It could have been a lot worse. Earlier this month, after five negotiation rounds, AstraZeneca and Germany’s statutory health insurance fund association, the GKV, agreed a price for clot-buster Brilique (Brilinta in the US). The price came in at about 17% below AZ’s original ‘free’ price — including the country’s mandatory 16% rebate.
As the first drug to go through — and emerge from — Germany’s no-nonsense new reimbursement system (AMNOG), Brilique’s price sends some important signals to the rest of the industry.
The first (and most important) is that the actual prices of new drugs in Germany — negotiated on the basis of an added-benefit score given to products based on their effectiveness relative to a chosen treatment standard — will indeed be published, at least for the foreseeable future. That was a subject for debate (and still is, in political circles), but the law as it stands promotes price transparency. It’s industry’s loss, given Germany’s position as a reference state for over two dozen other countries.
Secondly: Brilique’s price — E905.20 annually ($1,127), compared to a E1092 list price – suggests that German authorities aren’t out there to deliver an immediately fatal blow to pharma. Considering the mandatory 16% rebate, the cut was only about 4% (from E2.08 per day, to E2 per day). So German cost-watchdogs just want to do enough to compel manufacturers to provide the appropriate comparative effectiveness data: after all, Brilique’s added-benefit score was 2 (out of a possible 5, with 1 the highest), thanks to compelling head-to-head efficacy data vs. Plavix (clopidogrel).
So if 2 out of 5 means a 4% discount, drugs with poorer scores — including Victrelis, Fampyra or Benlysta — can expect far worse.
Against that backdrop, E2.00 per day looks pretty good — in particular considering the price of now-generic Plavix: E139 per year. (Small wonder the negotiations were “challenging,” according to AZ.). Now sure, Lilly’s Effient (prasugrel) comes in at E942 annually (pre-AMNOG price: it was launched before Jan. 1, 2011). But Brilique didn’t shine in all patient groups: in STEMI/PCI patients over 75, its additional benefit over prasugrel was not quantifiable (score: 4). In other STEMI/PCI patients there was no benefit at all (score: 5). (See the original German document here.)
In scoring Brilique, Germany’s reimbursement authority had to strike a balance between showing that they value innovation (per the premium over Plavix), but that they only do so when that innovation is clearly proven relative to the most appropriate comparator. The pricing result for Brilique: significantly higher than Plavix, but at a modest discount to expensive Effient.
In sum, Germany’s system is working, for Germany’s payers (both state and private payers will enjoy discounted Brilique). The message from the price is the same as the one from the added-benefit scores: show your relative worth, or else. It’s a message coming not only from payers in Germany; they’re just the ones being the most direct right now.