Background
Treatment add-ons are non-essential treatments that may be offered in fertility clinics in addition to routine treatment, with the claim that they can improve treatment outcomes.
In July 2022, the Authority defined the treatment add-ons which the HFEA will provide information on as:
- additional treatments (to the core treatment e.g. IVF or IUI), that are being offered to the general patient population in licensed fertility clinics in the UK,
- where there are published scientific studies which claim to demonstrate that the treatment add-on improves the chances of having a baby or other treatment outcomes rated by the HFEA; but
- where evidence of effectiveness for the use of the treatment in a clinical setting is lacking or absent; and
- where patients need unbiased information about the effectiveness and risks of this treatment.
View the minutes from the July 2022 Authority meeting on our website.
As with all new treatments or technologies being introduced into reproductive medicine, we expect the introduction of treatment add-ons into clinics to be preceded by good quality scientific research into the effectiveness and safety of these interventions. However, some treatment add-ons are being offered to patients without this evidence base for effectiveness at improving treatment outcomes. They are frequently offered outside of research settings and are charged for at an additional cost.
This form can be used to propose that the HFEA reviews the evidence base for a treatment add-on if they are concerned that a treatment add-on is being offered to patients in a UK licensed clinic:
- with the claim that it will improve a treatment outcome; and
- without conclusive evidence of its effectiveness at improving the treatment outcome; and
- it is not already listed in the HFEA’s rated list of add-ons; and/or
- there is evidence that an add-on treatment may reduce treatment effectiveness or there are potential safety concerns.
The HFEA will use the information given on the form to help us consider whether to include the proposed add-ons as part of the HFEA’s rated list of add-ons, which are periodically reviewed for evidence of their effectiveness for improving treatment outcomes.
Your submitted information could be used to inform other webpages, outside of the HFEA’s rated list of add-ons.
To access a copy of this application form please email enquiriesteam@hfea.gov.uk.
Application form guidance
The purpose of this guidance is to assist you in completing the treatment add-ons application form. Add-ons could include tests, drugs, equipment, alternative therapies, and surgical interventions.
Do not use this form to send information about treatment add-ons that are already on the HFEA’s rated list of add-ons.
Please use plain unabbreviated language (understandable to non-specialists) in your application.
SCAAC review
The HFEA’s Scientific and Clinical Advances Advisory Committee (SCAAC) considers advances in science and clinical practice which are relevant to the Authority's work. The SCAAC will review the current published evidence base for the treatment, alongside this application, and determine its suitability to be part of the HFEA’s rated list of add-ons. The SCAAC review will consider:
- whether the treatment is an additional, non-essential treatment
- if patients undergoing fertility treatment are currently being offered, or requesting, the treatment on a regular basis and/or are being charged for its use in their treatment;
- the likelihood that the treatment is unable to improve treatment outcomes, compared to using established ART techniques without the treatment;
- whether there is a lack of standardised procedure between different laboratories and the lack of potential for this treatment to be implemented by other centres;
- whether patients need information about the risks or safety of the procedure, for both patients and children born as a result of treatment.
Your application should be completed comprehensively to enable the committee to assess all areas.
A decision tree for SCAAC to use to determine what treatments are eligible for a HFEA rating under HFEA’s definition of a treatment add-on can be found in Annex A of the application form.
Submitted applications will be reviewed at the next available SCAAC meeting. If an application for this treatment has already been received and is currently under consideration, then we will let you know. If, after submitting your application, you wish to withdraw it from consideration, then please contact us as soon as possible.
If SCAAC recommends that this treatment is not suitable for inclusion in the HFEA’s rated list of add-ons, then we will notify you of this outcome by email. If, in the future, more evidence is published that supports this treatment as an add-on, i.e. conflicting evidence to show it can increase live birth rate or evidence to show it is not safe, then you will be able to re-apply.
Assignment of a rating
If SCAAC gives a recommendation that the treatment you told us about is suitable for inclusion in the periodically-updated rated list of add-ons, then the published evidence base investigating the treatment will be reviewed for the outcome of live birth, and other treatment outcomes, to allow SCAAC to assign a rating.
Once a rating has been assigned, the rated list of add-ons will be updated accordingly and reviewed periodically.
Thank you for taking the time to submit the application form and sharing your information.