Evidence Evaluation Framework
Our Evidence Evaluation Framework sets out the guidance criteria we use to evaluate treatments. Our framework gives our members and specialists a clear and reliable understanding of the standards of evidence we expect when we consider what cover our members have.
This framework helps us understand how strong the evidence is for a particular treatment. We use a traffic light system (Green, Amber, Red) to make this clear:
Green Light: Conventional treatments* that are well-established treatments, proven safe and effective as they have strong clinical evidence
Amber Light: Unproven treatments* that are proven safe but still needing more evidence for their effectiveness. We don't fund these treatments but may offer a financial contribution up to the cost of conventional proven treatment.
Red Light: Unproven Treatments* that have not met the standards for safety and effectiveness. These treatments will never be funded.
* Conventional treatment and Unproven treatment are terms we explain in our Membership Handbooks and may be amended by
The information in the table below is technical in nature and is designed to support specialists in understanding our approach to assessing clinical evidence. Any members wishing to understand more about what these terms mean please contact us.
If a specialist feels we should reconsider our position on a certain treatment, having considered the levels of evidence in this Evidence Evaluation Framework, they can contact us. Contact details for specialists can be found on the AXA Health Provider website
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Level of evidence |
Drugs |
Surgical Procedure |
Medical Devices (including surgical devices and implants) 3 |
Other |
|
Green: Conventional Treatments |
Licensed and used according to their licence and either National Institute for Health and Care Excellence (NICE) approved 1 or having high-quality clinical trial evidence defined as: systematic review of Randomised Controlled Trial (RCT) or a single large high-quality RCT either of which demonstrates moderate or high-quality evidence of safety and effectiveness.2 |
Listed in our published Schedule of Procedures and Fees and either NICE approved 1 or high-quality clinical trial evidence defined as: systematic review of RCTs or a single large high-quality RCT either of which demonstrates moderate or high-quality evidence of safety and effectiveness.2 |
Approved by current EU Medical Device Regulations and either NICE approved 1 or high-quality clinical trial evidence defined as: systematic review of RCTs or clinical trial evidence with three years of follow-up data either of which demonstrates moderate or high-quality evidence of safety and effectiveness. 2 |
NICE approved1 or high-quality clinical trial evidence defined as: systematic review of RCTs with moderate or high-quality evidence of safety and effectiveness.2 |
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Amber: Unproven Treatments |
Not meeting the definition of either red or green treatment e.g. NICE use with special arrangements for clinical governance, consent and audit or NICE use only in research or low-quality evidence of safety or effectiveness, which means further research is required. 2 |
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Red: Unproven Treatments |
No evidence of safety or effectiveness or evidence of GRADE certainty moderate or high-quality 2 of potential harm despite the presence of any green indicators or NICE “do not use” recommendation |
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By clinical trial we mean a prospectively registered trial in humans registered on the World Health Organization’s International Clinical Trials Platform (www.who.int/ictrp/en/) that includes a treatment group (the new treatment) and a control group (either usual care or a placebo). Randomised Clinical Trials (RCTs) are the best way to assess whether drug treatment is effective and safe. In an RCT patients are assigned randomly to the treatment group or the control group.
Systematic reviews (SR) summarise the results of more than one RCT and can provide a high level of confidence in the effectiveness of interventions.
Footnotes
1. NICE approval for ‘use with normal arrangements in place for clinical governance, consent and audit’.
2. Appraisal of the quality of evidence is based on the GRADE system (Grading of Recommendations, Assessment, Development and Evaluations); the
• The quality of a study defines the degree of confidence in the treatment effect. The higher the quality, the more confident we are that the
• The final grade for the quality of evidence is judged as ‘high’, ‘moderate’, ‘low’, or ‘very low’ for the important outcomes:
- High: we are very confident that the effect in the study reflects the actual effect
- Moderate: we are quite confident that the effect in the study is close to the true effect, but it is also possible that it is substantially
- Low: the true effect may differ significantly from the estimate
- Very Low: the true effect is likely to be substantially different from the estimated effect
For more details about GRADE, see NICE Manual Appendix K (30Nov2012) and the GRADE working group website.
3. A medical device is defined according to the EU’s Medical Device Directive (Regulation (EU) 2017/745). A ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. When a new treatment (either a new surgical procedure or ‘other’ treatment) involves a device, the levels of evidence will have to meet both relevant criteria for the procedure/treatment and device.