Summary of decisions

Recommended

The drug or treatment is recommended for use:

• in line with the marketing authorisation from the European Medicines Agency (EMA) or Medicines and Healthcare Products Regulatory Agency (MHRA) or
• in line with how it is used in clinical practice in the NHS (or both).

When we recommend a treatment 'as an option', the NHS must make sure it is available within 3 months (unless otherwise specified) of its date of publication. This means that if a patient has a disease or condition, and the doctor responsible for their care thinks that the technology is the right treatment, it should be available for use in line with our recommendations.

 An example of this type of recommendation is in technology appraisal 179. Sunitinib is recommended in line with its marketing authorisation for the treatment of unresectable or metastatic malignant gastrointestinal stromal tumours (GIST) after failure of imatinib mesilate treatment.

 Optimised

The technology is recommended for a smaller subset of patients than originally stated by the marketing authorisation.

Sometimes the committee decides that a drug is only cost-effective as a treatment option for a specific group of people, for example, those who are resistant to or can't tolerate other drugs.

An example of this type of recommendation is in technology appraisal 166 . The use of simultaneous bilateral cochlear implantation is only recommended in specific circumstances. Under this guidance, the technology is only considered to be a cost-effective use of NHS resources for people with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids; or children; or adults who are blind or who have other specific disabilities.

Only in research

The drug or treatment is recommended for use only in the context of a research study, for example a clinical trial.

This sometimes happens for new technologies when there isn't yet enough clinical evidence to make a recommendation for use in the NHS. In these cases we recommend that further research is carried out.

When making this type of recommendation, the committee takes into account whether:

• there is a reasonable prospect of the technology being cost-effective
• the research will inform future NICE guidance
• the research can realistically be set up, is already planned or is in progress
• the benefits and costs of conducting the research are favourable.

This type of recommendation was made for technology appraisal 17 in 2000 for laparoscopic surgery. The Appraisal Committee recommended that laparoscopic surgery for colorectal cancer can only be used as part of a randomised controlled clinical trial. The Medical Research Council carried out a clinical trial of the technology, and in 2006 when the appraisal was reviewed ( technology appraisal 105 ), the Appraisal Committee was able to recommend the use of the intervention based on the additional evidence collected.

Not recommended

The treatment is not recommended.

This happens when there is a lack of evidence for the clinical effectiveness of the technology, or if it's not considered to be a cost-effective use of NHS resources compared with current NHS practice.

An example of this type of recommendation is in technology appraisal 172 where cetuximab (in combination with platinum-based chemotherapy) was not recommended for the treatment of recurrent and/or metastatic squamous cell cancer of the head and neck.

The use of cetuximab was substantially less cost-effective than what is normally considered to be an acceptable use of NHS resources. In addition there was considerable uncertainty around the clinical data used in the economic model and the committee was concerned that it would be even less cost-effective than presented.

Recommended for use in the CDF (for cancer appraisals only)

It there is early evidence that a drug has clinical benefits for cancer patients, but still needs more evidence to prove its cost effectiveness, then we can recommend it for use within the Cancer Drugs Fund. This means that new cancer drugs can be made available to patients much more quickly than before.

Find out more about the Cancer Drugs Fund

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.

A marketing authorisation is the term used to describe the licence given to new medicines allowing the manufacturer to sell and promote the product. All drugs must be licensed before they can be used by patients.

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).

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 harm.

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.

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.

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

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 licence. In these cases, the recommendation may be classed as ‘recommended' because this is in line with clinical practice.

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.

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 18 times.

When NICE recommends a treatment 'as an option', the NHS must make sure it is available within 3 months (unless otherwise specified) of its date of publication. This means that, if a patient has a disease or condition and the doctor responsible for their care thinks that the technology is the right treatment, it should be available for use, in line with NICE's recommendations.

The technology being appraised is listed in the scope of an appraisal under 'intervention'. NICE can only issue guidance/make recommendations about the intervention being appraised. A comparator technology is one that is currently used in the NHS and could be replaced by the intervention, if recommended. NICE cannot issue guidance or make recommendations about comparator technologies (unless also listed as an intervention in a multiple technology appraisal).