What the first new approved NHS treatment for mesothelioma in 15 years means for people living with the disease
The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending the use of first line combination immunotherapy, with ipilimumab and nivolumab (IPI/NIVO), in NHS practice.
This treatment is considered to be innovative because it is the first new approved treatment for mesothelioma patients since 2008 and means that patients in England and Wales can now access the same treatment as those in Scotland, where the treatment was licensed by the Scottish Medicines Consortium for first line use in February 2022.
The approval not only covers mesothelioma of the lining of the lung, but also of the pericardium and the peritoneum - the linings of the heart and the abdomen.
Treatment for mesothelioma patients
When I first started in asbestos litigation, in 2004, patients with a mesothelioma diagnosis were often simply told to go home and sort their affairs. Their life expectancy was shockingly low.
In 2006, a new chemotherapy drug, Alimta, came on the scene, and patients were then able to access chemotherapy treatment, which had the effect of extending life expectancy to around 12 – 18 months.
However, since then, there have been no new treatments for mesothelioma patients until recent clinical trials involving immunotherapy commenced.
One of these trials was The Checkmate-743 trial which was conducted by a team of international specialists across 103 hospitals in 21 countries, between November 2016 and April 2018. The trial data suggested that treatment with IPI/NIVO conferred an 18.1 months average survival time, as compared to 14.1 months following treatment with traditional chemotherapy.
After three years, the post-diagnosis survival rates were also much improved, with 41 per cent of patients receiving IPI/NIVO reaching the two year point, versus 27 per cent of patients treated with chemotherapy. Survival time was significantly improved for those diagnosed with the sarcomatoid sub-type of mesothelioma.
In addition, patients receiving immunotherapy as a first line treatment also reported significantly less toxicities, and fewer side effects, although the risk of serious side effects from the treatment does remain.
Following publication of the trial results, clinicians were clear that treatment with IPI/NIVO was beneficial to patients diagnosed with mesothelioma.
Access to immunotherapy treatment
As the benefits to some patients were so clear, the Medicines and Healthcare products Regulatory Agency (MHRA) licensed IPI/NIVO as a treatment through the Early Access to Medicines Scheme (EAMS). In practice, this meant clinicians could apply for EAMS funding to use IPI/NIVO as a first line treatment.
However, the MHRA’s decision in July 2021 to license the drug meant that access for clinicians to IPI/NIVO through EAMS was removed, pending NICE approval for the treatment.
Patients recently diagnosed with mesothelioma, who would previously have been eligible for treatment with IPI/NIVO through EAMS, faced an anxious wait whilst the license progressed through the NICE protocols for approval.
IPI/NIVO remained available on a private basis, either through paying direct or through insurers via a compensation claim. However, given the speed with which the treatment needs to be commenced in a first-line setting, being able to access IPI/NIVO through private funding was a remote possibility, at best.
Charity hails momentous landmark
Liz Darlison, CEO of Mesothelioma has shared how she feels about the announcement.
She said: "We have waited 15 long years for a new NHS treatment for mesothelioma, this really is pivotal, a momentous landmark in mesothelioma treatment and care.
"Of course new treatments only happen if clinical trials take place which are dependent on funding. We need to take steps to remove the risk of exposure to asbestos to prevent mesothelioma in the first place and we also need to ensure this preventable cancer gets the research funding it needs.
"Mesothelioma UK would like to thank all those patients that took part in the clinical trials that led to this approval, congratulate the investigator and research teams who ran the trials."
Conclusion
Most civil claims that I settled, that included provision for private IPI/NIVO treatments together with a range of other treatments, dealt with options in a second or third line setting, after traditional chemotherapy had been completed.
However, patients without a civil claim and those claiming from schemes were still unable to access IPI/NIO unless they had substantial private funds available.
The approval of IPI/NIVO as a first line treatment now gives all eligible mesothelioma patients equal access to a new standard of care, regardless of their financial means or the status of their civil claim.
Find out more about Irwin Mitchell’s expertise in supporting people and families following a diagnosis of mesothelioma and other diseases at our dedicated asbestos-related disease section.
