Seattle Genetics is now in position to start selling its first new drug, and it won’t be cheap.
The Bothell, WA-based biotech company (NASDAQ: [[ticker:SGEN]]), fresh off its FDA approval of brentuximab vedotin (Adcetris) on Friday, said it will charge $13,500 per dose for the new drug for Hodgkin’s lymphoma and a related disease, anaplastic large cell lymphoma. The product is given as an intravenous infusion every three weeks.
Seattle Genetics says it doesn’t know how many doses patients will get in real world use, but if you assume an average of eight doses, it will cost $108,000 per patient. The average patient in clinical trials got 7 to 9 doses, CEO Clay Siegall said today on a conference call with analysts. If that’s how much patients will actually use, then Seattle Genetics’ price is in line with Wall Street expectations, which were about $110,000 per patient, according to a survey of five analysts Xconomy conducted last week. But the actual cost could be a lot higher. If a patient gets the maximum number of 16 doses described in the FDA-approved label, it will cost $216,000 per patient.
Seattle Genetics said it expects “some reimbursement issues” during the early days of the new product’s introduction, but that it based the price on extensive conversations with doctors, patients, and insurers.
“This drug has a superb value to patients,” Siegall told analysts.
In clinical trials, the Seattle Genetics product was able to significantly shrink tumors in about 75 percent of patients with Hodgkin’s disease, and in about 86 percent of patients with anaplastic large cell lymphoma (ALCL). The drug’s side effects include a depletion of infection-fighting white blood cells, nerve damage in the fingers and toes, fatigue, nausea, and other adverse events. The drug prompted about one-third of Hodgkin’s patients and one-half of ALCL patients to go into complete remission in clinical trials, but researchers still don’t know how much longer patients can expect to live on the new treatment, compared with existing chemo regimens.
Seattle Genetics, like all makers of expensive new cancer medicines, said it has set up a financial assistance program for people who are uninsured, underinsured, or who need help with making co-pays.
Cambridge, MA-based Millennium: The Takeda Oncology Company has the rights to market the product in the European Union, and it has sought approval from regulators there as well. Seattle Genetics didn’t comment on today’s call about what kind of price the product might fetch overseas.
