The National Institute for Health and Care Excellence (NICE) has recommended dupilumab (Dupixent, Sanofi) as an add-on maintenance therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) and raised blood eosinophil counts. 

As outlined in NICE’s final draft guidance, this self-administered biologic is the first targeted therapy for this specific population and could benefit approximately 30,000 people in England whose condition remains poorly managed despite optimal inhaler therapy.

Disease Impact

COPD is a progressive respiratory condition characterised by airway obstruction, reduced lung function, and episodic symptom flare-ups. The disease affects an estimated 1.2 million people with a confirmed diagnosis in the UK and accounts for approximately 130,000 emergency NHS hospital admissions annually in England. 

Common symptoms include shortness of breath, chronic cough, sputum production, wheezing, chest tightness, and exercise intolerance. Patient experts told the NICE committee that exacerbations are debilitating, often lasting 1-2 weeks and frequently requiring hospital admission and steroid treatment.

Targeting the Type 2 Inflammatory Phenotype

Dupilumab is a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin-13, key cytokines driving type 2 inflammation. Up to 40% of people with COPD exhibit this inflammatory phenotype, which is characterised by raised blood eosinophil counts. 

The treatment is delivered subcutaneously every 2 weeks via a pre-filled pen or syringe, targeting both symptoms and the underlying inflammatory mechanisms.

Eligible Patient Profile

NICE defines uncontrolled COPD as experiencing one or more severe flare-ups, or two or more moderate exacerbations, in the previous 12 months. Eligible patients must have raised blood eosinophils, defined as a count ≥ 0.3 × 10⁹ cells/L (≥ 300 cells/µL). 

Patients must already be receiving: 

• Triple therapy with an inhaled corticosteroid, long-acting beta 2-agonist (LABA), and long-acting muscarinic antagonist (LAMA), or
• Double therapy with LABA and LAMA if corticosteroids are unsuitable.

Healthcare providers must evaluate treatment response at 12 months and stop dupilumab if, compared with the previous year, the number of severe exacerbations increases, or if severe exacerbations remain unchanged but moderate exacerbations increase.

Lung Function and Symptom Gains

The recommendation was supported by evidence from the phase 3 BOREAS and NOTUS trials, which together enrolled 1874 participants (938 in the dupilumab arm and 936 in the placebo arm) with moderate-to-severe COPD and blood eosinophil counts ≥ 300 cells/µL. 

Both double-blind, randomised studies compared subcutaneous dupilumab 300 mg every 2 weeks with placebo, alongside standard background therapy. 

A pooled analysis demonstrated a 31% reduction in in the annualised rate of moderate or severe exacerbations, with 0.79 event per year in the dupilumab group vs 1.16 events per year with placebo.

Participants receiving dupilumab also experienced clinically meaningful improvements in lung function, with pre-bronchodilator forced expiratory volume in 1 second increasing by 83 mL at week 12 and 73 ml at week 52 compared with placebo. Quality-of-life measures also improved, with St George's Respiratory Questionnaire scores decreasing by 3.4 points at week 52.

The BOREAS trial also showed that patients reported improvement as early as week 4, which was sustained through week 52, with similar adverse event rates between treatment groups.

Access, Cost, and System Impact

Dupilumab has a list price of £1264.89 for a two-pack of 300 mg/2 mL pre-filled pens or syringes, although the company provides NHS access through a confidential commercial arrangement.

Under NICE’s recommendation, NHS England must fund dupilumab within 90 days of final guidance for eligible patients, where clinicians judge it to be the most appropriate treatment option. A commercial agreement has been put in place to support national rollout.

If half of the eligible population were to receive dupilumab, NICE modelling suggests this could result in approximately 3600 fewer COPD exacerbations per year, potentially saving the health system around £16.5 million, while reducing pressure on emergency and acute care services.