Last Updated Oct 15, 2008 6:00 AM EDT
Tyverb is a GlaxoSmithKline drug that targets advanced breast cancer. It is marketed in the U.S. as Tykerb. GSK has until Nov. 19 to change NICE's mind.
Trying to figure out from the news reports exactly why NICE rejected the drug is difficult -- most stories have the closely written ring of a reporter who doesn't quite understand the details of the story, and is thus sticking tightly to the press releases.
But you don't have to be a cancer expert to understand that the rhetoric surrounding the decision reveals how cancer treatment has departed the realm of pure science -- 'Does it work?' -- and entered the field of politics and pricing wars.
Given our involvement, it is difficult to comment without the appearance of self interest, however we strongly believe that the wrong decision has been made for patients, doctors and the NHS ... The way in which the decision has been made makes it very difficult to ever demonstrate the cost effectiveness of lapatinib [Tyverb's generic name] in this patient population ... The NICE draft recommendation would result in patients in the UK being disadvantaged compared to several other European countries that have already acknowledged the value of lapatinib and are reimbursing the medicine, including Austria, Denmark, Germany, Greece, Ireland, Luxembourg and Switzerland.Translation: The decision-making process was biased against us and you Brits are going to be worse off than -- horrors! -- the Greeks. You can almost see GSK wiping the tears away on its sleeve. Oh, the humanity.
To be fair to GSK, it has offered to provide the drug free for NHS patients for the first 12 weeks and then only bill the NHS for patients who see a clinical benefit after that. Sounds pretty good, right?
The problem is that GSK's priority (whether this drug shows any benefit) is not the same as the NHS's priority (whether this drug is worth the money). What the NHS is doing is grappling with the financial-cum-moral issue of whether it is really worth it to pay tens of thousands of dollars for a few extra weeks of life. (It's a debate we don't have in the U.S. because the "moral" answer is provided for you already by the size of your wallet and the scope of your insurance.)
One clue to this truth is in GSK's own statement:
Lapatinib, in combination with capecitabine (XelodaÂ®), significantly increased the time it took for ErbB2-positive breast cancer to worsen ('time to progression - TTP') compared with using capecitabine alone.GSK isn't actually claiming that women who take the drug lead prolongued lives. Rather, that it merely lengthens the period before it all gets worse. That is a modest claim for a drug that costs $36,000. It's also not cost-effective for a system that is focused on saving lives and preventing disease, rather than extending the lives of fatal cases. Lastly, as the FT points out, there seems to be some difficulty in actually measuring how Tyverb works:
There is no clear "biomarker" or blood test that quickly and easily demonstrates improvement.You can see why GSK is miffed. They've come up with a drug that shows improvements for some patients, only to find that in foreign territories non-science pricing decisions have precedence. The company has options, such as offering Tyverb at a much lower price until its cost-benefit is established. But as the last line of the FT story points out, GSK has incentives not to do that:
Companies are reluctant to cut prices in the UK for fear it would spark copycat pressures in other markets and limit their commercial flexibility.It appears that science could be taking a back seat to its dismal cousin, economics, but not for the reasons GSK might have us believe.