Imbruvica, a drug by Pharmacyclics Inc. (NYSE:PCYC) and Johnson & Johnson‘s (NYSE:JNJ) Janssen Biotech, Inc., has been approved by the Food and Drug Administration to treat patients with mantle cell lymphoma (MCL). The new drug comes at a high price for patients.
In Johnson & Johnson’s press release, Michael Wang, M.D., of the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center explained what the drug treats. “Mantle cell lymphoma is a rare, aggressive type of B-cell lymphoma,” Wang said. Imbruvica provides “a once-daily oral therapy that has been shown to affect the disease.”
MCL, Johnson & Johnson says, is an “orphan disease,” a disease with high unmet need, and fewer than 200,000 people affected. The company estimates that 2,900 new cases are diagnosed yearly, and the median age of patients is 65. Pharmacyclics said the cost of Imbruvica will be more than $130,000 annually for patients. The Wall Street Journal reports that this gave some doctors a bit of sticker shock. ”It’s a high price tag, especially for a therapy that’s not curative,” said Dr. Matthew Davids, a lymphoma specialist.
Davids works at the Dana-Farber Cancer Institute, and served as a clinical investigator in studies of Imbruvica and competing drugs. He hopes that the price will drop as other drugs enter the market. A spokesperson for Johnson & Johnson responded to the price in an email to the paper. ”The cost is in line with other new cancer therapies approved since 2012, which range from $8,700 to $15,000 per month.”
Pharmacyclics is providing assistance to people currently experiencing insurance coverage decision delays. If they have been prescribed Imbruvica they can obtain a free thirty-day supply. It also has a “You&i Access” option, for patients who meet certain criteria to lower the cost. Imbruvica was approved through the FDA’s accelerated approval program, which allows patients faster access to new treatments. It is also the second drug to receive the designation of being a breakthrough therapy. This means it has a substantial benefit, and is a better treatment option than what is currently available, according to the FDA’s announcement for the drug.
“Imbruvica’s approval demonstrates the FDA’s commitment to making treatments available to patients with rare diseases,” Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said in the statement. Johnson & Johnson has also applied for Imbruvica to be permitted by the FDA to treat chronic lymphocytic leukemia.