Cost watchdogs demand efficacy data on new Bayer cancer drugs

German pharma giant Bayer got back-to-back bad news on two of its newest drugs, from two different countries, no less. Last week, the Federal Joint Committee in Germany, which decides which products public insurers should cover, gave the thumbs-down to the company's colorectal cancer treatment Stivarga. And today, the U.K.'s National Institute for Health and Care Excellence (NICE) recommended against using Bayer's new prostate cancer treatment Xofigo.

Bayer has a chance to appeal both decisions. The German committee gave the company 18 months to provide data on the quality of life of patients taking Stivarga (regorafenib), according to Bloomberg Businessweek. Until it sees that information, the committee has advised that Stivarga only offers a slight benefit over currently used treatments, but at far greater cost: €137,200 ($189,000) for the new drug plus standard treatments vs. €66,600 ($91,000) for standard care alone.

A Bayer spokeswoman told Businessweek the company has two additional studies of Stivarga underway, one of which will report data soon.

In the U.K., NICE says Bayer hasn't provided adequate evidence that Xofigo offers enough benefits over other prostate cancer treatments to justify its cost, according to Reuters. One course of Xofigo costs about £24,240 ($40,000). The agency is now taking comments on its draft guidance in advance of issuing a final recommendation.

A Bayer spokeswoman told The Wall Street Journal the company is "disappointed" with NICE's decision. "We believe the medicine is an important new treatment option, and will continue to work with NICE," she said.

These decisions are setbacks for Bayer, which has pinned much of its future growth potential on the two new cancer drugs. The company has such high hopes for Xofigo--a radiation-based treatment for prostate cancer that has spread to bone--and any follow-up treatments that it boosted its buyout offer on development partner Algeta by $500 million, to $2.9 billion in December. That deal was finalized in February.

Bayer CEO Marijn Dekkers

Bayer CEO Marijn Dekkers has pegged Xofigo and Stivarga as two of the 5 drugs that he expects to drive 8% annual growth in the company's pharma unit through 2016. Dekkers predicts combined sales of the 5 drugs--which include macular degeneration treatment Eylea, blood thinner Xarelto and pulmonary arterial hypertension drug Adempas--will peak at more than $10 billion a year. The company is so determined to maximize that growth potential, he said during Bayer's most recent earnings announcement, that it will devote an extra $600 million to marketing and R&D for the Big 5 this year.

- here's the Bloomberg Businessweek story
- check out the Reuters report
- read more at the WSJ (sub. req.)

Special Reports: Top 15 drug launch superstars - Xarelto | Top 10 pharma companies by 2013 revenue - Bayer HealthCare