The National Institute for Health and Care Excellence (NICE) has issued a new draft guidance, advising against the use of Roche's Tecentriq (atezolizumab) for adult patients with untreated extensive-stage small-cell lung cancer (SCLC).

The guidance, which denies the therapy routine NHS coverage, indicated that the PD-L1 inhibitor "meets NICE's criteria to be considered a life-extending treatment at the end of life”, however “the cost-effectiveness estimates for Tecentriq with chemotherapy are higher than what is considered a cost-effective use of NHS resources."

The watchdog also revealed that the “long-term benefit on overall survival is uncertain", as the mean cost of a course of treatment for a patient with extensive-stage SCLC is £32,798 at the list price.

Roche already has a commercial arrangement with the NHS that makes the drug available at a discount, but would have also applied to the extensive-stage SCLC indication had it been recommended.

NICE ultimately made the decision as “Atezolizumab with chemotherapy improves overall and progression-free survival compared with chemotherapy but the long-term benefit is uncertain”. It went on to say that “Data from IMpower133 are not generalisable to people with an ECOG performance status score of two or higher which is likely in clinical practice in England”
Earlier this month the drug garnered US Food and Drug Administration (FDA) approval for adults with metastatic non-squamous NSCLC, who have no EGFR or ALK genomic tumour aberrations.

It was given the US green light in combination with chemotherapy, based on results from the Phase III IMpower130 study, which showed that the combo helped people live significantly longer compared to chemotherapy alone, demonstrating a median overall survival rate of 18.6 months compared to 13.9 months.

In September it was also approved with chemotherapy for the first-line treatment of adults with extensive-stage SCLC, based on data from the Phase III IMpower133 study.