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Wednesday 24th July 2019

How does NICE approve drugs?

12th May 2008

An article in The Times explores how the National Institute for Clinical Excellence approves medicines for use in the NHS.

Drugs & Money

NICE assesses medication by calculating the amount the health service has to pay out in order to "achieve a defined benefit to patients".

Drugs are given the go-ahead if the health service needs to pay out "less than about £30,000 per quality adjusted life year (QALY)."

By definition, this means that for every £30,000 the NHS pays out on drugs must equate to a patient who can have another "good-quality" year of life.

NICE frequently employs computer economics programmes - created by academics - in order to find out the costs per QALY.

Aricept, a drug used to treat Alzheimer's patients, had a cost ranging from £50,000 to £90,000, depending on the model used in the progamme.

Eisai and Pfizer, drug manufacturing companies, have challenged NICE's decision in court. Eisai has questioned "the model used in the Aricept appraisal" and said that NICE may have undervalued the medicine's beneficial effects.

NICE have objected to drug manufacturers viewing the model they used in the appraisal, arguing that the programme belongs to the academic institutions where it was created. NICE also say that the appraisal process will be slowed by giving the companies the full programme.

For example, a drug manufacturer could work backwards by filling in the figure it wants to see (a QALY of £30,000 or less). It could then find out what suppositions are required at the beginning in order to produce this result.

It could then put these suppositions forward at the appraisal, causing NICE to "unpick" the programme, which would be costly and take time.

Although this indicates that the model is flawed, as it can produce two different results, the programme is currently the "best" one available.

The success of Eisai and Pfizer in court - which ruled against NICE's decision on the drug - was "a first".

It is difficult to estimate whether Eisai or Pfizer will be able to show that the programme's model does not show the benefits of Aricept.

If the companies can prove that the apprasial method does not work properly patients could be offered Aricept who might not previously have been eligible for it. It could also "reopen some guidance given in the past by NICE that has denied drugs to patients."


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