Our technology appraisal recommendations are prepared by an independent advisory committee called the Technology Appraisal Committee (TAC). The committee can make 5 types of recommendation:
The drug or treatment is recommended for use:
- in line with the marketing authorisation (licence) 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 - technology appraisal 456
Ustekinumab is recommended, within its marketing authorisation for treating moderately to severely active Crohn’s disease.
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, those who are resistant to or can't tolerate other drugs.
Example - technology appraisal 493
Under this guidance, the technology 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.
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 specific 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.
Recommended for use in the Cancer Drugs Fund (CDF) (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 - technology appraisal 529
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 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.
Example - technology appraisal 17
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.
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.
Example - technology appraisal 506
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. 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.