According to the National Lung Cancer Audit, 2,814 patients(1) were incident with extensive small-cell lung cancer in 2017 across England and Wales, this represents 71%(1) of all patients diagnosed with the disease. Despite very poor outcomes and many patients being diagnosed with metastatic disease, treatment options have been slow to develop. In an age of targeted therapeutics small-cell lung cancer (SCLC) has been largely left behind, particularly in the 1st line setting where there have been no new approvals for ~20 years(2).
While other therapeutic areas such as non-small-cell lung cancer saw the introduction of new targeted and immunotherapies, the SCLC landscape has remained largely dormant. In March 2019 Tecentriq was approved for use in this setting based on the IMpower133 phase 3 clinical trial(3,4,5). While Roche succeeded in convincing regulators that the drug is both safe and efficacious, they have seemingly failed to convince NICE, the UK health technology assessment body of the drug’s value proposition.
On the 31st of December NICE published an appraisal consultation document, with their recommendation on the use of Tecentriq (Atezolizumab) for patients with extensive-stage Small-Cell Lung Cancer.
While NICE accepted that Tecentriq gave some benefit to patients with extensive stage small-cell carcinoma, the institute decided that the treatment was not cost effective and should not be supplied by the Cancer Drug fund while it awaits further evidence generation. Roche have until February to appeal NICEs decision and negotiate a price which would allow them access to access the English market, failure to do so will seriously hamper their ability to sell to this large patient group in the UK.
Concerns centred largely around the issue of long-term overall survival (OS), with outcomes from each arm of the trial converging at 30 months(6). This along with the associated drug costs meant that the drug has failed to gain reimbursement from the NHS.
The decision means that extensive stage SCLC patients in the UK still have no access to targeted therapies in the first line setting. While Tecentriq has failed to achieve the cost effectiveness hurdle, hope is not completely lost for these patients. Another immunotherapy, AstraZeneca’s Imfinzi has reported results from their phase 3 “CASPIAN” trial(7,8), and has priority review status meaning a decision from the FDA in Q1 of 2020 is likely. The results of the CASPIAN trial appear promising, however there are some cautionary notes. The trial has published data up to 24 months and while there was a difference in OS of 9% at 18 months(8) the time frame is smaller than the 30 month period referenced in the NICE report. Secondly while the list price per vial of Imfinzi is much lower than Tecentriq, £592 vs £3,807.69 the calculated cost per patient month (Vials per cycle * Cycles per month * Price per vial) was £8,192.86 vs £5620.88(9). (These calculations do not factor in rebates provided by the manufacturers to the NHS). If NICE rejected Tecentriq on the grounds of cost effectiveness, Imfinzi will have to show large improvements in patient outcomes to gain reimbursement in the UK.
SCLC is a disease area with a high unmet need where targeted therapeutic interventions would be a welcome addition to clinician’s toolbox, whilst clinical evidence suggests that new products will be safe and efficacious, manufacturers will need to ensure that their cost effectiveness argument is strong when entering discussions with HTAs. NICE has shown with this decision that failure to convince them of the economic argument could lead to patients having lesser access to the most effective therapies available.
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