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AstraZenca to appeal NICE rejection of Tagrisso

Pfizer’s Vizimpro wins recommendation

AstraZeneca

AstraZeneca will appeal NICE's decision not to recommend Tagrisso (osimertinib) for first-line non-small cell lung cancer (NSCLC).

The drug is licensed in untreated locally-advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive NSCLC in the EU.

However, NICE’s decision not to recommend Tagrisso was based on the cost effectiveness of the treatment, with the committee deciding that the drug does not meet eligibilty for End of Life (EoL) consideration.

This is defined, along with other criteria, as treatment which is given to patients whose life expectancy is normally less than 24 months.

As usual, it is clear that NICE's rejection has been based on uncertainty around clinical benefits of the treatment, but also its cost.

NICE agreed that Tagrisso extends progression-free (PFS) and overall survival (OS) compared with first generation EGFR-targeting drugs Iressa and Tarceva, but said the size of the benefit is unclear.

An interim analysis of AstraZeneca's FLAURA showed that PFS was statistically significantly longer with Tagrisso than with the older agents. At the latest data cut (June 2017) median PFS was 18.9 months for osimertinib (95% confidence interval [CI] 15.2 to 21.4) and 10.2 months for standard care (95% CI 9.6 to 11.1).

NICE concluded that OS data were very immature (25% of events). The interim results showed that Tagrisso extended OS compared with standard care, however this produced a hazard ratio of 0.63 (95% CI 0.45 to 0.88; p=0.007) which was not statistically significant.

On this basis, NICE judged the cost of the higher-priced new agent not cost effective, since its performance in OS hasn't yet surpassed the older (and cheaper) agents.

NICE has also judged the drug to be not eligible for inclusion in the Cancer Drugs Fund, as it says it doesn't have the potential to be cost effective at the price offered.

AstraZeneca says  analysis of real-world data from Public Health England shows the overall survival in NHS patients who would be eligible for treatment is less than 17 months, putting it within NICE's range for EoL consideration.

Pascal Soriot

Pascal Soriot, chief executive officer, AstraZeneca

This draft decision has been met with a high level of criticism from AstraZeneca, for whom Tagrisso is a vitally important engine for growth.

“We are very disappointed with this decision and will appeal. The UK has the second worst lung cancer survival outcomes in Europe and patients need new innovative treatments.

"Lung cancer patients in England will be deprived of a much needed new treatment option that is already available to patients in many other European countries and around the world” said Pascal Soriot, chief executive officer of AstraZeneca

The decision not to recommend Tagrisso  coincided with NICE’s recommendation of Pfizer’s Vizimpro (dacomitinib) in the same patient population.

Pfizer’s treatment will now be available on the NHS, a change from the committee’s initial decision which did not find the treatment cost-effective.

NICE has reviewed clinical results from Pfizer’s ARCHER 1050 trial which showed that people who used Vizimpro had longer overall survival rates than those who took AZ's older EGFR targeting drug Iressa, which is already recommended by NICE, with median patient survival at 34.1 months compared to 26.8 months.

Vizimpro also increased the length of time before disease progression compared to gefitinib, with 14.7 months for Pfizer’s treatment compared with the 9.2 months of Iressa.

However, NICE did acknowledge that Vizimpro had a higher incidence of side effects, so a lower dose may be necessary.

The recommendations from NICE is set to continue the battle between the two treatments, with Vizimpro gaining ground on Tagrisso steadily.

For AstraZeneca, NICE’s decision is part of a wider issue with methodologies

“It is time for a comprehensive review of how NICE values innovative medicines, concluded Soriot.

"This is needed to ensure British patients can access the latest medical advances, to support the ambitions of the NHS Long Term Plan to improve outcomes for people with cancer, and to help deliver the government’s ambition that the UK continues to be a globally leading centre for life sciences.”

5th July 2019

From: Regulatory

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