German cost agency spurns Xalkori, Komboglyze

The well-armed German pricing gatekeepers have dismissed two more Big Pharma drugs. Pfizer's ($PFE) lung cancer treatment Xalkori and the Bristol-Myers Squibb ($BMY)/AstraZeneca ($AZN) diabetes drug Komboglyze both got an initial thumbs-down from the Institute for Quality and Efficiency in Health Care (IQWiG).

Under recent healthcare reforms--and budget cuts--in Germany, IQWiG assesses new treatments in comparison with existing alternatives. The agency's decisions determine whether new drugs can wear premium price tags. If the treatments aren't deemed superior to older drugs, then companies' pricing power is virtually nil. "No additional benefit" is the operative phrase when IQWiG is least impressed. And that's the designation the agency awarded Xalkori and Komboglyze.

The Pfizer lung cancer drug is designed for patients with an abnormal ALK gene. That's about 5% of people diagnosed with non-small cell lung cancer. It was greeted with great fanfare in the U.S. when FDA approved it in 2011 as a highly effective, targeted drug for patients whose disease is particularly difficult to treat. But it's highly expensive as well.

IQWiG took issue with Xalkori's side effects in comparison with other NSCLC chemotherapies. And it slapped a "no additional benefit" on the drug in comparison with best supportive care because Pfizer hadn't provided any data.

Pfizer, in turn, took issue with the assessments in a statement titled "IQWiG method distorts the benefits of personalized cancer medicine." The company says it believes Xalkori offers a "significant benefit" for appropriate patients. And it plans to argue its case before the agency deadline in early March.

Meanwhile, IQWiG determined that Komboglyze, which pairs Onglyza with metformin, doesn't benefit patients any more than generic sulfa drugs paired with metformin. The agency took issue with Komboglyze data that compared it with a sulfa drug no longer sold in Germany. IQWiG also slapped a "no additional benefit" designation on Komboglyze in comparison with metformin plus human insulin. In that case, it said the data didn't conform to current treatment guidelines.

AstraZeneca, which submitted the data, defended the drug, saying it was convinced of Komboglyze's additional benefit. It also pointed out that the drug had a "significantly lower risk" of hypoglycemia compared with the older combination, and that, unlike the older meds, it didn't cause weight gain. AZ and BMS are working with IQWiG in advance of the next communiqué, expected in May.

- see the release from Pfizer (translated from German)
- check out the AstraZeneca statement (German)
- read the BioCentury story