AstraZeneca changes minds at NICE, winning Tagrisso coverage in 2 lung cancer indications

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England's NICE has reversed its previous decision and decided to back routine use of AstraZeneca's Tagrisso in previously untreated EGFR-mutated non-small lung cancer after the British pharma agreed to a confidential discount. (Pixabay)

Despite Tagrisso rapidly establishing itself as the new standard of care for EGFR-mutated non-small cell lung cancer, its maker AstraZeneca has had a hard time convincing England’s drug cost watchdog of its worth. As of Friday, though, it’s made some progress in that department, convincing the The National Institute for Health and Care Excellence (NICE) to reverse a negative decision.

England’s cost-effectiveness gatekeeper now recommends Tagrisso for routine NHS coverage in previously untreated EGFR-mutated NSCLC and as a second-line treatment for the T790M mutation subtype, it said.

The approval in newly diagnosed patients marks a U-turn from a previous outright rejection, while the second-line nod marks an improvement in coverage, getting Tagrisso off the Cancer Drugs Fund—which comes with a more onerous funding process—and into routine use.

The reason for the change of mind? AstraZeneca offered up an “updated commercial arrangement”—translation, price cut—that now makes it a cost-effective use of NHS resources, NICE said.

In trials, Tagrisso topped Roche’s Tarceva and AZ’s own Iressa at stalling cancer growth in new NSCLC patients with EGFR mutations. But NICE previously picked on the fact that AZ has no direct data pitting Tagrisso against Boehringer Ingelheim’s Gilotrif, another earlier-generation tyrosine kinase inhibitor that the NHS already covers.

But AZ has managed to convince NICE with a confidential discount off its list price of £5,770 ($7,395) per 30-tablet bottle.

RELATED: NICE shuts out AstraZeneca's Tagrisso—and dings J&J's Stelara, too

As for the upgrade of Tagrisso from the Cancer Drugs Fund to routine coverage in previously treated EGFR T790M-mutated NSCLC, NICE said it based the decision on new data from the AURA3 trial as well as those collected from real-world use of Tagrisso under the conditional pathway.

In the AURA3 trial, Tagrisso significantly stalled the time to cancer progression or death compared with standard platinum-based doublet chemotherapy. However, on the key life extension marker, Tagrisso missed the statistical significance mark by cutting the risk of death by just 13% over chemo.

NICE, though, acknowledged that the data should take into account a 71% rate of switching from chemo to Tagrisso after disease progression, which likely tilted the survival benefit in chemo’s favor. So after adopting a model provided by AZ, the organization decided Tagrisso’s life-extension benefits were worthy of routine coverage—after the discount.

Tagrisso is now AZ’s top-selling med, in Q2 crossing the quarterly blockbuster threshold for the first time. Sales hit $1.03 billion after 35% year-over-year growth at constant currencies.

RELATED: ASCO: AstraZeneca's Tagrisso, headed for big sales boost, cuts lung cancer recurrence by 83%

As the drug becomes the new EGFR-TKI of choice, AZ is aiming to push its use even earlier in the treatment. As an adjuvant therapy used after surgery, Tagrisso cut the risk of disease recurrence or death by 83% in stage II and stage IIIA EGFR-mutated NSCLC, the company unveiled at this year’s American Society of Clinical Oncology virtual meeting.

Upon seeing the data, SVB Leerink analyst Andrew Berens predicted that Tagrisso could hit $5.6 billion in peak sales in the adjuvant setting alone, and about $16 billion in total worldwide sales across its indications.

Meanwhile, NICE also this week turned down Celgene’s Revlimid as a maintenance treatment after autologous stem cell transplant for newly diagnosed multiple myeloma patients even though the dug showed in clinical trials that it could extend patients’ lives compared with simple monitoring, which is current common practice.

And Pfizer’s Eucrisa, sold under the brand Staquis in Europe, got the cold shoulder as second-line treatment for mild to moderate atopic dermatitis. NICE argued that the drug’s U.S. data don’t accurately reflect U.K. clinical practice.