Equity of access: Not for northern NHS patients requiring PGT-M

Individuals who are at risk of transmitting an inherited condition to their children have a few options to prevent transmission. Options include prenatal testing which may be invasive or non-invasive and consideration of alternative forms of parenting such as gamete donation. All these options are readily accessible via the NHS throughout England.

A further option is pre-implantation genetic testing (PGT) for monogenic (PGT-M) and structural (PGT-SR) disorders which involves an IVF cycle to create embryos which are then tested for the specific genetic condition and unaffected embryos are then selected for transfer. PGTM/SR is funded centrally by NHS England and is a cost saving investment for the NHS because it ultimately avoids the birth of children with serious genetic diseases which often require lifelong expensive care, as well as the psychological cost to the family. If couples choose to conceive naturally, and undergo prenatal testing to determine if the baby is affected, they then may opt for a termination which also has financial and psychological implications which can be avoided with PGT-M/SR.

While the first PGT cycles were carried out at the Hammersmith Hospital, London in the south led by Professor Alan Handyside, a team of scientists and clinicians at Leeds Teaching Hospitals NHS Trust in the north of England, funded by local hospital grants and the MRC , were also involved in the development of PGT-M/SR in its infancy in the 1990s. Professor Alan Handyside carried out further research into PGT techniques at University of Leeds and Leeds Teaching Hospitals NHS trust until early 2000s. The clinical service in Leeds was led by Anthony Rutherford an expert in the field, who went on to become a member of the Human Fertilisation and Embryology Authority (HFEA) Statutory Authorisation Committee 2014-2020. Anthony Rutherford was a key figure in the authorisation of PGT-M for a plethora of genetic conditions during this time and alongside a proficient team of scientists and specialist nurses remains dedicated to the provision of an NHS funded PGT-M/SR service in Leeds.

Prior to 2022 this service was provided by Leeds Centre for Reproductive Medicine (the fertility clinic allied to Leeds Teaching Hospitals NHS Trust) and currently provided by a service level agreement (SLA) between Leeds Teaching Hospitals NHS Trust and Care Fertility Leeds). Initially the service was available in its entirety in Leeds in 1990s, but when Professor Handyside returned to London an agreement was made with NHS England to send patients to the fertility clinic at Guys and St Thomas' in London in a 'satellite arrangement' with a view to centralise this very specialised service in order that all the laboratory work was carried out in one dedicated unit. This is because at this time there were not enough cases to warrant a full PGT service in Leeds.

As the number of genetic conditions deemed suitable for PGT-M increased and the demand from patients increased so did the referrals from all over England. By this stage there were commercial companies available to provide the genetic assessment, so it now made sense to develop clinics throughout the UK. Other fertility clinics outside London, in Birmingham and Oxford and Nottingham, were awarded NHS England contracts. It was therefore logical for the Leeds Centre for Reproductive Medicine fertility clinic, which had the necessary experience to retrain their embryologists to provide a PGT-M/SR service to serve the north of the country. 

Leeds Centre for Reproductive Medicine was granted an HFEA PGT licence to perform PGT-M/SR and applied to NHS England in 2016 for funding to provide the service for the north of England.

Leeds Centre for Reproductive Medicine were awarded funds to treat 50 patients in 2017 to reduce waiting times at Guy's in London. The clinic utilised highly skilled staff and the most up to date technology in an efficient patient-centred programme taking advantage of the multi-disciplinary team available at Leeds Teaching Hospital NHS Trust. The service flourished and success rates were excellent with patient testimonials describing a very positive experience. But this was a fixed amount of funds and the service had to revert back to sending patients to Guy's London, once the 50 patient limit had been reached.

NHS England agreed to go put the tender out for a PGT-M service in 2020 and to date there is no indication that funding will be allocated to a dedicated clinic in the north of England. 

Currently, there are a limited number of centres that are funded by NHS England to provide this treatment in the UK, including London, Oxford, Birmingham and the most northerly clinic is Nottingham.

The pathway for treatment is for the patients to be referred by their genetic counsellor to any of these centres, or alternatively, they can opt for a satellite service from Leeds to London. If they select one of the other centres, they will receive all their care there. This will include multiple visits from Leeds, at their own expense. If they select the satellite service from Leeds to London, some of their care can be provided locally including consultations, investigations and preparation for their treatment, but they will be required to travel to London for the multiple procedural parts of the treatment which involve the laboratory work.

Many of these patients have serious debilitating illnesses or have children who are unwell and very dependent, and travelling to London causes a great deal of distress. Sometimes, for some patients this is not a realistic option, for example a patient waiting for a kidney transplant with an inherited kidney disease cannot travel while on the waiting list. It is not infrequent that families have to travel with often more than one disabled and dependent child over 200 miles, and take them with them to the clinic based at Guy's and St Thomas' as there is no one else who can care for them.

The procedures are always organised at short notice due to the nature of the treatment, and transport for both partners is often more than £250 for each visit. They are required to stay local to Guy's and St Thomas', for safety reasons after the procedure, which they also have to fund themselves. Furthermore, the waiting times vary across the clinics, and not all offer the most up to date treatment. For some patients these costs and practicalities are prohibitive, and they are unable to pursue a treatment that they wish for, which not only will benefit themselves and their future children, but also the NHS in the longer term.

The current situation is inequitable across the country. At the present time there are over 100 patients who are at various stages of the treatment who are being penalised simply by the fact that they live in the north of England. Many of these patients have had multiple miscarriages, terminations for affected pregnancies, and lost children in infancy due to their inherited conditions, and this lack of service locally compounds their distress.

In January 2022, Leeds Teaching Hospitals NHS Trust reached an agreement with Care Fertility using an SLA as a vehicle to provide NHS funded licensed fertility treatment for the Yorkshire region Together, Leeds Teaching Hospitals NHS Trust and Care Fertility Leeds, through this SLA continue to run the PGT M/SR satellite service at Guy's and St Thomas'.

Leeds Teaching Hospitals NHS Trust together with Care Fertility, Leeds have a HFEA PGT licence, the skills, expertise and facilities to offer this service, with excellent success rates and patient testimonials. They also have collaboration with the genetic and medical experts in a large teaching hospital to manage the complex cases undergoing PGT-M/SR. This clinic can readily offer this service for patients in the north of England if NHS England would redistribute the funding fairly to allow all aspects of treatment to be delivered in Leeds.