Content under review
We're updating this page following the publication of our new methods, processes and topic selection manuals. Our previous manuals still apply to evaluations that started before 1 February 2022. The new manuals apply to evaluations that began after this date.
The NHS and patients need evidence that commissioners are funding medicines and treatments approved through the NICE Technology Appraisal (TA) or Highly Specialised Technologies Evaluation (HST) so they are available for use by NHS healthcare providers, in line with NICE recommendations, the NHS Constitution and within the defined timeframe.
A number of NHS professionals and organisations have asked NICE for clarification about how to demonstrate that patients are able to access clinically appropriate medicines and treatments recommended by NICE TA or HST guidance. This page sets out NICE’s definition of what constitutes compliance. It suggests how commissioners and providers might demonstrate that medicines and treatments are available to clinicians to consider as an option for use with their patients, and also show that the associated funding is in place without any local restrictions.
Compliance with a NICE-approved medicine or treatment
Commissioners have a statutory responsibility to make funding available for a drug or treatment recommended by a NICE TA or HST and to begin doing so no later than 90 calendar days (30 calendar days for EAMS products or for products appraised via the Fast Track Appraisal process) after the guidance is published, unless otherwise specified in the guidance. Compliance is achieved when a patient, after discussion with a clinician, is able to choose a NICE-recommended treatment without any local funding or formulary restrictions.
For the avoidance of doubt, when NICE recommends a drug as ‘an option’, this is an option for the clinician and patient to consider alongside other potential treatments, not an option for commissioners or providers to not make the treatment available.
How to evidence compliance with guidance, and its use in the delivery of care
Organisations wanting to evidence compliance with guidance and its use in the delivery of care might do so in the following ways:
- Commissioners publish policy statements, service level agreements and/or contracts which demonstrate funding is in place and that they require medicines and treatments recommended by NICE TA and HST guidance to be available for use, in consultation with the patient, and when recommended as part of their treatment
- Providers publish their formulary, policies and care pathways to demonstrate that medicines and treatments recommended by NICE TA and HST guidance are available for use, in consultation with the patient, and when recommended as part of their treatment.
- Organisations publish audit data and patient surveys to demonstrate the use of NICE TA and HST guidance by clinical indication. This would include evidence that patients believe treatment options were discussed with them and their preferences taken into account
Suggested measures to demonstrate compliance and use of NICE guidance in the delivery of care
Evidence that funding and processes are in place to allow clinicians to prescribe all medicines and use treatments recommended by NICE TA and HST guidance within the recommended timeframe.
Data source: Local formularies, contracts, policies and clinical pathways are published online
Evidence that medicines and treatments recommended in NICE TA and HST guidance have been offered to patients for whom they may be clinically appropriate and that this has been captured in the patient's notes
Data source: Targeted clinical audits of selected NICE TA and HST guidance
Evidence that patients believe treatment options were discussed with them and that their preferences were taken into account.
Data source: Patient surveys
What compliance and use of NICE guidance in the delivery of care means for commissioners, service providers and healthcare professionals
Demonstrate by publishing policy statements, service level agreements and/or contracts that when they are the relevant health body, funding is made available for medicines and treatments approved by NICE TA and HST guidance. This should be within the recommended timeframes and in accordance with the NHS Constitution
Service providers and healthcare professionals
Clinicians are able to offer their patients access to clinically appropriate NICE recommended medicines and treatments within the given timeframes and in accordance with the NHS Constitution. This means:
- Clinicians will need to be aware when NICE TA and HST guidance are part of their organisation’s clinical pathways and that they can record their decision making to show that the available options have been discussed with their patients and their preferences are taken into account.
- Providers will need to have processes in place to inform patients and staff of the availability of the treatment and that audit to demonstrate appropriate usage by clinical condition is publically available
NICE has produced a document addressing some frequently asked questions relating to compliance and local formularies:
What the use of NICE guidance in the delivery of care means for patients, service users and carers
Children, young people and adults will have access to the medicines and treatments recommended by NICE TA and HST guidance in accordance with the NHS constitution and when their clinician thinks it is the right treatment for them. It also means that the decision making process is shared so that they are able to say what treatment they would prefer from the available options, and that the decisions are recorded.
We welcome feedback on this statement, and any examples of where you have used any of the suggested measures to demonstrate compliance.
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NICE has produced a guideline on developing and maintaning local formularies