| Status: Not supported for use via the One Wales Medicines process | |
It is the view of the One Wales Medicines Assessment Group (OWMAG) that mepolizumab (Nucala®) should not be supported within NHS Wales for the treatment of chronic eosinophilic pneumonia. Individual Patient Funding Request (IPFR) consideration remains appropriate for those patients who are likely to obtain significantly more clinical benefit from the intervention than would normally be expected at a reasonable value for money. At the latest review of this recommendation in August 2023, the decision by the One Wales Medicines Assessment Group was to retain the current advice with no changes required. This decision will be reviewed again after three years or earlier if new evidence becomes available. |
Darllen yn Gymraeg / Read in English
Beth benderfynodd Grŵp Asesu Meddyginiaethau Cymru'n Un?
Penderfynodd Grŵp Asesu Meddyginiaethau Cymru’n Un (OWMAG) na ddylai mepolizumab gael ei ddefnyddio’n rheolaidd yn GIG Cymru i drin math o niwmonia o’r enw niwmonia eosinoffilig cronig. Mae'r math hwn o niwmonia yn glefyd yr ysgyfaint lle mae nifer fawr o eosinoffilau (math o gell gwyn y gwaed) yn cronni yn yr ysgyfaint, gan achosi peswch, diffyg anadl, twymyn a cholli pwysau. Fel arfer caiff ei drin â corticosteroidau (steroidau). Dangosodd y dystiolaeth a ystyriwyd gan OWMAG nad oedd mepolizumab yn darparu unrhyw fudd ychwanegol dros driniaethau eraill sydd ar gael ar gyfer y cyflwr hwn.
Os yw eich meddyg o'r farn eich bod yn debygol o gael budd sylweddol o gael mepolizumab, gall wneud cais ar eich rhan i ofyn am fynediad iddo drwy'r broses Ceisiadau Cyllido Cleifion Unigol (IPFR). Mae mwy am IPFR ar gael yn: https://cttcg.gig.cymru/mynediad-at-feddyginiaethau/mynediad-at-feddyginiaethau-yng-nghymru/ceisiadau-cyllido-cleifion-unigol-ipfr/.
Mae Grŵp Asesu Meddyginiaethau Cymru'n Un ac AWTTC yn adolygu'r penderfyniad hwn yn rheolaidd i weld a oes unrhyw dystiolaeth newydd a allai effeithio ar y penderfyniad hwn.
I gael rhagor o wybodaeth am niwmonia eosinoffilig cronig ewch i wefan Asthma + Lung UK: Eosinophilic lung conditions (Saesneg yn unig)
What did the One Wales Medicines Assessment Group decide?
The One Wales Medicines Assessment Group (OWMAG) decided that mepolizumab should not be routinely used in NHS Wales to treat a type of pneumonia called chronic eosinophilic pneumonia. This type of pneumonia is a lung disease in which large numbers of eosinophils (a type of white blood cell) build up in the lungs, causing coughing, breathlessness, fever and weight loss. It is usually treated with corticosteroids (steroids). The evidence considered by OWMAG showed that mepolizumab did not provide any additional benefit over other available treatments for this condition.
If your doctor thinks that you are likely to gain significant benefit from having mepolizumab they may apply on your behalf to request access to it through the Individual Patient Funding Request (IPFR) process. More about IPFR is available at: https://awttc.nhs.wales/ipfr.
The One Wales Medicines Assessment Group and AWTTC review this decision regularly to see if there is any new evidence that may affect this decision.
For more information on chronic eosinophilic pneumonia visit the Asthma + Lung UK website: Eosinophilic lung conditions
This report was prepared by the All Wales Therapeutics and Toxicology Centre in August 2023. It summarises any new evidence available since the last review in March 2021.
Background: Chronic eosinophilic pneumonia is a rare disease that is part of a larger group of lung diseases characterised by abnormal infiltrations of eosinophils in the lungs. It is characterised by the progressive onset of symptoms including cough, dyspnoea, malaise, chest pain, fever and weight loss. It is usually successfully treated with corticosteroids but the disease can relapse on tapering or stopping corticosteroids. The use of mepolizumab to treat chronic eosinophilic pneumonia in people who require chronic or repeat courses of corticosteroids is still ‘off-label’ (unlicensed). Clinicians in Wales considered there was an unmet need and identified a cohort of patients who could benefit from mepolizumab treatment.
Current One Wales decision: Not supported
Licence status: The use of mepolizumab (Nucala®) to treat chronic eosinophilic pneumonia remains off-label (unlicensed). AWTTC are not aware of any plans to pursue marketing authorisation of mepolizumab for this indication at this time.
Guidelines: There are no published guidelines for the treatment of chronic eosinophilic pneumonia.
Licensed alternative medicines or Health Technology Assessment advice for alternative medicines: None
Effectiveness: A literature search by AWTTC identified one retrospective review. Delcros et al. (2023) reported 29 patients with idiopathic chronic eosinophilic pneumonia who were treated with medicines targeting interleukin-5 or interleukin-5R. Patients were treated with off-label mepolizumab (n = 22) or benralizumab (n = 7), for 3 or more months. Results were reported for all 29 patients combined and not stratified by the biologic therapy received. The biological therapy was started because of frequent, severe asthma exacerbations in 69% of patients; corticosteroid-related side effects in 52%; and failure or side effects of other corticosteroid-sparing medicines in 28%.
Mepolizumab was given as per the licensed regimen for eosinophilic asthma, 100 mg by subcutaneous injection every 4 weeks, in the majority of patients (n = 20).
No relapse of chronic eosinophilic pneumonia was reported after a median duration of 13 months (8–24 months) of biological therapy. In total, 21 patients were eventually weaned from oral corticosteroids, of whom 18 remained free from asthma exacerbations (86%). Two patients each reported injection site reactions and flu-like symptoms. No patients discontinued treatment because of adverse events.
Mepolizumab treatment led to a rapid decrease in blood eosinophilia, and clinical and radiological improvement; although no improvement in lung function tests was reported.
Safety: No relevant safety analyses were identified in the repeat literature search.
Cost-effectiveness: No relevant cost-effectiveness analyses were identified in the repeat literature search.
Budget impact: The estimated eligible population reported in the first evidence review, published in 2019, was 35 patients per year in Wales. Since the last review in March 2022, no independent patient funding requests (IPFR) have been recorded in Wales for mepolizumab to treat chronic eosinophilic pneumonia.
Impact on health and social care services: Minimal.
Patient outcome data: None received. AWTTC is not aware of any patients in Wales having received mepolizumab for chronic eosinophilic pneumonia in the past 12 months.
Next review date: August 2026
References: a full reference list is available on request.
Disclaimer: This document includes evidence published since the last review or full assessment of this medicine for the indication under consideration. It does not replace the original full evidence status report. Any previous reviews and the original full evidence status report are available from this webpage in the section '
Care has been taken to ensure the information is accurate and complete at the time of publication. However, the All Wales Therapeutics and Toxicology Centre (AWTTC) do not make any guarantees to that effect. The information in this document is subject to review and may be updated or withdrawn at any time. AWTTC accept no liability in association with the use of its content. An Equality and Health Impact Assessment (EHIA) has been completed in relation to the One Wales policy and this found there to be a positive impact. Key actions have been identified and these can be found in the One Wales Policy EHIA document.
Information presented in this document can be reproduced using the following citation: All Wales Therapeutics & Toxicology Centre. Mepolizumab (Nucala®▼) for the treatment of chronic eosinophilic pneumonia (OW15). 2023
Copyright AWTTC 2023. All rights reserved.
Medicine details |
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| Medicine name | mepolizumab |
| One Wales decision status | Not supported for use via the One Wales Medicines process |
| Reference number | OW15 |
| Decision issue date | November 2019 |
| Date of last review | August 2023 |
| Review schedule | Every 3 years |