AZ’s Brillinta Is First Drug To Clear AMNOG Assessment, While Merck’s Victrelis Limps Forward

Lack of consistent approach in IQWiG/G-BA AMNOG-based decisions leaves industry confused about new reimbursement route.

 AstraZeneca PLC received an early holiday present in Germany, with its clot buster Brilique (ticagrelor) becoming the first drug to successfully clear the hurdle of the Joint Federal Committee’s (G-BA’s) added benefit assessment.

However, coming on the heels of the Institute for Quality and Efficiency in Health Care’s (IQWiG) Dec. 1 decision to recommend Merck & Co. Inc.’s Victrelis (boceprevir) only for a restricted subset of patients, it leaves drug manufacturers in Germany perplexed about precisely what data is required to present a new product successfully for reimbursement.

In its Dec. 15 decision, G-BA said that Brilique, approved in the U.S. as Brilinta in July , offered significant added benefit over existing therapies for patients with non ST-elevation myocardial infarction/unstable angina (NSTEMI/UA). G-BA confirmed additional but unquantifiable benefit for STEMI/percutaneous coronary intervention (PCI) patients over 75 years or those patients with prior stroke or transient ischemic attack (TIA), going beyond even the IQWiG’s recommendation.

While it was a brave decision by AZ to select such a big hitter as clopidogrel as the comparator for almost all indications, it clearly paid off, leaving G-BA with no doubt as to how good Brillique actually is.

 

To read the rest of this article click here

[Editor's note: More news on the pharmaceutical and biotech industries is available each day in ² 'The Pink Sheet' DAILY . Visit our Web site to ³ sign up for a free trial.]