing (including funding of patient groups, conferences etc) taking into account the expected endurance of its patents and other relevant factors. Whatever the outcome of the current legal action, if it is transparency the drug industry is after, many of us would welcome their showing us the way. Competing interests: None declared |
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David A Henry, Professor of Clinical Pharmacology School of Medicine and Public Health, The University of Newcastle, Australia
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Ruth Lopert is correct in saying that the Australia United States Free Trade Agreement (AUSFTA) has not led to the demise of the Australian Pharmaceutical Benefits Scheme (PBS). But it would be a mistake to conclude that the PBS has been unaffected. It was never likely that the AUSFTA would lead to immediate changes, but like NICE in the UK the PBS is under pressure to reward ‘innovative’ pharmaceutical products by granting higher prices. This pressure is reflected in policy changes just announced by the Australian Government. These will reduce the prices paid for some generic products, but the Government has stated that they expect that this will increase their capacity to pay for new expensive drugs. Significantly, the Government seems to have accepted industry arguments that they should shift from the principal of reference pricing based on a formal measure of non inferiority to a test of interchangeability at an individual patient level. This is a deft move by the industry; price cuts will be applied to medicines judged to be interchangeable, but not necessarily to those deemed to be equivalent in an average sense. This will give the pharmaceutical companies greater scope to argue against price restrictions on grounds other than clinical trial evidence. Non-interchangeable drugs will no doubt be described as innovative. There is a great need for some agreement on what constitutes an innovative drug. Drugs that offer genuine clinical benefits are likely to be worth a higher price, but the term seems to be applied to any product of a company that describes itself as innovative. Competing interests: Until 2001 I was a member of the Australian Pharmaceutical Benefits AdvisoryCommittee |
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Munir E Nassar, Retired physician Pittsford NY 14534
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To the Editor : Thank you for your analysis of the predicament facing NICE with drug companies, whose objection may end in legal action, that may result in monies spent on lawyers offsetting the cost effectiveness that Nice is trying to achieve. In my opinion two words may have to be included in such analyses: Flexibility of the Nice guidelines and second, the psychological effect on the patient's outcome when the drug treatment is stopped. The questions to be raised here are that guidelines maybe more effective when alternative less cost bearing measures are applied for a drug to be discontinued ? Have there been studies that measure the psychological harm or benefit when a treatment drug is stopped or a beneficial psycological outcome when not discontinued ? Sincerely, Munir E Nassar, M.D. Competing interests: None declared |
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David N Griffith, Consultant Physician CR7 7YE
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Fiona Godlee’s comments on NICE are very timely.1 Shortly after reading them I was disturbed to read a position statement issued by the British Geriatrics Society and the Royal College of Psychiatrists attacking NICE guidance on drug treatments for Alzheimer’s Disease.2 Of particular concern was the threatening tone. To cite just one example “In considering GMC guidance and their continued registration with the GMC, doctors should remember that they must make the care of their patient their first concern. [Doctors should] consider an individual patient’s needs and the circumstances that might warrant a departure from the general policy of NICE guidance.” This is incontrovertible but seems an unduly heavy-handed and bizarre way of presenting advice, carrying with it the implication that failure to prescribe Cholinesterase inhibitors might result in problems with the GMC. And where is the balancing note that prescribing a drug with marginal clinical benefit while increasing the risk of adverse drug effects or polypharmacy might also constitute suboptimal care? No details are given as to which individuals have contributed to the statement, or any conflict of interest they may have. Drug company pressures on clinicians and through patient groups are well known. 3 The whole article could well have come directly from the pharmaceutical industry. To find it bearing the imprimatur of the above bodies is of great concern. 1. Godlee F. Fear not the heat [Editor’s Choice] BMJ 2006; 333. (Nov 25) 2. British Geriatrics Society Newsletter. 2006; 8: 8-10 3. Tuffs A. Sponsorship of patients’ groups by drug companies should be made transparent [News]. BMJ 2006; 333 (Dec 16) Competing interests: None declared |
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