* Brilinta first drug assessed by new German price system
* UK's NICE due to issue guidance in October
* Reimbursement process faces delay in France
* Brilinta competes with branded and generic Plavix in EU
By Ben Hirschler
LONDON, April 6 (Reuters) - AstraZeneca's (AZN.L) big new drug hope Brilinta faces an uphill fight in Europe as its maker negotiates a series of hurdles that underscore the tough pharmaceutical landscape across the continent.
The heart drug was approved in Europe in December and has so far been launched, under the brand name Brilique, in Germany, Britain, Denmark and Norway, with more launches expected in the second half of 2011.
In all, it has been cleared for sale in more than 30 countries, although not yet in the all-important U.S. market, where a decision is expected in July.
Brilinta -- tipped as a $1 billion-plus seller -- is a rival to Sanofi-Aventis (SASY.PA) and Bristol-Myers Squibb's (BMY.N) blood thinner Plavix, the world's second biggest selling prescription drug, with annual sales of more than $9 billion.
It is a pivotal product for AstraZeneca, which needs to make up for sales of older drugs being lost to generic competition.
AstraZeneca has priced Brilinta at a premium to Plavix -- at 2.48 euros or 1.8 pounds for a day's treatment of two pills -- after a clinical trial called PLATO showed it to be superior.
"In the PLATO trial, using Brilinta resulted in the lower use of healthcare resources," a company spokeswoman said. "On the basis of the PLATO data, AstraZeneca believes Brilinta should be priced at a premium to branded Plavix."
Whether state-backed health systems will accept that pricing argument remains to be seen.
The market for blood-thinning drugs in Europe is increasingly competitive, following the launch of generic copies of Plavix in the past 18 months, which slashed branded sales of Plavix sales in Europe by 49.2 percent in 2010.
On top of that, AstraZeneca has to overcome a series of cost-effectiveness hurdles in order to get Brilinta established in Europe's biggest markets.
Brilinta has already had one setback in France, where the company announced last month it had decided to withdraw the reimbursement submission to the French Transparency Commission and would resubmit in the coming months. [ID:nLDE72M22Z]
It also faces an uncertain time in Germany, where Brilinta is the first drug from any company to be assessed under the country's new drug pricing system.
Under the so-called AMNOG scheme, introduced from Jan. 1, drugs are only allowed free pricing for one year, during which time a benefit assessment must be carried out.
If the review finds Brilinta offers additional therapeutic benefits, an appropriate price will be negotiated. If not, it will be grouped into a pricing band alongside cheap rivals.
In Britain, meanwhile, the cost-effectiveness watchdog NICE, which decides whether medicines should be paid for on the state health service, will hold its first meeting on Brilinta next month and is not due to issue guidance until October.
Until it gets the verdict back from authorities in these key European markets, AstraZeneca will not know for sure whether its premium pricing strategy will be accepted by payers.
The drugmaker is not commenting on how the launches in Europe are going, ahead of first-quarter results on April 28, but Sanford Bernstein analyst Tim Anderson said in a recent note he believed the uptake had been slow. (Editing by David Cowell)