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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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1 Recommendations

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1 Recommendations

1.1

Sotatercept, with other pulmonary arterial hypertension (PAH) treatments, should not be used to treat PAH in adults with World Health Organization functional class (WHO FC) 2 to 3, to improve exercise capacity.

1.2

This recommendation is not intended to affect treatment with sotatercept that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

What this means in practice

Sotatercept is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because the available evidence does not suggest that sotatercept is value for money in this population.

Why the committee made these recommendations

Usual treatment for PAH with a WHO FC of 2 to 3 is a combination of endothelin receptor antagonists and phosphodiesterase type-5 inhibitors as background treatments, plus selexipag. For PAH with a WHO FC of 3 usual treatment can also include prostaglandin I2 analogues. Sotatercept would be an alternative to selexipag.

The company asked for sotatercept to be considered only for people who have an intermediate–low-risk status to reflect the populations in the clinical trials. This does not include everyone it is licensed for.

Clinical trial evidence shows that sotatercept plus background treatments improves exercise capacity compared with placebo plus background treatments.

Sotatercept has not been directly compared in a clinical trial with selexipag, but indirect comparisons using data from 3 different studies suggest that sotatercept is likely to work better.

The cost effectiveness of sotatercept is unclear because of uncertainties with some of the assumptions in the economic model. These include:

  • the long-term treatment effects when comparing sotatercept with selexipag

  • how and when treatment with sotatercept or selexipag is started

  • how subsequent treatments are started when PAH gets worse

  • subsequent treatment effects.

Even when considering the condition's severity, and sotatercept's effect on quality and length of life, the most likely cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources.

So, sotatercept should not be used.