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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

1.1

Inhaled treprostinil should not be used to treat pulmonary hypertension associated with interstitial lung disease (WHO group 3) in adults.

1.2

This recommendation is not intended to affect treatment with inhaled treprostinil 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

Inhaled treprostinil 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 inhaled treprostinil offers benefit or is value for money in this population.

Why the committee made these recommendations

Usual treatment for pulmonary hypertension associated with interstitial lung disease is best supportive care.

Clinical trial evidence shows that inhaled treprostinil improves exercise capacity compared with placebo. But this is uncertain because of the trial design.

Results from an indirect comparison of inhaled treprostinil against best supportive care are also uncertain. This is because the study population is not representative of the likely NHS population.

There are uncertainties in the economic model, including the assumptions about how long people live and how long they have treatment with inhaled treprostinil. The model also does not include any implementation costs.

Because of the uncertainties in the economic model and clinical evidence it is not possible to determine the most likely cost-effectiveness estimates for inhaled treprostinil. So, it should not be used.