Monday, February 09, 2009

NICE Deal, Celgene

We imagine that Celgene is pleased with its cost-sharing scheme around multiple myeloma drug lenalidomide (Revlimid), approved, at least provisionally, by the UK cost-effectiveness watchdog NICE.

Having failed to get its GBP4,300-a-month drug past NICE the first time around, Celgene had a re-think, and came back with a plan. The UK's National Health Service, it suggested, should pay for the drug for 26 treatment cycles--that's about two years' worth--in those patients with previously-treated disease. Celgene would fund the drug (used in combination with dexamethasone) in patients benefiting from it thereafter.

Sound fair? The thing is, that the median time to progression figure for patients with this disease, as per trial data presented by Celgene to back up its submission, is 11 months. (TTP is what's typically used to determine whether patients continue to receive a therapy--in other words, whether it's working). So Celgene's onto a good deal, right, since it won't have many patients to fund?

Wrong, argues Celgene. It's just not possible to find the true median TTP or overall survival data from these trials because of limited follow-up and patient withdrawals. So Celgene used a model to extrapolate what is sees as more accurate TTP and survival data. That, is says, reveals that 15-20% of patients may continue to benefit from the drug beyond 26 treatment cycles. Even that estimate, the company argues, might be too conservative, since much existing overall survival data is based on current clinical practice, whereby Revlimid, an immunomodulatory agent, isn't part of the mix at all.

Those arguments were clearly sufficient for NICE (although it's worth mentioning that the agency has been under significant pressure to make a popular decision in recent months). And Celgene had two major tailwinds helping it: a) Recently-issued NICE guidance on end-of-life medicines, which relaxes the cost-effectiveness criteria for products that extend life for those with terminal diseases affecting fewer than 7000 new patients each year, and b) simple administration.

Celgene will administer the 'you-pay-then-we-pay' scheme itself, and easily, piggybacking on the drug's existing risk minimization plan, which is a condition of its license. (Since the drug is related to thalidomide, it must not be used in pregnant women.) That's a big deal, since the main barriers to any risk- or cost-sharing scheme in the UK, as we suggested in a previous post, appear to be practical ones.

Some critics say that NICE is bowing to popular pressure, with this and with recent revised guidance around kidney cancer treatment Sutent. That's a shame, they continue, because if Obama does copy it or any aspect of it in the US, he should copy the old NICE, not what some describe as the more submissive new one.

Now sure, with more risk-sharing proposals on the way, its value-assessment methods under scrutiny, plus the bunch of other responsibilities that come with its increased influence on drug pricing, NICE is going to have to be smart. (We'll have more about this in the next edition of The RPM Report.) But it's hard to argue with the ethics of providing end-of-life medicines, and of increasing patient access. It's also hard to argue with the economic benefits that come to Britain if access improves. Besides, at least companies and the UK Department of Health are engaging on such matters, even if the outcomes may appear, to some, to favor one side or the other.

No comments: