There’s an organisation in England known as NICE – The National Institute for Health and Clinical Excellence. Many countries have their equivalent organisations. Their job is to inform health service policy but in fact their advice tends to be taken as the definitive word……if NICE says “no” then that drug will NOT be available on the NHS.
Their decisions cause controversy. Most recently they’ve been in the news over treatments for a cause of blindness and anticancer drugs which are indicated for kidney cancer. In trying to defend their decisions I’ve seen NICE spokesmen struggling to insist that they don’t make a decision on the basis of cost, but on “clinical cost effectiveness”. What does this mean?
Across on the NICE website you can find a very clear explanation. It’s all about QALYs – Quality Adjusted Life Years. This is an international formula for calculating the cost of improving the length and quality of a person’s life. Here’s the detail – (the FULL detail) -
Although one treatment might help someone live longer, it might also have serious side effects. (For example, it might make them feel sick, put them at risk of other illnesses or leave them permanently disabled.) Another treatment might not help someone to live as long, but it may improve their quality of life while they are alive (for example, by reducing their pain or disability).
The QALY method helps us measure these factors so that we can compare different treatments for the same and different conditions. A QALY gives an idea of how many extra months or years of life of a reasonable quality a person might gain as a result of treatment (particularly important when considering treatments for chronic conditions)..
A number of factors are considered when measuring someone’s quality of life, in terms of their health. They include, for example, the level of pain the person is in, their mobility and their general mood. The quality of life rating ranges from 0 (worst possible health) to 1 (the best possible health). (See the box below for an example of how this works in practice.)
What about cost effectiveness?
Having used the QALY measurement to compare how much someone’s life can be extended and improved, we then consider cost effectiveness – that is, how much the drug or treatment costs per QALY. This is the cost of using the drugs to give someone an additional year of life..
Cost effectiveness is expressed as ‘£ per QALY’.
Each drug is considered on a case-by-case basis. Generally, however, if a treatment costs more than £20,000-30,000 per QALY, then it would not be considered cost effective.
How a QALY is calculated
Patient x has a serious, life-threatening condition.
- If he continues receiving standard treatment he will live for 1 year and his quality of life will be 0.4 (0 = worst possible health, 1= best possible health)
- If he receives the new drug he will live for 1 year 3 months (1.25 years), with a quality of life of 0.6.
The new treatment is compared with standard care in terms of the QALYs gained:
- Standard treatment: 1 (year’s extra life) x 0.4 = 0.4 QALY
- New treatment: 1.25 (1 year, 3 months extra life) x 0.6 = 0.75 QALY
Therefore, the new treatment leads to 0.35 additional QALYs (that is: 0.75 –0.4 QALY = 0.35 QALYs).
- The cost of the new drug is assumed to be £10,000, standard treatment costs £3000.
The difference in treatment costs (£7000) is divided by the QALYs gained (0.35) to calculate the cost per QALY. So the new treatment would cost £20,000 per QALY.
What do you think about this?
I think it’s riddled with problems!
In reality, nobody can tell how many months of life any particular individual human being will live. In fact, the greater the length of the prediction, the less accurate it is. So, not only are we unable to predict accurately how long a person with a particular disease will live, we are also unable to predict how long a person with a particular disease will live if they take a particular treatment. We can work out the averages, work out the probabilities, but we cannot KNOW these figures for any single real person. The use of definite figures such as “8 months without treatments and 13 months with drug X” convey a false sense of certainty. They pretend to be “scientific” and therefore some kind of believable truth. But they are guesses. Informed guesses no doubt, but guesses none the less. If YOU are the patient, are you prepared to make your decisions on the basis of what happens to the statistical average person? Or do you still hope that you might be one of the people who do better than the average? After all, there are always people who will have a better than average experience and nobody can tell you whether or not you are going to be one of those people.
So, the QALY is based on an estimate of a life course. The length of life part of the calculation is a guess. It always is.
Secondly, what about the “quality” part? Who decides that on a scale of 0 to 1 (0=death and 1=perfect health) your quality of life can be assessed as 0.4 or 0.8 or whatever? The questionnaires used have been heavily criticised for picking life values which the authors of the questionnaires rate as important, not the life values which a particular patient might have. Who, in fact, can judge quality of life better than the person whose life it is?
These are not only my criticisms – here are few from the National Library of Health -
- Values assigned to the quality of life component of the QALY may not reflect the values of patients receiving the interventions.
- They may lack sensitivity in some disease areas. For example for chronic disease or mental illness, as quality of life measures largely focus on physical rather than psychological or social disability.
- Some feel that QALYs can over-simplify complex healthcare issues and suggest ‘quick and easy’ resource allocation decision.
- In QALYs, all the emphasis is placed on the size of the health improvement, without taking into consideration the starting point.
- There is an issue with distribution – it is thought that the QALY approach maximises total welfare without regard to how such welfare is distributed between people.
- There is also criticism that conventional QALYs don’t account for attitudes towards risk.
- There are several technical assumptions that are implicit within the QALY model, and there is evidence that these do not accurately reflect real life
But my doubts don’t stop there. Did you read the part about considering the actual cost of the QALY? £20,000 – £30,000 is the limit. If a treatment costs more than that, then it will not be allowed. Who decided that? Why not £10,000 – £20,000? Or £30,000 – £50,000? Doesn’t this make you uncomfortable? That we decide whether or not a treatment should be available on the basis of this financial limit? It certainly makes me uncomfortable. Should we accept that there has to be a limit at all? We make plenty of other decisions as a society about how money is spent without considering these kinds of limits – fighting wars in Iraq, Afghanistan, building nuclear missiles which know will destroy us all if we use them, paying some footballers more than £30,000 a week, increasing economic inequality…….you can choose your own pet spending decision.
We do need a debate about all of this, but let me ask you to think about this. If the patient with the disease under consideration is someone you love, someone you really, really care about, will you still be happy to accept a decision on the basis of QALYs?
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