One view of what NICE is, and how it decides in the UK

I thought it might be helpful to post an overview for those not familiar with what happens in the UK regarding the National Institute for Health and Clinical Excellence (NICE) and how it comes to its decisions.

Bear in mind that I am no expert in these matters, just an interested bystander whose 'other half' has been through what many of you here have been through with HER2 BC. I have pulled together these comments from what I have found during my searching the internet. I believe what I say here is reasonably accurate but feel free to correct me if you know better (and I'm sure some of you will).

NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health, at least this is what it says on their website. It is not always publicly viewed as independent of the government by many people who feel that they are under pressure to meet costs first and decide on treatment second.

NICE uses a Quality Adjusted Life Year (QALY) to asses how a treatment measures up and if it is over a certain threshold, currently £20,000 ($28,000 US) it will go out for appeal on whether or not to proceed, if it is over £30,000 ($42,000 US) it normally says an outright NO.

One interpretation of QALY would be how much lifespan a person would be prepared to give up to deliver one year of perfect health from the current state of ill health. By comparing QALY values before and after treatment one could calculate the benefit delivered by a given treatment to a given person.

The cost of a treatment may be relatively easy to calculate but because people may be at different ages when they receive treatment, the gain may be different according to age. A heart operation on a small child may deliver many more years of quality of life than the same operation on a 76 year old man. By taking the cost of treatment and dividing it by the years gained an overall cost benefit ratio can be determined as the 'cost per quality-adjusted life year gained' or CQG.

NICE has pledged to speed up its appraisal process so that guidance is ready between three and six months after a drug is licensed. Currently the process can take up to two years.

Nice uses independent expert committees to evaluate new drugs for use on the NHS and they use a complicated calculation balancing the cost of the drug against how effective it is at improving length and quality of life.

The calculation arrives at an additional cost per "quality-adjusted life year" over and above
the price of existing treatments and if that figure is more than £30,000 then the drug is
generally not approved for use.

But the new rules will allow this level to be breached after a public consultation found most
people agreed that greater weight should be given to drugs that provide extra months of life for terminally ill patients.

It must be remembered that all of this is done for all drugs and the NHS budget has to cover all treatments not just cancer.

Now specifically there have been two recent decisions by NICE which have been brought up on this forum.

Firstly the Tykerb (often known as Tyverb in the UK) where they have come up with what is called a Final appraisal determination (PDF document) which can be read here.
You can see more comments on this here and here. Basically this document says that NICE is going to say NO to Tykerb. This can be appealed but is going to need a lot of people supporting this but I think it will need evidence as well as numbers.

Secondly the new Advanced breast cancer: diagnosis and treatment clinical guidelines which was published in February 2009. This is the document which says that Herceptin will be withdrawn from patients with advanced breast cancer. There are two sets of documents one for health professionals and another for patients both of which can be found here.

Both of these decisions mean that it unlikely that any NHS Hospital in the UK will consider giving either Tykerb or Herceptin for advanced breast cancer in future.

[hutchibk]

Thank you for spelling it out in terms for all to understand how morally corrupt it is to approach health care mainly from the perspective of financial calculations and formulas and how much of a "limited pie" can be devoted to various health segments and age groups of a population (essentially screwing the sick and elderly, and those of us who have MANY good years left with advanced treatments and pharma support). Bureaucrats and collectivism be damned!

[Laurel]

Sadly, I fear this is our way...

[Christine MH-UK]

You have provided a generally accurate description of what NICE is and does, but it should be noted that the NICE guidance for herceptin doesn't completely block the use of herceptin for stage IV patients. What is states is "For patients who are receiving treatment with trastuzumab for advanced breast cancer, discontinue treatment with trastuzumab at the time of disease progression outside the central nervous system. Do not discontinue trastuzumab if disease progression is within the central nervous system alone," which is rather different from what you state.

It should also be added, too, that NICE feeds into a general culture of delay. As you mention, it is designed to provide guidance. Technically, the primary care trusts can prescribe drugs after they are licensed but before NICE has provided guidance on whether they should be used. In practice, the PCTs generally tend to drag their heels and many may not just wait until NICE has ruled but delay introducing the drug for as long as possible thereafter.

It's not just that QALY is used, but also that the figure is so appalling low that is the problem. I don't think that many people in Britain are aware that NICE has put a value on a full-quality year of life at just 20,000-30,000 pounds. The figures used are at about the same level as annual median earnings for individuals, so don't even include activities that have an economic value but aren't included in income, such as volunteer work and essential caring activities. I have heard that some US insurers use QALY figures to decide what to cover, but the values used are at least 100,000 dollars a year, which is over twice individual annual median earnings, and that these can go up to 200,000 a year in practice. I don't know where the cutoff should be, but 20,000-30,000 pounds just doesn't make any sense. I think the QALY estimate for Tyverb/Tykerb was £60,000/year, so I don't see it coming into use in Britain any time soon.

Another aspect I think that has to be taken into account is that cost is only half of cost effectiveness. If Tykerb cured stage IV cancer, Glaxo could charge an arm and a leg for it and patients could still get it under QALY rules.

[Ellie F]

Hi Christine,totally agree with what you have said about NICE. Have just had a second opinion about my bc at a UK centre of excellence. Interestingly the oncologists there are challenging the decision not to authorise tykerb and are also very unhappy about the decisions regarding herceptin for advanced breast cancer.He encouraged us to continue the petition and try to get more political support . Ellie

Please take a look at my post in the Petition thread at http://www.her2support.org/vbulletin...6&postcount=29.

Exactly what I have said we need the oxygen of publicity, we need every single UK resident to contact their MP to to something about this. There is nothing that any individual can to do change what NICE does, it is governed by what they are required to do by the government. The only people who can appeal the NICE deterimation (as it is currently called) are those consultees in the process so we have to hope some or all of them will.

As to the comment re herceptin being used for treating the central nervous system it is well known that herceptin does not cross the blood brain barrier and so why continue to use it for the central nervous system when tykerb is a better drug.

[Ellie F]

Agree the issue of herceptin, NICE and CNS seems to make no sense at all when research shows tykerb is more effective. It doesn't even seem to make economic sense!