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How patients’ views helped inform the approval of a new CMV reactivation drug in Scotland

After the news that the Scottish Medicine Consortium has recommended letermovir (Prevymis) for routine use on the NHS in Scotland, Bradley from our Policy and Public Affairs team shares what this means for patients and how Anthony Nolan promoted the views and experiences of patients to help make this happen.

A new preventative treatment

The Scottish Medicine Consortium (SMC) have just announced that letermovir (Prevymis), a medicine used to prevent cytomegalovirus (CMV) from causing serious illness in patients after stem cell transplant, has been approved for routine use on the NHS in Scotland.

CMV is a very common virus, often caught during childhood, and is usually harmless. For healthy people, their immune system controls CMV and it lives dormant in the body without causing symptoms (much like chicken pox). After a donor stem cell transplant, a patient’s immune system can be weak and unable to keep CMV at bay as it normally does. The virus is then able to replicate, known as reactivation.

Before letermovir, doctors had to wait until CMV reactivation was apparent from blood tests, meaning that reactivation had already started to occur. Patients told us that the medicines used to treat a reactivation can have side-effects which significantly affect their quality of life.

For this reason, letermovir could be a particularly important victory for stem cell transplant patients, as it is the first drug of its kind to be able to be used to prevent the reactivation from occurring in the first place, potentially stopping progression and the need for other more difficult treatments.

Letermovir will only be available for patients in Scotland who have CMV present in their body ahead of their transplant, although we’re working with the National Institute for Health and Care Excellence to make this more widely available.

How the decision process works

We know that due to limited resources, the NHS only has a certain proportion of its budget allocated to medicines. This means that they can only fund the drugs which are proven to be both clinically-effective, where the medicine is successful according to research and trials, and cost-effective, where it gives a big enough benefit to patients according to its cost.

In order to decide which medicines will be funded by the NHS for patients in Scotland, the SMC looks carefully at each new medicine to ensure it ticks both these boxes. The decision process considers many different areas of information, such as data from clinical trials, the experiences of patients and carers, the views of doctors and nurses, and the price offered by the pharmaceutical company.

For drugs affecting very small groups of patients such as this one, there is also an extra step in the SMC process, called the Patient and Clinician Experience (PACE) panel. This ensures that patients’ and doctors’ experiences of the disease and other drugs are given extra emphasis in the process.

Understanding patient experience

The SMC asked Anthony Nolan, as the UK’s stem cell transplant charity, to make a submission and represent the views and experiences of stem cell transplant patients and their carers during the appraisal of this drug.

To ensure that we represented this group, we launched a survey on patient and carer experiences of CMV reactivation which was promoted via social media, as well as to our Patients and Families Panel. 23 patients or carers of someone who experienced CMV reactivation responded, and we conducted six follow-up telephone interviews.

What we found about the impact on recovery

In survey and interview response, CMV reactivation was described as a significant setback for patients. Over two thirds (67%) of respondents stated that this hindered or extended their recovery post-transplant, and over half (58%) said it had a negative or very negative effect on their emotional health and wellbeing. Many patients described this as feeling like CMV reactivation was hindering their recovery:

‘I think you want to put all your effort into getting better after the transplant, so it [CMV reactivation] felt like a massive backwards step and I was very concerned that I didn't have much of an immune system, and it was trying to fight this virus. Alongside having absolutely no energy from the transplant, this knocked me for six.’

Patients consistently told us that being able to manage their condition at home had a significant positive effect on their daily life and their mental health, and patients who were prescribed intravenous treatments found it frustrating to have to return to hospital for treatment or extend their stay because of CMV reactivation:

‘Because my CMV reactivated so soon after transplant, my immunity was still extremely compromised. The need to return to hospital, without the special isolation arrangement in the transplant unit, was therefore a very stressful turn of events for me.’

What we found about the impact on day-to-day life

We also heard how CMV reactivation had a significant effect on patients’ day-to-day life, including their ability to look after themselves, have a social life, travel, and live independently. These issues also caused patients to spend more time off work than anticipated, with one respondent losing their job as a consequence of reactivation.

The treatments to tackle CMV reactivation once it has already started come with a range of serious side-effects – patients talked about it effecting blood counts, causing nausea, and preventing engraftment:

‘A kinder treatment is definitely needed; after going through chemo and total body irradiation the treatment for CMV was by far the worst part.’

Carers highlighted the challenges of looking after someone experiencing CMV reactivation: all eight respondents said it was either ‘difficult’ or ‘very difficult’, and described it as challenging on their mental health. Some carers found it challenging to continue with their career when being a carer and described being away from work as incredibly stressful; others had to give up work altogether.

Promoting patient experience

These insights demonstrate the problems with CMV reactivation that aren’t taken into account when you simply look at the clinical- and cost-effectiveness of a drug. To make sure that these experiences were underlined when deciding whether this medicine should be available for use on the NHS, Anthony Nolan submitted them to the SMC medicine appraisal committee.

Anthony Nolan also fielded a representative on the PACE panel and put forward a patient to explain their ongoing experiences of CMV reactivation.

Next steps

While this decision is fantastic news for some patients, the medicine will only be available for routine use in Scotland. Efforts are underway to make sure this is available elsewhere in the UK.

The National Institute for Care and Health Excellence (NICE) is in the process of deciding whether this drug can be made available in England - Anthony Nolan has made a submission to their process and we are representing patients on the committee deciding whether it will be made available. The Welsh and Northern Irish health services may decide to follow NICE’s decision once it is made.

We will continue to work with NICE and the medicine’s manufacturer to make this medicine available to patients in England, Wales, and Northern Ireland as soon as possible.

If you or someone you know has experienced CMV reactivation and would find speaking to our Lead Nurse helpful, please don’t hesitate to contact Hayley Leonard in Patient Services on 0303 303 0303.