SmellTaste statement on NICE draft guidance for Dupilumab for treating severe chronic rhinosinusitis with nasal polyps
SmellTaste is a stakeholder in the National Institute for Health and Care Excellence (NICE) appraisal for Dupilumab to treat severe Chronic Rhinosinusitis with Nasal Polyps. NICE has published its draft guidance following the first committee meeting of the appraisal process. This is publicly available on the NICE website.
Having reviewed the draft guidance published by NICE, it is positive that the NICE appraisal committee has understood and recognised that severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) has a serious impact on people’s lives, that there is lack of effective treatment options for CRSwNP and a need for an effective, targeted treatment. The Committee also concluded that Dupilumab is an effective treatment.
However, the Committee’s decision is that Dupilumab not be recommended for treating patients with severe CRSwNP because it could not determine its preferred cost effectiveness estimate for the drug due to uncertainties in the economic model, because of:
- the data used to estimate how well dupilumab works in the long term
- how many people will need another surgery and how long they have to wait for it
- how quality of life is estimated
The third bullet point relates to how the data used to measure health-related quality of life that informs the economic model is captured. NICE prefers to use a tool called the Eq5d to capture health-related quality of life. When completing the Eq5d, the patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the following five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For many people with CRSwNP, mobility and self-care aren’t likely to be factors, whilst the wide-ranging quality-of-life impacts of the disease, including smell loss, are not readily captured by these five domains. The most widely used health utility for chronic rhinosinusitis, the SNOT-22, on the other hand, captures much more detail of the impact of the disease, including loss of smell.
In the draft guidance the Committee accepts that the EQ-5D is not as sensitive as the SNOT-22 to all aspects of health-related quality of life in people with CRSwNP, but at the same time they are not willing to deviate from using this. The data from Eq5d appears to one of the main reasons for the Committee’s recommendation not to approve the drug. We are disappointed with this and feel that the true impact of the more severe cases of this disease on people’s lives are not being fully captured in the economic model that the Committee is basing its recommendations on.
We want to see this drug approved for those patients with severe cases of the disease for whom the current gold-standard treatment, sinus surgery, does not provide lasting relief from symptoms because of the continued regrowth of nasal polyps. It is already available to CRSwNP patients in over 30 countries.
We would like the Committee to give more consideration to the issues with the Eq5d data and its lack of sensitivity in measuring health-related quality of life in people with severe CRSwNP when it meets again in September. SmellTaste will be providing further input on this as part of the consultation on the draft guidance.