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

  • Technology appraisal guidance
  • TA1166
  • Published: 

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1 Recommendations

1.1

Mepolizumab 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 (ICS), a long-acting beta-2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), and

  • the company provides mepolizumab according to the commercial arrangement (see section 2).

    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 a blood eosinophil count of 0.3 x 109 cells per litre or more (300 cells per microlitre or more).

1.2

Assess response to mepolizumab at 12 months. Stop mepolizumab 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 mepolizumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations 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

Mepolizumab 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. Mepolizumab must be funded in England within 90 days of final publication of this guidance.

There is enough evidence to show that mepolizumab 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 an ICS, a LABA and a LAMA. This is called triple therapy. Double therapy including a LABA and a LAMA may be also used if an ICS is not suitable. Usual treatment may also include dupilumab as an add-on maintenance treatment to triple therapy, or double therapy if ICSs are not suitable.

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 109 cells per litre or more (300 cells per microlitre or more).

The company included a rule that mepolizumab is stopped at 12 months if the COPD has not responded well enough.

Clinical trial evidence shows that mepolizumab plus triple therapy reduces the number of moderate or severe exacerbations compared with placebo plus triple therapy.

Mepolizumab plus triple therapy has not been directly compared in a clinical trial with dupilumab plus triple or double therapy. The results of an indirect comparison are too uncertain to say with certainty whether mepolizumab or dupilumab is more effective. But the most likely analysis suggests that mepolizumab may not reduce exacerbations as much as dupilumab. Mepolizumab is cost saving compared with dupilumab.

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