Dupilumab for maintenance treatment of uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils

  • Technology appraisal guidance
  • TA1142
  • Published: 
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1 Recommendations

1.1

Dupilumab can be used as an add-on maintenance treatment option for uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils in adults if:

  • they are having:

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

    • double therapy including a LABA and a LAMA if inhaled corticosteroids are not appropriate, and

  • the company provides dupilumab according to the commercial arrangement.

    Uncontrolled COPD is defined as 1 or more severe exacerbations or 2 or more moderate exacerbations in the previous 12 months. Raised blood eosinophils is defined as having a blood eosinophil count of 0.3 x 10^9 cells per litre or more (300 cells per microlitre or more).

1.2

Assess response to dupilumab at 12 months. Stop dupilumab if, compared with the 12 months before starting it, the number of severe exacerbations:

  • is higher, or

  • is the same, and the number of moderate exacerbations is higher.

1.3

These recommendations are 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 must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Dupilumab must be funded in England within 90 days of final publication of this guidance.

There is enough evidence to show that dupilumab provides benefits and value for money, so it can be used routinely across the NHS in this population.

NICE has produced tools and resources to support the implementation of this guidance.

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.

The clinical trials for this evaluation used the following definitions:

  • Uncontrolled COPD is 1 or more severe exacerbations or 2 or more moderate exacerbations in the previous 12 months.

  • Raised blood eosinophils is an eosinophil count of 0.3 x 10^9 cells per litre or more (300 cells per microlitre or more).

The company also included a rule that dupilumab is stopped at 12 months if the COPD has not responded.

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

The cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, dupilumab can be used.