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.
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