the Question

Should we, as society, offer pharmaceuticals and therapy sponsors (including academic developers) unique incentives to develop and clinically test combination therapies, prior to trying to get each component approved separately and then testing combinations?

ISSUE

With many pharmaceutical executives and managers believing the development of combination therapies—most particularly, drug cocktails—is “financial suicide,” the question is whether it is necessary or beneficial for society to offer unique incentives for the first-line development of combination products.  In theory, it is more risky for pharmaceuticals because of potential adverse drug interactions; it takes much more time to find the proper dosage, thus is more costly, and, the sponsor is reaching a smaller target market with the theoretic approval of a multi-dimensional targeted therapy (lower demand).  If true, this means more risk, lower demand, and more cost.  This reasoning appears to lead most biotechnology and pharmaceutical managers to develop therapies individually (rather than in concert); and, upon approval, subsequently test combination approaches.

I would argue that the aforementioned factors listed are partially if not fully balanced by the fact that a targeted combination is likely to have (1) higher efficacy and (2) lower side effects.  If you stratify your trial right, this likely means a near guarantee of approval if you have a high affinity molecule (it sticks to its target well) – all other factors the same.  With lower side-effects than if each drug were given individually, at a high dose, and a higher probability of a statistically significant mark in efficacy, I believe this short investment in time to discover the proper dosage and isolate the effects of each component within a combination therapy is well worth the investment (despite significantly lower revenues, you have a higher chance at approval b/c of a higher chance of statistically significant results).

However, with the boards and executive management in disagreement with my thoughts, combination therapies—likely the best hope for curing today’s worst diseases and infections—are stuck in a ditch.  The question then arises, “is it necessary or beneficial for society to offer unique incentives for pharmaceuticals and sponsors who develop and study combination therapies in a clinical setting, first, before trying to get each component separately approved and then testing combinations?”

PROPOSED SOLUTION

1. Offer unique incentives for the investigation of combinational therapies whose components are not previously approved.  (The notion behind this is to mitigate the perceived downsides previously mentioned.)

(1)  For each cocktail /combination therapy, market exclusivity for the therapy sponsor’s (i.e., pharmaceutical) component is extended 2 years.  However, the price of the cocktail / combination therapy must be 15% less than the sum of two products if manufactured individually.

Authored by: Ryan Witt

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