Some thoughts on personalized medicine

Personalized medicine could be seen from an economic point of view as delivering “mass customization” to people in a healthcare context at an affordable cost. Personalized medicine has attracted a lot of hype and is often perceived as a far-future initiative that is not yet ready for useful value delivery to real-world patients.

Personalized medicine uses an evidence based approach, maximizing efficacy and the best therapeutic outcome, while minimizing adverse events. So far, so good, who could say no to that?, but this utopic vision will need to overcome several barriers to become a reality. There are at least 4 problems to address:

#1 Personalized medicine is more expensive. Who will pay for the incremental cost? Why should payers pay for this without compelling and clear evidence of superior therapeutic outcomes in patients that can be delivered cost effectively? Our current healthcare systems pay for volume rather than for value, we cannot measure quality of delivered healthcare, and this is going to slow down personalized medicine adoption if we don’t solve the problem.

#2 The blockbuster model does not work here. The economics of delivering a large number of molecules targeted at smaller patient populations will demand a radical transformation from the current model predicated on the discovery, development and commercialization of a very small number of molecules targeted at large patient segments. How can we define viable business models of “targeted therapeutics” to very small populations of patients while assuring profitability? This will be clearly the age of biotech (small size, high speed, more adaptability), and pharma companies will suffer.

#3 Drug approval is so XXth century… It is so slow (7-10 years to market), it is so expensive, and more importantly it is so flawed when analysing drugs for very, very small populations of patients… Fundamental rethinking of the regulatory regime to assure safety and efficacy will be needed to be agile. Additional periods of exclusivity may be imperative for targeted therapeutics to be rendered viable.

#4 Protection of the patient’s privacy and non-discrimination laws need to be in place for personalized medicine to become a reality. Whether we like it or not, this is something that worries patients, and we need to be prepared to offer solutions to it.