Commissioning, funding and approval
What is the immediate commissioning requirement following NICE TA1142 (dupilumab)?
Dupilumab is now recommended as an add-on maintenance treatment option for adults with uncontrolled COPD with raised blood eosinophils. ICBs should ensure the medicine and associated pathway are available in line with NICE recommendation requirements.
NICE TA1142 was published on 26 March 2026 and ICBs are legally required to fund medicines recommended in a NICE technology appraisal within 90 days of publication.
What is the immediate commissioning requirement following NICE TA1166 (mepolizumab)?
NICE TA1166 was published on 17 June 2026, which recommends mepolizumab as an add-on maintenance treatment option for adults with uncontrolled COPD with raised blood eosinophils. ICBs will be legally required to fund this medicine within 90 days of publication.
Can an ICB add local restrictions beyond NICE criteria?
Local pathways can organise safe, phased implementation and prioritisation. However, blanket restrictions that prevent NICE-eligible patients from accessing treatment will create inequitable access. Any local triage should be transparent, clinically justified, time-limited and aligned to NICE.
How are COPD biologics medicines being funded?
COPD biologic therapy is currently funded via local commissioner/provider budgets. It is not funded centrally via high-cost drugs budget.
What information should be included in the local business case?
Business cases will vary by region and will depend on if the intended funder is a provider or commissioner. The appropriate local template should be used. RTP will be collecting and sharing examples.
Resources to support business cases include:
- NHS England has developed commissioning and business case guidance documents.
- NICE has also created report impact summaries for:
What approval route should be used for high-cost drug prescribing?
COPD biologics are not currently centrally funded and therefore there is no mandated national prescribing mechanism. Local approval routes should be agreed by the ICB and providers before initiation.
Patient eligibility
Which patients are in scope for dupilumab under NICE?
Adults with uncontrolled COPD and raised blood eosinophils who are receiving triple therapy including ICS/LABA/LAMA, or LABA/LAMA where ICS is not appropriate, are in scope if they meet the NICE criteria. NICE defines uncontrolled COPD as at least one severe exacerbation or at least two moderate exacerbations in the previous 12 months, and raised eosinophils as at least 0.3 x 10^9 cell/L (300 cells per microlitre or more). See NICE TA1142.
Which patients are in scope for mepolizumab under NICE?
Adults with uncontrolled COPD and raised blood eosinophils who are receiving triple therapy including ICS/LABA/LAMA, are in scope if they meet the NICE criteria. NICE defines uncontrolled COPD as at least one severe exacerbation or at least two moderate exacerbations in the previous 12 months, and raised eosinophils as at least 0.3 x 10^9 cell/L (300 cells per microlitre or more). See NICE TA1166.
Does COPD care need to be optimised before referral for biologic assessment?
NICE recommendations and commissioning guidance suggests biologics should be considered for patients with frequent exacerbations, elevated eosinophils and ongoing symptoms despite optimised care and appropriate background inhaler therapy. Optimisation should include accurate diagnosis, inhaler optimisation, vaccination, tobacco-dependence support and pulmonary rehabilitation where appropriate and accessible.
Local pathways should ensure these elements are offered and documented in the referral and MDT record, without making limited availability or waiting times an unfair barrier to biologic treatment.
Which eosinophil count should be used when determining eligibility for COPD biologic treatment?
NICE TA1142 (dupilumab) and TA1166 (mepolizumab) do not specify when the eosinophil count should be measured. The clinical trials underpinning these recommendations assessed eosinophil counts during the screening period before treatment initiation, which in practice is a recent pre-treatment count.
Eligibility review should combine the biomarker with clinical assessment. Eosinophil counts should be interpreted alongside the patient’s clinical history, including exacerbation patterns and any factors that may affect the result, such as recent systemic corticosteroid use, intercurrent infection or allergic events. Where possible, counts should reflect the patient’s stable clinical state.
Patient identification, prioritisation and referral
How should systems identify potentially eligible patients?
Systems are using a combination of reactive case finding e.g. recent admissions, outpatient clinics, and routine reviews, and proactive case finding using risk stratification tools and population health management. Further case studies will be available via RTP.
Which patients should be prioritised if capacity is limited?
Some systems are looking at a phased implementation which may focus on patients that local teams feel are a clinical priority. A phased operational roll-out may be needed where capacity is constrained. However, services must continue to work towards equitable access for all NICE-eligible patients.
If a prioritisation approach is adopted, this must be transparent, clinically agreed and regularly reviewed.
What information should be included in referrals to secondary care?
This should be developed based on local referral pathways and clinical services. The NRAP MDT dataset includes core information required for initiation and decision making by secondary care teams.
RTP will share best practice and example referral templates.
Equitable access and variation
How should systems avoid widening inequalities?
Health inequalities is a cross-cutting theme of the RTP programme. All systems are advised to consider the impact of pathway transformation and COPD biologic services on their local population. Examples of avoiding widening health inequalities includes community engagement schemes, proactive targeted case finding and ensuring health inequalities data is monitored to ensure equitable access and uptake.
How should regional variation be handled?
Variation in readiness is expected, but ICBs should aim for consistent minimum standards across places / providers. Data-led planning and regular review of variation in care and outcomes is recommended.
Service model and pathway delivery
Is a regular community respiratory MDT required before starting biologics?
Each MDT should have a clear terms of reference. A regular community MDT is not an explicit NICE prerequisite, but an MDT or equivalent governance process is needed to support consistent eligibility decisions, optimisation, follow-up and equity.
How will patient receive their injections?
Homecare and self-administration of COPD biologics will be the default way in which most patients receive their therapy.
The NHS England model pathway describes supervised administration of initial doses aligned with homecare, followed by patient self-administrated where appropriate. Some services have safely initiated COPD biologics at home.
Additional homecare support may be needed for patients who cannot self-administer.
How does this link to neighbourhood / community respiratory care?
NHS England commissioning guidance aligns COPD pathway development with proactive, data-led and neighbourhood-based care. Biologics should sit within the broader COPD pathway and patient optimisation. Neighbourhood and community teams will have a central role in the identification of patients who may benefit from COPD biologics.
What provider readiness checks are needed before launch?
ICB commissioning services are advised to review the commissioning support documents and RTP resources.
Provider readiness should ensure that their service takes a whole pathway approach, provides access to a respiratory consultant, the decision to initiate is taken at MDT and documented to ensure NICE criteria for initiation and follow-up are met, and that data on timely and equitable access to COPD biologics are collected through the NRAP dataset.
What communications are needed before launching the service?
Systems should communicate the pathway to all clinicians and teams involved in COPD care, including primary care, urgent care / admission avoidance teams and patient-facing teams.
Treatment initiation, follow up, monitoring and stopping treatment
Who should make the treatment initiation decision?
The decision to initiate COPD biologics should be made by an MDT led by a consultant in respiratory medicine, with the patient identified in line with NICE criteria.
Can patients be assessed or followed up remotely?
All patients should be assessed by a respiratory consultant prior to decision to initiate COPD biologics. Remote follow-up is encouraged and appropriate where clinically safe. The NHS England model pathway suggests remote reviews at 6 and 12 months, and care can include patient-initiated follow-up.
What follow-up schedule should be planned?
The NHS England model pathway includes reviews at 6 and 12 months, with an efficacy assessment at 12 months. NICE states that the response to therapy should be assessed at 12 months and dupilumab and mepolizumab stopped if exacerbation outcomes have not improved according to the NICE stopping rule.
It is recommended that services build 6-month, 12-month and annual reviews into their pathway, and ensure that baseline exacerbation count is recorded before initiation.
When should dupilumab and mepolizumab be stopped?
NICE recommends assessing the response to therapy at 12 months. Therapy should be stopped if severe exacerbations are higher in the 12 months before starting, or if severe exacerbations are the same and moderate exacerbations are higher.
What outcome measures should be monitored?
See NICE criteria for 12-month review and NRAP dataset.
Safety and governance
How should adverse events and safety concerns be handled?
Services should follow standard medicines governance protocols, product information, local incident reporting and MHRA Yellow Card processes. Patient information should include who to contact for suspected adverse effects, missed doses, infection concerns or worsening COPD symptoms.