SMC ‘U-turn’ on Uptravi® (selexipag)▼ for patients with PAH

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Actelion Pharmaceuticals UK have announced that NHS patients in Scotland with pulmonary arterial hypertension (PAH) are now able to access a tablet that targets a major disease pathway, the prostacyclin pathway. The Scottish Medicines Consortium (SMC) has recommended selexipag for restricted use for the long-term treatment of PAH in adult patients with one of the more severe forms of the disease (functional class (FC) III) who are insufficiently controlled on oral treatment with two other classes of PAH medicines.

PAH is a devastating condition that causes an increase in blood pressure in the blood vessels between the right side of the heart and the lungs, those with FC III live on average 2.5 years if left untreated.

Selexipag is an oral treatment that specifically targets the prostacyclin pathway – a major disease pathway involved in the development of PAH. It has been shown to improve long-term outcomes for patients with PAH in a Phase III clinical study in more than 1,000 people with the condition. The GRIPHON trial found that selexipag was significantly better than placebo as measured by a composite primary outcome of complications related to PAH or death. In the study, selexipag was generally well-tolerated by patients, with the majority of commonly reported side effects (such as headache, diarrhoea, and nausea) being mild to moderate.

In Scotland, there are currently 620 patients being managed for PAH at a leading specialist centre. Patients with PAH can experience debilitating symptoms that impair their quality of life, including struggling to breathe, fatigue, dizziness, fainting and chest pain. Current therapies that target an integral pathway of the disease known as the prostacyclin pathway, whilst effective, can be difficult for patients to administer.

Dr Martin Johnson, Consultant Physician at the Scottish Pulmonary Vascular Unit said, ” This treatment is the first licensed oral prostacyclin receptor agonist and the first tablet to work on this pathway available in the UK. This will increase the options open to people with Pulmonary Arterial Hypertension in Scotland.”

Dr Iain Armstrong, Chair, Pulmonary Hypertension Association UK said, “Whilst this is excellent news for Scottish patients, we are mindful that just across the border in England and Wales, NHS patients are still waiting for this much-needed medicine.”