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    Has all of the relevant evidence been taken into account?

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

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Draft guidance consultation

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1 Recommendations

1.1

Dupilumab should not be used as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) in adults with raised blood eosinophils, who are taking:

  • an inhaled corticosteroid, a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA; triple therapy), or

  • a LABA and a LAMA (double therapy) if inhaled corticosteroids are not appropriate.

1.2

This recommendation is not intended to affect treatment with dupilumab 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

Dupilumab is not required to be funded in the NHS in England to treat uncontrolled COPD in adults with raised blood eosinophils who are taking triple therapy, or double therapy if inhaled corticosteroids are not appropriate. It should not be used routinely in the NHS in England.

This is because there is not enough evidence to determine whether dupilumab is value for money.

Why the committee made these recommendations

Usual treatment for uncontrolled COPD with raised blood eosinophils is triple therapy, or double therapy if inhaled corticosteroids are not appropriate.

For this evaluation the company defines uncontrolled COPD as 1 or more severe exacerbations, or 2 or more moderate exacerbations, in the previous 12 months. It defines a raised blood eosinophil count as 300 cells or more per microlitre.

Clinical trial evidence shows that dupilumab reduces the number of exacerbations and improves lung function compared with triple therapy or double therapy.

There are uncertainties in the economic model about:

  • the impact of dupilumab on the rate of severe exacerbations and mortality

  • how long any benefits of dupilumab last.

Because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimates for dupilumab.

So, dupilumab should not be used.