Bayer AG will have to share more data about the quality of life for patients who take its costly new cancer medicine Stivarga after a request from a German panel that makes coverage decisions for public insurers.
The Federal Joint Committee voted to give the company 18 months to provide the new data, which could come in the form of a clinical trial. Pending those results, the panel made a temporary ruling today that Stivarga offers patients a slight added benefit compared to existing therapy that costs less than a quarter as much.
The committee’s rulings are important because they’re the basis for negotiations with drugmakers in Germany, Europe’s biggest market, on prices that are used as a reference throughout the region. Committee members signaled today they want to see more data about the quality of the additional weeks or months a cancer drug might give a patient.
“We work on the principle of hope,” Chairman Josef Hecken said at the committee’s meeting today in Berlin, adding that the committee could change its ruling if it’s not satisfied with the new data.
Patients with metastatic colorectal cancer who had already tried other therapies and then got Stivarga lived an average of 1.4 months longer than those who had placebo in a study that was the basis of the drug’s approval in Europe last year and in the U.S. in September 2012.
A year of Stivarga plus standard care can cost as much as 137,200 euros ($188,903), compared to a maximum of 66,600 euros for standard care alone, according to an assessment by the committee’s advisory board IQWiG, a panel that conducts cost-benefit studies of new drugs.
Bayer, based in Leverkusen, Germany, pays Amgen Inc. a royalty on sales of Stivarga in oncology.
The German company is already conducting additional studies of the drug, also known as regorafenib. A study called Concur is expected to provide data soon, according to Jutta Schulze, a spokeswoman. The company started a study called Recora in December to gather data on clinical day-to-day usage of the drug, she also said.
Side effects of Stivarga include severe and fatal liver toxicity, hand-foot skin reactions and rashes, high blood pressure and gastrointestinal perforation or fistula.
Stivarga is among the five new drugs Bayer has said will contribute combined peak sales of at least 7.5 billion euros. Analysts predict Bayer will have sales of 962 million euros from the drug in 2018, according to the average of seven estimates collected by Bloomberg.