NICE gives green light to AstraZeneta's lung cancer treatment Tagrisso after a confidential discount.

Guide: NICE initially refused to approve Tagrisso mainly because of the lack of cost-effectiveness of the treatment.
. On Friday, the National Institute for Health and Care Evaluation (NICE) reversed an earlier rejection of AstraZeneta's lung cancer treatment, Tagrisso, and agreed to approve the drug for treatment of two lung cancer adaptations in the UK.
Tagrisso's two lung cancer adaptations approved in the UK this time are: 1) for patients with non-small cell lung cancer (NSCLC) who have begun to spread to other parts of the body and have not yet been treated for cancer;
NICE said the main reason for the initial refusal to approve Tagrisso was the lack of cost-effectiveness of the treatment, but AstraZeneta offered a new business plan to address the problem, allowing Tagrisso to use NHS resources cost-effectively.
previous clinical trials have shown that Tagrisso's ability to inhibit cancer growth exceeds that of Roche Tarceva and AstraZeneta Iressa in patients with EGFR mutations newly diagnosed with NSCLC.
NICE had previously argued that AstraZeneca did not have direct data to prove that Tagrisso could compete with the efficacy of Grigg Ingham's Gilotrif, another older generation of tyrosine kinase inhibitors already covered by the NHS.
, however, AstraZeneta persuaded NICE to approve the offer at a confidential discount by selling Tagrisso, priced at 5,770 pounds ($7,395) per 30 tablets.
regarding the routine coverage of upgrading Tagrisso from the Cancer Drugs Fund (CDF) to the previously treated EGFR T790M mutation NSCLC, NICE said the decision was based on new data from the AURA3 trial and data collected from Tagrisso's actual use under the conditional path.
in the AURA3 trial, Tagrisso significantly extended the progress or death of a patient's cancer compared to platinum-based two-line chemotherapy.
, tagrisso did not achieve significant statistical significance at the critical end of life extension (reducing the risk of death by 13 percent compared to chemotherapy).
NICE believes the data should take into account the 71 percent conversion from chemotherapy drugs to Tagrisso after the disease develops, which may benefit the survival of the chemotherapy drug group.
, after adopting the model provided by AstraZeneta, the organization believes that Tagrisso's life-extending efficacy and discounted price meet the requirements for inclusion in conventional coverage.
announced earlier this year at this year's meeting of the American Society of Clinical Oncology that Tagrisso reduced the risk of recurrence or death by 83 percent in NSCLC of phase II and PHASE IIIA EGFR mutations as an ad-help therapy used after surgery.
Berens, an analyst at SVB Leerink, predicts that Tagrisso's peak sales alone could reach $5.6 billion, with global sales of about $16 billion.
, Tagrisso is AstraZeneta's best-selling drug, with sales up 35 percent year-on-year to $1.03 billion in the second quarter at a constant exchange rate.
as the drug becomes a new adaptor for NSCLC patients with EGFR-TKI gene mutations, AstraZenecom aims to promote the drug's use earlier in treatment.
source: 1. AstraZeneca changes minds at NICE, winning Tagrisso coverage in 2 lung cancer developments2. Targeted drug for lung cancer approved for NHS use in England.