UK’s National Institute for Health and Care Excellence (NICE) has published an Appraisal Consultation Document (ACD) for British pharmaceutical company AstraZeneca‘s Tagrisso (osimertinib).

Tagrisso (osimertinib) is recognised internationally as an effective medicine for treating a subset of patients with non-small-cell lung cancer (NSCLC).

The preliminary recommendation from NICE is to not recommend osimertinib for adult patients suffering from locally advanced or metastatic NSCLC, and whose tumour harbours the epidermal growth factor receptor (EGFR) and T790M mutations.

NICE stated that at this stage, osimertinib does not meet the criteria needed to be considered for inclusion in the Cancer Drug Fund (CDF).

Patients with epidermal growth factor receptor (EGFR) and NSCLC mostly develop resistance to first line targeted therapies (EGFRm tyrosine kinase inhibitors) as a result of a secondary mutation called T790M.

Osimertinib becomes the first targeted treatment for this group of patients, whose only other treatment option is cytotoxic chemotherapy.

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The NICE-published ACD revealed that, at this time, osimertinib cannot be considered to have met one of the criterion used for end-of-life consideration as the data on overall survival benefit are at present quite immature.

Though AstraZeneca could estimate what the overall survival data would show over a longer period of time using established health economic models, the NICE committee thought this to be associated with a large degree of uncertainty.

According to NICE, until further data confirming a survival benefit is available, the standard NICE cost-effectiveness threshold of £30,000 per quality-adjusted life year (QALY) should be used rather than the £50,000 per QALY threshold regarded appropriate for end-of-life medicines.

AstraZeneca’s submission to NICE showed a conservatively-estimated ICER of just below £43,000 per QALY for osimertinib, which though within the threshold for end-of-life medicines, is higher than the standard threshold.

"We will add the latest data to our NICE submission and are hopeful that osimertinib will eventually qualify as an end-of-life medicine and be made available routinely to UK patients."

AstraZeneca UK and Ireland country president Lisa Anson said: "It is disappointing that NICE has not been able to exercise more flexibility with regard to the degree of acceptable uncertainty around the overall survival data for osimertinib, especially given its recognition as a medical breakthrough.

"We will add the latest data to our NICE submission and are hopeful that osimertinib will eventually qualify as an end-of-life medicine and be made available routinely to UK patients.

"This delay in access could have significant consequences for NHS patients who are relying on the system to enable swift access to innovative medicines like osimertinib."

AstraZeneca will submit additional analyses and updated data on the medicine as part of the ACD consultation process that is slated to close on 14 July this year.

Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.