Frequently asked questions about technology appraisals

What is a technology appraisal?

NICE is asked by the Department of Health to look at drugs and other technologies that are used, or could be used by the NHS. An independent committee (the Appraisals Committee) examines the evidence and makes recommendations on the use of the technology in the NHS.

We base our recommendations on:

• information from patients, clinical experts, health economists and manufacturers, and
• a review of two types of evidence:
  
  • clinical evidence on how well the technology works compared to current NHS standard care; and
  • economic evidence on how well the medicine or treatment works in relation to how much it costs the NHS - value for money.

More information on technology appraisals.

What is the difference between a single and a multiple technology appraisal?

A single technology appraisal (STA) looks at a single technology for a single indication close to the introduction of a new technology to the NHS.

A multiple technology appraisal (MTA) will normally cover more than one technology (for example a class of drug), or one technology for more than one indication (for example, a drug for more than one place in a treatment sequence for a particular condition). The multiple technology appraisal process is also often used for reviews of published appraisals, regardless of the number of technologies involved, or if a new topic for an appraisal is particularly complex and not suited for the single technology appraisal process.

What do the different recommendation classifications mean?

See the category definitions.

What is a marketing authorisation?

A marketing authorisation is the term used to describe the licence given to new medicines allowing the manufacturer to sell and promote the product.

In Europe the European Medicines Agency (EMA) carries out this role, and many assessments in the UK are undertaken by the Medicines and Healthcare Products Regulatory Agency (MHRA). In the US this is done by the US Food and Drug Administration (FDA).

All drugs must be licensed before they can be used by patients.

The regulatory agency carries out an assessment to establish if the new medicine does what it is claimed to do. For example, does it lower blood pressure, shrink a tumour or prevent bone fracture? The regulator also makes a judgment on the balance of benefit to harms.

The resulting marketing authorisation allows the manufacturer to sell and promote the new medicine for the indication (s) that the regulatory agencies have assessed and approved.

Other organisations categorise your recommendations differently. Why is this?

Commercial databases are available which categorise NICE technology appraisal decisions using different criteria from NICE. As these criteria have been developed independently from NICE, their categories may be different from ours.

Why are there more recommendations than there are appraisals?

An individual appraisal often contains more than one recommendation. In some appraisals a number of technologies have been considered, and a number of recommendations made.

How up to date is this information?

The data in the full table of recommendations and the summary table was issued in July 2010 and is updated regularly.

How is a treatment classified when it is licensed for use more widely than is actually the case in clinical practice?

Each recommendation takes account of advice the Appraisal Committee receives (and incorporates into the guidance) from clinical experts. Sometimes experts suggest that the technology is unlikely to be used routinely in clinical practice in the UK, to the extent permitted by the license. In these cases, the recommendation may be classed as ‘recommended' because this is in line with clinical practice.

If a drug has a licence, surely that means it's effective? Why does NICE then recommend it only for specific use?

All licensed drugs are ‘effective' in so far as the licensing process requires manufacturers to provide evidence to support claims that their drug works in specific populations and specific circumstances. Obtaining a licence doesn't necessarily require any evidence about how the drug compares to other similar treatments in the NHS or how well it works in all people with a particular condition. NICE, on the other hand, compares the drug with what is currently used in the NHS and works out how well the drug would work in real life use.

Some recommendations could not be made in the absence of a submission from the manufacturer (‘non-submission'). What does this mean?

A single technology appraisal is based on a submission from the manufacturer of the technology. If there is no submission from the manufacturer, the appraisal is terminated and advice is issued to the NHS that NICE is unable to make a recommendation because the manufacturer has not provided a submission. To date this has occurred five times.

See related information

• what do the recommendation categories mean?
• summary of statistical information about TA recommendations
• full table of recommendations