Tagrisso Approved, but Can Patients With EGFR-Mutant NSCLC Afford It?

November 17, 2015

The drug is estimated to cost close to $13,000 per month.

Last week, AstraZeneca’s epidermal growth factor receptor (EGFR) inhibitor, osimertinib (Tagrisso), was approved in patients harboring T790M-mutated non-small cell lung cancer (NSCLC) who have regressed following treatment with other EGFR inhibitors. The approval comes within 3 years of the company having launched drug trials for osimertinib, which showed an objective response rate of 59% and a sustained response of over a year.

Having specifically developed the drug for a subset of NSCLC patients, AstraZeneca collaborated with Roche Diagnostics to develop a companion diagnostic, the cobas EGFR Mutation Test v2, which detects EGFR mutations in NSCLC tissue samples.

While oncologists such as Pasi A. Jänne, MD, PhD, director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, have hailed osimertinib to have the potential to be the standard of care in EGFRm T790M NSCLC, the question now is how much will it cost the patient and the healthcare system overall? And will this cost add value?

According to a company spokeswoman, a month’s supply of this oral medication is estimated to cost nearly $13,000—quite comparable with Pfizer’s Xalkori (prices at $11,500 a month) and Zykadia by Novartis ($13,200), both approved for treating Alk-mutated lung cancer. And we have not yet started talking about the cost of the companion diagnostic test that will determine patient eligibility for osimertinib.

While previous estimates from AstraZeneca projected a $3 billion annual market for the drug, the news of Clovis Oncology’s competitor product hitting a snag in their FDA review could further open up the market for AstraZeneca. CO-1686 or rociletinib, which has shown promising results in EGFR-mutated (T790M) NSCLC patients, now needs additional data for FDA review.

Meanwhile, Diplomat Pharmacy, the largest independent specialty pharmacy in the country, has announced plans to offer osimertinib to a few select patients. “Diplomat is proud to support patient adherence and compliance with therapy through enhanced clinical outreach programs, with customized messaging, developed in collaboration with AstraZeneca, to patients through various stages of treatment,” said Gary Kadlec, president of the company.