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It has been announced today, 13^th April, that the Scottish Medicines Consortium (SMC) has accepted the new PAH drug sotatercept for ‘restricted use’ in eligible patients in Scotland.

This means sotatercept (brand name Winrevair) can now be prescribed alongside existing PAH treatments for patients who meet specific clinical criteria. According to official SMC guidance, this includes adults considered to have an ‘intermediate-low risk status’ and who experience a ‘moderate or marked limitation in physical activity.’

This decision marks an important step forward, and one that reflects the collective efforts of the UK’s pulmonary hypertension community.

At the PHA UK, we have been closely involved throughout the process. By contributing to the SMC’s review meetings and sharing insights from our research into the lived experience of PH, we have helped highlight just how urgently new treatment options are needed. This means that if you’ve ever taken part in one of our surveys, you’ve played a direct role in helping to secure access to this first-in-class therapy.

This announcement does not change the current position in England, where a decision from the National Institute for Health and Care Excellence (NICE) is still pending following an initial rejection. Pricing discussions between NICE and the manufacturer are ongoing but have been described as being at an ‘impasse.’ You can read more about this, and find out what the PHA UK is doing to help, here. We will continue to keep you updated as this situation develops.

At present, there have been no submissions to commissioning bodies in Wales or Northern Ireland, although these nations typically follow NICE guidance.

Dr Iain Armstrong, PHA UK Chair, said: “This is really encouraging news. We haven’t had a new drug like this in pulmonary hypertension for many years, so this feels like a big step forward - and once again it demonstrates the power of the patient voice.

“Whilst this is a great development for eligible patients in Scotland, it is just the start of a process to secure equal access across the UK. We will continue to fight for everyone to get access to the treatments they deserve.”

There have currently been no submissions to the commissioning bodies in Wales and Northern Ireland. We understand that these nations typically follow the decision made by NICE in England.

Recognising the impact of fatigue

Official documentation from the SMC, issued with its sotatercept decision, describes PAH as a condition that causes high blood pressure in the arteries of the lungs leading to breathlessness and fatigue.

The inclusion of the word fatigue is significant, as it is the first time we at the PHA UK have seen this recognised so explicitly in documents of this kind. We believe this reflects the patient insight we shared during the decision-making process, where many people told us in this survey that fatigue can be just as challenging as breathlessness.

This is another powerful example of patient voices being heard, and crucially, making a difference.

About sotatercept

Sotatercept represents a completely new approach to treating PAH. Most existing treatments are known as vasodilators, which work by relaxing and widening narrowed blood vessels. These help manage symptoms but do not address the underlying cause of the disease.

Sotatercept works differently. It targets the signalling pathways involved in the disease process itself, helping to rebalance the ‘problem proteins’ that drive PAH. This makes it the first treatment of its kind to act more directly on the root cause of the condition.

It’s important to note that sotatercept is not a cure. It is also not suitable for everyone. For those who are eligible, it is used alongside existing treatments and is given as an injection under the skin every three weeks.