By Anthony Davies
Considering the pace of the arms race for haemophilia therapies, the recently-announced collaboration between Novo and Bluebird feels quite late. Given what we know about their current progress, they’re unlikely to reach a long-term therapy first or second, eliminating the possibility of being the fast follower for the next gold standard of haemophilia treatment. And we all know that the fast follower gets the worm, right?
But…what if there are other variables in place that haven’t been considered in the widely-agreed-upon fast follower phenomenon?
What if, in cases such as these, the fast follower is a fallacy?
The variable I’m thinking of in the world of gene therapies is the associated cost (recent case in point: ZolgensmaTM, at a cool $2.125M per person). 2019 marks the year when paying for life-changing therapies in installments, such as $425,000/year for five years for Zolgensma, became a real possibility. And, in a case of either serendipitous symmetry or savvy bedfellows (or both!), recall that Bluebird was among the first to conceptualize this option for ZyntegloTM, back in January.
The payment plan methodology makes a great deal of sense, if only because a drug pricey enough to single-handedly upend an insurer would completely break the system. Of course, the payment plan also increases consumer confidence with the assumed guarantee that payment stops if the drug doesn’t live up to its promise or a patient experiences a bad outcome. There are plenty of risks to the drugmakers and plenty of logistical and regulatory kinks to be ironed out, but for the purposes of my argument let’s assume that they are, if only by necessity. (hat tip: Michael Sherman, MD, of Harvard Pilgrim)
At that point, being first to market becomes even riskier than usual: recouping costs takes at least five times longer than the norm…and even that assumes a best-case scenario in which all payments are completed in full. (We know that they won’t be, due to either a defaulting on behalf of the consumer or insurer, an efficacy verification no-show, a failure to perform consistently across the population on behalf of the therapy…or some combination of the above. The burden—as it stands now—lies almost exclusively with the drug company.)
Oh, right, and even if a case can be made for patent timelines being adjusted accordingly—an extraordinarily BIG “if”—innovative biotechs will still find themselves fronting the costs for much longer than ever before.
Here’s where it gets interesting: the fast follower in such a scenario will suffer nearly as much as the first-to-market because the timeline for higher margins of success is drawn out in a way we haven’t seen before.
What if, for exorbitantly-priced life-changing gene therapies, a later follower such as Novo/Bluebird will actually be the one to win the race? (Do we refer to slower followers as “the tortoise” in this case?) They’ll arrive to market after the installment pricing difficulties have been addressed, with a product that’s had more time to develop as well as to adapt to the market reception of the earlier therapies. Oh, and that product will (by definition) have been developed with—and perhaps more significantly—manufactured by the most recent technologies. [I’ve got more to say on the subject of tools and technology: watch this space.]
My argument is the textbook definition of the term “time will tell.” So, let us wait, and see.