German authorities have given AstraZeneca ($AZN) a boost by issuing their final positive recommendation for the company's heart drug Brilique, which is known as Brilinta in the U.S. It's the first med to be evaluated under the new German drug pricing system, as Reuters notes.
The Federal Joint Committee (G-BA) determined the med offered an "important additional benefit" for non ST-elevation myocardial infarction and unstable angina. The word "additional" is key, as the new pricing system will automatically knock drugs without it into a lower pricing tier.
The committee works by issuing directives for the benefit catalogue of the statutory health insurance funds, specifying the services that are reimbursed by the funds.
The assessment came slightly earlier than expected and is good news to the company, which is looking to Brilique/Brilinta to help replace revenues lost to generic erosion. The drug, a rival of Sanofi ($SNY) and Bristol-Myers Squibb's ($BMY) Plavix, was licensed in Europe last December, but AstraZeneca must wait for decisions in individual nations, as Reuters notes.
Whether this bodes well for other drugs awaiting assessment remains to be seen. Many drugmakers have criticized the nation for its new pharma rules, including Eli Lilly ($LLY) CEO John Lechleiter (photo). "In no other place in the world has the environment for innovative pharmaceuticals changed more in the last 12 months than it has in Germany," he said over the summer, adding that the new rules will jeopardize innovation.
- get AstraZeneca's release
- see the statement from the G-BA (in German)
- check out the Reuters report