Our technology appraisal recommendations are prepared by an independent advisory committee.
The technology appraisal committee can make 5 types of recommendation. Each technology appraisal may contain more than one recommendation.
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)
- 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.
Example
Ustekinumab is recommended within its marketing authorisation for treating moderately to severely active Crohn's disease.
Optimised
The technology is recommended for a smaller group 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, people who are resistant to or can't tolerate other drugs.
If a drug has a licence, why do we only recommend it for a 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 circumstances.
Obtaining a licence doesn't 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. We compare the drug with what is currently used in the NHS and work out how well the drug would work in real life use.
Example
The use of cladribine is only recommended in specific circumstances. It is only considered to be a cost-effective use of NHS resources for people with:
- rapidly evolving severe relapsing–remitting multiple sclerosis, that is, at least 2 relapses in the previous year and at least 1 T1 gadolinium-enhancing lesion at baseline MRI or,
- relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity.
Recommended for use in the Cancer Drugs Fund
(cancer appraisals only)
If 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.
Example
Crizotinib is recommended for use within the Cancer Drugs Fund for treating ROS1-positive advanced non-small-cell lung cancer in adults.
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 is not 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.
Example
In 2000, 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. When the technology appraisal guidance was reviewed in 2006, the committee recommended 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
- it's not considered to be a cost-effective use of NHS resources compared with current NHS practice.