AstraZeneca's Tagrisso wins CDF coverage, marking a 'breakthrough moment' in England

After a delay in England for its new lung cancer med Tagrisso, AstraZeneca ($AZN) on Tuesday won some reprieve from the country’s cost watchdogs. The AZ drug, dubbed a "breakthrough" therapy by the FDA, will be the first available through the revamped Cancer Drugs Fund.

About 300 non-small cell lung cancer patients in England and Wales will have access to Tagrisso, which targets tumors with an EGFR mutation, NICE said Tuesday. It’s the first time the regulator will place a med on the reworked Cancer Drugs Fund after years of cost overruns prompted an overhaul earlier this year.

Tuesday’s decision marks a “breakthrough moment," Roy Castle Lung Cancer Foundation CEO Paula Chadwick said in a statement. It’s “a recognition that these new medicines can truly benefit people with an advanced form of the disease,” she added.

NHS England will pay for Tagrisso while it’s on CDF as investigators seek to learn more about its effectiveness in the real world. Carole Longson, who heads up NICE's health technology evaluation center director, said the Targrisso nod shows the new “system working as it should,” adding the agency plans to further evaluate the “promising new cancer treatment.”

AstraZeneca in a statement said it’s “delighted” Tagrisso will be available through the CDF, adding that the coverage will last until the end of 2018. Then, the company “will make a re-submission to NICE with mature overall survival data with the aim of securing reimbursement for baseline commissioning.”

But the road to Tuesday’s decision hasn’t exactly been smooth. Back in May, NICE decided Tagrisso couldn’t be deemed cost-effective because its long-term efficacy wasn’t known. That drew a harsh response from AstraZeneca, which called for NICE reform, adding its voice to a chorus of pharma peers who’ve lashed out at the agency's decisionmaking process.

Since then, though, the London-based pharma presented new data and analyses. They weren’t enough to win a wider NICE approval, but they win the drug a place on the CDF.

Already available through health programs in France, Germany, Sweden and several other European countries, Tagrisso in a Phase III trial bested chemo in advanced EGFR-positive cancer. The pharma is counting on the med to reach peak sales of $3 billion, a key cog in its overall push to reach $45 billion in sales by 2023.

Eisai and Roche ($RHHBY) have each criticized NICE for decisions in recent months. Eisai was unhappy with a delay over its thyroid cancer med Lenvima, while NICE's decision on Roche's breast cancer drug Perjeta didn't sit well with that pharma company.

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