Wednesday, May 11, 2011

AstraZeneca Polishes Up Brilinta As It Woos EU Payers

Still reeling from the FDA's knock-back to its blockbuster cardiovascular hopeful Brilinta, AstraZeneca is doing its utmost to push uptake in Europe. So on Monday the company issued a press release highlighting a health economics sub-study of PLATO – the 18,000-patient Phase III trial that underpinned EU approval in December– showing that even though Brilique (as ticagrelor is known in Europe) costs up to 20 times more than generic Plavix, it is actually, dear payers, more cost-effective…as a result of lower hospitalization costs.

The sub-study took patient data from PLATO and used it to work out event rates and thus ultimately a cost-per-quality adjusted life year (QALY) for the drug for one year, using Swedish health care costs. Since PLATO had shown a reduced rate of MI, stroke or death from vascular causes, without a significant increase in the rate of overall bleeding, relative to Plavix, the theoretical health care bill was lower. The study then used "necessary assumptions and external data sources" to extrapolate longer-term QALY data, according to a description in the International Society for Pharmacoeconomics and Outcomes Research's Value in Health journal.

The result: Brilinta's cost-per-QALY was in the €2,350-€5,700 range, making it look rather cheap against the backdrop of an informal €25,000-€38,000 cost-per-QALY threshold applied by watchdogs like NICE in England.

One of the professors behind the study described this result as "particularly impressive". Whether or not Europe's most important payers agree is still unclear. AZ concurrently announced that Scotland and Denmark had agreed to reimburse Brilique, but these tiny nations alone won't move the needle for the Big Pharma.

Decisions from Europe's biggest markets will. But France's health technology assessor has already requested further data, notably from AZ's response to FDA's complete response letter, delaying its decision (AZ withdrew its submission as a result, but plans to re-submit within months). Cost-effectiveness assessments in the UK and Germany are due to report later this year.

It's unlikely that this particular sub-study will sway NICE's decision. That agency often questions manufacturers' assumptions and models in their cost-effectiveness analyses; like many US payers, it's (probably rightly) skeptical of pharma-sponsored studies. Even the Scottish Medicines Consortium's approval document from April notes that "the manufacturer may have underestimated the potential uptake of this product" in its calculations of the impact of Brilique on the Scots' drug budget.

Meanwhile Germany has one of the highest generic usage rates in Europe and is notoriously harsh in its judgment of what constitutes innovation (and thus warrants a premium price). But it will at least appreciate that AstraZeneca bravely pitted Brilique head-to-head against the relevant competitor in its Phase III trials, rather than trying to get away with a placebo-controlled trial. Indeed, Germany now requires head-to-head trials with existing therapies before it will grant reimbursement at a premium relative to existing treatments.

As such, Gunnar Olssen, head of AZ's CV/GI iMed, reckons the company couldn't have done a lot more to prove Brilique's superiority, and thus its value to patients. "I don't believe in this case we should have done anything differently," he said. "The drug led to a statistically significant reduction in cardiovascular mortality."

At what price, that reduction, though? That's what the payers are asking.

image by engnr_chik from flickr, used under creative commons

1 comment:

Unknown said...

Interesting, but there was nothing "brave" about performing trials with active controls. It would have been completely impossible-- from any regulatory, ethical, or commercial perspective-- to perform a placebo controlled trial in ACS.