Fertility treatment add-ons – at what cost?

Fertility treatment add-ons can be defined as treatments that are optional to an ordinary cycle of fertility treatment and often come at an additional financial cost. They are widely available at fertility clinics in the UK (and beyond), but the use of some, in particular, is contentious and debate around their provision, evidence-base and uptake has been growing here and internationally (see BioNews 1142, 1144 and 1161).

Infertility manifests in many different ways. Indeed, some people will receive a diagnosis of 'unexplained infertility' because it is not clear what is causing their fertility issues. So, for some, standard fertility treatment does not work. Therefore, having it personalised to their specific profile, through the use of one or more 'add-ons', might help. At least this is the argument used by some clinics.

In my recent research, I interviewed a range of experts within the fertility sector about add-ons and one of the areas explored was the evidence-base. Some experts very ardently felt that randomised controlled trials (RCTs) were the solution. Others believed that they were not an option, reasons for this included, the high cost, how long they take, and patient variability - such as, the many ways infertility manifests, or they are not applicable to add-ons, or at least some types of add-ons.

Given the point that infertility affects people differently, it stands to reason that designing a robust RCT could prove difficult or impossible in some instances, but at a minimum there ought to be some sort of evidence-base that proves efficacy and at the very least safety, or a clear mechanism by which this information is gathered. One expert felt strongly that once something is put into the add-ons bag, then for them, there is really little evidence that it works. If it did, it would be a standard part of routine treatment, or routine for a particular subset of patients.

The UK's fertility regulator, the Human Fertilisation and Embryology Authority (HFEA) has a 'traffic light system', created to provide patients with further information and guidance about the efficacy and safety of some add-ons fertility clinics offer (see BioNews 1135). In the near future there are plans by the HFEA to make it more detailed than its current form. In response to concerns about adherence to consumer law raised by some in the sector (see BioNews 1160), the Competition and Markets Authority recently published guidance for fertility clinics and this states that clinics must provide appropriate information about the evidence and/or risks associated with add-ons (see BioNews 1099).

However, another crucial factor that needs to be examined is that add-ons come at a cost – sometimes a fairly significant one. (I refer here only to financial burdens and not psychological/mental ones, which also deserve attention.). One fertility doctor I spoke with said that even though they will sometimes advise a patient against using a specific add-on, because they did not feel it would work for them, the patient still wanted to try it because they had heard of other success stories. For the doctor, there is a fine line between telling a patient what they do or do not advise and a patient exerting their autonomy.

While it is true that patients should be in charge of their own decision-making, they need to be responsibly empowered to do this. Furthermore, it could be argued that the financial implication here creates hope. Patients may feel that if they are paying a premium for something offered in a regulated fertility clinic then surely there must be evidence it works. Otherwise, how could it be allowed to be offered, and for a fee? Of course, everything comes at a cost, but should it really be patients who are footing the bill for what could be argued as their participation in clinical research? While there is irrefutable merit to finding better treatments for fertility patients, the financial aspect of this rather goes against typical practice in clinical research and ethics.

The European Society for Human Reproduction and Embryology (ESHRE) is currently consulting on draft recommendations for good practice for the use of add-ons (see BioNews 1168); in these they propose that until studies prove efficacy they should not be offered to patients, certainly not at an additional cost. Moreover, there are signals from the UK government that fertility law could be revised in the near future with suggestions that the HFEA will launch a consultation on the types of changes that might be possible, it will be important to raise the question of cost in relation to add-ons. While it may not be the role of the HFEA to regulate these themselves, certainly guidance, recommendations and consensus statements should be closely respected and considered when clinics are offering add-ons.

Another expert I spoke with, who has researched the use of add-ons for more than 20 years, emphasised that what needs to change is the way in which licensing is understood and used: if a new technology is introduced, it must be done under a research licence where patients are not charged, appropriate data is collected and reported and then a decision is made about whether it can be turned into an accepted treatment or not.

The transformative potential of healthcare is incredibly promising, but discovering and testing new treatments should be done in an appropriate clinical research setting. The cost should not be met by patients, especially those who are full of hope and will really try anything that might just get them their baby.