NICE's chronic lung disease treatment decision could benefit over 5,200 people
NICE broadens nintedanib recommendation on chronic lung disease treatment.
NICE has today (Wednesday, 14 December) recommended that nintedanib to treat idiopathic pulmonary fibrosis (IPF) be extended to more people.
The treatment is currently recommended for people with a forced vital capacity (FVC) value of 50 to 80 percent of expected normal capacity.
Today’s recommendation extends this to people with a forced vital capacity of over 80 percent of expected normal lung capacity.
Forced vital capacity is the amount of air that can be forcibly exhaled from a person’s lungs after taking the deepest breath possible.
Nintedanib is administered by taking one or two capsules twice a day. It is estimated that more than 5,200 additional patients could be eligible to receive nintedanib in its first year, following this recommendation.
IPF is a chronic, progressive lung disease in which scarring (fibrosis) occurs. Most people with IPF experience symptoms of breathlessness and coughing, with an associated progressive decline in lung function and a reduced quality of life. The main aim of treatment is to relieve the symptoms as much as possible and slow down its progression. The median survival from diagnosis is 2 to 5 years.
Clinical trial evidence shows that nintedanib slows the decline of lung function compared with placebo in people with idiopathic pulmonary fibrosis with an FVC above 80%. Also, long-term evidence suggests that the effect of nintedanib is maintained over time.
Nintedanib is one of the first medicines to be recommended by NICE that went through part of its new proportionate approach to technology appraisals. It was completed 8 weeks faster than a standard appraisal of this type and in future NICE hopes to extend this to 10 weeks faster.
Idiopathic pulmonary fibrosis is a devastating condition which impacts the length and quality of people’s lives. Our independent appraisal committee’s recommendation means more people will be able to access this treatment sooner.
The proportionate approach is designed to develop a flexible and pragmatic approach to appraisals, learning from our experience and responding to the increased need of guidance for the healthcare system.
The approach recognises that not all technologies need the full intensity of our existing appraisals process. Some technologies can be evaluated with a simpler and shorter process, and by doing this we expect to be able to create extra capacity in our work programme.
We are simplifying, removing, or reconfiguring parts of the appraisals process. For this appraisal the technical engagement step was removed from the guidance development process and the committee decision was taken outside of a formal meeting allowing for faster development of final draft guidance. The normal single technology appraisal process is around 40 weeks from invitation to participate to final guidance and this change reduced the time by around eight weeks. You can find out more information on the proportionate approach on the NICE website.
The final draft guidance has been released for appeal to the company and registered stakeholders. If there are no appeals to NICE’s decision, final guidance is expected to be published in February 2023.
The company has a confidential commercial arrangement through a simple patient access scheme which makes nintedanib available to the NHS with a discount.
You can read the final draft guidance on nintedanib for treating idiopathic pulmonary fibrosis when forced vital capacity is above 80% predicted on the NICE website.